REACH is the Regulation on the registration, evaluation, authorization and restriction of chemical substances and preparations. In the European Economic Area, the manufacture or importation of a certain chemical substance must be registered in the REACH database. Unregistered substances cannot be marketed or used.
The REACH Regulation applies to:
o Manufacturers of substances and chemical products intended for sale or to other companies
o Importers of chemical substances and mixtures or products such as clothing, furniture or plastic items, coming from outside the EU
o Distributors that store and market chemical substances or mixtures
o Intermediate users who use chemical substances or mixtures within the framework of a business or professional activity.
REACH introduces new marketing standards that affect isolated substances, mixtures and substances used in the products.
It also allows the European Union to adopt additional measures when a complementary action is required at EU level. The European Chemicals Agency (ECHA), based in Helsinki (Finland), helps coordinate and implement all necessary measures:
o Prior registration is mandatory for companies that intend to manufacture or import a certain substance in amounts equal to or greater than one ton per year.
o In the evaluation, the European Chemicals Agency (ECHA) examines the information in the registration dossiers and all test proposals to avoid unnecessary tests, especially in animals. National authorities evaluate substances taking into account specific concerns in relation to human health and the environment.
o The authorization is mandatory for certain substances that raise particular concern. This ensures that the risks they pose are conveniently controlled and that they are replaced by safer alternatives when they are economically and technically viable.
o The restriction may limit or prohibit the production, marketing or use of certain substances that pose an unacceptable risk to health or the environment.
Hebron / Otsuka is a founding member of the ADCA Task Force (TF) created to defend the business interests of ADCA (azodicarbonamide) in the European Union.