• Regulation and Compliance

Authorisation of substances of very high concern under REACH

Authorisation under the REACH Regulation (Regulation (EC) No 1907/2006) is a mechanism designed to phase out substances of very high concern (SVHC) in Europe. When an SVHC is included in the Authorisation List (Annex XIV to the REACH Regulation), the substance cannot be used or placed on the market after the specific ‘sunset date’ mentioned in Annex XIV unless an authorisation has been granted for the envisaged use or unless and exemption applies. To obtain an authorisation, an application for authorisation needs to be submitted, in which it should be demonstrated that no suitable alternative is available yet and either the risks are adequately controlled or are outweighed by the socio-economic benefits of continued use (in case adequate control cannot be demonstrated).

Authorisation under REACH

The process preceding the inclusion of a substance in Annex XIV as well as the preparation of an application for authorisation when included in Annex XIV requires a proactive and multidisciplinary approach from industry 

 

Arcadis can support companies to:

Raise internal awareness and screen portfolios:

Screen companies’ full portfolios to check whether and where substances on the Candidate List for in inclusion in Annex XIV are used to identify the impact of potential phase-out on their business.

Assist in raising internal awareness throughout the company or helping to understand better the authorisation process and its consequences.

Get organised to define a strategy:

Assist companies with their internal organisation to tackle identified business risks.

Assist in discussions with suppliers / downstream users related to alternatives, uses and exposure scenarios, and their strategy related to authorisation.

Assist in discussions with trade associations and related advocacy work.

Assist in the formation and management of consortia to prepare (parts of) applications for authorisation jointly with sharing of cost between the participants.

Act as a Trustee to gather and manage confidential information.

Carefully prepare advocacy:

Provide support in the preparation of an in-house risk management option analysis to identify the most appropriate regulatory option to address (potential) SVHCs in your portfolio.

Assist in the preparation of responses to public consultations concerning inclusion of a substance in the Candidate List (Annex XV) and recommendation for inclusion in the Authorisation List (Annex XIV).

Prepare applications for authorisation:

Provide multidisciplinary support for the preparation of the different parts of an application for authorisation:

  • technical experts to support the Analysis of Alternatives (AoA)
  • risk assessors to develop use- and site-specific Chemical Safety Reports (CSR) and to quantify the impacts of continued use on human health and/or the environment
  • economists to develop socio-economic analyses (SEA) and monetise impacts
  • consortium managers to install and manage consortia to align strategies and minimise costs per company
  • project management to ensure all deliverables are finalised in due time and within budget

Discussion with ECHA during the Pre-Submission Information Session (PSIS) to touch base on the acceptability of the envisaged strategy of the application for authorisation.

Follow-up after submission:

Preparation of comments to the results of the Public Consultation and to the draft opinion of the RAC (Risk Assessment Committee) and the SEAC (Socio-Economic Assessment Committee).

After an authorisation has been granted: update of registration dossiers, Safety Data Sheets and other communication throughout the supply chain, downstream user notifications, preparation of review reports or re-applications for authorisation, etc.

 

Link to candidate list

https://echa.europa.eu/candidate-list-table

Link to authorisation list

https://echa.europa.eu/authorisation-list

Link to authorisation page on ECHA website

https://echa.europa.eu/substances-of-very-high-concern-identification-explained

Download the brochure here:

Authorisation of SVCH





Questions about this capability

Nele Deleebeeck

‎Senior Environmental Toxicologist +32 492 73 04 90 Ask me a question

Alain Vassart

Projectmanager Product Stewardship +32 492 972 330 Ask me a question