The Impact (or lack thereof) of Authorization
Eight more substances were added to Annex XIV, the list of Authorized Substances, on April 18 (effective April 21), for a total of 22 substances. Ten more were recommended by ECHA to the European Commission for addition to Annex XIV on January 17; a total of 16 proposed substances have not yet been added to the list (the European Commission must promulgate a regulation to update Annex XIV before substances are actually added to it).
Five more candidate list SVHCs were proposed to be added to Annex XIV (six initially, but DecaBDE was removedsince it is being proposed for addition to the Stockholm Convention POPs list of restricted substances by Norway) on June 24. The deadline for comment is September 23.
As noted last year, Authorization does not directly impact non-EU producers of articles which are imported in to the EU (it’s only a concern if the authorized substances is manufactured or used as a substance in the supply chain within the EU). This is because Title VII of REACH applies only to the manufacture or use of substances per Article 56 – it does not apply once the substance has been incorporated into an article. If your supply chain goes through the EU and an Annex XIV substance is incorporated – in the EU - into a mixture or to manufacture an article that your company produces, your use of that substance will be subject to authorization.
That said, we are seeing manufacturers moving away from Annex XIV substances regardless of whether they are directly impacted by Authorization. For instance, DEHP, a phthalate with a sunset date of 21 Feb 2015 (and latest application date of 21 Aug 2013), is being replaced in many articles that are not manufactured in the EU. This pre-emptive approach is, perhaps, the result of seeing how European laws and regulations can be implemented elsewhere in very different and unpredictable ways (e.g. note how RoHS has been implemented in China, Vietnam, India, various US states, and so on).
Note, too, that Denmark has restricted phthalates, which ECHA’s Risk Assessment Committee (RAC) and Committee for Socio-Economic Analysis (SEAC) were unwilling to do. The Danes found that they have to delay the implementation from the end of this year because of just how widespread the uses of phthalates are: it will take longer than a year to replace them in every application. In a deal where industry will, among other things, actively support an EU-wide ban, Denmark will now propose that industry should have until 2015 to remove phthalates. The final timeline is not yet published.
Note that the Danish restriction does not control the replacement substance(s). Readers would be well-advised to not replace one of the restricted phthalates with yet another phthalate; more members of the phthalate family continue to be scrutinized and added to the Candidate List and it’s probably only a matter of time before the whole family is on the list and ultimately facing authorization or restriction. Doing an assessment of human health and environmental impact along with your standard qualification when making material changes to products is increasingly advisable in order to avoid future regulatory and business risk due to substance toxicity.
CoRAP: the Community Rolling Action Plan
The Community Rolling Action Plan is a process for reviewing data and assessing whether more information is needed to clarify initial concerns of whether the manufacture and/or use of these substances could pose a risk to human health or the environment. The Community Rolling Action Plan was updated with an additional 62 substances; there are currently 152 substances undergoing or planned for evaluation. The evaluations of 36 substances, including silicon dioxide, begun in 2012 were – in theory – completed by Feb. 28, 2013, however no final decisions have been published on the ECHA website.
Data on Candidate List substances in articles
ECHA is now publishing application information for candidate list SVHCs in articles, pulling from registration data as well as Article 7-related notifications. The information is, in many cases, at a relatively high level and so non-specific as to be nearly useless (for instance, disodium tetraborate, anhydrous is used in adhesives for a variety of articles). Others, however, are adequately specific (for instance, 1,2-dimethoxyethane is used in Lithium manganese dioxide batteries).
The purpose of this is to inform consumers of the possible presence of SVHCs in articles they may use. For manufacturers the information is somewhat less useful, however a quick perusal may be helpful in risk assessment procedures to see whether you may have any risks with articles you’re using in your products.
This data is slated to be updated approximately every six months.
Next Steps for SVHCs
Here is a reminder to expect yet another list of proposed SVHCs at the end of August. The Registry of Intentionscurrently shows 7 substances, including yet another phthalate, slated to be in the upcoming list.
Note, too, that the scope of potential SVHCs has widened to potentially include sensitizers. A document on the SVHC roadmap published from a recent CARACAL meeting says
Work has started for the identification of SVHCs falling under Article 57(f) of REACH ("substances of equivalent concern" to CMRs and PBTs), focusing on sensitisers and endocrine disruptors. This work will lead, in the future, to the identification of less known and less regulated SVHCs.
So once again, if you want to keep ahead of REACH, make sure you’re paying attention to an ever-expanding set of toxicological properties of the chemicals used in your products.