What is the REACH Regulation?

The REACH regulation (Regulation (CE) No. 1907/2006) is the European regulation concerning the registration, evaluation, authorisation and restriction of chemicals.

How does REACH work?

REACH stipulates that chemical substances manufactured or marketed in the EU that exceed 1 tonne per year must be registered. This is relevant to both manufacturers and importers and applies to both chemical substances and mixtures. Manufacturers and importers of articles must also register the substances contained within them, provided that they comply with Article 7.

REACH also establishes an authorisation system in a bid to guarantee that substances of very high concern are appropriately controlled. Similarly, it also foresees the most effective mechanisms for exchanging information throughout the supply chain.

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What is REACH’s scope? What substances does it affect?

REACH affects all chemical substances, except those that are explicitly excluded. Radioactive substances.

  • Substances subject to customs supervision, provided that they are not subject to any treatment or processing and are in temporary storage or a duty-free zone or warehouse awaiting export or in transit. Non-isolated intermediates.

  • The transport of hazardous substances and hazardous substances in hazardous mixtures by rail, road or river, sea or air. Waste is not considered a substance, mixture or article in accordance with Article 3 of REACH Regulation.

  • Moreover, member States can expect exemptions in the interest of defence. There are certain uses that are exempt from REACH’s obligations: The substances used in human and veterinary medicines, as well as food and feedstuffs (including food additives and flavourings), are exempt from the following Regulation Titles (provided they are regulated by their sector legislation):

    • Title II: Registration of substances

    • Title V: Downstream users

    • Title VI: Evaluation

    • Title VII: Authorisation The following end product mixtures, aimed for end users, are exempt from Title IV (information in the supply chain): human and veterinary medicines, cosmetics, medical products that are invasive or are applied directly to the human body and foods and feedstuffs (such as additives and flavourings) (Art. 2.6).

  • Plant protection and biocidal products that are regulated by a specific regulation are registered (Art. 15). Substances covered by Annexes IV and V of the Regulation are exempt from Titles II, V and VI (Art. 2.7) “In situ” and/or “transported” non-isolated intermediates will have more lax registration regulations, as only information related to their risks is necessary (see articles 17 and 18). For more information, read the guidance document on intermediates.

  • Polymers are exempt from registration and evaluation (Article 2.9) but their constituent monomers are not. For more information, read the guidance document on monomers and polymers. Chemicals used for product and process-related research and development are exempt from mandatory registration (Article 9).

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A downstream user is any physical or legal person based in the EU – unlike a manufacturer or importer – who uses a chemicals or mixtures in their industrial or professional activities. Distributors and consumers are not downstream users.

The REACH Regulation established the European Chemicals Agency (ECHA) located in Helsinki.

The Agency is at the heart of the REACH system, as it manages the Regulation’s technical, scientific and administrative aspects, ensuring that it works well and acting as an interlocutor between all interested parties.

ECHA manages the registration process and evaluates dossiers (checking and evaluating testing proposals).

It also plays an essential role in supporting the Commission, Member States and other agents, coordinating actions to evaluate chemicals and setting and managing IT infrastructures.

The Agency has an important decision-making power, as well as a Board of Appeal, where decisions are made about appeals against its decisions.

ECHA creates and updates a classification and labelling inventory in the form of a database. It includes all the chemical substances that must be registered and chemical substances that meet criteria to be considered hazardous and are sold as they are or in mixtures in concentrations above the specified limits. The following information is included for each of these substances:

  • Identification of manufacturer or importer responsible for placing the substance on the market.

  • Chemical substance or mixture identification.

  • Chemical substance’s hazard classification.

  • Chemical substance’s hazard label.

  • Specific concentration limits, where relevant.

Substances considered of very high concern (SVHC) are those that include one of the criteria from Article 57 of the REACH Regulation. This type of substance will be included in Annex XIV (Authorisation List) and its use will remain subject to authorisation by ECHA..