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Registration, Evaluation, Authorisation 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.
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
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 United Kingdom (UK)- and EU-based professionals include Emma Louise Jackson, Manager, UK REACH, 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); Max L. Moseley, MSc, Regulatory Specialist, who, in addition to providing the full spectrum of support services for co-registrants and lead registrants, offers clients particular expertise in green chemistry, sustainability, life cycle analysis, Greenhouse Gas Protocol Carbon Accounting standards, the objectives of the EU Chemicals Strategy for Sustainability (CSS), and corporate circularity and sustainability goals; and Carolyn Wray, Regulatory Assistant, who assists with the preparation of legal agreements and provides efficient and timely support to clients and downstream users. Leading Acta’s science team is Christine M. Palermo, Ph.D., DABT, Director of Regulatory Sciences. Dr. Palermo, a recognized leader with over 15 years’ experience guiding global regulatory strategy for a Fortune 50 petrochemical company, provides clients with science-based solutions for complex regulatory challenges. She has particular expertise in toxicological testing within the regulatory framework of REACH, including for difficult-to-test substances and existing and emerging data requirements for new and existing chemistries. Dr. Palermo helps clients anticipate and manage regulatory compliance under evolving regulations, address REACH data-sharing obligations, and translate complex science into actional strategies that support defensible business decisions and sustained market access.
Acta’s scientific and regulatory team includes Jane S. Vergnes, Ph.D., Senior Toxicology and Regulatory Advisor and an esteemed toxicologist with an impressive track record of success directing global product stewardship for Fortune 500-listed chemical companies before joining Acta. Dr. Vergnes 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. 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. Lara A. Hall, M.S., a Registered Quality Assurance Professional in Good Laboratory Practice (RQAP-GLP), 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. Lindsay A. Holden, Ph.D., DABT, a board-certified toxicologist with an applied public health, research and development, and regulatory toxicology background, supports clients in the strategy and implementation of collecting, interpreting, and applying toxicological hazard data within the regulatory framework of REACH. 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.
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.