The key elements of the REACH-Regulation (Regulation (EC) 1907/2006) are the registration, evaluation, authorisation and restriction of chemical substances. The Regulation is directly applicable in the Member States of the European Union since it entered into force on 1 June 2007.
REACH has the aim “to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation” (Article 1(1)).
The REACH Regulation is based on the principle that the manufacturers, importers and downstream users need to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment. Its provisions are underpinned by the precautionary principle.
Thereby, the principle of “no data, no market” applies, i.e. manufacturing and placing on the market is only possible if the data needed for the registration of a substance have been generated. Substances of Very High Concern should be progressively replaced by suitable alternative substances or technologies where these are economically and technically viable.
The implementation of the technical, scientific and administrative aspects of REACH is undertaken by the European Chemicals Agency (ECHA) in Helsinki.
Processes under REACH
- Registration of all substances above one tonne per annum by the manufacturer or importer;
- Evaluation of selected registration dossiers and substances by ECHA and Member States;
- Identification and authorisation of Substances of Very High Concern;
- Restriction of the manufacture, use or placing on the market of certain hazardous substances, mixtures or articles.
Areas of application
The provisions of REACH apply to the manufacture, the placing on the market and the use of chemical substances on their own (e.g. methanol or sodium hydroxide), in mixtures (e.g. paints) or in articles (e.g. chairs, tires, etc.)
The regulation does not apply to:
- Radioactive substances;
- Substances, which are subject to customs supervision;
- Non-isolated intermediates;
- The carriage of dangerous substances and mixtures by rail, road, inland waterway, sea or air;
- Certain substances, where necessary in the interests of defence.
Further substances are partially exempt, i.e. for these substances only certain aspects of the REACH Regulation apply, e.g. medicinal products for human or veterinary use, food or feeding stuffs, cosmetic products, medical devices, plant protection products, biocidal products, etc.