Commission Implementing Regulation (EU) 2016/9 (Implementing Regulation) entered into force with retroactive effect on 26 January 2016, providing several new and important considerations and obligations for companies sharing data under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. The Implementing Regulation aspires to: (1) provide useful clarity on data sharing and data compensation under REACH by providing detail on the “fair, transparent and...
The Chemical Watch US Regulatory Summit included presentations, round table discussions and Q&As, brought together over 25 experts in global chemicals regulation. B&C Managing Partner Lynn L. Bergeson, Chairman of Day One of the Summit, led the session on TSCA reform along with B&C Senior Regulatory and Policy Advisor Charles M. Auer.
October 25, 2016
ECHA Board of Appeal Annuls Four Decisions Requesting Substance Identity Information on a Nano Structured Substance
In cases A-008-2015, A-009-2015, A-010-2015, and A-011-2015, the European Chemicals Agency (ECHA) Board of Appeal examined appeals against compliance check decisions made by ECHA requesting further substance identity information from four registrants of a “nano structured” substance. As reported in our July 29, 2015, blog item, ECHA adopted the contested decisions on December 17, 2014, following a compliance check under the dossier evaluation procedure of the...
October 25, 2016
“Under-appreciated Regulatory Barriers to Commercialization of Algae and Algal Products”
On October 25, 2016, Richard E. Engler, Ph.D., Senior Chemist with Bergeson & Campbell, P.C. (B&C®), presented “Under-appreciated Regulatory Barriers to Commercialization of Algae and Algal Products” at the Algae Biomass Summit in Phoenix, Arizona. Dr. Engler’s presentation was part of the Legal, IP and Regulatory Issues -- Challenges and Opportunities track of the summit, and explored how algae processing and use is regulated by the Federal Food, Drug, and Cosmetic...
October 24, 2016
Lynn L. Bergeson, “EPA Speeds Review of Chemicals,” Chemical Processing, October 24, 2016.
The U.S. Environmental Protection Agency (EPA) is continuing its brisk pace to be on target with implementing the new requirements of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (see “Grasp the Gravity of the New TSCA,” and “EPA Releases Q&As on New TSCA”). Congress has in its sights persistent, bioaccumulative, and toxic (PBT) chemicals — with the goal to reduce exposures to them. The EPA’s recent action...
Role of “Conditions of Use” Under Sections 5 and 6 of Amended Toxics Law The concept of “conditions of use” plays an important role in the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Conditions of use is a centralizing concept under which the U.S. Environmental Protection Agency (EPA) determines how a chemical is made, processed, used, and disposed. The term is defined in Section 3...
October 23, 2016
ISO Standard Provides Overview of Frameworks for Developing OELs and OEBs for NOAAs
On November 21, 2016, the International Organization for Standardization (ISO) released ISO/TR 18637:2016, “Nanotechnologies — Overview of available frameworks for the development of occupational exposure limits and bands for nano-objects and their aggregates and agglomerates (NOAAs).” ISO notes that occupational exposure limits (OEL) are generally substance-specific. In some case, there is insufficient data to develop an OEL, especially for substances such as nano-objects and...
The Algae Biomass Summit was the largest algae conference in the world. This is where leading producers of algae products went to network with industry suppliers and technology providers, where project developers conversed with utility executives, and where researchers and technology developers rubbed elbows with venture capitalists. B&C was a proud sponsor. B&C Senior Chemist Richard E. Engler chaired "Legal, IP, and Regulatory Challenges and Opportunities"...
October 22, 2016
Presentations Available from 2016 Nanosafe Conference
The fifth Nanosafe conference was held November 7-10, 2016, in Grenoble, France. The conference included panel discussions on responsible development with non-governmental organizations; urban particles mitigation: what is reasonably possible; and nanomedicine: benefit-risk. Topics addressed during the conference included: Measurement and characterization of nano objects; Exposure; Manufactured nano objects: Release from nano-enabled products; Safer by design...
On October 21, 2016, the U.S. Environmental Protection Agency (EPA) reopened the comment period on a proposed rule revising regulations governing significant new uses (SNU) of chemical substances under the Toxic Substances Control Act (TSCA), per a request from a commenter. EPA states in its Federal Register notice that this request was “reasonable and is therefore reopening the comment period … [for] all interested persons.” The proposed rule would amend the TSCA SNU...