REACH stands for: Registration, Evaluation, Authorisation and Restriction of Chemicals.
REACH is the European Chemicals Regulation for the Registration, Evaluation, Authorisation and Restriction of Chemicals. It has been in force since 2007 and is intended to ensure a high level of protection for human health and the environment. At the same time, it aims to ensure the free movement of chemicals in the internal market and to promote competitiveness and innovation. REACH is based on the principle that manufacturers, importers and downstream users take responsibility for their chemicals: They must ensure that chemicals they manufacture and place on the market are used safely. REACH is considered to be one of the strictest chemicals laws in the world.
REACH builds on the experience of the previous chemicals legislation. Under the old law, authorities had to test the safety of chemicals. For most chemicals, namely all those on the European market before 1981, no systematically collected information was available. Manufacturers were only required to submit missing information when a substance evaluation by the authorities revealed information gaps or indications of a risk to the environment or health. The procedure turned out to be slow and cumbersome. REACH is intended to remedy this situation. The manufacturers and importers of chemicals must now submit data with the obligatory registration and assess the risks posed by the substances themselves. Chemicals cannot be placed on the market without registration.
The core responsibility of manufacturers and importers of chemicals is to evaluate and register chemicals with ECHA (European Chemicals Agency). Registration of chemicals is done in three phases. The first phase ended November 2010, the second will run until November 2013 and the third will be completed by mid-2018.
The task of the authorities is to evaluate the registrations of the companies. 5% of all registration dossiers are assessed for quality. In addition, the authorities evaluate selected chemicals for properties of very high concern and risks to humans or the environment. During substance evaluation, the authorities review the registrations and the chemical safety assessments of the responsible companies. They decide whether further investigations are necessary, whether the risk management measures described by the companies are adequate or whether further regulatory measures are required to protect the environment or health.
With certain exceptions (e.g. pesticides), chemical substances are not subject to authorisation in the EU. REACH requires authorisation for substances of very high concern - so-called SVHC. The authorisation requirement is primarily a general ban on use. Upon application, ECHA can grant an authorisation. To do so, the applicant must demonstrate that the risks of the chemical are controlled or that the socio-economic benefits of the use outweigh the risk. There is also the possibility of banning or restricting the manufacture, marketing or uses of chemicals. Such regulation is called "restriction".
Authorisation means permission, regulated on a case-by-case basis, to proceed in a particular way with a substance or thing. It is therefore an approval procedure.
The purpose of authorisation is to ensure that the risks posed by substances of very high concern are adequately controlled or that these substances are progressively replaced by suitable alternative substances or technologies, provided that these are economically and technically viable. (Art.55). The EU Commission decides on an authorisation. ECHA provides a guideline for the preparation of an application for authorisation.
In addition to the authorisation procedure, the tried and tested instrument of restricting the manufacture and use of substances still exists. These are special uses which are associated with a high risk and which are or will no longer be authorised.
Relationship between authorisation and restriction
In both procedures, a socio-economic analysis will in future be included in the decision-making process. This analysis should help to make balanced decisions on the authorisation or prohibition of substances of concern, assessing equally the risks of a substance and the economic and social consequences of any regulation sought.