The REACH Regulation requires the registration of all substances manufactured or placed on the EU market in quantities equal to or greater than 1 tonne per year, whether by manufacturers or importers, either on their own or in mixtures.

Producers and importers of articles must also register the substances contained in them, provided they meet the conditions of Article 7.

REACH also establishes an authorisation system to ensure that substances of very high concern are properly controlled. In addition, it provides for the most effective mechanisms for information exchange throughout the supply chain.

El reglamento REACH afecta a todas las sustancias químicas, a excepción de las que están explícitamente excluidas, que son:
applies to all chemical substances, except those explicitly excluded, which are:

Radioactive substances.

Substances under customs supervision, provided they are not subject to any treatment or processing and are in a temporary storage, free zone, or free warehouse with the intention of being re-exported or in transit.

Non-isolated intermediates.
The transport of hazardous substances and of hazardous substances in hazardous mixtures by rail, road, inland waterway, sea, or air.

Waste is not considered a substance, mixture, or article within the meaning of Article 3 of the REACH Regulation.

There are certain uses that are exempt from some of the obligations of the REACH Regulation:

Substances used in human or veterinary medicines, as well as in food or feed (including food additives and flavourings), are exempt from the following Titles of the Regulation (provided they are regulated under their sectoral legislation):

-Title II: Registration

-Title V: Downstream users

-Title VI: Evaluation

-Title VII: Authorisation

The following mixtures, in their finished product stage and intended for the end user, are exempt from Title IV (Information in the supply chain): medicines for human or veterinary use, cosmetic products, medical devices that are invasive or applied in direct contact with the human body, and food or feed (such as additives or flavourings) (Art. 2.6).

Biocides and plant protection products regulated under specific legislation are considered registered (Art. 15).

Substances listed in Annexes IV and V of the Regulation are exempt from Titles II, V, and VI (Art. 2.7).

Isolated intermediates, “on-site” and/or “transported”, have less strict registration requirements and must only provide specific information on their risks (see Articles 17 and 18). For more information, consult the guidance document on intermediates.

Polymers are exempt from registration and evaluation (Art. 2.9), but not their constituent monomers. For more information, consult the guidance document on monomers and polymers.

Substances used for product and process-oriented research and development are exempt from general mandatory registration (Art. 9).