Rottapharm IPPC Licence Application Response to EPA ...

Rottapharm

IPPC Licence Application

Response to EPA Request for Further Information

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Rottapharm - IPPC Licence Application Response to Request for Additional Information

Register P0886-01

September 2009 Page 1 of 52

ROTTAPHARM LIMITED

IPPC LICENCE APPLICATION REGISTER P0886-01

RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION FROM ENVIRONMENTAL PROTECTION AGENCY DATED 18 AUGUST 2009

Table of Contents

Introduction

Background

Responses

Item 1 General

Item 2 Emissions to Air

Item 3 Solvents

Item 4 Emissions to Sewer

Item 5 Waste

Item 6 Miscellaneous

Tables

RFI Reference

Table No Description

2b A Table E.1(iv) information for supply AHUs

2d B Table F.1(i) for emission points containing APIs

2e C Table E.1(i) completed for boilers

2g(iii) D Table F.1(i) completed for the RTO

4a E Sources of process aqueous emissions

4f F F.1(i) Monitoring and controls of process effluent and domestic sewage.

5a G Table H.1 (i) Breakdown of the waste 'Chemicals'.

5c H Table H.1 (i) Wastes for deep burial, any wastes from abatement, (spent filters, pharmaceutical dust etc.

Figures

RFI Reference

Figure No Description

1b A A1. Internal Production Layout

A2. Plant Room AHUs & DCUs

2a B B1. Air Emission Points

B2. Emission points and the sources of the emissions for each emission point.

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B4, Emission points and the sources of the emissions for each emission point.


2g (i) C C1. Piping and Instrumentation Drawing of RTO

2g(vii) D D1: Vendor P&ID of the coater

D2: Lay out drawing of coater

2g(x) E E1. Piping and Instrumentation Drawing of RTO/Heat Recovery System

3c F F1. Locations and details of the coating pans and the route to the abatement system

6d G G1. Location of the nearest noise sensitive receptor

Appendices

RFI Reference

Appendix No

Description

1a A EIS

1f B Copy of the letter to the Planning Authority referred to in your correspondence dated 22 June 2009 (Ref A L0002).

2f C Report on air dispersion modelling

6f D Audited Accounts of Rottapharm for 2006, 2007 and 2008

7 E Non-Technical Summary

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Introduction

Rottapharm Ltd has applied to the Environmental Protection Agency (EPA) for an Integrated

Pollution Prevention and Control (IPPC) Licence, Register P0086-01.

The Agency has requested additional information in its letter dated 18 August 2009.

This document presents the required information.

Background

Rottapharm established a pharmaceutical finishing facility in Damastown, Mulhuddart, Dublin

15, construction of which was completed in 1999.

Rottapharm Dublin currently produce a range of products in the form of sachets and capsules

for the treatment of osteoarthritis, the bulk active pharmaceutical ingredient (API) for these

products is Crystalline Glucosamine Sulphate. This API is manufactured at the Dublin facility.

Rottapharm also produce an anti-inflammatory tablet containing the API Bromelain, which is

bought in to the facility.

Rottapharm Ltd. is also responsible for batch release of two medical devices called “GO-

ON®” and “GO-ON® Mini”. These products are manufactured by a subcontractor (Croma

Pharma) based in Austria and comprise a Sodium Hyaluronate solution.

In 2009 Rottapharm Ireland are expanding their current production capacity to produce

two new capsules – 150 mg and 300mg Tromalyt

one new sachet product called Plantaben and

one new caplet product called CGS Caplets.

Rottapharm also intend to take on the business of filling and packing the following sachets at

the Dublin facility:

Colofibre

Legalon

Spagulax.

These sachet products will not be manufactured at the Dublin facility.

The manufacture of these new products will require an increased usage of volatile organic

compounds, i.e. organic solvents, which will exceed the threshold at which an IPPC licence is

required:

Application has therefore been made for a licence to permit the carrying on of the following

two classes of activity at the facility:

5.16 The use of a chemical or biological process for the production of basic

pharmaceutical products.

12.2.2 The manufacture or use of coating materials in processes with a capacity to make

or use at least 10 tonnes per year of organic solvents, and powder coating

manufacture with a capacity to produce at least 50 tonnes per year, not included in

paragraph 12.2.1.

The facility is an existing facility but application is being made to permit the carrying on of

additional activities.

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1. General

1a. Confirm whether an EIS was required as part of the planning application for the expansion. Submit a copy of any previous EIS for the development.

Response:

An EIS was not required as part of the planning application for the expansion. A copy of the EIS for the original development is attached as Appendix A.

1b. Submit drawings showing the internal layout, production areas (Area 1, Area 2, Bulk) and the emissions arising. Show the locations of equipment including the coating pans, blenders, dedusters, etc.

Response:

The attached Drawings Nos A1 and A2 show the requested information.

The emission points are listed in the following table.

Emission Point Description Source(s) of Emission

Location of Source

A3-4 Exhaust air handler AH-201

General Room Extract Manufacturing Area 1 and F1 and F2, Ground Floor Production Building


General Room Extract Manufacturing Area 2 and Packaging Rooms, Ground Floor Production Building


General Room Extract Bulk Manufacturing Area

A3-7 Dust Collector DCU-101

Out of service


Coating Pan CO-201 M18, Manufacturing Area 2


Out of service


Central Vacuum Filling Rooms F1, F2, F3, F4, M4, Manufacturing Area 1


Coating Pan CO-202 M17, Manufacturing Area 2

1c. Provide the current and proposed production figures (tonnes/yr).

Response:

Current production levels are 1,458 tonnes/yr (based on 2008 output levels).

Proposed production figures are projected to be 1,984 tonnes/yr in 2009 increasing to 2,591 tonnes/yr in 2010.

1d. Provide a timetable for construction works and production of new products.

Response:

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Construction work is now essentially complete. Rottapharm is in the process of dismantling coating pans and other equipment at another location outside of Ireland and moving these to Dublin. All the new equipment will have arrived on site by the middle of November 2009. It is expected that this equipment will be installed during the fourth quarter of 2009 and commissioned as soon as possible after installation. It is expected that all new equipment will be in operation by the end of March 2010.

Rottapharm has also purchased a thermal oxidiser to abate emissions of VOCs from the coating pans. This will be installed and commissioned so as to be operational when operations under Class 12.2.2 commence.

1e. Confirm the proposed staff numbers for the expansion.

Response:

There are currently 167 staff numbers working on site (179 including temporary staff). These numbers include for those working in the expanded area. There are no plans to recruit further personnel.

1f. Provide a copy of the letter to the Planning Authority referred to in your correspondence dated 22 June 2009 (Ref A L0002).

Response:

A copy of the letter to the planning authority is attached as Appendix B.

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2. Emissions to Air

2a. Provide A3 engineering drawings showing all emission points and the sources of the emissions for each emission point. Provide a description to accompany the drawings. Include all sources of exhaust air, dust, and lab emissions.

Response:

Figure B1 is a revision of Figure E1 included with the licence application to include for emission points Nos A3-11 and A3-12. Figures B2, B3, B4 and B5 show emission points and sources.

A description of the emission points and sources is as follows:

The principal emission point is the proposed Regenerative Thermal Oxidiser (RTO). Emissions from three coating pans (CO-201 (existing), CO-203 (new) and CO-204 (new) will be ducted to the RTO where Volatile Organic Compounds (solvent vapours of acetone, ethanol and isopropanol) are oxidised to achieve an emission value of less than 20 mgC/Nm³. Natural gas is to be used as an auxiliary fuel.

Two boilers provide process heat and space heat to the Production Building. These are fired on natural gas and have a thermal input of 1.5 MW each, total 3MW.

A third boiler provides space heating for the Administration Building. This is also fired on natural gas and has a thermal input of 422 kW.

All three boilers are below the capacity threshold of 5MW (gas-fired boilers) above which their emissions would be regarded as being significant (Integrated Pollution Prevention and Control (IPPC) Licensing - Application Guidance Notes).

At present two coating pans (CO-201 and CO-202) discharge to atmosphere via Dust Collection Units DCU-201 and DCU-202 respectively. (The two new coating pans CO-203 and CO-204 are expected to be in operation in March 2010.)

A further Dust Collection Unit (DCU-301) is used as a central vacuum system for the Filling Rooms and Manufacturing Area 1. This discharges to atmosphere.

Other emission points are:

General extract air handling units (AHUs) which incorporate High-Efficiency Particulate Air (HEPA) filters.

Laboratory Fumehoods

These are not process emission points.

2b. Clarify that all emission points are included in Table E. 1 (iv). Procedure ENG-UTIL-001 refers to additional air handling units. Resubmit Table E.1(iv) where necessary.

Response:

Procedure ENG-UTIL-001 refers to nine additional air handling units (AHUs). These units supply air to the buildings and do not discharge air to the atmosphere. They were not included in Table E.1(iv) because they are not emission points. These supply AHUs are AHU-101, AH-102, AH-105, AH-302, AH-103, AH-104, AHU-301, AHU-501 and AHU-801. Note that AHU-701 is not mentioned in the SOP. It is the Administration Building AHU.

Please note that Dust Collectors DCU-301 and DCU-202 were inadvertently omitted from Table E.1(iv), and a revised version of this table is attached (Table A). As Dust Collector DCU-101 is currently out of commission, and DCU-301 covers all filling areas. Dust Collector DCU-202 serves the water-based coating pan. DCU-501 is also no longer used. It used to serve the Bulk Manufacturing area.

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2c. Give a description of the powder containment for each product.

Response:

Powder containment is primarily controlled via the maintenance of room differential pressures. Section 2.3 of SOP ENG-UTIL-001 (submitted with the application) addresses the production room differential pressure balancing for the plant. Central vacuum systems are utilised to remove fugitive dusts from process equipment. Other powder containment practices include LAF booths in dispensing areas. Minor spills when encountered are cleaned up using dedicated vacuum cleaners. The plant is a GMP facility and as such a strict regime is in place to maintain and monitor cleanliness.

2d. Clarify the emission points, which may contain active pharmaceutical ingredients. For these emission points provide an estimate of the emission rates (in kg/hr).

Complete Table F.1(i) for these emission points.

Response:

The emission points that might contain active pharmaceutical ingredients (APIs) are:

Equipment Existing

(E) or New (N)

Location Discharges to Comments

Coating Pan CO-201

E Room M17, Area 2

Atmosphere via Dust Collector DCU-201

Dust Collection Unit DCU-501

E Extract from some equipment and general areas

Atmosphere

Dust Collection Unit DCU-301

E Extract from some equipment and general areas

Atmosphere

Coating Pan CO-202

E Room M18, Area 2

Atmosphere via Dust Collector DCU-202

Water based coater and as such is not currently a source of VOC emissions. If converted to solvent coating, will be routed to RTO

Laboratory Fumehood Vents

E Laboratory Atmosphere Low concentration of dust because of small quantities of powder, short duration of handling and infrequent use.

Extract AHU AH-201

E Sachet Area Bulk Synthesis Low concentration of dust because these are room extracts

Extract AHU AH-401

E Tabletting Area Bulk Synthesis Low concentration of dust because these are room extracts

Extract AHU AH-601

E Bulk Synthesis Area

Bulk Synthesis Low concentration of dust because these are room extracts

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Table F.1(i) has been completed for these emission points and is attached (Table B).

2e. Complete Table E.1(i) for each boiler. Clarify the purpose of the production boilers, and if they operate together or duty/standby etc. Provide an estimate of NOx emissions for each boiler.

Response:

See attachment „Table E.1(i)‟ (Table C).

The purpose of the production boilers is to provide medium pressure hot water for the following site applications: hot water supply for radiators, hot water taps, AHU heating batteries, process heating (vessel jackets), cleaning. They operate together in line with demand.

The maximum NOx emissions for each boiler are estimated to be as follows:

Boiler NOx Emissions (kg/hr) at full load

A3-1 – Production Building 0.35

A3-2 – Production Building 0.35

A3-3 – Administration Building 0.12

2f. Submit in electronic form (e.g. excel/access), a copy of the input and output files and meteorological data for the SCREEN3 assessment.

Clarify if the ground level concentrations are maximum concentrations.

Clarify the height of the adjacent building (in metres) and the height of the stack above roof level.

Clarify whether operation of all three boilers and TO simultaneously would have any effect on the outcome of the Screening assessment, with particular regard to emissions of NOx.

Response:

Following subsequent discussions with the Environmental Protection Agency, it was agreed that modelling of emissions from the Thermal Oxidiser and all three boilers would be carried out using the AERMOD model. See modelling report attached as Appendix C.

The input and output files for the AERMOD assessment are attached in electronic format.

The ground level concentrations are maximum 1-hour average concentrations.

The height of the building adjacent to each of the stacks of the boilers serving the Production Building is 10 m. The height of each of these stacks is 3 m above roof level.

The height of the building adjacent to the stack of the boiler serving the Administration Building is 8 m. The height of this stack is 3 m above roof level.

2g. Provide the following in relation to the Thermal Oxidiser (TO):

i. A description of the specifications, type and details of its operation. Include details as A3 engineering drawings in addition to Figure Fl.

Response:

The exhaust from the process directs through the main 1m duct to the RTO where the exhaust air fan directs the exhaust air stream into the RTO system.

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Once within the RTO unit, the exhaust stream is directed alternately by time-controlled dampers to the appropriate zones of hot ceramic heat exchanger media.

The heat exchanger bed is comprised of three regenerator columns; at any given moment, the exhaust stream moves upward through one and downward through two columns.

The exhaust passes vertically upwards through the media taking on heat thereby raising the temperature up to the combustion temperature that oxidises and cleans the air.

In the combustion area, the natural gas-fired burner provides additional energy if required to maintain the necessary temperature level of approximately 800-850°C.

After passing through the combustion chamber, the air flows down through the exchanger media returning its heat back to the system.

In this RTO system, part of the clean air flows through one of the two upward zones in order to purge the zone prior to entering the clean side.

Due to this operation mode, one of the columns is always purged; therefore no pollutant leaks into the pure gas while switching over of the RTO inlet valves is occurring.

The RTO is started and heated up at a reduced air flow rate by the natural gas burner system. For safety reasons, the RTO will be operated for start up and shut down only with fresh air.

The system is especially designed for a high thermal efficiency to redure the energy consumption of the burner to a minimum. The solvent loading in the waste air gives additional energy for the oxidation process.

Due to the high VOC concentration in the off-gas the excess heat of the exothermal oxidation in the RTO results in autothermal operation most of the time, without consumption of supplement gas – during autothermal operation, the burner system is switched off automatically.

Three LEL sensors in the exhaust ducting ensure that the maximum allowed inlet concentration will not be exceeded. Dilution air will be added automatically.

Excess heat from the high solvent input is discharged out of the combustion chamber with a temperature-controlled hot-gas bypass.

Figure C1 is a Piping and Instrumentation Diagram of the RTO.

ii A description of the TO operating conditions (temperature, residence times etc.) and monitoring for each parameter (discrete or continuous).

Response:

The RTO Operating Conditions are as follows:

Exhaust air flow volume from process (without dilution air) 300-6000 m3/h

Exhaust air flow volume (with max. required dilution air) 17,200 m3/h

Exhaust air temperature from process 15-65 °C

Exhaust air inlet pressure through ducting (designed) -5 mbar

Pollutant concentration from process, maximum 70 g/m3

Pollutant concentration to RTO, maximum1 12.5 g/m

3

RTO combustion chamber temperature, approx. 850 °C

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Autothermal concentration, approx. 2.3 g/m3

Note 1. =25% of Lower Explosive Limit of isopropyl alcohol

iii. Completed Table F.1(i).

Response:

Table F.1(i) completed for the RTO is attached (Table D).

iv. The expected oxygen content in the flue gas.

Response:

The RTO vendor advises that there is no reliable method for calculating the oxygen content in the RTO exhaust and that this will have to be measured once up and running. The oxygen concentration in the RTO inlet will be maintained high as the concentration of solvent in the stream is maintained below 25% of the LEL. It is expected that the minimum oxygen concentration will not be less than 18%.

v. The TO thermal input capacity (MW) and the hours of operation.

Response:

RTO Thermal Input Capacity = Total power rating of burner system = 0.45 MW

Average hours of operations:

50 minutes/hour

16 hours/day

300 days/years

vi. List all processes contributing gases to the TO, how gases are directed to the TO and any process controls before reaching the TO.

Response:

The following process contributes gases to the RTO:

Coating of Tromalyt Pellets using solvents acetone and isopropanol.

Coating of Fortilase pellets using solvent ethanol

Coating of Extranase pellets using solvents ethanol and acetone

Process gases from the coating of Tromalyt pellets are directed from the plant ducting into the main 1m diameter supply duct for the RTO. Each coating pan has a separate inlet into the main duct controlled by means of a double damper. Once the process gases are inside the main duct the RTO exhaust air fan directs the exhaust air stream through the RTO system.

The following process controls are in place to regulate the process gases before reaching the RTO:

LEL control (Lower Explosive Limit) with inlet air dilution in the event of higher solvent concentration, comprising of a series of LEL sensors at various locations along the main duct and a suitable dilution air assembly.

Redundant LEL safety surveillance of inlet air with suitable equipment and stack for emergency isolation of the RTO.

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vii. A drawing of the Pan coating system and a description.

Response:

The following drawings are attached:

Vendor P&ID of the coater (Figure D1)

Lay out drawing of coater (Figure D2)

The layout drawing shows the dimensions of the coater in its original configuration. While the principle of this may be correct there are minor differences to the current set-up.

Description:

Pre-formed tablets are loaded into the coating pan. Coating solution (previously made-up) is pumped from a holding vessel to the coating pan and is applied to the tablets from above by means of spray nozzles/guns. The tablets are moved and mixed by the rotating drum. The introduction of the process air evaporates the fluid and dries the film coating.

viii. An outline of response procedure in the event of a bypass of the TO, an estimate of the likely duration and frequency of bypass events and how these will be monitored.

Response:

In the event of a bypass of the RTO, an alarm will provide visual and audible indication of the bypass to production operators. An SOP will detail the appropriate response to such occurrences. A controlled shutdown of the coating process will occur, generally following this sequence: spraying will stop, followed by a period of intermediate drying and then the process will stop. Supervisors and maintenance personnel will be informed.

The frequency of bypass events will be rare and will be monitored under standard engineering maintenance procedures.

ix. An outline of measures to be taken under abnormal operating conditions, including start-up, shutdown, leaks, malfunctions, breakdowns etc.

Response:

The process will not start under abnormal operating conditions, until the RTO is ready and operational.

Any conditions that would cause the RTO to operate outside of its set parameters will cause the unit to go into bypass. Alarms will sound and operators will carry out a controlled shutdown of the coating pans to preserve the product.

Shutdown occurs after the coating process has ceased.

Operators will be specifically trained in the operation of the RTO including all „abnormal‟ operations and all such operations will be governed by SOP.

x. A description, including drawings, of any proposals for heat recovery, heat exchange and link to the boilers.

Response:

There exists the option of passing combustion gases from the RTO through a warm water heat recovery system before emission to atmosphere. This recovery system, comprising of a heat exchanger (water tube boiler) is designed to provide a maximum capacity of 800kW of recoverable energy with 90°C outlet temperature for the warm water loop. This recovery system will be linked to the boiler system. When operating conditions are at an optimum level, it is intended to be possible to switch off the boilers and allow the heat recovery system to meet the plant‟s requirements.

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Drawings of the heat recovery, heat exchange and link to the boilers are attached as Figure E1.

2h. Provide details of any stand-by generator and the fuel type.

Response:

The site does not have a stand-by generator.

2i. Is any fuel other than natural gas is proposed for the TO or boilers.

Response:

Natural gas is the only fuel used for the boilers and TO.

Note that technically the vapour stream is a fuel for the TO as under optimum operating conditions it is possible to operate the TO without the usage of natural gas.

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3. Solvents

3a. Provide an estimate of the potential fugitive emissions from the facility when the class 12.2.2 activity is in operation. Explain how the installation will comply with the requirements of the Solvents Directive accordingly.

Response:

Emissions of Volatile Organic Compounds from Organic Solvents Regulations 2002 (SI No 543 of 2002) transpose Directive 1999/13/EC (the “Solvents Directive”) into Irish legislation. The specific requirements for the manufacture of pharmaceutical products with solvent consumption exceeding 50 tonnes per year are set out below.

Class Activity (Solvent

consumption in

tonnes/year)

Threshold (solvent

consumption threshold in tonnes/year)

Emission limit

values in waste gases

(mg/C/Nm³)

Fugitive emission

values (percenta

ge of solvent input)

Total emission limit values

Special provisions

20 Manufacturing of pharmaceutical products (>50)

20(1) (New) 5 (2)

(Existing) 15 (2)

(New) 5% of solvent input

(Existing) 15% of solvent input

(1) If techniques are used which allow reuse of recovered solvent, the emission emit value shall be 150.

(2) The fugitive emission limit value does not include solvent sold as part of products or preparation in a sealed container.

As neither the existing or proposed consumption of solvents at Rottapharm exceed 50 tonnes per year, the Solvent Directive does not apply to the facility. However, even if the threshold consumption rate was such that the Directive applied to Rottapharm, the requirements of Class 20 would be met.

Waste Gases

The specification for the Regenerative Thermal Oxidiser is that the waste gases should not contain more than 20 mgC/Nm³, and this complies with the ELV in the table above. No other waste gases containing solvents are or will be emitted from the facility.

Fugitive Emissions

The limit for fugitive emissions from new facilities is 5% of solvent input.

The fugitive emissions of solvent have been calculated to be 3.6% of solvent input, using the methodology set out in the Directive. This complies with the requirements of the Directive.

Total Emissions

The total emissions of solvent have been calculated to be 3.8% of solvent input, using the methodology set out in the Directive. This complies with the requirements of the Directive.

Use of Solvents with Specified Risk Phrases

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The solvents with specified risk phrases used at Rottapharm are listed in the following table, with usage per year, where this information is available.

Risk Phrase Relevant Solvent Name(s)

Solvent Consumption (t/yr)

R45 (may cause cancer) Hydranal working medium k 0.004

1,2-dichloroethane No information

Arsenic (III) oxide Reag. Ph

Eur

No information

Diarsenic trioxide No information

R46 (may cause heritable genetic damage)

Hydranal working medium k 0.004

R49 (may cause cancer by inhalation)

None No information

R60 (may impair fertility) None No information

R61 (may cause harm to the unborn child)

Barbital sodium No information

Dimethylformamide,

Normapur

No information

N,N - Dimethylformamide

extra pure

No information

Lead (II) Perchlorate

trihydrate

0.0027

Lead Nitrate 0.1M 0.004

R40 (limited evidence of a carcinogenic effect) and halogenated

1,4-dioxan No information

Acetaldehyde No information

Aniline GR No information

Chloroform No information

Crystal violet No information

Dimethyl yellow No information

Emission Limit Values (ELVs) for Certain Discharges of Solvents with Specified

Risk Phrases

The Emission Limit Values (ELVs) for substances with risk phrases R45, R46, R49, R60, R61, or R40 and halogenated are as follows, where discharges are above the specified mass flows:

Risk Phrase Threshold mass flow of the sum of such compounds

Emission limit value (mass sum of the individual compounds)

R45 (may cause cancer)

10 g/h 2 mg/Nm³ R46 (may cause heritable genetic damage)

R49 (may cause cancer by

inhalation)

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R60 (may impair fertility)

R61 (may cause harm to the unborn child)

R40 (limited evidence of a carcinogenic effect) and halogenated

100 g/h 20 mg/Nm³

The materials with the specified risk phrases are all laboratory chemicals, used in very small quantities. Data on usage is not available for most, but available usage figures indicate that it is not credible that the threshold mass flows are even approached.

3b. Provide a breakdown of the current and proposed solvent use (tonnes/year) for each product or process including coating, laboratory, cleaning or other purposes. Clarify if chlorinated organic solvents are in use or proposed, give the type, quantity and purpose.

Response:

The only production process in which solvents are used is Coating.

Current (2008) and proposed solvent use in production is summarised in the following table:

2008

Product Ethanol Acetone IPA Total

Tromalyt - 1.423 1.858 3.554

Fortilase 0.241 - - 0.241

Extranase 1.419 0.924 - 2.343

Total 1.660 2.347 2.131 6.138

Proposed

Product Ethanol Acetone IPA Total

Tromalyt 0 11.4 14.8 26.2

Extranase 1.2 0.7 0 1.9

Fortilase 0.2 0 0 0.2

Total 1.4 12.1 14.8 28.3

Laboratory use of solvent will not increase due to increased production levels. Current usage is less than 1 tonne per year.

Usage of solvent for cleaning purposes is less than 250 litres per annum.

Chlorinated organic solvents are not in use on site, nor are they proposed for use on site.

3c. Identify all sources of VOC emissions. Provide the locations and details of the coating pans (described as 1, 2 & 3) and the route to the abatement system.

Response:

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Register P0886-01


Equipment Existing

(E) or New (N)

Location Discharges to Comments

Coating Pan CO-201

E Room M18 Manufacturing Area 2

Via DCU-201, will discharge to RTO

Coating Pan CO-202

E Via DCU-202. and thence to atmosphere

Water based coater and as such is not currently a source of VOC emissions. If converted to solvent coating, will be routed to RTO

Coating Pan CO-203

N Room M23 Manufacturing Area 2

Will discharge to RTO

Coating Pan CO-204

N Room M23 Manufacturing Area 2

Will discharge to RTO

Laboratory Fumehood Vents

E Laboratory Atmosphere Very minor

The route to the abatement system is as shown in Figure No F1 attached (as requested in Item 2a).

3d. Identify any VOC emissions not directed to the TO. Provide details of any other VOC abatement, recovery or treatment on site, as necessary.

Response:

VOC emissions from laboratory fumehoods are not directed to the TO.

Once commissioned all VOC emissions from coating pans CO-201, 203 and 204 will be directed to the TO.

Currently VOC emissions from CO-201 are discharged directly to atmosphere.

No other VOC abatement system is in use on site.

3e. Provide details on the timeframe for commencement of operations under Class 12.2.2, including a timeframe for commissioning of abatement.

Response:

Construction work is now essentially complete. Rottapharm is in the process of dismantling coating pans and other equipment at another location outside of Ireland and moving these to Dublin. All the new equipment will have arrived on site by the middle of November 2009. It is expected that this equipment will be installed during the fourth quarter of 2009 and commissioned as soon as possible after installation. It is expected that all new equipment will be in operation by the end of March 2010.

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Register P0886-01


Rottapharm has also purchased a thermal oxidiser to abate emissions of VOCs from the coating pans. This will be installed and commissioned so as to be operational when operations under Class 12.2.2 commence.

3f. Clarify details of solvent storage; location, volume at any one time, and type of containment, size etc. for the current and proposed situation. Clarify if bulk storage or a tank farm is proposed and give details.

Response:

Current Operation:

Solvents are stored in two dedicated lockable bunded flammable stores adjacent to the warehouse. Acetone and IPA account for the greatest volume of solvent used on site. IPA is delivered to the site in 25 litre drums, on pallets of 32 drums. Acetone is delivered to site in 210 litre drums on pallets of 4 drums. The maximum storage within each of the solvent stores is 1500 litres. All solvents (lab and production use) for use on site are stored in these solvent stores.

Proposed Operation:

It is proposed to deliver acetone and IPA to site in 1000 litre IBCs, stored within a dedicated lockable bunded flammable store located in a bunded area. Connection to a distribution network is available in this store. The maximum storage of solvent will be 12000 litres (6 x 1000 litre IBCs of acetone and 6 x 1000 litre IBCs of IPA). The store will be located adjacent to the north of the production building and the bunded area will be sized appropriately.

Further bulk storage or a tank farm is not proposed.

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Register P0886-01


4. Emissions to Sewer

4a. Provide a detailed description of all sources of process emissions (e.g. wash water), the product and stage in the process and the volumes generated. Clarify the main source for each substance emitted. Include the existing and proposed operations.

Response:

Process aqueous emissions are summarised as follows:

Aqueous Emissions Quantity (litres)

Existing Proposed

Daily emissions 2,950 4,450

Weekly emissions 10,870 15,370

Monthly emissions 1,550 5,350

Total (L/Month)* 111,716 167,116

*Based on 5 days per week, 4.3 weeks per month (year average)

Table E attached shows all sources of process aqueous emissions for existing and proposed operations.

4b. Submit details on the aqueous wastes being filtered, referred to in the application.

Response:

The Non-Technical Summary (section A.11 – Wastes) contained the following statement:

Aqueous waste, consisting mostly of water and trace organics are filtered, balanced

and monitored before discharge to the Fingal County Council sewer which

discharges to the Dublin City Council Waste Water Treatment Plant at Ringsend.

The word “filtered” is a typographical error. Aqueous waste is not filtered. Treatment comprises balancing and pH adjustment only.

4c. If revised emission limits are proposed, provide details and any correspondence with Fingal Co. Co. Complete Table E.3(i).

Response:

Revised limits are not proposed. The effluent discharge by Rottapharm is well within the limits set out in the trade effluent licence. It is not envisaged that even in full production that the limits would need to be revised. Table E.3(i) does not need to be adjusted.

4d. Provide details of effluent analysis associated with the proposed production.

Response:

Increased solvent usage will primarily result in an increase in atmospheric emissions and not aqueous emissions. No change in effluent quality is anticipated.

4e. Explain why pH adjustment is required and the chemicals used for this. Clarify how sludge settlement is monitored and give details of sludge analysis.

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Register P0886-01


Response:

pH adjustment is required to bring the process aqueous emissions to meet the pH specification of 6 – 10 required by Fingal Co. Co. prior to discharge into the trade sewer. Washes of equipment containing traces of Crystalline Glucosamine Sulphate (CGS) result in acidic solutions being sent to the waste water treatment plant. All process effluent is routed to a balancing tank to allow the pH to equilibrate prior to the addition of chemicals for pH adjustment.

Caustic soda (30%) and Hydrochloric acid (36%) are used in pH adjustment.

Sludge settlement is monitored monthly. It is done via a visual inspection. Regular operations (e.g. dosing) occur at the Waste Water Treatment Plant (WWTP) and as such any significant build-up of sludge is noticed. Over the years there has been a need to remove sludge only once per year. Due to increased volumes, it is envisaged that sludge will be removed every 6 months.

Superdrain Ltd. are contracted to remove sludge from the WWTP. They transport to Dublin City Council (DCC) Ringsend Treatment Works. Each tanker is sampled by DCC upon entry to the treatment plant. All tankers from Rottapharm have been allowed discharge at Ringsend. Superdrain have not been contacted by DCC regarding any out of specification tanker loads. Sludge is not analysed by Rottapharm. The EWC Code is 19 11 06.

Sludge analysis is not available.

4f. Complete Table F.1(i). Provide a description of the monitoring and controls of process effluent.

Response:

Table F.1(i) is complete and attached (as Table F). Additional controls on process effluent include a level sensor on the height of the balance tank and a composite sample of the discharge is retained for analysis purposes if required. The process effluent is sampled monthly by a specialised company (Aquachem), the following parameters are tested for to ensure compliance with the trade effluent license (BOD, MBAS, oil/fats/grease/, COD, temperature, suspended solids, sulphate, pH, TOC and temperature).

4g. Provide effluent monitoring data for the previous 3 months.

Response:

The results of effluent monitoring for samples taken in June, July and August 2009 are shown in the following table:

Parameter License Limit Units 08-Jun-09 11-Jul-09 28-Aug-09

Temperature 42 oC 32 32 32

pH 6 – 10 pH Units 8.3 7.74 7.11

BOD 2000 mg/l 56 253 57.7

COD 5000 mg/l 120 446 132

Suspended Solids 400 mg/l 21 81 50

Oil/Grease 100 mg/l 1 1 1

MBAS 100 mg/l 0.1 0.1 0.1

Sulphates 400 mg/l 81 114 73.7

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Register P0886-01


4h. Provide any relevant correspondence with Fingal Co. Co. in the previous 12 months.

Response:

The only correspondence on file is the notification of application for the IPPC licence. This is included as Appendix B. Rottapharm is not aware of any other correspondence between the company and Fingal County Council in the last 12 months.

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Register P0886-01


5. Waste

5a. Resubmit Table H.1 (i) providing of breakdown of the waste 'Chemicals'. Clarify the EWC code, source, quality and destination and method of recovery/ disposal for each waste stream (waste solvents, general lab waste etc,). Include changes is any, for the proposed operations.

Response:

Table H.1(i) has been revised to include the requested information and is attached (Table G).

5b. Provide the EWC code for Non-regulated polysorbate

Response:

The EWC Code for non-regulated polysorbate is 16 05 08 (discarded organic chemicals consisting of or containing dangerous substances).

5c. Include in Table H.1: any wastes for deep burial, any wastes from abatement, (spent filters, pharmaceutical dust etc.).

Response:

Table H.1 (i) has been revised and is attached (Table H).

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Register P0886-01


6. Other

6a. Provide the location of water purification plant and uses of purified water.

Response:

The purified water skid is located in the plant room, 1st floor main production building.

Purified water is used in the production of CGS (Bulk Manufacturing) where it is added to the Blender and in Manufacturing Area 2 for the preparation of coating solution. It is also used throughout the production areas for cleaning of process equipment.

6b. Clarify what is 'Eudragit spraying' referred to for Tromalyt.

Response:

Eudragit spraying is the spraying of a coating product called Eudragit L 12.5 onto the Tromalyt tablets. It is a pharmaceutical excipient. The only hazardous component is isopropanol.

6c. Give the specifications of the interceptors (Class and full retention/ bypass).

Response:

Both interceptors on site are Class I Bypass Separators.

6d. Show the locations of the nearest noise sensitive receptors.

Response:

Figure G attached shows the nearest noise-sensitive receptor, which is a private dwelling house.

6e. Provide the annual water consumption for 2008.

Response:

The water consumption for the year 2008 was 9,924 m³.

6f. Provide information to show that Rottapharm Limited is likely to be in a position to meet any financial commitments or liabilities, for example a copy of the Audited Accounts for the most recent year available.

Response:

A copy of the Audited Accounts of Rottapharm for 2006, 2007 and 2008 are attached as Appendix D. Note: 2008 was an exceptional year for the subsidiary company Rotta Finance. The losses incurred by Rotta Finance in 2008 related to trading activities. Rottapharm Ltd made substantial profits from its core business of manufacturing in 2008 as in previous years.

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Register P0886-01


7. Non-Technical Summary

An updated non-technical summary that reflects the information provided in the above

response is attached as Appendix E.

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Register P0886-01


Tables

RFI Reference

Table No Description

2b A Table E.1(iv) information for supply AHUs

2d B Table F.1(i) for emission points containing APIs

2e C Table E.1(i) completed for boilers

2g(iii) D Table F.1(i) completed for the RTO

4a E Sources of process aqueous emissions

4f F F.1(i) Monitoring and controls of process effluent and domestic sewage.

5a G Table H.1 (i) Breakdown of the waste 'Chemicals'.

5c H Table H.1 (i) Wastes for deep burial, any wastes from abatement, (spent filters, pharmaceutical dust etc.

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Rottapharm - IPPC Licence Application - Response to Request for Additional Information Register P0886-01


TABLE A

TABLE E.1(iv): EMISSIONS TO ATMOSPHERE - Minor atmospheric emissions

Emission

point

Description Emission details1 Abatement system employed

Reference

Numbers

material mg/Nm3(2) kg/h. kg/year

A3-1 Natural gas (Production) boiler 1.5 MW

not available not

available

not

available not

available NOT AVAILABLE

A3-2 Natural gas (Production) boiler 1.5 MW

not available not

available not

available not


A3-3 Natural Gas (Administration) boiler 0.422 MW

not available not

available not

available not


A3-4 Exhaust air handler AH-

201

Crystalline Glucosamine

Sulphate / Plantago

1 0.000015 0.14 HEPA filters


401

Acetylsalicyclic Acid 1 0.000011 0.09 HEPA filters (monitored by DP gauges -

calibrated annually)


601

Crystalline Glucosamine

Sulphate

1 0.0000051 0.05 HEPA filters (monitored by DP gauges -


A3-7 Dust collector DCU-101 Crystalline Glucosamine

Sulphate / Plantago

10 0.0000042 0.04 Bag and HEPA filters (DP gauges


A3-8 Dust collector DCU-201 Acetylsalicyclic Acid 10 0.00000315 0.03 Bag and HEPA filters( DP gauges


A3-9 Dust collector DCU-501 Crystalline Glucosamine 10 0.0000042 0.04 Bag and HEPA filters (DP gauges

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Sulphate calibrated annually)

A3-10 Laboratory fume hoods

and extracts

Miscellaneous laboratory

reagents not

available not

available not

available None

A3-11 Dust collector DCU-301 Crystalline Glucosamine

Sulphate / Plantago

10 0.0000042 0.04 Bag and HEPA filters (DP gauges


A3-12 Dust collector DCU-202 Acetylsalicyclic Acid 10 0.00000315 0.03 Bag and HEPA filters( DP gauges


1 The maximum emission should be stated for each material emitted, the concentration should be based on the maximum 30

minute mean.

2 Concentrations should be based on Normal conditions of temperature and pressure, (i.e. 0oC101.3kPa). Wet/dry should be

clearly stated. Include reference oxygen conditions for combustion sources.

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TABLE B

TABLE F.1(i): ABATEMENT / TREATMENT CONTROL

Emission point reference number : A3-4, A3-5 & A3.6 Exhaust Air Handlers and A3-7, A3-8, A3-9, A3-11 & A3-12 Dust

Collectors

Control1 parameter Equipment 2 Equipment maintenance Equipment calibration Equipment back-up

Pressure Drop across

HEPA Filter

Differential Pressure (DP)

gauges

Annually Annually None

Control1 parameter Monitoring to be carried out3 Monitoring equipment Monitoring equipment

calibration

Pressure Drop across HEPA

Filter

DP Gauge checked weekly DP Gauge Annually

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1 List the operating parameters of the treatment / abatement system which control its function.

2 List the equipment necessary for the proper function of the abatement / treatment system.

3 List the monitoring of the control parameter to be carried out.

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Emission point reference number : A3-1, A3-2 and A3-3 Natural Gas Boilers________________________


O2/CO/CO2 concentration

in flue gas

Flue Gas Analyser Annual service by boiler

service company

Annually Boiler controlled to lock

out on equipment failure


calibration

O2/CO/CO2 concentration in flue

gas

Annually Flue Gas Analyser Prior to use


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Emission point reference number : A3-10 Laboratory Fumehoods______________


Face velocity Extract Fan Annually None None


calibration

Face velocity Annually Anemometer Prior to use



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TABLE C

Table E.1 (i) BOILER EMISSIONS TO ATMOSPHERE (1 Page for each emission point)

Emission Point:

Emission Point Ref. No:

A3-1 (This is a Minor Emission Point)

Location:

Plant Room Boiler Room, 1st Floor Production Building

Grid Ref. (12 digit, 6E,6N):

305415, 241297

Vent Details

Diameter: 0.38m

Height above Ground(m):13m

Date of commencement of emission:

May 1999

Characteristics of Emission:

Boiler rating

Steam Output:

Thermal Input:

0kg/hr

1.5 MW

Boiler fuel

Type:

Maximum rate at which fuel is burned

% sulphur content:

Natural gas

102kg/hr

negligible

NOx 120 mg/Nm3

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0oC. O2(Liquid or Gas), O2(Solid Fuel)

Maximum volume* of emission

2,938 m3/hr

0oC, O2 (liquid or gas), O2 (solid fuel)

Temperature

250oC(max) 230 oC(min)

240 oC (avg)

* Volume flow limits for emissions to atmosphere shall be based on Normal conditions of temperature and pressure, (i.e. 0oC,101.3kPa), dry gas; 3% oxygen for liquid and gas fuels; 6% oxygen for solid fuels.

(i) Period or periods during which emissions are made, or are to be made, including daily or seasonal variations (start-up/shutdown to be included):

Periods of Emission

(avg)

10-30 min/hr 24 hr/day 365 day/yr

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Emission Point:



Location:

Plant Room Boiler Room, 1st Floor Production Building


305415, 241297

Vent Details

Diameter: 0.38m



May 1999


Boiler rating

Steam Output:

Thermal Input:

0kg/hr

1.5 MW

Boiler fuel

Type:


% sulphur content:

Natural gas

102kg/hr

negligible

NOx 120 mg/Nm3


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2,938 m3/hr


Temperature


240 oC (avg)



Periods of Emission

(avg)


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Emission Point:



Location:

Plant Room Boiler Room, 1st Floor Administration Building


305362, 241236

Vent Details

Diameter: 0.38m



May 1999


Boiler rating

Steam Output:

Thermal Input:

0kg/hr

0.422 MW

Boiler fuel

Type:


% sulphur content:

Natural gas

29kg/hr

negligible

NOx 120 mg/Nm3


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1,037 m3/hr


Temperature


240 oC (avg)



Periods of Emission

(avg)


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TABLE D


Emission point reference number : A2-1 (RTO)


Pressure at inlet to RTO Unit Exhaust fan controlled by pressure at inlet

2-yearly inspection N/A N/A

Concentration of Flammable Gases at RTO inlet

Valve on dilution air inlet (bypass) controlled by LEL Meters on air supply

Regular inspection of

function

Annual calibration Redundant LEL meters

for safety

Combustion Temperature Thermo couples in combustion chamber

2-3yearly inspection and

replacement

N/A 3 redundant

thermocouples

Deposits on ceramic bed Filters on inlet 2-yearly inspection and dp measurement

N/A N/A

Temperature of RTO exhaust air

Defined by equipment design (~60K above inlet air temperature, max.300°C), measured by thermocouple

2-yearly inspection N/A N/A

Exhaust gas composition Defined by equipment and process design

N/A N/A Regular external

measurement of Exhaust

gas composition

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calibration

Pressure at inlet to RTO Unit Continuous monitoring and

control of pressure

Pressure indicator and data

logger

N/A

Concentration of Flammable Gases at RTO inlet

Continuous monitoring and

control of concentration

3 LEL meters and data logger Annual calibration

Combustion Temperature Continuous monitoring and

control of temperature

3 redundant thermocouples N/A

Deposits on ceramic bed Continuous monitoring of

pressure drop across ceramic

bed

Pressure indicator N/A

Temperature of RTO exhaust air Continuous monitoring of

temperature

Temperature measurement

device and data logger

N/A

Exhaust gas composition Regular external measurement

of Exhaust gas composition

External contractor equipment As per contractor calibration

schedule/ prior to measurement




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Table E

Sources of Process Aqueous Emissions

Area Source Product Stage in Process

Approx Volume Generated - (Litres)

Frequency of Operation

Existing Proposed

Bulk Manufacturing Dispensing System (B4) Glucosamine Hydrochloride / Sodium Sulphate

Equipment Clean 100 100 Weekly

Bulk Manufacturing Bicone Blender (B5) Crystalline Glucosamine Sulphate Equipment Clean 100 100 Weekly

Bulk Manufacturing Condenser Glucosamine Hydrochloride / Sodium Sulphate

CGS Drying 100 100 Daily

Bulk Manufacturing Blender Filter Cartridge (B5)

Crystalline Glucosamine Sulphate Equipment Clean 50 50 Daily

Bulk Manufacturing Mill (B5) Crystalline Glucosamine Sulphate Equipment Clean 100 100 Monthly

Manufacturing Area 1

LAF Booth Dispensing Room M6

Bromelaine / Crystalline Glucosamine Sulphate



Discharge Station BB-105 and LAF Booth (M8)

Crystalline Glucosamine Sulphate / Plantaben

Equipment Clean 200 200 Monthly


Discharge Stations BB-101 & BB-103 (M9)

Crystalline Glucosamine Sulphate / Plantaben



Parts Wash M10 Crystalline Glucosamine Sulphate / Sorbitol / Plantaben



IBC Wash Room M10 Crystalline Glucosamine Sulphate / Sorbitol / Plantaben

Equipment Clean 1000 1500 Daily


Capsule Filler G140 (M5) Crystalline Glucosamine Sulphate Equipment Clean 100 100 Monthly

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Existing Proposed


Capsule Filler G60 (M4) Crystalline Glucosamine Sulphate Equipment Clean 100 100 Monthly


Tablet Press (M3) Crystalline Glucosamine Sulphate Equipment Clean 100 100 Monthly


Suberblender (M31) Crystalline Glucosamine Sulphate / Plantaben



Dispensing Room M21 Acetylsalicylic Acid / Tromalyt Equipment Clean 50 50 Weekly


Dispensing Room M24 Ethyl Cellulose / Sugar Pellets / Triacetin / Kollidon VA-64



Sieving (M25) Acetylsalicylic Acid / Tromalyt Equipment Clean 50 50 Monthly


Parts Wash M26 Tromalyt / Fortilase / Extranase / Ananase



IBC Wash Room M26 Tromalyt / Fortilase / Extranase / Ananase

Equipment Clean 1000 2000 Daily


BL-201 Tromalyt / Fortilase / Extranase / Ananase



CO-201 (M18) Acetylsalicylic Acid Equipment Clean 400 400 Daily


CO-202 (M17) Sucrose Equipment Clean 300 300 Daily

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Existing Proposed


Coating Solution Prep (M16)

Sucrose Equipment Clean 100 100 Daily

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TABLE F


Emission point reference number : SE1


pH Effluent treatment plant Preventive maintenance

every 12 weeks

pH probes calibration

every 12 weeks

Spares held on site


calibration

pH Continuous pH probe pH probes calibration every 12

weeks

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Emission point reference number : SE2 (sewage)

This table is not applicable to emission point to sewer SE2 as no treatment of foul effluent from the site takes place.


None None None None None

Note: Foul effluent is discharged to sewer without treatment, as is the norm at most industrial premises.


calibration

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TABLE G

TABLE H.1(i): WASTE - Hazardous Waste Recovery/Disposal

Waste material EWC Code Main source1 Quantity On-site

Recovery/Disposal

Off-site Recovery,

reuse or recycling

Off-site Disposal

Tonnes /

month*

m3 / month

(Method &

Location )

(Method, Location

&

Undertaker)

(Method, Location

&

Undertaker)

Thioglycollic Acid 16 05 08 QC Lab 0.012 Eco-safe Systems (R3 Recycling/reclamation of organic substances which are not used as solventa R4 recycling/reclamation of metals and metal compounds)

Ecosafe Systems (D10 Incineration on land)

Lead Perchlorate / Methanol

16 05 08 QC Lab 0.24 Eco-safe Systems (R3 Recycling/reclamation of organic substances which are not used as solventa R4 recycling/reclamation of metals and metal compounds)

Eco-safe Systems

(D10 Incineration on

land)

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Recovery/Disposal

Off-site Recovery,

reuse or recycling

Off-site Disposal

Tonnes /

month*

m3 / month

(Method &

Location )

(Method, Location

&

Undertaker)

(Method, Location

&

Undertaker)

UN 1993 Acetone 16 05 08 QC Lab 0.021 Eco-safe Systems (R3 Recycling/reclamation of organic substances which are not used as solventa R4 recycling/reclamation of metals and metal compounds)

Eco-safe Systems

(D10 Incineration on

land)

Non-regulated polysorbate

16 05 08 Production 0.037 Eco-safe Systems (R3 Recycling/reclamation of organic substances which are not used as solventa R4 recycling/reclamation of metals and metal compounds)

Ecosafe Systems (D10 Incineration on land)

* total over a year divided by 12

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TABLE H

TABLE H.1(i): WASTE - Hazardous Waste Recovery/Disposal


Recovery/Disposal

Off-site Recovery,

reuse or recycling

Off-site Disposal

Tonnes /

month*

m3 / month

(Method &

Location )

(Method, Location

&

Undertaker)

(Method, Location

&

Undertaker)

Bulky waste

including Rejected

Product, Wastes

from Abatement -

pharmaceutical dust,

Filter elements and

Contaminated

Packaging

20 03 07 Manufacturing

Process, Dust

Collectors, Air

Handling

Equipment and

Raw Material

delivery

26 Not Available Not applicable Not applicable Deep Burial,

Knockharley, Co

Meath, Greenstar

* total over a year divided by 12

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Figures

RFI Reference

Figure No Description

1b A Drawings showing the internal layout, production areas (Area 1, Area 2, Bulk) and the emissions arising. Show the locations of equipment including the coating pans, blenders, dedusters, etc

2a B A3 engineering drawings showing all emission points and the sources of the emissions for each emission point.

2g (i) C A3 engineering drawings of RTO (in addition to Figure Fl)

2g(vii) D D1: Vendor P&ID of the coater

D2: Lay out drawing of coater

2g(x) E P&ID of RTO/Heat Recovery System

3c F Locations and details of the coating pans and the route to the abatement system

6d G Location of the nearest noise sensitive receptor

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Appendices

RFI Reference

Appendix No

Description

1a A EIS

1f B Copy of the letter to the Planning Authority referred to in your correspondence dated 22 June 2009 (Ref A L0002).

2f C Report on air dispersion modelling

6f D Audited Accounts of Rottapharm for 2006, 2007 and 2008

7 E Non-Technical Summary

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September 2009

Internal Production Layout

Figure A1

Rottapharm IPPC Licence Application RFI

D6400.42

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September 2009

Plant Room AHUs & DCUs

Figure A2


D6400.42

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September 2009

Air Emission Points

Figure B1


D6400.42 October 2009

305300 E305250 E

305350 E305400 E

305450 E305500 E

241250 N

241300 N

241350 N

241400 N

Emissions to atmosphere

Figure E.1 Rev A

Rottapharm IPPC Licence Application

D6400.40

Scale 1:1,000

0 metres 40

Ordance Survey Ireland Licence Number EN 0002809 © Government of Ireland

A3-4A3-5A3-6

A3-1A3-2

A4-1

A2-1

A3-10

A3-3

A3-7A3-8A3-9A3-11A3-12

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September 2009

Emission points and the sources of the emissions for each emission point

Figure B2


D6400.42

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September 2009


Figure B3


D6400.42

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September 2009


Figure B4


D6400.42

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September 2009


Figure B5


D6400.42

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September 2009

Piping and Instrumentation Drawing of RTO

Figure C1


D6400.42

1.0 1.1 3.0 5.0 6.0 6.01 6.02 6.03 6.04 6.05 6.06 8.0 8.11 8.12 WG153 VP111 VV141

Brennkammer

Comb. chamber

Kamin KA190

Stack

Brenner

Burner

Prozess.vent.

Process air fan

Verbrenn. ventilator

Combustion air fan

MediumWarmwasser

Warm water

Warmwasser

Warm water

Druckluft

Compressed air

Erdgas

Natural gas

Abluft

Exhaust air

Abluft

Exhaust air

Abluft

Exhaust air

Abluft

Exhaust air

Reingas

Clean gas

Reingas

Clean gas

Spülluft

Purge air

Verbrennungsluft

Combustion air

Frischluft

Fresh air

Frischluft

Fresh air

Erdgas

Natural gas

Prozessluft

Process air

Verbrennungsluft

Combustion air

Durchflussmenge nominal 30 30 5 10 2.000 6.000 6.000 6.000 HOLD HOLD 1.000 100 4.000 - HOLD HOLD HOLD

Flow rate max. 30 30 - 45 6.000 17.200 17.200 17.200 HOLD HOLD 1.000 400 11.200 - HOLD HOLD HOLD

[ Nm³/h ] min. Rottapharm Rottapharm - 0 900 4.500 4.500 4.500 HOLD HOLD 1.000 0 0 - HOLD HOLD HOLD

Temperatur nominal 85 105 20 20 45 HOLD HOLD 830 90 150 90 20 20 20 HOLD HOLD HOLD

Temperature max. 92 120 20 20 65 HOLD HOLD 950 130 300 130 20 20 20 HOLD HOLD HOLD

[ °C ] min. 70 72 20 20 15 HOLD HOLD 820 75 80 75 20 20 20 HOLD HOLD HOLD

Druck nominal Rottapharm Rottapharm 6.000 100 -5 -5 17 9 2 1 -5 -1 -1 -1 HOLD HOLD HOLD

Pressure max. Rottapharm Rottapharm 7.000 Rottapharm Rottapharm Rottapharm 38 20 3 1 Rottapharm -1 -1 -1 HOLD HOLD HOLD

[ mbar ] min. Rottapharm Rottapharm 6.000 100 Rottapharm Rottapharm 10 5 1 1 Rottapharm -1 -1 -1 HOLD HOLD HOLD

Konzentration nominal - - - - 10.000 4.000 4.000 - - - HOLD - - - HOLD HOLD HOLD

Concentration max. - - - - 70.000 HOLD HOLD - - - HOLD - - - HOLD HOLD HOLD

[ mg/Nm³ ] min. - - - - 2.000 HOLD HOLD - - - HOLD - - - HOLD HOLD HOLD

Leistung Power kW - - - - - - - - - - - - - - - - -

Hersteller Manufacturer - - - - - - - - - - - - - - - - -

Ausrüstung /

Equipment

Nr. / No.

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September 2009

Vendor P&ID of the coater

Figure D1


D6400.42

350 CLASSIC

NICOMATIC COATING SYSTEM

SK.NCS.241

REAR VIEW

/ELITE

PRELIMINARY

TOP VIEW

SIDE VIEW

FRONT VIEW

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September 2009

Lay out drawing of coater

Figure D2


D6400.42

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September 2009

Piping and Instrumentation Drawing of RTO/Heat Recovery System

Figure E1


D6400.42

1.0 1.1 3.0 5.0 6.0 6.01 6.02 6.03 6.04 6.05 6.06 8.0 8.11 8.12 WG153 VP111 VV141

Brennkammer

Comb. chamber

Kamin KA190

Stack

Brenner

Burner

Prozess.vent.

Process air fan

Verbrenn. ventilator

Combustion air fan

MediumWarmwasser

Warm water

Warmwasser

Warm water

Druckluft

Compressed air

Erdgas

Natural gas

Abluft

Exhaust air

Abluft

Exhaust air

Abluft

Exhaust air

Abluft

Exhaust air

Reingas

Clean gas

Reingas

Clean gas

Spülluft

Purge air

Verbrennungsluft

Combustion air

Frischluft

Fresh air

Frischluft

Fresh air

Erdgas

Natural gas

Prozessluft

Process air

Verbrennungsluft

Combustion air

Durchflussmenge nominal 30 30 5 10 2.000 6.000 6.000 6.000 HOLD HOLD 1.000 100 4.000 - HOLD HOLD HOLD

Flow rate max. 30 30 - 45 6.000 17.200 17.200 17.200 HOLD HOLD 1.000 400 11.200 - HOLD HOLD HOLD

[ Nm³/h ] min. Rottapharm Rottapharm - 0 900 4.500 4.500 4.500 HOLD HOLD 1.000 0 0 - HOLD HOLD HOLD

Temperatur nominal 85 105 20 20 45 HOLD HOLD 830 90 150 90 20 20 20 HOLD HOLD HOLD

Temperature max. 92 120 20 20 65 HOLD HOLD 950 130 300 130 20 20 20 HOLD HOLD HOLD

[ °C ] min. 70 72 20 20 15 HOLD HOLD 820 75 80 75 20 20 20 HOLD HOLD HOLD

Druck nominal Rottapharm Rottapharm 6.000 100 -5 -5 17 9 2 1 -5 -1 -1 -1 HOLD HOLD HOLD

Pressure max. Rottapharm Rottapharm 7.000 Rottapharm Rottapharm Rottapharm 38 20 3 1 Rottapharm -1 -1 -1 HOLD HOLD HOLD

[ mbar ] min. Rottapharm Rottapharm 6.000 100 Rottapharm Rottapharm 10 5 1 1 Rottapharm -1 -1 -1 HOLD HOLD HOLD

Konzentration nominal - - - - 10.000 4.000 4.000 - - - HOLD - - - HOLD HOLD HOLD

Concentration max. - - - - 70.000 HOLD HOLD - - - HOLD - - - HOLD HOLD HOLD

[ mg/Nm³ ] min. - - - - 2.000 HOLD HOLD - - - HOLD - - - HOLD HOLD HOLD

Leistung Power kW - - - - - - - - - - - - - - - - -

Hersteller Manufacturer - - - - - - - - - - - - - - - - -

Ausrüstung /

Equipment

Nr. / No.

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September 2009

Locations and details of the coating pans and the route to the abatement system

Figure F1


D6400.42

350 CLASSIC

NICOMATIC COATING SYSTEM

SK.NCS.241

REAR VIEW

/ELITE

PRELIMINARY

TOP VIEW

SIDE VIEW

FRONT VIEW

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September 2009D6400.42

Location of the nearest noise sensitive receptor

Figure G1


Nearest Noise Sensitive Receptors

Scale 1:1,000

0 metres 400

Ordance Survey Ireland Licence Number EN 0002809 © Government of Ireland

N3

Damastown Road

Damastown Ave.Dam

asto

wn D

rive

Pinkeen River

Tolka River

Tolka Valley RiverClonee Bypass

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Appendices

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EPA Export 26-07-2013:16:05:22

Appendix A Environmental Impact Statement

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EPA Export 26-07-2013:16:05:22

6th April 1998

1997/97017/processJdesign/eis.doc

Environmental Impact Statement

ENVIRONMENTAL IMPACT STATEMENT

ROTTAPHARM LTD.Damastown, Mulhuddart,

Dublin 15.

DPS ENGINEERING & CONSTRUCTION,St. Patricks House,

Lower Glanmire Road,Cork.

DPS Engineering & Ccnstructlon • 97017

Page 1 of37

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1.

2.

3.

4.

5.

6.

7.

6th April 1998

1997/97017fprocess/designfeis. doc


CONTENTS

Introduction

Non-technical Summary

The Project3.1 General Proposal3.2 Company Background3.3 Site Selection3.4 Company Environmental Policy

The Proposed Facility4.1 Layout of Plant4.2 Processing Equipment4.3 The Products4.4 Material Storage and Handling4.5 Landscape

Emissions to the Environment5.1 Effluent5.2 Atmospheric Emissions5.3 Noise5.4 Wastes5.5 Clean Technology

The Receiving Environment6.1 Land Use6.2 Flora and Fauna6.3 Pinkeen & Tolka Rivers6.4 Groundwater and Soil6.5 Air Quality and Climate6.6 Noise6.7 Socio-EconomicFactors6.8 History and Archaeology

Impact of the Development7.1 Flora and Fauna7.2 Water7.3 Wastes7.4 Air & Climate7.5 Noise7.6 Socio-Economic Factors7.7 History and Archaeology7.8 Roads7.9 Visual Impact7.10 Other Impacts

Page 2 of37DPS Engineering& Construction - 97017

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6th April 1998

Iml97017/procm/designleis.doc

1.

2.

3.

4.

5.


APPENDICES

Site Location Maps and Site Plan

Process Schematics

Soil and Groundwater Quality Investigation

Meteorological Data

Noise Monitoring

DPS Engineering& Construction ~ 97017Page 3 of37

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1.0 INTRODUCTION

Rottapharm Ltd. propose to construct a new Finished Pharmaceutical Manufacturing Facility atDamastown, Mulhuddart, Co. Dublin. The new development will comprise an AdministrationBuilding, a Bulk Manufacturing Building, a Secondary Manufacturing and Packaging Building and aWarehouse Building. The facility will produce Bulk Active and Solid Dosage Form Products.

The facility will be designed and constructed to reflect the Current Industry Standards ensuring it'soperation is to the satisfaction of the relevant regulatory authorities, notably the Irish MedicinesBoard (1MB) for EU markets and the Food and Drug Administration (FDA) for US markets. It willincorporate up-to-date manufacturing technology to ensure necessary GMP Guideline compliance andcost effective operation.

DPS Engineering & Construction Ltd., as project engineering consultants have responsibility for fulldesign, project management and validation of the new facility as well as preparation of thisEnvironmental Impact Statement. The scope and format of this E.I.S. are in accordance withEuropean Communities (Environmental Impact Assessment) Regulations, S.1. 349 of 1989 andEuropean Communities (Environmental Impact Assessment) (Amendment) Regulation S.1. 84 of1994.

6th April 1998

1997/97017/proce0designfeis.doc

Page 4 of 37DPS Engineering & Construction - 97017

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2.0 NON-TECHNICAL SUMMARY

Rottapharm Ltd. proposes to construct a new Solid Dosage Form Pharmaceutical facility on agreenfield site at Damastown, Mulhuddart, Co. Dublin. The plant will manufacture tablets, granulesand capsules. The facility will be a fully integrated unit and will incorporate Production Facilities,Filling, Dispensing and Packaging Areas, Warehousing, Laboratory Facilities, Utilities and Officeand Administration Accommodation.

The land consists of grassland and hedgerows, lying to the east of the existing Yamanouchi site andto the west of the existing Loctite site. The existing Helsinn Birex Pharmaceuticals and HelsinnChemicals sites lie to the Southwest and the new IBM facility to the Northwest. The siteincorporates a section of the Pinkeen River which runs through it in a north/south direction.

A range of products is to be manufactured and packaged at the new facility. The core activity willbe the production of Glucosamine Sachets and Capsules for anti-rheumatic treatments, BromelainTablets for anti-inflammatory treatments and selected other products.

The new facility will have a floor area of approximately 8000m2 and while all manufacturingactivities are carried out on a single ground floor level, upper floor areas are provided for Offices,Plant Rooms, USP Water Storage, Various Utilities and Access. The plant will be self-sufficientwith respect to all utilities.

Process effluent will be generated by washing activities which will amount to approximately25m3/day in normal circumstances and to a maximum of 50m3/day. This will be treated byautomatic continuous pH monitoring and correction with acid/caustic followed by settling which willremove insoluble contaminants. This effluent will then be discharged to the municipal sewer leadingto the primary treatment plant at Ringsend.

Domestic waste will be passed directly to this sewer and surface water will be directed to the RiverPinkeen via an oil interceptor.

Emissions to atmosphere will arise from general and specific ventilation as well as from TabletCoating Operations. All general and specific ventilation points will be fitted with high efficiencyparticulate filters or reverse jet type-dust collectors as necessary to prevent any dust emissions. Allsolvents used in Tablet Coating Operations will be recovered and collected as necessary to bringemission levels within those outlined in T.A. Luft. In general, all emissions will be withinBATNEEC limits for pharmaceutical emissions.

Solid wastes will principally be packaging materials and general wastes. Any contaminated materialswill be stored separately and disposed of as hazardous waste. General wastes will be disposed of tocontrolled landfill by local contractors.

6th April 1998

1997t970I7lprocessldesignleis.doc

Page 5 of37DPS Engineering& Construction - 97017

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Environmental hnpact Statement

2.0 NON-TECHNICAL SUMMARY (Cont'dl

Noise emissions will be minimised by the fact that noise sources are internal to the building and alsonoise control measures will be fitted to equipment such as air handling units, compressors andchillers. The distance to the nearest residence (approx. 500 metres) means that the impact of plantnoise will be negligible, especially in light of the proximity of the N3 dual carriageway.

Flora and Fauna on the site and surrounding areas are unremarkable. Emissions from the plant willhave no impact on these. Landscaping of the site will be carried out with particular emphasis on thePinkeen River which shall be a focal point for the site.

A total of 70 people will be employed at the plant when it is in initial production with plans to doublewithin 5 years. The construction phase will call for 100 - 150 people and will last 12 months with afurther 2 month period required for commissioning. The development represents a modest butimportant contribution to local employment, and is in accordance with the Dublin County DraftDevelopment Plan of 1991 which states as its employment objective: "It is the concern of thecouncil that a range of job opportunities be available throughout the county and in areas of highunemployment, particularly the western towns."

Based on the office of Public Works sites and monuments records for County Dublin, there are noknown sites or features of archaeological interest within the new site to be developed.

The development and landscape proposals are of a standard consistent with its surroundings and willinclude extensive screening by the use of planted raised earthen berms. Existing boundary hedgeswill be retained and augmented by further planting.

6th April 1998

1997/97017rprocess/deslgn/eis.doc


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3.0 TIlE PROJECT

The proposed new development will comprise the following:

• Administration Building - including offices, changing rooms, canteen, reception area, laboratoryand plant rooms.

• Manufacturing and Packaging Building - including change rooms, dispensing, filling andpackaging rooms and plant rooms.

• Bulk Manufacturing Building - including change rooms, offices, dispensing, production and plantrooms.

• Warehouse Building - including storage areas, quarantine and sampling areas.

A treatment facility for neutralisation of process plant effluent will be located externally to the east ofthe Manufacturing and Packaging Building.

The facility will be fire protected with a Sprinkler System. A Sprinkler Water Storage Tank andassociated Pump House will be located on the eastern side of the site.

It is estimated that the construction phase of the project will last 12 months from July 1998 to July1999. Production is intended to commence in October 1999.

6th April 1998

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3.0 THE PROJECT

3.2 Company Background

The history of the Rotta Research Group is somewhat complex and goes back to 1961 whenRotta Research Laboratorium, a pharmaceutical research, manufacturing and marketingcompany was established at Monza, Italy. In 1962, Rorer (USA) took a 50% share in thecompany. Rorer took over and managed the manufacturing and marketing side of thecompany, as part of Rorer Italia, while the R&D side of the company was run separately andindependently under the name Rotta Research Laboratorium SpA.

During the 1960's and 1970's, Rotta Research Laboratorium SpA researched and developednew drugs, which it licensed out for sale around the world to companies including Rorer andMerck (USA).

In 1979, Rotta Research Laboratorium SpA purchased two manufacturing and marketingcompanies outside Italy: Delta (Portugal) and Opfermann (Germany).

In 1986, Rotta Research Laboratorium SpA bought back it's manufacturing and marketingactivities from Rorer and regained the rights to the drugs it had developed and licensed out.

In 1987, it created a new company, Rottapharm Sri, to manufacture and market it's productsin Italy.

In 1989, Rotta acquired a Spanish company, Laboratorios Gamir, which is now calledRottapharm SA.

In 1991, Rotta set up a subsidiary in France, Rottapharm Sarl.

In 1993, Rotta acquired the Spanish drug company Fides, which is now called FidesRottapharm.

In 1995, Rotta announced the signing of an important licensing-out agreement with Pfizer(USA).

Due to increased demand for frnished forms of Rotta's main products, it is proposed toconstruct a new finishing plant at Mulhuddart, Dublin 15. This plant will be calledRottapharm Ltd. and will supply finished products to Rotta's world-wide markets.

The Rotta Group employs over 700 people world-wide in R&D, Manufacturing andMarketing roles. The proposed new Dublin facility will employ approximately 70 peopleinitially on a single shift basis with plans to double this within five years.

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3.0 THE PROJECT

3.3 Site Selection

The site selected for this development is a 20 acre site on industrially zoned land atDamastown, Mulhuddart, Dublin 15. The site incorporates a section of the Pinkeen Riverwhich runs in a north/south direction to where it joins the Tolka River. The site was chosenon the basis of it's infrastructural facilities, i.e. roads, sewer, etc. and the company'spreference for a Dublin location.

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3.0 THE PROJECT

3.4

6th April 1998

Company Environmental Policy


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4.0 THE PROPOSED FACILITY

4.1 Layout of Plant

The new plant will be located on a 20 acre site at Damastown, Mulhuddart, Co. Dublin andwill comprise of the following:-

4.1.1 Administration Building

• This building shall be located on the western side of the river and shall cater forAdministration and Personnel facilities for the site including Reception Areas,Changerooms, Offices, Canteen Facilities, Toilets and Showers, Corridors andPlant Rooms. The main plant Laboratory will also be located in this building withadequate space provided for central Q.C.lQ.A. activities.

• The floor area of the building will be utilised as follows:-Ground Floor: - Reception, Offices Changerooms, Corridors etc.

Laboratory

First Floor Offices, etc.Plant Rooms

492m'344m'836 m'782 nr'

32 m'814 nr'

• The building height will be 8.1m with first floor level at 3.5m.

4.1. 2 Secondary Manufacturing and Packaging Building

• This building will be located on the eastern side of the river and shall cater for allSecondary Manufacturing, Filling and Packaging operations. A range of productsare to be manufactured and packaged in this area including Glucosamine granulesin sachets and capsules, Bromelain tablets and other products. In general,separate areas will be provided for Glucosamine and Bromelain production witheach area having separate secondary Changerooms and In-Process Laboratories.

• The floor area of the building will be utilised as follows:-

Ground Floor: - ProductionFillingPackagingCorridors, etc.

First Floor: Plant RoomsCorridors

870m'225 m'405 m'373 m'1873 m'732 m'213 m'945m'

6th April 1998

• The building height will be 1O.5m with first floor level at 5m.

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4.0 THE PROPOSED FACILITY (Cont'd)

4.1.3 Bulk Manufacturing Building

• This building will also be located on the eastern side of the river and will cater forthe bulk preparation of the Glucosamine Active Ingredient which will involve asimple bulk manufacturing step. The active ingredient will be collected in mc'sto be used in further processing steps in the Glucosamine Manufacturing Area.

The Bulk Manufacturing Building will have it's own separate air handling unitslocated in a plant room on the first floor and will share other utilities with theSecondary Manufacturing Area.

The Bulk Manufacturing Building will have it's own dedicated secondaryChangerooms and In-Process Laboratory.

• The floor area of the building will be utilised as follows:-

Ground Floor

First Floor

ProductionOffices

Plant RoomStability Room

144m2

198m2

198m2

6th April 1998

• The building height will be 1O.5mwith first floor level at 5m.

4.1.4 Warehouse Building

• The Warehouse Building will also be located on the eastern side of the river andwill be used for storing raw materials, finished products, packaging materials, etc.Separate Goods Inwards and Goods Outwards doors will be provided forsegregation of materials. A Sampling Booth and Raw Material Quarantine Areawill be provided at the Goods Inwards Area. The Warehouse will be designed toaccommodate 3700 Europallets with the Pallet Racking Layout to allow fornarrow aisle forktruck access. A dedicated Alcohol Storage Room will beprovided for excise control.

The Warehouse Building floor area will be 2520m2 of which 1728m2 will be usedfor the Pallet Racking. The remainder will be used for access corridors, excisestorage rooms, sampling and quarantine areas, dynamic warehouse, etc.

The building height will be 14.5m with a clear height below beams in theWarehouse of 12m.

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4.0 THE PROPOSED FACILITY (Cont'dl

4.1.5 Access Corridors

The configuration of the 4 buildings will provide for logical movements of materialsand personnel with unidirectional flow to be achieved where practical. Adequatecorridor areas will be provided so that materials and personnel can move withadequate weather protection.

The Administration Building located on the western side of the river will be connectedto the other buildings located on the eastern side by a link corridor and bridge.

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4.2 Processing Equipment

The manufacturing technology involved in the proposed plant is that of bulk preparation,formulation and finishing, The operations involved in production are:

• Dispensing

• Bulk Preparation

• Granulation

• Blending

• Sachet Filling

• Capsule Filling

• Capsule Bottling

• Tablet Compression

• Tablet Coating

• Blister Filling

• Packaging

• Other Operations

Process schematics are included in Appendix 2.

4.2.1 Dispensing

In the Bulk Manufacturing Area, Glucosamine Solid Active Materials are transferredfrom 25kg drums to FIBC's which will be used for further processing or for off-sitesale. For further processing the contents of the FIBC are vacuum transferred to avacuum drier along with quantities of other materials and are milled in-line. Thisdispensing operation will be carried out under clean conditions to minimise dustgeneration and operator exposure.

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In the Secondary Manufacturing Area solid raw materials are dispensed toIntermediate Bulk Containers from bags, drums and FmC's. The materials areweighed and dispensed via a security sieve to the mc. All dispensing operations willbe carried out under clean conditions to minimise dust generation and operatorexposure.

4.2.2 Bulk Preparation

The preparation of the Glucosamine Active Ingredient will require a simple bulkmanufacturing step which will include charging by vacuum to a Double Cone VacuumDrier via an in-line mill, mixing and wetting with purified water, vacuum drying,blending, cooling and discharging. The Drier will discharge to mc's and to kegs.

4.2.3 Granulation

Certain products will require wet granulation to achieve the consistency required fortablet manufacture. This will be effected by a Fluid Bed Type Granulator Systemwith a removable bowl. The Granulator System will be provided with all ancillaryrequirements including heated air handling, exhaust filtration, lifting and tilting devicefor bowl emptying, vessels for preparation of binder solutions, etc. Granulatedproduct is collected in an mc for further processing.

4.2.4 Blending

To achieve the required product uniformity blending is required. Blending will takeplace within dedicated Blending Rooms on Twin Plinth mc Blenders with noexposure of products. Separate mc Blenders will be provided for both theGlucosamine and Bromelain Area. Blending will be carried out for various timeperiods depending on the product in question.

4.2.5 Sachet Filling

An mc containing the blended Glucosamine product will be transported to dedicatedrooms where it will be lifted by an mc Pillar Lifter unit and positioned on an mcDischarge Station which shall feed to two Sachet Filling machines through chargechutes. The flow of product to the machines will be based on level in the producthoppers of the receiving machines. The machines comprise a powder dosing systemand systems to seal, print, cut and checkweigh the sachets.

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4.2.6 Capsule Filling

Separate rooms will be provided for filling of capsules which will be carried out ondedicated machines for Glucosamine products and certain other products. An mc ofblended product will be lifted by a stacker truck and positioned on an mc DischargeStation which shall feed a Capsule Filler via a charge chute. The flow of product tothe Capsule Filler will be based on level in the product hopper of the Filler. Filledcapsules will be collected in drums and moved to a holding area pending Q.C. releasefor packaging.

4.2.7 Capsule Bottling

Filled capsules will be manually charged to a Capsule Bottling machine where bottlesof various sizes will be filled with known quantities of capsules and then capped.

4.2.8 Tablet Compression

Separate rooms will be provided for tablet compression which will be carried out indedicated machines for Bromelain Products and certain other products. An mc ofblended product will be lifted by a stacker truck and positioned on a discharge stationwhich will feed a Tablet Press via a charge chute. The flow of product to the TabletPress will be based on level in the product hopper of the Press. Tablets will bededusted, checkweighed, collected in drums and moved to a holding area pendingQ.c. release for either coating or direct packaging.

4.2.9 Tablet Coating

The coating process will be carried out in two stages in stainless steel coating panswithin a coating suite. The application of coating solutions will double the weight ofthe tablet cores. The coating process involves the application of Enteric Coating witha solvent solution of Shellac material followed by sub-coating and fmishing withsugar-solution. The final stage of coating will be polishing with a wax solution.Coated tablets are collected in drums and held for in-process Q.C. pending release forblistering.

4.2.10 Blister Filling

Tablets and capsules are transported to dedicated Blister Filling Rooms where they arefed to the receiving hopper of a fully automated Blister Filling Machine. Themachine comprises feed plates, form, fill and seal plates, cutting plates and varioussafety and product checking devices.


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4.2.11 Packaging

The finished products are packaged for shipment as required. Sachets and blisters arecounted, cartoned, checkweighed and automatically packed into shipping cases.Capsule bottles are labelled automatically and loaded to cartons. All packagingoperations will take place in separate rooms from the filling operations with machineslinked by through wall conveyors.

4.2.12 Other Operations

Cleaning operations are responsible for most of the effluent from the plant. IBC's arethoroughly cleaned internally on an automatic IBC Washing Station. Hot and coldwater rinses followed by final USP Purified Water rinse and drying with hot filteredair will be used. External surfaces of the IBC's will be manually cleaned. Cleaningfacilities will be provided in each section of the production area for other equipment.A USP Purified Water recirculation loop is provided fed from a storage anddistribution system located in a dedicated room on the first floor of the SecondaryManufacturing Building.

Maintenance and workshop facilities and equipment storage facilities will also beprovided within the building.

Plant Rooms will be located on the first floors of the Secondary Manufacturing Areaand Bulk Preparation Area and will include Air Handling Systems, Boilers,Compressors, MCC Room etc. A Chiller Compound will be located outside thebuildings.


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4.0 TIlE PROPOSED FACILITY (Cont'dl

4.3 Raw Materials & Products

4.3.1 The Products

The products to be manufactured at the Rottapharm facility are as follows:-

Product Trade Name Use

Glucosarnine Sachets: Dona, Xicil, GSC, An anti-rheumaticViartril S produced in sachet and

Capsules: Dona, Viartril S capsule formBromelain Ananase & Extranase A vegetable based anti-

inflammatory enzymeproduct produced incoated tablet form

Monofluourophosphate/ Tridin An anti-osteoporoticCalcium produced in uncoated

tablet form.Pro-Glutemacin Afloxan An anti-inflammatory

produced in capsule form.Glucuronic Acid Jetepar A hepatic protector

produced in capsule form.Cyclidrol Mucoflux A mucolytic agent

produced in capsule form.


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The Glucosamine Area will be designed to annually produce:

• 150 Million Sachets• 75 Million Capsules

with the flexibility to produce as an alternative:

• 80 Million Sachets• 75 Million Capsules• 70 Million Coated Tablets• 100 Million Uncoated Tablets

The Bromelain Area will be designed to annually produce:

• 124 Million Coated Tablets

The Filling and Packaging Areas will be designed to produce annually:

• Fill 80 Million of 150 Million Sachets.• Blister Pack 100 Million Uncoated Tablets.• Bottle Fill 61.5 Million Capsules• Blister Pack 13.5 Million Capsules• Blister Pack 124 Million Coated Tablets• Blister Pack 70 Million Coated Tablets

The Bulk Manufacturing Area will be designed to produce 460 tonnes of Bulk Activeannually.

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4.3.2 Raw Materials

6th April 1998

Raw Materials

Glucosamine HydrochlorideAnhydrous Sodium SulphateSorbitol Granules M.G.Citric Acid PowderPoliwax 4000AspartameCorn StarchMagnesium StearateTalc.Mannitol M.G.Glutamine MFFOrange FlavourCA Glue. Gran.Tricalcium CitrateCab-O-SilStearic AcidCalcium Phos. DibasicDi-TabLactose 80 MeshBromelainShellacEthyl AlcoholCalcium PhosphateJelly SolutionSodium Hydroxide Soln. (I %)Opalux 3084Bee WaxA-TabAcetoneEthyl Alcohol BAcetate CelluloseDiethylphthalateGum ArabicTitanium DioxideTween 60Beta-Carotene TPlO%Sodium MonofluorideLactic GumNicotinamidePolysorbate 60

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Storage Container

25kg Keg25kg Keg25kg Bags & 1000 kg FIEC's25kg Bag25kg Bag25kg keg50kg Bag15kg Bag25kg Bag50kgKeg25 kg KegCarton50kgKeg25kg Bag20kg Bag15kg Bag23kg Bag25kg Bag25kg Bag25kg KegCarton49.6 It. Drum23kg BagDrumDrumCartonCarton25kg Bag251t. Drum49.6It. Drum50kg Keg25kg Keg25kg Keg25kg Bag25kg KegCarton25kg Bag25kg BagCartonCarton

DPS EngineerJng & Construction - 97017

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4.4 Material Storage and Handling

Raw materials will be delivered to the Goods Inwards Area of the Warehouse. These will becontained in cartons, bags, kegs, drums and FIEC's. A Quarantine Area with a SamplingBooth will be provided into which all incoming raw materials will first be placed untilapproved. They will then be moved to an approved raw material area and then to a stagingarea. The Warehouse is designed to separate raw materials from finished products withseparate entrances for each. No raw materials or products will be stored externally. A palletchanging area will be provided in the warehouse where materials can be transferred to cleanpallets for use in production.

The Glucosamine Active Ingredient (approx. 300 Tonnes/yr.), will be delivered to site in25kg kegs. To ease material handling, a dedicated room will be provided for the transfer ofthe material to 500kg FIEC's for easier storage and downstream handling. The GlucosamineActive will be vacuum transferred with another ingredient to the Vacuum Drier under cleanconditions. Dried material will be discharged from the Drier into either 25kg kegs for offsite sale or to 1500 It. IEC's for further processing.

In general, in-production materials will be dispensed to mc's in LAF booths via securitysieves until the materials are discharged to filling and packaging machines. All mc liftingwill be by stacker truck except when lifting over the sachet fillers where a fixed pillar lifterdevice will be used.

All transfer steps where there is the possibility of dust generation will be protected byproprietary dust caps or other charging/discharging arrangements.

4.5 Landscape

The existing site consists at present of farmland slopes towards the South of the site. Theovergrown hedgerows on the site will be removed as part of the development The site willbe landscaped and extensive planting will be carried out, featuring native species. Particularemphasis will be placed on the Pinkeen River which shall be a focal point for the site. Theriver will be landscaped, with it's banks formed into terraces, whilst maintaining the existingchannel. The terraces will provide a more diverse ecological environment in which to plantnative marginal planting associated with water. A lawn-type sward will be utilised ongrassed areas of the site.

Raised earthen berms of 2m height will be maintained on the site boundaries as screeningfrom the service road to the south. These mounds will also be planted with native and seminative deciduous and evergreen species.

The car park located on the west side of the site will have planting beds between the rows toaccommodate ornamental groundcover and tree planting.

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5.0 EMISSIONS TO THE ENVIRONMENT

5.1 Effluent

The effluent discharge philosophy is as follows:

Process drainage, which will result from bin washing and other cleaning operations, will bedischarged to sewer, receiving eventual treatment at the Ringsend Sewage Treatment Plant.Treatment on-site at Rottapharm Ltd. will involve neutralisation and settling facilities, priorto release to sewer. Surface water will be discharged to the River Pinkeen, via an oilinterceptor.

5.1.1 Process Effluent

The proposed facilitycharacteristics:

pHBODCODSuspended Solids

IS expected to produce effluent having the following

6-101,000 - 2,000 mg/1t.2,000 - 4,000 mg/lt.100 - 200 mg/lt.

6th April 1998

The normal flowrate expected is 25m3/day with a maximum of 50m3/day.

Effluent from the proposed plant would be discharged separately to the Councilsewer, via a neutralisation/settling facility. The source of the effluent will be cleaningoperations in the plant, principally the mc Bin Washing System. Contaminants in theeffluent will be solid and will thus settle readily in the treatment facility. ContinuouspH monitoring and correction will be used to maintain a pH range of 6-10.

As the normal discharge of effluent will be neutral, the philosphophy for controllingdischarge will be:

• A pH measuring device will be installed in the discharge pipeline.• In normal operation, when pH is neutral, discharge will be direct to the sewer.• In exceptional circumstances, when pH is measured outside the discharge limits of

6 - 10, a valve will automatically close and the effluent flow will be diverted to a25m3 holding tank.

• The volume of effluent which is outside specification will be automaticallyneutralised with authorisation by a technical supervisor.

• When the main flow has returned to within the specification limits, the directdischarge will resume automatically.

The holding tank will be lined reinforced concrete and adequate manholes and valvechambers will be provided for access.

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5.0 EMISSIONS TO THE ENVIRONMENT (Cont'd)

5.1.2 Domestic Effluent

The domestic effluent due to the toilet and canteen facilities for the 70 staff will bedischarged directly to the foul sewer.

5.1.3 Surface Water Run-Off

Uncontaminated rainwater will be discharged to the Pinkeen River, via an oilinterceptor. This will guard against any leakage from motor vehicles using the site.

5.2 Atmospheric Emissions

ocess utilises the organic solvents Ethyl Alcohol and Acetone;e for Bromelain tablets. Rottapharm's R&D section areess which will not require the use of solvents and hope toess developed by the end of 1998.

JiJfetv1 natural gas, and will meet all relevant BATNEEC emission

As the proposed development comprises mainly dry processing of solids, dust generation isthe main potential atmospheric contaminant. For this reason, sophisticated measures toprevent <1no' ~--' ontain any dust generated, are employed. The production areas

and general ventilation systems to ensure removal of any dust.oassed through reverse jet type dust collectors, with backuprentilation extract units will also be fitted with filters. TheEEC emission standards of 0.15mg/m3 concentration ofIS the active ingredient, and I.Omg/nr' of total dust.

)

(I' [/

-0 ~, nurtllaSe tablets requires 16.9kg Ethyl Alcohol per 326kg batch. The annUal{requirement for Ananase is 38 million 200mg tablets which is equivalent to 24 batches peryear. Therefore, the total usage of Ethyl Alcohol for Ananase will be 406kg/yr.

The coating of Extranase tablets requires 27.8kg Ethyl Alcohol and 17kg Acetone per 200kgbatch. The annual requirement for Extranase is 86.4 million 100mg tablets which isequivalent to 43 batches per year. Therefore the total usage of Ethyl Alcohol and Acetonefor Extranase will be 1195kg/yr. and 734kg/yr. respectively.

Rottapharm have carried out tests at their existing Italian facility on levels of solvent \emissions from Coating Operations. A range of flowrates from 1.5kg/hr to 4.9kg/hr ofsolvent were recorded.

BotIJ Ethyl Alcohol and Acetone are Class III solvents according to T.A. Luft 1986 forOrganic Compounds with concentration limit values for waste gas discharges of 150mg/m3

and quantity limit values of 3.0kg/hr.6th April 1998 DPS Engineering & Construction - 97017

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Enviromnental Impact Statement

5.0 EMISSIONS TO THE ENVIRONMENT (Cont'dl

A suitable technology (i.e. low temperature condensation, carbon adsorption) will be utilisedto ensure that emissions to air will meet the above emission limits. The Solvents will berecovered and collected for either re-use on-site for further use off-site.

5.3 Noise

Background Noise

The noise level in the area is dominated by traffic noise associated with the N3 dualcarriageway. This road is used at high speed by traffic travelling to and from Navan and theNorth West of the country. Background noise is also present due to the three existingindustrial facilities. Background noise levels have been measured at:

Site Noise

La", =

=

54.2 dB (A) Daytime

48.6 dB (A) Nightime

The noise sources in the new development will mostly be contained within the productionbuildings and thus will be of little significance from the point of view of environmental noise.The facility will be designed to ensure that noise levels due to the proposed development willmeet limits of 50 dB (A) between 07.00 and 22.00 hours and 45 dB (A) at other times, at offsite locations. The principle sources of noise would be:

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•

•

•

•

•

Production Equipment, e.g. granulators, blenders, packaging machines.These are all located internally in the production building.Ventilation air handling units will be located on the first floor of the buildingand will be equipped with soundproof enclosures designed to ensure that theywill have no significant effect on off-site noise levels.Compressors, boilers, etc. These will also be located in a plant room on thefirst floor of the building and will thus have little impact on off-site noiselevels. They will also be equipped with appropriate noise control measures tomaintain a sound level which will have no significant impact on off-site noiselevels.Chiller compound will be located outside the main production buildings butthe compound will be equipped with appropriate noise control measures.Forklift and vehicular movements. The entrance to the warehouse is to thesouth of the building and forklift and vehicular movements will not have anysignificant effect on noise levels in residential areas. Most forklift movementswill take place within the building.

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5.0 EMISSIONS TO THE ENVIRONMENT (Cont'd)

5.4 General Wastes

The principle wastes generated will be packaging materials and other general wastes. Thesewill be stored in skips pending collection by a licensed contractor for landfill at the FingalCounty Council tiphead at Balleally near Lusk. Packaging which has been contaminated byraw materials will be collected and disposed of separately. This will be performed by a fullylicensed waste contractor and full documentation will be maintained.

Laboratory wastes including small quantities of solvents will be stored in a controlled mannerand disposed of in a fully documented manner by licensed undertakers.

5.5 Clean Technology

The design of the plant takes into account opportunities for use of clean technologies andwaste minimisation techniques to minimise any generation of waste.

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Dust in the most significant source which has the potential to create waste. Thisavoidance of dust generation at source is given prime consideration. Dispensing ofloose raw materials is confined to Laminar Air Flow Booths, which minimise dustentertainment in the air. Material transfer to and from I.B.C. 's involves the use ofproprietary dust caps to contain any dust within the process container. The fact thatblending does not take place in fixed blenders, but retains the product within theI.B.C., also eliminates two material transfer steps which would have the potential togenerate waste.Solvents used in the tablet coating process also have a significant potential to createwaste. Rottapharm's intention is to eliminate this waste at source by substitution ofthe solvents with aqueous based coating solutions.Strict quality control procedures including approval of raw materials will bemaintained. This will reduce the likelihood of off-specification product.PLC Control Systems on the processing equipment will also reduce the likelihood ofoff-specificationproduct.Inventory control will be used to prevent over-ordering of raw materials. Alsofmished products will only be packaged to order, reducing waste of packagingmaterials.Opportunities for recycling of pallets, cardboard, paper etc., will be examined andimplemented as appropriate.All material storage is internal and material transfer is within enclosed areas. Thisprevents the possibility of wind or rain damaging materials.The bin washing system which will be the primary liquid effluent source, will besemi-automated, which will minimise effluent generation.Programmed preventative maintenance will also be used which will minimise any losswhich could arise due to equipment failure.

DPS Engineering & Construction ~ 97017

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6.0 THE RECEIVING ENVIRONMENT

6.1 Land Use

The Rottapharm plant is to be sited in the townland of Damastown, Co. Dublin on fullyserviced lands zoned for industrial use. This zoning objective was incorporated in the 1983Dublin County Council Development Plan and has been reiterated in the 1991 Draft Plan.The general location of the site is close to the Meath-Dublin county boundary line, 0.3kilometres north of the N3 Dual Carriageway and approximately halfway betweenMulhuddart and Clonee. It lies within the valley of the Tolka River and is close to the centreof the area zoned for industrial and related uses. The current site occupies 20 acres of thedesignated 150 acre industrial zone.

Immediately to the West of the Rottapharm site, the lands are occupied by the YamanouchiIreland Company Ltd. Pharmaceutical Plant. IBM have established a plant to the North ofthe site and Helsinn Chemicals and Helsinn Pharmaceuticals have sites to the south west.Loctite have a site to the east of the Rottapharm site.

Beyond the designated industrial area, unzoned lands, for agriculture use, lie to the north andwest. Future residential development is planned for the area adjacent to the East side of theindustrial zone, at a distance of over 500 metres from the proposed plant.

The site incorporates a section of the Pinkeen River which runs in a north/south direction towhere it feeds into the Tolka Rover south of the site. The Tolka River meanders gently in aneasterly direction.

The site is approached from the N3 Dual Carriageway via a distributor road built by theCouncil in 1986/1987 to service the designated industrial zone. The nearest existingresidential property is "Ashleigh House" which is situated approximately 500 metres to thesouth west of the site. This property is owned by Fingal County Council and is currentlyused as a residential drug treatment centre. This property is within the designated industrialzone. The closest significant residential area (existing or planned future) would beapproximately 700 metres due south on the south side of the Navan Road.

6.2 Flora and Fauna

The site consists of sloping grassed field with the Pinkeen River running through it in anorth/south direction. Hedgerows, consisting primarily of hawthorn and elder, overgrownwith bramble and dog rose bushes are evident on the site. Such hedgerows are typical of thearea and are unexceptional. This hedgerow will be removed as part of the development.

There are no "Areas of Scientific Interest" listed for the area. The closest, some 5km to thesouth is Luttrellstown Woods which are classed on a scale of importance as being of "Local"botanical interest.

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6.3 Pinkeen and Tolka Riyers

Water quality in the Pinkeen and Tolka Rivers downstream of Mulhuddart was examined in1987 and 1990 both chemically and biologically. It was found to be highly eutrophic(nutrient rich). This was attributed to run-off from agricultural land upstream. Water qualitybased on the An Foras Forbartha rating system was Q3 - Q2 (Doubtful to Poor).

The river was examined again in 1992 and 1993 and met the requirements for an A2 categoryriver as defined in S.1. No. 294 of 1989 (European Communities (Quality of surface waterintended for the abstraction of drinking water) Regulations 1989).

A summary of ranges obtained was:

ColourTurbityTemperaturepHBOD%D.O.Faecal ColiformTotal Organic Nitrogen

20 - 40° Hazen1.5 - 6.6 ppm2.6 - 15°C7.5-8.50- 2.7 mg/lt.70 - 150100 - 7000/100ml.1.2 - 3.6 mg/It.

A category A2 surface water is defmed (for the purposes of treatment for transformingsurface water into drinking water) as:

"Normal physical treatment, chemical treatment and disinfection e.g. prechlorination,coagulation, flocculation, decantation, filtration, disinfection."

6.4 Groundwater and Soil

Seven cable tool boreholes were drilled on the site of the proposed development by IrishGeotechnical Services Ltd. A Groundwater and Soil Quality investigation was carried outand this report is included in Appendix 3. The boreholes were monitored for groundwateringress potential, landfill gas ingress and tests were carried out on the recovered soil samples.

Four samples of the made ground were chemically analysed to determine sulphate content andpH. Results show low concentrations of sulphates (Class 1) and a near neutral pH. It wasconcluded that no special precautions are necessary to protect good quality foundationconcrete. The samples also had their liquid and plastic limits assessed as well as analysis oftheir particle size distributions by wet sieving.

Groundwater was encountered in a number of the boreholes and water ingress was monitoredover a certain period of time. Details of water ingress are shown on the borehole recordings.

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The boreholes were also monitored for potential landfill gas build-up. Gas readings takenhave shown no Methane to be present and a maximum level of 0.30% carbon dioxide acrossthe site. Oxygen levels of approximately 20% were recorded in the boreholes monitored. Itwas concluded that no gas preventative measures will be required in the construction of thedevelopment.

6.5 Air Ouality & Climate

Air quality in the vicinity of the site is regarded as good. The County Council has monitoredair quality on an on-going basis. These samples were analysed by Gas Chromatography/MassSpectroscopy which would detect concentration in parts per billion. No more than trace (i.e.less than 1OJ.lg/m3

) amounts of any compound were measured.

Meteorological data is also presented in Appendix 4. This indicates that the North Dublinarea experiences predominantly south-westerly winds of speed 4-16 knots and a relatively lowannual rainfall (750mm).

6.6 Noise

There are several noise sources in the area, namely the four existing plants : HelsinnChemicals, Helsinn Birex Pharmaceuticals, Yamanouchi, Mallinckrodt Medical, as well astraffic noise from the N3 dual carriageway which is the dominant noise source in the area dueto the speed and volume of its traffic. The nearest residence, Ashleigh House is locateddirectly adjacent to the N3 and thus the development will have little impact on noise levels atthis location.

Noise monitoring has been carried out in the area and this gives a good indication of baselinenoise levels. The results obtained were mean equivalent continuous noise levels. The resultsobtained were mean equivalent continuous noise levels of:

DaytimeNightime

54.2 dB(A)48.6 dB(A)

Results of this monitoring are included in Appendix 5.

6.7 Socio Economic Factors

The subject site is located at Damastown in County Dublin, approximately 0.75km East ofthe border between County Meath and County Dublin. Approximate distances to urbancentres include Dublin City Centre, 13km to the South East; Lucan population 12,259, 7kmto the South; Leixlip, population 11,938, 7.5km to the South West; Maynooth, population4,768, 12km West of the site; Navan, population 3,660, 32km North West of the site andDunboyne, population 1,989, 4km to the West.


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The proposed development site is situated immediately off the Dublin-Navan Road (N3).This road has been upgraded to dual carriageway in accordance with National Roadsimprovement proposals. Additionally, the M50 motorway by-pass of Dublin is accessible atBlanchardstown approximately 5.5km from the proposed site. The motorway by pass willalso form a part of the intended Euroroute EO! extending between the ports of Lame andRosslare. Dublin International Airport is approximately 12km East North East of the subjectsite. The nearest mainline railway station is at Clonsilla, approximately 3km South of thesubject site. This station forms part of the Iarnrod Eireann suburban network. Journey timeto Clonsilla from Connolly Station in Central Dublin is about half an hour.

The site lies entirely within the County Dublin District Electoral Division (DED) ofBlanchardstown-Tyrrelstown, which along with the adjoining DED of BlanchardstownBlakestown, may be considered the primary hinterland of the site. The secondary hinterlandincludes parts of County Meath and County Kildare approximating largely to DunshaughlinRural District in Meath and Celbridge NO.1 Rural District in Kildare. The modal breakdownof people travelling to work in Meath and Kildare according to 1986 Census data shows thatin the case of both counties, at least 60% of the travelling workforce did so by car. Incontrast, less than 10% travelled by public transport. The relatively high mobility of theprivate car means that the subject site would be accessible to a large percentage of thepopulation of Dunshaughlin Rural District and Celbridge No. 1 Rural District and thus theseareas provide a suitable secondary hinterland.

The subject site is located in an area which experienced population growth at a rate wellabove the average for the State as a whole. This rate of growth, although still high, is muchless than for the period of the 1970's and is expected to moderate further. It seems likely thatthe recommended population capacity to 2001 of 15,000 persons for the combined towns ofMaynooth, Leixlip and Celbridge, which was provided for by the revised ERDO EasternRegion Development Strategy 2001, represents the highest level of likely growth in the area.(It should be noted that the ERDO strategy was not adopted by the Government or the Local

Planning Authorities and therefore has no statutory effect). As a result of this high level ofimmigration, the population age profile reveals a youthful population for the primary andsecondary hinterlands.

Preliminary results from the 1991 Census of Population indicate a slowing down in the rateof growth in the Greater Dublin Area over the past five years. During this period, thepopulation of Dublin-Belgard grew by 4.6%, while the rate of increase for Dublin-Fingal was10.3%. The population of Co. Kildare grew by 5.4%, but the increase recorded by Co.Meath was just 1.6% during this period.


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6.7 Socio Economic Factors (Continued)

Despite the national drop in total number of persons at work between 1981 and 1986, the sitehinterlands witnessed an increase in the size of the workforce, reflecting the high rate ofdevelopment and population growth in the area. Nevertheless the site hinterlands experienceda sharp rise in the unemployment rate which although lower than the national rate ofunemployment, constituted a greater rise in absolute terms. Since 1986, unemployment hasbeen declining slightly. However, the levels still remain high and the combined effect of anincreased labour supply due to the young nature of the population plus emigrants returninghome from abroad, means that the employment situation faces increasing pressure. Thesectoral composition of employment reflects the subject sites proximity to Dublin City with agreater proportion of the workforce employed in services and fewer employed in agriculture.

SECTORAL COMPOSITION OF EMPLOYMENT 1986

Agriculture Industry Services

State 15.0% 29.0% 56.0%

Dublin Region* 0.8% 25.5% 73.3%

Celbridge No.1 R.D. 6.0% 28.0% 66.0%

Meath County 19.2% 34.5% 46.3%

(Source : Census of Population)

* from Greater Dublin Area Development Programme, Final Report

6.8 History and Archaeology

6.8.1 Blanchardstown

The subject site is located approximately 4km from the village of Blanchardstown.As a settlement, the growth of Blanchardstown can be defined by two distinct stagesseparated by quite a lengthy period. Along with the neighbouring settlement ofLucan, Clondalkin and Tallaght, Blanchardstown's origins lie in the Anglo-Normanperiod from the 12'" to the 15'" Century. During this period Blanchardstown relates tothe increase in the size and influence of the Dublin Region within Ireland during the20"' Century. As a result of this phenomenon settlements like Blanchardstown,Lucan, Clondalkin and Tallaght have assumed new town or satellite town roles at thefringe of the Dublin Metropolitan Region.

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6.0 THE RECEIVINGENVIRONMENT

Approximately 2.5km to the East of Blanchardstown is sitnated the List 3 structnre ofDunsink Observatory. (List 3 structnres include State Buildings which the PlanningAuthority desires to have preserved). The listed structure includes the South Domeand Observatory House. Between 1782 and 1921 the Observatory belonged to TrinityCollege Dublin. Since 1947 it has been used by the School of Astronomical Physicsof the Dublin Institute for Advanced Stndies. The Observatory is located on a hilldescribed as "commanding a delightful prospect". The buildings themselves convey awarm solid yet unobtrusive 18"' Centnry feel. Sir William Rowan Hamilton (18051865) who was the author of the acclaimed "Lectnres on Quaternions" in 1835 wasconnected with Dunsink Observatory.

About lkm North East of Mulhuddart Bridge (which is located approximately 2km tothe North West of Blanchardstown Village) can be found fragments of the 14"'Centnry nave and chancel as well as the 15"' Centnry tower of the parish church of theBlessed Virgin Mary. The church and graveyard are located on a hill which providesa pleasant view over and beyond the rich lowlands towards the distant mountains inthe South. Richard Belling, Secretary to the Supreme Council of the CatholicConfederation of Kilkenny who it is suggested may have been the author of"Vindiciae Catholicorum Hiberniae" is buried in the graveyard. Nearby to the Southof the Church and graveyard is Lady Well which is a List 2 structure as well as theChurch. In former times the well was a place of popular pilgrimages. ClonsillaProtestant Church 3.5km West of Blanchardstown, contains the Evie Hone window(St. Fiacre 1937).

6.8.2 Local Demesnes

There are a number of splendid demesnes in the hinterland of the subject site. Theseinclude the riverside Lucan demesne, the Carton demesne at Maynooth andLuttrellstown Woods about 3km North of Lucan. Lucan house which stands in thegrounds of Lucan demesne is a Palladian design which was built by AgmondishamVesey, The Second in 1772 to replace the 16"' Centnry Sarsfield Castle, whose ruinsstill stand. In the demesne is located a memorial to Patrick Sarsfield in the form of agarden ornament.

Carton demesne is a 1,000 acre area of land at the eastern end of Maynooth mainstreet. Within the demesne an artificial lake is fed by the Rye Water. In the late 17"'Centnry the grounds and parklands surrounding Carton House were laid out in anopen natnral fashion. A shell cottage was built by the side of the artificial lake andhundreds of trees were planted.

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The woods at Luttrellstown border the River Liffey for most of their length. Theirimportance has merited their designation as an Area of Scientific Interest. The mainreasons for the designation are the botanical and ornithological qualities of the area.The woods are described as estate woodlands with diverse bird life and unusualplants. At the western end of the woods is located the Anna Liffey mills, while to thenorth is situated the List 2 Structure, Luttrellstown House.

6.8.3 Archaeology

The research involved in this section included an inspection of the National Museumof Ireland records regarding archaeological sites and finds in this area and of therecords of the Office of Public Works concerning Sites and Monuments in CountyDublin. Historical references to any standing monuments in this area were alsochecked.

6.8.4 Archaeological Assets

A study of the National Museum of Ireland records regarding archaeological sites andfmds, revealed that one fmd of archaeological potential had been made in thetownland of Damastown. The archaeological feature concerned is a large stone withthe dimensions of approximately 3ft. x 2ft. almost entirely submerged in a field at theWestern Boundary of Damastown in the direction of Clonee. Two iron hooks areattached to the stone. Although found in the townland of Damastown, the location ofthis archaeological feature would not therefore be affected by the proposeddevelopment. The National Museum has no records of the recovery of any finds fromthe townlands of Huntstown, Little Pace or Macetown South.

Based on the Office of Public Works Sites and Monuments records for County Dublinthere are no known sites or features of archaeological interest within the area to bedeveloped. The nearest standing Monuments are a well (Lady's Well) and a Churchin the townland of Tyrrelstown approximately 2.5km from the development site.Areas of associated settlement related to these monuments would not be endangeredby the development. In any case no obvious traces of the existence of such areapparent.


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7.0 IMPACT OF THE DEVELOPMENT

7.1 Flora & Fauna

The development will have minimal impact on local flora and fauna. The overgrownhedgerow through the site will be removed, however this hedgerow is typical of thearea and unexceptional. Certain boundaries of the site will retain the existinghedgerows, with additional planting on the Southern boundary on a raised earthenberm of height Zm, consistent with that provided at the existing Yamanouchi site.This planting will both offset the effect of the hedgerow removal and give improvedscreening of the plant from the N3 roadway.

7.2 ~

All plant effluent will be eventually discharged to sewer. Prior to this it will betreated by neutralisation with settlement of suspended solids. Continuous pHmonitoring and correction will be used to maintain an outlet pH between 6 and 10.Any contaminants in the effluent will be insoluble and will readily settle out. Thiseffluent treatment will be a carried out on a diverted stream based on in-line pHmonitoring in a 25m3 neutralization/holding tank. Normal discharge will be direct tothe Council sewer. The effluent emitted is due to washing operations and is expectedto be approximately 25m3/day under normal circumstances with a maximum of50m3/day. This is discharged to sewer which goes to the Ringsend Sewage TreatmentPlant. This plant receives approximately 330,OOOm3/day and thus the additional loadis negligible.

Surface water will be allowed run-off to the Pinkeen River via an oil interceptor.This will be uncontaminated and of no environmental significance to the aquaticenvironment.

There will be no discharge to groundwater, as areas where spillage could occur willbe fully drained and there is no bulk storage of liquids other than water. For the samereasons, soil quality will not be affected.


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7.0 IMPACT OF THE DEVELOPMENT (Cont'dl

7.3 Wastes

Solid wastes associated with the plant will primarily be packaging materials and othergeneral wastes. These will be collected in skips pending collection by a licensedcontractor. Packaging which has been contaminated by raw materials or other processmaterials will be collected and disposed of separately. This will utilise the techniqueof deep burial. This will be performed by a fully licensed waste undertaker and fulldocumentation will be maintained. General waste will be collected by Ipodec Ltd.and landfilled at the Fingal Co. Council tiphead at Balleally near Lusk. Opportunitiesfor recycling of pallets, packaging materials and paper, etc. will be examined andimplemented as appropriate. Small quantities of laboratory organic and aqueousliquid wastes, will be disposed of in a controlled manner to licensed undertakers.Since all wastes are handled in a controlled manner and licensed contractors and wasteundertakers are used, the impact of wastes generated will be minimal.

7.4 Air & Climate

All air emission points will be designed to meet BATNEEC and T.A. Luft limits.Dust emissions will meet the limits of 0.15mg/m3 concentration of pharmaceuticaldust expressed as active ingredient, as well as the total dust limit of Lflmg/m'.Solvent emissions will be controlled to meet BATNEEC and T.A. Luft Standards of150mg/m3 and a maximum of 3kg/hr All emission points will be periodically sampledto ensure compliance with these limits. Thus air quality will not be affected by thedevelopment. Also, the development is neither of a size nor nature which could affectthe climate.

7.5 Noise

Due to the proximity of the N3 dual carriageway to the site, the dominant noisesource in the area is traffic. The road is heavily used by traffic between Dublin andNavan, and the North West of the country, travelling at high speed. All equipment inthe new plant will be specified so that noise levels contributed by the developmentwill not exceed 50 dB (A) between 7.00 and 22.00 and 45 dB (A) otherwise, outsidethe site boundary. For these reasons, local residents will not be affected by thedevelopment in terms of noise emissions.


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7.0 IMPACT OF THE DEVELOPMENT lCont'd)

7.6 Socio Economic Factors

During the construction phase of this development, approximately 100-150 personswill be occupied on a full-time basis, for approximately 12 months. These jobs willspan a wide range of building and construction skills.

Once the plant is operational, employment will be provided for 70 people, of whom50 will be engaged in production and related activities.

These opportunities will be both for school leavers and those with third levelqualifications, in technical, science and engineering disciplines. The skills requiredwill range from highly qualified technical personnel including Chemists, Pharmacistsand Engineers through maintenance skills and operating skills. Skills of operatingpersonnel will be developed by on-site training by the company.

The total capital cost of the proposed development is approximately IR£12.5 million.

7.7 Hist01:Y and Archaeology

There are no known archaeological features in the area to be developed byRottapharm. The nearest standing monuments are a well and church in the townlandof Tyrrelstown, approximately 2.5km away, any areas of associated settlement wouldnot be affected by the development. Thus the proposed plant would have no impacton the cultural heritage of the area.

7.8 Roads

With a workforce of 70, it is anticipated that the number of cars arriving on site willbe approximately 50 per day. In comparison with the volume of traffic which usesthe N3 Dual Carriageway, this additional traffic will be negligible. The majority ofthis traffic will also be travelling from Dublin City in the morning and returning inthe evening, whereas the greater volume of traffic will be travelling in the oppositedirection. The fact that the proposed site is accessed via a slip road and tworoundabouts, also means that the site can be reached easily and without causing trafficcongestion, even at peak times.

Deliveries, shipments and service vehicles will amount to approximately 6 trucks perday and 2 vans per day. These will generally not arrive at peak periods. Again theslip road and roundabout system will ensure that such traffic does not causecongestion. The service road to the South of the Rottapharm site is only used byvehicles coming to and from Helsinn Chemicals, Helsinn Birex Pharmaceuticals,Yamanouchi and some other small companies.


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7.0 IMPACT OF THE DEVELOPMENT (Cont'd)

The construction phase of the project is expected to generate approximately 60 vehiclemovements per day. Contractors are expected to operate a pick-up system which willminimise the number of vehicles arriving in the morning period. Again, theaccessibility of the site will mean that there is no significant impact on traffic levels orcongestion.

7.9 Visual Impact

The proposed development is composed of four buildings, an AdministrationBuilding, a Secondary Manufacturing Building, a Bulk Manufacturing Building and aWarehouse Building. These buildings are connected via a link corridor and also by abridge structure which crosses the existing stream on the site. The buildings are ofvarying height with the Administration Building being 8.1 metres high and thewarehouse building being 14.5 metres high.

The building layout is oriented in response to the geometry of the existing stream, aswell as the site contours which run at an angle to the main road, so as to minimise theeffects on the existing landscape.

The Administration Building is a stand alone building 40 metres back from the accessroad and clad in a light metal sandwich panel with aluminium double glazed powdercoated windows. It is linked to the production warehouse buildings across the streamby an elegant bridge structure. The scale of the warehouse building is reduced byintroducing a stepped elevation with the front section of the warehouse building beingof the reduced heights to match the Administration Building. The SecondaryManufacturing Bulk and Warehouse buildings are also clad in light coloured metalsandwich panels and here the use of different colour and texture helps to both breakdown the scale of the buildings and also to link the overall composition of thedevelopment.

A separate entrance for staff and service traffic is proposed, located on either side ofthe existing stream. The car parking for the complex is located to the left of theAdministration Building but will be screened by a line of trees to minimise it's visualimpact when viewed from the main road. The site will be strategically landscaped asdescribed earlier in Section 4.5 which will serve to enhance the environment of theexisting site and this will include the retention of trees were possible as well as therevival and reinforcement of the existing stream by means of grassed terraces.

Overall it is felt that the visual impact will be one of improving and enhancing theenvironment of the area.

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7.0 IMPACT OF THE DEVELOPMENT (Cont'd)

7.10 OtherImpacts

Human Beings

Due to the low level of emissions, proximity of other plants and distance to residentialareas, the new development is neither a threat nor a nuisance to human beings.

Material Assets

As the development is entirely on industrially zoned land and three other plants arealready in production in this zoned area. there will be no impact on the material assetsof the area.


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APPENDIX 1

Site Location Maps and Site Plans

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APPENDIX 2

Process Schematics

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APPENDIX 3

Soil and Groundwater Quality Investigation

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APPENDIX 4

Meterorological Data

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APPENDIX 5

Noise Monitoring

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Appendix B Letter to the Planning Authority

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Directors Jerry Mehigan (Chairman & Managing) Joe Burns Troy Burton Gerald Bythell Sean Clarke Tim Corcoran

Gary Cotter Paul Coughlan Denis Crowley Phelim Devine Paul Dunne Mike Evans Peter Flynn Marina Hand Terry Hill (British) Pat Kenny Liam Luddy Ria Lyden Eoghan Lynch Sean Mason Donal McDaid Don Menzies Declan Monaghan Fergus Monaghan Seamus Mulherin John O’Mahony Niamh O’Sullivan Associate Directors Peter Adams Tom Blake Paul Brady Ger Breen John Burgess Michael Daly James Duggan Alan J Duggan John Flaherty Ken Freeman Hugh Gray Hugh Griffin Clem Hussey Conor Lavery Tony Lynch Eileen McCarthy Robert McGrath Finbar Murphy John Mundy Andrew Nixon Joanna O’Brien Gavin O’Donnell Hugh O’Dwyer Noel O’Hara John O’Sullivan David O’Keeffe John Reale Barry Ryan Joe Ryan Grainne Wolfe Ove Arup & Partners Ireland trading as Arup Consulting Engineers Company Reg No 37037 Company Secretary Marina Hand Reg Office 50 Ringsend Road Dublin 4 08080808

Cork 15 Oliver Plunkett St

Tel +353 (0)21 427 7670

Dublin 50 Ringsend Road

Tel +353 (0)1 233 4455

Galway 21 Middle St

Tel +353 (0)91 894 700

Limerick Hartstonge House, Upr Hartstonge St

Tel +353 (0)61 212 100

Your ref

Our ref D6400/40/CL/AP

File ref A L0001

Date 22 June 2009

50 Ringsend Road

Dublin 4 Ireland

Tel +353 1 233 4455

Fax +353 1 668 3169

[email protected]

www.arup.ie

Fingal County Council

Planning Department

PO Box 174

Swords

Fingal

Co Dublin

Dear Sir

D 6400/40 Rottapharm Ltd

Notice to Local Authority of IPPC Licence Application

On behalf of our client, Rottapharm Ltd, we wish to notify you that Rottapharm have applied for an IPPC

Licence for their facility at Damastown Industrial Park, Mulhuddart, Dublin 15 (National Grid Reference

305440E, 241380N). Rottapharm Ltd previously wrote to Fingal County Council Water Services Department

on 3 April 2009 informing the County Council of their intention to apply for an IPPC licence. This letter

revises the class of activity under the First Schedule of the Protection of the Environment Act 2003 for which

the licence is being applied.

The Application relates to the use of a chemical or biological process for the production of basic

pharmaceutical products (Class 5.16) as the principal activity and, also, the manufacture or use of coating

materials in processes with a capacity to make or use at least 10 tonnes per year of organic solvents (Class

12.2.2) in accordance with the First Schedule of the Protection of the Environment Act 2003.

A copy of the Application for the IPPC Licence may be inspected at or obtained from the Environmental

Protection Agency, Johnstown Castle Estate, Co. Wexford, as soon as is practicable after the receipt by the

Agency of the Application (Tel: 053-9160600 Lo Call: 1890 335599).

Yours sincerely

for

Arup Consulting Engineers

Colm Leahy

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Appendix C Report on Air Dispersion Modelling

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Rottapharm EPA RFI Air Quality Modelling Assessment Black

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Rottapharm EPA RFI Air Quality Modelling Assessment

October 2009

This report takes into account the

particular instructions and requirements

of our client.

It is not intended for and should not be

relied upon by any third party and no

responsibility is undertaken to any third

party Arup Consulting Engineers

50 Ringsend Road, Dublin 4 Ireland

Tel +353 1 233 4455 Fax +353 1 668 3169

www.arup.ie

Job number D 6400/42

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http://www.arup.ie/

\\DUBNTS03\DUBLIN_JOBS\D6400-D6499\D6400\5) DESIGN\42\AIR EMISSIONS\AIR QUALITY MODELLING ASSESSMENT_D6400-42_ISSUE.DOC

Arup Consulting Engineers Issue 2 October 2009

Document Verification

Page 1 of 1

Job title EPA RFI Job number

D 6400/42

Document title Air Quality Modelling Assessment File reference

Document ref

Revision Date Filename Air Quality Modelling Assessment_D6400-42.doc

Draft 1 23/09/09 Description First draft

Prepared by Checked by Approved by

Name Sinead Whyte Don Menzies Don Menzies

Signature

Issue 02/10/09 Filename Air Quality Modelling Assessment_D6400-42_Issue.doc

Description


Name Sinead Whyte Don Menzies Don Menzies

Signature

Filename

Description


Name

Signature

Filename

Description


Name

Signature

Issue Document Verification with Document

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Arup Consulting Engineers Issue 2 October 2009

Contents

Page

1 Introduction 1

2 Methodology 1

3 Air Quality Standards 1

4 Background Concentrations 2

5 Dispersion Modelling 2

5.1 Emission Sources 3

5.2 Building Wake Effect 3

5.3 Receptor Locations 3

5.4 Meteorological Data 3

6 Results 3

6.1 NO2 4

6.2 NOx 4

6.3 Carbon Monoxide 4

7 Conclusion 5

8 References 5

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Page 1 Arup Consulting Engineers Issue 2 October 2009

1 Introduction

Rottapharm operates a pharmaceutical facility making a range of capsule, sachet and

tablets at its premises at Damastown, Co. Dublin. This modelling study assesses the

impact of emissions from three existing boilers and a proposed thermal oxidiser located on

site on the atmospheric environment. The pollutants modelled for this study are carbon

monoxide (CO) and nitrogen oxides (NOx).

Air quality standards for carbon monoxide and oxides of nitrogen (NOx) are specified in

Directive 2000/76/EC, transposed into Irish law by the Air Quality Standards Regulations,

2002 (SI No 271 of 2002). Emissions predicted by this air dispersion modelling assessment

are compared to these standards.

2 Methodology

Emissions to atmosphere from three existing natural gas boilers and a proposed thermal

oxidiser were modelled using AERMOD. The modelling predictions represent the most

conservative or worst-case concentrations which may arise. Several worst-case conditions

are assumed to be coincident:

Emission sources are operating at maximum flow rates, continuously;

Emission sources are operating at maximum emission concentrations, rather than average emission concentrations;

Emission sources are operating for every hour of every day of the year;

Meteorological conditions are those which give rise to the maximum predicted concentration, identifying the worst hour from three years of hourly meteorological data;

A receptor is located at that point which experiences the maximum predicted concentration;

Short-term NO2 concentrations were calculated from the predicted NOx concentrations using

a conversion factor of 0.5 as advised by the EPA (2004). For long-term concentrations, it

was assumed 100% of nitrogen oxides are nitrogen dioxide.

Background concentrations for consideration with the short-term average concentrations

have also been applied in the modelling analysis, at a level of twice the annual mean

background concentration. This is in accordance with UK guidance (UK EA, 2002). There

is no equivalent Irish methodology or EPA guidance.

3 Air Quality Standards

In order to reduce the risk of poor air quality impacting on human health and on the

environment, national and European statutory bodies have set limit values in ambient air for

a range of air pollutants. These limit values or Air Quality Standards (AQS) are defined for

the protection of human health and ecosystems.

The Air Quality Standards (AQS) Regulations, 2002 (S.I. No. 271 of 2002) specify the Limit

Values for total oxides of nitrogen (NOx), for nitrogen dioxide (NO2) and for carbon

monoxide. Table 1 shows the AQS Limit Values relevant to this assessment

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Table 1 Air Quality Standards (AQS Regulations S.I. No. 271 of 2002)

Parameters AQS (μg/m3) Averaging period

NO2 40 Calendar year

NO2 200 (exceeded ≤

18 times) 1 hour

NOx 30 (v) Calendar year

CO 10,000 8 hour

(v) denotes an AQS for the protection of vegetation or ecosystems, rather than for the

protection of human health.

4 Background Concentrations

The EPA has established a zoning system for area of Ireland for air quality purposes. The

Rottapharm facility appears to be located in Zone D (rural area) outside of Dublin City and

its environs (which is classified as Zone A).

NO2 and NOx monitoring results recorded by the EPA in Zone D in 2007 were averaged for

concentrations recorded at all relevant monitoring sites to represent typical annual mean

background levels. Data for Zone B was used to represent background CO levels as

insufficient data for valid set of results was available for Zone D (refer to Table 2).

Table 2 Background concentrations (annual mean)

Parameters

Annual Mean

Background

Concentration

(µg/m3)

NOx 8 (annual mean)

NO2 5.5(annual

mean)

CO 5001 (8-hour)

1 Data for Zone B as insufficient data for valid set of results for Zone D

5 Dispersion Modelling

Emissions were modelled using the Breeze AERMOD software package, approved by the

EPA and the US EPA (2005). This is a computer model that predicts the ground level

concentration due to emissions from specified sources. The model requires information on:

Emission sources;

Neighbouring buildings;

Receptor locations and;

Meteorological conditions.

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The model was used to predict maximum ground level concentrations over 1-hour, 24-hour

and annual averaging periods.

5.1 Emission Sources

The emission source characteristics are given in Table 3

Table 3 Emissions Sources Data

Emission Data Thermal

Oxidiser

Production Boiler

1

Production Boiler

2

Administration

Boiler

Location Co-

ordinates 305362, 241313 305415, 241297 305415, 241297 305362, 241236

Height (m) 13 13 13 11

Diameter (m) 0.75 0.38 0.38 0.38

Volumetric flow

(m3/hr) 2,000 2,938 2,938 821

Temperature °C 65 240 240 240

Nox Concentrations

(mg/m³) 100 120 120 120

CO Concentrations

(mg/m³) 100 50 50 50

5.2 Building Wake Effect

The length, width and height of buildings in the vicinity of the sources were taken into

account in modelling. Building data was taken from information supplied by Rottapharm.

AERMOD includes a software utility called BPIP to calculate direction-specific building

downwash factors using the relative positions and dimensions of sources and neighbouring

buildings.

5.3 Receptor Locations

Two nested, Cartesian receptor grids were used, centred on the facility, as in previous

assessments. One has receptors covering a 10km by 10km area at 1km intervals. The

other has receptors covering a 2km by 2km area at 100m intervals.

5.4 Meteorological Data

Meteorological data from Met Éireann’s synoptic station at Dublin Airport was used for the

years 2005 to 2007 inclusive. The meteorological data includes hourly values for wind

speed, wind direction, atmospheric stability, ambient temperature and mixing height.

6 Results

The maximum predicted ground-level concentrations (GLCs) from the air dispersion

modelling assessment are presented in Table 4 below for the worst-case year (2006) and

discussed below.

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6.1 NO2

The impact of NO2 emissions is predicted to total 42% of the air quality standard for the

annual mean and 28% of the 99.79 percentile of the one-hour values including background

concentrations.

6.2 NOx

The impact of NOx emissions is predicted to total 64% of the air quality standard for the

annual mean for the protection of vegetation including background concentrations. This

maximum occurs adjacent to the site boundary. However, there are no ecologically

sensitive sites in the vicinity of the facility.

6.3 Carbon Monoxide

The impact of CO emissions is predicted to be 5% of the AQS for the 8 hour mean including

background concentrations.

Table 4 Results of Air Quality Modelling

Parameter AQS (μg/m

3)

Predicted concentration (μg/m

3)

Background concentration (μg/m

3)1

Predicted concentration plus background concentration (μg/m

3)

Predicted concentration plus background concentration as % of limit value

Location of Maximum Concentration

Easting

Northing

NO2 40 (annual)

11.3 5.5 16.8 42% 305492 241328

NO2 200 (1-hour exceeded ≤ 18 times)

45.5 (99.79

th%ile

of 1-hour)

111 56.5 28% 305554 241234

NOx 30 (v) 11.3 8 19.3 64% 305492 241328

CO 10,000 26 500 526 5% 315554 241234

1 UK Environment Agency H1 p. 26 “Note that the background concentration in the case of

assessing short term effects is assumed to be twice the long term ambient concentration. “

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7 Conclusion

The predicted concentrations comply with the relevant air quality standards and guidelines.

8 References

EPA Environmental Protection Agency (2004) Personal communication (D4265.11)

O’Leary, B. (2007) “Air Quality in Ireland 2006 – Key Indicators of Ambient Air Quality”,

Office of Environmental Assessment, Environmental Protection Agency, PO Box 3000,

Johnstown Castle, Co. Wexford.

UK Environment Agency (EA) (2002) “Integrated Pollution Prevention and Control (IPPC)

Environmental Appraisal and Assessment of BAT; Horizontal Guidance Note IPPC H1”

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Appendix D Audited Accounts of Rottapharm for 2006, 2007 and 2008

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Rottapharm Limited

Directors' report andfinancial statements

Year ended 31 December 2006

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Rottapharm Limited

Directors' report and financial statements

Contents

Directors and other information

Directors' report

Statement of directors' responsibilities

Independent auditors' report

Statement of accounting policies

Profit and loss account

Balance sheet

Notes forming part of the financial statements

Page

1

2

4

5

7

9

10

11 - 21

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Rottapharm Limited

Directors and other information

Directors

Registered office

Secretary

Auditors

Bankers

Solicitors

Registered number

R. BurkeP. Dekker (Dutch)P. GarrahyL. Rovati (Italian)

Damastown Industrial ParkMulhuddartDublin 15

R. Bonfanti

KPMGChartered Accountants1 Stokes PlaceSt. Stephen's GreenDublin 2

Allied hish BankMain StreetBlanchardstownDublin 15

Anglo Irish Bank Corporation picStephen Court18/21 St. Stephen's GreenDublin 2

Credit Agricole lndosuez (Suisse) SALugano BranchPO Box 5822 6901Lugano 1Italy

McCann FitzgeraldOne RiversideSir John Rogerson's QuayDublin 2

226092

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Rottapharm Limited

Directors' report

The directors submit their annual report together with the audited financial statements of the Company forthe year ended 31 December 2006.

Principal activities, business review and business risks

The principal activity of the Company is the production and sale of drugs used in the treatment of osteoarthritis, on behalf of its parent Group. The major active ingredient of these drugs is GlucosamineSulphate, a natural component extracted from shrimps. The product is packaged in sachets and capsulesand distributed to different markets and customers worldwide.

The Company also produces and sells Bromelain related products (anti inflammatory), in blistered tabletform, to both Italy and France. In addition to this the Company purchases and sells a number of otherproducts in the forms of patches, syringes and tablets.

During 2006 the Company successfully achieved and exceeded both its target production levels and salesexpectations while further developing its cost management program.

Credit risk

The Company sells almost one third of its output to third parties; the rest is sold to other companies withinthe Group. Payments from third parties are regularly received by the due dates. Management reviewsdebts in excess of the normal credit limits and have procedures in place to follow-up on any outstandingamounts due. There are no indications that there should be any concems about the ability of any entitywithin the group to pay amounts due.

Management believes that the bad debt provision in the books at year end 2006 is adequate to cover anybad debts related to prior years.

Liquidity risk

This risk is mitigated by ensuring that the Company remains profitable, cash is collected on a timely basisand cash payments are monitored closely. Cash flow forecasts are prepared to ensure that the Company isalways in a position to meet cash demands.

Foreign exchange risk

The Company is incorporated in Ireland and its operations are largely transacted in Euro. A portion of theCompany's sales and outward payment transactions are undertaken in other non Euro denominatedcurrencies and consequently the Company holds cash reserves in these currencies as needed.

Results and dividends

The results for the year are summarised on pages 9 and 10 of the financial statements. No dividends wereapproved and paid during the year (2005: €3.5 million).

2

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Rottapharm Limited

Directors' report (continued)

Directors and secretary and their interests

In accordance with the Articles of Association, the directors are not required to retire by rotation.

The directors and secretary who held office at 31 December 2006 had no interests in the shares of theCompany or group undertakings.

Electoral Act, 1997

The Company made no political donations during the year.

Books of account

The directors believe that they have complied with the requirements of Section 202 of the Companies Act,1990, with regard to books of account by employing accounting personnel with appropriate expertise andby providing adequate resources to the financial function. The books of account of the Company aremaintained at its registered office.

Health and Safety at work

The safety, health and welfare of Rottapharm employees are safe-guarded through its strict adherence tothe requirements of the "Safety, Health and Welfare at Work Act 2005" and all relevant regulations.Roltapharm maintains a proactive approach towards health and safety by continually assessing risks andputting control measures in place. The directors ensure that such measures take account of changingcircumstances and the general principles of prevention. Rottapharm maintain the presence of competentpersons on site and also where necessary obtain the services of external contractors. The Companymaintains a Safety Statement which is updated as required.

Auditors

In accordance with Section 160 (2) of the Companies Act, 1963, the auditors, KPMG, CharteredAccountants, will continue in office.

0" be 1freJ R~'\W~tr

Lu RovatiDirector

Robert BurkeDirector

3

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Rottapharm Limited

Statement of directors' responsibilities

The directors are responsible for preparing the Directors' report and financial statements in accordancewith applicable law and regulations.

Company law requires the directors to prepare financial statements for each financial period. Under thatlaw, the directors have elected to prepare the financial statements in accordance with Generally AcceptedAccounting Practice in Ireland, comprising applicable company law and the accounting standards issuedby the Accounting Standards Board promulgated by the Institute of Chartered Accountants in Ireland. Thecompany's financial statements are required by law to give a true and fair view of the state of affairs ofthe company and of the profit or loss for the period.

In preparing the financial statements, the directors are required to:

• select suitable accounting policies and then apply them consistently;

• make judgments and estimates that are reasonable and prudent; and

• prepare the financial statements on the going concern basis unless it is inappropriate to presume thatthe company will continue in business.

The directors are responsible for keeping proper books of account which disclose with reasonableaccuracy at any time the financial position of the company and to enable them to ensure that the financialstatements comply with the Companies Acts, 1963 to 2005. They are also responsible for taking suchsteps as are reasonably open to them to safeguard the assets of the company and to prevent and detectfraud and other irregularities.

The directors are also responsible for preparing a Directors' report that complies with the requirements ofthe Companies' Acts 1963 to 2005.

On behalf

Luca l} va iDirector

~~{,~,-tLRobert BurkeDirector

4

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KPMGChartered Accountants1 Stokes PlaceSt. Stephen's GreenDublin 2Ireland

Independent auditors' report to the members of Rottapharm Limited

We have audited the financial statements of Rottapharm Limited for the year ended 31 December 2006,which comprise the profit and loss account, balance sheet and related notes. These financial statementshave been prepared under the accounting policies set out therein.

This report is made solely to the company's members, as a body, in accordance with section 193 of theCompanies Act, 1990. Our audit work has been undertaken so that we might state to the company'smembers those matters we are required to state to them in an auditors' report and for no other purpose.To the fullest extent permitted by law, we do not accept or assume responsibility to anyone other than thecompany and the company's members as a body, for our audit work, for this report, or for the opinionswe have formed.

Respective responsibilities of directors and auditors

The directors' responsibilities for preparing the director's report and the financial statements inaccordance with applicable Irish law and accounting standards issued by the Accounting Standards Boardand promulgated by the Institute of Chartered Accountants in Ireland (Generally Accepted AccountingPractice in Ireland) are set out in the Statement of Directors' Responsibilities on page 4.

Our responsibility is to audit the financial statements in accordance with the relevant legal and regulatoryrequirements and International Standards on Auditing (UK and Ireland),

We report to you our opinion as to whether the financial statements give a true and fair view and havebeen properly prepared in accordance with the Companies Acts 1963 to 2006. We also report to youwhether, in our opinion proper books of account have been kept by the company; whether at the balancesheet date, there exists a financial situation requiring the convening of an extraordinary general meetingof the company; and whether the information given in the Director's Report is consistent with thefinancial statements. In addition we state whether we have obtained all the information and explanationsnecessary for the purposes of our audit, and whether the financial statements are in agreement with thebooks of account.

We also report to you if, in our opinion, any information specified by law regarding the directors'remuneration and directors' transactions with the company is not disclosed and, where practicable,include such information in our report.

We read the Directors' report and consider implications for our report if we become aware of anymisstatements within it.

5KPMG, a partnersh'p es\ab"shed under Irish law, ;$ the Irishmember firm of KP/AG international, a svxss cooperative

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Independent auditors' report to the members of Rottapharm Limited (continued)

Basis of opinion

We conducted our audit in accordance with International Standards on auditing (UK and Ireland) issuedby the Auditing Practices Board. An audit includes examination, on a test basis, of evidence relevant tothe amounts and disclosures in the financial statements. It also includes an assessment of the significantestimates and judgments made by the directors in the preparation of the financial statements, and ofwhether the accounting policies are appropriate to the company's circumstances, consistently applied andadequately disclosed.

We planned and performed our audit so as to obtain all the information and explanations which weconsidered necessary in order to provide us with sufficient evidence to give reasonable assurance thatthe financial statements are free from material misstatement, whether caused by fraud or otherirregularity or error. In forming our opinion we also evaluated the overall adequacy of the presentationof information in the financial statements.

Opinion

In our opinion, the financial statements

• give a true and fair view, in accordance with Generally Accepted Accounting Practice in Ireland,of the state of the company's affairs as at 31 December 2006 and of its profit for the year thenended; and

• have been properly prepared in accordance with the Companies Acts, 1963 to 2006.

We have obtained all the information and explanations we considered necessary for the purposes of ouraudit. In our opinion, proper books of account, have been kept by the company. The financialstatements are in agreement with the books of account.

In our opinion, the information given in the Directors' report is consistent with the financial statements.

The net assets of the company, as stated in the balance sheet on page 10, are not less than half of theamount of its called up share capital and, in our opinion, on that basis there did not exist at 31 December2006 a financial situation, which under Section 40(1) of the Companies (Amendment) Act, 1983, wouldrequire the convening of an extraordinary general meeting of the company.

Chartered AccountantsRegistered Auditors

6

12 July 2007

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Rottapharm Limited

Statement of Accounting Policiesfor the year ended 31 December 2006

The following accounting policies have been applied consistently in dealing with items which areconsidered material in relation to the company's financial statements.

Basis of preparationThe financial statements are prepared in accordance with generally accepted accounting principles underthe historical cost convention and comply with financial reporting standards of the Accounting StandardsBoard, as promulgated by the Institute of Chartered Accountants in Ireland. The company does notprepare consolidated financial statements availing of the exemption for subsidiaries of ED companieswhich themselves prepare consolidated financial statements including those of the company and itssubsidiaries.

Financial fixed assetsInvestment in subsidiary undertakings are stated at cost less provisions for permanent diminutions invalue.

Tangible fixed assets and depreciationTangible fixed assets are reported at cost less accumulated depreciation. No depreciation is provided onland or construction in progress. The charge for depreciation is calculated to write down the cost oftangible fixed assets to their estimated residual values by equal annual installments over their expecteduseful lives as follows:

BuildingsPlant and machineryOffice equipmentMotor vehicles

33 years12 years7 years5 years

Provision is made for any impairment of tangible fixed assets below their carrying amounts.

Intangible fixed assetsPatents, licences and trademarks are stated at cost less amortisation. Intangible fixed assets are amortisedover their expected useful life of 5 years, in line with the benefit accruing. A provision is made for anyimpairment to the carrying value of intangible fixed assets when appropriate.

Foreign currencyTransactions in foreign currencies are recorded at the rate ruling at the date of the transactions or at acontracted rate. The resulting monetary assets and liabilities are translated at the balance sheet rate or thecontracted rate and the exchange differences are dealt with in the profit and loss account.

Cash flow statementA cash flow statement is not prepared as required by Financial Reporting Standard 1 (Revised), "CashFlow Statements", because the directors have decided to avail of the exemptions under FRS 1 forcompanies whose parent undertaking prepares financial statements containing a consolidated cash flowstatement.

7

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Rottapharm Limited

Statement of Accounting Policiesfor the year ended 31 December 2006 (continued)

TaxationCurrent tax is provided on the company's taxable profits, at amounts expected to be paid (or recovered)using the tax rates and laws that have been enacted or substantially enacted by the balance sheet date.

Deferred tax is recognised in respect of all timing differences that have originated but not reversed at thebalance sheet date. A provision is made at the rates expected to apply when the timing differences reverse.Timing differences are differences between the company's taxable profits and its resnlts as stated in thefinancial statements that arise from the inclusion of gains and losses in taxable profits in periods differentfrom those in which they are recognised in the financial statements.

A net deferred tax asset is regarded as recoverable and therefore recognised only when, on the basis of allavailable evidence, it can be regarded as more likely than not that there will be suitable taxable profitsfrom which the future reversal of the underlying timing differences can be deducted.

StocksStocks are stated at the lower of cost and net realisable value. In the case of finished goods and work inprogress cost is defined as the aggregate cost of raw materials, direct labour and the attributable proportionof direct production overheads. Net realisable value is based on normal selling price less further costsexpected to be incurred to completion and disposal.

TurnoverTurnover represents the fair value of goods, excluding value added tax, and is recognised on delivery ofgoods.

PensionsContributions in respect of the company's defined contribution pension scheme are charged to theoperating profit in the year in which they fall due.

Government grantsRevenue based grants are credited to the profit and loss account in the period in which the expenditure towhich they relate is incurred.

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Rottapharm Limited

Profit and loss accountfor the year ended 31 December 2006

2006 2005Note € €

Turnover - continuing operations 1 69,473,419 69,684,502Cost of sales (35,686,624) (35,243,676)

Gross profit 33,786,795 34,440,826

Net operating expenses 2 (3,724,721) (3,379,503)Exceptional item - impairment of financial fixed

asset 9 (l ,961,000)

Operating profit - continning operations 30,062,074 29,100,323

Profit on disposal of fixed asset 3,593

Profit on ordinary activities before interest 30,065,667 29,100,323

Interest receivable 273,142 155,166Interest payable and similar charges 3 (9,612) (8,907)

Profit on ordinary activities before taxation 4 30,329,197 29,246,582

Tax on profit on ordinary activities 5 (3,412,587) (3,627,580)

Profit for the financial year 26,916,610 25,619,002

((~~~R. BurkeDirector

The company had no recognised gains or losses other than those shown above and accordingly no statement oftotal recog ised gains and losses is presented.

On behal~ .

L. Ro tiDirector

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Rottapharm Limited

Balance sheetfor the year ended 31 December 2006

2006 2005€ €

Fixed assetsTangible assets 7 17,152,496 17,137,544Intangible assets 8 13,185 122,377Financial assets 9 202,340,042 174,340,042

219,505,723 191,599,963

Current assetsStocks 10 9,419,110 8,999,439Debtors 11 15,095,368 18,914,086Cash at bank and in hand 10,081,662 8,092,153

34,596,140 36,005,678

Creditors: amounts falling due within one year 12 (2,588,790) (2,938,495)

Net current assets 32,007,350 33,067,183

Total assets less current liabilities 251,513,073 224,667,146

Provisions for liabilities and charges 17 (469,541) (540,224)

Net assets 251,043,532 224,126,922

Capital and reservesCalled up share capital 13 317,500 317,500Capital contribution reserve 14 127,029,117 127,029,117Other reserves 15 1,269,738 1,269,738Profit and loss account 16 122,427,177 95,510,567

Sharehold s'Tunds ~';" 251,043,532 224,126,922

f~ .. R~~~LOn behalf~/

L R0ft,tl R BurkeDirec'or Director

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Rottapharm Limited

Notesforming part ofthe financial statements

1 Turnover

The analysis of turnover by activity andgeographical area are as follows:

Activity:Sale of pharmaceutical products

Geographical area:EuropeSouth AmericaAsia

2006e

69,473,419

68,409,433248,837815,149

69,473,419

2005€

69,684,502

69,153,590164,176366,736

69,684,502

Other segmental information as required by Statement of Standard Accounting Practice No. 25, hasnot been included in these financial statements as the directors are of the opinion that such disclosurewould be seriously prejudicial to the company's competitive position.

2 Net operating expenses 2006 2005€ €

Administration expenses 3,159,035 3,334,099Research and development expenses 18,248 222,500Exchange gain/loss 547,438 (177,096)

3,724,721 3,379,503

3 Interest payable and similar charges

Bank charges

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2006€

9,612

2005€

8,907

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Rottapharm Limited

Notesforming part of the financial statements

4 Statutory and other information2006 2005

€ €

Auditors' remuneration 49,200 52,200

Research and development expenditure 18,248 225,000

Revenue grauts received 437,823

Directors' remunerationFees 6,000 4,000Other remuneration including pension 186,281 167,795

Depreciation and amortisation of:Owned tangible fixed assets 1,728,834 1,437,526Intangible fixed assets 109,192 109,192

5 Tax on profit on ordinary activities2006 2005

€ €Current tax:Irish corporation taxation at 10% 1,703,470 1,387,355Irish corporation taxation at 12.5% 1,706,185 2,003,342Irish corporation taxation at 25% 69,306 42,034

3,478,961 3,432,731Tax withheld from payments made 10,477 7,277Prior year over provision (6,168)

Total current tax 3,483,270 3,440,008

Deferred tax:Charge/(credit) in year (note 17) (70,683) 187,572

Total tax on profit on ordinary activities 3,412,587 3,627,580

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Rottapharm Limited


5 Tax on profit on ordinary activities (continued)

The difference between the total current tax shown above and the amount calculated by applying thestandard rate of Irish corporation tax to the profit before tax is as follows:

Profit on ordinary activities before tax

2006€

30,329,197

2005€

29,246,582

Tax on profit on ordinary activities at standardIrish corporation tax rate of 12.5% (2005: 12.5%)3,791,1503,655,823

Effects of:Capital allowances in excess of depreciationExpenses not deductible for tax purposesPassive incomeNon taxable itemsManufacturing reliefWithholding tax at sourcePrior year over provisionDeferred tax

Current tax charge for the year

6 Staff numbers and costs

85,1371,660

35,161(8,281)

(425,867)10,478(6,168)

(70,683)

3,412,587

(193,748)207,830

80,044(39,747)

(277,471)7,277

187,572

3,627,580

The average number of persons employed by the company (including executive directors)during the year, analysed by category, was as follows:

Number of employees2006 2005

Management and administrationOperatives, technical and other staff

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22104

126

2298

120

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Rottapharm Limited


6 Staff numbers and costs (continued)

The aggregate payroll costs of these persons was as follows:2006 2005

€ €

Wages and salaries 4,456,148 4,072,354Social welfare costs 458,803 423,525Pension costs (note 18) 207,166 158,454

5,122,117 4,654,333

Staff costs inclnde all remuneration of directors employed by the company.

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Rottapharm Limited


7 Tangible fixed assets Office Plant & Motor ConstructionLand Buildings equipment machinery vehicles in progress Total

€ € € € € € €CostAt beginning of year 1,613,914 6,604,188 425,373 18,060,372 135,195 1,019,480 27,858,522Additions 116,439 73,000 1,562,855 1,752,294Disposals (46,315) (46,315)Transfer from CIP 21,313 950,004 247,720 (1,219,037)

At end of year 1,613,914 6,625,501 1,491,816 18,308,092 161,880 1,363,298 29,564,501

--DepreciationAt beginning of year 1,395,710 227,791 9,028,092 69,485 10,721,078Charge for year 195,042 203,003 1,303,449 27,241 1,728,735Acc'd Dep on Disposals - (37,808) (37,808)

At end of year - 1,590,752 430,794 10,331,541 58,918 - 12,412,005

-Net book valueAt 31 December 2006 1,613,914 5,034,749 1,061,022 7,976,551 102,962 1,363,298 17,152,496

At 31 December 2005 1,613,914 5,208,478 197,582 9,032,280 65,810 1,019,480 17,137,544

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Rottaphann Limited


8 Intangible assets2006

€Licenses, trade marks and patents

CostAt beginning of yearAdditions in year

At end of year

AmortisationAt beginning of yearAmortised in year

At end of year

Net book valueAt end of year

9 Financial fixed assets

545,960

545,960

423,583109,192

532,775

13,185

2006 2005€ €

CostAt beginning of yearAdditions/other increases during the yearImpairment provision - Rotta Pharmaceuticals, Inc.-

At end of year

174,340,04228,000,000(1,961,000)

202,340,042

141,301,04235,000,000

174,340,042

In the opinion of the directors the realisable value of the investments is not less than the book valueamounts shown above.

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Rottapharm Limited


9 Financial fixed assets (continued)

The subsidiaries below are not listed on a recoguised stock exchange.

The operating subsidiaries of the company are set out below:

Undertakings Registered Office

Rotta Finance AIB International CentreWest BlockIPSCDublin I

Rotta Pharmaceuticals, Inc. 1340 Campus ParkwayNeptuneNJ07753USA

10 Stocks

Nature of Business

Financial instrumentstrading

Sales and marketingcompany

OwnershipHolding100%

100%

2006 2005€ €

Raw materials 5,732,558 6,444,592Finished goods 2,945,316 1,899,298Work in progress 741,236 655,549

9,419,110 8,999,439

In the opinion of the directors, the replacement cost of stocks is not significantly different from thevalue stated above.

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Rottapharm Limited


11 Debtors2006 2005

€ €

Trade receivables 3,129,678 3,381,587Amounts due from fellow group undertakings 10,939,375 15,006,777Prepayments and accrued income 528,554 355,713Other debtors 24,719 55,693VAT recoverable 102,904 4,845Corporation tax recoverable 370,138 109,471

15,095,368 18,914,086

All amounts fall due within one year.

12 Creditors: amounts falling due within one year2006 2005

€ €

Trade creditors 389,732 1,104,502Accrued expenses 838,654 739,061Other creditors including tax and social welfare 186,800 177,942Amounts due to fellow group undertakings 1,073,604 716,990Deferred income 100,000 200,000

2,588,790 2,938,495

2006 2005€ €

Tax creditorsTax and social welfare included in other creditors:Corporation taxPAYEfPRSI 186,800 177,942

186,800 177,942

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Rottapharm Limited


13 Share capital 2006 2005€ €

Authorised:1,000,000 ordinary shares of El each 1,000,000 1,000,000

1,000,000 1,000,000

Allotted, called up and partly paid:317,500 ordinary shares of €l each 317,500 317,500

14 Capital contribution reserve2006 2005

€ €

At beginning and end of year 127,029,117 127,029,117

15 Other reserves2006 2005

€ €

At beginning and end of year 1,269,738 1,269,738

In 2000 the directors approved the transfer of the euro equivalent of IR£1 million from the capitalcontribution reserve to a special non-distributable reserve as required under the provisions of anagreement with the IDA, dated 18 September 1998.

16 Reconciliation of shareholders' funds

Total recognised gains and losses for the yearTransactions with shareholders:

Dividend paid (€11.023 per share)Opening shareholders' funds

19

2006 2005€ €

26,916,601 25,619,002

(3,500,000)224,126,922 202,007 ,920

251,043,523 224,126,922

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Rottapharm Limited


17 Provision for liabilities and charges

Deferred taxation liabilityAt beginning of yearAmounts provided/(utilised) (note 5)

At end of year

Difference between accumulated depreciationand capital allowances (provided at 12.5%)

2006 2005€ €

540,224 352,652(70,683) 187,572

469,541 540,224

2006 2005€ €

469,541 540,224

18 Pensions

The company operates a defined contribution pension scheme. The assets of the scheme are heldseparately from those of the company in an independently administered fund. The pension costcharge represents contributions payable by the company to the fund and amounted to €207,166(2005: €158,454). Contributions totaling €52,472 (2005: €30,787) were payable to the fund at theyear end and are included in accrued expenses.

19 Ultimate parent undertaking

The company's ultimate parent undertaking is FIDIM SrL, a company registered in Italy. Theconsolidated financial statements of Fidim SrL are available to the public and may be obtained fromthe Chamber of Commerce (Milan), Via Meravigli, 11/6, 20123 - Milan, Italy. The smallest group inwhich the results of the company are consolidated in that headed by Fidim SrI.

20 Contingent liabilities

Government grantsUnder an agreement between the company and the IDA, dated 18 September 1998, the company hasa contingent liability to repay in whole or in part grants received amounting to €I ,328,239 (2005:€1,328,239) if certain circumstances set out in the agreement occur.

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Rottapharm Limited


21 Related parties

The company has availed of the exemption under Financial Reporting Standard 8, "Related PartyDisclosures", for companies consolidated by a parent owning more than 90% of the ordinary sharecapital and, accordingly, have not disclosed details of transactions with other group undertakings.Details on the availability of the group consolidated financial statements are given in Note 19.

22 Approval of financial statements..-.-

These financial statements were approved by the directors on d.. (c:,~~~1

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ROTTAPHARM LIMITED

DIRECTORS' REPORT AND

FINANCIAL STATEMENTS

FOR THE YEAR ENDED

31 DECEMBER 2007

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ROTTAPHARM LIMITED

DIRECTORS' REPORT AND FINANCIAL STATEMENTS

for the year ended 31 December 2007

TABLE OF CONTENTS

COMPANY INFORMATION

DIRECTORS' REPORT

INDEPENDENT AUDITORS' REPORT

PROFIT AND LOSS ACCOUNT

BALANCE SHEET

NOTES TO THE FINANCIAL STATEMENTS

PAGE

2

3

6

8

9

10

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ROTTAPHARM LIMITED

COMPANY INFORMATION

DIRECTORS

SECRETARY

REGISTERED NUMBER

REGISTERED OFFICE

SOLICITORS

BANKERS

AUDITORS

- 2 -

R. BurkeP. Dekker (Dutch)P. GarrahyL. Rovati (Italian)

R. Bonfanti (Italian)

226092

Darnastown Industrial ParkMulhuddartDublin 15

McCann FitzgeraldOne RiversideSir John Rogerson's QuayDublin 2

Allied Irish BankMain StreetBlanchardstownDublin 15

Anglo Irish Bank Corporation picStephen Court18/21 SI. Stephen's GreenDublin 2

Ernst & YoungChartered AccountantsErnst & Young BuildingHarcourt CentreHarcourt StreetDublin 2

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ROTTAPHARM LIMITED

DIRECTORS' REPORTfor the year ended 31 December 2007

The directors submit their annual report together with the audited financial statements of theCompany for the year ended 31 December 2007.

PRINCIPAL ACTIVITIES AND REVIEW OF THE DEVELOPMENT OF THE BUSINESSThe principal activity of the Company is the production and sale of drugs used in the treatmentof osteo-arthritis, on behalf of its parent Group. The major active ingredient of these drugs isGlucosamine Sulphate, a natural component extracted from shrimps. The product ispackaged in sachets and capsules and distributed to different markets and customersworldwide.

The Company also produces and sells Bromelain related products (anti inflammatory), inblistered tablet form, to both Italy and France. In addition to this, the Company purchases andsells a number of other products' in the forms of patches, syringes and tablets.

PRINCIPAL RISKS AND UNCERTAINTIESThe directors consider the following to be the principal risks and uncertainties which may havean impact on its ability to achieve continued success within its market:

• CREDIT RISK - The Company sells almost one third of its output to third parties; therest is sold to other companies within the Group. Payments from third parties areregularly received by the due dates. Management reviews debts in excess of thenormal credit limits and has procedures in place to follow-up on any outstandingamounts due. There are no indications that there should be any concerns about theability of any entity within the group to pay amounts due. Management believes thatthe bad debt provision in the books at year end 2007 is adequate to cover any baddebts related to prior years.

• LIQUIDITY RISK - This risk is mitigated by ensuring that the Company remainsprofitable, cash is collected on a timely basis and cash payments are monitoredclosely. Cash flow forecasts are prepared to ensure that the Company is always in aposition to meet cash demands.

• FOREIGN EXCHANGE RISK - The Company is incorporated in Ireland and itsoperations are largely transacted in Euro. A portion of the Company's sales andoutward payment transactions are undertaken in other non Euro denominatedcurrencies and consequently the Company holds cash reserves in these currenciesas needed.

RESUL TS AND DIVIDENDSThe profit and loss account for the year ended 31 December 2007 and the balance sheet atthat date are set out on pages 8 and 9. The profit on ordinary activities for the year amountedto €31,242,699 (2006: €30,329,197). After charging taxation of €3,469,813 (2006:€3,412,587) an amount of €27,772,886 (2006: €26,916,610) is available for dividends andretention. The directors did not payor propose to pay any dividend during the currentfinancial year.

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ROTTAPHARM LIMITED

DIRECTORS' REPORTfor the year ended 31 December 2007 (Continued)

KEY PERFORMANCE INDICATO~S

The directors consider sales and costs incurred as being the key performance indicators.During 2007 the Company successfully achieved and exceeded both its target productionlevels and sales expectations while further developing its cost management program. TheFinancial Manager reports the P&L results on a monthly basis, and also a set of businesscontrol indicators for production, logistics, and quality department's processes execution(equipment efficiency, process scrap percentages, inventory turnover, on-time delivery, batchrelease timeliness etc.)

DIRECTORS AND SECRETARY AND THEIR INTERESTSIn accordance with the Articles of Association, the directors are not required to retire byrotation.

The directors and secretary who held office at 31 December 2007 had no interests in theshares of the Company or group undertakings.

ELECTORAL ACT, 1997The Company made no political donations during the year.

IMPORTANT EVENTSThere have been no important events since the year-end

BOOKS OF ACCOUNTThe directors believe that they have complied with the requirements of Section 202 of theCompanies Act, 1990, with regard to books of account by employing accounting personnelwith appropriate expertise and by providing adequate resources to the financial function. Thebooks of account of the Company are maintained at its registered office.

EMPLOYEE AND ENVIRONMENTAL MATTERSThe safety, health and welfare of RoUapharm employees are safe-guarded throughadherence to health and safety standards. Rottapharm maintains a proactive approachtowards health and safety by continually assessing risks and putting control measures inplace. The directors ensure that such measures take account of changing circumstances andthe general principles of prevention. Rottapharm maintain the presence of competent personson site and also where necessary obtain the services of external contractors. The Companymaintains a Safety Statement which is updated as required. The Company will seek tominimise adverse impacts on th~ environment from its activities.

STATEMENT OF DIRECTORS' RESPONSIBILITIES IN RESPECT OFTHE FINANCIAL STATEMENTSThe directors are responsible for preparing the financial statements in accordance withapplicable Irish law and Generally Accepted Accounting Practice in Ireland including theaccounting standards issued by the Accounting Standards Board and promulgated by theInstitute of Chartered Accountants in Ireland.

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ROTTAPHARM LIMITED

• select suitable accounting policies and then apply them consistently;

make judgements and estimates that are reasonable and prudent; and

- 5 -

Mr. Robert BurkeDirector

Date: 16th April, 2008

Oob ~~.'D . Luca RovatiDirector

• prepare the financial statements on the going concern basis unless it isinappropriate to presume that the Company will continue in business.

STATEMENT OF DIRECTORS' R;SPONSIBILITIES IN RESPECT OFTHE FINANCIAL STATEMENTS (continued)

AUDITORSThe auditors, Ernst & Young, Chartered Accountants, were first appointed auditors to theCompany during the year and will continue in office in accordance with Section 160(2) of theCompanies Act, 1963. The previous auditors, KPMG resigned during the year.

Company law requires the directors to prepare financial statements for each financial yearwhich give a true and fair view of the state of affairs of the Company and of the profit or lossof the Company for that period. In preparing these financial statements, the directors arerequired to:


The directors are responsible for keeping proper books of account that disclose withreasonable accuracy at any time the financial position of the Company and enable them toensure that the financial statements comply with the Companies Acts, 1963 to 2006. Theyare also responsible for safeguarding the assets of the Company and hence for takingreasonable steps for the prevention and detection of fraud and other irregularities.

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•,,,IIIIIIIIIIIIII

11111111111111111111111111111 II"" :uERNST& YOUNG

INDEPENDENT AUDITORS' REPORT TO THE MEMBERS OF ROTIAPHARM LIMITED

We have audited the company's .financial statements of Rottapharm Limited for the yearended 31 December 2007 which comprise the Profit and Loss Account, the Balance Sheetand the reiated notes 1 to 23. These financiai statements have been prepared under theaccounting policies set out therein.

This report is made solely to the company's members, as a body, in accordance with section193 of the Companies Act, 1990. Our audit work has been undertaken so that we might stateto the company's members those matters we are required to state to them in an auditors'report and for no other purpose. To the fullest extent permitted by law, we do not accept orassume responsibility to anyone othe\ than the company and the company's members as abody, for our audit work, for this report, or for the opinions we have formed.

Respective responsibilities of directors and auditorsThe directors are responsible for the preparation of the financial statements in accordancewith applicable Irish law and Accounting Standards issued by the Accounting Standards Boardand promulgated by the Institute of Chartered Accountants in Ireland (Generally AcceptedAccounting Practice in Ireland) as set out in the Statement of Directors' Responsibilities.

Our responsibility is to audit the financial statements in accordance with relevant legal andregulatory requirements and International Standards on Auditing (UK and Ireland).

We report to you our opinion as to whether the financial statements give a true and fair viewand are properly prepared in accordance with the Companies ,cects, 1963 to 2006. We alsoreport to you our opinion as to: whether proper books of account have been kept by thecompany; whether, at the balance sheet date, there exists a financial situation which mayrequire the convening of an extraordinary general meeting of the company; and whether theinformation given in the Directors' Report is consistent with the financial statements. Inaddition, we state whether we have obtained all the information and explanations necessaryfor the purposes of our audit and whether the financial statements are in agreement with thebooks of account.

We also report to you if, in our opinion, any information specified by law regarding directors'remuneration and other transactions is not disclosed and, where practicable, include suchinformation in our report.

We read the Directors' Report and consider the implications for our report if we become awareof any apparent misstatements within it.

Basis of audit opinionWe conducted our audit in accordance with International Standards on Auditing (UK andIreland) issued by the Auditing Practices Board. An audit includes examination, on a testbasis, of evidence relevant to the amounts and disclosures in the financial statements. It alsoincludes an assessment of the significant estimates and judgments made by the directors inthe preparation of the financial statements, and of whether the accounting policies areappropriate to the company's circumstances, consistently applied and adequately disclosed.

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11111111111111111111111111111,"'" ~ERNST& YOUNG

INDEPENDENT AUDITORS' REPORT TO THE MEMBERS OF ROTIAPHARM LIMITED(continued)

Basis of audit opinion (continued)We planned and performed our audit so as to obtain all the information and explanationswhich we considered necessary in order to provide us with sufficient evidence to givereasonable assurance that the financial statements are free from material misstatement,whether caused by fraud or other irregularity or error. In forming our opinion we alsoevaluated the overall adequacy of the presentation of information in the financial statements.

OpinionIn our opinion, the financial statements give a true and fair view, in accordance with GenerallyAccepted Accounting Practice in Ireland, of the state of affairs of the company as at 31December 2007 and of its profit for the year then ended and have been properly prepared inaccordance with the Companies Acts, 1963 to 2006.

We have obtained all the information and explanations we consider necessary for thepurposes of our audit. In our opinion proper books of account have been kept by thecompany. The financial statements are in agreement with the books of account.

In our opinion the information given in the Directors' Report is'consistent with the financialstatements.

In our opinion, the baiance sheet does not disciose a financial situation which under section40(1) of the Companies (Amendment) Act, 1983 would require the convening of anextraordinary general meeting of the company.

Ernst & YoungChartered Accountants and Registered Auditors

Dublin

Date If ~ (L,( ,} Oo€' .

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ROTTAPHARM LIMITED

2007 2006Note € €

Turnover - continuing operations 2 69,414,146 69,473,419Cost of sales (35,715,984) (35,686,624)

Gross profit 33,698,162 33,786,795

Administration expenses (2,847,533) (3,721,128)

273,142(9,612)

(3,412,587)

26,916,610

30,065,667

30,329,197

401,497(9,427)

(3,469,813)

27,772,886

30,850,629

31,242,699

5

3

4


no recognised gains or losses other than those shown above andent of total recognised gains and losses is presented.

rd on 16th April, 2008

Dr,. Luca RovatiDirector

Profit for the financial year

Tax on profit onordinary activities

Operating profit - continuing operations

Profit on ordinary activities before taxation

PROFIT AND LOSS ACCOUNTfor the year ended 31 December 2007

Interest receivable and similar incomeInterest payable and similar charges

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2007 2006Note € €

ASSETS EMPLOYED

FIXED ASSETSTangible assets 7 16,145,339 17,152,496Intangible assets 8 10,160 13,185Financial assets 9 224,752,608 202,340,042

240,908,107 219,505,723

CURRENT ASSETSStocks 10 8,229,780 9,419,110Debtors 11 14,411,758 15,095,368Cash at bank and in hand 17,973,659 10,081,662

CREDITORS: amounts falling due within one year 12

251,043,532

317,500127,029,117

1,269,738122,427,177

40,615,197 34,596,140

(2,287,159) (2,588,790)

38,328,038 32,007,350

279,236,145 251,513,073

(419,727) (469,541)

278,816,418 251,043,532

13 317,50014 127,029,11715 1,269,73816 150,200,063

17 278,816,418

18


Dr. Lu a RovatiDirector

Shareholder ' funds

Approved ~"'''' ~"" 2008

- 9 -

FINANCED BY

CAPITAL AND RESERVESCalled up share capitalCapital contribution reserveOther reservesProfit and loss account

Provisions for liabilities and charges

TOTAL ASSETS LESS CURRENT LIABILITIES

NET CURRENT ASSETS

NET ASSETS

ROTTAPHARM LIMITED

BALANCE SHEETat 31 December 2007

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ROTTAPHARM LIMITED

1. ACCOUNTING POLICIES,

Provision is made for any impairment of intangible assets below their carryingamounts.

5 years5 years5 years

33 years12 years7 years5 years

PatentsLicencesTrademarks

BuildingsPlant and machineryOffice equipmentMotor vehicles

(e) ForeigncurrencyTransactions in foreign currencies are recorded at the rate ruling at the date of thetransactions or at a contracted rate. The resulting monetary assets and liabilities aretranslated at the balance sheet rate or the contracted rate and the exchangedifferences are dealt with in the profit and loss account.

(d) Intangible assetsPatents, licences and trademarks are stated at cost less amortisation. The charge foramortisation is calculated to write down the cost of intangible assets to their estimatedresidual values by equal annual installments over their expected useful lives asfollows:

The following accounting policies have been applied consistently in dealing with itemswhich are considered material in relation to the Company's financial statements.

Provision is made for any impairment of tangible fixed assets below their carryingamounts.

(c) Tangible fixed assets and depreciationTangible fixed assets are reported at cost less accumulated depreciation. Nodepreciation is provided on land or construction in progress. The charge fordepreciation is calculated to write down the cost of tangible fixed assets to theirestimated residual values by equal annual installments over their expected usefullives as follows:

(a) Basis of preparationThe financial statements are prepared in accordance with generally acceptedaccounting principles under the historical cost convention and comply with financialreporting standards of the Accounting Standards Board, as promulgated by theInstitute of Chartered Accountants in Ireland.

(b) Financial fixed assetsInvestment in subsidiary undertakings are stated at cost less provisions for permanentdiminutions in value.

NOTES TO THE FINANCIAL STATEMENTS31 December 2007

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ROTTAPHARM LIMITED

NOTES TO THE FINANCIAL STATEMENTS31 December 2007 (Continued)

1. ACCOUNTING POLICIESc(continued)

(f) Cash flow statement -.A cash flow statement is not prepared as required by Financial Reporting Standard 1(Revised), "Cash Flow Statements", because the directors have decided to avail ofthe exemptions under FRS 1 for companies whose parent undertaking preparesfinancial statements containing a consolidated cash flow statement.

(g) TaxationCurrent tax is provided on the Company's taxable profits, at amounts expected to bepaid (or recovered) using the tax rates and laws that have been enacted orsubstantially enacted by the balance sheet date.

Deferred tax is recognised in respect of all timing differences that have originated butnot reversed at the balance sheet date. A provision is made at the rates expected toapply when the timing differences reverse. Timing differences are differencesbetween the Company's taxable profits and its results as stated in the financiaistatements that arise from the inclusion of gains and losses in taxable profits inperiods different from those in which they are recognised in the financial statements.

A deferred tax asset is regarded as recoverable and therefore recognised only when,on the basis of all available evidence, it can be regarded as more likely than not thatthere will be suitable taxable profits from which the future reversal of the underlyingtiming differences can be deducted.

(h) StocksStocks are stated at the lower of cost and net realisable value. In the case of finishedgoods and work in progress, cost is defined as the aggregate cost of raw materials,direct labour and the attributable proportion of direct production overheads. Netrealisable value is based on normal selling price less further costs expected to beincurred to completion and disposal.

I(i) Turnover

Turnover represents the fair value of goods, excluding value added tax, and isrecognised on delivery of goods.

0) PensionsContributions in respect of the Company's defined contribution pension scheme arecharged to the operating profit in the year in which they fall due.

(k) Government grantsRevenue based grants are credited to the profit and loss account in the period inwhich the expenditure to which they relate is incurred.

(lj Research and development activityResearch and devolpment costs are expensed to the profit and loss account asincurred.

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ROTTAPHARM LIMITED


1. ACCOUNTING POLICIES (continued)

(m) Group financial statementsThese financial statements present information about the Company as an individualundertaking and not about its group. The Company is exempt from the obligation todraw up group financial statements under Regulation 8 of the European Communities(Companies: Group Accounts) Regulations, 1992.

2. TURNOVER

2007 2006€ €

The analysis of turnover by activity andgeographical area are as follows:

Activity:Sale of pharmaceutical products 69,414,146 69,473,419

Geographical area:Europe 68,372,860 68,409,433South America 180,368 248,837Asia 860,918 815,149

69,414,146 69,473,419

Other segmental information as required by Statement of Standard AccountingPractice No. 25, has not been included in these financial statements as the directorsare of the opinion that such disclosure would be seriously prejudicial to theCompany's competitive position.

3. INTEREST PAYABLE AND SIMILAR CHARGES

Bank charges

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2007€

9,427

2006€

9,612

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5. TAX ON PROFIT ON ORDINARY ACTIVITIES2007 2006

€ €Current tax:Irish corporation taxation at 10% 1,744,841 1,703,470Irish corporation taxation at 12.5% 1,678,810 1,706,185Irish corporation taxation at 25% 100,374 69,306

3,524,025 3,478,961Tax withheld from payments made 12,838 10,477Prior year over provision (6,168)R&D Tax Credit (17,236)

Total current tax 3,519,627 3,483,270

Deferred tax:credit in year (note 18) (49,814) (70,683)

Total tax on profit on ordinary activities 3,469,813 3,412,587

Profit on ordinary activities before taxation is stated after charging the following items

ROTTAPHARM LIMITED

.

2006€

49,20018,248

6,000186,281547,438

1,728,834109,192

2007€

5,000207,329

49,308

49,200124,813

1,833,6338,025

Auditors' remunerationResearch and development expenditureRevenue grants receivedDirectors' remuneration

feesother remuneration including pension

Exchanges lossesDepreciation and amortisation of:

owned tangible fixed assetsintangible fixed assets

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4. PROFIT ON ORDINARY ACTIVITIES BEFORE TAXATION


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ROTTAPHARM LIMITED


,

TAX ON PROFIT ON ORQINARY ACTIVITIES (Continued)

The difference between the total current tax shown above and the amount calculatedby applying the standard' rate of Irish corporation tax to the profit before tax is asfollows:

The average number of persons employed by the Company (including executive directors)during the year, analysed by category, was as follows:

Number of employees2007 2006

IIIIIIIIIII

5.

6.

Profit on ordinary activities before tax

Tax on profit on ordinary activities at standardIrish corporation tax rate of 12.5% (2006: 12.5%)

Effects of:Capital allowances in excess of depreciationExpenses not deductible for tax purposesPassive incomeNon taxable itemsManufacturing reliefWithholding tax at sourcePrior year over provisionIncome Taxable at higher rateR&D Tax CreditUnrealised exchange gain

Current tax charge for the year

Manufacturing relief is scheduled to expire in 2010.

STAFF NUMBERS AND COSTS

Management and administrationOperatives, technical and other staff

- 14 -

2007€

31,242,699

3,905,337

60,869441

(5,029)(436,210)

12,838

50,188(17,236)(51,571)

3,519,627

2299

121

2006€

30,329,197

3,791,150

85,1371,660

35,161(8,281)

(425,867)10,478(6,168)

3,483,270

22104

126

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ROTTAPHARM LIMITED

Staff costs include all remuneration of directors employed by the Company.

•

2006€

4,456,148458,803207,166

5,122,117

4,542,075484,074162,437

2007€

5,188,586

Wages and salariesSocial welfare costsPension costs (note 19)


6. STAFF NUMBERS AND C9STS (Continued)

The aggregate payroll costs of these persons was as follows:

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,--------_ .... ~

ROTTAPHARM LIMITED


7. TANGIBLE FIXED ASSETS Office Plant & Motor ConstructionLand BUildings equipment machinery vehicles in progress Total

€ € € € € € €CostAt beginning of year 1,613,914 6,625,501 1,491,816 18,308,088 161,880 1,363,298 29,564,497Additions - - - - - 831,980 831,980cDisposals - - - (18,147) (59,780) - (77,927)Transfer from C/P - 40,853 245,227 1,821,098 68,200 . (2,175,378)

--~ At end of year 1,613,914 6,666,354 1,737,043 20,111,039 170,300 19,900 30,318,5500>

,

DepreciationAt beginning of year 1,590,752 430,794 10,331,541 58,918 - 12,412,005-Charge for year 195,859 222,769 1,382,243 32,762 - 1,833,633-Acc'd Dep on Disposals (18,147) (54,280) - (72,427)-

At end of year - 1,786,611 653,563 11,695,637 37,400 - 14,173,211

Net book valueAt 31 December 2007 1,613,914 4,879,743 1,083,480 8,415,402 132,900 19,900 16,145,339

At 31 December 2006 1,613,914 5,034,749 1,061,022 7,976,547 102,962 1,363,298 17,152,492

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ROTTAPHARM LIMITED

2007€

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8. INTANGIBLE ASSETS

Licenses, trade marks and patents

CostAt beginning of yearAdditions in year

At end of year

AmortisationAt beginning of yearAmortised in year

At end of year

Net book valueAt end of year

At beginning of year

9. FINANCIAL ASSETS

Cost

At beginning of year 202,340,042Additional investments in Rotta Finance during year 22,000,000Current year adjustment 412,566

2007€

545,9605,000

550,960

532,7758,025

540,800

10,160

13,185

2006€

174,340,04228,000,000

At end of year 224,752,608 202,340,042

The Investment in Rotta Pharmceuticals INC is fully provided for.

The current year adjustment relates to a correction to the investment in the sharecapital of Rotta Finance as a result of exchange losses recognised during conversionof the Company's financial statements to Euro on adoption of the Euro as the singlecurrency in the European Union.

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"----------~-=-========..,.

ROTTAPHARM LIMITED


9. FINANCIAL FIXED ASSETS (Continued)

The subsidiaries below are not listed on a recognised stock exchange.

The operating subsidiaries of the Company are set out below:

Undertakings Registered Office Nature ofBusiness OwnershipHolding

Rotla Finance AlB International Centre Financial instruments 100%IFSC trading

Dublin 1

Rotla Pharmaceuticals, 1340 Campus Parkway Sales and marketing 100%Inc. Neptune Company

NJ 07753USA

10. STOCKS2007 2006

€ €

Raw materials 4,196,613 5,732,558Work in progress 2,082,479 741,236Finished goods 1,950,688 2,945,316

8,229,780 9,419,110

In the opinion of the directors, the replacement cost of stocks is not Significantly differentfrom the value stated above.

11. DEBTORS

Trade receivablesAmounts due from fellow subsidiary undertakingsPrepayments and accrued incomeOther debtorsVAT recoverableCorporation tax recoverable

All amounts fall due within one year.

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2007€

3,029,96910,319,329

742,632169,405150,423

14,411,758

2006€

3,129,67810,939,375

528,55424,719

102,904370,138

15,095,368

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ROTTAPHARM LIMITED

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186,800

317,500

2006€

1,269,738

2006€

186,800

2006

1,000,000

389,732838,654186,800

1,073,604100,000

2,588,790

2006€

127,029,117

4,060147,919

317,500

151,979

2007€

898,997673,534151,979512,649

50,000

2007€

1,269,738

2007

1,000,000

2,287,159

2007€

127,029,117

OTHER RESERVES

At beginning and end of year

CAPITAL CONTRIBUTION RESERVE

At beginning and end of year

Allotted, called up and partly paid:317,500 ordinary shares of €1 each

Tax creditorsTax and social welfare included in other creditors:Corporation taxPAYE/PRSI

Authorised:1,000,000 ordinary shares of €1 each

In 2000 the directors approved the transfer of the euro equivalent of IR£1 million from thecapital contribution reserve to a special non-distributable reserve as required under theprovisions of an agreement with the IDA, dated 18 September 1998.

CREDITORS (amounts falling due within one year)

Trade creditorsAccrued expensesOther creditors including tax and social welfareAmounts due to fellow subsidiary undertakingsDeferred income

15.

14.

13. SHARE CAPITAL

12.


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ROTTAPHARM LIMITED


16. PROFIT AND LOSS ACCOUNT

At start of year

Profit for the year

At end of year

2007€

122,427,177

27,772,886

150,200,063

2006€

95,510,567

26,916,610

122,427,177

17. RECONCILIATION OF SHAREHOLDERS' FUNDS2007 2006

€ €

At start of year 251,043,532 224,126,922

Profit for the year 27,772,886 26,916,610

At end of year 278,816,418 251,043,532

18. PROVISION FOR LIABILITIES AND CHARGES 2007 2006€ €

Deferred taxation liabilityAt beginning of year 469,541 540,224Amounts utilised (note 5) (49,814) (70,683)

At end of year 419,727 469,541

Difference between accumulated depreciationand capital allowances (provided at 12.5%) 419,727 469,541

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ROTTAPHARM LIMITED


19. PENSIONS.

The Company operates a' defined contribution pension scheme. The assets of thescheme are held separately from those of the Company in an independentlyadministered fund. The pension cost charge represents contributions payable by theCompany to the fund and amounted to € 162,437 (2006: €207,166). Contributionstotaling € 25,081 (2006: €52,472) were payable to the fund at the year end and areincluded in accrued expenses.

20. ULTIMATE PARENT UNDERTAKING

The immediate parent undertaking and controlling party of the Company is RollaResearch International BV, a company registered in Holland. The ultimate parentundertaking and controlling party and the smallest group of undertakings for whichgroup financial statements are drawn up, and for which the Company is a member, isFIDIM SrL, a company registered in Italy. The consolidated financial statements ofFidim SrL are available to the public and may be obtained from the Chamber ofCommerce (Milan), Via Meravigli, 11/6,20123 - Milan, Italy.

21. CONTINGENT LIABILITIES

Government grantsUnder an agreement between the company and the IDA, dated 18 September 1998,the has a contingent liability to repay in whole or in part grants received amounting to€1,328,239 (2006: €1,328,239) if certain circumstances set out in the agreementoccur.

22. RELATED PARTIES

The Company has availed of the exemption under Financial Reporting Standard 8,"Related Party Disclosures", for companies consolidated by a parent owning morethan 90% of the ordinary share capital and, accordingly, have not disclosed details oftransactions with other group undertakings. Details on the availability of the groupconsolidated financial statements are given in Note 20.

23. APPROVAL OF FINANCIAL STATEMENTS

These financial statements were approved by the directors on Ib~L :l..t:sv"i5

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ROTIAPHARM LIMITED


STATEMENT OF DIRECTORS' RESPONSIBILITIES IN RESPECT OFTHE FINANCIAL STATEMENTS

The directors are responsible for preparing the financial statements in accordance withapplicable Irish law and Generally Accepted Accounting Practice in Ireland including theaccounting standards issued by the Accounting Standards Board and promulgated by theInstitute of Chartered Accountants in Ireland.

Company law requires the directors to prepare financial statements for each financial yearwhich give a true and fair view of the state of affairs of the Company and of the profit or lossof the Company for that period. In preparing these financial statements , the directors arerequired to:

select suitable accounting policies and then apply them consistently;

make judgements and estimates that are reasonable and prudent; and

prepare the financial statements on the going concern basis unless it isinappropriate to presume that the Company will continue in business.

The directors are responsible for keeping proper books of account that disclose withreasonable accuracy at any time the financial position of the Company and enable them toensure that the financial statements comply with the Companies Acts, 1963 to 2006. Theyare also responsible for safeguarding the assets of the Company and hence for takingreasonable steps for the prevention and detection of fraud and other irregularities.

AUDITORSIn accordance with Section 160 (2) of the Companies Act, 1963, the auditors, Ernst & Young,Chartered Accountants, will continue in office.

.,

Date: ~ ~nr --,

Robert BurkeDirector

irectors

Luca RovatiDirector

----;=.>

Date:

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111111111111111111111111111,,""" ~ERNST& YOUNG

INDEPENDENT AUDITORS' REPORT TO THE MEMBERS OF ROTTAPHARM LIMITED

We have audited the company's financial statements of Rottapharm Limited for the yearended 31 December 2008 which comprise the Profit and Loss Account, the Balance Sheetand the related notes 1 to 24. These financial statements have been prepared under theaccounting policies set out therein.

This report is made solely to the company's members, as a body, in accordance with section193 of the Companies Act, 1990. Our audit work has been undertaken so that we might stateto the company's members those matters we are required to state to them in an auditors'report and for no other purpose. To the fullest extent permitted by law, we do not accept orassume responsibility to anyone other than the company and the company's members as abody, for our audit work, for this report, or for the opinions we have formed.

Respective responsibilities of directors and auditorsThe directors are responsible for the preparation of the financial statements in accordancewith applicable Irish law and Accounting Standards issued by the Accounting Standards Boardand promulgated by the Institute of Chartered Accountants in Ireland (Generally AcceptedAccounting Practice in Ireland) as set out in the Statement of Directors' Responsibilities.

Our responsibility is to audit the financial statements in accordance with relevant legal andregulatory requirements and International Standards on Auditing (UK and Ireland).

We report to you our opinion as to whether the financial statements give a true and fair viewand are properly prepared in accordance with the Companies Acts, 1963 to 2006. We alsoreport to you our opinion as to: whether proper books of account have been kept by thecompany; whether, at the balance sheet date, there exists a financial situation which mayrequire the convening of an extraordinary general meeting of the company; and whether theinformation given in the Directors' Report is consistent with the financial statements. Inaddition, we state whether we have obtained all the information and explanations necessaryfor the purposes of our audit and whether the financial statements are in agreement with thebooks of account.

We also report to you if, in our opinion, any information specified by law regarding directors'remuneration and other transactions is not disclosed and, where practicable, include suchinformation in our report.

We read the Directors' Report and consider the implications for our report if we become awareof any apparent misstatements within it.

Basis of audit opinionWe conducted our audit in accordance with International Standards on Auditing (UK andIreland) issued by the Auditing Practices Board. An audit includes examination, on a testbasis, of evidence relevant to the amounts and disclosures in the financial statements. It alsoincludes an assessment of the significant estimates and judgments made by the directors inthe preparation of the financial statements, and of whether the accounting policies areappropriate to the company's circumstances, consistently applied and adequately disclosed.

Continued/...

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,i~1111111111111111111111 111""" " " Ell ERNST& YOUNG

INDEPENDENT AUDITORS' REPORT TO THE MEMBERS OF ROTTAPHARM LIMITED(Cont inued)

Basis of audit opinion (continued)We planned and performed our audit so as to obtain all the information and explanationswhich we considered necessary in order to provide us with sufficient evidence to givereasonable assurance that the financial statements are free from material misstatement,whether caused by fraud or other irregularity or error. In forming our opinion we alsoevaluated the overall adequacy of the presentation of information in the financial statements.

OpinionIn our opinion, the financial statements give a true and fair view, in accordance with GenerallyAccepted Accounting Practice in Ireland, of the state of affairs of the company as at 31December 2008 and of its loss for the year then ended and have been properly prepared inaccordance with the Companies Acts, 1963 to 2006.

We have obtained all the information and explanations we consider necessary for thepurposes of our audit. In our opinion proper books of account have been kept by thecompany. The financial statements are in agreement with the books of account.

In our opinion the information given in the Directors' Report is consistent with the financialstatements.

In our opinion, the balance sheet does not disclose a financial situation which under section40(1) of the Companies (Amendment) Act, 1983 would require the convening of anextraordinary general meeting of the company.

Ernst & YoungChartered Accountants and Registered Auditors

Dublin

./

22 April 2009

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2008 2007Note € e

Turnover - continu ing operat ions 2 64,688,039 69,414 ,146Cost of sales (35,153,581) (35,715,984)

Gross profit 29,534,458 33,698,162

Administrative expenses (2,539,674) (2,847,533)

Operating profit - continuing opera tions 26,994,784 30,850,629

Interest receivable and similar income 212,783 401,497Amounts written off financial assets 19 (90,553,025)Interest payable and similar charges 3 (12,101) (9,427)

ROTTAPHARM LIMITED

PROFIT AND LOSS ACCOUNTfor the year ended 31 December 2008

(Loss)/profit on ordinary activities before taxation 4

Tax on (Ioss)/profit on ordinary activ ities 5

(Loss)/profit for the financial year

(63,357,559)

315,792

(63,041,767)

31,242,699

(3,469,813)

27,772,886

The Company had no recognised gains or losses other than those shown above andaccordingly no statement of total recognised gains and losses is presented.

Approved by the oard of directors

Luca RovatiDirector= =;i,l

,Robert BurkeDirector

./

Date:

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ROTTAPHARM LIMITED

Note

BALANCE SHEETat 31 December 2008

40,615 ,197

(2,287,159)

(419 ,727)

38 ,328 ,038

8,229 ,78014,411 ,75817,973,659

2007€

278 ,816,418

317 ,500127 ,029,117

1,269,738150,200 ,063

279 ,236 ,145

240,908,107

10,16016,145,339

224 ,752,608

(8,819,769)

39 ,000,970

30,181 ,201

(89 ,236)

2008€

10,418,91421,434 ,340

7,147,716

317,500127 ,029,117

1,269,73887 ,158,296

215 ,774,651

215,863 ,887

3,21017,979,893

167,699,583

185,682 ,686

879

13141516

18

12

1011

Provisions for liabilities and charges

FINANCED BY

TOTAL ASSETS LESS CURRENT LIABILITIES

CAPITAL AND RESERVESCalled up share capitalCapital contribut ion reserveOther reservesProfit and loss account

NET ASSETS

NET CURRENT ASSETS

CURRENT ASSETSStocksDebtorsCash at bank and in hand

CREDITORS: amounts falling due withinone year

FIXED ASSETSIntangible assetsTangible assetsFinancial assets

ASSETS EMPLOYED

Shareholders' funds 17 215,774 ,651 278,816,418

Approved by the 0Q1adof dire or~

Luca RovatiDirecto"-==-'id..·-

~"'clJ,)A~t?Robert BurkeDirector

Date: <::~ - C"-" _O~

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ROTIAPHARM LIMITED

NOTES TO THE FINANCIAL STATEMENTS31 December 2008 (Conti nued)

20. PENSIONS

The Company operates a defined contribution pension scheme. The assets of thescheme are held separately from those of the Company in an independentlyadministered fund. The pension cost charge represents contributions payable by theCompany to the fund and amounted to €236,592 (2007: €162,437). Contributionstotaling €17,086 (2007: €25,081) were payable to the fund at the year end and areincluded in accrued expenses.

21. ULTIMATE PARENT UNDERTAKING

The immediate parent undertaking and controlling party of the Company is RollaResearch International BV, a company registered in Holland. The ultimate parentundertaking and controlling party and the smallest and largest group of undertakingsfor which group financial statements are drawn up, and for which the Company is amember, is FIDIM SrL, a company registered in Italy. The consolidated financialstatements of Fidim SrL are available to the public and may be obtained from theChamber of Commerce (Milan), Via Meravigli, 11/6,20123 - Milan, Italy.

22. CONTINGENT LIABILITIES

Government grantsUnder an agreement between the company and the IDA, dated 18 September 1998,the company has a contingent liability to repay in whole or in part grants receivedamounting to € 1,328,239 (2007: €1,328,239) if certain circumstances set out in theagreement occur.

23. RELATED PARTIES

The Company has availed ot the exemption under Financial Reporting Standard 8,"Reiated Party Disclosures", for companies consolidated by a parent owning morethan 90% of the ordinary share capital and, accordingly, have not disclosed details oftransactions with other group undertakings. Details on the availability of the group,consolidated financial statements are given in Note 21.

24. APPROVAL OF FINANCIAL STATEMENTS

These financial statements were approved by the directors on

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Appendix E Non-Technical Summary

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Rottapharm IPPC Licence Application Attachment No. A

A - 1 of 6

ATTACHMENT No. A

NON-TECHNICAL SUMMARY

TABLE OF CONTENTS

A.1. Introduction ............................................................................................................. 2

A.2. The Site ..................................................................................................................... 2

A.3. Surroundings ........................................................................................................... 2

A.4. Materials and Process ............................................................................................. 2

A.5. Seveso Classification ............................................................................................... 3

A.6. Atmospheric Emissions ........................................................................................... 3

A.7. Emissions to Waters ................................................................................................ 3

A.8. Noise Emissions ....................................................................................................... 4

A.9. Wastes ...................................................................................................................... 4

A.10. Monitoring ............................................................................................................... 4

A.11. Environmental Considerations .............................................................................. 4

A.12. Accidental Emissions .............................................................................................. 5

A.13. Statutory Requirements .......................................................................................... 5

A.14. Cessation of Activity ............................................................................................... 5

A.15. Site Management and Control ............................................................................... 6

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A - 2 of 6

A.1. Introduction

Rottapharm Ltd. is part of the Rotta Research group, which has its headquarters in Monza,

Italy. The parent company was established in 1960 and the company is privately owned. The

company’s product range is primarily in the therapeutic categories of rheumatology,

gastroenterology, osteoporosis and HRT, and is marketed in 62 countries. The main markets

are Europe, South America and the Far East. The group has 3 other manufacturing plants in

Europe and employs approximately 1000 people in total. The Rottapharm Ltd. facility in

Dublin has been constructed to manufacture solid oral dosage products and bulk active

material. It is a fully integrated unit incorporating manufacturing, packaging, warehousing,

laboratory facilities, utilities and office accommodation.

A.2. The Site

The Rottapharm Ltd plant consists of 2 discrete buildings: Administration and Production /

Warehouse linked by enclosed corridors. Construction was completed in 1999.

The Administration building is a 2-storey steel framed building with a precast concrete first

floor and metal deck roofing. The Production building is composed of a steel structure with

metal deck roofing and a concrete slab in parts of the first floor to support plant and

equipment servicing the production facility. The Warehouse is single storey steel structured

building with a long span roof truss and a combination of block work with architectural

sheeting to the perimeter walls.

There are more than 150 employees on the Dublin site.

A.3. Surroundings

The Rottapharm plant is located in the townland of Damastown, Co. Dublin on fully serviced

lands zoned for industrial use. The site is located adjacent to the N3 Dual Carraigeway within

the valley of the Tolka River. The site occupies 20 acres of the designated 150 acre industrial

site, refer to Figure A.1. A site plan is shown in Figure A.2.

Immediately to the west of the Rottapharm site, the lands are occupied by the Yamanouchi

Ireland Company Pharmaceutical Plant. IBM is located to the North with Helsinn Chemicals

and Helsinn Pharmaceuticals to the southwest. Loctite are positioned to the east of the

Rottapharm site.

The nearest sensitive receivers are located approximately 500m to the south of the site on the

south side of the N3.

A.4. Operating Hours

The Production department normally works a 2-cycle shift: 7am-3pm and 2.50pm-11pm, 5 days a week, with regular overtime working on Saturdays and Sundays.

There is currently a temporary night shift in operation for stock-building purposes. This runs

from 11pm-7am Sunday to Friday. This is a short term measure, however may be required at some stage in the future also.

Office hours are from 8am to 5pm.

A.5. Materials and Process

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A - 3 of 6

Rottapharm Dublin currently produces a range of products in the form of sachets and capsules

for the treatment of osteoarthritis, the active ingredient for which is Crystalline Glucosamine

Sulphate.

Rottapharm also produce an anti-inflammatory tablet containing the active ingredient

Bromelain, this active Bromelain is bought in to the facility from sister facilities.

Rottapharm Ltd. is also responsible for batch release of two medical devices called “GO-

ON®” and “GO-ON® Mini”. These products are manufactured by a subcontractor (Croma

Pharma) based in Austria.

In 2009 Rottapharm Ireland are expanding their current production capacity to produce two

new capsules, namely 150mg and 300mg Tromalyt. One new sachet product called Plantaben

and one new caplet product called CGS Caplets. Rottapharm also intend to take on the

business of filling and packing the following sachets at the Dublin facility namely; Colofibre,

Legalon, Spagulax. These sachet products will not be manufactured at the Dublin facility.

Rottapharm’s Annual Thermal Fuel Consumption in 2007 was 4,057,720 kW. The Annual

Electricity Consumption in 2007 (kWh) was 4,693,061 kWh.

A.6. Seveso Classification

The site is not an establishment for the purpose of the EC COMAH (Seveso 2) Control of

Major Accident Hazards Directive (Directive 96/82/EC) as amended by Directive

2003/105/EC of the European Parliament and of the Council of 16 December 2003 because

the threshold quantities of dangerous substances are not exceeded.

A.7. Atmospheric Emissions

There are two boilers serving the production area which have an input capacity of 1.5MW

each and one boiler serving the administration building which has an input capacity of

0.422MW. These are considered minor emission points.

Emissions from the abatement system for solvent vapours are considered as main emissions.

Emissions from the boilers and the abatement system were modelled using the model

AERMOD to determine the atmospheric impact on the surrounding area. Predicted

concentrations of nitrogen oxides (including background concentrations) a maximum of 64%

of the air quality limits. The concentration of carbon monoxide reaches a concentration of 5%

of the air quality standard. This impact will not have a significant impact on the atmospheric

environment.

A.8. Emissions to Surface Waters

Surface water run-off from impervious areas are via petrol interceptors into the emission

point. Petrol interceptors are provided on the drainage system to prevent emissions of

hydrocarbon pollutants to surface waters in the unlikely event of a spill on-site. Emissions are

to the River Pinkeen which flows through the site.

A.9. Emissions to Sewer

Rottapharm holds a licence (reference number WPS/F/108) to discharge trade effluent to a

sewer. There are two emission points to sewer: process effluent to the public sewer

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A - 4 of 6

following treatment and foul effluent directly to the public sewer. Rottapharm is in consultation with Fingal County Council regarding the review of emissions to sewer.

A.10. Noise Emissions

Based on a noise survey carried out for this application, site activities are currently not

audible at the site boundary. It is not anticipated that there will be any discernible noise

impact at sensitive receptors associated with the Rottapharm facility. Therefore there is no

requirement for any noise abatement measures within the facility.

A.11. Wastes

Wastes arising at the Rottapharm facility from process, laboratory, packaging, and other

typical sources are classified in accordance with Rottapharm procedures in conjugation with

contracted licensed waste management companies, EPA classification requirements and

relevant waste legislation.

Hazardous waste streams are collected, segregated and transported off-site by licensed waste management companies for appropriate treatment, recycling and/or disposal.

Non- hazardous waste originates primarily from the canteen and various general refuse bins around the site.

Various measures for waste control and minimisation have been implemented by Rottapharm

including the use of solvents with aqueous based coating solutions and inventory control to prevent over-ordering of raw materials.

Aqueous waste, consisting mostly of water and trace organics, is balanced and monitored

before discharge to the Fingal County Council sewer which discharges to the Dublin City

Council Waste Water Treatment Plant at Ringsend.

A.12. Monitoring

Based on the local authority monitoring upstream and downstream of the Rottapharm facility,

it can be concluded that the overall impact on emissions to surface water from Rottapharm is

not significant. The extension of the facility is not expected to have an adverse impact on surface water.

Rottapharm carries out a programme of monitoring and maintenance of its effluent system.

The licensed trade effluent is held in a balancing tank prior to discharge to the sewer. Trade

effluent requiring pH adjustment is transferred to an alternative tank. Due to the settlement of

suspended solids in this balancing tank a build-up of sludge develops. The settlement is

monitored.

Four boundary locations were selected for the Environmental Noise Survey which was carried

out in January 2009. The noise environment in the area is dominated by traffic noise from the

Damastown Industrial Estate access road, the N3 National Primary Route and the M50. Site

activities were not audible at the site boundary.

A.13. Environmental Considerations

Rottapharm has continually invested in BAT based technologies. The proposed Regenerative

Thermal Oxidiser (RTO) for the abatement of Volatile Organic Carbons (VOCs) complies

with European Standards for Best Available Techniques.

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A - 5 of 6

Rottapharm endeavours to recover and recycle waste where possible. Where this is not

feasible, disposal of waste is conducted using licensed waste hauliers and licensed waste

facilities in order to minimise any environmental impact.

Rottapharm’s Emergency Response Procedure outlines the accident prevention and

emergency response procedures in place at Rottapharm in the event of a fire, a spill of

flammable or environmentally harmful material, or any other major industrial accident.

Emergency response training in the following procedures is also provided to all Rottapharm employees:

A.14. Accidental Emissions

All operations and activities are carried out in accordance with the relevant Rottapharm

procedures, which are designed to minimise accidents. Rottapharm has developed the

Emergency Response Plan which sets out the responses to such events in order to minimise any consequences for the environment.

A.1.5. Energy Efficiency

A Sustainable Energy Ireland (SEI) advisor has been appointed as Rottapharm Energy

Advisor through SEI's Advice, Mentoring and Support programme the energy Advisor will

discuss energy use and suggest actions to use resources more efficiently.

A.1.6. Statutory Requirements

The emissions from the Rottapharm facility will not result in any significant environmental

pollution as required by the relevant legislation.

Air dispersion modelling has indicated that air emissions would not result in significant

environmental pollution. A noise survey of site operations was carried out. Noise from the

activities does not result in any significant noise pollution at the site boundary. Process

effluent is discharged to the trade sewer; surface waters are directed to the River

Pinkeen via petrol interceptors. Discharge of the surfacw water to the River Pinkeen has

not resulted in pollution of the water course.

Rottapharm has employed Best Available Techniques in construction and upgrades at the

works to ensure it minimises its impact on the local environment. Where possible, the

generation of waste streams at source is avoided. Where this is not achievable, suitable

abatement and recovery systems are put in place.

Wastes disposed of off site are fully documented and controlled, using licensed waste

contractors, in full compliance with the Waste Management Act 1996 and associated

Statutory Instruments from 1997 to date.

There are no ecological designated areas in the vicinity of the Rottapharm site.

No employees of Rottapharm have been convicted of any offence under the EPA Acts 1992

and 2003, the Local Government (Water Pollution) Acts 1977 and 1990 or the Air Pollution

Act 1987.

A.1.7. Cessation of Activity

Rottapharm intends to operate at the Damastown site for the foreseeable future. However, in

the event of definitive cessation of activities at the site, Rottapharm will ensure that

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A - 6 of 6

appropriate measures are taken to avoid any pollution risk and return the site to a satisfactory state.

A.1.8. Site Management and Control

The structures for the management and responsibility for the operation and control of

abatement/treatment systems on-site are set out in Rottapharm’s Environmental, Health and

Safety Statement.

Training is provided to all employees and managers, including induction training, and training

records are maintained.

Consultation between management and employees is facilitated by the Safety Representative

and the Safety Committee. Accidents and incidents are recorded and reported as required.

Concerns can be notified to management using a Safety Observation Report.

The written procedures for the calibration and maintenance systems and waste control

systems have been prepared by Rottapharm.

Product quality is monitored throughout the process via an established quality control system.

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Rottapharm IPPC Licence Application Response to EPA ...

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