Assent Compliance Environmental Compliance Ebook

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i n f o @ a s s e n T c o m p l i a n c e . c o m

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 ]

w w w. a s s e n T c o m p l i a n c e . c o m T e l : 6 1 3 . 2 9 0 . 8 0 4 4

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ASSENT EbOOka guide for 2011

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TAbLE OF CONTENTSIntroduction .............................................................................................................................................. 03

Kubler Ross Model of Compliance ........................................................................................................... 04

REACH in 2011 ........................................................................................................................................ 07What is REACH? ................................................................................................................................... 08SVHC Basics .......................................................................................................................................... 09REACH SVHC Authorization Lists ......................................................................................................... 10Fulfilling SVHC Obligations ................................................................................................................... 11Authorization ........................................................................................................................................ 12Standard Compliance Methodologies ........................................................................................................ 13Advantages/Disadvantages ....................................................................................................................... 14Business Impacts ..................................................................................................................................... 15Practical Applications .............................................................................................................................. 16Case Study in REACH Compliance .......................................................................................................... 17

RoHS – RoHS 2 in 2011 ........................................................................................................................... 23Legislation Overview ............................................................................................................. 24, 25, 26, 27Scope ..................................................................................................................................................... 28Business Impacts ..................................................................................................................................... 29EU Declaration of Conformity ................................................................................................................ 30Presumption of Conformity and Enforcement ............................................................................................ 31EU Parliament Issues, What to Do ........................................................................................................... 32RoHS Past, Present, Future ..................................................................................................................... 33

CLP in 2011 .............................................................................................................................................. 36Legislation Overview, Scope .................................................................................................................... 37Business Impacts ..................................................................................................................................... 38CLP 101 ................................................................................................................................................ 39

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INTrOduCTIONAssent Compliance is proud to bring you a compliance guide for 2011. This Ebook has been developed by the Assent Compliance team consisting of our industry leading consulting division, our IT developers and our project managers. Our goal is to leave readers well informed on compliance trends, keep readers up to date on what indus-try leaders are doing and provide a well researched road map for compliance in 2011.

Assent Compliance also hosts regular webinars, publishes weekly blog posts and speaks to companies and industry organizations on a regular basis. This Ebook has also combined much of our outbound and inbound educational resources to give readers interesting real world compliance content.

Upon conclusion of reading if you have any questions or comments with any content contained within this Ebook please contact the Assent team at [email protected].

On behalf of all the Assent Compliance team,

Thank you for reading and all the best in your on-going compliance efforts.

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kübLEr-rOSS GrIEF MOdEL of environmenTal compliance requiremenTs

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kübLEr-rOSS GrIEF MOdEL OF ENvIrONMENTAL COMPLIANCE rEquIrEMENTSAssent Compliance global consultants have seen North American businesses react to REACH environmental regu-lations in a manner not unlike the Kübler-Ross grief model. The five company stages break out as follows:

1. Denial – an outright denial by some companies to acknowledge that this regulation can affect them. While the majority of companies are beyond this stage, it’s still a prevalent sentiment –about 25 percent.

2. Anger – any change from the status quo in a large organization may cause anger in those burdened with extra work. This can undoubtedly cause internal frustration with regard to means of compliance, budget decisions and plans for moving forward. During this early planning stage, companies have trouble making decisions and typically seek advice – about 30 percent.

3. Bargaining – with any legislation there can be exemptions, addendums or clauses that may absolve a party of some portion of their responsibility. This is not typically the case for REACH. Although the “bargaining” stage is not prevalent, it does occur in some companies – about 5 percent.

4. Depression – typically a company will tender several requests for consultants to make suggestions and to better inform internal stakeholders on instituting a compliance process or system. Although this phase does not effect the organization as a whole, the compliance team itself frequently feels incapable of undertaking the task either due to perceived understaffing or adverse impact by their supply chain. This stage is more of a “micro” state, which follows the organization’s acceptance of REACH requirements – about 20 percent.

5. Acceptance – once organizations accept the reality that environmental regulations are real, enforce-able and can affect their bottom line, the typical response is an “Alright, let’s do it” approach – about 20 percent. As one Assent client noted: “Has our business model changed? No? If our business model includes selling our products globally then we’re going to comply with environmental regulations. It’s simple. We’re not afraid of challenges at this company.”

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At Assent we encounter companies at all stages. It is important to note however, whatever stage your company may be at, this need not be a painful, expensive or largely time consuming process if executed with the right partners. We just have to:

1. Identify your obligations

2. Put a plan / system in place

3. Execute

While it is naive to think that in a large company the process is as simple as the three steps outlined but for the most part in a company large or small complying with REACH, RoHS/RoHS II , CLP and other environmental regulations can be done quickly and effectively with the right partners.

Where is your company in the K-S Stages?

assenT provides:• Software Solutions for Environmental Compliance (RoHS, RoHS II, REACH, CLP etc)

• RoHS, REACH, WEEE Consulting

• Engineering Assessments

• Custom Solutions and Support

• General Sustainability Consulting

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rEACH IN 2011

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WHAT IS rEACH?quick overview of THe regulaTionRegistration, Evaluation, Authorization and Restriction of Chemicals

•Regulation(EC)No1907/2006,

•Initialregulationwasover700pages

•Severalthousandadditionalpagesofguidance

•AdministeredbytheEuropeanChemicalAgency(ECHA)

Requires industry to be responsible for the safe manufacture and use of chemical substances

•Manufacturers/ImportersmustEvaluateandRegistersubstances

•Awarenessofsubstancesofveryhighconcern(SVHC)

•Restrictionsonchemicalsposingunacceptablerisk

Obligations for nearly all products, parts, substances and mixtures manufactured or imported in the EU

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SvHC bASICSsvHc = subsTance of very HigH concern

REACH Definition

•SubstancessuchasCMRs,PBTs,vPvBsandendocrinedisrupters

•ResponsibilitiesforproductscontaininganSVHC:

1. IdentificationinMSDSdocuments

2. Communication obligations to customers (articles w/ >0.1%)

3. Notification obligations to ECHA

•w/>0.1%,over1tonneperyear

4. Authorizations required to continue using after sunset date

C = Carcinogenic

M=Mutagenic

R = Reproductive Toxin

P = Persistent

B=Bioaccumulative

T = Toxic

vP = very Persistent

vB=veryBioaccumulative

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rEACH SvHCSHow are THe svHc candidaTe and auTHorizaTion lisTs creaTed?

ProposalforSVHCRestrictions

(EU member states)a

Consultationand Review

SVHCCandidateList

Draft PrioritySVHC

Substances

Authorization List

(Priority SubstancesaddedtoAnnexXIV)

Communicate Infoon CandidateSVHCstocustomers

ConsultationReview

Prioritize

Consultationand Review

Sunset Date

Notification ofCandidateSVHCs

to ECHA(June 1, 2011)

Authorization touseAnnexXIV

SVHCafter sunset date

ocTober 28, 2008

January 14, 2009

april 14, 2009

June 1, 2009

2012+

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if svHc presenT > 0.1%

applies To all arTicles manufacTured/imporTed To THe eu

manufacTurers/imporTers - inform cusTomers of (minimum):

•cHemical name

• informaTion on safe use

consumers may requesT informaTion abouT THe presence of svHc in arTicles

(musT reply wiTHin 45 days)

FuLFILLING SvHC ObLIGATIONS?communicaTion – reacH arTicle 33

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AuTHOrIzATIONsubsTances lisTed in reacH annex xivAnnexXIVhasListofSubstancessubjecttoAuthorization

• Manufacturers/Importers/Downstreamusersmustreceiveauthorizationtocontinueusing these substances

Have until the “Sunset Date” to receive authorization

• Mustbesubmittedatleast18monthsbeforeSunsetDate

• Authorization request requires details on which use(s) the authorization request covers

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rEACHsTandard compliance meTHodologies

• Testing method

• WetchemicaltestingforsubstancesontheSVHClist

• Declaration method

• BusinessesasksuppliersiftheirmaterialscontainSVHCs.

• Use responses as proof of REACH compliance

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rEACH

advanTages

• Testing method

• Direct• Conclusive


• Lower cost • Can cover entire

product line

disadvanTages

• Testing method

• High cost per test• Mustberedoneeveryrevision


• Significant human resource time is expended

• Updates & supplier responses must be con-stantly tracked

• InfoneedstobemergedwithexistingPLM/ERP systems

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rEACHbusiness impacTs

• BusinessisthecurrentdriverofSVHCcompliancethroughProductSpecificationsandRFP’s.

• Eventually, any company whose products end up in the EU will have to completely disclose the SVHCstatusofalltheirproducts.

• ECHA guidance states that supply chain communication must be documented in order to demon-strate REACH compliance.

• Notificationsaretobeginthisyear—youmustobtainyourSVHCinformationinordertocompleteany necessary Notifications

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PrACTICAL APPLICATIONSideal qualiTies of a declaraTion of conformiTy

• A declaration should ideally be part of a process that keeps all your information current and your declarations consistent.

• Upon request, you should be able to show the following items:

• Who sent the declaration (person, not just company)?

• What was the exact response?

• When was it sent?

• How(Email,FTP,snailmail)?

• What was asked of the supplier on the Declaration?

• When?

• How?

• How these declarations are stored?

• How they are verified?

• How/when they are updated?

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ASSENT COMPLIANCE2010 case sTudy

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HigHligHTs • 35% compliant with strictly passive requests.

(1 month)

• 72% compliant with 2nd passive request and limited direct contact / information (within 3 months of launch.)

• $0.00 spent in Testing Costs.

• Foundation/PrecedenceSetforAllFutureRequests and Products Added to Database

• Elimination of Reliance on Wet Chemical Testing

clienT summary:The client associated with this project is a leading aerospace technology provider with a market capi-talization of over 3 billion dollars. They have a glob-al outreach and are considered innovative leaders in the compliance space.

proJecT purpose: Ensure an enterprise size product is backed by a REACH compliance process in order to be able to complywithRFP.(Requestsforproposal).

proJecT scope: • Installation of Assent Software and Set Up.

• Database Size: 30 000 parts

• Supply Chain: 250 unique suppliers

• ImportofBOBtoDatabaseand DataIntegrityVerification

• Supply Chain Engagement

• Data Collection (phase 1 passive, phase 2 active)

• Reporting

SuMMAry

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Having achieved 72% of all required declarations for the product with continued contact with the THE ASSENT CLIENT supply chain represents risk mitigation and a REACH compliance system. This is representative of suffi-cienteffort/successtobeabletoanswerandwinRFPcompetitionsTHE ASSENT CLIENT is currently working towards and or already currently awarded.

This program has been deemed a success by management on all levels inclusive of the sales division through to the VPandCEOlevel.

After completion of the first simulator as a pilot program THE ASSENT CLIENT has committed to using Assent for ALL products being sold into the EU with 27 new products being brought on board and an alternate division of the company using Assent as its REACH compliance program supplier.

Any reliance and cost of testing has been removed as part of the THE ASSENT CLIENT compliance mandate which has in turn reduced costs at present and will exponentially reduce costs moving forward.

GOAL ACHIEvEMENT

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A lesson in procuring documentations from your supply chain.

In July 2010, THE ASSENT CLIENT undertook a new REACH compliance program using Assent’s REACH SVHCComplianceSoftware.ThegoalofthisprogramwastosufficientlymitigatetheriskofSVHCsbeingcon-tained in their product without proper communication and notification to downstream users. These goals needed to be achieved in order to meet contractual obligations in the EU and prevent losing the EU as a viable market due to business requirements (IE: the pushback of REACH obligations by THE ASSENT CLIENT customers).

(InthisspecificinstanceRFP’sintheEUcouldnotbewonwithoutaREACHprograminplace)

THE ASSENT CLIENT and Assent created a program based on 3 principles from which to base the compliance program:

• ECHA recommended approach

• Current Industry Practice

• Expected enforcement methodology

Multiplesourceswereusedtoforguidelinesforeachoftheprinciplesabove:

ecHa recommended approacH:ECHAGuidanceonrequirementsforsubstancesinarticles(Version2.2):http://guidance.echa.europa.eu/docs/draft_documents/Draft%20Guidance%20on%20requirements%20for%20SiA_CARACAL.pdf ”http://guidance.echa.europa.eu/docs/draft_documents/Draft%20Guidance%20on%20requirements%20for%20SiA_CARACAL.pdf

CASE STudy

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Section 2.5 - Documentation

Section 5.1 - Information via the Supply Chain

Section 5.2.1 – Difficulties of chemical analyses

Section 5.2 – Chemical analysis of substances in articles

currenT indusTry pracTice:AerospaceBoeing’sREACHpositionwithsuppliers:http://www.boeingsuppliers.com/environmental/reach.html

Airbus REACH requirements outlined in RFPs

Electronics IndustrySchneider-Electric’s REACH/RoHS approach: http://www.schneider-electric.com/sites/corporate/en/products-services/reach-rohs-compliance/substances.page

expecTed enforcemenT meTHodology:Current REACH Enforcement program – REACH Enforce-1:http://www.echa.europa.eu/doc/about/organisation/forum/ref_1_facts_report.pdf ”http://www.echa.europa.eu/doc/about/organisation/forum/ref_1_facts_report.pdf

Other restricted substance enforcement methodologies - UK RoHS 2010 enforcement report: http://www.rohs.gov.uk/Docs/Enforcement%20Annual%20Report%202009-2010.pdf

http://www.rohs.gov.uk/Docs/Enforcement%20Annual%20Report%202009-2010.pdf

Basedonthesourcesandguidelinescitedabove,THE ASSENT CLIENT and Assent designed a program that would assess and document potential risk of THE ASSENT CLIENTarticlescontainingSVHCs.Oncethisas-sessment was complete, THE ASSENT CLIENT suppliers were prompted to login to a web-based portal hosted by Assent where the suppliers could make declarations for the parts they supplied THE ASSENT CLIENT which were in scope of the program.

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Training and education was provided to suppliers by Assent. The system used by Assent Compliance was simplified and streamlined, allowing for mass or individual declarations to be submitted to the system by suppliers.

After receiving 30 minutes of training on Assent’s system, suppliers took an average of less than 5 minutes to complete their declarations. Declarations were targeted for verification based on response and risk level (identified previously).

After the first run through, THE ASSENT CLIENT received a response rate of approximately 35%. The remaining suppliers who had not responded were then separated into 2 separate groups:

• Suppliers with the most number of parts left unchecked in the system.

• Suppliers with the heaviest and/or highest risk parts left unchecked in the system.

All suppliers were then sent a second notification from THE ASSENT CLIENT outlining the need for action and the possibility of loss of sales if this request was not met. In parallel, the 2 groups mentioned above were contacted personally by Assent and THE ASSENT CLIENT together in order to emphasize the importance of their compli-ance with these requirements.

The current level of response is at 72% and rising. It is fully expected that the overall response rate will exceed at least 90% by November including over 90% of high risk parts. This will allow for the sufficient mitigation of risk of non-compliance as per the goals of the program according to its guidelines.

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roHS & roHS II IN 2011

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rOHS IIlegislaTion overview

• The recast of the RoHS Directive (RoHS II) was approved in November of 2010.

• No new substances have been immediately added to the scope of the RoHS Directive.

• There is a process for adding new substances. 4 substances are up for review for addition to RoHS within a maximum of 3 years:

• HBCDD

• DEHP

• BBP

• DBP

• Additional substances can be added in the future

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rOHS II (CONT’d)legislaTion overview

• All current exemptions are included in the Recast

• RoHSwillnowbeapartoftheCEMarkingDirective

• This will create a uniform approach to Technical Documentation and Declarations of Conformity.

• Products in scope of CE may not necessarily be in scope of RoHS

• RoHS Declaration of Conformity format is now outlined in the RoHS Recast.

• Product number

• Manufacturername

• Product info

• Declaration statement

• Etc

• Mustbetranslatedintolanguageofmemberstatewhereproductisplacedonmarketormadeavailable

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• AllactorsinasupplyhavethelegalresponsibilitytoinformtheMemberstateNationalAuthorityiftheydiscovera non-compliant product.

• Products must then be withdrawn from the market, recalled or have corrective measures implemented to ensure compliance.

• Information and documentation must be provided to a National Authority upon request.

• Manufacturersanddistributorsmustkeeparegisterofallnon-compliantproductsandproductrecalls.

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• There are Specific requirements for withdrawal from market:

“Manufacturers who consider or have reason to believe that a EEE which they have placed on the market is not

in conformity with this Directive immediately take the necessary corrective measures to bring that EEE into con-

formity, to withdraw it or recall it, if appropriate and immediately inform the competent national authorities of

the Member States in which they made the EEE available to that effect, giving details, in particular, of the non-

compliance and of any corrective measures taken;”

• Recall means any measure aimed at achieving the return of a product that has already been made available to the end user

• Withdrawal means any measure aimed at preventing a product in the supply chain from being made available on the market.

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rOHS II—SCOPEscope cHanges

• Applies to all electrical equipment

• MostexemptionsfromRoHSIarestillinplace(military,auto,largescalestationaryandfixed,etc)

• MedicalDevicesareinscope3yearsfromentryintoforce

• In-vitroMedicalDeviceswillbeinscope5yearsfromentryintoforce

• Monitoringandcontrolinstruments–3yearsfromentryintoforce

• IndustrialMonitoringandcontrolinstruments–5yearsfromentryintoforce

Timeline

• RoHS II takes affect on the 20th day after publication in the EU Journal.

• Should be publish within the next 2 months. Could be as early as this month

• RoHSisaDirectivenotaRegulation—IndividualMemberstatesmustpassNationalLegislationatleast18 months after that date.

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rOHS IIbusiness impacTs

• Enforcement is much more formal and RoHS must be addressed by manufacturers and their downstream users:

• Legal responsibility to notify national authority means no more internalized or private corrective action

• Mandatoryproductwithdrawal

• Registry of product recalls

• 4newsubstanceshavebeendelayedandmustfollowasimilarprocesstoSVHCsforinclusiontoRoHSII.

• Substances will very likely pass through this process (they did for REACH) and will be on RoHS II within 3 years at the most.

• Incorporation of RoHS II into the CE mark means a failure on RoHS will invalidate your CE mark—this is a stop shipment issue.

• Manufacturer’smustmakesuretheirRoHSprogramisaccurateandnotmerelyapaperworkexercise.

• Downstream user’s must establish the importance of RoHS II with their suppliers and write it into T&Cs (if they have not already).

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Eu dECLArATION OF CONFOrMITyThe manufacturer must draw up and have available an EC Declaration of Conformity that states the product satisfies the requirements of the RoHS substance restrictions and that the fulfillment of these restrictions has been demonstrated.

“Where the compliance of an EEE with the applicable requirements has been demonstrated by that procedure, manufacturers shall draw up an EC declaration and affix the CE marking”

“Manufacturers shall keep the technical documentation and the EC declaration of conformity for ten years after the EEE has been placed on the market.”

“By drawing up the EC declaration of conformity, the manufacturer shall assume responsibility for the compliance of the EEE.”

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PrESuMPTION OF CONFOrMITy ANd ENFOrCEMENTpresumpTion of conformiTy• “MemberStatesshallpresumeelectricalandelectronicequipmentbearingtheCEmarkingasconformingto

this Directive.”

• Electrical and electronic equipment, which have been tested in accordance with harmonized standards, shall be presumed to comply with all the relevant requirements of this Directive to which such standards relate.

enforcemenT• Stronger language for purposes of enforcement.

• RequiresEUMemberStatestoenforcetherequirementsoftheDirective

• Requires economic operators to maintain documentation of conformity.

• Requires economic operators to identify suppliers and customers to market surveillance authorities if requested.

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Eu PArLIAMENT ISSuESAmongtheMembersoftheEuropeanParliament,contentionremainsoverseveralimportantissuesincluding:

• Whether to expand the directive to all electronic products

• Solar panels?

• Whether to conduct an impact assessment before expanding scope

• Whether to include all brominated and chlorinated flame retardants

• Whethertoincludepolyvinylchloride(PVC)

WHAT TO dO?a summary

• Still a “PROPOSAL”

• Re-assess product scope.

• Stronger market surveillance mechanisms will provide enhanced enforcement on “grey area” products

• ForMedicalDevicesandMonitoringandControlInstruments,begintomakeconversiondecisionsandplans

• If you do not have restricted substance control (RSC) measures in place, they need to be created

• Existing RSC measures should be reviewed

• ConsiderRoHSrequirementstogetherwithREACHSVHCobligations

• Investigate substitution options for the 4 substances currently under review.

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rOHS: PAST, PrESENT…FuTurEWe have certainly come a long way since July 1, 2006 when the EEE industry was introduced to the Restriction of Certain Hazardous Substances (RoHS). In the four years that have passed, RoHS has been debated and opposed, accepted and overdone, enforced and neglected, and most importantly, continually changed.

FromtheverymomentthatRoHSwasintroduced,thequestionwasasked:“howwillenforcementbecarriedoutbyauthorities?” Just how did the country authorities expect to monitor and enforce a law that pushed the boundaries of how EEE was designed and manufactured when there were so many exemptions and areas of uncertainty? The answer to this question has been apparent over the past 4 years – it won’t.

At least not by country authorities.

The truth is that the industry itself is responsible for the majority of RoHS enforcement, with many large manufac-turerskeepingtightcontrolontheirsupplychainandkeepingauditing/duediligencein-housewiththeirownXRFand wet-chemical test facilities. Japanese industry took RoHS to a higher level with the adoption of JGPSSI (Japan Green Survey Standard Initiative) that required suppliers to comply with RoHS and a multitude of other substance restrictions and declaration requirements. With big names such as NEC and Sony enforcing JGPSSI, RoHS was being mandated through non-legislative channels and the fallout for being exposed as non-compliant (and subse-quently dropped as a supplier) was/is massive. This was only the beginning.

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Fromitsinception,industrywasreallysplitintheirapproachtoRoHS.Whilesomebignamesdecidedtoignorematerialdeclarationandcompliance,otherswentinthecompleteoppositedirection.IfLead,Cadmium,Mercury,HexavalentChromiumandPBB/PBDEwereofsuchaconcerntoauthorities,whatwerethenextitemstofollow?FromthiswasborntheindustrytrendtowardinternalRSL(restrictedsubstanceslist)developmentandenforcement.Any manufacturer of EEE components/subassemblies reading this article will know that the days of single digit RSL lists are gone. What was once 6 substances now ranges into the hundreds ,depending on the company, and covers much more than RoHS and REACH. It seems that the only real consistencies for restricted substances are:

• Enforcement is industry driven

• Restrictions vary by company

• Change is constant

• Compliance declaration is largely homogeneous (no pun intended) across industries

If the last 4 years are any indication, industry will continue to lead restricted substances enforcement.

Now,takingalookattheNMO(NationalMeasurementOfficeoftheUK)RoHSenforcementreportfromthepastyear(April12009throughMarch312010),weseethatthelonganticipatedsummaryofactionis largelyindirect. No stories of non-compliances resulting in penalty or prosecution are highlighted, no aggressive initiatives are stated and the reader is simply left to comply by the governance of industry and look to the enforcement agen-ciesforeducationalresources.ThatistosaythattheNMOtalksaboutthe“indirectapproach”toRoHSenforce-ment, which is founded on the “belief that most UK industry would aim to operate in a lawful manner and would therefore work towards full compliance”.

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Thefollowingisthesummaryof“direct”enforcementbytheNMO.Ofparticularinterestarethe10warninglet-ters, 0 cautions and 0 prosecutions. Stacking these up next to a single global manufacturer with thousands of sup-pliersandthebusinessimpactofenforcementbybeingdroppedfromapreferredsupplierlist,theNMOhasnotreally enforced anything.

BetweenApril12009andMarch312010,theNMO:

resoluTions Type no.

Investigations 326

Resolution after initial engagement (1) 143 CompliantBusiness

Resolution requiring direct intervention (2) 158 Administrative resolution

Improvement plans 6

Compliance Notices 5

EU Notifications 2

Product Withdrawals/quarantines 2

Warning letters 10

Simple cautions 0

Prosecutions 0

In summary, RoHS, REACH and RSL lists in general are here to stay. The authorities create the requirements and the industry enforces them.

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CLP IN 2011

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CLPlegislaTion overview

• CLP aligns existing EU legislation to the United Nations Globally Harmonised System (GHS).

• CLP contributes to the GHS aim that the same hazards will be described and labeled in the same way all around the world.

• Under the CLP regulation, a company must notify the European Chemical Agency (ECHA) of hazardous substances it imports on their own or in mixtures above 0.1% by weight.

• The deadline was January 3rd, 2011 for products currently placed on the market.

• 1 month after product is placed on the market for products placed on the market after December 2010.

scope

• Who this applies to:

• Importers or manufacturers of substances over one (1) ton per annum into the EU

• Importers or manufacturers of substances classified as hazardous under CLP and placed on the market—irrespective of the tonnage (no one (1) ton limit).

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CLPbusiness impacTs

• How will this affect my company?

• You must either notify your substances in scope with the ECHA or make sure someone in your supply has covered you in their notification

• Covers substances that were pre-registered for REACH but have a deadline of 2013 or 2018.

• Includes substances imported at a volume less than 1 metric ton per annum

• What if I missed the deadline?

• Contact your supply chain—has anyone already covered you with their CLP notification?

• Contact a service provider to see what your options are.

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CLP 101 – yOu’vE bEEN ASkING.At Assent we always look forward to answering your regulatory questions. Once the same question is asked more than a hand full of times it is more than just a question, it’s a trend. Recently we’ve been asked on almost a daily basis about CLP under the REACH regulation.

For this postwe have attached a brief summary and link aswell as touched on someof theways thatAssentCompliance helps companies comply with CLP through a combination of software tools and world class consulting.

clp 101The CLP regulation sets the rules for classification and labeling of chemicals. It aims to determine whether a sub-stance or mixture displays properties that lead to a classification as hazardous.

CLP itself does not set information requirements (except for determining physical properties). The information requirements laid down in REACH will however, ensure availability of much data.

Once such properties are identified and the substance or mixture is classified accordingly, manufacturers, im-porters, downstream users and distributors of substances or mixtures, as well as producers and importers of certain specific articles (explosive articles which are subject to classification according to Part 2 of Annex I to CLP) should communicate the identified hazards of these substances or mixtures to other actors in the supply chain, including to consumers.

The hazard of a substance or mixture is the potential for that substance or mixture to cause harm. It depends on the intrinsic properties of the substance or mixture. In this connection hazard evaluation is the process by which information about the intrinsic properties of a substance or mixture is assessed to determine their potential to cause harm. In cases where the nature and severity of an identified hazard meets the classification criteria, hazard clas-sification is the assignment of a standardized description of this hazard of a substance or a mixture causing harm to human health or the environment.

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Hazard labeling allows for the communication of hazard classification to the user of a substance or mixture, to alert the user to the presence of a hazard and the need to avoid exposures and the resulting risks.

CLP sets general packaging standards, in order to ensure the safe supply of hazardous substances and mixtures.

wHaT do THese cHanges mean for you?If you supply a chemical, you should:

• MakesureyouunderstandwhatyourdutiesareunderthenewCLPRegulation.Youwillhavedutiesifyou:import, manufacture, formulate, mix, distribute, or sell chemicals.

• Makesureyouunderstandthetransitionalperiodstoensurethatyoure-classify,labelandpackageontime.

• Cooperate with others in your supply chain, to make sure the changes are managed smoothly.

• Check that your chemicals are correctly classified and that your product labels are accurate.

Source: http://ec.europa.eu/enterprise/sectors/chemicals/classification/how-does-clp-work/

Furtherreadingonthesubject:http://ec.europa.eu/enterprise/sectors/chemicals/files/ghs/clp_introduction_en.pdf

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ASSENTCOMPLIANCE

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wHaT can assenT do ?Our team of IT developers, engineers and REACH consultants have developed a module in Assent Compliance Suite as well as provide expert guidance for companies with CLP requirements. If you think you may have CLP requirements and are unsure about any compliance related issue feel free to contact Assent anytime and we would be happy to provide a free assessment. (www.AssentCompliance.com)

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