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Assent Compliance Environmental Compliance Ebook

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Assent Compliance Ebook on the topic of REACH, RoHS, RoHSII, CLP and various compliance trends for 2011. Assent Compliance provides software and consulting for environmental regulations. Visit www.assentcompliance.com for more info

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Assent Compliance Environmental Compliance Ebook

  1. 1. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 ASSENT EbOOk a guide for 2011cusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 1 ]
  2. 2. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044TAbLE OF CONTENTSIntroduction .............................................................................................................................................. 03Kubler Ross Model of Compliance ........................................................................................................... 04REACH in 2011 ........................................................................................................................................ 07 What is REACH? ................................................................................................................................... 08 SVHC Basics .......................................................................................................................................... 09 REACH SVHC Authorization Lists ......................................................................................................... 10 Fulfilling SVHC Obligations ................................................................................................................... 11 Authorization ........................................................................................................................................ 12 Standard Compliance Methodologies ........................................................................................................ 13 Advantages/Disadvantages ....................................................................................................................... 14 Business Impacts ..................................................................................................................................... 15 Practical Applications .............................................................................................................................. 16 Case Study in REACH Compliance .......................................................................................................... 17RoHS – RoHS 2 in 2011 ........................................................................................................................... 23 Legislation Overview ............................................................................................................. 24, 25, 26, 27 Scope ..................................................................................................................................................... 28 Business Impacts ..................................................................................................................................... 29 EU Declaration of Conformity ................................................................................................................ 30 Presumption of Conformity and Enforcement ............................................................................................ 31 EU Parliament Issues, What to Do ........................................................................................................... 32 RoHS Past, Present, Future ..................................................................................................................... 33CLP in 2011 .............................................................................................................................................. 36 Legislation Overview, Scope .................................................................................................................... 37 Business Impacts ..................................................................................................................................... 38 CLP 101 ................................................................................................................................................ 39cusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 2 ]
  3. 3. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044INTrOduCTIONAssent Compliance is proud to bring you a compliance guide for 2011. This Ebook has been developed by theAssent Compliance team consisting of our industry leading consulting division, our IT developers and our projectmanagers. 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 industryorganizations on a regular basis. This Ebook has also combined much of our outbound and inbound educationalresources 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 Ebookplease contact the Assent team at info@assentcompliance.com.On behalf of all the Assent Compliance team,Thank you for reading and all the best in your on-going compliance efforts.cusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 3 ]
  4. 4. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044kübLEr-rOSS GrIEF MOdEL of environmenTal compliance requiremenTscusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 4 ]
  5. 5. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044kübLEr-rOSS GrIEF MOdEL OF ENvIrONMENTALCOMPLIANCE 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.”cusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 5 ]
  6. 6. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044At Assent we encounter companies at all stages. It is important to note however, whatever stage your company maybe 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. ExecuteWhile it is naive to think that in a large company the process is as simple as the three steps outlined but for themost part in a company large or small complying with REACH, RoHS/RoHS II , CLP and other environmentalregulations 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 ConsultingcusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 6 ]
  7. 7. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 rEACH IN 2011cusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 7 ]
  8. 8. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044WHAT IS rEACH?quick overview of THe regulaTionRegistration, Evaluation, Authorization and Restriction of Chemicals • Regulation (EC) No 1907/2006, • Initial regulation was over 700 pages • Several thousand additional pages of guidance • Administered by the European Chemical Agency (ECHA)Requires industry to be responsible for the safe manufacture and use of chemical substances • Manufacturers/Importers must Evaluate and Register substances • Awareness of substances of very high concern (SVHC) • Restrictions on chemicals posing unacceptable riskObligations for nearly all products, parts, substances and mixtures manufactured or imported in the EUcusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 8 ]
  9. 9. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044SvHC bASICSsvHc = subsTance of very HigH concern C = CarcinogenicREACH Definition M= Mutagenic• Substances such as CMRs, PBTs, vPvBs and endocrine disrupters R = Reproductive Toxin• Responsibilities for products containing an SVHC: P = Persistent 1. Identification in MSDS documents B = Bioaccumulative 2. Communication obligations to customers (articles w/ >0.1%) T = Toxic 3. Notification obligations to ECHA vP = very Persistent • w/ >0.1%, over 1 tonne per year vB = very Bioaccumulative 4. Authorizations required to continue using after sunset datecusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 9 ]
  10. 10. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044rEACH SvHCSHow are THe svHc candidaTe and auTHorizaTion lisTs creaTed? Proposal for SVHC Consultation Restrictions (EU member states)a and Review January 14, 2009 april 14, 2009 Consultation SVHC Candidate Review List Prioritize June 1, 2009 2012+ Draft Priority Consultation SVHC and Review Substances ocTober 28, 2008 Authorization List (Priority Substances Sunset Date added to Annex XIV) Communicate Info Notification of Authorization to on Candidate Candidate SVHCs use Annex XIV SVHCs to to ECHA SVHC customers (June 1, 2011) after sunset datecusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 10 ]
  11. 11. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044FuLFILLING SvHC ObLIGATIONS?communicaTion – reacH arTicle 33 applies To all arTicles manufacTured/imporTed To THe eu if svHc presenT > 0.1% 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)cusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 11 ]
  12. 12. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044AuTHOrIzATIONsubsTances lisTed in reacH annex xivAnnex XIV has List of Substances subject to Authorization • Manufacturers/Importers/Downstream users must receive authorization to continue using these substancesHave until the “Sunset Date” to receive authorization • Must be submitted at least 18 months before Sunset Date • Authorization request requires details on which use(s) the authorization request coverscusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 12 ]
  13. 13. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044rEACHsTandard compliance meTHodologies• Testing method • Wet chemical testing for substances on the SVHC list• Declaration method • Businesses ask suppliers if their materials contain SVHCs. • Use responses as proof of REACH compliancecusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 13 ]
  14. 14. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 rEACH advanTages disadvanTages • Testing method • Testing method • Direct • High cost per test • Conclusive • Must be redone every revision • Declaration method • Declaration method • Lower cost • Significant human resource time is • Can cover entire expended product line • Updates & supplier responses must be con- stantly tracked • Info needs to be merged with existing PLM/ ERP systemscusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 14 ]
  15. 15. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 rEACH business impacTs • Business is the current driver of SVHC compliance through Product Specifications and RFP’s. • Eventually, any company whose products end up in the EU will have to completely disclose the SVHC status of all their products. • ECHA guidance states that supply chain communication must be documented in order to demon- strate REACH compliance. • Notifications are to begin this year—you must obtain your SVHC information in order to complete any necessary NotificationscusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 15 ]
  16. 16. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044PrACTICAL 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, snail mail)? • 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?cusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 16 ]
  17. 17. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 ASSENT COMPLIANCE 2010 case sTudycusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 17 ]
  18. 18. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044SuMMAryclienT summary: HigHligHTsThe client associated with this project is a leading • 35% compliant with strictly passive requests.aerospace technology provider with a market capi- (1 month)talization of over 3 billion dollars. They have a glob- • 72% compliant with 2nd passive request andal outreach and are considered innovative leaders in limited direct contact / information (within 3the compliance space. months of launch.)proJecT purpose: • $0.00 spent in Testing Costs.Ensure an enterprise size product is backed by a • Foundation/Precedence Set for All Future REACH compliance process in order to be able to Requests and Products Added to Databasecomply with RFP. (Requests for proposal). • Elimination of Reliance on Wet Chemical TestingproJecT scope:• Installation of Assent Software and Set Up.• Database Size: 30 000 parts• Supply Chain: 250 unique suppliers• Import of BOB to Database and Data Integrity Verification• Supply Chain Engagement• Data Collection (phase 1 passive, phase 2 active)• ReportingcusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 18 ]
  19. 19. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044GOAL ACHIEvEMENTHaving achieved 72% of all required declarations for the product with continued contact with the THE ASSENTCLIENT supply chain represents risk mitigation and a REACH compliance system. This is representative of suffi-cient effort / success to be able to answer and win RFP competitions THE ASSENT CLIENT is currently workingtowards and or already currently awarded.This program has been deemed a success by management on all levels inclusive of the sales division through to theVP and CEO level. After completion of the first simulator as a pilot program THE ASSENT CLIENT has committed to using Assentfor ALL products being sold into the EU with 27 new products being brought on board and an alternate divisionof 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 mandatewhich has in turn reduced costs at present and will exponentially reduce costs moving forward.cusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 19 ]
  20. 20. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044CASE STudyA lesson in procuring documentations from your supply chain.In July 2010, THE ASSENT CLIENT undertook a new REACH compliance program using Assent’s REACHSVHC Compliance Software. The goal of this program was to sufficiently mitigate the risk of SVHCs being con-tained in their product without proper communication and notification to downstream users. These goals neededto be achieved in order to meet contractual obligations in the EU and prevent losing the EU as a viable market dueto business requirements (IE: the pushback of REACH obligations by THE ASSENT CLIENT customers).(In this specific instance RFP’s in the EU could not be won without a REACH program in place) THE ASSENT CLIENT and Assent created a program based on 3 principles from which to base the complianceprogram:• ECHA recommended approach• Current Industry Practice• Expected enforcement methodologyMultiple sources were used to for guidelines for each of the principles above: ecHa recommended approacH: ECHA Guidance on requirements for substances in articles (Version 2.2): http://guidance.echa.europa.eu/docs/draft_documents/Draft%20Guidance%20on%20requirements%20 for%20SiA_CARACAL.pdf ”http://guidance.echa.europa.eu/docs/draft_documents/Draft%20Guidance%20 on%20requirements%20for%20SiA_CARACAL.pdfcusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 20 ]
  21. 21. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 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: Aerospace Boeing’s REACH position with suppliers: http://www.boeingsuppliers.com/environmental/reach.html Airbus REACH requirements outlined in RFPs Electronics Industry Schneider-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.pdfBased on the sources and guidelines cited above, THE ASSENT CLIENT and Assent designed a program thatwould assess and document potential risk of THE ASSENT CLIENT articles containing SVHCs. Once this as-sessment was complete, THE ASSENT CLIENT suppliers were prompted to login to a web-based portal hostedby Assent where the suppliers could make declarations for the parts they supplied THE ASSENT CLIENT whichwere in scope of the program.cusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 21 ]
  22. 22. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044Training and education was provided to suppliers by Assent. The system used by Assent Compliance was simplifiedand 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 tocomplete their declarations. Declarations were targeted for verification based on response and risk level (identifiedpreviously).After the first run through, THE ASSENT CLIENT received a response rate of approximately 35%. The remainingsuppliers 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 andthe possibility of loss of sales if this request was not met. In parallel, the 2 groups mentioned above were contactedpersonally 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 atleast 90% by November including over 90% of high risk parts. This will allow for the sufficient mitigation of riskof non-compliance as per the goals of the program according to its guidelines.cusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 22 ]
  23. 23. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 roHS & roHS II IN 2011cusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 23 ]
  24. 24. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044rOHS 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 futurecusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 24 ]
  25. 25. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044rOHS II (CONT’d)legislaTion overview• All current exemptions are included in the Recast• RoHS will now be a part of the CE Marking Directive • 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 • Manufacturer name • Product info • Declaration statement • Etc • Must be translated into language of member state where product is placed on market or made availablecusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 25 ]
  26. 26. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044rOHS II (CONT’d)legislaTion overview• All actors in a supply have the legal responsibility to inform the Member state National Authority if they discover a 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.• Manufacturers and distributors must keep a register of all non-compliant products and product recalls. cusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 26 ]
  27. 27. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044rOHS II (CONT’d)legislaTion overview• 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.cusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 27 ]
  28. 28. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044rOHS II—SCOPEscope cHanges• Applies to all electrical equipment• Most exemptions from RoHS I are still in place (military, auto, large scale stationary and fixed, etc)• Medical Devices are in scope 3 years from entry into force• In-vitro Medical Devices will be in scope 5 years from entry into force• Monitoring and control instruments – 3 years from entry into force • Industrial Monitoring and control instruments – 5 years from entry into forceTimeline• 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 • RoHS is a Directive not a Regulation—Individual Member states must pass National Legislation at least 18 months after that date.cusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 28 ]
  29. 29. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044rOHS 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 • Mandatory product withdrawal • Registry of product recalls• 4 new substances have been delayed and must follow a similar process to SVHCs for inclusion to RoHS II.• 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’s must make sure their RoHS program is accurate and not merely a paperwork exercise.• Downstream user’s must establish the importance of RoHS II with their suppliers and write it into T&Cs (if they have not already).cusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 29 ]
  30. 30. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044Eu dECLArATION OF CONFOrMITyThe manufacturer must draw up and have available an EC Declaration of Conformity that states the product satisfies therequirements 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.”cusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 30 ]
  31. 31. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044PrESuMPTION OF CONFOrMITy ANd ENFOrCEMENTpresumpTion of conformiTy• “Member States shall presume electrical and electronic equipment bearing the CE marking as conforming to 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.• Requires EU Member States to enforce the requirements of the Directive• Requires economic operators to maintain documentation of conformity.• Requires economic operators to identify suppliers and customers to market surveillance authorities if requested.cusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 31 ]
  32. 32. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044Eu PArLIAMENT ISSuESAmong the Members of the European Parliament, contention remains over several important issues including:• 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• Whether to include polyvinyl chloride (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• For Medical Devices and Monitoring and Control Instruments, begin to make conversion decisions and plans• If you do not have restricted substance control (RSC) measures in place, they need to be created• Existing RSC measures should be reviewed• Consider RoHS requirements together with REACH SVHC obligations• Investigate substitution options for the 4 substances currently under review.cusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 32 ]
  33. 33. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044rOHS: PAST, PrESENT…FuTurEWe have certainly come a long way since July 1, 2006 when the EEE industry was introduced to the Restriction ofCertain 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.From the very moment that RoHS was introduced, the question was asked: “how will enforcement be carried out by authorities?” Just how did the country authorities expect to monitor and enforce a law that pushed the boundariesof how EEE was designed and manufactured when there were so many exemptions and areas of uncertainty? Theanswer 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-turers keeping tight control on their supply chain and keeping auditing/due diligence in-house with their own XRF and wet-chemical test facilities. Japanese industry took RoHS to a higher level with the adoption of JGPSSI (JapanGreen Survey Standard Initiative) that required suppliers to comply with RoHS and a multitude of other substancerestrictions and declaration requirements. With big names such as NEC and Sony enforcing JGPSSI, RoHS wasbeing 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.cusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 33 ]
  34. 34. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044From its inception, industry was really split in their approach to RoHS. While some big names decided to ignore material declaration and compliance, others went in the complete opposite direction. If Lead, Cadmium, Mercury, Hexavalent Chromium and PBB/PBDE were of such a concern to authorities, what were the next items to follow? From this was born the industry trend toward internal RSL (restricted substances list) development and enforcement. Any manufacturer of EEE components/subassemblies reading this article will know that the days of single digit RSLlists are gone. What was once 6 substances now ranges into the hundreds ,depending on the company, and coversmuch 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 industriesIf the last 4 years are any indication, industry will continue to lead restricted substances enforcement.Now, taking a look at the NMO (National Measurement Office of the UK) RoHS enforcement report from the past year (April 1 2009 through March 31 2010), we see that the long anticipated summary of action is largely indirect. No stories of non-compliances resulting in penalty or prosecution are highlighted, no aggressive initiativesare stated and the reader is simply left to comply by the governance of industry and look to the enforcement agen-cies for educational resources. That is to say that the NMO talks about the “indirect approach” to RoHS enforce-ment, which is founded on the “belief that most UK industry would aim to operate in a lawful manner and wouldtherefore work towards full compliance”.cusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 34 ]
  35. 35. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044The following is the summary of “direct” enforcement by the NMO. Of particular interest are the 10 warning let-ters, 0 cautions and 0 prosecutions. Stacking these up next to a single global manufacturer with thousands of sup-pliers and the business impact of enforcement by being dropped from a preferred supplier list, the NMO has not really enforced anything.Between April 1 2009 and March 31 2010, the NMO: resoluTions Type no.Investigations 326Resolution after initial engagement (1) 143 Compliant BusinessResolution requiring direct intervention (2) 158 Administrative resolutionImprovement plans 6Compliance Notices 5EU Notifications 2Product Withdrawals/quarantines 2Warning letters 10Simple cautions 0Prosecutions 0In summary, RoHS, REACH and RSL lists in general are here to stay. The authorities create the requirements andthe industry enforces them.cusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 35 ]
  36. 36. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044 CLP IN 2011cusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 36 ]
  37. 37. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044CLPlegislaTion 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).cusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 37 ]
  38. 38. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044CLPbusiness 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.cusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 38 ]
  39. 39. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044CLP 101 – yOu’vE bEEN ASkING.At Assent we always look forward to answering your regulatory questions. Once the same question is asked morethan a hand full of times it is more than just a question, it’s a trend. Recently we’ve been asked on almost a dailybasis about CLP under the REACH regulation.For this post we have attached a brief summary and link as well as touched on some of the ways that Assent Compliance 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 informationrequirements 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 ofcertain specific articles (explosive articles which are subject to classification according to Part 2 of Annex I toCLP) should communicate the identified hazards of these substances or mixtures to other actors in the supplychain, including to consumers.The hazard of a substance or mixture is the potential for that substance or mixture to cause harm. It depends onthe intrinsic properties of the substance or mixture. In this connection hazard evaluation is the process by whichinformation about the intrinsic properties of a substance or mixture is assessed to determine their potential to causeharm. 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 tohuman health or the environment.cusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 39 ]
  40. 40. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044Hazard labeling allows for the communication of hazard classification to the user of a substance or mixture, to alertthe 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: • Make sure you understand what your duties are under the new CLP Regulation. You will have duties if you: import, manufacture, formulate, mix, distribute, or sell chemicals. • Make sure you understand the transitional periods to ensure that you re-classify, label and package on time. • 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/Further reading on the subject: http://ec.europa.eu/enterprise/sectors/chemicals/files/ghs/clp_introduction_en.pdfcusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 40 ]
  41. 41. ASSENTCOMPLIANCEinfo@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044wHaT can assenT do ?Our team of IT developers, engineers and REACH consultants have developed a module in Assent ComplianceSuite as well as provide expert guidance for companies with CLP requirements. If you think you may have CLPrequirements and are unsure about any compliance related issue feel free to contact Assent anytime and we wouldbe happy to provide a free assessment. (www.AssentCompliance.com)did you know?Assent Provides: • Software Solutions for Environmental Compliance • RoHS, REACH, WEEE Consulting • Engineering Assessments • Custom Solutions and Support • General Sustainability ConsultingcusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ] [ 41 ]

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