REACH Regulation

Any company manufacturing or importing a chemical substance in quantities exceeding 1 tonne per year must register that substance with the European Chemicals Agency (ECHA). Registration includes:

• identification of the substance,
• its properties and uses,
• assessment of risks and measures for their control.

The first step is submitting an inquiry, followed by the preparation of the so-called registration dossier. Both are prepared using the IUCLID software tool and submitted via the REACH-IT system. The documentation can be submitted individually or jointly with other companies. The principle of “one substance, one registration” applies, meaning that all entities must submit the registration jointly.

Registration applies to substances on their own, to substances in mixtures, and in certain cases also to substances in articles (e.g. in products). Exemptions from registration apply, for example, to medicinal products, food or radioactive substances.

Three-phase evaluation process:

• 1. Evaluation – collection and analysis of available data on the substance.
• 2. Decision-making – ECHA may request additional information if it is not sufficient.
• 3. Follow-up steps – based on the decision, the applicant may be requested to submit or obtain additional data.

If the evaluation reveals serious risks, the substance may be restricted or included among substances subject to authorisation. In this way, REACH aims to gradually limit the presence of the most hazardous substances on the European market.

Some substances may be completely banned or used only under specific conditions – typically due to risks to health or the environment.

Restrictions may apply not only to the substance itself, but also to substances contained in mixtures or in articles. All currently applicable restrictions are listed in Annex XVII of the REACH Regulation. The list of restrictions is continuously updated.

The restriction process includes:

• proposal – submitted by any Member State or the ECHA,
• documentation – includes identification of the substance, description of the proposed restriction and justification, and is prepared in accordance with Annex XV of the REACH Regulation,
• public consultation – comments from all interested parties,
• assessment by the RAC and SEAC committees,
• Commission decision and update of Annex XVII of REACH.

Once a restriction is approved, it becomes binding for all actors in the supply chain – from manufacturers, through importers and distributors, to downstream users and retailers.