The Effect of Adding Additional Substances to the Reach Candidate List
9:47 AM MDT | October 11, 2011 | By GILES CHAPPELL
Following the procedure established under Article 59 of the Reach Regulation, on 29 August 2011, the European Chemicals Agency (ECHA; Helsinki) published a proposal to identify an additional 20 chemicals for inclusion on the Candidate List of Substances of Very High Concern (SVHC) and thus as possible candidates for authorization. Interested parties are invited to comment on the proposals by 13 October 2011 (via the ECHA website http://echa.europa.eu).
Nineteen substances are proposed because of their potentially serious effects on human health. They are classified as carcinogenic and/or toxic for reproduction. Additionally, one substance - 4-tert octylphenol - becomes the first substance to be proposed as a substance of equivalent concern in accordance with Article 57(f) of the REACH Regulation, based on its endocrine disrupting properties and potential for serious effects to the environment. This could pave the way for further substances being included based on their endocrine disrupting properties, particularly after the NGO ChemSec included 22 endocrine disruptors in their updated Substitute It Now (“SIN”) list on 3 May 2011 (see: http://www.chemsec.org/).
The inclusion of a substance on the Candidate List triggers several required procedures, and potential limitations, impacting EEA (the EU Member States, plus Iceland, Liechtenstein) manufacturers, importers and users of the substance and the producers and importers of articles containing the substance. In particular:
* REACH Article 33: a duty to communicate to customers and consumers that these substances are contained in articles above 0.1%.
* REACH Article 7: specific to the articles’ producers and importers is an obligation to notify ECHA of the presence of Candidate List substances in their articles, in case SVHCs in their articles exceed 1 tonne in all of their articles annually, their concentration is above 0.1% w/w, exposure cannot be excluded and the substance has not been registered for that use.
* REACH Article 31: EU suppliers of SVHCs are required to provide their customers with safety data sheets.
* Submitting substances for nomination to the Candidate List is the first step towards submitting SVHCs to the authorization requirement pursuant to REACH Article 57. Unless their use is exempted from authorization under REACH (e.g., uses in intermediates) companies wishing to market or use substances included in the Annex XIV authorization list will have to submit an application for authorization to ECHA.
It is expected that the Candidate List will be updated approximately twice a year and may eventually include up to 1500 substances. The more substances included, the greater the probability that more and more companies will be affected by the obligations. This includes not only EEA-based companies but also non-EEA companies that supply or sell products to EEA-based entities, who are likely to receive more and more requests for information on product composition. There is also the growing risk that EEA downstream users will change their non-EEA suppliers in order to avoid the above-mentioned obligations. Thus, business is already advised to monitor the SIN List and other indications of possible future additions to the Candidate List in order to anticipate the future direction of the EU’s REACH regime.
About the author
Giles Chappell is an attorney in the Brussels office of McKenna Long & Aldridge LLP. His practice focuses on chemicals (REACH and the CLP Regulation), electronic waste and disposal legislation (WEEE, RoHS), biocides and pesticides legislation, and the developing legal and regulatory framework for nanomaterials.