Substance of very high concern

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A substance of very high concern (SVHC) is a chemical substance (or part of a group of chemical substances) concerning which it has been proposed that 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 or restriction of use of a chemical. The first list of SVHCs was published on 28 October 2008 and the list has been updated many times to include new candidates. The most recent update occurred in January 2022 to include a total of 223 SVHC. [2]

Contents

Criteria

The criteria are given in article 57 of the REACH Regulation. [3] [4] A substance may be proposed as an SVHC if it meets one or more of the following criteria:

The "equivalent concern" criterion is significant because it is this classification which allows substances which are, for example, neurotoxic, endocrine-disrupting or otherwise present an unanticipated environmental health risk to be regulated under REACH. [6]

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. [7] SVHCs are substances for which the current restrictions on use (where these exist) might be insufficient. There are three priority groups for assessment: [8]

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. [14]

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 July 2021; find the complete list in references. [18] [2]

Substance name EC number CAS number Date of inclusionReason for inclusionPriorityLatest application dateSunset date
Cobalt(II) chloride (cobalt dichloride) 231-589-4 7646-79-928 October 2008
20 June 2011		carcinogenNo--
1,2-benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich 276-158-1 71888-89-620 June 2011Toxic for reproduction--
1,2,3-Trichloropropane 202-486-1 96-18-420 June 2011Carcinogen
Toxic for reproduction		--
1-methyl-2-pyrrolidone 212-828-1 872-50-420 June 2011Toxic for reproduction--
Hydrazine 206-114-9 302-01-2/7803-57-820 June 2011Carcinogen--
1,2-benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters 271-084-6 68515-42-420 June 2011Toxic for reproduction--
Strontium chromate 232-142-6 7789-06-220 June 2011Carcinogen--
2-ethoxyethyl acetate 203-839-2 111-15-920 June 2011Toxic for reproduction--
Chromic acid, Oligomers of chromic acid and dichromic acid, Dichromic acid 231-805-1
-
236-881-5 		7738-94-5
-
13530-68-2		15 December 2010Carcinogen--
Chromium trioxide 215-607-8 1333-82-015 December 2010Carcinogen
Mutagen		--
2-Ethoxyethanol 203-804-1 110-80-515 December 2010Toxic for reproduction--
2-Methoxyethanol 203-713-7 109-86-415 December 2010Toxic for reproduction--
Cobalt(II) diacetate 200-755-8 71-48-715 December 2010Carcinogen
Toxic for reproduction		--
Cobalt(II) carbonate 208-169-4 513-79-115 December 2010Carcinogen
Toxic for reproduction		--
Cobalt(II) dinitrate 233-402-1 10141-05-615 December 2010Carcinogen
Toxic for reproduction		--
Cobalt(II) sulfate 233-334-2 10124-43-315 December 2010Carcinogen
Toxic for reproduction		--
Sodium chromate 231-889-5 7775-11-318 June 2010Carcinogen
Mutagen
Toxic for reproduction		--
Potassium chromate 232-140-5 7789-00-618 June 2010Carcinogen
Mutagen		--
Ammonium dichromate 232-143-1 7789-09-518 June 2010Carcinogen
Mutagen
Toxic for reproduction		--
Potassium dichromate 231-906-6 7778-50-918 June 2010Carcinogen
Mutagen
Toxic for reproduction		--
Tetraboron disodium heptaoxide, hydrate 235-541-3 12267-73-118 June 2010Toxic for reproduction--
Disodium tetraborate, anhydrous 215-540-4 1303-96-4/1330-43-4/12179-04-318 June 2010Toxic for reproduction--
Boric acid 233-139-2 / 234-343-4 10043-35-3/11113-50-118 June 2010Toxic for reproduction--
Trichloroethylene 201-167-4 79-01-618 June 2010Carcinogen--
Acrylamide 201-173-7 79-06-130 March 2010Carcinogen
Mutagen		--
Aluminosilicate Refractory Ceramic Fibres -Extracted from Index no. 650-017-00-813 January 2010Carcinogen--
Zirconia Aluminosilicate Refractory Ceramic Fibres -Extracted from Index no. 650-017-00-813 January 2010Carcinogen--
Tris(2-chloroethyl)phosphate 204-118-5 115-96-813 January 2010Toxic for reproduction--
Pitch, coal tar, high temp. 266-028-2 65996-93-213 January 2010Carcinogen
PBT
vPvB		--
2,4-Dinitrotoluene 204-450-0 121-14-213 January 2010carcinogen--
Anthracene oil 292-602-7 90640-80-513 January 2010carcinogen
PBT, vPvB		--
Anthracene oil, anthracene paste 292-603-2 90640-81-613 January 2010carcinogen
mutagen
PBT, vPvB		--
Anthracene oil, anthracene paste, anthracene fraction 295-275-9 91995-15-213 January 2010carcinogen
mutagen
PBT, vPvB		--
Anthracene oil, anthracene paste, distillation lights 295-278-5 91995-17-413 January 2010carcinogen
mutagen
PBT, vPvB		--
Anthracene oil, anthracene-low 292-604-8 90640-82-713 January 2010carcinogen
mutagen
PBT, vPvB		--
Diisobutyl phthalate (DIBP) 201-553-2 84-69-513 January 2010toxic for reproduction--
Lead chromate 231-846-0 7758-97-613 January 2010carcinogen
toxic for reproduction		--
Lead chromate molybdate sulfate red (C.I. Pigment Red 104) 235-759-9 12656-85-813 January 2010carcinogen
toxic for reproduction		--
Lead sulfochromate yellow (C.I. Pigment Yellow 34) 215-693-7 1344-37-213 January 2010carcinogen
toxic for reproduction		--
Arsenic pentoxide (diarsenic pentaoxide) 215-116-9 1303-28-228 October 2008carcinogenNo--
Arsenic trioxide (diarsenic trioxide) 215-481-4 1327-53-328 October 2008carcinogenNo--
4,4'-Diaminodiphenylmethane (MDA) 202-974-4 101-77-928 October 2008carcinogenYes21 February 201321 August 2014
Lead hydrogen arsenate 232-064-2 7784-40-928 October 2008carcinogen
toxic for reproduction		No--
Sodium dichromate 234-190-3 7789-12-0
10588-01-9		28 October 2008carcinogen
mutagen
toxic for reproduction		No--
Triethyl arsenate 427-700-2 15606-95-828 October 2008carcinogenNo--
Benzyl butyl phthalate (BBP) 201-622-7 85-68-728 October 2008toxic for reproductionYes21 August 201321 February 2015
Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 117-81-728 October 2008toxic for reproductionYes21 August 201321 February 2015
Dibutyl phthalate (DBP) 201-557-4 84-74-228 October 2008toxic for reproductionYes21 August 201321 February 2015
Anthracene 204-371-1 120-12-728 October 2008PBTNo--
Hexabromocyclododecane (HBCDD),
including all major diastereomers		 247-148-4
221-695-9 		134237-50-6
134237-51-7
134237-52-8		28 October 2008PBTYes21 February 201421 August 2015
Short chain chlorinated paraffins
(C10–C13 chloroalkanes, SCCP)		 287-476-5 85535-84-828 October 2008PBT
vPvB		Yes--
Tributyltin oxide (Bis(tributyltin) oxide, TBTO) 200-268-0 56-35-928 October 2008PBTNo--
Musk xylene (5-tert-butyl-2,4,6-trinitro-m-xylene) 201-329-4 81-15-228 October 2008vPvBYes21 February 201321 August 2014
Notes

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References

  1. ↑ Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency. OJEC L396, 30.12.2006, pp. 1–849.
  2. 1 2 3 "Candidate List updated with eight hazardous chemicals". echa.europa.eu. 8 July 2021. Retrieved 10 May 2022.
  3. ↑ Article 57, REACH Regulation, at pp. 141–42.
  4. ↑ "Legislation - REACH - Chemicals - Environment - European Commission". ec.europa.eu.
  5. ↑ Annex XIII, REACH Regulation, at pp. 383–85.
  6. ↑ European Chemicals Agency. "Proposals to identify Substances of Very High Concern current consultations" . Retrieved 2012-08-17.
  7. ↑ Annex XVII, REACH Regulation, at pp. 395–849.
  8. ↑ Article 58.3, REACH Regulation, at p. 144–45.
  9. ↑ Article 59, REACH Regulation, at pp. 146–48.
  10. ↑ Article 58, REACH Regulation, at pp. 143–46.
  11. ↑ Article 31.1, REACH Regulation, at p. 107.
  12. ↑ Article 31.3, REACH Regulation, at p. 108.
  13. 1 2 Article 7, REACH Regulation, at pp. 63–66.
  14. ↑ "REACH Compliance. Made Easy" (PDF). TÜV Rheinland. Archived from the original (PDF) on 3 May 2013. Retrieved 18 October 2012.
  15. ↑ Decision ED/67/2008.
  16. ↑ "Previous recommendations". European Chemicals Agency (ECHA). Archived from the original on 16 January 2017. Retrieved 8 April 2015.
  17. ↑ Bouwman, Yvonne; Fenton-May, V'Iain; Le Brun, Paul (2015). Practical Pharmaceutics: An International Guideline for the Preparation, Care and Use of Medicinal Products . Springer. pp. 555.
  18. ↑ "Candidate List of substances of very high concern for Authorisation - ECHA". echa.europa.eu.
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