Regulation of hazardous substances in the EU

Regulatory background

When it comes to the handling and placing on the market of hazardous substances, many people ask how these substances are regulated in the EU. In addition to the CLP Regulation, which deals with the classification of hazardous substances, the REACH Regulation (EC) No 1907/2006 is considered one of the most important pieces of legislation. It primarily addresses the registration, evaluation, authorisation and restriction of substances. It is worth noting that these regulations are not only applicable in some member states but throughout the European Union, meaning that a uniform regulatory framework applies to chemical substances across the Community, thereby facilitating the free movement of substances, mixtures and articles.

One of the most important provisions of REACH is that substances manufactured or imported in quantities exceeding one ton per year (whether as substances on their own, in mixtures or in articles) must be registered with the Agency. In such cases, various physicochemical, toxicological and ecotoxicological properties of the substances must be provided, with the required level of information depending on the quantity of the substance manufactured or supplied. This raises the question of whether suppliers are exempt from these obligations in the case of imports. The answer is no. The Regulation does not distinguish between manufacture and import into the Community, meaning that the importer is responsible for registering substances manufactured outside the EU and imported into the EU.