A substance of very high concern (SVHC) is a chemical substance (or part of a group of chemical substances) for which it has been proposed that the use within the European Union be subject to authorisation under the REACH Regulation.^[1] Indeed, listing of a substance as an SVHC by the European Chemicals Agency (ECHA) is the first step in the procedure for authorisation and restriction of use of a chemical. The first list of SVHCs was published on 28 October 2008.

Contents 1 Criteria 2 Procedure for listing 3 Consequences of listing 4 List of substances of very high concern 5 References 6 External links

[edit] Criteria

The criteria are given in article 57 of the REACH Regulation.^[2] A substance may be proposed as an SVHC if it meets one or more of the following criteria:

• it is carcinogenic;
• it is mutagenic;
• it is toxic for reproduction;
• it is persistent, bioaccumulative and toxic according to the criteria set our in Annex XIII to the REACH Regulation^[3] (PBT substances);
• it is very persistent and very bioaccumulative according to the criteria set our in Annex XIII to the REACH Regulation^[3] (vPvB substances);
• there is "scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern"; such substances are identified on a case-by-case basis.

Simply because a substance meets one or more of the criteria does not necessarily mean that it will be proposed as an SVHC. Many such substances are already subject to restrictions on their use within the European Union, such as those in Annex XVII of the REACH Regulation.^[4] SVHCs are substances for which the current restrictions on use (where these exist) might be insufficient. There are three priority groups for assessment:^[5]

• PBT substances and vPvB substances;
• substances which are widely dispersed during use;
• substances which are used in large quantities.

[edit] Procedure for listing

Proposals for inclusion of a substance on the list of SVHCs can come either from the European Commission or one of the Member States of the European Union. The proposals are made public by the European Chemicals Agency (ECHA) and are open for public comment for 60–90 days. If the substance is deemed to meet one or more of the criteria, it is then listed as an SVHC.^[6]

Once a substance has been listed as an SVHC, the Agency commissions a technical report from one or more national or private laboratories, which analyses the available information on manufacture, imports, uses and releases of the substance, as well as possible alternatives. On the basis of this technical report, the Agency decides whether to prioritise the substance, in effect, whether to make a recommendation to the European Commission to add the substance to Annex XIV of the REACH Regulation, making its use subject to authorisation. The draft recommendations must be made public and opened for comment for three months before the final recommendations are sent to the Commission.^[7] The first draft recommendations were published on 14 January 2009, and new draft recommendations must be issued at least once every two years.

[edit] Consequences of listing

The list of SVHCs is primarily a public list of substances for which the European Chemicals Agency is considering imposing a requirement for authorisation for some or all uses. However, there are some direct consequences of including a substance on the list of SVHCs. Suppliers of pure SVHCs must provide their customers with a safety data sheet (SDS).^[8] Suppliers of mixtures of substances which contain more than 0.1% by weight of any SVHC must provide their customers with a safety data sheet on request.^[9] Manufacturers or importers of articles containing more than 0.1% by weight of any SVHC must provide their customers, and consumers on request, with adequate information on the safe use and disposal of the article, including the name of the SVHC(s) concerned.^[10] From 1 June 2011, manufacturers and importers of articles will also have to notify the European Chemicals Agency of the quantities of SVHCs used in their articles.^[10]

[edit] List of substances of very high concern

The following substances were all listed by the European Chemicals Agency on 28 October 2008.^[11] The Agency published draft recommendations for the priority substances on 14 January 2009.

Substance name	EC number	CAS number	Reason for inclusion	Priority
Arsenic pentoxide (diarsenic pentaoxide)	215-116-9	1303-28-2	carcinogen	no
Arsenic trioxide (diarsenic trioxide)	215-481-4	1327-53-3	carcinogen	no
4,4'-Diaminodiphenylmethane (MDA)	202-974-4	101-77-9	carcinogen	YES
Cobalt(II) chloride (cobalt dichloride)	231-589-4	7646-79-9	carcinogen	no
Lead hydrogen arsenate	232-064-2	7784-40-9	carcinogen toxic for reproduction	no
Sodium dichromate	234-190-3	7789-12-0 10588-01-9	carcinogen mutagen toxic for reproduction	no
Triethyl arsenate	427-700-2	15606-95-8	carcinogen	no
Benzyl butyl phthalate (BBT)	201-622-7	85-68-7	toxic for reproduction	YES
Bis(2-ethylhexyl) phthalate (DEHP)	204-211-0	117-81-7	toxic for reproduction	YES
Dibutyl phthalate (DBP)	201-557-4	84-74-2	toxic for reproduction	YES
Anthracene	204-371-1	120-12-7	PBT	no
Hexabromocyclododecane (HBCDD), including all major diastereomers	247-148-4 221-695-9	134237-50-6 134237-51-7 134237-52-8	PBT	YES
Short chain chlorinated paraffins (C10–C13 chloroalkanes, SCCP)	287-476-5	85535-84-8	PBT vPvB	YES
Tributyltin oxide (Bis(tributyltin) oxide, TBTO)	200-268-0	56-35-9	PBT	no
Musk xylene (5-tert-butyl-2,4,6-trinitro-m-xylene)	201-329-4	81-15-2	vPvB	YES

Notes

• The CAS numbers for groups of compounds such as "SCCP" are indicative. Such groups can include several compounds, each of which has a different CAS number.
• PBT = persistent, bioaccumulative and toxic
• vPvB = very persistent and very bioaccumulative

[edit] References

[edit] External links

• List of substances from ECHA
• Obligations Linked to the Candidate List of Substances of Very High Concern from ECHA