On August 29 2011 the European Chemicals Agency (ECHA) published proposals to identify 20 chemicals as substances of very high concern (SVHC).(1) These substances are destined to be placed on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Candidate List of SVHCs.(2) Once the substances are placed on the list, new obligations will arise for some suppliers of articles that contain the substances when those articles are supplied to customers within the European Union.
The list includes the following substances which are used in certain articles that are manufactured and exported to the European Union by various companies:
- N,N-dimethylacetamide (DMAC) – used as a solvent, mainly in the manufacture of various substances and in the production of fibres for clothing and other applications. Also used as a reagent and in products such as industrial coatings, polyimide films, paint strippers and ink removers.
- Bis(2-methoxyethyl) phthalate – mainly used as a plasticiser in polymeric materials and paints, lacquers and varnishes, including printing inks.
- 2-Methoxyaniline (o-Anisidine) – mainly used in the manufacture of dyes for tattooing and the colouration of paper, polymers and aluminium foil.
- 4-(1,1,3,3-tetramethylbutyl)phenol (4-tert-Octylphenol) – mainly used in the manufacture of polymer preparations and of ethoxylates. Also used as a component in adhesives, coatings, inks and rubber articles.
- Bis(2-methoxyethyl) ether – used primarily as a reaction solvent or process chemical in a wide variety of applications. Also used as a solvent for battery electrolytes. Possibly used in other products such as sealants, adhesives, fuels and automotive care products.
- Arsenic acid – mainly used to remove gas bubbles from ceramic glass melt and in the production of laminated printed circuit boards.
The ECHA announcement lists all 20 substances and their uses.(3)
Once the substances are transferred to the candidate list, they may eventually be selected for authorisation. Substances which then appear on the authorisation list (in Annex XIV of the REACH regulation) can, after a transition period, be placed on the market or used in the European Union only if a specific authorisation is granted.
Nevertheless, an important obligation is triggered once a substance is placed on the candidate list. Suppliers of articles that contain an SVHC on the list, in a concentration of more than 0.1%, must provide all relevant safety information available to them about the SVHC to downstream customers of the article; as a minimum they must name the substance. This obligation is contained in Article 33(1) of the regulation.
The relevant information is to be provided automatically – there is no tonnage trigger for this obligation and the obligation cannot be exempted. Information available to the article's supplier that is necessary to ensure safe use of the article must also be provided to consumers upon request (within 45 days of the request, free of charge) in accordance with Article 33(2) of the REACH regulation.
For example, were buttons for clothing to be exported to the European Union from a non-EU country, and those buttons contained an SVHC in a concentration of 0.2%, the relevant information would have to be communicated to the recipient. The obligation to provide all available information on SVHCs to the recipients of the articles applies as soon as a substance has been included on the candidate list. Therefore, companies should regularly check the list for new additions.
Importers and exporters must bear in mind that, under the REACH Regulation, SVHCs in articles in quantities totalling over one tonne per producer or importer a year, and which are present in those articles above a concentration of 0.1% by weight, must be notified to the ECHA. No notification was required before June 1 2011. Substances which are present in articles must be notified six months after they have been included on the candidate list.
However, such notification need not be made where:
- the producer or importer of an article can exclude exposure of humans and the environment during normal or reasonably foreseeable conditions of use, including the disposal of the article (in such cases appropriate instructions must be supplied to the recipient of the article) (Article 7(3) of the REACH regulation); or
- the substance has already been registered for that use (Article 7(6) of the REACH regulation).
There is some disagreement between the European Commission and certain member states as to how the 0.1% limit of Candidate List substances is to be calculated. Should interested parties be in any doubt, they would be well advised to seek expert legal advice.
There are already 53 substances on the candidate list. The latest proposals are available for comment until October 13 2011. Should interested parties wish to comment, they should focus primarily on the hazardous properties that qualify the chemicals as SVHCs. In addition, interested parties may provide comments and further information on the uses, exposures and availability of safer alternative substances or techniques.
For further information on this topic please contact Reshad Forbes at Van Bael & Bellis by telephone (+32 2 647 73 50), fax (+32 2 640 64 99) or email ([email protected]).
(1) The announcement can be accessed at http://echa.europa.eu/news/pr/201108/pr_11_20_svhc_consultation_20110829_en.asp.
(2) The list can be accessed at http://echa.europa.eu/chem_data/authorisation_process/candidate_list_en.asp.
(3) The detailed proposals regarding the 20 substances are available can be accessed at http://echa.europa.eu/consultations/authorisation/svhc/svhc_cons_en.asp.