REACH out for better

As the industry raises the bar once again to protect human health and the environment against chemical substances, Ali S. Faqi discusses the implications of the REACH initiative for manufacturers of chemical substances.

What exactly is REACH?

Ali S. Faqi. Established by the European Chemicals Agency (ECHA), the Registration, Evaluation, Authorisation, and Restriction of Chemical Substances (REACH) regulations were put into effect in June 2007 in an effort to improve the level of protection of human health and the environment through better and earlier identification of the intrinsic properties of chemical substances.[1] In addition to requiring companies to provide more safety information, REACH specifies a progressive substitution process for more dangerous chemicals when suitable alternatives are known.

If the regulations were put into effect more than three years ago, why is a sense of urgency associated with the REACH regulations today?

AF. When the REACH regulations were established, provisions were made to phase them in over an 11-year period. The deadline for registration of high-volume chemicals (those typically known as hazardous substances) is 30 November 2010. To continue manufacturing and selling these products, manufacturers and importers must document their risk according to REACH guidelines.

How can I ensure that my company is meeting the REACH requirements?

AF. It is essential that producers of chemical substances work with contract research organizations that are knowledgeable about the REACH requirements. For example, companies may need assistance in determining the minimum number of vertebrate animals necessary to meet REACH specifications. Guidance may also be necessary in determining the number and types of tests that should be performed. MPI Research scientists work diligently to avoid overestimation, a problem acknowledged by the European Chemicals Agency, which results primarily from lack of knowledge and improper interpretation of the regulations[2]. Avoiding overestimation can result in significant cost savings for MPI Research Sponsors who are working toward REACH compliance.

Are there any special considerations for developmental or reproductive testing?

AF. Yes. When conducting research on chemical substances, it is important that companies consider the classification scheme used by REACH to label a substance with known developmental and/or reproductive toxicity.  The criterion used does not appear to be based on the exposure level producing these effects, barring excessive generalized toxicity.  Therefore, labeling these chemical substances without consideration of the effective dose level does not provide meaningful data about their actual risk. For additional details, see Anthony R. Scialli's 2008 article, The challenge of reproductive and developmental toxicology under REACH (Scialli, A.R., The challenge of reproductive and developmental toxicology under REACH, Regul. Toxicol. Pharmacol. [2008], doi:10,1016/j.yrtph.2008.04.008.)[3]

How can I get more information about the REACH regulations?

AF. Manufacturers of chemical substances can get most of their questions answered about these regulations by reviewing the ECHA publication, "REACH in Brief"[4].

How can I be assured that my REACH testing strategy is solid and cost-effective for my company?

AF. Work with a contract research organization that has an accomplished scientific team that is knowledgeable about REACH regulations. It is important that they have a comprehensive understanding of the implications of REACH for your chemical substances. To discuss how you can be sure of a solid and cost-effective strategy for complying with REACH, discuss the development of a customized testing strategy for your chemical substances with Dr. Faqi at 269-668-3336, ext 1618, or ali.faqi@mpiresearch.com.

NB: You can connect with Dr. Faqi's references on our website www.npharma.com

About

Ali S. Faqi, DVM, PhD, DABT is Director of Developmental and Reproductive Toxicology at MPI Research. He received his PhD from the University of Leipzig and serves on the Editorial Board of Reproductive Toxicology and on the Board of Scientific Counselors Computational Toxicology at the United States Environmental Protection Agency.

[1] http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm

[2] http://echa.europa.eu/doc/press/pr_09_11_animal _testing_20090828.pdf

[3] http://www.sciences.com/professionals/pubs/Scialli-REACH.pdf

[4] http://ec.europa.eu/environment/chemicals/reach/pdf/2007_02_reach_in_brief.pdf