REACH Alert: Tips to Securing European Markets - Avoiding Annex XIV Listing Under REACH

REACH Alert: Tips to Securing European Markets - Avoiding Annex XIV Listing Under REACH

Under REACH, the European Commission makes the decision on whether to move substances from the Candidate List to the Annex XIV (Authorisation List). The Decision is made by the Member State Committee procedure based on recommendations by the European Chemicals Agency (ECHA). ECHA has to make recommendations at least every second year. The Authorities are already working on the Second List of Recommendations. See http://echa.europa.eu/consultations/authorisation/draft_recommendations_en.asp

The draft Annex XIV entries that emerge from the process include:

  • Sunset date(s): the date(s) from which placing on the market and use of the substance is prohibited, unless an authorisation is granted;
  • Application dates(s): the date or dates at least 18 months before the sunset date(s) by which applications must be received if the applicant wishes to continue to use the substance or place it on the market after the sunset date(s);
  • Review periods for certain uses, if appropriate;
  • Uses or categories of uses exempted from the authorisation requirement, if any, and conditions for such exemptions, if any

The draft recommendation is published on ECHA's website and interested parties are invited to submit comments within 3 months of the date of publication, in particular, on uses which should be exempt from the authorisation requirement.

Reviewing the Response to Comments on the substances that have gone through the process to-date is highly illustrative and offers important practice pointers:

  • "Choice of policy" related considerations are beyond the remit of ECHA in the "Recommendation for inclusion in Annex XIV" process. ECHA's role is only to verify on a technical and functional level whether a substance on the Candidate List meets the prioritization criteria and whether inclusion in Annex XIV would be pertinent to achieve the risk management objectives required for that substance.
  • Arguments about the inherent properties of the substance are not relevant for this part of the authorisation process, as the identification of the substance as a Substance of Very High Concern has already been agreed by the Member State Committee at the time of Candidate listing, or even before as part of the C&L harmonization process.
  • The availability and suitability of alternatives is not been taken into account by ECHA in the process of prioritizing substances for inclusion in Annex XIV.
  • Similarly, information on the level of risk associated with the substance is also not part of the Annex XIV inclusion process.
  • Socioeconomic factors are also not relevant at this stage of the process.
  • According to Article 58(2) of REACH it is possible to exempt from the authorisation requirement uses or categories of uses "provided that, on the basis of the existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled."

The ECHA considers the following in deciding whether an exemption of a use of a substance could be included in ECHA's recommendation:

  • Whether there is existing Community legislation addressing the specific use (or categories of use). Only Community legislation is relevant in this context (not national legislation).
  • The Community legislation should address the substances in question either by naming the substance specifically or the chemical group to which the substance belongs.
  • The Community legislation must properly control the risks over the lifecycle of the substance.
  • The Community legislation needs to impose binding and enforceable minimum requirements for the substance.

Taking account of the above criteria:

  • Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work is not considered as imposing binding minimum requirements for controlling risks to human health.
  • Directive 2008/1/EC (IPPC) is also not sufficient.
  • Both Directive 2002/95/EC (Directive of the European Parliament and of the Council of 27 January 2003 on the restriction of the use of certain hazardous substances in electrical and electronic equipment; RoHS) and Directive 2000/53/EC (Directive of the European Parliament and of the Council of 18 September 2000 on end-of life vehicles; ELV) are also not considered sufficient.

Obviously a successful strategy to deprioritize a substance for Annex XIV inclusion requires considerable strategy and effort.

The lawyers and scientists at Keller and Heckman LLP can shepherd companies through the Authorisation process by, among other things:

  • Providing effective advocacy to forestall Candidate Listing
  • Deprioritize substances for Annex XIV inclusion
  • Secure Use Exemptions
  • Prepare Authorisation petitions
  • Prepare Socioeconomic analysis
  • Pursue Administrative appeals
  • Bring appropriate Court actions

This Article is part of a series on the REACH Authorisation Process. The Brussels office of Keller and Heckman LLP has been assisting clients on REACH Registration for a number of years, and is now focusing its attention on Dossier and Substance Evaluation, Authorisation, Restriction, and REACH Enforcement. For further information, contact Herb Estreicher (Tel: 01-202-434-4334; +32 (0)2 645 50 96; e-mail at estreicher@khlaw.com), Marcus Navin-Jones (Tel: +32 (0)2 645 50 97); e-mail at navin-jones@khlaw.com), or Mark Boelens (Tel: +32 (0)2 645 50 68); e-mail at boelens@khlaw.com.