Allison Tracy is a Chemicals Policy Fellow. Richard Denison, Ph.D., is a Senior Scientist.
The European Commission today identified the first six chemicals to be made subject to authorization under the European Union’s Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals, or REACH.
The long road to today’s decision began in October 2008, when the European Chemicals Agency (ECHA) identified these chemicals as Substances of Very High Concern (SVHCs) and placed them on its Candidate List for chemicals potentially to be subject to authorization. Under REACH, a chemical qualifies as a SVHC as a result of being: (1) carcinogenic, mutagenic, or a reproductive toxicant (CMR), (2) being persistent, bioaccumulative and toxic (PBT), (3) being very persistent and very bioaccumulative (vPvB), or (4) being found to “give rise to an equivalent level of concern.” Clearly these are the types of chemicals we want to pay attention to!
Today’s formal addition of these chemicals to REACH’s Annex XIV serves to notify manufacturers and importers that they must apply for, and obtain, authorization for specific uses of these chemicals if they want to continue using them beyond their designated sunset dates in 2014 and 2015. It is of note that this rule applies to the chemicals in question regardless of their production volumes.
The chemicals added to Annex XIV and their SVHC designations are as follows:
- 5-tert-butyl-2,4,6-trinito-m-xylene (musk xylene) (CAS #81-15-2, vPvB)
- hexabromocyclododecane (HBCDD) (CAS #25637-99-4 and #3194-55-6, PBT)
- 4,4'-diaminodiphenylmethane (MDA) (CAS #101-77-9, carcinogenic)
- bis(2-ethylexyl) phthalate (DEHP) (CAS #117-81-7, toxic for reproduction)
- benzyl butyl phthalate (BBP) (CAS #85-68-7, toxic for reproduction)
- dibutyl phthalate (DBP) (CAS #84-74-2, toxic for reproduction)
REACH outlines specific criteria that must be met in order to receive authorization for a specific use of a chemical listed in Annex XIV. Authorizations must be applied for by each company that wishes to produce a listed chemical for a given use. Applicants must generally demonstrate that they have put in place control measures to “adequately control” the risks posed by the chemical.
However, certain SVHCs – including all PBTs and vPvBs and some CMRs – are not eligible for authorization based on “adequate control,” because it is not possible to determine a threshold below which they do not have an adverse effect. For such chemicals, their use can only be authorized if the applicant can make the case that the economic and social benefits outweigh the risks of the chemical and that there are no viable alternatives. The European Commission’s press release outlines the details of this procedure.
Of the six chemicals listed above, at least the first two and possibly more of them will be eligible for authorization only by the second of the two routes just described.
The addition of these six chemicals to Annex XIV is a bit of a seminal moment in the history of REACH, but it is only the first of such steps we can expect. There are currently nearly 40 additional SVHCs on the Candidate List that may eventually move to Annex XIV.
We can also expect that additional chemicals will be placed on the Candidate List and eventually onto to Annex XIV as more information is developed under REACH on the full range of chemicals in commerce across EU member states. The first batch of registration dossiers submitted to ECHA this past December will be an important source of such data.
This latest development is one more indication that, regardless of how one feels about it, REACH is a reality that is here to stay.