By now, most of us have heard that REACH involves the registration of substances used within Lubrizol’s products. Lubrizol has been actively involved in pursuing registrations of substances for both the 2010 and 2013 registration deadlines – i.e., the “R” in REACH. The remainder of REACH is starting to have an impact on the chemical industry, and this article will briefly explain the rest of REACH.
The “E” in REACH stands for Evaluation. Evaluation can take two separate forms: the evaluation of the substance dossiers submitted and the evaluation of the properties of the substances themselves. Dossier evaluation is performed by the European Chemicals Agency (ECHA) to ensure that the dossier meets all of the regulatory requirements. ECHA also evaluates testing proposals for any additional toxicology testing proposed to be performed to ensure that the tests are necessary and the proposed methodologies are appropriate.
Substance evaluation, on the other hand, is performed by the various Member States Competent Authorities (MSCAs) in the EU. A rolling action list of substances, called the CoRAP list, is developed by the MSCAs and serves to identify substances that will be investigated by the MSCAs in the upcoming three years. Substance evaluation is intended to investigate any concerns about the potential human health and environmental hazards of substances. If the MSCA determines that the hazards of a substance are not adequately controlled, there are several options that the MSCAs can pursue. One option is to identify the substance as a Substance of Very High Concern (SVHC) and propose that the substance be subject to Authorization.
The “A” in REACH stands for Authorization. If a substance is determined to pose unreasonable risk to human health and the environment during the evaluation phase, an authorization must be obtained prior to continuing to place the substance on the market or to use the substance in the EU. Authorizations are obtained by submission of an authorization dossier containing data demonstrating that the use of the substance is adequately controlled and that there are no suitable alternatives. If it cannot be demonstrated that the use of the substance can be adequately controlled, and there are no suitable alternatives, then industry can perform a socio-economic benefit analysis to demonstrate that the benefits of continued use outweigh the risks associated with continued use of the substance. As an example, the airline industry is currently employing this strategy in an attempt to ensure that certain substances can still be utilized in airplane manufacturing. An authorization is issued for a set period of time, currently expected to be seven years, to encourage industry to innovate and find suitable alternatives.
In addition to the processes described above, if an MSCA believes that risks of a substance are unacceptable, a substance can be further nominated for restriction. Restrictions are limitations on how a substance can be used across Europe as well as additional risk management measures. Similar to the authorization process, a restriction is implemented through the creation of a restriction dossier, but is authored by a MSCA rather than an industry representative. Once adopted, restrictions are enforceable throughout Europe.