Chemical Regulation under REACH

Overview:  

Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) is the European Union’s (EU) chemical management regulation. It is an ambitious chemical control initiative with significant duties placed on industry. Companies whose businesses are affected by REACH need skilled consultants and scientists who are not only familiar with the current regulatory framework, including the various laws that implement REACH, but who are also equipped, both in terms of skill set and experience, to guide clients successfully as the REACH framework continues to evolve.

The end of the “registration deadlines” in 2018 marked the start of a new era under REACH, and this new phase includes a strong emphasis on information quality and compliance. Companies globally have taken measures to address REACH compliance, and they must now remain connected to manage the new and evolving REACH requirements and concerns of regulators. Various activities are ongoing in the REACH arena under each of the regulation’s specific processes, and chemical companies with business interests across the EU can benefit substantially from expert, well-informed, and timely REACH support.

The Acta Group (Acta^®) is uniquely well suited to navigate thousands of pages of rules and guidelines included in the REACH legal text, implementing regulations, and the European Chemicals Agency’s (ECHA) guidance documents. Our professionals have been, are, and will remain extensively involved in all aspects of REACH and can assist clients in complying with the REACH framework today -- and also in foreseeing future developments under REACH.

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 include UK-based Manager, REACH, Emma Louise Jackson, CBiol MSB, who delivers skilled REACH assistance, including 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 in 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 as part of Acta’s Only Representative services, 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 REACH-IT 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
  • Support on submission of registration dossiers and applications for authorization
• Training –
  • Provide tailored educational training seminars, webinars, or 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 routinely assists EU and non-EU clients under various REACH processes, including registration, evaluation, and authorization.
• Acta manages all aspects related to its OR and TPR roles under REACH, including communications, data sharing, legal negotiations, and dossier updates.
• Acta routinely provides tailored client REACH training.
• Acta has worked successfully with EU counsel to file successful appeals of decisions under REACH.
• Acta successfully worked with an industry association in obtaining clarity on procedural aspects of an EU process while engaging appropriate European Commission (EC) and Member State (MS) personnel to assist with complex administrative process, classification, and trade issues.
• Acta personnel routinely provide representation and perform suitable advocacy in chemical substance co-registrations and consortia.
• REACH dossier preparation and/or review is routinely performed by Acta personnel as part of its OR and general support services.
• Acta counsels on REACH substances of very high concern (SVHC) issues and developing effective business strategies around SVHC issues.
• Acta assists clients globally in managing all matters pertaining to dossier and substance evaluation under REACH, including communicating effectively with ECHA and MSs and organizing testing.
• Acta assists companies to manage product portfolios and regulatory compliance in accordance with the REACH Annex XVII Restrictions List.