Chemical Regulation under REACH
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. REACH is still relatively new -- effective as of June 2007 -- and its structure still in flux. Companies whose businesses are implicated by REACH need skilled consultants and scientists who are not only familiar with the current regulatory framework, but who are also equipped to guide clients as that framework changes.
The Acta Group (Acta®) is uniquely well-suited to navigate the 140 different articles, 17 distinct annexes, almost 300 pages of text, and hundreds of pages of guidance that currently comprise REACH. Our professionals have been extensively involved in REACH and can assist clients in complying with REACH today and assist in foreseeing the future developments of REACH.
Since REACH's inception, Acta science and regulatory professionals have actively assessed the legislation and its implications and have prepared clients for its requirements. Our professionals include EU-based regulatory specialist Emma Louise Jackson, CBiol MSB, who delivers skilled REACH assistance, including classification and labeling of substances and mixtures, testing strategy advice, literature searching and reliability assessment, and compilation of regulatory documents, such as IUCLID 5 and Chemical Safety Reports (CSR). She is an excellent resource for preparation of Safety Data Sheets (SDS) and product labels, as well as liaising with various regulatory authorities. Also in the EU, Louise Boardall provides experienced support to Acta's regulatory specialists in the technical areas of physical chemistry and analytical methods, efficacy, toxicology, and ecotoxicology. She is also proficient in dossier preparation, data assessment, statistics packages such as SPSS and STATA, and utilization of national authority websites and databases.
Leading Acta's science team is Jane 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. Brian Xu, M.D., Ph.D., DABT®, is a board-certified toxicologist with an M.D. in pathology and a Ph.D. in pharmacology and toxicology, who also works in this area. With over 15 years of industry experience as a senior toxicologist and scientist at major chemical companies, he assists clients in designing safety testing, risk assessment, product safety, and regulatory compliance programs under REACH.
Acta's scientific team includes Lara 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.
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:
- General Compliance Reviews –
- Review in detail client product portfolios to identify REACH obligations, opportunities, and ramifications
- 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 Chemical Safety Reports (CSR)
- Training –
- Provide tailored educational training seminars 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 –
- Identify potential consortium partners and forming consortia
- Provide targeted technical services to consortia
- Representative Services –
- Only Representative (OR) services
- Third Party Representative (TPR) services
- Acta routinely assists EU and non-EU clients in evaluating the pros and cons of all aspects of REACH.
- Acta routinely provides tailored client REACH training.
- Acta successfully worked with EU counsel to file the first and successful appeal of a decision in association with 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 personnel to assist with complex administrative process, classification, and trade issues.
- Acta successfully partnered with EU counsel to work cooperatively with the EC on behalf of an industry association that concluded in legal action being taken against the EC resulting in a successful final outcome.
- Acta personnel routinely provide representation in SIEF consortia and related chemical consortia.
- REACH dossier preparation and/or review is routinely performed by Acta personnel.
- Acta counsels on REACH substances of very high concern (SVHC) issues and developing effective business strategies around SVHC issues.