Ask Dr Reach: How many substances will be included in the 'candidate list' and when?
QUESTION: How many substances will be included on the ‘candidate list’ and when? The questioner is a regulatory consultancy in the USA
ANSWER: The European Chemicals Agency (ECHA) is required to recommend by June 2009 a first priority list of substances for inclusion as authorised substances in Annex XIV. These will be selected from a ‘candidate list’ of substances considered to meet criteria set out in the REACH regulation defining them as being of ‘very high concern’.
Ultimately, all ‘substances of very high concern’ require authorisation to enable their continued manufacture, sale or use in the EU. In practice, both the candidate list and the Annex XIV list will be prioritised. Both are considered to be ‘living lists’.
An appearance on the candidate list triggers immediate requirements under REACH, while Annex XIV substances have a ‘sunset date’ by which time applications must be made. Any unauthorised use of a substance after that date is banned.
Specifically, the presence of candidate list substances must be communicated in safety data sheets. Their presence in articles must also be made known, if the substances exceed a specific concentration threshold,
Estimates of the number of substances that could be processed under authorisation typically range from 5 to 50 substances per year. As authorisation is use-specific and can be subject to reviews, the process is considered as particularly administratively burdensome.
Companies are preparing for the imminent publication of the first candidate list – possibly by the autumn. The number of substances could potentially run to several thousands. But currently, it is expected that the initial list will be limited – containing no more than several dozen or several hundred substances. For instance, many think that the oil and tar derivatives in Annex I of Directive 67/548 will be excluded at least initially.
Arguably, an excessively long candidate list could give the impression that EU regulators have bitten off more than they can chew – as only a fraction are likely to proceed through authorisation each year. Managing a massive list would also be more challenging with regards to communication through the supply chain, compliance monitoring and regulatory enforcement.
On the other hand, some stakeholders may seek a longer list, regardless of the practical implications, as it represents a larger number of substances identified as facing phase-out.
Dr Steffen Erler
Legal Disclaimer: The information contained in this communication follows a technical interpretation of REACH to serve as a thought-starter for discussions; it does not constitute legal or any other form of advice. Note that technical aspects are subject to review and references should be checked for updates. The legal text of the REACH Regulation must serve as the basis for REACH compliance and it may be advisable to seek legal and/or other expert advice on any given issue. The author and Chemical Watch accept no liability whatsoever with regard to the use of information contained in this communication.
