On 29 August 2011, the European Chemicals Agency (ECHA) published proposals to identify twenty chemicals as "Substances of Very High Concern" (SVHCs). Companies should be alerted to this development, as the substances are destined to be placed on the so-called REACH Candidate List of SVHCs. Once on this list, new obligations will arise for some suppliers of articles that contain the substances, when the articles are supplied to customers within the EU.
The proposed substances include the following, which may be of special interest due to their uses in particular articles manufactured and exported to the EU by various companies:
- N,N-dimethylacetamide (DMAC), which is 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, for which the main uses were found to be as a plasticiser in polymeric materials and paints, lacquers and varnishes, including printing inks.
- 2-Methoxyaniline; o-Anisidine, which is mainly used in the manufacture of dyes for tattooing and coloration of paper, polymers and aluminium foil.
- 4-(1,1,3,3-tetramethylbutyl)phenol, (4-tert-Octylphenol), which is mainly used in the manufacture of polymer preparations and of ethoxylates, and further used as a component in adhesives, coatings, inks and rubber articles.
- Bis(2-methoxyethyl) ether, which is used primarily as a reaction solvent or process chemical in a wide variety of applications, and also used as a solvent for battery electrolytes, and possibly 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.
For a full list of the twenty proposed substances and their uses, those manufacturing articles exported to the EU may like to examine the following ECHA announcement:
Once the substances are transferred to the Candidate List, they may eventually be selected for authorisation. Substances then appearing on the Authorisation List (Annex XIV of the REACH Regulation) can, after a transition period, only be placed on the market or used in the EU if a specific authorisation is granted.
An important obligation is, nonetheless, triggered once a substance is placed on the Candidate List. Suppliers of articles containing an SVHC that is included on the Candidate List, in a concentration above 0.1%, have to provide the relevant safety information available to them about the SVHC to their downstream customers of the articles, and as a minimum the name of the substance. This obligation is contained in Article 33.1 of the REACH Regulation.
This information is to be provided automatically: there is no tonnage trigger for this obligation and the obligation cannot be exempted. Information available to the articles supplier necessary to ensure safe use of the article has to be provided also 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, if buttons are exported to the EU from a non-EU country (for use on jackets) and the buttons contain an SVHC in concentrations of 0.2%, the information would need to be communicated to the recipient as noted above. The obligation to provide 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 Candidate List, for additions of new SVHCs.
As a separate matter, companies are reminded that under the REACH Regulation, substances in articles that are SVHC in quantities totalling over one tonne per producer or importer per year and which are present in those articles above a concentration of 0.1% weight by weight, must be notified to the ECHA. No notification was required before 1 June 2011. After that date, substances present in articles have to be notified six months after they have been included on the Candidate List.
However, such notification does not have to be made where (as per Article 7.3 of the REACH Regulation), 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 need to be supplied to the recipient of the article); or (as per Article 7.6 of the REACH Regulation), the substance has already been registered for that use.
It should be noted that there is disagreement between the European Commission and some Member States over how the 0.1% limit value of Candidate List substances is to be calculated, vis-à-vis the articles containing them. Should companies be in any doubt, they should seek expert legal advice on this matter.
There are already 53 substances on the Candidate List of SVHCs. Companies may like to know that anybody can comment on the latest proposals by 13 October 2011. Should traders wish to comment, they should focus primarily on the hazardous properties that qualify the chemicals as SVHCs. In addition, interested parties can provide comments and further information on the uses, exposures and availability of safer alternative substances or techniques.
The detailed proposals on the twenty substances are available on the ECHA website using the following link:
The Candidate List can be found at the following link:
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.