REGULATORY ROUNDUP MATERIALS MANAGEMENT. / / / Assent Compliance 2016

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1 REGULATORY ROUNDUP MATERIALS MANAGEMENT / / / Assent Compliance

2 Today s Moderator Travis Miller Assent Compliance General Counsel info@assentcompliance.com / / / Assent Compliance

3 Agenda EU REACH Compliance EU & China RoHS Proposition 65 Q&A info@assentcompliance.com / / / Assent Compliance

4 Today s Panelists Joe Langton Intertek Manager Market Access U.S. Operations Valerie Kuntz Assent Compliance Subject Matter Expert Materials Management Mario Fernandez OEHHA Staff Counsel info@assentcompliance.com / / / Assent Compliance

5 EU REACH Compliance Presented by Joe Langton / / / Assent Compliance 2017

6 EU REACH Compliance Joe Langton Manager Market Access - US Operations February 8,

7 REACH Regulation What is REACH? Registration, Evaluation, Authorization and restriction of CHemicals (REACH) Administered by the European Chemical Agency (ECHA) Enforced at the Member-state level (national authorities) Requires industry to be responsible for the safe manufacture and use of chemical substances Manufacturers/Importers must Register substances Manufacturers, Importers and Retailers must Communicate substances of very high concern (SVHC) Restrictions are placed on chemicals posing unacceptable risk Obligations exist for nearly all products, parts, substances and mixtures manufactured in or imported into Europe 7

8 Definitions Article: An object where its shape and function is more important than its chemical composition. SVHC: Substances of Very High Concern RSC: Restricted Substance Control Program 8

9 REACH Responsibilities Finished Products (Articles) Communicate if SVHC s are above 0.1% w/w of component/material. Substance Name Safe Use Instructions (if required) Notify ECHA if you are importing 1 tonne of a particular substance. Manufacturers inside the EU must gain Authorization for use of substances found in Annex XIV (Authorization List) Annex XVII - Restrictions Mixtures / Substances Importers of a substance >1 tonne must pre-/register the substance Registration deadlines specific to 1, 100, & 1,000 Tonnes. Foreign exporters must assign an Only Representative to take on responsibility Importers responsible of ensuring Safety Data Sheets (SDS) compliance to current standards 9

10 Initial Article Interpretation 10

11 Now Once an Article Always an Article 11

12 REACH SVHC Communication Requirements B2B - Ensure that Supplier(s) have provided a disclosure statement to Retailer for articles that contain 0.1% or more of an ECHA listed SVHC B2C - Provide disclosure to consumer within 45 days of request for information on presence of an ECHA listed SVHC in concentration of 0.1% or more in products Confirm REACH registration compliance on all products that contain chemical substances in volumes of 1 tonne or more per year prior to trading the product within the EU. 12

13 REACH Compliance How Do You Hit A Moving Target? No current standards for compliance EU authorities expect companies to have due diligence in place for communication to downstream users. This can include the following: RSC Program Product Risk Assessment Material Declarations from suppliers / manufacturers Testing Reports 13

14 REACH Compliance Due Diligence Risk Assessment Review of product materials and SVHC list Weight of materials and composition need to be considered to determine risk. Should also review Authorisation list if you are making materials or integrated articles. Plastics will provide highest level of risk. (Cables) Accessories and packaging need to be considered. These may have different communication requirements than your main article. Will provide focus on large list and create compliance plan 14

15 REACH Compliance Due Diligence Material Declarations No current specific material declaration, but there are standards IEC62474 Minimum requirements should be a certificate of compliance (Company letterhead, calls our REACH Regulation, SVHC Substance List, SVHC Substance if above 0.1%) Full Material Declarations would be ideal, but not currently realistic for all materials. Requests for declarations can be focused if Risk Assessment is carried out. More familiarity for suppliers. Potentially less effort required to determine presence on subset of list. 15

16 REACH Regulation Summary Following REACH Registry Of Intentions and Candidate List to ensure ongoing compliance. An internal Restricted Substance Control program will add level of due diligence and risk mitigation. Risk Assessments will be critical to ensure compliance. Focused compliance list should enable more effective compliance efforts. Combination of Risk Assessment, Supply Chain Management and Testing should be utilized. Collect declarations from suppliers for high risk materials for high risk substances Test for High Risk substances in High Risk Materials 16

17 Thank You Joe Langton Manager Market Access - US Operations Intertek Health, Environmental and Regulatory Services (HERS) Joe.Langton@intertek.com (484)

18 EU RoHS & China RoHS Presented by Valerie Kuntz / / / Assent Compliance 2017

19 EU RoHS & China RoHS / / / Assent Compliance 2016

20 EU RoHS 2 Directive: 2011/65/EU RoHS 2 Directive 2011/65/EU of the European Parliament and the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment Substances and Threshold: Cadmium(Cd) and its compounds: 0.01% Mercury and its compounds: 0.1% Lead(Pb) and its compounds: 0.1% Hexavalent chromium (Cr6+) and its compounds: 0.1% Polybrominated biphenyls (PBB): 0.1% Polybrominated diphenyl ethers (PBDE): 0.1% Included after July 22, 2019 per Directive (EU) 2015/863 (RoHS 3.0): Bis(2-Ethylhexyl) phthalate (DEHP): max 0.1% Benzyl butyl phthalate (BBP): max 0.1% Dibutyl phthalate (DBP): max 0.1% Diisobutyl phthalate (DIBP): max 0.1% Effective Date: January 2, 2013 info@assentcompliance.com / / / Assent Compliance

21 EU RoHS 2 Included Products: info@assentcompliance.com / / / Assent Compliance

22 EU RoHS 2 Excluded Products: Industrial Category 9 products (until July 22, 2017) Category 11 products (until 2019 RoHS 2.1) Military/security equipment Equipment designed to be sent into space Equipment designed to be part of non-scope equipment Large-scale stationary industrial tools (LSSIT) Large-scale fixed installations (LSFI) Transportation vehicles Non-road mobile machinery (NRMM) Active implantable medical devices Photovoltaic panels R&D equipment info@assentcompliance.com / / / Assent Compliance

23 EU RoHS 2 Exemptions: EU RoHS exemptions from Annex III and IV applicable to included products. COMPLIANCE How to show compliance: Declaration of Conformance (not a specific form) CE marking can be placed on products that are compliant and meet the other appropriate regulations or directives required for CE marking Industry standards like IPC-1752A and IEC can also be used to provide information about compliance to the Directive EN (soon to be EN 63000) Standard defining technical documentation requirements to meet RoHS 2 info@assentcompliance.com / / / Assent Compliance

24 China RoHS 2 Regulation: Management Methods for the Restriction of the Use of Hazardous Substances in Electrical and Electronic Products. Substances and Threshold: Cadmium(Cd) and its compounds: 0.01% Mercury and its compounds: 0.1% Lead(Pb) and its compounds: 0.1% Hexavalent chromium (Cr6+) and its compounds: 0.1% Polybrominated biphenyls (PBB): 0.1%; Polybrominated diphenyl ethers (PBDE): 0.1% Effective Date: July 1, 2016 info@assentcompliance.com / / / Assent Compliance

25 China RoHS 2 Included Products: Electrical and Electronic Products (EEP) = Equipment dependent on electric current or electromagnetic fields for operation and equipment for the generation, transfer and measurement of such currents and fields, with a working voltage rating not to exceed 1,000 volts alternating current or 1,500 volts direct current. Products placed on the market" are in scope. info@assentcompliance.com / / / Assent Compliance

26 China RoHS 2 Excluded Products: Equipment related to electric energy production, transmission and distribution, such as systems and devices used for power station, power distribution station and building power supply and distribution Electrical and electronic equipment used for military purposes Electrical and electronic equipment used in special or extreme environment Electrical and electronic equipment used for export Note: Electrical and electronic equipment used for export shall comply with provisions related to restricted use of hazardous substances in the country/region of ultimate destination Electrical and electronic equipment which are temporarily imported or imported for repair, but not for sale Prototypes used for scientific research / research and development and testing Samples and exhibits used for exhibition and display, but not for sale 26 info@assentcompliance.com / / / Assent Compliance 2017

27 China RoHS 2 Exemptions: None at this time. Exemptions How to show compliance: Labeling and declaration using custom table in Chinese included in the product documentation. Labeling includes Environment Friendly Use Period (EFUP) indicating the period during which the hazardous substances do not leak or mutate under normal use. info@assentcompliance.com / / / Assent Compliance

28 China RoHS 2 Condition Label None of the six substances exist in the product above threshold Product contains one or more of the six substances above threshold. The number indicates the minimum number of safe years. info@assentcompliance.com / / / Assent Compliance

29 China RoHS 2 How to show compliance: Partial example of China RoHS 2 Table (note: must be in Chinese) info@assentcompliance.com / / / Assent Compliance

30 Summary RoHS regulations or directives have been implemented around the world to help protect citizens and the environment EU RoHS and China RoHS are very similar, but have different requirements Products that are not currently in scope for EU RoHS, are in scope for China RoHS EU RoHS includes restrictions of the noted substances above threshold China RoHS requires documentation of the substances above threshold, but are not yet restricted / / / Assent Compliance

31 Proposition 65 Presented by Mario Fernandez / / / Assent Compliance 2017

32 Proposition 65: 32 Clear and Reasonable Warnings Presentation for the Assent Compliance San Jose Supply Chain Summit February 8, 2017 MARIO FERNANDEZ STAFF COUNSEL OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT

33 33 Office of Environmental Health Hazard Assessment (OEHHA) Lead CA agency for conducting health risk assessments of chemicals. Lead agency for Proposition 65. OEHHA assessments from public-health basis for CA s drinking water and air-quality standards and regulations. Sport-fish advisories, pesticide reviews, study impacts of climate change.

34 Proposition 65: The Law 34 Official name: Safe Drinking Water and Toxic Enforcement Act of 1986 (CA Health and Safety Code section , et. seq.) Approved by CA voters as a ballot initiative in November 1986 by a vote. Amendments require a 2/3 vote of CA Legislature and must further the purpose of the statute.

35 Proposition 65: The Law, cont. 35 HSC Section No person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual.

36 36

37 37 Article 6: Overview Clarifies responsibilities to provide warnings Retains safe harbor approach for warnings to provide flexibility for businesses o o Includes changes to warning methods and content Provides for more specificity and clarity in warnings Added tailored warnings for specific kinds of exposures. o Examples: dental care, furniture, diesel engines, automobiles, recreational vessels, amusement parks.

38 Subarticle General. o Mandatory provisions applicable throughout Article 6 o o o Subsection (b) allows for warnings to be provided in accordance with the revised Article 6 prior to the two-year effective (operative) date of August 30, 2018 Subsection (c) allows for businesses to request tailored warnings through a Petition for Rulemaking, and provides that Interpretive Guideline Requests and Safe Use Determinations are available under other OEHHA regulations. Subsection (e) restates that OEHHA recognizes court ordered settlements and final judgments as to parties to those settlements and judgments

39 Subarticle 1, cont General, cont. o Subsection (f) makes clear that a business is not required to use the clear and reasonable warning methods and content in Subarticle 2 in order to comply with the Act Definitions Responsibility to Provide Consumer Product Exposure Warnings. o Sets forth manufacturer/retailer responsibilities

40 Section , Cont. Manufacturer/Retail Seller Responsibilities Product manufacturers have primary responsibility for warning. Manufacturer can label product or: o Provide notice to distributor/importer/retail seller that a product may cause an exposure to a listed chemical, and o Provide warning signs, materials (unless they make other arrangements via contract). o Can modify allocation of responsibility by entering into written agreement with retail seller so long as consumer receives a warning prior to exposure. Retail sellers o Confirm receipt of notice o Act as pass-through for warning Provide non-english language warnings in certain situations. 40

41 Subarticle 2. Safe Harbor Methods and Content 41 Section Safe Harbor Methods and Content o Sets forth methods and content for providing safe harbor warning. Section Methods of Transmission o Includes point of display warnings, electronic device or process, labels, on-product ( short-form ) warning, and internet purchase warnings. Section Consumer Product Exposure Warnings Content o This product contains This product can expose you to o o o o The name of at least one chemical in the warning. Warning required for chemicals A and B. Business can include the name of A or B, or both. Named chemicals are those for which warning is being provided Business selects which chemical(s) to include in warning Answers question: What am I being exposed to?

42 42 Section Consumer Product Exposure Warnings, cont., o o OEHHA web site URL Warning symbol Section Environmental Exposure Warnings Methods of Transmission Section Environmental Exposure Warnings Content Section Occupational Exposure Warnings. o Substantially retained provisions of September 2008 version of regulations

43 Safe Harbor Warnings: Comparison of Current and New Content 43 WARNING: This product contains a chemical known to the State of California to cause cancer. Ex. 1 Current safe harbor warning WARNING: This product can expose you to chemicals including arsenic, which is known to the State of California to cause cancer. For more information go to Ex. 2 New safe harbor warning

44 Safe Harbor Warnings: Short-form Warning Content 44 WARNING: This product contains a chemical known to the State of California to cause cancer. Ex. 1 Current safe harbor warning WARNING: Cancer - Ex. 2 New safe harbor short-form, on-product warning

45 Subarticle 2. Safe Harbor Methods and Content 45 Section Specific Product, Chemical and Area Exposure Warnings. o o o o o Tailored warnings for specific types of exposures Food, alcohol, restaurants, prescription drugs, dental care, raw wood, furniture, diesel engines, vehicles, recreational vessels, enclosed parking facilities, service stations, vehicle repair facilities, smoking areas, BPA in canned products Warnings about the exposures that can occur through these products and facilities Must use the tailored warning for the specific exposure type in order to meet the safe harbor Significant stakeholder input in development of tailored warnings Will continue to develop tailored warnings

46 46 Phase-In Phase-in period of two years Operative date of regulation: August 30, 2018 Consumer products manufactured prior to August 30, 2018 will not require new warnings if they meet existing safe harbor requirements Court-approved warnings expressly recognized and considered clear and reasonable for parties to litigation.

47 Proposition 65 resources 47 OEHHA web site: o Statute, regulations, listings, Safe Harbor numbers, lay-friendly fact sheets OEHHA warnings website: o Additional information on listed chemicals, exposure to listed chemicals from products and places, information for businesses Attorney General web site: oag.ca.gov/prop65 o Enforcement actions, settlements

48 48 For more information: Mario Fernandez Staff Counsel Office of Environmental Health Hazard Assessment Ph: (916)

49 Q&A Discussion Questions? / / / Assent Compliance