Regulatory Roundup – 2015

In an effort to keep you informed of the latest regulatory changes affecting material content compliance programs, the following is a review of the major regulatory developments from the past year.

RoHS

In June, the EU commission amended RoHS with Directive (EU) 2015/863. This adds four new substances, all phthalates, to the Restricted Substances list as found in Annex II of the RoHS Directive (2011/65/EU).

The new substances and common usage are found in the table below.

Substance CAS No. Where Used
Bis(2-Ethylhexyl) phthalate (DEHP) 117-81-7 Plasticizer (PVC products), hydraulic fluid, dielectric fluid in capacitors.
Benzyl butyl phthalate (BBP) 85-68-7 Plasticizer (vinyl foams)
Dibutyl phthalate (DBP) 84-74-2 Plasticizer, cosmetic additive, used in printing inks and adhesives, ectoparasiticide
Diisobutyl phthalate (DIBP) 84-69-5 Plasticizer (nitro cellulose plastic), lacquer manufacture, methyl methacrylate applications

 

Restriction of the new substances comes into force on July 22, 2019. Category 8 & 9 products (medical devices & monitoring and control devices) are given an additional two years to comply and will be enforced on July 22, 2021.

RoHS exemptions are set to expire on July 21, 2016. Guidance from the EU had been expected prior to 2016. Nothing has been published, yet. Please continue to monitor the Q Point blog for further updates.

 

REACH

On December 17, 2015, ECHA added five new substances of very high concern (SVHC) to the REACH candidate list. The SVHC list is now at 168 substances. The new SVHC and common usage are found in the table below.

SVHC CAS No. Reason for Inclusion Where Used
Nitrobenzene

 

98-95-3 Toxic for reproduction Manufacture of other substances (aniline)
2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327) 3864-99-1 Very persistent and very bioaccumulative (vPvB) UV-protection agents in coatings, rubber, plastics, and cosmetics
2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350) 36437-37-3 vPvB UV-protection agents in coatings, rubber, plastics, and cosmetics
1,3-propanesultone

 

1120-71-4 Carcinogenic Lithium ion batteries – electrolyte fluid
Perfluorononan-1-oic-acid and its sodium and ammonium salts 375-95-1

21049-39-8

4149-60-4

Toxic for reproduction

 

Persistent, bioaccumulative, and toxic (PBT)

Processing aid for fluoropolymer manufacture, lubricating oil additive for fire extinguishers, cleaning agent, textile antifouling finishing agent, polishing surfactant, waterproofing agents and in liquid crystal display panels.

 

On September 10, 2015, the Court of Justice of the European Union (EU Court of Justice) ruled on the interpretation of an “article” per the previous interpretation of REACH. In their ruling, the EU Court of Justice indicates “there is no need to draw a distinction between the situation of articles incorporated as a component of a complex product and that of articles present in an isolated manner.”

The court also ruled “that each of the articles incorporated as a component of a complex product is covered by the relevant duties to notify and provide information when they contain a substance of very high concern in a concentration above 0.1% of their mass” The European Chemicals Agency (ECHA), the regulatory authority of REACH, has adopted this ruling by the EU Court of Justice.

On December 17, 2015, ECHA updated its “guidance on requirements for substances in articles.” This update removes reference to the 0.1% SVHC limit that is no longer consistent with the ruling by the EU Court of Justice. ECHA further declares that a comprehensive update to the guidance will follow in 2016. Please continue to monitor the Q Point blog for further updates.

 

Conflict Minerals

The Conflict Free Sourcing Initiative (CFSI) has updated the Conflict Minerals Reporting Template (CMRT) to version 4.01b. This replaces version 4.01(a) with a current smelter list. All versions of CMRT version 4 are still considered acceptable for the 2015 Reasonable Country of Origin Inquiry (RCOI).

On December 11, 2015, the SEC has issued proposed Resource Extraction Payment rules. Comments are due by January 25, 2016. These proposed rules apply to commercial entities issuing payments to foreign governments for resource extraction that (a.) are required to file annual reports under the Securities Exchange Act, and (b.) engage in the commercial development of oil, natural gas, or minerals.

On August 18, 2015, while upholding the majority of the regulation, a US federal appeals court maintained that public US companies do not need to disclose whether products contain 3TG from conflict sources. Requirements for RCOI and submission of the SEC Form SD are upheld. An independent private sector audit (IPSA) is no longer required unless a company’s filing indicates any part or product to be “DRC conflict free.”

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