Memoranda

The European Chemicals Agency’s (ECHA) Directors’ Contact Group (DCG) recently posted guidance for companies that are required to register under the European Union’s (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation by May 31, 2018.  This guidance focuses on specific important issues for companies managing compliance under the 2018 REACH deadline, and should be read in conjunction with DCG’s “Summary Paper on [Four]...

There are less than five months before the effective date of the California Office of Environmental Health Hazard Assessment (OEHHA) revisions to its Proposition 65 (Prop 65) Article 6 “clear and reasonable warnings” regulations.  By August 30, 2018, companies must comply with the revised regulations for consumer product, occupational, and environmental exposures.  While some companies have already revised warning requirements prior to this deadline, and an exception permits...

The South Korean Ministry of Environment (MOE) announced on March 14, 2018, that amendments to the Act for the Registration and Evaluation of Chemicals (K-REACH) will be promulgated on March 20, 2018, and be enforced beginning January 1, 2019. As reported in our January 4, 2018, “Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2018,” MOE proposed changes at the end of 2016 that would drastically alter the current legislation and...

On February 8, 2018, the U.S. Environmental Protection Agency (EPA) announced that EPA Administrator Scott Pruitt signed a proposed rule regarding user fees for the administration of the Toxic Substances Control Act (TSCA). As amended by the Frank Lautenberg Chemical Safety for the 21st Century Act, TSCA provides EPA the authority to levy fees on certain chemical manufacturers, including importers and processors, to “provide a sustainable source of funding to defray resources that are...

Click here for a PDF brochure of the memorandum Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) are pleased to offer you our Forecast 2018. The document distills key trends in U.S. and global chemical law and regulation, and provides a sneak preview of what our legal, scientific, and regulatory professionals believe we are likely to see in the New Year. Our unique business platform and global team of highly skilled professionals are perfectly suited...

On December 6 2017, the California Office of Environmental Health Hazard Assessment (OEHHA) issued a notice alerting stakeholders that amendments were approved related to its August 28, 2016, adopted revisions to its Proposition 65 (Prop 65) Article 6 “clear and reasonable warnings” regulations. These amendments, first proposed on July 21, 2017, are intended to clarify and correct certain sections of Article 6 that OEHHA believed “would be beneficial to the regulated community in...

As previously reported in our blog item on October 26, 2017, the U.S. Environmental Protection Agency (EPA) proposed triennial electronic reporting requirements pertinent to the supply, use, and trade of mercury in the United States. 82 Fed. Reg. 49564. This memorandum provides more information and an in-depth look into EPA’s proposed rule. The 2016 amendments to the Toxic Substances Control Act (TSCA) require EPA to establish periodic mercury reporting requirements for any...

On October 27, 2017, the U.S. Consumer Product Safety Commission (CPSC) issued a final rule prohibiting children’s toys and child care articles that contain specified phthalates.  The rule caps off almost a decade of effort since Congress passed the Consumer Product Safety Improvement Act (CPSIA) in 2008, which requires regulatory action on certain phthalates.  Under the final rule, children’s toys and child care articles that contain concentrations of more than 0.1...

On October 15, 2017, California Governor Jerry Brown (D) signed the Cleaning Product Right to Know Act of 2017 (S.B. 258). The new law requires manufacturers of cleaning products to disclose certain chemical ingredients on the product label and on the manufacturer’s website. The online disclosure requirements apply to a designated product sold in California on or after January 1, 2020. The product label disclosure requirements would apply to a designated product sold in...

In August 2017, the California Office of Environmental Health Hazard Assessment (OEHHA) released a Questions and Answers for Businesses (Q&A) document related to its August 28, 2016, adopted revisions to its Proposition 65 (Prop 65) Article 6 regulations covering “clear and reasonable warnings” requirements. Information related to OEHHA’s past actions modifying Prop 65 warning regulations, including the August 28, 2016, adoption and the November 27, 2015, and March 25, 2016,...

On October 1, 2017, the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment’s (OEHHA) regulations amending the content required in Proposition 65 (Prop 65) Notices of Violation involving occupational exposure became effective.  The regulations (found at Title 27 of the California Code of Regulations, Section 25903(b)(2)(E)), first proposed on May 19, 2017, are intended to clarify that the “Special Compliance Procedure Proof of...

KKDIK, Turkey REACH, was published on June 23, 2017, after long delays, and will enter into force on December 23, 2017. Turkey’s Ministry of Environment and Urbanization (MoEU) will make available 13 guidance documents by the end of the year to assist industry with compliance. Guidance documents to be issued by the end of the year will address the following issues, among others: (1) dossier and substance evaluation; (2) dossier preparation and harmonized...

On October 4, 2017, the U.S. Food and Drug Administration (FDA) announced the availability of final guidance that helps to clarify FDA and U.S. Environmental Protection Agency (EPA) jurisdiction over the regulation of mosquito-related products intended to function as pesticides, including those produced through the use of biotechnology.  The notice was published in the Federal Register on October 5, 2017.  82 Fed. Reg. 46500.  Guidance for Industry #236,...

On September 29, 2017, the U.S. Environmental Protection Agency (EPA) announced the availability of two final test method Standard Operating Procedures (SOP) for evaluating the efficacy of antimicrobials against spores of Clostridium difficile (C. diff).  EPA Microbiology Laboratory Branch (MLB) SOP MB-28:  Procedure for the Production and Storage of Spores of Clostridium difficile for Use in the Efficacy Evaluation of Antimicrobial Agents; and EPA MLB SOP MB-31:...

On September 13, 2017, the California Senate passed the final version of the Cleaning Product Right to Know Act of 2017 (S.B. 258), which would require manufacturers of cleaning products to disclose certain chemical ingredients on the product label and on the manufacturer’s website. The Senate passed the bill by a vote of 27 to 13. The California Assembly passed the bill by a vote of 55 to 15, with nine votes not recorded, on September 12, 2017. Governor Jerry Brown (D) has until October...

As reported in our Global Regulatory Update for August 2017, on June 23, 2017, Turkey’s Ministry of Environment and Urbanization (MoEU) published its REACH-like KKDIK Regulation. As reported in The Acta Group’s memorandum entitled “Turkey Catching Up with the [EU’s REACH] Regulation,” the name “KKDIK” is derived from the first letters of “Registration,” “Evaluation,” “Authorization,” and “Restriction” in Turkish. Similar to EU REACH, KKDIK requires companies to...

Cefic Provides Circular Economy Comments On EC’s Stakeholder Consultation: In July, the European Chemical Industry Council (Cefic) provided comments in response to the European Commission’s (EC) “Stakeholder Consultation Paper” on chemicals, products, and waste legislation. In its “feedback to the targeted consultation,” Cefic responded to each of the key issues identified in the EC’s consultation paper. Regarding the first issue of “insufficient information about...

EC Officially Adopts EDC Identification Criteria For BPR: On September 4, 2017, the European Commission (EC) issued a press release entitled “Endocrine disruptors: adoption of scientific criteria for biocides.” The EC’s press release stated that following endorsement by Member States, on July 4, 2017, of the scientific criteria for identification of endocrine disrupting chemicals (EDC) in pesticides, the EC adopted on September 4, 2017, the scientific criteria for identification of...

The Ministry of Environmental Protection of China (MEP) released on August 31, 2017, the Amendment on Data Requirements to the “Guidance for New Chemical Substance Notification and Registration.”  The revisions are expected to become effective on October 15, 2017.  As explained below, the new requirements reduce the data requirements for registration of low tonnage bands, particularly for the Level 1 regular registration but, as the amendment is in abbreviated table...

As Toxic Substances Control Act (TSCA) aficionados know well, September 19, 2017, is a banner date.  By then, information that was submitted and claimed as Confidential Business Information (CBI) between June 22, 2016, and March 21, 2017, must be substantiated.  If you have not already done so, the September 19th deadline looms large. Background On January 19, 2017, the U.S. Environmental Protection Agency (EPA) issued an interpretation of TSCA Section 14 concerning...