Registration, Evaluation, Authorisation and Restriction of Chemicals

  • stands for an EC Regulation on the Registration, Evaluation, and Authorization of Chemicals,
  • requires the producer or importer to determine the dangerous properties (e.g., toxic, carcinogenic, environmentally hazardous) of substances (chemicals and natural materials) and to assess their effects relating to health and the environment,
  • also covers the use of the substance as a component of products,
  • prohibits or limits certain hazardous materials,
  • introduces an approval procedure for particularly dangerous substances,
  • requires the producer or importer to provide information both about the dangerous properties as well as the safe uses of the substances,
  • requires commercial users to perform their own safety analysis if the user deviates from the recommendations of the producer or importer,
  • establishes, in this way, a tight safety net down to the level of the products,
  • will expand its effect over a longer period. Approximately 30,000 substances must be registered over an 11-year period. First in line are those substances which are produced in large quantities or are already known to be particularly dangerous.

Responsible Authorities

The European Chemicals Agency

The European Chemicals Agency (ECHA) is the central hub of REACH. It consists of several committees and a secretariat, which supports the committees on an administrative level as well as in scientific and technical terms. It receives the registration documents from the producers and importers and reviews the filed documents.

The European Chemicals Agency

  • develops, together with the authorities from the Member States, opinions on the risks posed by the substances as well as on the socioeconomic consequences of the planned risk mitigation measures (prohibitions, restrictions, authorizations),
  • forms a network with the authorities from the Member States for the implementation and monitoring of the chemical safety provisions,
  • maintains a central substance database and develops guidelines to support businesses,
  • decides, upon the agreement of all Member States, on the toxicological and ecotoxicological examinations that are to be carried out to clarify the possible hazardous properties of the substances,
  • but otherwise has very limited decision-making power.
    More information:
    ec.europa.eu/echa: The European Chemicals Agency website

The European Commission

  • decides on prohibitions or restrictions of certain hazardous materials and issues authorizations for certain uses of particularly dangerous substances.
  • reviews the comments of the European Chemicals Agency and develops, on this basis, proposals for measures,
  • requires producers and importers to perform certain toxicological and ecotoxicological examinations,
  • decides, in cases which are disputed between the Member States, on the toxicological and ecotoxicological examinations which are carried out to clarify the possible hazardous properties of the substances,
  • requires the approval of a majority of Member States for all the measures stated above.
  • More information:
    ec.europa.eu: The European Commission website
  • Federal Chemicals Office (Bundesstelle für Chemikalien)
    The Federal Chemicals Office is located at the Federal Institute for Occupational Health and Safety (BAuA) and advises the producers, importers, and commercial users of chemical substances about their obligations according to the REACH Regulation (REACH Helpdesk).

Federal Chemicals Office

  • is the connection between the European Chemicals Agency and the national assessment bodies,
  • informs the population about the risks involved in handling dangerous substances, supports the German members of the European Chemicals Agency committees.
  • More information:
    www.baua.de: Federal Chemicals Office website
    Assessment Bodies
    The assessment bodies are located in the Federal Environmental Agency (UBA) (environmental risks), the Federal Institute for Risk Assessment (BfR) (general health risks and consumer protection), and the BAuA (occupational health and safety), and support the Federal Chemicals Office.

The Assessment Bodies

  • examine the risks posed by the substances and propose risk reduction measures, develop recommendations on the toxicological and ecotoxicological examinations that are required to clarify the possible hazardous properties of the substances.
  • More information:
    www.umweltbundesamt.de/chemikalien: Federal Environmental Agency website
    www.bfr.bund.de: Federal Institute for Risk Assessment website