PRACTICES

Chemical Regulation under UK REACH

Overview:
 
On December 31 2020, the United Kingdom (UK) implemented UK REACH, a “lift and shift” of the European Union’s (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. This new legislation features transitional arrangements and REACH modifications to make it more appropriate for the Great Britain (GB) market. Companies that manufacture, import, use, or place on the market substances, mixtures, or articles are required to comply with the provisions set out in this legislation.
 
Companies aiming to put new products on the market must register relevant substances with the UK Health and Safety Executive (HSE) prior to manufacturing or importing more than one metric ton per year. Substances already on the market may benefit from transitional arrangements such as grandfathering or Downstream User Import Notification (DUIN) if they meet certain criteria. These transitional processes allow eligible companies to continue market access until the registration deadlines of October 27, 2023, 2025, or 2027, depending on the tonnage and intrinsic hazards of the substance.
 
Although these transitional arrangements reflect current UK law, the Department for Environment, Food and Rural Affairs (DEFRA) has stated publicly that it is exploring an alternative model for transitional UK REACH registrations and proposes extending the 2023 deadline to 2025.
 
Additionally, companies that handle substances on the UK REACH candidate list, authorization list, or restriction list must comply with the regulatory obligations set out in the respective legislative text.
 
The Acta Group (Acta®) is uniquely well-suited to navigate the rules and guidelines included in the UK REACH legal text and in the HSE or DEFRA guidance. Our professionals have been, are, and will remain extensively involved in all aspects of UK REACH and can assist clients in complying with the UK REACH framework today and in the future.
 
Our Experience:
 
Since REACH’s inception, Acta science, legal, and regulatory professionals have actively assessed the legislation and its implications and have prepared clients for its requirements. Our professionals in the UK include Emma Louise Jackson, CBiol MSB, Manager, REACH, who delivers skilled REACH assistance, including OR services, testing strategy advice, literature searching and reliability assessment, and compilation of regulatory documents, such as IUCLID 6 registration dossiers and Chemical Safety Reports (CSR), and Carolyn Wray, Regulatory Assistant, who assists with the preparation of legal agreements and provides support to clients and downstream users.
 
Leading Acta’s science team is Jane S. Vergnes, Ph.D., DABT®. Dr. Vergnes, an esteemed toxicologist with an impressive track record of success directing global product stewardship for Fortune 500-listed chemical companies before joining Acta, has particular expertise in toxicological testing within the regulatory framework of REACH, including study design, laboratory practices, and data requirements for new chemical introductions, having started her career as a research scientist and laboratory supervisor.
 
Acta’s scientific team includes Lara A. Hall, M.S., a Registered Quality Assurance Professional for Good Laboratory Practice (RQAP-GLP). Ms. Hall offers clients expertise in the monitoring, quality assurance, and interpretation of ecotoxicology, environmental fate, physical-chemical properties, product chemistry, and analytical method validation studies in support of submissions under REACH. Karin F. Baron, MSPH, Senior Regulatory Consultant at Acta, is instrumental in assisting our clients to obtain and maintain compliance under REACH. Ms. Baron supports comprehensively various clients, provides targeted training to Acta clients, and is an expert on classification and labeling. Karen L. Lorusso is a Regulatory Consultant with a focus on the classification and labeling of substances and mixtures. She has experience with submitting dossiers in the information technology (IT) system called Comply with UK REACH and preparing dossiers in IUCLID 6. Scott J. Burya, Ph.D., a Regulatory Chemist with a Ph.D. in analytical chemistry, managed compliance programs and coordinated teams focused on commercializing new products for a multinational chemical corporation. Well versed in REACH physicochemical properties testing guidelines and requirements, Dr. Burya monitors GLP studies and prepares technical documentation to support registrations.
 
What We Do:
 
Acta’s extensive involvement in REACH makes us especially suited to address client issues that arise under the regulatory scheme. Areas in which we advise clients include the following:

  • Representative Services –
    • Only Representative (OR) services
    • Third Party Representative (TPR) services
  • General Compliance Reviews and Consulting –
    • Review in detail client product portfolios to identify REACH obligations, opportunities, and risks
    • Advise clients on specific REACH issues covering a range of matters, including substance identity, testing, evaluation processes, authorization and restriction, and data compensation
  • Specific Compliance Assistance, such as –
    • Design, implement, and complete cost-effective testing programs and proposals
    • Prepare study summaries or robust study summaries
    • Assist with classification and labeling
    • Perform Chemical Safety Assessments (CSA) and prepare CSRs
    • Prepare and submit registration dossiers and applications for authorization
  • Training –
    • Provide tailored educational training seminars, webinars, and workshops
  • Communication –
    • Prepare supply chain communication letters and documents
    • Provide regular updates on the latest REACH developments, including new guidance and tools
  • Consortia Management –
    • Provide targeted technical and regulatory services to consortia

Representative Engagements:

  • Acta successfully grandfathered EU REACH registrations into UK REACH as Only Representative.
  • Acta completed DUINs.
  • Acta routinely provides bespoke REACH training for companies in a variety of industrial sectors.
  • Acta’s consultants have supported the first new authorization application for UK REACH.
  • Acta counsels companies on the ongoing evolution of the UK REACH regulation and its potential impacts on their compliance strategies.
 
THE ACTA GROUP, L.L.C.
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