Memoranda

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...

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...

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...

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...

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...

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...

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...

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...

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on August 3, 2017, providing the names and affiliations of additional candidates currently under consideration for appointment to the Science Advisory Committee on Chemicals (SACC). The notice states that the purpose of the SACC is to provide independent advice and expert consultation at the request of the EPA Administrator with respect to the scientific and technical aspects of risk...