PRODUCT SAFETY

REACH Program Compliance

"REACH" (Registration, Evaluation, and Authorization of Chemicals) is a European Commission (EC) comprehensive program for increasing its regulation of chemicals. The REACH legislation is based on the “Precautionary Principal” which shifts the burden from Government to Industry for proving, prior to marketing, that the chemical can be used safely. The new system will require manufacturers and importers of chemicals into the European Union (EU) to submit hazard, use, and risk data for many substances. Formulations sold in the EU also will be subject to these new regulations. Although REACH is a European program, it impacts manufacturers worldwide.

One of the key aspects of the REACH program is the requirement to submit data concerning the physical/chemical properties, toxicity and environmental effects of the chemicals under consideration. Registration will be mandatory before a new chemical can be marketed and to keep an existing chemical on the market. The extent of the information required for each chemical by REACH will depend on the volume of the chemical produced or imported. Chemicals classified as carcinogens, mutagens, reproductive toxins (CMRs), persistent, bio-accumulative, toxic (PBTs), very persistent, and very bioaccumulative (vPvBs) under REACH will be banned entirely if the manufacturer cannot demonstrate that risks associated with the chemical can be controlled.

The REACH program will require the sharing of information and joint applications by multiple manufacturers. Sharing of animal data will be mandatory. Downstream users of the chemicals will be required to do their own Chemical Safety Assessment (CSA) or secure data from suppliers. A Registration Dossier for a given chemical will include physicochemical characteristics, toxicity data, and ecotoxicity data. The data submission also may include existing data; therefore, the gathering of data for each of these dossiers will involve a significant amount of research into the literature and into company files to determine the adequacy of the available data before any new studies are undertaken. Once complied, the available data will be used to develop Chemical Safety Assessments which may include human health hazard assessments involving exposure scenarios.

Considering the impending activation of the REACH pre-registration program in the Years 2007 and 2008, efforts should get underway soon to identify other manufacturers of specific chemicals and coordinate data-sharing with them in order to insure the most complete and economical structuring of the required dossier. It may be appropriate to employ the services of a consultant to coordinate these efforts, aid in the pre-registration process, and eventually to help structure the appropriate dossiers to meet the guidelines of the REACH program.

Dr. Richard A. Parent, is board certified by the American Board of Toxicology, the Academy of Toxicological Sciences, and The Regulatory Affairs Certification Board. He is a European Registered Toxicologist, a long-time member of EUROTOX, and the Société Française de Toxicologie. His experience includes over 30 years in the field of toxicology, 20 years of which are in consulting, qualifying him to help your company meet the requirements of the REACH program. He can coordinate your efforts with other companies to consolidate and present your combined data in a Chemical Safety Report that is acceptable dossier for a REACH submission. He has access to the many databases and literature sources that will be needed to accomplish the requirements of this program. Dr. Parent can help you develop a regulatory strategy; negotiate with competitors for data sharing in Consortia or the Substance Information Exchange Fora (SIEF); help you to manage your REACH program; and participate in Task and Trade groups in formulating strategies. He can prepare the appropriate dossiers, Chemical Safety Assessments (CSAs), and Chemical Safety Reports (CSRs), including exposure and hazard assessments. The following are some of the REACH program services that Dr. Parent can provide.

• Compile an inventory of substances that you manufacture, import or use in the pure form or in a formulation and identify the scientific information required by REACH and note any gaps in the data
• Act as your agent in the pre-registration phase of the program while maintaining your confidentiality
• Help you to conform to GHS (Global Harmonized System of Classification and Labeling of Chemicals) as part of your pre-registration process
• Form and participate in Consortia or participate in SIEFs (Substance Information Exchange Programs) as your representative in accordance with data sharing efforts to reduce use of animal testing
• Aid in negotiation of the purchase or selling of data, toxicological and other data, to/from competitors based on today’s market value of the experimental data
• Make certain that your chemicals used to manufacture downstream consumer products meet the registration requirements, thereby insuring a continuity in your downstream customers sales and distribution
• Determine if specific substances meet the registration requirements of REACH as economically and efficiently as possible
• If appropriate, plan and execute a REACH registration plan for substances that you manufacture that may be exposed to regulatory restrictions on sales and distribution in Europe
• With the cooperation of your own representatives, manage the REACH regulatory process, including evaluation of existing internal and published data; test program design and study placement, including toxicology studies if appropriate; and provide liaison with regulatory bodies and continuing involvement through the evaluation and authorization process
• Preparation of required documents including technical dossiers, Chemical Safety Assessments (CSA), Chemical Safety Reports (CSR) including hazard evaluations, and rigorous human health and environmental risk modeling and assessments

Dr. Parent is available either on an hourly or a retainer basis to assist you with your REACH compliance task. There is no cost for an initial consultation, and his credentials are available upon request. He can be reached at rparent@consultox.com or at