Annex XVII of the REACH Regulation defines restrictions applicable to the manufacture, placing on the market, and use of certain chemical substances, with the aim of protecting human health and the environment from the risks associated with their use.

Restrictions may concern both substances themselves and, in certain cases, substances present in articles, and may include:

• total or partial bans on manufacturing and placing on the market;
• restrictions on use for certain sectors, products, or applications;
• maximum concentration limits for the substance;
• labeling requirements;
• specific technical requirements or conditions of use.

The list of restricted substances, contained in Annex XVII, is updated over time based on new scientific evidence and assessments conducted under the REACH system.

Restriction Process

The procedure can be initiated by a Member State or by ECHA, at the request of the European Commission, when a substance is deemed to pose an unacceptable risk to human health or the environment that must be addressed at the European Union level.

ECHA can also propose restrictions for substances present in articles, including substances already listed in Annex XIV of REACH (List of Substances Subject to Authorization).

1. Register of Intentions

Before the restriction dossier is prepared, the intention to submit a proposal is made public in the Registry of Intentions.

This step ensures transparency and allows interested parties to be informed in advance of the initiation of the procedure.

2. Preparation and Submission of the Dossier

The restriction proposal is documented in a dossier prepared according to the requirements of Annex XV of the REACH Regulation.

The dossier may include, among other elements:

• the identity and properties of the substance;
• A description of the identified risks;
• The rationale for the proposed restriction;
• Information on uses and exposures;
• Possible alternatives;
• An assessment of the economic, environmental, and health impacts;
• The costs and benefits associated with the proposed measure.

The dossier must be submitted to ECHA within 12 months of notification of the intention.

3. ECHA’s evaluation and public consultation

Once the dossier is received, ECHA verifies whether the proposal meets the requirements of Annex XV.

If the proposal complies, the dossier is made public and a consultation is opened, during which companies, associations, authorities, non-governmental organizations, and other interested parties can submit information and comments.

4. European Commission Decision

• Within 3 months of receiving the committees’ opinions, the Commission prepares a proposal to amend Annex XVII;
• the proposal is submitted to the procedure established by the REACH Regulation;
• Once adopted, the new restriction becomes part of Annex XVII and is directly applicable according to the conditions and dates set out in the relevant provision.

Once a restriction enters into force, the economic operators concerned must comply with the obligations set out in Annex XVII.