If the substances you are producing or importing are classified as CMRs, PBTs, vPvBs and included in Annex XIV, you have to ask for an authorisation for your specific use.

The request for authorisation should be sent to the Commission.

Authorisation dossier should include:

  • Chemical safety report
  • Analysis of the alternatives considering their risks and the technical and economic feasibility of substitution
  • Research and development activities by the applicant;
  • Substitution plan including a timetable for proposed actions by the applicant

Authorisation dossier may include:

  • Socio-economic analysis
  • Justification for not considering risks to human health and the environment arising either from emissions or discharges
  • The European Commission grants authorisation assisted by the Agency and a Committee.

Authorisation of use is granted if:

  • risk to health and environment is controlled, including discharges, emissions, losses; if not:
  • socio-economic benefits outweigh risk and no suitable substitutes available

Authorisation is time limited, subject to review

Exemptions of uses if EU legislation provides for requirements & management measures related to heath & envi protection and risk is controlled