REACH Authorisation and Restriction

The final deadline for the registration of phase-in (existing chemical) substances under the EU’s REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) scheme has now passed, and currently, the European Chemicals Agency (ECHA) is focused on assessing which substances pose an unacceptable risk to human health or the environment and what risk management measures need to be applied. ECHA refers to this process as “mapping the chemical universe”. Risk management measures may be imposed on substances or groups of substances and can have a significant impact on manufacturers, importers, and downstream users, and they apply regardless of tonnage. They include:

  • REACH Authorisations

  • REACH Restrictions

REACH Authorisations

After a Substance of Very High Concern (SVHC) has been included in the REACH Authorisation List (REACH Annex XIV), using the substance or selling it in the EU will be prohibited from a specific date onwards (referred to as the “sunset” date) unless an authorisation is granted. Manufacturers, importers, and downstream users or an only representative can submit an Application for Authorisation (AfA) and, if successful, will be able to continue using the substance for a specified time.

AfAs are both complex and extensive and require careful preparation involving scientific risk assessment and socio-economic expertise. After an AfA is submitted, ECHA’s Scientific Committees review it, and there are stringent controls on what further information may be provided by the applicant and the timing of its provision. The European Commission makes the final decision on whether to grant an authorisation.

REACH Restrictions

REACH restrictions can impose specific use conditions or limit or ban the manufacture, import, sale, or use of a substance. A restriction may apply to any substance on its own, in a mixture, or in an article and can include certain polymers.

Proposals for restrictions can be made by EU Member States, the European Commission, or ECHA, and these lengthy proposals involve scientific risk assessment and socio-economic considerations. Proposals for restrictions are assessed by ECHA’s Scientific Committees, and there are stringent controls on what further information may be provided by affected parties and the timing of its provision. As with an AfA, the European Commission makes the final decision on a restriction.

How Exponent Can Help

Exponent provides a complete service to assist companies whose substances are under scrutiny to ensure regulatory compliance and to represent their interests. Our staff have strong scientific and regulatory expertise from prior experience in industry, contract research, and in many cases have worked as regulators—including with ECHA—prior to joining Exponent, making them ideally positioned to navigate REACH requirements.

We can provide a full AfA or restriction service or support your team. Examples of assistance we can provide include:

  • Full project management and documentation – Management of all aspects of the AfA or restriction, efficient communication with the client, regular updates on progress, and completion and submission of all documentation to ECHA and the European Commission.

  • Regulatory intelligence – Monitoring regulatory processes and providing alerts about key developments.

  • Pre‐submission meetings – Support the applicant for an AfA at pre‐submission meetings with ECHA, including initial documentation preparation and responding to identified actions.

  • Communication – With other companies to determine their willingness to collaborate, as well as communication with other interested parties such as NGOs and EU Authorities.

  • Chemical Safety Report (CSR) – Preparation of the CSR for an AfA, scientific review of relevant reports submitted for restrictions, highlighting strengths and potential vulnerabilities.

  • Analysis of Alternatives (AoA) – For AfAs, identification and analysis of possible alternatives and preparation of suitable report and review of AoA for submitted restrictions.

  • Substitution plan – Preparation of a substitution plan (when necessary) to replace the substance to be authorised.

  • Socio‐Economic Analysis (SEA) report – Production of a SEA report for AfAs and review of the SEA aspects in the relevant report submitted for restrictions.

  • Commenting periods – Identification and provision of comments acceptable to ECHA at the correct time.

  • Follow-up support - Assistance with follow up queries or requested actions from ECHA.

  • Safety Data Sheet (SDS) – Update of the SDS following the completion of the authorisation or restriction processes and providing downstream users with updated details.

With offices and experts in the UK, EU, US, and Asia, we offer a comprehensive range of technical and regulatory expertise to help companies meet their REACH obligations.



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