assent compliance webinar rohs ii

i n f o @ a s s e n t s v h c . c o m w w w. a s s e n t s v h c . c o m t e l : 8 6 6 . 9 6 4 . 6 9 3 1

ASSENTCOMPLIANCE

c u s t o m s o l u t i o n s f o r c o m p l i a n c e [ r e a c h | r o h s | c p s i a | r s l | p r o p 6 5 ]

ROHS II – What is Changing?

assent compliance

Krystal Noseworthy-BaKer phone: 613.882.1429

[email protected]


ASSENTCOMPLIANCE

c u s t o m s o l u t i o n s f o r c o m p l i a n c y [ r e a c h | r o h s | c p s i a | r s l | p r o p 6 5 ]

INTROduCTION TO ASSENT COMPLIANCEassent compliance

•Consulting•GlobalRequirements•ComplianceStrategies•RegulatoryInterpretationsandImpacts

•IT•CloudComputing•ApplicationDesign

•Operations•ProgramImplementation•DataManagement



ASSENTCOMPLIANCE

AgENdA•Overview

•Scope

•Exemptions

•Timelines

•CEMarking

•EffectofREACH(Phthalates)

•Q&A



ASSENTCOMPLIANCE

ROHS II – OvERvIEw•DIRECTIVE2011/65/EUOFTHEEUROPEANPARLIAMENTANDOFTHECOUNCIL of 8 June on the restriction of the use of certainhazardoussubstancesinelectricalandelectronicequipment(recast)

•PublishedintheOfficialJournaloftheEuropeanUnion:July 2011•RoHSIIwasapprovedbytheEUParliament:November 2010•ACorrigendumwascreatedinApril2011andapprovedinMay2011•RoHSIIwasapprovedbytheEUCommissionandCouncil:May 2011

•InEffect: July 21, 2011

•IntoMemberStatelaw:January 2, 2013•PreviousRoHSDirective(2002/95/EC)repealed:January 3, 2013



ASSENTCOMPLIANCE

ROHS II – OvERvIEwcategories – annex i (a refresher!):1. Largehouseholdappliances.

2. Smallhouseholdappliances.

3. ITandtelecommunicationsequipment.

4. Consumerequipment.

5. Lightingequipment.

6. Electricalandelectronictools.

7. Toys,leisureandsportsequipment.

8. Medicaldevices.

9. Monitoringandcontrolinstrumentsincludingindustrialmonitoringandcontrolinstruments.

10. Automaticdispensers.

11. OtherEEEnotcoveredbyanyofthecategoriesabove.



ASSENTCOMPLIANCE

ROHS II – OvERvIEwMajorDifferencesbetweenRoHSRecastandRoHS

•SizeandComprehensiveness•RoHSRecast–Twenty-three(23)pages•RoHS–Five(5)pages

•CEMarking

•RoHSIIispartoftheFreeMovementofGoods–Regulation765/2008/EC•Conformityassessmentproceduresareaffected

•Scope•Furtherdetailsgivenlaterinthepresentation



ASSENTCOMPLIANCE

ROHS II – OvERvIEwkey Definition changesDefinition of EEE:•Article 3.1: ‘Electrical and electronic equipment’ or ‘EEE’ means equip-

ment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measure-ment of such currents and fields and designed for use with a voltage rating not exceeding 1 000 volts for alternating current and 1 500 volts for direct current;

•Previously included “falling under the categories set out in Annex IA to Directive 2002/96/EC (WEEE)”before“…and designed for…”

•Article 3.2: ‘Dependent’ means, with regard to EEE, needing electric currents or electromagnetic fields to fulfil at least one intended function;

•NOTE: If theproductwasoutofscopeandnotspecifically listed inarticle4(3)or4(4),theequipmenthasuntilJuly22,2019tocomply

•4.3: Paragraph 1 shall apply to medical devices and monitoring and control instruments which are placed on the market from 22 July 2014, to in vitro diag-nostic medical devices which are placed on the market from 22 July 2016 and to industrial monitoring and control instruments which are placed on the market from 22 July 2017.



ASSENTCOMPLIANCE

•4.4: Paragraph 1 shall not apply to cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of the following:

a. EEE placed on the market before 1 July 2006;

b. Medical devices placed on the market before 22 July 2014;

c. In vitro diagnostic medical devices placed on the market before 22 July 2016;

d. Monitoring and control instruments placed on the market before 22 July 2014;

e. Industrial monitoring and control instruments placed on the market before 22 July 2017;

f. EEE which benefited from an exemption and which was placed on the market before that exemption expired as far as that specific ex-emption is concerned.



ASSENTCOMPLIANCE

ROHS II – OvERvIEwkey Definition changes•Homogeneousmaterialsandcoatings

•NevermentionedinRoHS•RoHS II states:

» Article 4.2: For the purposes of this Directive, no more than the maxi-mum concentration value by weight in homogeneous materials as specified in Annex II shall be tolerated.

» AnnexIIofcoursedetailstherestrictedsubstanceswhichhavenotchanged:•Lead(0,1%)•Mercury(0,1%)•Cadmium(0,01%)•Hexavalentchromium(0,1%)•Polybrominatedbiphenyls(PBB)(0,1%)•Polybrominateddiphenylethers(PBDE)(0,1%)

NOTE: Article 4.2 goes on to state that the Commission is responsible forcreating detailed rules for complying with the maximum concentrationvaluesforsurfacecoatings



ASSENTCOMPLIANCE

ROHS II – SCOPE•Medicaldevices•Controlandmonitoringinstruments•Category11

NowallpartofRoHSRecast

•Directivedoesnotapplyto:•Equipment which is necessary for the protection of the essential interests of

the security of Member States, including arms, munitions and war mate-rial intended for specifically military purposes

»Defense•Equipment to be sent into space•Equipment which is specifically designed, and is to be installed, as part

of another type of equipment that is excluded or does not fall within the scope of this Directive, which can fulfil its function only if it is part of that equipment, and which can be replaced only by the same specifically designed equipment



ASSENTCOMPLIANCE

•Large-scale stationary industrial tools•Large-scale fixed installations•Means of transport for persons or goods, excluding electric two-wheel

vehicles which are not type-approved•Non-road mobile machinery made available exclusively for professional use•Active implantable medical devices•Photovoltaic panels intended to be used in a system that is designed,

assembled and installed by professionals for permanent use at a defined location to produce energy from solar light for public, commercial, industrial and residential applications

•Equipment specifically designed solely for the purposes of research and development only made available on a business-to-business basis.

»R&DB2B



ASSENTCOMPLIANCE

ROHS II – ExEMPTIONSRoHS recast has two (2) groups of Exemptions:

•AnnexIII–ApplicationsexemptedfromtherestrictioninArticle4(1)•AnnexIV–ApplicationsexemptedfromtherestrictioninArticle4(1)spe-cifictomedicaldevicesandmonitoringandcontrolinstruments

Validity Date•AnnexIII:

•FortheexemptionslistedinAnnexIIIasat21July2011,themaxi-mumvalidityperiod,whichmayberenewed,shall,forcategories1to7and10ofAnnexI,be5yearsfrom21July2011and,forcategories8and9ofAnnexI,7yearsfromtherelevantdateslaiddowninArticle4(3),unlessashorterperiodisspecified.

•AnnexIV:•FortheexemptionslistedinAnnexIVasat21July2011,themaximumvalidityperiod,whichmayberenewed,shallbe7yearsfromtherelevantdateslaiddowninArticle4(3),unlessashorterperiodisspecified.



ASSENTCOMPLIANCE

•Unlessotherwisespecified•Thirty-eight (38) Annex III exemptions currently have a specifiedsunsetdate

If an exemption is not renewed, it would proceed to a revocation process

•Applicationsforrenewalarerequiredtobesubmittedatleasteighteen(18)monthsbeforetheexpirydateofanexemption

•SimilartotheAuthorisationProcessunderREACH

•If adecision ismade to revoke an exemption, the exemptionwill expiretwelve(12)toeighteen(18)monthsfromthedateofthedecision



ASSENTCOMPLIANCE

ROHS II – ExEMPTIONScomplications in sunset Dates anD exemptionsExample•IndustrialMonitoringandControlInstruments

•Article4.3–CompliancerequiredbyJuly22,2017•Category9•7yearsvalidityforbothAnnexIIIandIVexemptions

» July22,2024»Unless it is one of the thirty eight (38) already specifiedexemptionsinAnnexIII

•Exemption7(c)-IIILeadindielectricceramicincapacitorsforaratedvoltageoflessthan125VACor250VDC

•SunsetdateofJanuary1,2013•Would not be available for RoHS compliance ofproducts after January 1, 2013 (and therefore notavailable to Industrial Monitoring and ControlproductsonJuly22,2017)



ASSENTCOMPLIANCE

ROHS II – TIMELINES

NOTE:Pleasenote thatnotallexemptionsare includedwithinthis timeline.(Thosedeemedtobeminor/affectlesscompanieshavebeenexcluded.)

ExpiryofC-RingandC-PressPb

Exemption Sept 2010

PublicationofRoHSRecastJuly2011

ExpiryofHighPbContentSolderExemption

ExpiryPbasActivatorinFluorescentPowder

Jan2011

ReductionofCFLExemptionsDec2011

ReductionHgandOdExemptions

Jan2012IVD Devices

In Scope July 2016

Expiry of Pb in Ceramic

Capacitators Exemption Jan 2013

Technical File Requirement

Jan 2013

Medical Devices & Consumer Control & Monitoring In Scope

July 2014

Industrial Control & Monitoring

In Scope July 2017

TODAYOctober12,2011



ASSENTCOMPLIANCE

ROHS II – CE MARkINgRegulations and Directives:•CE Mark:

•Directive93/68/EECof22July1993•SubjecttoArticle30ofRegulation(EC)No765/2008.

•Declaration of Conformity:•DecisionNo768/2008/EC

•Technical file:•ModuleAofDecisionNo768/2008/EC

RoHS Recast is under CE marking•Manufacturers–DeclarationofConformity•OnProduct–CEMark•Applicableto:

•FinishedproductsinscopeofRoHSrecast•PlacedonthemarketafterJanuary2,2013



ASSENTCOMPLIANCE

CE Marking1:•It states that the product is assessed before being placed on the market and

meets EU safety, health and environmental protection requirements.A CE mark does NOT specifically identify that a product is compliant with RoHS Recast.

•This marking is the visible symbol showing that the manufacturer has taken all necessary measures to ensure that the product complies with the applicable safety legislation

•By placing CE marking on a product, manufacturers declare on their sole responsibility that the products comply with all the legal requirements in force in Europe. It is the manufacturer’s responsibility to verify that the goods they are selling comply with all relevant legislation.

•The CE marking statements all predicate on the reality ofplacingaproductonthemarketandthereforehavingthemarkonly indicates that a product is compliant with all relevantlegislationatthetimeofplacingonthemarket.

1 As per the EU Commission Enterprise and Industry Website.



ASSENTCOMPLIANCE

ROHS II – CE MARkINgDeclaration of conformityGeneral Requirements:

1. No…(uniqueidentificationoftheEEE):

2. Nameandaddressofthemanufacturerorhisauthorisedrepresentative:

3. Thisdeclarationofconformity is issuedunder the sole responsibilityofthemanufacturer(orinstaller):

4. Objectofthedeclaration(identificationofEEEallowingtraceability.Itmayincludeaphotograph,whereappropriate):

5. The object of the declaration described above is in conformity withDirective2011/65/EUoftheEuropeanParliamentandoftheCouncilof8June2011ontherestrictionoftheuseofcertainhazardoussubstancesinelectricalandelectronicequipment(recast)



ASSENTCOMPLIANCE

6. Whereapplicable,referencestotherelevantharmonisedstandardsusedorreferencestothetechnicalspecificationsinrelationtowhichconfor-mityisdeclared:

7. Additionalinformation:•Signature

» Signedforandonbehalfof:» (placeanddateofissue):» (name,function)(signature):

NOTE: Declaration must be translated into the language or languagesrequiredbytheMemberStateofthemarketonwhichtheproductisplacedormadeavailable



ASSENTCOMPLIANCE

ROHS II – CE MARkINgeu technical file•BasedonModuleAofDECISIONNo768/2008/EC•Hastocontainatleastthefollowingelements:

•A general description of the product•Conceptual design and manufacturing drawings and schemes of

components, sub-assemblies, circuits, etc.•Descriptions and explanations necessary for the understanding of those

drawings and schemes and the operation of the product•A list of the harmonised standards and/or other relevant technical

specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the legislative instrument where those harmonised

•Standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied

•Results of design calculations made, examinations carried out, etc.•Test reports



ASSENTCOMPLIANCE

ROHS II – CE MARkINgeu technical file•MandatoryforRoHSRecastcompliance

•Nationalauthorityrequestforfile=FirstStageofEnforcement•Specificpenaltiesassociatedwiththisnon-compliance

•Standards•CurrentlynospecificstandardsforRoHSrecast

•Language•AvailableinlanguagethatcanbeeasilyunderstoodbytheEUNationalAuthorityrequestingit



ASSENTCOMPLIANCE

ROHS II – EffECT Of REACHprocess for aDDition of new substances•Article6nowallowsfornewsubstancestobeaddedtotherestrictions:

•With a view to achieving the objectives set out in Article 1 and taking account of the precautionary principle, a review, based on a thorough assessment, and amendment of the list of restricted substances in Annex II shall be considered by the Commission before 22 July 2014, and periodically thereafter on its own initiative or following the submission of a proposal by a Member State…

•4Substanceshavealreadybeenprioritized(Section10ofthePreamble)•Hexabromocyclododecane(HBCDD)–InAnnexXIVofREACH–SunsetDateAug21,2015

•Bis(2–ethylhexyl)phthalate(DEHP)–InAnnexXIVofREACH–SunsetDateFeb21,2015

•Butylbenzylphthalate(BBP)–InAnnexXIVofREACH–SunsetDateFeb21,2015

•Dibutylphthalate(DBP)–InAnnexXIVofREACH–SunsetDateFeb21,2015



ASSENTCOMPLIANCE

•Moresubstancescanbeaddedto/includedintherevie•Article6alsosetsoutthecriteriaforinclusiontothereview:

a. Could have a negative impact during EEE waste management operations, including on the possibilities for preparing for the reuse of waste EEE or for recycling of materials from waste EEE;

b. Could give rise, given its uses, to uncontrolled or diffuse release into the environment of the substance, or could give rise to hazardous residues, or transformation or degradation products through the preparation for reuse, recycling or other treatment of materials from waste EEE under current operational conditions;

c. Could lead to unacceptable exposure of workers involved in the waste EEE collection or treatment processes;

d. Could be replaced by substitutes or alternative technologies which have less negative impacts.



ASSENTCOMPLIANCE

QuESTIONS?PleasesubmityourquestionsinwritingusingtheQ&Atoolalongthetopmenutoolbar.

AnyquestionsnotaddressedduringtheQ&Aportionofthiswebinarwillbeaddressedinprivatecorrespondenceafterthewebinar.

assent compliance webinar rohs ii

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