Assent Compliance Guide for 2011 REACH/RoHS

850 views

Published on

RoHS, CLP and REACH Guide for 2011. Assent Compliance provides expert consulting and software solutions for local, national and global environmental regulations. Visit www.assentcompliance.com for more information

1 Comment
0 Likes
Statistics
Notes
  • Be the first to like this

No Downloads
Views
Total views
850
On SlideShare
0
From Embeds
0
Number of Embeds
1
Actions
Shares
0
Downloads
22
Comments
1
Likes
0
Embeds 0
No embeds

No notes for slide

Assent Compliance Guide for 2011 REACH/RoHS

  1. 1. ASSENTCoMPLIANCEinfo@assentsvHC.Com w w w. a s s e n t s v H C . C o m tel: 866.964.6931 RoHS II, CLP & REACH A Guide for 2011 assent ComplianCe Jonathan hughes pHone: 613.290.8044 Jon.HugHes@assentComplianCe.ComCustom solutions for ComplianCe [ reaCH | roHs | Cpsia | rsl | prop65 ]
  2. 2. ASSENTCoMPLIANCEinfo@assentsvHC.Com w w w. a s s e n t s v H C . C o m tel: 866.964.6931 INTRoduCTIoN To ASSENT CoMPLIANCE assent ComplianCe • Consulting • Global Requirements • Compliance Strategies • Regulatory Interpretations and Impacts • IT • Cloud Computing • Application Design • Operations • Program Implementation • Data ManagementCustom solutions for ComplianCy [ reaCH | roHs | Cpsia | rsl | prop65 ]
  3. 3. ASSENTCoMPLIANCEinfo@assentsvHC.Com w w w. a s s e n t s v H C . C o m tel: 866.964.6931 AgENdA • RoHS II • CLP • REACH • 2011 timeline • Q&ACustom solutions for ComplianCy [ reaCH | roHs | Cpsia | rsl | prop65 ]
  4. 4. ASSENTCoMPLIANCEinfo@assentsvHC.Com w w w. a s s e n t s v H C . C o m tel: 866.964.6931 RoHS II legislation 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 ComplianCy [ reaCH | roHs | Cpsia | rsl | prop65 ]
  5. 5. ASSENTCoMPLIANCEinfo@assentsvHC.Com w w w. a s s e n t s v H C . C o m tel: 866.964.6931 RoHS 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 ComplianCy [ reaCH | roHs | Cpsia | rsl | prop65 ]
  6. 6. ASSENTCoMPLIANCEinfo@assentsvHC.Com w w w. a s s e n t s v H C . C o m tel: 866.964.6931 RoHS 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 ComplianCy [ reaCH | roHs | Cpsia | rsl | prop65 ]
  7. 7. ASSENTCoMPLIANCEinfo@assentsvHC.Com w w w. a s s e n t s v H C . C o m tel: 866.964.6931 RoHS 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 conformity, to withdraw it or recall it, if appropriate and immedi- ately inform the competent national authorities of the Member States in which they made the EEE available to that effect, giving details, in par- ticular, 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 ComplianCy [ reaCH | roHs | Cpsia | rsl | prop65 ]
  8. 8. ASSENTCoMPLIANCEinfo@assentsvHC.Com w w w. a s s e n t s v H C . C o m tel: 866.964.6931 RoHS II—SCoPE sCope 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 force Custom solutions for ComplianCy [ reaCH | roHs | Cpsia | rsl | prop65 ]
  9. 9. ASSENTCoMPLIANCEinfo@assentsvHC.Com w w w. a s s e n t s v H C . C o m tel: 866.964.6931 RoHS II 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 • RoHS is a Directive not a Regulation—Individual Member states must pass National Legislation at least 18 months after that date.Custom solutions for ComplianCy [ reaCH | roHs | Cpsia | rsl | prop65 ]
  10. 10. ASSENTCoMPLIANCEinfo@assentsvHC.Com w w w. a s s e n t s v H C . C o m tel: 866.964.6931 RoHS II Business 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 ComplianCy [ reaCH | roHs | Cpsia | rsl | prop65 ]
  11. 11. ASSENTCoMPLIANCEinfo@assentsvHC.Com w w w. a s s e n t s v H C . C o m tel: 866.964.6931 CLP legislation 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.Custom solutions for ComplianCy [ reaCH | roHs | Cpsia | rsl | prop65 ]
  12. 12. ASSENTCoMPLIANCEinfo@assentsvHC.Com w w w. a s s e n t s v H C . C o m tel: 866.964.6931 CLP 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 ComplianCy [ reaCH | roHs | Cpsia | rsl | prop65 ]
  13. 13. ASSENTCoMPLIANCEinfo@assentsvHC.Com w w w. a s s e n t s v H C . C o m tel: 866.964.6931 CLP Business 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 ComplianCy [ reaCH | roHs | Cpsia | rsl | prop65 ]
  14. 14. ASSENTCoMPLIANCEinfo@assentsvHC.Com w w w. a s s e n t s v H C . C o m tel: 866.964.6931 REACH svHC BasiCs artiCle 33 – sourCe of ComplianCe requirement: Duty to communicate information on substances in articles: 1. Any supplier of an article containing a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) in a concen- tration above 0,1 % weight by weight (w/w) shall provide the recipient of the article with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance. 2. On request by a consumer any supplier of an article containing a sub- stance meeting the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0,1 % weight by weight (w/w) shall provide the consumer with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance. The relevant information shall be provided, free of charge, within 45 days of receipt of the request.Custom solutions for ComplianCy [ reaCH | roHs | Cpsia | rsl | prop65 ]
  15. 15. ASSENTCoMPLIANCEinfo@assentsvHC.Com w w w. a s s e n t s v H C . C o m tel: 866.964.6931What Does this mean? • Once a substance has been added to the SVHC List, you must declare its presence to your downstream users if the concentration is above 0.1% of your products weight. • This is to be done upon immediately for professional customers and within 45 days from request for consumers.Contact a service provider to see what your options are.Custom solutions for ComplianCy [ reaCH | roHs | Cpsia | rsl | prop65 ]
  16. 16. ASSENTCoMPLIANCEinfo@assentsvHC.Com w w w. a s s e n t s v H C . C o m tel: 866.964.6931 REACH Current svHC Candidate list Link to the SVHC Candidate List: http://echa.europa.eu/chem_data/authorisation_process/ candidate_list_table_en.asp • Currently at 46 substances • New additions planned every 6 months • Any substances contained in products at a level greater than 0.1% w/w must be communicated to downstream users imme- diately for B2B relationships and the information needs to be made available within 45 days for consumers (the public). Custom solutions for ComplianCy [ reaCH | roHs | Cpsia | rsl | prop65 ]
  17. 17. ASSENTCoMPLIANCEinfo@assentsvHC.Com w w w. a s s e n t s v H C . C o m tel: 866.964.6931 REACH most reCent additions to tHe Candidate list suBstanCe Cas # eC # Common uses 2-Ethoxyethanol 110-80-5 203-804-1 Solvent and chemical intermediate 2-Methoxyethanol 109-86-4 203-713-7 Solvent, chemical intermediate and additive for fuels Used in the manufacture of catalysts, production of Cobalt di (acetate) 71-48-7 200-755-8 other chemicals, surface treatment, alloys, pigments, dyes, rubber adhesion, and feed additive. Used in the manufacture of catalysts, production of other chemicals, surface treatment, alloys, pigments, Cobalt (II) carbonate 513-79-1 208-169-4 dyes, rubber adhesion, and feed additive. coat frit) and other chemicals and used as a feed additive. Used to manufacture catalysts and other chemicals, Cobalt dinitrate 10141-05-6 233-402-1 used in surface treatments and batteries. Manufacture of catalysts and driers, surface treat- ments (such as electroplating), corrosion preven- Cobalt (II) sulphate 10124-43-3 233-334-2 tion, production of pigments, decolourizing (in glass, pottery), batteries, animal food supplement, soil fertilizer, and other chemicals Used for metal finishing and as fixing agent in Chromium trioxide 215-607-8 1333-82-0 waterborne wood preservatives. Acids generated from chromium Substances are generated when chromium trioxide trioxide and their oligomers: 1) 231-801-5 1) 7738-94-5 is dissolved in water. Consequently, the uses of these 1) Chromic acid 2) 236-881-5 2) 13530-68-2 substances are the same as indicated for chromium. 2) Dichromic acidCustom solutions for ComplianCy [ reaCH | roHs | Cpsia | rsl | prop65 ]
  18. 18. ASSENTCoMPLIANCEinfo@assentsvHC.Com w w w. a s s e n t s v H C . C o m tel: 866.964.6931 REACH future additions to tHe svHC list Here is an excerpt from ECHA’s press release on March 25, 2010 regarding REACH: “Accelerating addition of substances to the Candidate List: Both Commissioners expressed disappointment at their con- firmation hearings at the low number of SVHCs that had been placed on the REACH Candidate List for authorisation. They revealed that they had discussed the matter at length with ECHA and had secured the agency’s commitment to a “roadmap” that would allow another 106 “top priority” substances to be added to the Candidate List by 2012. ECHA indicated that this was the maximum number of substances it felt it could administer without compromising on the quality of assessment.” Link: http://europa.eu/rapid/pressReleasesAction.do?reference=IP/10/360&format= HTML&aged=0&language=EN&guiLanguage=enCustom solutions for ComplianCy [ reaCH | roHs | Cpsia | rsl | prop65 ]
  19. 19. ASSENTCoMPLIANCEinfo@assentsvHC.Com w w w. a s s e n t s v H C . C o m tel: 866.964.6931 REACH autHorisation overview • The Authorisation process • Starts with the identification of SVHC’s by Member State Competent Authorities or the ECHA • Preparation & Submission of Annex 15 dossiers. • Decisions on prioritisation of these SVHCs and the sub- sequent release of the final list of substances subject to au- thorisation is decided by the Commission. • Industry has to apply to the ECHA for authorisation for uses of these substances. • After an approval process, the holder of an authorisation can use and place on the market the substance for the uses he was grant- ed an authorisation. Summary Substances on the current SVHC List will eventually require an Authorisation for their use on a per substance, per company, per use basis.Custom solutions for ComplianCy [ reaCH | roHs | Cpsia | rsl | prop65 ]
  20. 20. ASSENTCoMPLIANCEinfo@assentsvHC.Com w w w. a s s e n t s v H C . C o m tel: 866.964.6931 REACH tHe aim of autHorisation • As per article 55 of the REACH Regulation: “…the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable”. • All Authorisation applicants shall analyse the availability of alterna- tives, consider their risks, and the technical and economic feasibility of substitution. • If the risk is not adequately controlled, an authorisation may still be granted if it is proven that the socio-economic benefits outweigh the risks and there are no suitable alternative substances or technologies.Custom solutions for ComplianCy [ reaCH | roHs | Cpsia | rsl | prop65 ]
  21. 21. ASSENTCoMPLIANCEinfo@assentsvHC.Com w w w. a s s e n t s v H C . C o m tel: 866.964.6931 REACH autHorisation proCess 1. Registry of intentions – Intention to submit dossier 2. Submission of Annex XV dossier (SVHC Dossier) to ECHA for Compliance Check 3. Publication of Annex XV dossier (once it has passed compliance check) 4. After Commenting periods – Candidate List (Article 33 Requirements kick in) 5. Prioritisation list – Order in which substances will be reviewed for Authorisation 6. Authorisation List – Restrictions and Authorisations handed outCustom solutions for ComplianCy [ reaCH | roHs | Cpsia | rsl | prop65 ]
  22. 22. ASSENTCoMPLIANCEinfo@assentsvHC.Com w w w. a s s e n t s v H C . C o m tel: 866.964.6931 REACH svHC Candidate list addition timelineCustom solutions for ComplianCy [ reaCH | roHs | Cpsia | rsl | prop65 ]
  23. 23. ASSENTCoMPLIANCEinfo@assentsvHC.Com w w w. a s s e n t s v H C . C o m tel: 866.964.6931 REACH standard 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 ComplianCy [ reaCH | roHs | Cpsia | rsl | prop65 ]
  24. 24. ASSENTCoMPLIANCEinfo@assentsvHC.Com w w w. a s s e n t s v H C . C o m tel: 866.964.6931 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 • Can cover entire time is expended product line • Updates & supplier responses must be constantly tracked • Info needs to be merged with existing PLM/ERP systemsCustom solutions for ComplianCy [ reaCH | roHs | Cpsia | rsl | prop65 ]
  25. 25. ASSENTCoMPLIANCEinfo@assentsvHC.Com w w w. a s s e n t s v H C . C o m tel: 866.964.6931 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 demonstrate REACH compliance. • Notifications are to begin this year—you must obtain your SVHC information in order to complete any necessary NotificationsCustom solutions for ComplianCy [ reaCH | roHs | Cpsia | rsl | prop65 ]
  26. 26. ASSENTCoMPLIANCEinfo@assentsvHC.Com w w w. a s s e n t s v H C . C o m tel: 866.964.6931 PRACTICAL APPLICATIoNS ideal 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 ComplianCy [ reaCH | roHs | Cpsia | rsl | prop65 ]
  27. 27. ASSENTCoMPLIANCEinfo@assentsvHC.Com w w w. a s s e n t s v H C . C o m tel: 866.964.6931 SERvICE offERINgS Consulting serviCes • Manage the compliance to ROHS, REACH, CLP and other Environmental standards • Ensure compliance with regulatory agencies and compliance regulations • Review and evaluate environmental requirements and changes as published by regulating bodies • Support sourcing and selection of electronic and mechanical components • Serve as subject matter expert on regulatory matters • Specification and drawing review for compliance • Obsolescence management and part substitution • Work with suppliers on corrective actions More experience and less cost than hiring a full time component engineer.Custom solutions for ComplianCy [ reaCH | roHs | Cpsia | rsl | prop65 ]
  28. 28. ASSENTCoMPLIANCEinfo@assentsvHC.Com w w w. a s s e n t s v H C . C o m tel: 866.964.6931 SERvICE offERINgS software • Automatically gather data environmental compliance data from your supply chain (Declarations, COC’s, DOC’s, etc.) • Platform for suppliers to enter environmental compliance information • Generate custom reports based on gathered compliance data: • Allows for a top level view of compliance progress or a drill down to product or part level compliance • Instantly isolate problem areas based on products, parts or materials. • Generate compliance documents for Enforcement agencies and downstream users. • Acts as a platform for internal teams to manage environmental data and make internal declarations based on obtained information: • Engineering Override • Automatic communication tool to inform suppliers of changes to envi- ronmental regulations • Free model for large cap companies looking to implement a software platform with their supply chainCustom solutions for ComplianCy [ reaCH | roHs | Cpsia | rsl | prop65 ]
  29. 29. ASSENTCoMPLIANCEinfo@assentsvHC.Com w w w. a s s e n t s v H C . C o m tel: 866.964.6931 QuESTIoNS? Please submit your questions in writing using the Q&A tool along the top menu tool bar. Any questions not addressed during the Q&A portion of this webinar will be addressed in private correspondence after the webinar.Custom solutions for ComplianCy [ reaCH | roHs | Cpsia | rsl | prop65 ]

×