REACH Regulation is based on the principle that the manufacturers, importers and downstream users have to prove that the chemicals they manufacture, import or place on the market do not pose any hazards for human health or the environment.
REACH procedures are based on the precautionary principle.
Therefore, REACH places the burden of proof on the companies. To comply with the Regulation, companies must identify and manage the risks linked to the substances they manufacture and place on the market in the EU. Additionally, they must communicate the risk management measures to the users, in a way that in the long term, the most hazardous substances will be replaced by others, less hazardous.
REACH procedures
- REACH establishes procedures for collecting and assessing information on the properties and hazards of chemical substances.
- Companies need to Register their substances and, in order to do this, they need to work together with other companies who are registering the same substance.
- The European Chemicals Agency (ECHA) receives and Evaluates individual registrations for their compliance. The EU Member States evaluate selected substances to clarify initial concerns for human health or for the environment. Authorities and ECHA's Scientific Committees assess whether the risks of the substances can be managed.
- Authorities can ban hazardous substances if their risks are unmanageable. They can also decide to Restrict a use or make it subject to a prior Authorisation.
Who is affected by the REACH Regulation
Manufacturer: Any natural or legal person established within the Community who manufactures a substance within the Community. If you make chemicals, either to use yourself or to supply to other people (even if it is for export), then you will probably have some important responsibilities under REACH.
Importer: Any natural or legal person established within the Community who is responsible for import. If you buy anything from outside the EU/EEA, you are likely to have some responsibilities under REACH. It may be individual chemicals, mixtures for onwards sale or finished products, like clothes, furniture or plastic goods.
Downstream user: Any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities. Most companies use chemicals, sometimes even without realising it, therefore you need to check your obligations if you handle any chemicals in your industrial or professional activity. You might have some responsibilities under REACH.
Producer of an article: Any natural or legal person who makes or assembles an article within the Community (and uses chemicals).
Who has Registration obligations?
The following actors are under registration obligations:
- EU manufacturer or importer of substances on their own or in a mixture.
- EU producer or importer of articles, meeting the criteria explained in the Guidance on requirements for substances in articles.
- "Only Representative" established in the EU and appointed by a manufacturer, formulator or article producer established outside the EU to fulfil the registration obligations of importers.
Questions and Answers about REACH
Guidance documents on REACH
REACH/CLP tips for users of chemicals