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Assent compliance Webinar RoHS II
Assent compliance Webinar RoHS II
Assent compliance Webinar RoHS II
Assent compliance Webinar RoHS II
Assent compliance Webinar RoHS II
Assent compliance Webinar RoHS II
Assent compliance Webinar RoHS II
Assent compliance Webinar RoHS II
Assent compliance Webinar RoHS II
Assent compliance Webinar RoHS II
Assent compliance Webinar RoHS II
Assent compliance Webinar RoHS II
Assent compliance Webinar RoHS II
Assent compliance Webinar RoHS II
Assent compliance Webinar RoHS II
Assent compliance Webinar RoHS II
Assent compliance Webinar RoHS II
Assent compliance Webinar RoHS II
Assent compliance Webinar RoHS II
Assent compliance Webinar RoHS II
Assent compliance Webinar RoHS II
Assent compliance Webinar RoHS II
Assent compliance Webinar RoHS II
Assent compliance Webinar RoHS II
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Assent compliance Webinar RoHS II

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Assent Compliance hosts regular webinars which cover compliance for REACH, RoHS , CLP and many other environmental regulations. To view the web cast online visit www.assentcompliance.com

Assent Compliance hosts regular webinars which cover compliance for REACH, RoHS , CLP and many other environmental regulations. To view the web cast online visit www.assentcompliance.com

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  • 1. AS SENTCOM PLIANCEinfo@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 ROHS II – What is Changing? assent compliance Krystal Noseworthy-BaKer phone: 613.882.1429 krystal.baker@assentcompliance.comcustom solutions for compliance [ reach | rohs | cpsia | rsl | prop65 ]
  • 2. AS SENTCOM PLIANCE info@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 Management custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 3. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 AgENdA • Overview • Scope • Exemptions • Timelines • CE Marking • Effect of REACH (Phthalates) • Q&A custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 4. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 ROHS II – OvERvIEw • DIRECTIVE 2011/65/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast) • Published in the Official Journal of the European Union: July 2011 • RoHS II was approved by the EU Parliament: November 2010 • A Corrigendum was created in April 2011 and approved in May 2011 • RoHS II was approved by the EU Commission and Council: May 2011 • In Effect: July 21, 2011 • Into Member State law: January 2, 2013 • Previous RoHS Directive (2002/95/EC) repealed: January 3, 2013 custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 5. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 ROHS II – OvERvIEw categories – annex i (a refresher!): 1. Large household appliances. 2. Small household appliances. 3. IT and telecommunications equipment. 4. Consumer equipment. 5. Lighting equipment. 6. Electrical and electronic tools. 7. Toys, leisure and sports equipment. 8. Medical devices. 9. Monitoring and control instruments including industrial monitoring and control instruments. 10. Automatic dispensers. 11. Other EEE not covered by any of the categories above. custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 6. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 ROHS II – OvERvIEw Major Differences between RoHS Recast and RoHS • Size and Comprehensiveness • RoHS Recast – Twenty-three (23) pages • RoHS – Five (5) pages • CE Marking • RoHS II is part of the Free Movement of Goods – Regulation 765/2008/EC • Conformity assessment procedures are affected • Scope • Further details given later in the presentation custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 7. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 ROHS II – OvERvIEw key Definition changes Definition of EEE: • Article 3.1: ‘Electrical and electronic equipment’ or ‘EEE’ means equip- ment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measure- ment of such currents and fields and designed for use with a voltage rating not exceeding 1 000 volts for alternating current and 1 500 volts for direct current; • Previously included “falling under the categories set out in Annex IA to Directive 2002/96/EC (WEEE)” before “…and designed for…” • Article 3.2: ‘Dependent’ means, with regard to EEE, needing electric currents or electromagnetic fields to fulfil at least one intended function; • NOTE: If the product was out of scope and not specifically listed in article 4(3) or 4(4), the equipment has until July 22, 2019 to comply • 4.3: Paragraph 1 shall apply to medical devices and monitoring and control instruments which are placed on the market from 22 July 2014, to in vitro diag- nostic medical devices which are placed on the market from 22 July 2016 and to industrial monitoring and control instruments which are placed on the market from 22 July 2017. custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 8. AS SENTCOM PLIANCEinfo@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 • 4.4: Paragraph 1 shall not apply to cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of the following: a. EEE placed on the market before 1 July 2006; b. Medical devices placed on the market before 22 July 2014; c. In vitro diagnostic medical devices placed on the market before 22 July 2016; d. Monitoring and control instruments placed on the market before 22 July 2014; e. Industrial monitoring and control instruments placed on the market before 22 July 2017; f. EEE which benefited from an exemption and which was placed on the market before that exemption expired as far as that specific ex- emption is concerned.custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 9. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 ROHS II – OvERvIEw key Definition changes • Homogeneous materials and coatings • Never mentioned in RoHS • RoHS II states: » Article 4.2: For the purposes of this Directive, no more than the maxi- mum concentration value by weight in homogeneous materials as specified in Annex II shall be tolerated. » Annex II of course details the restricted substances which have not changed: • Lead (0,1 %) • Mercury (0,1 %) • Cadmium (0,01 %) • Hexavalent chromium (0,1 %) • Polybrominated biphenyls (PBB) (0,1 %) • Polybrominated diphenyl ethers (PBDE) (0,1 %) NOTE: Article 4.2 goes on to state that the Commission is responsible for creating detailed rules for complying with the maximum concentration values for surface coatings custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 10. AS SENTCOM PLIANCE info@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 • Medical devices • Control and monitoring instruments • Category 11  Now all part of RoHS Recast • Directive does not apply to: • Equipment which is necessary for the protection of the essential interests of the security of Member States, including arms, munitions and war mate- rial intended for specifically military purposes » Defense • Equipment to be sent into space • Equipment which is specifically designed, and is to be installed, as part of another type of equipment that is excluded or does not fall within the scope of this Directive, which can fulfil its function only if it is part of that equipment, and which can be replaced only by the same specifically designed equipment custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 11. AS SENTCOM PLIANCEinfo@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 • Large-scale stationary industrial tools • Large-scale fixed installations • Means of transport for persons or goods, excluding electric two-wheel vehicles which are not type-approved • Non-road mobile machinery made available exclusively for professional use • Active implantable medical devices • Photovoltaic panels intended to be used in a system that is designed, assembled and installed by professionals for permanent use at a defined location to produce energy from solar light for public, commercial, industrial and residential applications • Equipment specifically designed solely for the purposes of research and development only made available on a business-to-business basis. » R&D B2Bcustom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 12. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 ROHS II – ExEMPTIONS RoHS recast has two (2) groups of Exemptions: • Annex III – Applications exempted from the restriction in Article 4(1) • Annex IV – Applications exempted from the restriction in Article 4(1) spe- cific to medical devices and monitoring and control instruments Validity Date • Annex III: • For the exemptions listed in Annex III as at 21 July 2011, the maxi- mum validity period, which may be renewed, shall, for categories 1 to 7 and 10 of Annex I, be 5 years from 21 July 2011 and, for categories 8 and 9 of Annex I, 7 years from the relevant dates laid down in Article 4(3), unless a shorter period is specified. • Annex IV: • For the exemptions listed in Annex IV as at 21 July 2011, the maximum validity period, which may be renewed, shall be 7 years from the relevant dates laid down in Article 4(3), unless a shorter period is specified. custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 13. AS SENTCOM PLIANCEinfo@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931• Unless otherwise specified • Thirty-eight (38) Annex III exemptions currently have a specified sunset dateIf an exemption is not renewed, it would proceed to a revocation process• Applications for renewal are required to be submitted at least eighteen (18) months before the expiry date of an exemption • Similar to the Authorisation Process under REACH• If a decision is made to revoke an exemption, the exemption will expire twelve (12) to eighteen (18) months from the date of the decisioncustom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 14. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 ROHS II – ExEMPTIONS complications in sunset Dates anD exemptions Example • Industrial Monitoring and Control Instruments • Article 4.3 – Compliance required by July 22, 2017 • Category 9 • 7 years validity for both Annex III and IV exemptions » July 22, 2024 » Unless it is one of the thirty eight (38) already specified exemptions in Annex III • Exemption 7 (c)-III Lead in dielectric ceramic in capacitors for a rated voltage of less than 125 VAC or 250 V DC • Sunset date of January 1, 2013 • Would not be available for RoHS compliance of products after January 1, 2013 (and therefore not available to Industrial Monitoring and Control products on July 22, 2017) custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 15. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 ROHS II – TIMELINES IndustrialExpiry of C-Ring Medical Devices & Control & and C-Press Pb Publication of Reduction of CFL Technical File Consumer Control & Monitoring Exemption RoHS Recast Exemptions Requirement TODAY Monitoring In Scope In Scope Sept 2010 July 2011 Dec 2011 Jan 2013 October 12, 2011 July 2014 July 2017 Reduction Hg and Expiry of High Pb Od Exemptions Expiry of Pb IVD Devices Content Solder Jan 2012 in Ceramic In Scope Exemption Capacitators July 2016 Expiry Pb as Activator Exemption in Fluorescent Powder Jan 2013 Jan 2011NOTE: Please note that not all exemptions are included within this timeline. (Those deemed to be minor/affect less companies have been excluded.) custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 16. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 ROHS II – CE MARkINg Regulations and Directives: • CE Mark: • Directive 93/68/EEC of 22 July 1993 • Subject to Article 30 of Regulation (EC) No 765/2008. • Declaration of Conformity: • Decision No 768/2008/EC • Technical file: • Module A of Decision No 768/2008/EC RoHS Recast is under CE marking • Manufacturers – Declaration of Conformity • On Product – CE Mark • Applicable to: • Finished products in scope of RoHS recast • Placed on the market after January 2, 2013 custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 17. AS SENTCOM PLIANCEinfo@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931CE Marking1:• It states that the product is assessed before being placed on the market and meets EU safety, health and environmental protection requirements.A CE mark does NOT specifically identify that a product is compliant with RoHS Recast.• This marking is the visible symbol showing that the manufacturer has taken all necessary measures to ensure that the product complies with the applicable safety legislation • By placing CE marking on a product, manufacturers declare on their sole responsibility that the products comply with all the legal requirements in force in Europe. It is the manufacturer’s responsibility to verify that the goods they are selling comply with all relevant legislation. • The CE marking statements all predicate on the reality of placing a product on the market and therefore having the mark only indicates that a product is compliant with all relevant legislation at the time of placing on the market.1 As per the EU Commission Enterprise and Industry Website.custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 18. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 ROHS II – CE MARkINg Declaration of conformity General Requirements: 1. No…(unique identification of the EEE): 2. Name and address of the manufacturer or his authorised representative: 3. This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer): 4. Object of the declaration (identification of EEE allowing traceability. It may include a photograph, where appropriate): 5. The object of the declaration described above is in conformity with Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast) custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 19. AS SENTCOM PLIANCEinfo@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.69316. Where applicable, references to the relevant harmonised standards used or references to the technical specifications in relation to which confor- mity is declared:7. Additional information: • Signature » Signed for and on behalf of: » (place and date of issue): » (name, function) (signature):NOTE: Declaration must be translated into the language or languages required by the Member State of the market on which the product is placed or made availablecustom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 20. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 ROHS II – CE MARkINg eu technical file • Based on Module A of DECISION No 768/2008/EC • Has to contain at least the following elements: • A general description of the product • Conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc. • Descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product • A list of the harmonised standards and/or other relevant technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the legislative instrument where those harmonised • Standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied • Results of design calculations made, examinations carried out, etc. • Test reports custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 21. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 ROHS II – CE MARkINg eu technical file • Mandatory for RoHS Recast compliance • National authority request for file = First Stage of Enforcement • Specific penalties associated with this non-compliance • Standards • Currently no specific standards for RoHS recast • Language • Available in language that can be easily understood by the EU National Authority requesting it custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 22. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 ROHS II – EffECT Of REACH process for aDDition of new substances • Article 6 now allows for new substances to be added to the restrictions: • With a view to achieving the objectives set out in Article 1 and taking account of the precautionary principle, a review, based on a thorough assessment, and amendment of the list of restricted substances in Annex II shall be considered by the Commission before 22 July 2014, and periodically thereafter on its own initiative or following the submission of a proposal by a Member State… • 4 Substances have already been prioritized (Section 10 of the Preamble) • Hexabromocyclododecane (HBCDD) – In Annex XIV of REACH – Sunset Date Aug 21, 2015 • Bis (2 – ethylhexyl) phthalate(DEHP) – In Annex XIV of REACH – Sunset Date Feb 21, 2015 • Butyl benzyl phthalate (BBP) – In Annex XIV of REACH – Sunset Date Feb 21, 2015 • Dibutyl phthalate (DBP) – In Annex XIV of REACH – Sunset Date Feb 21, 2015 custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 23. AS SENTCOM PLIANCEinfo@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931• More substances can be added to/included in the revie• Article 6 also sets out the criteria for inclusion to the review: a. Could have a negative impact during EEE waste management operations, including on the possibilities for preparing for the reuse of waste EEE or for recycling of materials from waste EEE; b. Could give rise, given its uses, to uncontrolled or diffuse release into the environment of the substance, or could give rise to hazardous residues, or transformation or degradation products through the preparation for reuse, recycling or other treatment of materials from waste EEE under current operational conditions; c. Could lead to unacceptable exposure of workers involved in the waste EEE collection or treatment processes; d. Could be replaced by substitutes or alternative technologies which have less negative impacts.custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 24. AS SENTCOM PLIANCE info@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 ]

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