SVHC
SVHC
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.[9]
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.[10] The first draft recommendations were published on 14 January 2009, and new draft recommendations must be issued at least once every two years.
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).[11] 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.[12] 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.[13] From 1 June 2011, manufacturers and importers of articles also have to notify the European Chemicals Agency of the quantities of SVHCs used in their articles.[13]
In addition to the obviously involved chemical industry, there are many more industries affected by this regulation: drapery and leather industry, plastic processing, cosmetic industry, food industry, petroleum processing, printing industry, sports equipment industry, toys industry, recycling industry, electrical engineering industry, fine mechanics industry, optics industry, engine and plant production industry.
Candidate list of substances of very high concern
The following substances are included on the candidate list of substance of very high concern. This list is updated at regular intervals by the European Chemicals Agency (ECHA), with the first substances listed on 28 October 2008.[15] In June 2012, ECHA updated the Candidate List of Substances of Very High Concern (SVHC) for Authorization by including 13 new substances.[16] Among the 13 newly added SVHCs on June 18, 2012, four of them (C.I. Basic Violet 3, C.I. Basic Blue 26, C.I. Solvent Blue 4 and 4,4′-bis(dimethylamino)-4′-(methylamino)trityl alcohol) are identified as SVHC only if the presence of the carcinogenic constituents Michler’s ketone or Michler’s base is ≥ 0.1% w/w. Therefore, all the proposed substances are carcinogenic, mutagenic and toxic for reproduction (CMR substances; H-phrases H340, H341, H350, H351, H360, H361),[17] which may pose serious effects on human beings. To sell or use these substances, manufacturers, importers and users in the European Union (EU) need to apply for authorization from the ECHA.
This list is referred to as the “candidate” list because all substances placed on it are candidates for inclusion in Annex XIV of REACH. If a substance is added to Annex XIV, it is given a “latest application date” and a “sunset date”. The sunset date is the date after which the substance cannot be used or imported into the EU without authorisation from the ECHA, and the latest application date is the date by which any applications for use must be submitted to the ECHA.[2]
The most recent update is from June 2020; find the complete list in references
Substance name | Date of inclusion | Reason for inclusion | Priority | Latest application date | Sunset date | ||
Cobalt(II) chloride (cobalt dichloride) | 7646-79-9 | 28 October 2008 | carcinogen | No | – | – | |
1,2-benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich | 71888-89-6 | 20 June 2011 | Toxic for reproduction | – | – | ||
96-18-4 | 20 June 2011 | Carcinogen | – | – | |||
872-50-4 | 20 June 2011 | Toxic for reproduction | – | – | |||
302-01-2/7803-57-8 | 20 June 2011 | Carcinogen | – | – | |||
1,2-benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters | 68515-42-4 | 20 June 2011 | Toxic for reproduction | – | – | ||
7789-06-2 | 20 June 2011 | Carcinogen | – | – | |||
111-15-9 | 20 June 2011 | Toxic for reproduction | – | – | |||
Chromic acid, Oligomers of chromic acid and dichromic acid, Dichromic acid | 7738-94-5 | 15 December 2010 | Carcinogen | – | – | ||
1333-82-0 | 15 December 2010 | Carcinogen | – | – | |||
110-80-5 | 15 December 2010 | Toxic for reproduction | – | – | |||
109-86-4 | 15 December 2010 | Toxic for reproduction | – | – | |||
71-48-7 | 15 December 2010 | Carcinogen | – | – | |||
513-79-1 | 15 December 2010 | Carcinogen | – | – | |||
10141-05-6 | 15 December 2010 | Carcinogen | – | – | |||
10124-43-3 | 15 December 2010 | Carcinogen | – | – | |||
7775-11-3 | 18 June 2010 | Carcinogen | – | – | |||
7789-00-6 | 18 June 2010 | Carcinogen | – | – | |||
7789-09-5 | 18 June 2010 | Carcinogen | – | – | |||
7778-50-9 | 18 June 2010 | Carcinogen | – | – | |||
12267-73-1 | 18 June 2010 | Toxic for reproduction | – | – | |||
1303-96-4/1330-43-4/12179-04-3 | 18 June 2010 | Toxic for reproduction | – | – | |||
10043-35-3/11113-50-1 | 18 June 2010 | Toxic for reproduction | – | – | |||
79-01-6 | 18 June 2010 | Carcinogen | – | – | |||
79-06-1 | 30 March 2010 | Carcinogen | – | – | |||
– | Extracted from Index no. 650-017-00-8 | 13 January 2010 | Carcinogen | – | – | ||
– | Extracted from Index no. 650-017-00-8 | 13 January 2010 | Carcinogen | – | – | ||
115-96-8 | 13 January 2010 | Toxic for reproduction | – | – | |||
65996-93-2 | 13 January 2010 | Carcinogen | – | – | |||
121-14-2 | 13 January 2010 | carcinogen | – | – | |||
90640-80-5 | 13 January 2010 | carcinogen | – | – | |||
Anthracene oil, anthracene paste | 90640-81-6 | 13 January 2010 | carcinogen | – | – | ||
Anthracene oil, anthracene paste, anthracene fraction | 91995-15-2 | 13 January 2010 | carcinogen | – | – | ||
Anthracene oil, anthracene paste, distillation lights | 91995-17-4 | 13 January 2010 | carcinogen | – | – | ||
Anthracene oil, anthracene-low | 90640-82-7 | 13 January 2010 | carcinogen | – | – | ||
Diisobutyl phthalate (DIBP) | 84-69-5 | 13 January 2010 | toxic for reproduction | – | – | ||
7758-97-6 | 13 January 2010 | carcinogen | – | – | |||
12656-85-8 | 13 January 2010 | carcinogen | – | – | |||
1344-37-2 | 13 January 2010 | carcinogen | – | – | |||
Arsenic pentoxide (diarsenic pentaoxide) | 1303-28-2 | 28 October 2008 | carcinogen | No | – | – | |
Arsenic trioxide (diarsenic trioxide) | 1327-53-3 | 28 October 2008 | carcinogen | No | – | – | |
101-77-9 | 28 October 2008 | carcinogen | Yes | 21 February 2013 | 21 August 2014 | ||
7784-40-9 | 28 October 2008 | carcinogen | No | – | – | ||
7789-12-0 | 28 October 2008 | carcinogen | No | – | – | ||
15606-95-8 | 28 October 2008 | carcinogen | No | – | – | ||
Benzyl butyl phthalate (BBP) | 85-68-7 | 28 October 2008 | toxic for reproduction | Yes | 21 August 2013 | 21 February 2015 | |
Bis(2-ethylhexyl) phthalate (DEHP) | 117-81-7 | 28 October 2008 | toxic for reproduction | Yes | 21 August 2013 | 21 February 2015 | |
Dibutyl phthalate (DBP) | 84-74-2 | 28 October 2008 | toxic for reproduction | Yes | 21 August 2013 | 21 February 2015 | |
120-12-7 | 28 October 2008 | PBT | No | – | – | ||
Hexabromocyclododecane (HBCDD), | 134237-50-6 | 28 October 2008 | PBT | Yes | 21 February 2014 | 21 August 2015 | |
Short chain chlorinated paraffins | 85535-84-8 | 28 October 2008 | PBT | Yes | – | – | |
Tributyltin oxide (Bis(tributyltin) oxide, TBTO) | 56-35-9 | 28 October 2008 | PBT | No | – | – | |
Musk xylene (5-tert-butyl-2,4,6-trinitro-m-xylene) | 81-15-2 | 28 October 2008 | vPvB | Yes | 21 February 2013 | 21 August 2014 |
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