One of the central pillars of REACH is the so-called Authorisation process, where individual uses of chemicals of ‘very high concern’ are examined and either permitted or prohibited. The chemicals which go through this process are those which have been previously nominated and adopted to the Candidate List. The European Chemicals Agency published the first nominations for this list on June 30th. See ECHA website.
What has happened? EU member states have nominated and submitted dossiers for substances which they think should go on the candidate list. The 16 substances of very high concern (SVHCs) were proposed by 7 Member States. The list covers following chemicals:
| Substance name | Reason for proposing | Country |
|---|---|---|
| anthracene | (PBT)* | Germany |
| 4,4’-diaminodiphenylmethane | (CMR)* | Germany |
| dibutyl phthalate | (CMR) | Austria |
| benzyl butyl phthalate | (CMR) | Austria |
| cyclododecane | (PBT) | France |
| cobalt dichloride | (CMR) | France |
| diarsenic pentoxide | (CMR) | France |
| diarsenic trioxide | (CMR) | France |
| sodium dichromate, dehydrate | (CMR) | France |
| musk xylene | (vPvB)* | Netherlands |
| bis (2-ethyl(hexyl)phthalate) | (CMR) | Sweden |
| hexabromocyclododecane | (PBT) | Sweden |
| C10-C13 chlorinated paraffins | (PBT) | UK |
| bis (tributyltin) oxide | (PBT) | Norway |
| lead hydrogen arsenate | (CMR) | Norway |
| triethyl arsenate | (CMR) | Norway |
(* PBT = persistent, bioaccumulative and toxic, CMR = carcinogenic, mutagenic and reproductive toxin, vPvB = very persistent and very bioaccumulative.)
What comes next? Any interested parties have 45 days from publication to give comments on various aspects about the individual substances. The commenting period will last until 14 August 2008, after which Member States and ECHA will have a chance to respond to any comments received. The comments can be as general as supporting a substance’s nomination to the candidate list; to giving specific information about the human health hazards; information on risks related to the substance; information on uses and exposure; and information on environmental hazards, amongst other categories. If you wish to submit comments, we suggest you refer to the dossier submitted by the nominating Member State for that chemical (See “Link to commenting form“). The dossier may omit studies or information that is important for the subsequent decision on ranking this chemical in relation to others for the Authorisation procedure – the ‘priority’ or ‘working list’ due to be published in June 2009. Please note that in the individual dossiers occasionally the sentence ‘this is not relevant for this dossier’ may appear. This may indicate that this section has already been dealt with under the listing of that substance in Annex I of Directive 67/548 where Carcinogens, Mutagens and Reproductive Toxins (CMRs) category 1-3 are listed. Or it may indicate that this section is not relevant for the dossier when used for the Candidate List, as the dossier has a standard format that is also applicable to two other REACH procedures. To make comments, please see ECHA website.
After the commenting and response period There will be a vote in the Chemicals Agency Member State Committee in October, to adopt the official ‘candidate list’. This vote in the Member State Committee will be one of the first major opportunities for groups and individuals from the health community to express their views on the importance of having certain substances on the Candidate List. If the vote in the Committee is split, the subsequent decision passes to a so-called ‘REACH Committee’ with the EU’s commitology process.
Why is the candidate list important? Once a substance is on the candidate list, the consumer right-to-know clause kicks in - consumers can ask whether a candidate substance is in a product they are buying and must receive an answer within 45 working days (this applies to European consumers). Also companies know ahead of time which chemicals will eventually be put through the authorisation process and can start arranging to stop using them, an early signal to encourage innovation, green chemistry and safer substitutes.
Half a year after that, in June 2009, the Agency will also propose a ‘priority’ or working list for which chemicals are to go first through REACH authorisation process, and this working list will be drawn from the candidate list.
Further information:
Written on 8 July 2008.