Registration, Evaluation, Authorisation and Restriction of Chemicals

REACh Dates

Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is a European Union regulation adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemical industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals.

Overview

REACH establishes procedures for collecting and assessing information on the properties and hazards of substances. Companies are required to register the substances they manufacture or import at or above one tonne per year with the European Chemicals Agency (ECHA). The regulation applies to all chemical substances; not only those used in industrial processes but also in our day-to-day lives, for example in cleaning products, paints, as well as in articles such as clothing, furniture, and electrical appliances. Therefore, the regulation has a wide-ranging impact on most companies across the EU.

Registration

Registration is the first step in the REACH process. It requires manufacturers, importers, and only representatives of non-EU manufacturers to gather information on the properties of their chemical substances and to register the information in a central database managed by the ECHA. The registration dossier must include information on the substance's identity, classification, and labeling, its manufacturing process, and its uses. It also must contain assessments of the substance's potential risks to human health and the environment and suggested risk management measures.

Evaluation

Evaluation is the second step, which is divided into dossier evaluation and substance evaluation. Dossier evaluation checks the compliance of the registration dossiers, while substance evaluation assesses the risk that a substance may pose to human health or the environment. The ECHA or the member states may require registrants to provide further information if there are concerns about a substance.

Authorisation

Certain substances of very high concern (SVHC), such as those that are carcinogenic, mutagenic, toxic for reproduction, or persistent, bioaccumulative, and toxic (PBT), may be subject to authorisation. Companies wishing to use or market these substances must obtain an authorisation. The aim is to ensure that SVHCs are progressively replaced with less dangerous substances or technologies where economically and technically viable alternatives exist.

Restriction

Restriction is the most direct form of regulatory control in REACH. It can limit or ban the manufacture, placing on the market, or use of a substance. Restrictions can be proposed by a member state or by the ECHA on behalf of the European Commission if there is an unacceptable risk to human health or the environment that needs to be addressed on a Community-wide basis.

Impact

REACH has significantly impacted how chemicals are managed in the EU, promoting a better understanding of chemical risks and the implementation of safety measures. It has also encouraged innovation in the development of safer and more environmentally friendly chemicals.

Challenges

Despite its benefits, the implementation of REACH has faced challenges, including the high costs and administrative burdens for small and medium-sized enterprises (SMEs), the need for more data on chemicals, and the complexity of the regulation itself.