REACH
REACH Regulation (Regulation of the European Parliament and of the Council (EC) No. 1907/2006), in force since June 1, 2007, is currently the most important tool of the European Union regulating the rules of production, import and use of chemicals. The main aim of the Regulation is to ensure a high level of protection of human health and the environment and the free movement of substances on their own, as ingredients in mixtures or in articles.
The REACH regulation applies not only to the chemical industry, but also to many other industries that use chemicals (food, pharmaceutical, metallurgical, automotive and other industries).
The most important element resulting from the content of the Regulation is the obligation of substance registration. The following substances are subject to this procedure:
» substances manufactured or imported on their own or in a mixture, in the amount of at least 1 tonne per year
» on-site isolated intermediates manufactured in quantities of at least 1 tonne per year
» substances contained in articles if:
» the amount of the substance exceeds 1 tonne per year;
» the substance is present in the article in a concentration greater than 0.1% by weight;
» the substance is intended to be released during use of the article.
Joint Submission Registration Procedure
Registration as a member of a Joint Submission is the most common case of registration that occurs when the substance is already registered by the Lead Registrant. In this case, registration is based on the following actions:
» performing spectral tests of substances that will confirm the identity of the substance,
» acquisition of the so-called Letter of Access from the Lead Registrant,
» confirmation of participation in the Joint Submission,
» preparation of a registration dossier in IUCLID,
» submitting the dossier to ECHA
» The Agency issues a registration number
As a result of the evaluation of a registered substance, it is possible for the European Chemicals Agency (ECHA) to apply restrictions to substances of particular concern.
Additional requirements for chemical substances are restrictions (Annex XVII) and the authorization procedure for substances listed in Annex XIV of the REACH Regulation.