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Chemical Regulation in Eurasia

Overview:
 
In 2017, the Eurasian Economic Union (EAEU) issued, in final, a regional chemical framework, Technical Regulation (TR) EAEU 041/2017.  Member countries of the EAEU include the Republic of Armenia, the Republic of Belarus, the Republic of Kazakhstan, the Republic of Kyrgyzstan, and the Russian Federation.
 
The implementation date for the chemicals framework is June 1, 2021, and the framework includes the registration of mixtures as well as substances.  To begin, each Member State will develop an inventory of the chemicals in commerce in its country by January 1, 2021.  These inventories are to be consolidated into a regional inventory by June 1, 2021.  The regulation provides for late nominations to the inventory until June 1, 2023, for substances or mixtures on the market prior to June 1, 2021.
 
The framework is a hybrid of the U.S. Toxic Substances Control Act (TSCA) with the formation of an initial inventory, and of the European Union’s (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation with the registration of new substances.  Submissions can be made in any language, but they must be accompanied by a Russian translation.  Additional details are to be established in the sub-regulations.
 
The Russian Federation prepared, in final, a chemicals framework with similar implementation dates, but the regulation is expected to be rescinded when the EAEU sub-regulations are implemented.  Until then, the Russian regulation has entered into force, and the process for submitting substance information to the inventory of the Russian Federation is open through August 1, 2020.
 
Entities exporting products to the Russian market should nominate their substances and mixtures to the Russian chemical inventory to ensure continued access to the Russian market.  New substance registration is required for substances or mixtures not on the inventory after the nomination process closes.  Chemicals submitted to the Russian and other Member State inventories will form the basis for the inventory of chemical substances and mixtures of the EAEU.
 
A company without a legal entity in the EAEU can appoint an Authorized Representative (AR) to submit information on its behalf and cover importation by its customers in the region.  The appointment of an AR and timely submission allow a non-EAEU company to maintain an uninterrupted supply chain into the region and support its EAEU customers.
 
The Acta Group (Acta®), with offices in Manchester, UK, Brussels, Belgium, Beijing, China, and Washington, D.C., is well suited to provide guidance to companies with business interests in the EAEU.  Our global teams of scientists, regulatory consultants, and policy experts, augmented by our network of strategic partners that includes experienced boots on the ground in Russia, delivers the expertise to register and maintain chemical products on the global market.
 
Our Experience:
 
Acta professionals are scientists and business and regulatory consultants.  This combination makes Acta an exceptional resource for companies in the chemical space.  Acta’s science and regulatory professionals support clients with global chemical notification and registration needs and have a deep understanding of the legislation and its implications.
 
Heather Blankinship, Senior Regulatory Consultant, with experience managing and directing global teams engaged in regulatory compliance; she has developed an extraordinary talent for understanding and devising effective solutions for multijurisdictional and novel or emerging chemical regulatory challenges.  Her project management experience is invaluable for ensuring thorough and timely execution of regulatory requirements for clients.
 
Jane Vergnes, Ph.D., DABT®, has extensive global experience in chemical regulation and risk and exposure assessment, having led global product stewardship efforts for several Fortune 500-listed companies.  She has managed toxicology, hazard communication, and regulatory affairs programs for a wide array of industrial and specialty chemical products, including personal care ingredients, household and industrial ingredients, biocides, performance chemicals, acetylenics, food and beverages, tablet coating systems, encapsulation technologies, and elastomers.
 
Karin Baron, MSPH, Senior Regulatory Consultant, has more than 15 years' experience developing, implementing, and managing complex chemical regulatory compliance matters for some of the largest industrial and specialty chemical companies in the world.  Her comprehensive grasp of worldwide chemical control regulations is a powerful asset for clients bringing products to market in multiple jurisdictions.
 
Richard Engler, Ph.D., Director of Chemistry, has extensive experience addressing issues at the intersection of chemistry and regulations.  He is especially adept in addressing issues related to chemical identity and assists clients in ensuring compliance across global regulatory schemes.
 
What We Do:
 
Acta’s extensive involvement in EU REACH and other REACH-like global programs as well as U.S. TSCA positions it to address routine and uniquely challenging client issues that arise under the EAEU regulatory scheme.  Acta’s engagement in matters relating to the EAEU regulatory framework and its strong business relationships are significant assets for Acta clients.  Areas in which we advise clients include the following:

  • General Compliance Reviews -- Review in detail client product portfolios to identify regulatory obligations, opportunities, and implications
  • Specific Compliance Assistance, such as --
    • Design, implement, and complete cost-effective testing programs and proposals
    • Support clients in addressing all issues pertaining to EAEU inventory nominations and new chemical registrations
    • Support comprehensively the development of study summaries and other regulatory documents
    • Assist with classification and labeling
  • Training --
    • Provide tailored educational training seminars or workshops
  • Communication --
    • Provide regular updates on the latest EAEU developments, including new guidance and tools
  • Representative Services --
    • Assist with AR appointment and provide broad-based hands-on support in collaboration with Acta’s Russian AR and business partner to support clients’ regulatory compliance and business success

Representative Engagements:

  • Global strategies for chemical registration.
  • Supporting and tracking global chemical restriction issues.
  • Assist global clients with ARs.

 
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