How to prepare an Annex XV report
How to prepare an Annex XV report
Guidance documents
- Guidance on Annex XV for restriction
- Guidance and Guidance fact sheet on SEA - Restrictions
- Addendum: Calculation of Compliance costs [PDF]
- Guidelines on the structure, documentation and writing style you should use in the Annex XV report:
- Fit-for-purpose dossiers: good practice guide [PDF]
- Substances identification and naming
- Guidance on information requirements and chemical safety assessment
Procedural documents of RAC and/or SEAC
- How to evaluate PBTs and vPvBs in SEAC [PDF]
- SEAC’s evaluation of qualitative assessments in restriction reports [PDF]
- Working procedure for RAC and SEAC on the conformity check [PDF]
- Working procedure for RAC and SEAC on the opinion development [PDF]
- Framework for conformity check and opinion development [PDF]
- Conformity check template [PDF]
- Recommendation template related to conformity check [PDF]
Other documents
- Guiding principles for uncertainty analysis in Annex XV Restriction Reports - a proposal based on EFSA’s guidance material [PDF]
- Fact sheet for timely and efficient consideration of uncertainties [PDF]
- Recommendations from the Restriction Task Force [PDF]
- Setting a clear scope in Annex XV restriction proposals [PDF]
- Description of uncertainties in the evaluation of restriction proposal [PDF]
- Thought starter: how to better regulate professional users’ border-lining with industrial and consumer users under REACH restriction [PDF]
- Grouping of substances to be covered in a single restriction dossier [PDF]
- RTF document on stocks, second-hand goods and recycling [PDF]
- Dossier submitters and ECHA's restriction team's involvement in the restriction process [PDF]
- Inputting to the consultation phase of the Annex XV restriction report and SEAC draft opinion [PDF]
- Working procedure for developing Forum advice [PDF]
- Forum Guide on Enforcement for Dossier Submitters[PDF]
Contact points
- If you need help to prepare the Annex XV report, you can ask at any time from ECHA staff by using the dedicated mailbox:
restriction (at) echa.europa.eu - If you want to get support or information directly from the Member State competent authorities, you can find the link to the contact details in
- Accredited stakeholders could also help you reach out to a wider audience.