ASD Sectoral Guidance - asd-europe.org SiA... · About ASD The AeroSpace and Defence Industries Association of Europe represents the aeronautics, space, defence and security industries

AboutASDThe AeroSpace andDefence Industries Association of Europe represents the aeronautics, space, defence and security industries inEuropeinallmattersofcommoninterestwiththeobjectiveofpromotingandsupportingthecompetitivedevelopmentofthesector.ItsmembershipcomprisesmajorEuropeanaerospaceanddefencecompaniesaswellasnationalassociations.

ASD|RueMontoyer10I1000Brussels,BelgiumIT:[email protected]

ASDSectoralGuidancefor

SubstancesinArticlesunderREACH

Version1-November2017

SectoralGuidanceonSubstancesinArticlesunderREACH

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LegalDisclaimerThisdocumentaimstoassistusersincomplyingwiththeirobligationsundertheRegistrationEvaluationAuthorisation and Restriction of Chemicals (REACH) Regulation and the later judgement by theEuropean Court of Justice (CJEU), [Case C-106/14] in September 2015. However, users are remindedthatthetextoftheREACHRegulationistheonlyauthenticlegalreferenceandthattheinformationinthis document does not constitute legal advice. Usage of the information remains under the soleresponsibilityoftheuser.ASDdoesnotacceptanyliabilitywithregardtotheusethatmaybemadeoftheinformationcontainedinthisdocument.

DocumentHistoryVersion1.0–November2017


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Contents1GENERALINTRODUCTION..................................................................................................................................4

1.1 EXECUTIVESUMMARY...................................................................................................................................................51.2 BACKGROUNDANDLEGALCONTEXT..................................................................................................................................61.3 OBJECTIVEANDSCOPEOFTHEASDSECTORALGUIDANCE......................................................................................................9

2ASDSPECIFICITIESINPRODUCTCOMPLEXITIES,BUSINESSMODELS&PRODUCTLIFECYCLES..........................11

2.1 PRODUCTLIFECYCLESINRELATIONTOREACHTIMELINES..................................................................................................122.2 A&DSPECIFICCONSIDERATIONSFORMROACTIVITIES.......................................................................................................142.3 EXAMPLESOFCOMPLEXPRODUCTSTRUCTURESINAERONAUTICS,SPACEANDDEFENCESECTOR...................................................152.4 HIGHLEVELDESCRIPTIONOFDISMANTLINGANDDISPOSALCONDITIONS.................................................................................192.5 TECHNICALPRODUCTDOCUMENTATION...........................................................................................................................20

3IMPLEMENTATIONOFART.33(1):REPORTINGONSIA.....................................................................................21

3.1 SUBSTANCEREPORTINGDOWNTHESUPPLYCHAIN.............................................................................................................213.1.1 Whentoreportsubstances....................................................................................................................213.1.2 ContentoftheArticle33(1)information...............................................................................................223.1.3 Aggregationofinformation...................................................................................................................223.1.4 TransmissionmodesandformattingofArticle33(1)information........................................................233.1.5 AddresseesoftheREACHdeclaration...................................................................................................25

3.2 ARTICLE33(1)INFORMATIONONSAFEUSE......................................................................................................................273.2.1 AssessingthepotentialforexposurerisksrelatedtoCLSVHCsinA&Dproducts..................................273.2.2 Providingmeaningfulinformationtoallowsafeuse.............................................................................313.2.3 Localisationofaffectedcomponentarticlesinthecontextofsafeuse.................................................34

4IMPLEMENTATIONOFART.7(2):NOTIFICATIONTOECHA...............................................................................35

4.1 WHENISART.7(2)NOTIFICATIONREQUIRED?.................................................................................................................354.2 WHATINFORMATIONISREQUIREDTOBESUBMITTEDINANARTICLE7(2)NOTIFICATIONTOECHA?............................................37

5HOWTODETERMINEWHETHERACLSVHCISPRESENTINTHEARTICLE...........................................................38

APPENDICES.......................................................................................................................................................42

APPENDIXA:ASDPRODUCTEXAMPLESWITHMULTI-LAYERSUPPLYCHAINS.....................................................................................42APPENDIXB:TEMPLATEFORART.33REACHDECLARATIONS......................................................................................................48APPENDIXC:ILLUSTRATIVEEXAMPLEOFAGGREGATIONMETHOD...................................................................................................49APPENDIXD:EXAMPLEOFAMETHODOLOGYANDSTANDARDFORHAZARDOUSMATERIALSDATAFLOWINTECHNICALDOCUMENTATION.......51APPENDIXE:LISTOFCOMMONCLSVHCSUSEDINTHEA&DINDUSTRIESSECTORFORARTICLEMANUFACTURING..................................55

GLOSSARY..........................................................................................................................................................57

REFERENCES.......................................................................................................................................................58


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1GeneralintroductionTheAeroSpaceandDefenceIndustriesAssociationofEurope(ASD)representstheAeronautics,Space,Security and Defence industries in Europe. ASD’s membership today comprises 15 major Europeanaerospaceanddefence(A&D)companiesand26memberassociationsin19countries:Austria,Belgium,Bulgaria, the Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, the Netherlands,Norway,Poland,Portugal,Spain,Sweden,Switzerland,TurkeyandtheUK.ASDprovidesasingleplatformforthedevelopmentofjointpositionsfortheindustriesitrepresents.Inthiscontext,ASDalsogivesvoicetothe industry inmattersrelatedtoREACH, i.e.Regulation(EC)No.1907/20061whichconcernstheRegistration,Evaluation,AuthorisationandRestrictionofChemicals intheEuropeanUnion.REACHaimstoimproveboththeavailabilityofinformationonchemicalsandtheriskmanagementassociatedwiththosechemicals.OneprovisionoftheREACHregulationisrelatedtosubstances of very high concern listed on the REACH candidate list (hereafter: CL SVHCs) whencontainedwithinarticles.ThedutyofArticle33(1)andArticle7(2)-toreportonthepresenceofsuchsubstancesindeliveredarticles-hasledtomanyquestionsanddifferentinterpretationsacrosstheEU,especiallywithrespecttothresholdsofreportingrelatedtocomplexobjects2(CO)(whichareassembliesofmultiplearticles).A judgmentby theEuropeanCourtof Justice (CJEU), [caseC-106/14]3 inSeptember2015determinedthat CL SVHCs are reportable for assemblies if they are present greater than 0.1%weight byweight(w/w)inanycomponentarticleofthatassembly.Thisprincipleisoftenreferredtoas‘OnceAnArticle,AlwaysAnArticle’,orO5A.Whilsttheprinciplesofthejudgmentaresupported,thereremainanumberofquestionsastohowtofulfiltheclarifiedobligations.TheexplanationsproposedinthelatestversionoftheEuropeanChemicalAgency(ECHA)SubstancesinArticlesGuidance(ECHA-17-G-19-EN)fromJune2017 does not provide sufficient guidancewhen highly complex assemblies comprising thousands ofcomponentarticles-likeaircraft,spacecraft,landornavalbasedplatforms-aretobereportedupon.ASD has therefore developed the present sector specific guidance in order to support the A&DindustryincomplyingwiththeexistingobligationsandwiththeaimtoensurethattheobjectivesofREACHArticle33(1)andArticle7(2)areachievedinaconsistentandpragmaticway.

1LinktotheconsolidatedtextoftheREACHregulation:http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1509457066697&uri=CELEX:02006R1907-201710102 The term “complexobject” is not given in the text of theREACHRegulation, butwas created after theCJEU judgment toidentifyproductsthatconsistofseveralindividualarticlesascomponents.CJEUusestheterm“complexproduct”whileECHArefers to“complexobject” in theupdatedGuidance;bothspeakof“articles”whichareusedascomponents in thecomplexobject.3LinktotheCJEUjudgment:http://curia.europa.eu/juris/document/document.jsf;jsessionid=9ea7d2dc30d69fdf3b369364468bb338b9c279b262c5.e34KaxiLc3qMb40Rch0SaxyMbhz0?text=&docid=167286&pageIndex=0&doclang=EN&mode=lst&dir=&occ=first&part=1&cid=768173


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1.1ExecutiveSummaryInthepresentsectorspecificguidance,ASDproposestousethefollowingmethodologywhenreporting,asrequiredbyArticle33(1)andarticle7(2)oftheREACHregulation,thepresenceofCandidateList(CL)SVHCsincomplexobjectsassembledofmanyarticles:

• It is mandatory to communicate information on substances in complex objects (assemblies)wheneveraCLSVHCs ispresent ina concentrationgreater than0.1%w/w inanycomponentarticle.However,thisinformationcanbeaggregatedatassemblyorsub-assemblyleveltomakethe information flowmanageable, provided that the presence of any CL SVHC is thereby not“hidden”.

• Informationonthespecificlocationofanaffectedcomponentarticlewithinacomplexobjector

assembly should only be passed on if the manufacturer determines that such additionalinformationisnecessaryinordertoallowsafeuseoftheproduct.

• Aerospace and defence products are produced, operated, maintained and repaired by

professional or industrial users only. It is therefore appropriate to adapt the detail ofinformation,wheneversuchhavetobeprovided,towhateverpre-knowledgecanbeexpectedfromtheusers.

• Thecommunicationofinformationnecessarytoallowsafeuseofproductsisprimarilydrivenby

sector-specificandgenericproduct-basedlegislationandstandards,whicharemoreappropriateformanagingproductsafetyrisks.

Furthermore,inthepresentsectorspecificguidanceonSubstancesinArticles(hereafter:SiA)reporting,ASDgivesexamplesofour industry,which is characterisedbyverycomplexobjects inhighlycomplexmulti-tierandglobalsupplychains.ToalignwithECHASiAGuidanceterminology,aproductconsistingofseveralarticleswillbereferredtoas“complexobject”withinthisdocument(esp.section2.3).


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1.2BackgroundandlegalcontextArticle33(1)oftheREACHregulationestablishesthedutytocommunicateinformationonCLSVHCsinarticlesinthesupplychain:

AnysupplierofanarticlecontainingasubstancemeetingthecriteriainArticle57andidentifiedin accordancewithArticle 59 (1) in a concentrationabove 0.1%weight byweight (w/w) shallprovidetherecipientofthearticlewithsufficientinformation,availabletothesupplier,toallowsafeuseofthearticleincluding,asaminimum,thenameofthatsubstance.

Inparallel,Article7(2)oftheREACHRegulationobligesimportersandproducersofarticlestonotifythepresenceofCLSVHCsinarticlestotheECHAunderspecificconditions:

AnyproducerorimporterofarticlesshallnotifytheAgency…ifasubstancemeetsthecriteriainArticle57andis identifiedinaccordancewithArticle59(1), ifboththefollowingconditionsaremet:• Thesubstanceispresentinthosearticlesinquantitiestotallingoveronetonneperproducer

orimporterperyear;

• Thesubstance ispresent inthosearticlesaboveaconcentrationof0.1%weightbyweight(w/w);

unlessthesubstancehasalreadybeenregisteredforthatuse(seeArticle7(6)).

The fulfilment of these two legal obligations in respect to SiA reporting is subject to nationalenforcement.Whilethespecifictypeandamountofthepenaltiesmayvary,thenon-implementationofthe duties of Article 33(1) and Article 7(2) is sanctioned in all EU member states.4 The followingexamplesillustratethepenaltiesthatcanapplyforbreachesofREACHArticle33(1)intherespectiveEUmemberstate:

4Seeforfurtherinformationthe“ReportonpenaltiesapplicableforinfringementoftheprovisionsoftheREACHRegulationintheMemberStates”,submittedinMarch2010:http://ec.europa.eu/environment/chemicals/reach/pdf/report_reach_penalties.pdf.


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Germany Nocriminalsanctions.AbreachoftheinformationobligationunderArt.33REACHissubjecttoanadministrativefineofupto50.000€.Theexactamountofthefineisdeterminedona case-by-casebasis andadministrative fineswill be recorded intothecommercialcentralregister.5

France Administrativesanctions,i.e.afineupto15.000€andadailypenaltyof1.500€,plusprohibitiontoimport,produce,placeonthemarketorobligationtowithdrawfromthemarket;andcriminalsanctionswhichdependofinfringement(fineupto450€foranaturalperson,upto2.250€foralegalperson).6

UK The UK REACH enforcement does not outline penalties for the breach of Article33(1)dutiesspecifically,butonlyforbreachesofREACHingeneral.Theseconsistoffinesuptothestatutorymaximumand/orimprisonment(asitisacriminaloffence),penaltiesincludeunlimitedfinesandimprisonment.7

Spain Setofadministrativeoffenceswithfinesfrom6.001€upto85.000€.Theoffenderis obliged to return the altered situation to its original state and compensatedamagesandlosses.8

Italy For the omission of communicating CL SVHCs in articles, administrative sanctionsfrom5.000to30.000€apply.9

Sweden Is a criminal offence. For inadequate information, the responsible person can besentencedtofinesorimprisonmentforamaximumoftwoyears.Thefineappliesatpersonallevel,nottothecompany.10

PriortotheCJEUjudgement(C-106/14),itwasunclearwhethertheconcentrationof>0.1%mentionedin theRegulationshould refer to theweightofanentireproductas supplied,or to theweightof theindividual component articles of which a product is assembled. The different interpretations in thiscontextleadtodifferentapproachesintheapplicationoftherespectivedutiesbetweentheEUMemberStates.Thiscreatedmuchuncertaintyandinconsistencyforindustry.TheCJEUjudgement,issuedon10September 2015, clarified that the >0.1%w/wCL SVHCdeclaration threshold applies for every singleconstituentarticlepresentinaproduct,whereaproductismadeupofmorethanonearticle(andthusassembled).

5See§6(1)No.17ChemSanktionsV(http://www.gesetze-im-internet.de/chemsanktionsv/ChemSanktionsV.pdf)and§26(1)No.11ChemG(https://www.gesetze-im-internet.de/chemg/ChemG.pdf).6 French Environmental Code : Articles L. 521-17 and L. 521-18, Environmental Code Part 6 Penalties; Chapter 29 Penaltiesprovisionsandforfeiture;Paragraph6.7UKREACHEnforcementRegulations2008No.2852.8SpanishSanctionRegimeLaw8/2010.9ItalianDecretoLegislativo133/2009.10Swedishenvironmentallaw1998:808.


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Since the judgment made it clear that even ECHA had applied a now invalid methodology in its“Guidanceonrequirementsforsubstancesinarticles”,ECHAundertooktoupdatethenamedGuidanceinorder toadapt the sections referring toArticle33(1)andArticle7(2) to reflect theCJEU judgment.Thisworkwas finalised in June2017withthe issuingof theupdatedGuidance(version4.0; referenceECHA-17-G-19-EN11).WhiletheGuidanceexplainsthebasicmethodologyofhowtoreportsubstancesinarticlestorecipientsornotifytoECHA,theECHAGuidancecannotbynaturecoverallexistingproducttypes and their specificities. Therefore, a need for industry specific guidelines as for A&D companiesarisessincetheECHAGuidancedoesnotgiveenoughdetailsespeciallywithregardtothechallengesofreportingsubstancespresentinverycomplexobjectssuchasairplanes,submarines,satellitesortanksinawaythatdoesnotunnecessarilyexceedtheprincipleofproportionality.

REACHArticle7(2)andArticle33(1)requireindustryto:

• managetheincominginformationonCLSVHCsinarticlesprovidedbysuppliers;

• generateinformationonCLSVHCsinownarticles,ifsuchsubstancesareusedduringtheproductionprocessandarepresentontheproducedcomponentabove0.1%w/w;

• communicatetheinformationalongthesupplychain(Article33(1));

• provide sufficient information to the recipients of the articles to allow safe use of theproduct;and

• sendanotificationtoECHA(Article7(2),whenapplicable).

11LinktoECHAGuidanceonrequirementsforsubstancesinarticles,version4.0:https://echa.europa.eu/documents/10162/23036412/articles_en.pdf/cc2e3f93-8391-4944-88e4-efed5fb5112c


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1.3ObjectiveandscopeoftheASDsectoralguidanceASDherebyprovidesasectorspecificguidance inordertoaddmoredetailed informationontheO5AinterpretationthanwhathasalreadybeenwrittenintheASDGuideontheInterpretationofREACH,12andwhichcomplementstheECHAguidancedocument,especiallywithregardtotheimplementationofSiAobligations. Itaddressesallrelevantstakeholdersoftheaerospaceanddefence industry,actorsoftheirrespectivesupplychains,andrelevantauthorities.AspermittedintheECHASiAguidance,thisASDguidanceelaboratesfurtherbyprovidinganindustry-specificperspectiveforSiAsinthecontextofverycomplexobjectsinhighlycomplexmulti-tierglobalsupplychains.

ThisASDguidanceisthenaturalsuccessortotheASDTechnicalPaper"REACHSubstancesinArticles"asdeveloped in 2016 and intends to reduce uncertainty for the Aerospace and Defence industry andprovidesamethodologyfortheuniformcompliancewiththeprovisionsofArticle33(1)andArticle7(2)across the industrysectorcoveredbyASD. Inorder toreducetheadministrativeburdenofsubstancereportingwithoutcompromisingtheneedformeaningfulinformationtoallowsafeuseASDproposestosimplifythedataflowbyapplyingthefollowingprinciples:

• InaCLSVHCdeclarationaccordingtoArticle33(1),datacanbeaggregatedatsub-assemblylevels

(i.e. very complex object level), provided that all CL SVHCs present are still reported upon,includingthosecontainedincomponentarticlesatthesub-assemblylevel.

• Additionalinformation,likelocalisationoftheCLSVHCsinthegivencomplexobject,isonlygivenifmeaningfulandusefultotheuser,i.e.whenheneedstotakemitigationactioninresponsetothepresenceofthisCLSVHCsundernormalorreasonablyforeseeableconditionsofuse.

• Where necessary and applicable, information to allow safe use can be presented in existingdocumentation formats known to the user, such as in operation, maintenance or equipmentmanuals,whichareusuallygovernedbyspecificproductsafetylaws.

Thisguidancefocusesonthesubstanceinarticlereportingobligationstorecipients(Article33(1)),andnotifications to ECHA (Article 7(2)). Registration requirements for substances in articles that areintended for release are not discussed in this guidance [please refer to ECHA SiA Guide Ch. 4“Requirementsforsubstancesintendedtobereleasedfromarticles”],noraretheobligationsonuseofrestrictedsubstancesofAnnexXVIIinarticles.Additionally,itisassumedthatthereaderisfamiliarwithhowtodeterminewhenaproductisclassedasan‘article’underREACH[pleaserefertoECHASiAGuideCh.2“DecidingWhatisanArticleunderREACH”].Finally,astheECHASiAGuidancedoesdescribesometopics already in full depth, and that some SiA topics are not very relevant for the majority of theAerospace and Defence Industry, this ASD Guidance does not further elaborate on calculationmethodologiesforCLSVHCsinarticles,norontheintentionalreleaseofCLSVHCs.

12 ASD Guide on the Interpretation of REACH, latest version available at http://www.asd-europe.org/chemicals-hazardous-materials.


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ConsumerusesarenotconsideredasnormalusecircumstancesforAerospaceandDefenceproducts,and are therefore not covered in this sectoral guidance. Accordingly, the examples provided in thisguidanceareadaptedinformatandcontenttothelevelofknowledgeandawarenessthat isrequiredfromindustrialandprofessionalusersinnormalbusiness-to-business(B2B)orbusiness-to-government(B2G)relationships.TherelationshipbetweenREACHCLSVHCdeclarationandtheend-of-lifetreatment(i.e.dismantlinganddisposal)oftypicalproductsofASDmembersisbrieflydiscussedinchapter2.4.

TheprimaryfocusoftheexamplesprovidedinthisASDsectoralguidanceistoillustratehowtocomplywith the legal obligations for CL SVHCs contained in articles. Additional considerations (e.g.obsolescenceriskmanagement)arenot inthefocusofthisguidanceandareonlypresentedonsomeoccasionstoprovidethefullpictureforfurtherconsiderationbyASDmembers.

Thisguidancedoesnotproposeanobligatorymethodology,norestablishastandard,norprescribe inanyway how substance reporting for REACH shall be carried out. Instead, examples are provided assuggestions for voluntary implementation by the industry with the intention to enable or improve aconsistentandeffectivereportingscheme.

InordertofacilitatethereportingforASDmembersandtheirsupplychainactors,thissectoralguidancealsoprovides a list of CL SVHCs that aremost common inour industry for articlemanufacturing (seeAppendixE).

ThisASD sectoral guide complements the existingASDGuideon Interpretationof REACH, aswellas theECHAGuidanceonSiA. It focusesonprovidingrecommendations for theefficientandpragmaticcompliancewiththerequirementsofREACHArticle33(1)andArticle7(2)withregardtoverycomplexobjects.IllustrativeexamplesrelatedtoprofessionalorindustrialuseofA&Dproducts(includingmanufacture,assembly,operation,maintenance,repairandoverhaul)inactivitiesforeseeableundernormaluseconditionsareprovided.


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2ASDSpecificitiesinProductComplexities,BusinessModels&ProductLifeCyclesThe Aerospace, Defence and Security sector has many specific characteristics, which can causedifficultieswithcomplyingtosomeprovisionsofREACH.Thesecharacteristicsare:• Lowproductionseriesandlongproductiontimelines(typically10-30years)forsingleplatformandtotalproductionruns;

• Verylowvolumeconsumptionofchemicalscomparedtootherindustrysectorsandconsumeruse;

• Theneedtokeeptheproductsinoperationalconditionsovertheirlonglifecycle(30-50years);

• Supply chainswhichareboth international andhighly complex,holding stock for longperiodsoftime,re-saleandre-useofrefurbishedassets;

• Manufacture of extremely complex objects both for platforms produced by Original EquipmentManufacturer (OEM), e.g airplane manufacturer and for high complex systems and subsystemsdevelopedandproducedbyspecializedsuppliers;

• Maintenance, repair and overhaul must only be undertaken by approved organisations inaccordancewithcontrolledandapproveddesigndata;

• Special confidentialityaspectsespecially in thedefencesector (nationaleyeonly, classificationofinformationassecret);

• AllactorsinthelifecyclephasesofA&Dproducts(production,use,maintenance,repair,overhaul)are industrial and professional users. It lies in the nature of the ASD product portfolio (civil andmilitary aircraft, helicopter, frigates, submarines, tanks, missile systems, satellites, securetelecommunication infrastructure), that this business is performed as B2B and B2G. Business toConsumers(B2C)israrelyrelevant.

ForfurtherreadingpleaserefertoASDGuideontheInterpretationofREACH.TounderstandthechallengesofArticle33(1)compliancefortheASDsector,itisimportanttorecallthataeronautic,defencesecurityandspacecompaniesaretypicallyproducersofhighlycomplexproducts.Thesemayconsistofmanymillionsofarticleswhereasasingleelectroniccomponentisanassemblyofarticles. The corresponding supply chains are complex, multi-tier and global. Major A&D systemintegrators must deal with several tens of thousands suppliers in scope of REACH. Collection ofcomprehensivechemicalinformationthroughoutthesupplychainisverychallengingduetothevariouslevels of data that are available and because there is no aligned standard across all sectors andcompaniesforthedeliveryofsubstanceinformationacrossthesupplychain.


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2.1ProductLifeCyclesinrelationtoREACHtimelinesProductsintheindustrysectorofaeronautics,space,securityanddefencearedesigned,manufacturedandmaintainedforusephasesofseveraldecades:forcivilaircrafttypically30-40years,forspacecrafttypically15-25years,andinmilitaryapplications(air, land,naval)for40-50yearsinalotofcases(seeFigure2.1.a).

Time/Periodinyears CivilA/C FighterA/CTelecomSatellite Tank Frigate

Development 15y 15y 5y 15y 15y

Production 30y 20y 5y 20y 20y

UsePhase 30y 50y 20y 50y 40y

Figure2.1.aTypicalProductLifeCyclesinA&DindustrysectorComparedwiththislongevityofrepresentativeASDproducts,thereisastrongmismatchbetweenthetimelinesofREACHprocesses(e.g.CLupdateeverysixmonths,possibleannualupdateofauthorisationlist, sunset dates of typically three years after Annex XIV inclusion and review periods for grantedauthorisationsrangingfrom4to12years)andtheverylongproductandequipmentlifetimesintheASDsector.

Figure2.1.bProductLifeCycleofaMil.AircraftinrelationtoREACHCLevolution


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This leads to significant compliance challenges for companies that have to continuouslymonitor theincreasing flow of incoming REACH SiA declarations and Safety Data Sheets (SDSs) from suppliers inordertobeabletodeclareCLSVHC`sforthefinal,extremelycomplexproduct.

This isespecially thecase forMaintenance,RepairandOverhaul (MRO)operationsofso-called legacyproducts,i.e.forproductswhoseproductionhasalreadyceased(sometimesevenbeforeREACHwasinplace).Despitenotbeingproducedanymore,suchlegacyproductsstillneedtobemaintained,oftenbyusing replacementor spare items/equipment that havebeen kept in stock for years.However,whensucholdpartsareata latermomentintegratedintotheproduct,theoriginalArticle33(1)declarationprovided by the supplier is often outdated, since new Candidate List updates have taken place sincestockingtheitem.

Activity Timeline RevisionofCL No.ofSVHC`sonCL

Productproduced 05/2000 n.a. 0

Sparepartproduced 09/2011 06/2011 51

SparesusedinMRO 01/2016 12/2015 168Product undergoing multipleMRO&UpdatesuntilEOS 12/2060 12/2060 >174

Table2.1.cExampleofMROactivitieswithinProductLifeCycleinrelationtoREACHCLevolutionA&DcompaniesfaceuniquechallengesforensuringcompliancewithArticle33(1)duetothesupplychaincomplexities and long product lifecycles, in contrast to the relatively quick timelines for addition ofsubstancestotheCandidatelist.WhentheCandidateListofSVHCsisupdatedafteranarticlehasalreadybeen receivedby an actor in the supply chain, butprior to theonwarddeliveryof that article (e.g. as aspare or as part of a larger assembly), then there is a potential for gaps in the Article 33(1) CL SVHCreporting, since there are no requirements on a supplier to provide a more up to date Article 33(1)declaration after articles have already been delivered to their customer. This is especially challenging incaseswheremanufacture of certain articles has been discontinued long before the onward supply of aproducte.g.forlegacyitems.AllcollectedSiAinformationhastobeaccessible,understandable,maintainableovertheduecourseofa product’s lifecycle, i.e. for decades following all changes of manufacturing procedures, articlemodifications,regulatoryupdatesandMROactivities.


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2.2A&DspecificconsiderationsforMROactivitiesMROincludestheoverhaul,repair,inspectionormodificationofanA&Dproductorcomponentsrelatedtosuchproducts.SuchactivitiesareoftennecessaryforA&Dproducts,duetotheirlongevity.Maintenance of aircraft, defence and security products requires that the organization complies withspecific procedures and materials described in maintenance manuals which are issued by and theresponsibility of the OEMs.Maintenance (unexpected and regular) includes industrial activities usingsubstances and mixtures (that may contain CL SVHCs e.g. for corrosion protection of airframestructures) as well as replacement of product components (e.g. electronic equipment, wheels, etc).Whereas the safe use of substances and mixtures are covered by the MRO risk assessment andmanagement, guidance on the safe use of a product and related equipment is provided within thetechnicalpublicationsdocuments,whichareprovidedbytheOEMuponproductdeliveryandaretobestrictlyfollowedbytheMROshop.

For example, companies (bothOEMandMRObusiness) in the aviation industry arehighly controlledand regulated by authorities. They have to comply with many standardised design requirements,manufacturing andmaintenance procedureswhich contain a high level of stringency to ensure flightsafetyandairworthiness13:

• The OEM for aeronautic products is responsible for issuing instructions for continuedairworthinesstobeusedbymaintenanceorganisations.

• TheA&Dproductoperators (civil/military)mustoperateandmaintaintheA&Dproductper theOEM instructions. They may choose to utilize MRO organisations to provide maintenance inaccordancewithapprovedprograms,proceduresandprocesses;

• ThesuppliersofpartsorequipmenthavetoprovideOEMs,Aircraftoperators(Airlines),MinistriesofDefence(MoD)andMROshopswithinstructionsinconformitywiththeirspecifications.

ImplicationsforREACHArticle33(1)AnMROserviceproviderdoesnotplacecompleteproductsonthemarket, inthesenseoftheREACHregulation. Those products are placed on themarket by the originalmanufacturer.Nevertheless, theMROproviderusuallyhasanobligationtodeclareCLSVHCsforeverynewormodifiedarticlethatheinstallsintheproductorusesforitsrepair.InthecasethatMROactivitiesleadtoamodificationofthearticle,(i.e.achangeoccurredfromaproductenteringMRObusinessandbeingdeliveredafterMRO),informationwhichallowsthesafeuseofthearticlehastobecommunicated.

ExampleApartialrepaintingmayneedapreliminarypolishing.IfthepaintcontainsaCLSVHCawarninghastobementionedinthetechnicaldocumentation.

13ECHA-EASApaper“Anelaborationofkeyaspectsoftheauthorisationprocessinthecontextofaviationindustry”(April2014)


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2.3Examplesofcomplexproductstructuresinaeronautics,spaceanddefencesectorThis section includesan illustrativeexampleof theproduct structureofa typicalaeronautic, spaceordefence product (a so-called complex object in the terminology of REACH/ ECHA guide) in order todemonstratethecomplexitiesthatneedtobetakenintoaccountwhenconsideringREACHcomplianceapproaches for A&D products that potentially comprise hundred thousands of individual articles atvariouslayersoftheproductassembly.Thedifferentlevelsofcomplexobjectsandtheirabbreviationsasdefinedbelowareonlyusedinthisguidanceforthepurposeofillustration.

Figure2.3.aillustratesthedifferenthierarchical levelsofacomplexproduct,suchasanaircraft,whichare(byincreasinglevelofcomplexity):

• CO-ComplexObjects:Thislowestlevelofcomplexityalreadycomprisesassembliesofmultiplearticles,mixturesandsubstances.AtypicalexampleforaCOarePrintedBoardAssemblies.COsaretypicallyshopreplaceableunits(SRU).Theycanberepairedoroverhauled,butthisisdonebyspecialisedsuppliersonly.

• VCO-VeryComplexObjects:Thenexthigherlevelofcomplexity,theVCO,isanassemblyofmanyCOs,plus(whereapplicable)additionalarticles,mixturesandsubstanceswhichformpartofthelargerassembly.AtypicalexampleforaVCOisaFlightComputer.Usually,VCOsareLineReplaceableUnits(LRU).Theyarenormallyexchangedasawholeunitwithrepairsusuallydoneattheoriginalmanufacturerspremises.

• ECO-ExtremelyComplexObjects:AbovetheVCOlevel,theECOisanobjectofalreadyveryhighcomplexityasitconsistsofmanyVCOsplusCOsplusfurtherarticles,mixturesandsubstanceswhichformpartofthelargerassembly.NotableexamplesforanECOaresystemsliketheengine,thelandinggear,thesolarpanelsinsatellitesandthelike.

• SCO-SuperComplexObjects:Thefinal,uppermostlevelofanobjectwiththehighestcomplexityisthesupercomplexobject.AnSCOisassembledfrommanyECOs,VCOs,COsandarticles,mixturesandsubstances.ExamplesforSCOsarethe“finalproducts”typicalfortheAerospaceandDefencesector,suchasaircraft,spacecraft,armouredfightingvehiclesorspacerocketlaunchers.


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Figure2.3.aTheoreticalillustrationofthecomplexityofatypicalA&DproductInreality,aSCOwillcontainonlyalimitednumberofCLSVHC’sinthearticleswhichcompriseit.Whereused,CLSVHC’swillbe includedduringmanufacturetoprovideaspecificdesignrequirementsuchasenhanced product safety, life, reliability, maintenance capability or performance, where there is noviablealternative.TheCLSVHCwouldnotbeinaformwhichwouldgenerateexposuretotheoperatorortheuseroftheSCO.ExposureriskswouldbehighestduringmanufactureormaintenanceandrepairofthearticlecontainingtheCLSVHC,andworkprocesseswouldidentifythehazardsattheleveltheCLSVHCisusedtominimiserisktoworkersduringtheseoperations.

Whilethefigure2.3.ashowninthischapterillustratesthecomplexityofA&Dproductsinatheoreticalrepresentationthatcanbeadaptedtomanyproducttypes,AppendixAofthisASDGuidecontainsalsoanumberof“real-life”examplesthatusethesameillustrativeprinciple.Theyshowthecomplexproductstructuresofanairplane,a tank,andasatellite,highlightingthe levelsofcomplexityof theVCO,ECOandSCOdescribedinthischapter.

Ineverycase,theSuperComplexObject(SCO)comprisesmultipleassembliesofComplexObjects(CO’s),whicharetypicallysourcedfromacomplexsupplychain.AlthoughA&Dproductsusuallycontainonlyavery limitednumberofCL SVHCs (if any), someCO’smay includeCL SHVCs (highlighted in red in theFigure2.3.a).WheresuchCO’sareusedtoassembletheSCO,theArticle33(1)reportingdutiesonCLSVHCscanbetriggered.


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IllustratingthecomplexityofA&DSupplyChains

ThecomplexstructureofA&DproductsrequiringthesupportofmanyspecialistprovidersmeansthatthesupplychainofatypicalA&Dproductisverycomplicated(seeFigure2.3.b).SomesupplierswouldbeEUbased;otherscouldbenon-EUsuppliers.

Figure2.3.bTypicalsupplychainintheA&DsectorWhenapplied toagenericproduct structure like inFigure2.3.c,differentpartsof the super complexobject are produced by different suppliers (S1 to S5, illustrated by different colours) and ultimatelyassembledtogetherintothefinalproduct.

Manufacturer Manufacturer Manufacturer

Distributor Importer Distributor

Manufacturer

Formulator

Importer

Processor Processor Processor

ComponentManufacturer

OEM


Processor

Formulator



Sub-SystemSupplier Sub-SystemSupplier

Customer Customer Customer Customer

MROShop MROShop MROShop MROShop

EU NonEU


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Figure2.3.cSupplychainforSuperComplexObjectsTheexampleshown ismuchsimplifiedand includesonly fivemainCOsuppliers.The largenumberofadditional article producers, formulators and substance manufacturers supporting these five COsuppliersisnotrepresentedintheexampleforclarityreasons.ImpactonabilitytoeffectivelycomplywithREACHArticle33(1)

Inorder tobeable tounderstandwhetherobligationsarisedue toArticle33(1), theproducerof thefinalproduct(likeanairplane,armouredfightingvehicleorsatellite)needstounderstandifthisSupercomplex object (SCO) contains any articles with >0.1% w/w CL SVHC, at any layer of the productassembly.GiventhattheCLSVHCthattriggerstheArticle33(1)informationdutycanbeburiedseverallayersdeepwithin theproduct tree,andconsidering that inpractice, thereareusuallyamultitudeofsuppliersinvolvedintheproductionoftheA&Dproduct,thechallengesofhowtomanageArticle33(1)informationinverycomplexobjectsandacrossverycomplexsupplychainsbecomeapparent.


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2.4HighLevelDescriptionofdismantlinganddisposalconditionsWhilstwasteisclearlyoutofscopeoftheREACHregulationaccordingtoArticle2(2),itcanneverthelessbenecessarytoconsiderrisksofexposureduringdismantlinganddisposalactivitiesofA&Dproducts.

Reporting obligations through the supply chain, such as Article 33(1) REACH, are unlikely to be apractical solution to give recyclers the necessary information and resolve the issue of substances ofconcern in recycledmaterials. Throughouta long life cycleofA&Dproducts (typicallyup to60years)reporting obligations as well as design and manufacturing processes will change. The complex A&Dsupplychainholdsmorethan10tiersandmanythousandsofenterpriseswhichcomeandgoovertime.

SubstancesofconcernarebeingtrackedwithinregulationssuchasREACHthroughoutaverycomplexsupply chain. Also, existing regulations demand that A&D products, which are out-of-service, can betracedatalltimes.

Theaeronauticalindustryhasbuiltupitsowndismantlingfacilitiesandisdevelopingreuseandrecyclingapproachesappropriatetoourproductcontexttoaccommodatebestpracticeforend-of-lifeaircraftatthe International Civil AviationOrganization (ICAO) level.14 Due to aeronautical regulations, a specificcertificationisrequiredinordertoreplaceonthemarketusedcomponentsandparts.Deconstructionfacilitiesarethereforecertifiedsites,withthesameskillsasmaintenanceshopsandarewelltrainedinparticularinusingtechnicaldocumentationavailableforanycomponentandpartofanaircraft.

Fordefenceproducts,dismantlinganddisposalarealsostrictlycontrolled.Forexample,inEurope,thereisonlyonecompanycertifiedbyNATO fordismantlingand recyclingof tanks. Ina first step,oils andgreasesareremoved,thenallcomponentsarestrippedfromthetankuntilonlythemetal"shell"isleft.Thisshell iscut intosmallmetalpieces inorder tomakesurethat thepiecescannotbereassembled.Eachremnantofeverypiecemustbethoroughlytrackedanddemonstratedbyextensivepaperwork.

Forammunition,oldammunition isofteneitherrefurbished(byreplacingpartssubjecttoageingwithnewcomponentssothattheammunitionisagainsafetouseforuptoanotherdecade),ordestroyedbywilful explosion. Both activities must take place at facilities specifically qualified and certified forhandlingexplosives,ordirectlyatthetrainingrangesaofthemilitarycustomer.

Professional, low volume, long life cycle products with particular recycling needs canmore easily behandledinasector-specificway.

14https://www.icao.int/Newsroom/Pages/ICAO-and-AFRA-Enhance-Cooperation-on-Aircraft-Recycling-and-Lifecycle-Management.aspx


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2.5TechnicalproductdocumentationIt is common practice for many OEMs in the A&D Industry to incorporate hazardousmaterials datawithinthetechnicaldocumentationthatisproducedduringthedesignofcomplexobjectsandsupportsolutions for complex objects, and also within the Technical Publications provided for users andmaintainers (e.g. seeexample inAppendixA,FigureA.a indicatingvarious technicalpublications thatmaybeprovidedforequipment).AsCLSVHCdataisasub-setofhazardousmaterialsdata,OEMsmaychoose to include it within the aforementioned technical documentation and to communicateinformation to allow safe use to users andmaintainerswithin the Technical Publications, in order toachieve compliance with the requirements of REACH Article 33(1). Furthermore, it may not beappropriateincaseofsupercomplexobjectsandextremelycomplexobjectstosimplyforwardalloftheinformationthatwasprovidedwiththeindividualarticleswhichmakeuptheequipment. Instead, it isoftennecessarythatsuchinformationtoallowsafeuseisfirstanalysedandaggregatedinthecontextoftheequipment.

Standards are available which contain methodologies that may be helpful in managing hazardousmaterials data, including CL SVHC data, for complex objects. The standards, or the principles withinthem, may be followed voluntarily, or they may be agreed in contract, and in some instances, byregulation.

PrinciplesofSystemsEngineeringforcomplexobject(s)

Itishelpfulforthereaderofthissectoralguidancetounderstandtheprinciplesofsystemsengineeringforcomplexobjects.

Multiple specific skills and analyses are required to develop, produce and operate complex objects.These tasks are normally performed by dedicated specialists. Analysis outcomes may influence thefunctionalaswellaslogicaldesignanditisconsequentlyrecommendedtoinitiatetheseanalysesearlyin the system lifecycle and perform them iteratively in order to quickly detect unsuitable designsolutionsandmitigaterisksfortheend-user.

Thefollowinganalysescanbeconsideredduringdesignphaseforcomplexobjects:

• systemsafetyanalysis;

• environmentalanalysistoevaluateandinfluencetheidentifieddesignsolution;

• logisticssupportanalysis,consideringreliability,maintainabilityandtestability;

• producabilityanalysis.

Thepurposeoftheseanalysesistoidentifyhazards,andtoanalyseandmitigaterisks(includingriskstohealth and the environment) for complex systems. Systems engineering outputs include technicalpublicationsandmanualsforoperatorandmaintenancepersonnel.

AnexampleofmethodologyandstandardisprovidedwithinAppendixD.


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3ImplementationofArt.33(1):ReportingonSiAAfterhavingoutlinedthespecificitiesof theA&D industry inchapter2,chapter3givesmoredetailedinformation on how to comply with the provisions of Article 33(1), i.e. the communication betweensuppliersandrecipients,inawaythatismanageableinpracticefortheA&Dindustry.What information is necessary to allow for safe use depends on the respective use scenario andrecipientand is thereforediscussed inmoredepth in subchapter3.2. Incontrast, chapter3.1 focusesprimarilyontheminimumreportingrequirementsonsubstancesinarticlesincaseswherenoadditionalinformationisnecessarytosatisfysafeuseneeds.

3.1Substancereportingdownthesupplychain

3.1.1 Whentoreportsubstances

Suppliersofarticlesmustpasson informationonthe ingredientsubstances ifthefollowingconditionsaremet:

• The substance is identified as a substance of very high concern (SVHC) and included in theCandidate List. (The Candidate List is available on the ECHA website15 and will normally beupdatedtwiceayear,typicallyinJuneandDecember).

• Thesubstanceispresentinanycomponentarticleofthecomplexobjectinaconcentrationabove0.1%weightbyweight.

This obligation comes into force without any delay on the date a new substance is included on thecandidate list. It applies to articles placed on the market after an update to the Candidate list ispublished.ItistheresponsibilityofthesuppliertopassontheArticle33(1)informationtotherecipientofthearticle;thereisnoneedforproactiverequests.

CLSVHCsmust inallcasesbedeclared if theyarepresentabove0.1%w/w inthearticle.Companiesmay use calculation, testing or other means for determining this concentration threshold (see theextensiveexplanationofpossiblemeansintheECHASiAGuidance).

Since the concentration limit for the CL SVHCs applies to the individual article, there is no need tocalculate or test CL SVHC concentrations at higher-level assemblies or the final complex object.IfaCLSVHCexceeds0.1%w/winanycomponentarticle,thentheCLSVHCmustbereportedforanycomplexobjectcontainingit,irrespectiveofthecomplexobject’sweight.ThissimplifiestheprocessofSiAreportingforeachactorinthesupplychain.

CompaniesshouldbecarefulnottoforgetthatArticle33(1)doesnotonlyapplytotheproduct,butalsoto the packaging (if such is present). The communication duty applies only once per legal entity anddeliveryoftheaffectedarticle.Betweenproductionfacilitiesofthesamelegalentity,thereisnoneedtoprovideArticle33(1)information.15https://echa.europa.eu/candidate-list-table


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While many companies deal with the REACH communication duties by themselves, especially largercompaniesmay rely on professional content providerswhich offer CL SVHC information in own databases.Althoughprofessionalcontentprovidersmayhaveaveryvastinformationbasis,suchservicesaretypicallynotfreeofchargeanddonotreplacesubstancereportingbythesupplier.

3.1.2 ContentoftheArticle33(1)information

Incaseswherethereisnoneedtogiveadditionalinformationtoallowsafeuse,theprovisionofArticle33(1)REACHonlyrequiresthatthesubstancenameiscommunicatedtotherecipient,togetherwithaspecification of the context, i.e. that the information is given because the substance is listed in theREACHcandidatelist.However,astradenamesofchemicalsvary,thesubstancenameisoftennotidealforclearidentificationofthesubstancepresentinthearticle.

Therefore,ASDstronglyrecommendsprovidingatleastonenumericalidentifierofthesubstance,suchas the CAS number or EC number. EC numbers are specific to the European Union; therefore CASnumbersmaybemorecommonlyunderstoodalsobynon-EUsuppliers.Tofurtherfacilitatethecorrectidentificationofthesubstance, it isoftenusefulto indicatethesubstancenamesuchaslistedontheREACHcandidatelist.

Anyinformationgoingbeyondthis,likeconcentrationorlocalisationoftheCLSVHC,isnotrequiredbyREACH(unlessnecessarytoallowsafeuseofthesuppliedarticle).

Finally,REACHdoesnotrequirenorpreventthesubmissionofnegativecertifications(i.e.adeclarationthattherearenoSHVCsabove0.1%w/wthresholdpresentinthesuppliedproduct).AppendixBshowsan illustrative template of a REACH Article 33(1) declaration which can be used by companies on apurelyvoluntarybasis.

3.1.3 Aggregationofinformation

When reporting substance information on products that contain several hundred thousands ofcomponent articles, it may become impossible to present the information in a meaningful andmanageable way if the individual component articles are reported individually. ASD thereforerecommends aggregating the substance reporting on the level of the very complex object (VCO) orextremelycomplexobject(ECO,seechapter2.3forexplanation)bythefollowingfourways:

• Tobeconsistentwiththelaw,thepresenceofaCLSVHCmustalwaysbereportedifpresentinaconcentrationabove0.1%inanycomponentarticle.However,REACHdoesnotnecessarilyaskfor the respective article to be named or identified; and naming the respective componentarticleinameaningfulwaymaybedifficultastheyoftenhavecrypticproductdesignationsthatarenotnecessarilyunderstoodbytherecipient. Insuchcases,ASDrecommendstodeclaretothe recipientnot thenameof the component article(s), but thenameof the sub-assembly inwhichthisarticleisintegrated.


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• Equally, if the sameREACH candidate list substance is present inmultiple component articles(either of the same kind, or of different kinds) within the same sub-assembly, ASD deems itsufficient to only indicate that this substance is present in the sub-assembly, but not in howmany different articles or in which component article types specifically, unless provision offurtherinformationisnecessarytoallowsafeuse.

• Furthermore, if one component article contains several REACH candidate substances at thesametime,ASDproposes to informtherecipientabout theirpresence inonedata-set for thesub-assemblyinsteadofoneseparatereportpersubstance.

• Finally,inordertofurtherreducethenumberofREACHdeclarationsthatneedtobemanaged,itmaybeusefultoreportseveralproductsinjustoneREACHdeclaration.

Ofcourse,thepresenceofasubstanceofveryhighconcernmustneverbehiddenbythesemeansofaggregation.AmethodofaggregationisillustratedinanexampleshowninAppendixC.

3.1.4 TransmissionmodesandformattingofArticle33(1)information

Since REACH Article 33(1) does not specify how the information on substances in articles should becommunicatedtoarecipient,severalformats,documenttypesandtransmissionroutescanbeused:

Formats Transmissionmodes• PDF• Word• Excelspreadsheet• Hard-copyprint-out• Technicaldocumentationofproduct

• Mail(letter)• E-Mail• Linktoweb-page• Third-party(IT)solution

In order to facilitate the management of incoming Article 33(1) information and the onwardtransmission of REACH declarations, suppliers and their customersmay find it helpful to agree on acommonformatandmethodofprovidingsuchinformation,whichtakesintoaccountthecapabilitiesofallactorsinthesupplychain,andtheeaseofextractingtherequireddataforonwardtransmissionbytherecipients.Forexample,hard-copytransmissionscanbedifficulttomanageasthecontentneedstobe manually re-typed by the recipient, but can be a solution for supply chains with limited ITinfrastructuresorforproductswhichareaffectedbyREACHonlytoalimiteddegree.

TheexamplesbelowillustrateArticle33(1)reportingvia letter,E-mail,andviaadirect linktoproductspecificcontentoncompanywebpage.


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Figure3.1.aIllustrativeexampleoftransmissionbyletter

Figure3.1.bIllustrativeexampleoftransmissionbyE-mail

REACHDeclaration–DéclarationREACH

English

InaccordancewiththeREACHregulationEC1907/2006article33andwithrespecttothecandidatelist,updatedasofxxyyyy.WedeclarethatourzzzcapacitorsdocontainboricacidCASNo.10043-35-3withaconcentrationhigherthan0.1%(w/w).Foranyinformationrelatedtoourproductutilization,pleaseconsultourtechnicaldocumentationorcontacttheSalesDepartmentortheREACHinterlocutor.

FrenchConformémentaurèglementREACHEC1907/2006article33etenreferenceàlalistedesubstancescandidates,miseàjourxxyyyy.Nousdéclaronsquenoscondensateurszzzcontiennentdel’acideboriqueN°CAS10043-35-3avecuneconcentrationsupérieureà0.1%(masse/masse).Pourtouteinformationrelativeàl’utilisationdenosproduits,veuillez-vousréféreràladocumentationtechniqueoucontacterleDépartementCommercialoul’interlocuteurREACH.


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Figure3.1.cIllustrativeexampleoftransmissionbycompanywebpageIncontrast,exchangingREACHinformationinXML(ExtensibleMarkupLanguage)format,viadedicatedonline data exchange platforms, or via end-to-end IT solution often enables the recipient to quicklyprocess the information as the content is directly readable for the recipient’s IT system. However,dedicatedtoolsmaybeexpensiveandrequirethatallparticipantsofthesupplychainuseacomparableIT infrastructure inordertoworkefficiently.OnecannotexpectallcompaniestohavesuchITtools inplacethatgobeyondstandardITapplications.Havinginmindtheverycomplexobjectstypicalforoursector, some A&D companiesmay however consider it helpful to use such electronic means for SiAcommunication.

TheREACHregulationdoesnotspecifywhetherArticle33(1)declarationsmustbesigned.

3.1.5 AddresseesoftheREACHdeclaration

REACH Article 33(1) does not specify to whom the REACH information should be sent. Accordingly,REACHinformationcan inpracticebeaddressedtovariouspossiblerecipients,suchasthepurchasingagent, to the quality department, the CEO of the company, or the department of incoming goods.However,asSiA informationdonothavea fixedformatorcontent, the individual recipientmayhavedifficultiesrecognisingtheinformationasrelatedtoREACH,misinterpretitscontentorsimplynotknowwhattodowiththeinformation.

Besidesprovidingdedicatedinformationtothestaffmembersofthoseinternaldepartmentsmostlikelyto receive REACH information, it may therefore help to install a dedicated address ([email protected])withinthecompanyandtospecifythisaddresstothesuppliers,e.g.onthewebsite,inthecompany’sgeneraltermsandconditionsofpurchase,orinthecontractagreements.Whendoingthis,thepreferredformatforreceivingthedatacouldbespecified,too.


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Thereby, it is not only easier to ensure that no relevant information ismissed, but it also eases theprocess for suppliers as they can be confident that their information is received by competentpersonnel.Thisstreamliningoftheinformationflowalsoeasestheadministrativeburden.

REACH requires the provision of information to recipients situated within the European Union (plusNorway, Liechtenstein and Iceland).However, itmaybe useful to provideREACH information also tonon-EU recipients; especially in multi-national complex supply chains, such as typical for the A&Dindustry,asthearticleswillpossiblybere-importedintotheEUatalaterstageandthenon-EUsuppliershouldthenbeinapositiontocommunicatetheREACHinformation,too.Inaddition,itmaybeeasierforthesystemtonotdistinguishbetweenEUandnon-EUcustomersbuttosendtheREACHinformationineverycase.


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3.2Article33(1)informationonsafeuseArticle 33(1) aims to provide the recipient of the article with sufficient information, available to thesupplier, to allow safe use of the article throughout the entire supply chain. Where CL SVHC’s arepresent inaproduct,theymayinmanycasesposenoexposurerisktotheuser(e.g.becauseit isnotaccessible),dependingonthespecificusesituation.Insuchcases,nofurtherinformationonsafeuseisneededotherthanidentifyingthesubstancename.

Additional information,suchasthelocationoftheaffectedcomponentarticlewithintheproduct,andpossiblyinstructionsonriskmanagementmeasuresthatneedtobeappliedinordertosafelyhandletheproduct,areonlyrequiredinverylimitedcaseswherethepresenceoftheCLSVHCcreatesanadditionalriskthatcanandmustbemitigatedbyadditionalmeasuresthatwouldotherwisenotbetaken.So, inordertoassesswhatadditionalriskinformationtoprovide,oneneedstoassess,

1. therisksrelatedtotheusescenariosoftheproduct;and

2. thealreadyexistingtechnicaldocumentationthatsupportstheseuses.

ForA&Dproducts,safeuserequirementscausedbyREACHmostlycomplementwhatisalreadycoveredbyexisting safeproduct legislation (see chapter2.5). If thepresenceof aCL SVHC in a complexA&Dobjectposesarisktotheusers,necessaryinformationtoallowsafeusecanandwillalreadyhavebeeninmanycases integrated intoexistingdocuments. Themain concernofASDmembers is therefore toprovidemeaningfulinformationtoallowsafeuseforverycomplexobjectswithoutitbecomingdilutedbyexcessivedetail.

3.2.1 AssessingthepotentialforexposurerisksrelatedtoCLSVHCsinA&Dproducts

InthelimitedcaseswhereaCLSVHCispresentinanA&Dproduct,theCLSVHChasvaryingpotentialtoindeedcauseexposureduringtheSCO’s(seechapter2.1forexplanation) lifecyclethatwouldrequiretheprovisionoffurtherinformation(inadditiontothemandatoryCLSHVC’sname).Manufacture,productionandassembly

Usually, exposure to CL SHVCs ismost likely to occur at the time of their inclusion into or onto therespectivearticle,i.e.duringmanufactureandproductionwheretheCLSVHCisusedasasubstanceormixture, e.g. galvanic plating, surface treatment, formulationof pyrotechnicmixtures et al.However,exposuretoCLSVHCsasasubstanceormixture isnot inthescopeofArticle33(1)orArticle7REACHduties(onthedeclarationofsubstancesinarticles),andthereforenotrelevantforthisguide.

Exposure to CL SVHCs during production ormanufacturing processes can also occurwhere an articlethatcontainsaCLSVHCistreatedandtherebyreleasestheCLSVHC,e.g.machining,grinding,drilling,orothermechanicalworkingof thearticle.However, therisks relatedtosuchexposureareusuallywell-knowntotherespectivecompanyandaddressedbyriskmanagementmeasuresprescribedbyexistingworkplacesafetyregulationsotherofREACH.ManufacturingprocessesthereforedousuallynottriggertheneedtoprovideadditionalREACHinformationtoallowsafeuse.


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Operation

A&Dproductsaredesignedtoperformaparticulartask.DuetoproductsafetyregulationsotherthanREACH,A&DproductsdonotnormallyreleaseCLSVHCsthatcauseanexposurerisktotheoperatoroftheproduct(i.e.soldier,pilotorotherprofessionaluser).Accordingly,exposurerisksdousuallynotexistatthisstageoftheproduct’slife-cycle,becausetheCLSVHCsareusuallyboundinthematrixoronthesurface of the affected article,which is usually not accessible to the user or does not release the CLSVHC (see Figure 3.2.a for a theoretical illustration of the limited exposure). In the rare caseswherethereisariskduringoperationoftheA&DproductduetoexposuretoCLSVHCs,suchriskswillalreadybe covered by existing technical documents and operation manuals, so that additional REACHinformationtoallowsafeusewouldbeaduplication.

Figure3.2.aSCOwithoutexposuresundernormalconditionsofoperation


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Maintenance,RepairandOverhaul(MRO)

IfanA&DproductissubjecttoMROactivity(whichisnormalformanyA&Dlonglifecycleproducts),CLSVHCs present in the product may pose a risk of exposure to those persons undertaking the work.Surfacegrindingorabrasion,andtheneedtorepairarticlescontainingCLSVHCswhicharenotusuallyaccessible during normal operations, may produce a exposure risk. To adequately address suchexceptional risks, the producer or design authority holder of the SCO will normally provide a set oftechnical documents specifically detailing the repair process and including the risk managementmeasures necessary during maintenance and repair of the SCO and its component parts (i.e.MaintenanceManuals).

Figure3.2.billustratesthepotentialforhigherCLSVHCexposureduringMROactivities(incomparisonto the low probability of exposure during operation of the product illustrated in Figure 3.2.a).ServiceableitemscontainingCLSVHCs,anditemswhichcontainCLSVHCsbutarereturnedtotheOEMfor repair, may produce an exposure hazard not present during normal operation, and requireinformation to reduce risk to personnel undertaking maintenance or repair. Examples (based onAppendixA)could includerepairorreplacementoftheGlideSlopeAntennaonthenose landinggear(seeFigureA.b),orthepaintedGearRibonthewing(seeFigureA.d).Non-serviceableitemscontainingCLSVHCsmayonlyproduceanexposureriskduringdisposal.

Figure3.2.bTheoreticalComplexObjectexposureriskduringMRO


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Repair and high level maintenance will tend to require the same level of CL SVHC information andexposureprotectionaswouldberequiredtosupportmanufacturingoperations.Itmaybenecessarytoprovide information relating to the CL SVHC presence in the articles and CO’s at lower levels in theoverall SCO, if they containCL SVHCs and theMROactivity causes an exposure risk. The informationrequiredtosupportMROworkisgenerallysimilartothatneededforproductionandMRO(asshowninFigure3.2.c).

Figure3.2.cInformationtoallowsafeuseflowsforMROThe informationflowtosupportthemanufacturingstage isshownbythesolidarrows,wherearticlesand complex objects are assembled together at each level of assembly. Circular ended lines showCLSVHCdataforthearticleswhicharesubjecttoornecessaryforMROactivities.Solidlinesindicatewherethedataisequivalenttothatinthemanufacturinglevel;dashedlinesareusedwherethereisaneedforadditionaldatafromalowerlevelofassembly.


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3.2.2 Providingmeaningfulinformationtoallowsafeuse

As itwas justoutlinedwithhelpofgenericexamples,additionalREACH information toallowsafeuseareusuallynotrequiredduringtheoperationoftheproduct,butratherduringmaintenance,repairandoverhaulactivities.TheREACHinformationtoallowsafeuseshouldthereforebeadjustedtothelevelofpre-knowledgeandexpertiseoftheprofessionalandindustrialpersonnelengagedinsuchactivities.SinceMROpersonnelarefamiliarwithexistinghealthandsafetywarningsinmaintenanceinstructions,itmaybesufficienttolimittheinformationtoallowsafeusetohighlightingthepresenceofthespecificSVHC in the product and detailing its intrinsic properties. This information can also be used by theprocess safety experts and health & safety experts to adapt the risk management measures at therespectivelocalworkplace.

Figure3.2.d illustratesanexamplefor informationtoallowsafeuserelatedtoaCLSVHCpresent inacomplexobject (hereinArsenic,Cadmium, Lead in “PrintedBoardAssemblies”), Figure3.2.e illustratetheinformationtoallowsafeuserelatedtoaHazmatpresentinaCO(herein:Cadmiumonfasteners).

Figure3.2.d Exampleforinformationonsafeuse(Arsenic,Cadmium,Lead

insidecomponentsonPrintedBoardAssemblies”)


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Figure3.2.eExampleforinformationonsafeuse(Cadmiumonfasteners)

Most products in the A&D sector are regulated by product specific legislation or sector specificrequirements (seechapter2.5).Suchproductspecific legislationoften imposesthedutytopassalonginformationonthesafehandlingoftheproductsdelivered,includingonhazardoussubstancespresentin the product (whose scope is usually far broader than REACH) and on adequate risk managementduringoperationorMROactivities. ItmaythereforebepossibletoeitherintegratetheinformationtoallowsafeusebyREACHintoexistingproductdocumentation,orallnecessaryinformationmayalreadybeincludedinthenameddocumentsonthebasisofotherobligations.Insuchcases,creatingadditionaldocumentation to provide information to allow safe use to the recipients of the products will beunnecessary.

Example3.2.fillustratesinformationtoallowsafeuseasalreadyincludedinexistingdocumentationforanA&Dproduct.

Cadmiumonfasteners:• Anycadmiumplatedfastenercontainscadmium(CAS:7440-43-9)above0.1%w/w.• Potentialhealtheffects.

When used as intended, cadmium plated fasteners should not pose any health hazard.Thehealtheffectslistedbelowshouldnotoccurunlessimproperprocessingorinstallationofthefastenergeneratesdustorfumes.

Thefastenershallnotbeshaved,sanded,ground,weldedorotherwisealtered.

Thefollowingstatementssummarizethehealtheffectsgenerallyexpectedincasesofover-exposures:• EyesDustandfumesfromprocessing:

Ø Cancauseirritation.

• SkinDustandfumesfromprocessing:Ø Cancauseirritation.

• InhalationDustandfumesfromprocessing:Ø causeirritationoftherespiratorytract.Ø Acuteoverexposures:Cancauseshortnessofbreathandinflammationofthelungtissues.Ø Chronicoverexposures:Cancausecentralnervoussystemdamage,liverdamage,lungdamage,

reproductiveharmandlungcancer.Ø Medicalconditionsaggravatedbyexposuretodustandfumesfromprocessing:

Asthma,chroniclungdisease,secondaryParkinson'sdiseaseandskinrashes.


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Figure3.2.fExampleforinformationonsafeuse(LeadTitaniumZirconiumOxideinPiezoceramics)Integrating information to allow safe use into existing documentation has the advantage that,whileREACH does not further specify the content and format of the information to allow safe use , theproduct specific legislation often does, which makes their handling and administration easier.Furthermore, the users (e.g. maintenance staff) are often already familiar with the existingdocumentation, e.g. maintenance or operational manuals, which increases the likelihood that theinformationismeaningfulandindeedaccessibletothepersonswithprobableexposure.

Whileintegratinginformationtoallowsafeuseintoexistingdocumentation(ifitisnotalreadyincludedonbasisofotherrequirementsthanREACH)maybeaviableoptionforsomeA&Dproducts,therearealsocaseswheresuchis:

• notpractical,forexamplebecauseupdatingtheuserorMROmanualsmayrequirelong-lastingadaptationprocedureswithinthecompanyorwiththecustomer,or

• notfeasible,(e.g.forconsumables,standardpartsandpieceparts).

Insuchcases,thecompanymightdecidetorathercreatededicatedformatsfortheinformationtoallowsafeuse,orincludetheinformationtoallowsafeuseintheCLSVHCdeclaration.Inthelattercase,therecipient’sREACHorganisationshouldensurethat therelevant information iseffectivelypassedontotheoperationalandmaintenancepersonnellikelytobeexposed.


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3.2.3 Localisationofaffectedcomponentarticlesinthecontextofsafeuse

REACHdoesnotaskfortheSVHC-containingcomponentarticletobespecificallyidentifiedbyprovidingdetails on its localisation within the complex object. However, such localisation information may benecessaryinsomecaseswherethisinformationisneededforensuringthesafeuseoftheproduct,e.g.when the SVHC’s presence may pose a risk if the respective component article is handled duringmaintenance. If several similar component articles are present in the same product, it may inmanycases bebest to aggregate the informationon the levelwhere the exposure for theuser can indeedoccur,inordertopreventexcessiveduplicateinformation.

When providing localisation information, suppliers should be aware that detailed information on thelocalisationof a component articlewithin a complexobjectmay, especially in the contextofdefenceequipment,createconcernwith regard toconfidentialityneedsorexportcontrol restrictions,e.g. theInternational Traffic in Arms Regulation (ITAR), it may therefore be useful to provide localisationinformationina(separate)documentwithrestrictedcirculation.


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4ImplementationofArt.7(2):NotificationtoECHA

4.1WhenisArt.7(2)notificationrequired?AnotificationtoECHAunderarticle7(2)mustbemadewithinsixmonthsofanSVHCbeingaddedtotheREACHcandidatelist.ThisnotificationtoECHAregardingthepresenceofanCLsubstanceinarticlesisrequiredwhenallfourofthefollowingcriteriaaremet:

1 CLsubstanceisinthearticlesabove0.1%w/w

2 TotaltonnageoftheCLsubstanceinthearticlesis>1tonneperyear

3 TheuseoftheCLsubstanceinthearticleshasnotalreadybeenincludedintheregistrationdossier

4 ExposureoftheCLSVHCwithinthearticlestohumansandtheenvironment,undernormalandreasonablyforeseeableconditionsofuse(whichincludesdisposal)(REACHArt.7(3),cannotbeexcluded

Table4.1.aCriteriathatmustallbemetfortriggeringanotificationtoECHAunderarticle7(2)SinceA&DusesofSVHCsaretypicallyexpectedtobelowvolume,itisanticipatedthatmanycompaniesdealingwithproductscomprisingarticlesthatcontain>0.1%w/wCLSVHCwillnotmeetthe1tonneperyear threshold,andmay thereforenothaveproducts falling intoscopeof theArticle7(2)notificationrequirements.

For imported(complex)objectsthatarenotmanufacturedwithEEAsourcedCLsubstances, itmaybedifficulttomeetcriterion3ofTable4.1.a.Inordertoensureasubstanceisalreadyregisteredforause,it first needs to be confirmed that the substance is indeed the ‘same’ as that already registered.AccordingtoECHAguidance,‘sameness16’ofasubstancecanonlybeconfirmedbyappropriateanalysisand identification of the substance, as is the requirement when submitting a dossier for a jointregistration.

Converselythereisnorequirement,whenmakinga7(2)notification,toensurethatthesubstancebeingnotified for the particular use in articles has been identified with the same rigour required for aregistration.Itfollowsthatforarticles(presumedtofulfilcriteria1and2oftable4.1.a)withanunclearor unknown registration status for the incorporated CL SVHCs, the easiest way to demonstratecompliancewill be to completea7(2)notificationwithECHA. This is expected tobe the case for themajorityofarticlesimportedintotheEEA.

16seeECHAGuidanceinaNutshell–IdentificationandnamingofsubstancesunderREACHandCLP.Sections4&5.


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A simplification is to treat all imports of articles where a CL substance is estimated >1t p.a. as“notificationrequired”becausethetestofnon-applicabilityongroundsofregistereduseistoodifficultonwhichtodemonstratecompliance.

The flow chart in figure 4.1.b illustrates the scenarioswhen a notification to ECHAunder article 7(2)should be made and when alternative measures are indicated (e.g. substance registration orcommunication of uses upstream for inclusion in an existing registration dossier). The flow chartassumesthatthearticleinquestioncontainsaCLsubstanceabove0.1%w/wandthatthetotaltonnageoftheCLSVHCwithinthearticle is1tonneperyearormore.Wherethestatus is ‘unknown’then‘N’shouldbeassumed.

Figure4.1.bDecisionflowfordeterminingnotificationobligationsunderREACHArticle7(2)(forarticlescontaining0.1%CLSVHCwithtotalCLSiAquantityat1tonneperyearormore)

For articles that areproduced in the EEA, using substances andmixtures that are sourcedwithin theEEA,thereshouldnotbeanyobligationunderREACH7(2).AnyusesofCLsubstancesinarticlesabove1tonne per year should already be captured in the registration. If they are not, the use can becommunicatedbackupstreamforsuchinclusionintheregistrationdossier.

Bythelatestregistrationdeadline(May2018),itcanbeexpectedthatallsubstancesabove1top.a.areregistered.


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4.2WhatinformationisrequiredtobesubmittedinanArticle7(2)notificationtoECHA?The required data points on the presence of a CL substance in articles, that are to be submitted toECHA17 under REACH Article 7(2), via online submission, are summarised in Table 4.2.a. SuggestedcontentisprovidedwheretheymaybevalueinaconsistentapproachtotheprovisionofinformationbyASDmembers.

Informationrequired Detail/RecommendationArticleName FreetextfieldArticlecategory(AC) For complex objects where it is not knownwhere the CL substance resides in

(location),itisadvisabletoselect“ArticleCategory”AC0andenter‘Aerospace&Defence’

TechnicalFunctionofthesubstance

Thetechnical functionof thesubstancewithin thearticle,orcomponentarticleshould be entered. For example, if a CL substance is present in a coating toprevent corrosion, the function ‘Corrosion inhibitors and anti-scaling agents’ isselected.Forcomplexproducts,where it isnotknownwhichcomponentarticle(location) that the CL substance resides in, the technical function of thesubstance inthearticlemaynotbeobvious. Inthiscase it isadvisabletoselect‘Other’andenter‘Notdisclosed’

Exposurerelateddescriptionofarticle

For complexobjects,where it is not knownwhich component article (location)that the CL substance resides in, the exposure related descriptionmay not beknown.Inthiscaseitisadvisedtoselectallthatcouldreasonablyapply

Processcategory SelectthemostapplicablePROC(ProductCategory)codesifknownEnvironmentalreleasecategory

Most A&D articles are expected to fall under ERC10a (wide dispersive outdooruseof long-lifearticlesandmaterialswith lowrelease),owingtotheconditionsofuseandlongevity.PleaserefertofigureR.12.7intheECHAmanual‘Howtoprepareasubstanceinarticlesnotification’,whichcontainsadecisiontreetoassistinassigningERCs

Usergroup(s) A&Darticlesarenottypicallyexpectedto fallunderconsumeruses.Theoption‘workers’shouldbeselectedinthemajorityofcases

Tonnageofsubstance HastobeenteredasnumericvalueConcentrationofthesubstanceinwholearticle(%)

Hastobeenteredasnumericvalue

Give the overall description of the article and its different parts, describe where in the article theCandidateListsubstanceispresentandgivetheestimatedconcentration(w/w)inthatpart/materialDescribetheforeseenuseofthearticle.Includealldifferentfutureusesduringthearticleservicelife(e.g.processingofasemi-finishedarticle,installationofthearticle,maintenanceanduseofthefinishedarticle,disposal)NOTE:Itismandatorytosubmitinformationfortherequirementshighlightedingreyintable4.2.a.OtherinformationmaybeprovidedtoECHA,butisnotmandated.

Table4.2.aRequiredinformationforCLSVHCSiAnotificationtoECHAunderREACHArticle7(2)

17SeealsoECHAmanual“Howtoprepareasubstanceinarticlesnotification”


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5HowtodeterminewhetheraCLSVHCispresentinthearticleThischaptermeanstoexplainhowtodeterminewhetheraCLSVHCisintroduced,duringmanufacturingorassembly,intoorontoanarticle.Everycompanyinthesupplychainneedstoindividuallymakethisdeterminationfortheproducts itproducesormanufacturers,and ifaCLSVHCis indeedpresent,givetheresult(i.e.theArticle33(1)declaration)tothenextcompanyinthesupplychain.

ThischapterdescribesthebasicconsiderationsregardingchemicalreactionsinvolvingSVHCsubstances.Itisonlyapplicableforthosecompanies,thatuseCLSVHC`sintheirmanufacturingprocesses.Pleasebeawarethatthechemistryinvolvedismostlyverycomplex,sodetailinvestigationshallbeundertakenbychemist/process specialists. Only intended reactions and physical state changes are covered;unintendedreactionduetoinappropriatestorage,environmentalinfluenceslikeUVradiation,moistureand air or aging are out of scope of this guidance. Please be aware that, due to the complexity ofchemical processes involved, it is often necessary to either involve chemistry or process technologyspecialists(in-houseorfromexternalserviceproviders),ortoturntothechemicalsupplierforhelp,inordertogetthenecessaryknowledgetodeterminewhetheraCLSVHCisorisnotpresentinanarticle.

Figure5.aSiAdeterminationprocessflowchart


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ACLSVHCsubstancecanbepresent inanarticle ifamaterialoraprocessusedfor itsmanufacturingcontainssuchasubstance.Therefore,inordertodeterminewhetherthereisapossibilityforhavingaCLSVHC substance in a given article, a systematic approach per substance at each manufacturing andassemblysiteisuseful.Theaboveflowchart(Figure5.a)illustrateshowtoapproachthedeterminationprocess.

“Substance”Logic

First,withthesubstancelogic(intheblueboxinFigure5.a),thecompanycandeterminewhetheraCLSVHCsubstance isused fora specificmanufacturingprocess. Fordoing this, thecompanycanusuallyrelyontheexisting inventoryofchemicalproductsused inarticlemanufacturing.Suchan inventory isestablishedby looking intotheSafetyDataSheets(SDS)providedbythesuppliersofchemicals. ItcanusuallybeadaptedinawaytoshowonlychemicalproductsthatareorcontainCLSVHCs.

Once having determined all chemical products that contain a CL SVHC, the company can be able todetermineinwhichproductionprocessestheseproductsareusedin,orwhetherthechemicalproductisdirectly integrated intothearticleFor further informationaboutCLSVHCused intheA&Dindustry,seeAppendixE.

Figure5.bFlowchartforchemicalreactionscenariosThe next step consists of determining whether the CL SVHC remains in the article (i.e. it does notdisappearduringtheprocess,likesolvents).Thisdeterminationusuallyrequiresinputfromexpertsthathaveknowledgeabouttechnicaldetailsoftheprocessesormaterials.Thedeterminationdifferentiatestwopossiblescenarios(seefigure5.b):


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Scenario1In the first scenario,whenusing a substanceormixture containing oneormoreCL SVHCs totreatanarticleorincludeitinthearticle,inthecourseofthechemicalreaction,theCLSVHCcanbe consumed (e.g. by conversion to another substance), or removed by evaporation, orremovedbyactivitiessuchasrinsing.Insuchcases,theresidualconcentrationcandropbelowthe0.1%w/wthreshold,dependingontheexactenvironmentalconditionsandcircumstances.Typical examples of such cases are surface treatment activities and adhesives, but it is notlimitedtothis.

Notableexamples:

• Chromicacidanodizing(noCrO3remaining);• Hardchromiumplating(noCrO3remaining);• Solvents(evaporate).

Insuchcases,anArticle33(1)declarationistypicallynotrequired.

Scenario2Incontrast, in thesecondscenario, theCLSVHCspresent in thesubstanceormixtureusedtotreat thearticleor included into thearticle, isnotalteredduring the followingmanufacturingprocess, is not or only partly involved in the chemical reaction (if such takes place), and isthereforepresentinthefinalproduct.

Typicalexamplesforthisscenarioare:

• Chromateprimersandsealants(Strontiumchromateetc.);• NPOE/OPEOinsealants;• Leadcompoundsinpyrotechnicmixtures.

WhendeterminingwhethertheCLSVHCispresent>0.1%w/winthefinalarticle,especiallyinthecaseofpaints,itisnecessarytotakeintoaccountthattheconcentrationoftheCLSVHCusuallyincreasesintheresidualreactionproductduetosolventevaporation.Incontrast,sealantsnormallydonotchangemuchinweight,whileadhesivesaresobroadinpossiblebehaviourthatacase-by-caseapproachmustbeapplied.

TheresultofthestepsjustoutlinedisaninventoryofthetechnicalprocesseswhichcanleaveaCLSVHCinoronanarticlewhenappliedformanufacturingorassembly.

“Component-related”logicIn a second, component-related logic (illustrated in the green box in Figure 5.a), it is necessary toidentify thearticlesorassembliesof theproduct thataremanufacturedorproducedwithhelpof thetechnicalprocessesjustidentified.Thiscross-checkingofprocessesandaffectedarticles(parttypes)isusuallymanageablefortheA&Dindustrybecausetheindustrytypicallyhasabroadanddetailedcontrolon the design of articles and their material and manufacturing processes, due to Certification andAgreementprotocols.


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Theresultofthisstepisthelistofarticles(orgroupofarticles)designed,manufacturedorassembledbythe company that have a CL SVHC in or on the article and that therefore need to be reported in anArticle33(1)declaration.ThisoutcomecanthenbemergedwiththeArticle33(1)declarationsreceivedfrom the article suppliers in the supply chain (see the step of collecting and storing article supplierinformation,illustratedinthegreyboxinFigure5.a),andpassedontotherecipientofthefinalproduct.

If used in the entire supply-chain, the process illustrated in this chapter usually allows a reliableidentificationof CL SVHCs in the complexobjects provided to the customers,which is thebasis for acompliantandcomprehensiveArticle33(1)declaration.


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Appendices

AppendixA:ASDproductexampleswithmulti-layersupplychainsThisappendixAillustratesthecomplexityofA&Dproducts(SCO)withexemplaryaeronautic,spaceanddefenceproductsincludingtheirbreakdownintoECO's,VCO'sandCO'sasdescribedinchapter2.3.

There are more than 20,000 different equipment parts (VCO, ECO) per aircraft with a dedicatedtechnical documentation for installation, operation and maintenance (usually called ComponentMaintenaceManual-CMM).Thereismorethan1millionelementarypartnumber(CO)peraircraftforstructuralparts,withmaintenanceandrepairdocumentationatoverallassemblylevel.

FigureA.aCommercialAircraftBOMbreakdownexample


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ThefollowingexampleshowstheconnectiontotheNoselandinggearequipment.

FigureA.bNoselandinggearequipmentforaircraft(ref.toA.a)ThefamilyofthisNoselandinggearequipmentiscomposedofapprox.1,200parts.

FigureA.cAircraftEnginemodulebreakdownexample(ref.toA.a)The engine is assembled from several individualmodules. Eachmodule comprisesmany componentsandassemblies(ECOs,VCOsandCOs),whichwillhaveundergonemanymanufacturingprocesses,someof which have the potential to introduce SVHCs into the product. Typically, a single engine contains30,000–40,000parts,ofvariouscomplexitylevels.


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Itisrecognisedthataircraftcomeinmanydifferentconfigurations,fromthesmallprivate,tothelargepassengerandtransporterplatforms.Whatever the type, theyall conformtostringentmanufacturingandmaintenanceregulations(i.e.airworthiness).Aircraftmanufactureisonatrulyglobalscale,withthelarge aerospace enterprises managing vast supply-chains. A multitude of materials, processes andsubstancesareusedinavarietyofwaysinaircraftfrom‘Articles’,‘ComplexObjects’throughto‘SuperComplexObjects’.

Theexampleshowsacommercialaircraft-asupercomplexobject,withawingassemblycascadesdowntoasinglearticle–a‘GearRib’.

FigureA.dExampleAerostructure/Wingbreakdown(ref.toA.a)


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Example of a simplified product breakdownof a telecommunication satellite consisting ofmore than7 levels and indication of the rough amount of parts integrated within the individual levels:

• Level1–TelecomSatellite SCO(~1,000,000‘sparts)• Level2–Platform ECO(~100,000‘sparts)• Level3–RemoteInterfaceUnit VCO(~10,000‘sparts)• Level4–ElectronicAssembly VCO(>1,000‘sparts)• Level5–PrintedCircuitBoard CO(~1,000‘sparts)• Level6–HybridComponent CO(~100‘sparts)• Level7–ElectronicComponent CO(~10-100parts)

FigureA.eBreakdownofaTelecommunicationSatellite


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ExampleofSatelliteLauncherBreakdownwithSystemControlAttitude(SCA)includingtwotanksofliquidmonopropellantandsixthrusters”anda“VehicleEquipmentBay”.

FigureA.fExampleofSatelliteLauncherBreakdownwithSystemControlAttitude(SCA)

1)VehicleEquipmentBaywithSCA-MetallicstructurewithtenhundredlinesofArticles 2)Hydrazinethruster 3)Hydrazinebladdertank 4)Interfacetotheupperstage


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Tanks, like thismainbattle tank, are super complexobjectsand consistof at least350,000 individualcomponentarticles.Inthisexample,thetoweralonecomprises6,500differentequipmentnumbersand45,750 individual componentarticles. Equally, thevehicle chassis consistof another45,000 individualcomponentarticles,whichare listedas7,400partnumbers.This showsthatonepartnumberusuallycomprises several component articles (i.e.meets the definition as a VCO or ECO) - for example, thescreenandthemotorareeachcountedasonlyonepartinthepartslist.

FigureA.gExampleoftankproductbreakdown


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AppendixB:TemplateforArt.33REACHdeclarationsThisappendixshowsanillustrativetemplateofhowanArticle33(1)declarationcouldlooklike.Itfollowstherulesandsuggestionsexplainedinfurtherdetailinchapter3.1.However,thistemplateisinnowaymandatoryorbinding,butmerelyasuggestionforvoluntaryusebyASDmembersorcompanies in theA&Dsupplychain.Asmentioned inchapter3.2.2, theCLSVHCdeclarationandinformation on safe use can be either communicated via separate documents, or included inexistingtechnicalorotherpublications.

. Companylogoandaddress . ContactdetailsofREACHexpert(incaseclarificationisneeded)

REACHDeclarationonsubstancesinarticlesReferringtotheproduct:

• XXXXproductname,possiblyotherindicatorsXXXX

Dateofissue:XXXXXXX

Ifapplicable:furtherinformationonissuingfacilityofthelegalentity

XXXX_Company name_XXXXX confirms awareness of the obligations arising from the REACHregulation(Regulation(EC)No.1907/2006)andherebydeclarescompliancewithapplyingduties.In compliance with Article 33(1) of the REACH regulation, we hereby inform the recipient of ourproductthatthesuppliedproductcontainsatleastoneso-calledREACHCandidatelistsubstanceinaconcen-trationabove0.1%weightbyweight;i.e.asubstanceofveryhighconcernmeetingthecriteriainArticle57and identified inaccordancewithArticle59(1)of theREACHRegulation. Inaccordancewith CJEU judgment C-106/14, issued 10 September 2015, the concentration threshold of thesubstancewasdeterminedinreferencetotheweightoftheaffectedcomponentarticlecontainedintheproduct.

Substancename CASNumber ECNumber PresentinXXXXXX XXXXXX XXXXXX XXXXXXXXXXXX XXXXXX XXXXXX XXXXXXXXXXXX XXXXXX XXXXXX XXXXXXsuchasinREACHcandidatelist

Orothernumericalidentifier Componentarticleidentifier,ornameofahigherlevelassemblyincaseofaggregation

Whereapplicable,additionalinformationtoallowforsafeuseoftheproductcanbefoundinXXXXXXX_nameofapplicabledocument,e.g.maintenancemanual_XXXXXX.Signature(ifapplicable)

FigureB.aIllustrativeTemplateofREACHArticle33(1)declaration


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AppendixC:Illustrativeexampleofaggregationmethod

Fig.C.aIllustrationofhowaggregationcanbedoneforthepurposeofSiAdeclaration(exampleofgroundweaponsystem,note:onlyCLSVHCs>0.1%w/wneedtobereportedinArt.33(1)declaration)


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FigureC.bFinalArticle33(1)declarationfor“GroundCombatWeaponSystem”asaggregatedaccordingtomethodshowninFigureC.a


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AppendixD:ExampleofamethodologyandstandardforhazardousmaterialsdataflowintechnicaldocumentationDisclaimer:ThisAppendixillustratesonepossiblepracticethatcompaniesmayuseduringdevelopmentoftechnicalpublications in order to assess and include the information on hazardousmaterials provided by theirsuppliers.Thepracticeoutlined isonewayamongstvariousexistingpossibilitiesandcanbeusedonavoluntarybasis.Nevertheless,companiesmightfind ithelpfultousethisorasimilarpracticeofsafetyanalysiswhengeneratinginformationtoallowsafeuse,especiallyforproductsofhighcomplexity.The flow of hazardous materials data from suppliers into technical documentation, and on intoTechnicalPublications,isoutlinedinchapter2.5.Itcanbecomprisedoffourstagesasdescribedbelowandshownschematicallyasfollows:

FigureD.aHazardousMaterialsDataFlowwithinTechnicalDocumentation


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Stage1:HazardousMaterialsData(includinginformationtoallowsafeuse)fromSuppliers

Wherearticlesand simpleassembliesare supplied for incorporationwithin complexobjects,CLSVHCdata,perhapsasa subsetofhazardousmaterialsdata,mightbeprovidedviaanyof the transmissionmodesdescribedinChapter3.1.4.

However, in order to facilitate efficient data management, it can be helpful to flow data along thesupplychain inaccordancewiththerequirementsofMaterialsDeclarationStandards,or toadopttheprincipleswithinthem.Suchstandardstocommunicatesubstanceinformationinclude:

• IPC-1752A“MaterialsDeclarationManagementStandard”establishingtherequirementsforexchangingmaterialandsubstancedatavoluntarilybetweensuppliersandtheircustomersforelectricalandelectronicproduct(i.e.COorVCO).Thisstandardappliestoproducts,components,sub-productsandmaterialsthataresuppliedtoproducersofelectricalandelectronicproductsforincorporationintotheirproducts.Itcoversmaterialsandsubstancesthatmaybepresentinthesuppliedproductorsub-product.Itdoesnotapplytoprocesschemicals,unlessthoseprocesschemicalsconstitutepartofthefinishedproductorsub-productandisformattedinXMLformat.

• IPC-1754“MaterialDeclarationStandardforAerospaceandDefence”,havingthefocustoexchangeinformationofmaterialcontentforcomplexobjects.ThisvoluntarystandardhasthesamebasicprinciplesasIPC-1752AexchangingmaterialandsubstancedatabetweensuppliersandtheircustomersusingXMLformat.However,theIPC-1754hasextendedscopeofexchangingdatathroughitaswellcontainedrequirementsforexchangingdataforsubstancesinprocesses(manufacturingprocessesandtreatments).(NotethatIPC-1754isattimeofpublication-November2017-underdevelopment)

Itshouldbenotedthattheabovestandardsdonotsupporttheprovisionofsafeusecommentaryintextualformat.Wherethestandardsareagreed by thesupplychain,provisionofsafeusecommentarymustbedoneadditionally.

Hazardousmaterialsdata,and theCLSVHCsubset,willnormally includesubstance identifiers suchastheChemicalAbstractService(CAS)orEuropeanCommunity(EC)Numberandchemicalnameofeachsubstance and article identifier or article family. The location informationmay be aggregated at anylevelintheBillofMaterial(BoM)inordertomakeitmeaningful,asdescribedinChapter3.1.3.Wherenecessarytoallowsafeuse,hazardcommentaryshouldalsobeprovided.

Suppliers of complex objects to systems integrators producing VCOs, ECOs or SCOs may providehazardous materials data, including the CL SVHC sub set, within documents such as Health HazardAssessments(HHA)andEnvironmentalHazardAssessments(EHA),asoutlinedinstage2below.HazardLogs, Safety Assessment Reports and similar documents may also be utilised. Alternatively, thehazardous materials data, including the CL SVHC sub-set, may be provided directly within TechnicalPublications,asoutlined in stage4below.Allof theabovedatamaybean input to theOEMSystemSafetyAnalysis.


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Stage2:OEMSystemSafetyAnalysis

TheoverallSystemSafetyapproachforidentifyingandassessinghazardsinvolvesconductinganumberof analytical tasks throughout the development of the system's design. One common feature of thesystemsafetystandardsistheprovisionofinstructionsandguidancetoidentifyandanalysehazardousmaterials(Hazmat).CLSVHCsareasubsetofHazmatandshouldthereforebeincludedintheanalysisand mitigation of hazards (health and environmental aspects). The ECHA Guidance supports thisintegratedapproach18:“…informationcommunicatedunderArt.33…canbecombined/integratedwithother legal communication requirements (e.g. under the General Product Safety Directive or sectorspecificlegislation)”.

Relevantoutputsofthesystemsafetyanalysisinclude:

• Health Hazard Assessment (HHA): The purpose of this assessment is to identify and evaluatehumanhealth hazards arising fromproposed use of hazardousmaterials and processes usingsuchmaterials, and to proposemeasures to eliminate the hazards, or reduce the associatedriskswhenthehazardscannotbeeliminated.

• Environmental Hazard Assessment (EHA): The purpose of this assessment is to identify andevaluate environmental hazards, provide guidelines on how the associated risks can beeliminated or controlled, and determine if handling measures and protective equipment areneeded.

• Safety Instructions (and Restrictions) that complement design and structuralmeasures in themitigationofhazards.InformationtoallowsafeuseforarticlesisasubsetofSafetyInstructions.TheSafetyInstructionsareimplementedwithinsystemoperationinstructionsorsimilar.

Therelevantoutputsof thesystemsafetyanalysis,which includetheCLSVHCsubset,arean input totheIntegratedLogisticsSupport(ILS)Assessmentandtheoperatingmanuals.

Stage3:OEMIntegratedLogisticsSupportAssessment

ILSisanintegratedanditerativeprocessfordevelopingamaterialandsupportstrategythatoptimisesfunctionalsupport,leveragesexistingresources,andguidesthesystemengineeringprocesstolowerlifecyclecostanddecreasethelogisticsfootprint,makingthesystemeasiertosupport.Althoughoriginallydeveloped for military purposes, it is also used in commercial product support or customer serviceorganisations.

ALogisticsSupportAnalysis(LSA)ofthesystemisanimportantelementoftheILSscopeofwork.Theaimof this activity is to contribute to theefficientoperationandmaintenanceof the system.KnowndataandpredictionsareinputtotheLSA.Therearemanyinputs;examplesinclude:

• Designdata,definitionofthesystem,andserviceanddesignlife

18SeeECHASiAGuidancev4,Chapter3.4.1,p.52


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• Safety assessments, including the HHA and EHA, and associated requirements/safetyinstructions.

• Numberofproductstobesupported,operatingcycles,operatingandstorageenvironments• Maintenancelevels,availablefacilities,suppliesandpersonnel

Theoutputof theLSA is theLogisticsSupportAnalysisRecord (LSAR), fromwhichdata is fed into theTechnical Publications for the system. This will contain safety assessments, as detailed above, whichmayincludetheCLSVHCsubset.

Stage 4: HazardousMaterialsData (including information to allow safe use) to CustomerwithinTechnicalPublications

Various international specifications for technical publications exist, defining information models andprovidingguidanceonhowtechnicaldocumentation(maintenancemanualsetc.)shouldbewrittenforsystemoperatorsandmaintainers. Itcanbehelpful to followtheprincipleswithin, inordertoenableinformationtoallowsafeuseforcomplexobjectstobe incorporatedwithinTechnicalPublicationsforthebenefitofendusersandmaintainers.

Where it isnecessarytoprovideparticular informationtoallowsafeuseofthearticlecontainingaCLSVHC(e.g.locationdataorcommentary),thereisnoneedtoseparatelyidentifyitfromtheremainingHazmatdata.

For complexobjects it canbeuseful thatdocuments for chemical reportingareestablished suchasaREACH Declaration. The source information provided to the Technical Publications may also beincorporatedwithin the REACHDeclaration for the complex object. Either documentmay be used tocommunicate information to allow safe use in accordance with the Reach Article 33(1) obligation.ThebenefitsarethatstatementsandverificationofArticle33(1)compliancecanbemadeduringdesignmilestonesinthedevelopmentphase.


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AppendixE:ListofcommonCLSVHCsusedintheA&DindustriessectorforarticlemanufacturingOf the current REACH candidate list (issued on July 7th 2017), the following CL SVHCs are mostcommonly used in the manufacturing of articles in the A&D industry. However, while used duringmanufacturingprocesses,thenamedsubstancesarenotnecessarilypresentabove0.1%w/winthefinishedarticlethusbenotmandatorytobereportedinArt.33(1)declarationtotherecipient.

Name Descriptionofuse ECno. CASno. Cadmium Fasteners,connectors,connectors

housing,platedcomponents,solder,corrosionprotectionplating(steelparts),ballbearings.

231-152-8 7440-43-9

Chromiumtrioxide Surfacetreatmentagainstcorrosion(ChromicAcidAnodizing,ChromateConversionCoating)foraluminummechanicalparts,waveguides,RFparts(adapters,filters,switches...),Hightemperaturecements.

215-607-8 1333-82-0

Strontiumchromate Paintprimersforparts:ReactionWheelAssembly,AircraftDoorAssembly,NotchFilter,HoneycombPanelFaceskins.

232-142-6 7789-06-2

Potassiumdichromate Hardeners,magnesiumsurfacetreatment,corrosionresistanttreatmentofaluminumcomponents.

231-906-6 7778-50-9

4,4'-isopropylidenediphenol(BPA)

PCB-Layer,epoxyadhesives,hardeners,Polycarbonate.

201-245-8 80-05-7

Cadmiumoxide Cadmiumplating,pigments,electricalcontacts.

215-146-2 1306-19-0

Dibutylphthalate(DBP) Softenerandsolventinpropellantpowderforammunition,sealants,nitrocellulosepaints,filmcoatingsandglassfibres.Plasticiserinpolymers,suchasPVC.

201-557-4 84-74-2

Sodiumdichromate Etching/picklingsolutions,mechanicalparts.Sealingsolutionfollowingsulphuricacidanodisingofaluminium.PassivationofsteelsandCadmiumplating.

234-190-3 10588-01-9,7789-12-0


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Name Descriptionofuse ECno. CASno. AluminosilicateRefractoryCeramicFibres

Heatshield/insulationmedia,Solenoidvalves,Insulatedducting,thinlayerintheinsideofammunitioncasing(sothatitdoesnotmelt),heatbarrierinbatteriesforemergencies.

- -

Pentazincchromateoctahydroxide

Resincatalysts,corrosionresistantpaintsandprimers.

256-418-0 49663-84-5

Potassiumhydroxy-octa-oxodizincate-dichromate

Corrosionresistantpaintsandprimers. 234-329-8 11103-86-9

1-Methyl-2-pyrrolidone(NMP)

Outersheathofinsulationcovers,aerospaceadhesives,hardenersandsealingcompounds,SBRLatexproduction,PCBmanufacture.CriticaluseformanufactureofSpaceLi-ionbatteries.

212-828-1 872-50-4

Chromicacid Aluminumetchandsurfacetreatment. 231-801-5 13530-68-2

Bis(2-ethylhexyl)phthalate(DEHP)

Plasticiserinthemanufacturerofpolymerproducts(PVC).

204-211-0 117-81-7

Leadmonoxide(leadoxide) Piezoceramiccomponents,batteries,ab-sorbents,catalysts,lubricants,corrosioninhibitors,explosives&rubberproducts.

215-267-0 1317-36-8

N,N-dimethylacetamide Insulatingplates,Adhesivetapeforelectronics,solventinmanufacturerofvarioussubstancessuchasproductionoffibresforclothingindustrialcoatings,polyimidefilms(spacethermalblanketmaterial),paintstrippers,inkremovers.

204-826-4 127-19-5

Leaddiazide,Leadazide Componentofpyrotechnicmixtures(forammunition),initiatororboostersindetonators/fuses.

236-542-1 13424-46-9

Leadstyphnate Componentofpyrotechnicmixtures(forammunition),primerforsmallcalibreandrifleammunition,pyrotechnics,powderactuateddevicesanddetonators/fuses.

239-290-0 15245-44-0

Dichromiumtris(chromate) Surfacetreatmentinvolvingimmersionofmetalcomponents.

246-356-2 24613-89-6

Dichromicacid ConstituentofChromicAcidetchforAluminiumusedpriortoothertreatmentsandChromicAcidAnodising.

236-881-5 7738-94-5

TableF.aTop20CLSVHCsusedinASDindustrysectorforarticlemanufacturing


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GlossaryAbbreviation ExplanationA/C AircraftA&D Aerospace&DefenceAFRA AircraftFleetRecyclingAssociationAMM AircraftMaintenanceManualAD-DSL Aerospace&DefenceDeclarableSubstanceListASD AerospaceandDefenceIndustriesAssociationofEuropeASDSTAN AerospaceandDefenceIndustriesAssociationofEurope–StandardisationBoM BillofMaterialsB2B Business-to-BusinessB2C Business-to-ConsumerB2G Business-to-GovernmentCAA ChromicAcidAnodizingCAS ChemicalAbstractService(numericalidentify)CL CandidateList(ofsubstancesofveryhighconcernforauthorisation)CLSVHC SVHClistedintheCandidateListforauthorisationCMM ComponentMaintenanceManualCO ComplexObjectEC EuropeanCommunityECHA EuropeanChemicalsAgencyECO ExtremelyComplexObjectCJEU CourtofJusticeoftheEuropeanUnionEEA EuropeanEconomicAreaEHA EnvironmentalHazardAssessmentEOS EndofServiceERC EnvironmentalReleaseCategoryHazmat HazadousMaterials(asclassifiede.g.inEUCLPRegulation)HHA HealthHazardAssessmentICAO InternationalCivilAviationOrganizationILS IntegratedLogisticsSupportIPC AssociationConnectingElectronicsIndustries

(formerInstituteforInterconnectingandPackagingElectronicCircuits)ITAR InternationalTrafficinArmsRegulationLRU LineReplaceableUnitLSA LogisticsSupportAnalysisMILSTD MilitaryStandardMRO Maintenance,Repair&OverhaulO5A Once-An-Article-Always-An-Article(newCJEUrulingSept2015onREACHArt.33)OEM OriginalEquipmentManufacturerPCB PrintedCircuitBoard(assembled)


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PDR PreliminaryDesignReviewPHA PreliminaryHazardAnalysisREACH RegistrationEvaluationandAuthorisationofrestrictedCHemicalsRIWG REACHImplementationWorkingGroupofASDRMM RiskManagementMeasuresSCO SuperComplexObjectSDS SafetyDataSheetSE SystemsEngineeringSiA SubstanceinArticleSRU ShopReplaceableUnitSVHC SubstanceofVeryHighConcernSWG2 Sub-WorkingGroup2(ofASDRIWG)VCO VeryComplexObjectw/w WeightbyweightXML ExtensibleMarkupFormat

ReferencesDocumentsreferencedwithinthisGuidance

REACHRegulation(EC)No1907/2006

EuropeanCourtofJustice(CJEU,caseC-106/14)inSeptember2015

ECHASubstancesinArticlesGuidance(ECHA-17-G-19-EN)fromJune2017

ECHAManual“Howtoprepareasubstanceinarticlesnotification”(ECHA-16-B-16-EN)fromJanuary2017

ASDTechnicalPaper"REACHSubstancesinArticles"dated22Sept2016

ASDGuideonInterpretationofREACH

ECHAGuidanceinaNutshellonRequirementsforSubstancesinArticles

IPC1754MaterialDeclarationStandardfortheAerospaceandDefense

CommonECHA-EASApaper“Anelaborationofkeyaspectsoftheauthorisationprocessinthecontextofaviationindustry”(April2014)