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Regulatory and Commercial ObsolescenceRisks of Materials and Processes

Paavo Heiskanen, Premysl Janik, Oliver Reiff-Musgrove, Mikko Nikulainen and TimBecker*

This article summarises the current challenges related to legal obligations and restrictionsassociated with the use of chemicals, directly affecting space industrial sector. It also high-lights issues surrounding the obsolescence of materials and processes, which are indirectlylinked to the restrictions in use, but often have a serious impact on the space industry. Meth-ods for risk assessment and means for the mitigation of risks associated with material andprocess obsolescence are described in the article. The most relevant substances under re-strictions are discussed in detail. Lastly, the evolution in waste management, as well as someimplications of the UK withdrawal from the EU are additionally analysed.

I. Introduction

Health, safety and environmental regulations and di-rectives such as REACH, CLP and RoHS affect the fu-ture availability of space components, materials,manufacturing processes and related technologies.Space programmes are exposed to regulatory obso-lescence risk due to legal obligations restricting orbanning the use of hazardous substances. Further-more, commercial obsolescence risks are evident aslarger business sectorsmaydrive the evolutionof keymarkets to their needs, which are not necessarily fitfor purpose for space applications. The issue impactsspace industry competitiveness due to higher costsof new product qualifications, coupled with a weak-er heritage position. These regulations are very de-

sirable and ambitious, contributing to a safer andhealthier environment and support transfer to amore circular economy and non-toxic environment.However, they cause engineering and managementchallenges in highly regulated niche markets such asspace. Managing these risks correctly will greatly in-crease the likelihood of project success and businesssustainability.

II. Legal Background

1. REACH and CLP Regulations

All substances manufactured in or imported to theEU/EEA (European Economic Area) in quantities ofone tonne or more per year require a REACH1 regis-tration for continued placing on the market, unlessspecific exemptions apply. The registration authori-ty is the European Chemicals Agency (ECHA). Thefinal registration deadline for existing substancespassed on 31 May 2018. In total, more than 20 000substances have been registered to date, as part ofapproximately 100 000 registrations.Wheremore in-formation is needed to confirm the risk to humanhealth or the environment, the registered substancesare evaluated with respect to their physico-chemicaland toxicological properties.

Authorisation and restriction requirements areapplied to substances identified as being of particu-lar concern. So-called Substances of Very High Con-cern (SVHC) are placed on the candidate list for au-

DOI: 10.21552/icrl/2020/1/4* Paavo Heiskanen, former ESA REACH officer, Technical Reliability

and Quality Division (TEC-QE), European Space Agency, forcorrespondence: <reach.officer@esa.int>. Premysl Janik, presentESA REACH Officer, Technical Reliability and Quality Division(TEC-QE), European Space Agency,for correspondence: <pre-mysl.janik @esa.int>. Oliver Reiff-Musgrove, Young GraduateTrainee, Technical Reliability and Quality Division (TEC-QE),European Space Agency, for correspondence: <oliver.mus-grove@esa.int>. Mikko Nikulainen, Head of Technical Reliabilityand Quality Division (TEC-QE), European Space Agency, forcorrespondence: <mikko.nikulainen@esa.int>. Tim Becker, SeniorLegal Advisor, REACHLaw Ltd, for correspondence: <tim.becker@reachlaw.fi>. The presented paper was supported by ESAfunding, contracts: CTR#4000106152 and CTR#4000112903(CCN1).

1 Regulation (EC) No 1907/2006 of the European Parliament and ofthe Council of 18 December 2006 concerning the Registration,Evaluation, Authorisation and Restriction of Chemicals (REACH).

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thorisation. Safe use information regarding suchSVHCs present in articles above 0.1 % weight-by-weight (w/w) must be communicated in the supplychain by EU/EEA article suppliers under REACH Ar-ticle 33.

Currently there are 54 substances in the authori-sation list (Annex XIV) of the REACH regulation,which mandates that for continued use after a sun-set date an authorisation is required, unless a specif-ic exemption applies. The latest update of the autho-risation list took place through Commission Regula-tion (EU) 2020/171 of 6 February 2020. The candidatelist for authorisation currently contains 205 sub-stances and is updated biannually, with the last up-date having taken place on 16 January 2020. Fig. 1shows the evolution of the numbers of substanceswithin these regulatory lists over time.

Restrictions are included in REACH Annex XVIIfor hazardous substances (also other than SVHCs)when there is an unacceptable risk to human healthor the environment, arising from their manufacture,use or placing on the market, which needs to be ad-dressed on an EU-wide basis. Restriction means anycondition for, or prohibition of, themanufacture, useorplacingon themarket.Restrictionsneed tobe com-plied with by industry, as it is not possible to applyfor authorisation to usewithin such restriction.How-ever, derogations and extended use timelines for cer-tain critical applications may be foreseen in the con-ditions of the restriction. Furthermore, some gener-

al exemptions from restrictions apply, such as for sci-entific research and development.

The CLP2 Regulation (EC) No 1272/2008 comple-ments REACH by setting out rules for the classifica-tion, labelling and packaging of substances and mix-tures. These rules follow the United Nations’ Global-ly Harmonised System of Classification and La-belling of Chemicals (UN GHS). Annex VI of CLP es-tablishes an evolving list of substances with a legal-ly binding harmonised classification and labelling. Ifa substancemeets the criteria for classification in thehazard class carcinogenicity, germ cell mutagenicityor reproductive toxicity (CMR) category 1A or 1B, itshall normally be subject to such harmonised classi-fication and fulfils the REACH definition of anSVHC. Thus, it will be eligible for inclusion in theREACH candidate list for authorisation.

ECHA’s Integrated Regulatory Strategy (IRS)3

brings together the various regulatory processes. ItsPublic Activities Coordination Tool (PACT)4 displaysthe substances under regulatory scrutiny. In Decem-ber 2019, ECHA has also published the ‘universe ofregistered substances’5, indicating the general regu-latory roadmap for each registered substance (chem-ical universe list). These strategies and tools are use-ful monitoring instruments for industry.

2. RoHS Directive

The RoHS6 Directive governs specific restrictions ofthe use of certain hazardous substances in electricaland electronic equipment, for example lead metal.RoHS does not directly affect space systems, as it hasclear exclusions from its scope for a number of cas-es, with ‘equipment designed to be sent into space’being one of them. However, it may affect groundsystems and other facilities, such as launch sites andground stations, unless other general exclusions

2 Regulation (EC) No 1272/2008 of the European Parliament and ofthe Council of 16 December 2008 on classification, labelling andpackaging of substances and mixtures (CLP).

3 See <https://echa.europa.eu/substances-of-potential-concern> ac-cessed 13 May 2020.

4 See <https://echa.europa.eu/pact> accessed 13 May 2020.

5 See <https://echa.europa.eu/universe-of-registered-substances>accessed 13 May 2020.

6 Directive 2011/65/EU of the European Parliament and of theCouncil of 8 June 2011 on the restriction of the use of certainhazardous substances in electrical and electronic equipment.

Figure 1: Evolution of the number of substances onREACH candidate and authorisation lists (Source:ECHA)

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from the scope or specific exemptions can be estab-lished.However, asmore andmore satellites use sub-systems that consist in part or fully of CommercialOff The Shelf (COTS) electronics components andsurface mount assemblies, this directive also in ef-fect limits the available market for space use. In theframe of the ongoing RoHS review, the space indus-try has communicated to the European Commissionthat the existing exclusions from the RoHS scopecovering the space sector are essential for the con-tinued availability of reliable electronics. Also, if newsubstances should be included in the list of restrict-ed substances under RoHS, it may affect space usedue to commercial obsolescence as mentionedabove.

3. Waste Framework Directive (as revised)

The recent revision of the Waste Framework Direc-tive ‘WFD’7 introduces a new specific obligation forarticle suppliers in the EU (and potentially EEA),which will apply starting from 5 January 2021.8 Ac-cording to Article 9(1)(i) of the revisedWFD these ac-tors have to communicate safe use information relat-ing to SVHCs in their supplied articles and complexobjects to ECHA, in line with the supply chain com-munication obligation underREACHArticle 33men-tioned above. ECHA is currently establishing a data-base for Substances of Concern in Products (SCIP)to collect the information received from industry andprovide access to it, primarily to waste operators.

Member States have to transpose the revised WFDinto their national laws by 5 July 2020.

4. OSH Directives

Chemical safety at work in the EU is regulated bythree key directives: the Occupational Safety andHealth Framework Directive (OSH)9, the ChemicalAgents Directive (CAD)10 and the Carcinogens andMutagens Directive (CMD)11. These directives setminimum standards to ensure the safety and healthof workers at work. CAD introduces specific rules toprotect workers from the risks related to chemicalagents at work, and the CMD introduces specific re-quirements for carcinogenic and mutagenic sub-stances. These directives provide the basis for the set-ting of EU-wide Occupational Exposure Limits(OELs) for defined hazardous substances. Since thebeginning of 2019, ECHA has been tasked to providescientific recommendations on these limits. OELsmay be defined to be measured from the workplaceair, unless otherwise specified. In addition, Biologi-cal Limit Values (BLV) may be foreseen under CAD.For a practical example on how OSH directives areaffecting the space industry seeparagraph5.3 on leadmetal.

III. Obsolescence

Asdefined in the InternationalElectrotechnicalCom-mission (IEC) standard 62402:201912, obsolescenceis the transition of an item from available to unavail-able from the manufacturer, in accordance with theoriginal specification. Chemical legislation hascaused instances in the European space industrywhere a material or process has become obsolete.This causes difficult, expensive and resource inten-sive issues for the industry due to needs for requali-fication, delays, project risks and their mitigation. Inmany cases substitution alternatives exist, but theirtechnical maturity and suitability is often very di-verse. The metric for assessing the technological ma-turity of replacements is defined in terms of Tech-nology Readiness Levels (TRL)13.

Obsolescence can be divided into two categories:regulatory and commercial obsolescence. Regulato-ry obsolescence means that a material or process hasbecome unavailable to the industry due regulatory

7 Directive (EU) 2018/851 of the European Parliament and of theCouncil of 30 May 2018 amending directive 2008/98/EC onwaste

8 The need for a possible postponement of the deadline due to theimpacts of the COVID-19 situation is currently being reviewed bythe European Commission (DG ENV), based on various stake-holder requests.

9 Council Directive 89/391/EEC of 12 June 1989 on the introduc-tion of measures to encourage improvements in the safety andhealth of workers at work [1989] OJ L 183, 1–8

10 Council Directive 98/24/EC of 7 April 1998 on the protection ofthe health and safety of workers from the risks related to chemicalagents at work [1998] OJ L 131, 11–23

11 Directive 2004/37/EC of the European Parliament and of theCouncil of 29 April 2004 on the protection of workers from therisks related to exposure to carcinogens or mutagens at work[2004] OJ L 158, 23–34

12 IEC 62402:2019 – Obsolescence management [2019]

13 ECSS-E-AS-11C – Adoption Notice of ISO 16290, Space systems –Definition of the Technology Readiness Levels (TRLs) and theircriteria of assessment [2014]

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incompatibility, ie a specific coating process can nolonger be performed as the required chemical sub-stance is no longer permitted. Commercial obsoles-cence dictates that a material or process has becomeunavailable to the industry as a consequence of nolonger being offered by the market for commercialreasons. For example, this can be due to the exces-sive costs of fulfilling the regulatory requirements, ashrinking market due to strict authorisation of use,the negative image for using a hazardous chemical,or other reasons. The space industry has witnessedcritical chemicals becoming obsolete in the span ofa few years from the first indication that it has be-come under scrutiny by the regulators. This timescale is incompatiblewith commonproject durationsin the space domain.

IV. Risk Assessment and Mitigation

The European Cooperation for Space Standardiza-tion (ECSS)14 uses the industry standard definitionof risk consisting of two components: likelihood ofoccurrence and impact of the negative consequence(severity). In the context of environmental regulationcausing risks to projects, we define a quantitativequantized metric for the severity of the risk in termsof volume of use and ease of replacement as shownin Eq. 1.

S= V ×D (1)Where S is severity, V is the volume of use and D

is the difficulty of replacement. The parameters aredefined as follows, and the resultingmetric is shownin Fig 2.

Volume of Use [V]:– Low – No widespread usage– Medium –Widespread usage in a limited domain

of applications– High – Widespread usage in multiple domain of

applications

Difficulty of Replacement [D]:– Low – Easy to replace (TRL7 substitutes exist– Medium–Moderately difficult to replace (3+ years

needed for TRL7 substitutes)– High – Very difficult to replace (5+ years needed

for TRL7 substitutes)Obsolescence risk is thus defined in Eq. 2.R= S ×L (2)Where the Likelihood L is defined in terms of the

status of the substance in regulatory processes as fol-lows:

Likelihood of Obsolescence [L]:– Low – Fulfilling SVHC criteria, included in ‘Sub-

stitute It Now’ (SIN) list, under CommunityRolling Action Plan (CoRAP) evaluation or otherindication of obsolescence risk (eg specific AnnexXVII restrictions not constituting a ban, but de-tailed conditions of use).

– Medium – Prioritized for inclusion to the AnnexXIV, Candidate list

– High – Annex XIV, sunset date known; AnnexXVII restrictionbanning ause, including for space

The overall risk metric is shown in Fig. 3.

14 ECSS-S-ST-00-01C – ECSS system Glossary of terms [2012]

Figure 2: Severity MetricFigure 3: Obsolescence risk metric

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The resulting actions for a given overall risk levelare in turn determined by the level of risk acceptancefor a given organization or project. We propose thefollowing baseline for actions for the risk levels:– Low – Tolerate, investigate– Medium – Monitor, plan– High – Mitigate, control

Continuous monitoring of the relevant regulatoryevolutions, especially under REACH and CLP, andpractical assessment of their impact on the futureavailability of space-qualified materials and process-es are essential elements of the risk assessment andmitigation process. The Materials and ProcessesTechnology Board of the European Space Compo-nents Coordination (ESCC15 MPTB) has been a keyplatform for space agencies and industry to collabo-rate on this important topic and pool resources.

V. Substances Under Scrutiny

A number of specific substances of interest to thespace community that are under REACH regulatoryscrutiny are highlighted below. This listing is not in-tended to be exhaustive, but rather an illustration ofhow different substances are being addressed in var-ious REACH regulatory processes.

1. Chromium trioxide (CAS: 1333-82-0)

Overall obsolescence risk is High. Obsolescence riskparameters are: High Likelihood, Medium Volumeof Use, Medium Difficulty of Replacement.

Chromium trioxide is a key enabling substance formanufacturing corrosion resistant coatings of metalalloys, with limited replacements available. It is in-cluded in Annex XIV, with an elapsed sunset date in2017. Space industry supported16 an upstreamAppli-cation for Authorisation (AfA) thatwas submitted bythe ‘CTACSub’ consortium (Chromium TrioxideREACH Authorization Submission Consortium) in2015. In 2016, the ECHACommittees for Risk Assess-

ment (RAC) and Socio-Economic Analysis (SEAC)recommended to grant the authorisation with a re-view period of 7 years under ‘strict conditions’. InFebruary 2019, this outcome was also initially sup-ported by the REACH Committee of EU MemberState representatives assisting the European Com-mission. However, due to a legal challenge before theCourt of Justice of the European Union (CJEU) in an-other authorisation case (T-837/16), a resolution ofthe European Parliament of 27 March 2019 andchanges in the European Commission, the outcomeof the application is still pending today, and a newvote by the REACH Committee is expected to be re-quired. In the meantime, downstream uses coveredby the CTACSub AfA are continued to be allowed, inspite of the long expired sunset date.

The experience with the CTASub application hascaused a number of important lessons learned andbest practices being announced for future AfAs. It isclear that broad-scope upstream applications with-out a clear definition of the use, a detailed chemicalsafety assessment and analysis of alternatives willnot be a feasible way forward, but rather more nar-row applications with strict limitations and a substi-tution plan (where alternatives are available in gen-eral) are now expected.

Several actions are ongoing in European SpaceAgency, national space agencies and in the Europeanspace industry. Substitution of the substance varieson case-by-case basis depending on the alloy select-ed for coating.Oneof themain substancesbeingusedas a replacement is trivalent chromium, and the risksassociated are explained in paragraph 5.5.

2. Hydrazine (CAS: 302-01-2)

Overall obsolescence risk is Medium. Obsolescencerisk parameters are: Medium Likelihood, MediumVolume of Use, Medium Difficulty of Replacement.

Hydrazine has been included in the candidate listsince 20 June 2011. Space industry, together withagencies, carried out dedicatedREACH technical andlegal assessments in the frame of theHydrazine TaskForce (HTF) established for this purpose. The result-ing position paper was presented to the EuropeanCommission in October 2012. It advocates continuedusage of hydrazine as a space vehicle propellant un-der automatic REACH authorisation exemptionclauses, especially the ‘use as fuels in closed systems’

15 ESA, ‘Charter of the European Space Components Coordination’,[2018] 2 ESCC 1-19; See <https://spacecomponents.org/> ac-cessed 13 May 2020.

16 See <https://echa.europa.eu/documents/10162/18074545/a4a_comment_665_1_attachment_en.pdf> accessed 13 May 2020.

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according toREACHArticle 56 (4)(d), 2nd alt. Current-ly the legal clarification by the European Commis-sion is still pending.

In 2019, HTF has been re-activated in order to ex-tend the exemption analysis to liquid bi-propellantsMonoMethyl Hydrazine (MMH), Unsymmetrical Di-Methyl Hydrazine (UDMH) and Dinitrogen Tetraox-ide (NTO), and include the conclusions in the hy-drazine position paper, together with some regulato-ry updates. The overall exemption position is not af-fected by this revision. The Revised Space IndustryPosition 202017was published by ASD-Eurospace on15 April 202018 and sent to the European Commis-sion for its pending legal clarification.

3. Lead metal (CAS: 7439-92-1)

Overall obsolescence risk is High. Obsolescence riskparameters: Medium Likelihood, High Volume ofUse, High Difficulty of Replacement.

Used for soldering (tin-lead) in electronic assem-blies, as well as in copper and brass alloys and insome cases plating and mechanical lubrication (seeEurospace Position Paper19 for further applicationdetails). Leadmetalwas included in the candidate listfor authorisation in 2018. Furthermore, OEL revisionprocess for lead was initiated in 2019.

Several actions are ongoing in agencies and indus-try. Substitutes in soldering applications have beenstudied for many decades, but currently no replace-ments are available at a high TRL. More detailed re-views show the effects of REACHon electronics com-ponents in Europe20.

4. N-Methyl-2-pyrrolidone (CAS:872-50-4)

Overall obsolescence risk is High. Obsolescence riskparameters: High Likelihood, Medium Volume ofUse, Medium Difficulty of Replacement.

N-Methyl-2-pyrrolidone (NMP) is used, for exam-ple, as a solvent in the production of the positive elec-trodewithin Li-ion batteries that are qualified for useon European space launchers and vehicles, and as acatalyst for adhesive formulation. NMP has been onthe REACH candidate list since 20 June 2011. NMPwas part of the 8th recommendation of ECHA of 5February 2018 for inclusion on Annex XIV (autho-

rization path). The space industry has advocatedagainst Annex XIV inclusion (see NMP Position21).Even though ECHAhas recommended the substancefor Annex XIV inclusion, a Regulatory ManagementOption Analysis (RMOA) by the European Commis-sion with the collaboration of ECHA for three apro-tic solvents (incl. NMP) concluded that targeted re-strictions underREACHAnnexXVII aremost appro-priate. Restrictions on use took effect on 9May 2020.ECHA published a guideline document on compli-ance to the new restriction, focusing on handling, aswell as biomonitoring of workers.22 Even though thesubstance was not included in Annex XIV, the regu-latory activities caused at least one supplier to senda last-buy note for a family of products containingthe substance in question.

5. Chromium (III) oxide (CAS: 1308-38-9)

Overall obsolescence risk is Low. Obsolescence riskparameters: Low Likelihood, Low Volume of Use,Low Difficulty of Replacement.

Chromium (III) oxide, trivalent chromium, is usedin many substances that are being investigated assubstitutes for chromium trioxide, hexavalentchromium. However, this substance is also being in-vestigated for its toxicological properties. The inves-tigation is performed in the frame of a CoRAP eval-uation.23 Therefore, a risk of regrettable substitutionexists, meaning that a hazardous substance is substi-tuted with another one, which in turn is under obso-lescence risk. The timelines of the evaluation arenon-deterministic and difficult to estimate, which makesrisk assessment particularly challenging.

17 See <https://eurospace.org/wp-content/uploads/2020/04/hydrazine-revised-reach-position-2020-final.pdf> accessed 13 May 2020.

18 See <https://eurospace.org/asd-eurospace-reinforces-reach-exemption-position-for-hydrazine-and-other-liquid-propellants/>accessed 13 May 2020.

19 See <https://p7665.phpnet.org/wp-content/uploads/2018/05/ltffinalcommentonpb-20042018.pdf> accessed 13 May 2020.

20 Paavo Heiskanen, ‘REACH update – Impact on availability ofcomponents for Space in Europe’ (European Space ComponentsConference, Noordwijk, March 2019)

21 See <https://p7665.phpnet.org/wp-content/uploads/2018/05/es-nmp-spaceindustrycontribution.pdf> accessed 13 May 2020.

22 See <https://echa.europa.eu/fi/-/advice-on-how-to-comply-with-nmp-restriction> accessed 13 May 2020.

23 Latest status, <https://echa.europa.eu/information-on-chemicals/evaluation/community-rolling-action-plan/corap-table/-/dislist/details/0b0236e1820e1d0f> accessed 13 May 2020.

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VI. Regulatory Obsolescence RiskManagement

As shown in previous paragraphs, health, safety andenvironmental regulations may create obsolescencerisks for materials and processes that need to be mit-igated. Any organisation that manufactures spacehardware should generate an Obsolescence Manage-ment Plan (OMP) that defines the key elements onthe organisation’s approach to obsolescence. TheECSS handbook24 defines the key resources, ap-proaches and concepts to obsolescencemanagement.

We propose an example process, which is shownin Fig. 4. The risk assessment for materials, mechan-ical parts and processes (MMPP) takes input infor-mation from suppliers and regulatory market intel-ligence. In addition, updates to the Declared Materi-als List or Declared Process List (DML/DPL)25 ofprojects are continuously and proactively assessed inorder to determine their exposure to different typesof obsolescence. If a change is detected, the impactshould be assessed, such as through using a method-ology similar to the one introduced in paragraph 4.

If a risk metric value exceeds a predefined thresh-old, a set of actions are automatically initiated, start-ing a risk mitigation process. When the mitigationplan is in place to reduce the risk sufficiently, theplan is executed and the process ends. SVHCs con-tained in substances used for manufacturing is read-ily available information, and a key consideration forthis typeofprocess.This informationcanbeacquiredfrom Safety Data Sheets (SDS), which are obtainedfrom the suppliers of the substances and mixtures.

Considering that projects in the space industryhave a very high complexity, consisting of supplychains that can be up to ten layers deep andhundredsof organisations wide at the base, it is necessary thatthis process is executed in an automated fashion, iean obsolescence management database is needed. Itis also important to ensure that sub-suppliers havetheir own OMPs drafted and effective obsolescencemanagement processes in place.

VII. Other Considerations

1. Responsibilities of article and complexobject suppliers

REACH (Article 33) defines an article as ‘an objectwhichduringproduction is givena special shape, sur-

24 ECSS-Q-HB-70-23A – Materials, mechanical parts and processesobsolescence management handbook

25 ECSS-Q-ST-70C – Materials, mechanical parts and processes

Figure 4: Obsolescence Risk Management Process

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face or design which determines its function to agreater degree than does its chemical composition’.Complex object, respectively, is a collection of arti-cles as such joined or assembled. For example, theplated metal sheet used to cover an electronics as-sembly is an article, and the assembly itself is a com-plex object.

Substance manufacturers and mixture formula-tors have responsibilities to communicate safe useinformation, on certain hazardous substancespresent in their products, through SDSs to their cus-tomers. In addition, EU/EEA article and complex ob-ject producers and importers have the responsibilityunder REACH to communicate sufficient informa-tion, available to them, on candidate list substancesin articles in the supply chain to allow safe use. Thecommunication requirements are set out in REACHArticle 33, and thus the corresponding document isoften called a ‘REACH Article 33 declaration’, or a‘REACH declaration’. The candidate list substanceconcentration threshold triggering the reporting re-quirement is 0.1%w/w in the article supplied as suchor as part of a complex object. This means that if the0.1% w/w threshold is exceeded in a component ar-ticle, the substance must be reported in the supplychain in the declaration. This was clarified in a judg-ment of the European Court of Justice of 10 Septem-ber 2015 (case C-106/14) which ruled ‘Once an Arti-cle, Always an Article’, meaning that the concentra-tions in complex objects supplied cannot be calculat-edbasedon theoverallweightof theobject, but ratherthe concentration in each component article contain-ing the substance26. Thismeans – according to ECHA– that suppliersmust now also report the componentarticle(s) containing the substance, eg for solderjoints. To support the aerospace and defence indus-tries on how to fulfil the REACH Article 33 require-mentunder theaforementioned judgment,EuropeanAeronautics, Space, Defence and Security Industries(ASD) has generated a guidance document27, whichpromotes the concept of aggregation of informationto higher levels of very complex objects (sub-/assem-blies).

Another requirement that is becoming more rele-vant to the space industry is the notification to be di-rected to ECHA if a substance under an approved up-streamAfA is being used. This REACHArticle 66 no-tificationwill become relevant for cases such aswhenthe authorisation decision for chromium trioxide isformally adopted by the European Commission and

ismade known to the downstreamusers (through theauthorisation holder or publication on the internet).It is important to note that this notification duty on-ly applies to the company acting as a chemical user(eg a company carrying out surface treatment opera-tions using chromium trioxide); it does not apply toassemblers and suppliers of already surface-treatedhardware (theymay be subject to REACHArticle 33).

2. SCIP Database

During the course of 2019, ECHA has published itsfirst detailed plans on how the SCIP database underthe revised Waste Framework Directive is going tobe implemented. Currently, an ECHA SCIP ‘proto-type’ is available for testing purposes. SCIP notifica-tions by industry shall be possible from the end ofOctober 2020.

The space industry impact of this new SCIP noti-fication and database requirement is currently stillbeing determined. A dedicated WFD Task Force hasbeen created to this end28. As a result of this taskforce, Eurospace has published a position paper29 on9 September 2019, advocating that SCIP notificationshould not apply to equipment designed to be sentinto space and relatedmeans of transport (launch ve-hicles and spacecraft, such as satellites for telecom-munication, navigation or space exploration) whichdoes not result in waste on the EU territory. In theabsence of an authoritative exemption for suchequipment, the task force has now started the devel-opment of sectoral guidelines for compliance withSCIP notification tailored to its specific case.

ECHA is proceedingwith the SCIP database devel-opment based on its detailed information require-ments30. This means that EU (and potentially EEA)

26 The judgment is available at <http://curia.europa.eu/juris/document/document.jsf?text=&docid=167286&pageIndex=0&doclang=EN&mode=lst&dir=&occ=first&part=1&cid=754885>accessed 13 May 2020.

27 ‘Sectoral Guidance for Substances in Articles under REACH’,[2017] 1 ASD 1–57

28 Eurospace: New Space Industry Task Force to address the EU’srevised Waste Framework Directive, 8 August 2019

29 See <https://eurospace.org/space-industry-position-regarding-article-9-of-the-revised-waste-framework-directive-2008-98-ec/>(accessed 13 May 2020)

30 ECHA, Detailed information requirements for the SCIP database,September 2019, available at <https://echa.europa.eu/documents/10162/28213971/scip_information_requirements_en.pdf> ac-cessed 15 November 2019.

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suppliers of articles on each level of the supply chainneed to report the required information on all theirproducts placed on the market, provided that theycontain candidate list substances above 0.1% w/w inany component article. The information require-ments and envisioned public access to data, pub-lished by ECHA, seem to go above and beyond therequirements that are specifically listed in the legaltext and REACH Article 33, causing concerns on In-tellectual Property rights and the feasibility for in-dustry to fulfil the responsibilities. A legal analysis31

of the approach has been performed.

3. UK withdrawal from the EU

Thewithdrawal of the United Kingdom from the Eu-ropean Union has caused uncertainty for the spaceindustry. After several deferrals, the UK left the Eu-ropean Union on 31 January 2020. This means thatthe UK is no longer an EU Member State startingfrom 1 February 2020. However, based on the With-drawal Agreement concluded between the EU andthe UK, the EU REACH Regulation and all other EUlaw will continue to apply in the UK as they current-ly do, for the time of the so-called transition periodlasting at least until 31 December 2020. During thistransitionperiod itwill be ‘business as usual’ for com-panies in both the EU and the UK. The transition pe-riod will be used by the EU and the UK to agree ona new partnership for the future.

When considering the industry implications for anon-EU entity of the REACH regulation, it needs tobe recalled that the regulation is also applied in thenon-EU Member States of the EEA, ie Norway, Ice-

landandLiechtenstein32. Switzerland,despitenotbe-ing an EU/EEA Member State, pursues an indepen-dent harmonisation of its national chemicals legisla-tion with EU REACH33.

The EU-UK negotiations on the new partnershipwill also determine if a separate chemical safety reg-ulation (‘UK REACH’) will apply after the end of thetransition period. One possible scenario under sucha ‘UKREACH’ is that theUKwould have its own cen-tral regulatory authority, the Health and Safety Exec-utive (HSE). The regulatory frameworkmaybe basedon the EU REACH system, with similar processes inplace for authorisation, supply chain communica-tion, etc. However, it is important to note that achange of authorities in charge away fromECHA, EUinstitutions andMember States to UK-only decision-makers may result in a regulatory divergence in thefuture, ie a substance may be under a REACH autho-risation or restriction in the EU/EEA, but not in theUK or vice versa. This will create added complexityon the supply chain considerations that go across thetwo regulatory regimes. Furthermore, it would implythat manufacturers, formulators and suppliers thatoperate in both systems will need to comply withboth regimes separately, one for EU and one for theUK. In respect of Northern Ireland, EU REACHwould continue to apply even longer than in the re-maining UK, subject to the Protocol on Ire-land/Northern Ireland34,.

An alternative scenario is that the transition peri-od would be extended beyond 2020 for up to twoyears, ie until 31 December 2022 at the latest. In thiscase EU REACH would continue to apply in the en-tireUKduring such extended period. Such extensionwould need to be agreed by a decision of the UK-EUJoint Committee before 1 July 2020. However, thiswould require the UK domestic ban on extendingtransition under Section 15A of the EU (Withdraw-al) Act 2018 currently in force35 to be repealed. A pos-sible factor determining this could be the COVID-19disruptions.

VIII. Conclusions and Outlook

Health, safety and environmental regulations are im-pacting production for the EU/EEA market at everylevel of the value chain, particularly in industrial sec-tors with complex supply chains and long project du-rations, such as the space industry. It was concluded

31 Tim Becker, ‘The SCIP Database under Directive (EU) 2018/851’(2019) 2 StoffR 156

32 See <https://www.efta.int/eea-lex/32006R1907> accessed 20April 2020.

33 See <https://www.anmeldestelle.admin.ch/chem/en/home/themen/recht-wegleitungen/stand-der-harmonisierung-mit-internationalen-vorschriften.html> accessed 15 April 2020.

34 Revised Protocol on Ireland and Northern Ireland included in theWithdrawal Agreement, 17 October 2019; See <https://ec.europa.eu/commission/publications/revised-protocol-ireland-and-northern-ireland-included-withdrawal-agreement_en> accessed29 April 2020; European Commission, Notice to stakeholders,Withdrawal of the United Kingdom and the EU rules in the fieldof chemicals regulation under REACH, 30 March 2020; see<https://ec.europa.eu/info/sites/info/files/notice_to_stakeholders_brexit_reach.pdf> accessed 29 April 2020.

35 See <http://www.legislation.gov.uk/ukpga/2018/16/section/15A>accessed 19 May 2020.

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early on36 that the whole industry needs to respondto the requirements and issues generated by the in-creasing regulations. Potentially any hazardous sub-stance fulfilling SVHC criteria or presenting an un-acceptable risk used in manufacturing may becomeobsolete in the span of five to six years from the firstindication of regulatory activity.

This timescale is incompatible with space projectdurations and mandates a strong and proactive ob-solescence management programme for all industri-al actors. Due to the vast number of materials andprocesses used tomanufacture products, that consistof tens of thousands of parts, automated systems arerequired to manage the obsolescence risk, in addi-tion to company and sector level working groups op-erating on a continuous basis (such as the MPTB).These systems rely on timely and accurate informa-tion on the substances under regulatory scrutiny.This task is not made easier by recent developmentsin the regulatory framework. For example, the can-didate list now contains several substance entriesthat are not identified byCASnumbers. Aprominentexample is a recent entry ‘perfluorobutane sulfonicacid (PFBS) and its salts’, where the industry esti-mates well over one thousand CAS numbers to be in-cluded under one substance name. The entry in-cludes all current forms of the substance, as well asthe ones that will be invented in the future. Whilethis approach is, according to the regulators, chemi-cally and toxicologically sound, it raises questions onthe feasibility of implementation by industry, wheresupply chain communication is based on clear nu-merical identifiers. This problem is exacerbated bythe growing number of SMEs and other new spacecompanies that operate on small budgets and with alimited experience. It is important to remember thatevery entry in the candidate list also generates re-quirements with respect to Article 33 declarations,and in the future for SCIP notifications (unless anexclusion or exemption applies).

The processing of the upstream CTACSub AfA forchromium trioxide in the EU decision-makingprocess has taken several years and is still ongoing,andmeanwhile endusersof this critical enablingsub-stance for the space industry are working based onthe assumption that the AfA will be approved. How-ever, the authorisation will only be granted for a lim-ited duration, and the start date is typically countedfrom the original sunset date, not from the date ofadoption of the authorisation decision (with some

exceptions). Therefore theupcoming timeperiod, be-fore a re-authorisation will become necessary, mayalso be shrinking as long as the decision is still pend-ing. It should be recalled that a primary substitute(based on trivalent chromium) is also subject to a pos-sible obsolescence risk, in an assessment process(REACH substance evaluation) where the timelinefor future regulatory activities is neither known norpredictable. This issue of regrettable substitution isvery prominent for energetic materials, nominallypropellants and explosives. These are very widelyused in the space domain, and are often by theirchemical nature volatile and hazardous. This gener-ates an obvious risk for all space projects.

Finally, it should be noted that the regulations dis-cussed are highly desirable and ambitious, contribut-ing to human health and a safer environment. Thesuccess of the RoHS Directive and the REACH Reg-ulation can be seen by the number of countries glob-ally that have followed their examples. This is alsogood news for the competitiveness of the Europeanindustry. As European companies are substitutingtheir hazardous chemicals and qualifying safer alter-natives already, they will have a competitive advan-tage on other markets when these substances comeunder regulatory scrutiny overseas.

Overall, despite the issues listed in this paper, ithas to be acknowledged that REACH is contributingtowards a better protection of human health and theenvironment. It incentivizes research and develop-ment in innovative substitution of hazardous chem-icals and enables sustainable global competitivenessfor European industry for years to come. Within theEuropean space industry, it has been observed thatcompanies have engaged in deep technical collabo-rationbetweencompetitors rather thanusing the reg-ulation as a competitive advantage. Key business en-ablers have been proactive obsolescence risk man-agement, communication, and collaboration.

Acknowledgements: The authors would like tothank all the members of the MPTB for their contin-ued support and collaboration on the field of obso-lescence risk management for space industry. With-

36 Thomas Rohr, ‘Impact of REACH legislation on European spaceprograms’, International workshop on environment and alternativeenergyESAC, 12 November 2015, See: <https://tdglobal.ksc.nasa.gov/servlet/sm.web.Fetch/Rohr_- 151112_REACH_presentation_1.0.pdf?rhid=1000&did=916169&type=released> accessed 14 May 2019.

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out their willingness to share information and co-op-erate on refining the best practices and ongoing is-sues this paper would not have been possible.

Disclaimer: The information in this article reflectsthe opinion of the authors. It is not considered a re-quirementnora comprehensive treatmentof the sub-jectmatter, and any action to the described issues aresubject to project or programme decision. The arti-cle is intended for information only and whilst it is

provided in utmost good faith and has been basedon the best information currently available and ade-quate technical standards, is to be relied upon at thereader’s own risk. No representations or warrantiesare made with regards to its completeness, or accu-racy andno liabilitywill be accepted by the EuropeanSpace Agency, REACHLaw Ltd and the authors fordamagesof anynaturewhatsoever resulting fromtheuse of or reliance on the information.