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Authorisation is a process which starts with the identification of Substances of Very High Concern (SVHC), which is done by the EU Member States together with ECHA (the European Chemicals Agency) on the Candidate List. The identification is followed by priority setting of substances. ECHA makes a recommendation to the European Commission on which substances should be prioritised to be restricted. Based on this recommendation the Commission decides if a substance should be banned by including it in Annex XIV. From that moment on producers, importers and downstream users will have to ask for authorisation for a specific use of the substance.

Around 2000 substances are eligible for inclusion on the Candidate List, however these substances will be gradually included. The first list of substances with candidates for a potential ban was published in October 2008 listing 15 substances. It will be updated twice a year, in December and June. The list will not have a prohibitive effect and the use of the listed substances can continue. However, as soon as a substance is published on the candidate list there are immediate obligations .

Do the substances you produce, import or use require authorisation?

We can help you to prepare an authorisation dossier and guide you through the approval process to secure a positive decision. In short we can do the following for you:

Prepare, submit and defendyour authorisation dossier

The authorisation dossier will comprise the following elements:

  • Scientific aspects

    • Chemical safety report.

    • Analysis of the alternatives, considering their risks and the technical and economic feasibility of substitution.

    • Substitution plan, including a timetable for proposed actions.

  • Socio-economic analysis

EPPA will present the dossier to the European Commission, ensure follow up with members of the Regulatory Committee and ECHA officials to secure a positive decision. We will also apply for renewal of the authorisation after it expires.

Anticipating substance ban

  • Get early intelligence on member states, the European Commission and ECHA’s priorities for the assessment of substances in view of a ban and alert the client.

  • Advise on process and timing.

  • Actively report on the ECHA substance assessment process.

  • Analyse the impact of the potential inclusion of a substance in Annex XIV on your legal obligations.

  • Participate in the consultation process and submit comments to ECHA on substances subject to assessment.

If substances of your interest are included in the “Authorisation annex”, you should request a specific authorisation. We can help you prepare your request for authorisation and submit it to the European Commission and ECHA.

Provide REACHauthorisation strategy advice

Provide advice on the best way forward under the REACH authorisation procedure:

  • Regulatory timeline from authorisation until latest application and sunset dates.

  • Regulatory and business implications.

  • Time required to prepare and submit a dossier.

    • Analysis of different options for submitting the authorisation dossier (who will submit the dossier and when).

    • Advantages/disadvantages.

      • Costs of different options.

      • Consequences of late submission.

      • Supply chain implications.

      • Strategies adopted by other companies.

  • EPPA offers advice on the best way forward.

Prepare regulatory risksand strategy recommendations

The recommendations will assist the company management to assess regulatory risks to substances with the aim of taking long-term, critical business decisions:

  • Regulatory status of the substance

    • Analysis of current legislation impacting the substances.

    • Detailed timeline on key procedures.

    • Future developments

  • Policy analysis around the substance.

    • Identification of active stakeholders (political organisations, business organisations, research institutes, etc.) and their positions, by order of importance.

    • Summary of key policy developments.

    • Opinions of the member states, ECHA and the European Commission.

  • EPPA Strategy Recommendations

    • Possible regulatory scenarios and their business impact.

    • Recommended way forward on advocacy and scientific advice.

Identify if substances ofhigh concern arecontained in your products

  • Verify the chemical composition of your products. Together with our technical partner DEKRA, a leading EU chemical testing company, we assess what substances are contained in your products and in what concentrations.

  • Check the classification of substances and assess if they meet the SVHC criteria.

Set up REACH-compliancecertification system

We can put in place a management system to check and certify REACH compliance. This system can be built around your company’s quality management system , adapting it to integrate REACH requirements.

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