Substance of very high concern
Encyclopedia
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. 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 and updated on 13 January 2010.
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. SVHCs are substances for which the current restrictions on use (where these exist) might be insufficient. There are three priority groups for assessment:
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.
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. The first draft recommendations were published on 14 January 2009, and new draft recommendations must be issued at least once every two years.
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.
Notes
Chemical substance
In chemistry, a chemical substance is a form of matter that has constant chemical composition and characteristic properties. It cannot be separated into components by physical separation methods, i.e. without breaking chemical bonds. They can be solids, liquids or gases.Chemical substances are...
(or part of a group of chemical substances) for which it has been proposed that the use within the European Union
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
be subject to authorisation under the REACH Regulation. Indeed, listing of a substance as an SVHC by the European Chemicals Agency
European Chemicals Agency
The European Chemicals Agency is an agency of the European Union which manages the technical, scientific and administrative aspects of the Registration, Evaluation, Authorisation and Restriction of Chemicals system...
(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 and updated on 13 January 2010.
Criteria
The criteria are given in article 57 of the REACH Regulation. A substance may be proposed as an SVHC if it meets one or more of the following criteria:- it is carcinogenCarcinogenA carcinogen is any substance, radionuclide, or radiation that is an agent directly involved in causing cancer. This may be due to the ability to damage the genome or to the disruption of cellular metabolic processes...
ic; - it is mutagenMutagenIn genetics, a mutagen is a physical or chemical agent that changes the genetic material, usually DNA, of an organism and thus increases the frequency of mutations above the natural background level. As many mutations cause cancer, mutagens are therefore also likely to be carcinogens...
ic; - it is toxic for reproductionReproductive toxicityReproductive toxicity is a hazard associated with some chemical substances, that they will interfere in some way with normal reproduction. It includes adverse effects on sexual function and fertility in adult males and females, as well as developmental toxicity in the offspring...
; - it is persistentPersistent organic pollutantthumb|right|275px|State parties to the Stockholm Convention on Persistent Organic PollutantsPersistent organic pollutants are organic compounds that are resistant to environmental degradation through chemical, biological, and photolytic processes...
, bioaccumulativeBioaccumulationBioaccumulation refers to the accumulation of substances, such as pesticides, or other organic chemicals in an organism. Bioaccumulation occurs when an organism absorbs a toxic substance at a rate greater than that at which the substance is lost...
and toxic according to the criteria set out in Annex XIII to the REACH Regulation (PBT substances); - it is very persistent and very bioaccumulative according to the criteria set out in Annex XIII to the REACH Regulation (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. SVHCs are substances for which the current restrictions on use (where these exist) might be insufficient. There are three priority groups for assessment:
- PBT substances and vPvB substances;
- substances which are widely dispersed during use;
- substances which are used in large quantities.
Procedure for listing
Proposals for inclusion of a substance on the list of SVHCs can come either from the European CommissionEuropean Commission
The European Commission is the executive body of the European Union. The body is responsible for proposing legislation, implementing decisions, upholding the Union's treaties and the general day-to-day running of the Union....
or one of the Member States of the European Union. The proposals are made public by the European Chemicals Agency
European Chemicals Agency
The European Chemicals Agency is an agency of the European Union which manages the technical, scientific and administrative aspects of the Registration, Evaluation, Authorisation and Restriction of Chemicals system...
(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.
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. 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). 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. 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. 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.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.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.
| Substance name | EC number | CAS number CAS registry number CAS Registry Numbersare unique numerical identifiers assigned by the "Chemical Abstracts Service" toevery chemical described in the... |
Date of inclusion | Reason for inclusion | Priority | Latest application date | Sunset date |
|---|---|---|---|---|---|---|---|
| Cobalt(II) chloride Cobalt(II) chloride Cobalt chloride is an inorganic compound of cobalt and chloride, with the formula CoCl2. It is usually supplied as the hexahydrate CoCl2·6H2O, which is one of the most commonly used cobalt compounds in the laboratory. The hexahydrate is deep purple in color, whereas the anhydrous form is sky blue... (cobalt dichloride) |
7646-79-9 | 28 October 2008 20 June 2011 |
carcinogen | no | - | - | |
| 1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich | 71888-89-6 | 20 June 2011 | Toxic for reproduction | - | - | ||
| 1,2,3-Trichloropropane 1,2,3-Trichloropropane 1,2,3-Trichloropropane is a chemical compound that is commonly used as an industrial solvent. Although it is not currently labeled as a contaminant by the United States federal government, new research shows that it could have severe health effects... |
96-18-4 | 20 June 2011 | Carcinogen Toxic for reproduction |
- | - | ||
| 1-methyl-2-pyrrolidone | 872-50-4 | 20 June 2011 | Toxic for reproduction | - | - | ||
| Hydrazine Hydrazine Hydrazine is an inorganic compound with the formula N2H4. It is a colourless flammable liquid with an ammonia-like odor. Hydrazine is highly toxic and dangerously unstable unless handled in solution. Approximately 260,000 tons are manufactured annually... |
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 | - | - | ||
| Strontium chromate | 7789-06-2 | 20 June 2011 | Carcinogen | - | - | ||
| 2-ethoxyethyl acetate | 111-15-9 | 20 June 2011 | Toxic for reproduction | - | - | ||
| Chromic acid Chromic acid The term chromic acid is usually used for a mixture made by adding concentrated sulfuric acid to a dichromate, which may contain a variety of compounds, including solid chromium trioxide. This kind of chromic acid may be used as a cleaning mixture for glass. Chromic acid may also refer to the... , Oligomers of chromic acid and dichromic acid, Dichromic acid |
- |
7738-94-5 - 13530-68-2 |
15 December 2010 | Carcinogen | - | - | |
| Chromium trioxide Chromium trioxide Chromium trioxide is the inorganic compound with the formula CrO3. It is the acidic anhydride of chromic acid, and is sometimes marketed under the same name.This compound is a dark-red/orange brown solid, which dissolves in water concomitant with hydrolysis... |
1333-82-0 | 15 December 2010 | Carcinogen Mutagen |
- | - | ||
| 2-Ethoxyethanol 2-Ethoxyethanol 2-Ethoxyethanol, also known by the trademark Cellosolve or ethyl cellosolve, is a solvent used widely in commercial and industrial applications... |
110-80-5 | 15 December 2010 | Toxic for reproduction | - | - | ||
| 2-Methoxyethanol 2-Methoxyethanol 2-Methoxyethanol, or methyl cellosolve, is an organic compound that is used mainly as a solvent. It is a clear, colorless liquid with an ether-like odor. It is in a class of solvents known as glycol ethers which are notable for their ability to dissolve a variety of different types of chemical... |
109-86-4 | 15 December 2010 | Toxic for reproduction | - | - | ||
| Cobalt(II) diacetate | 71-48-7 | 15 December 2010 | Carcinogen Toxic for reproduction |
- | - | ||
| Cobalt(II) carbonate | 513-79-1 | 15 December 2010 | Carcinogen Toxic for reproduction |
- | - | ||
| Cobalt(II) dinitrate | 10141-05-6 | 15 December 2010 | Carcinogen Toxic for reproduction |
- | - | ||
| Cobalt(II) sulfate Cobalt(II) sulfate Cobalt sulfate is the inorganic compound with the formula CoSO4. It is the divalent cobalt salt of sulfuric acid. The most common form of cobalt sulfate are the hydrates CoSO4.7H2O and CoSO4.H2O... |
10124-43-3 | 15 December 2010 | Carcinogen Toxic for reproduction |
- | - | ||
| Sodium chromate Sodium chromate Sodium chromate is a yellow solid chemical compound used as a corrosion inhibitor in the petroleum industry, a dyeing auxiliary in the textile industry, as a wood preservative, and as a diagnostic pharmaceutical in determining red blood cell volume.... |
7775-11-3 | 18 June 2010 | Carcinogen Mutagen Toxic for reproduction |
- | - | ||
| Potassium chromate Potassium chromate Potassium chromate is a yellow chemical indicator used for identifying concentrations of chloride ions in a salt solution with silver nitrate... |
7789-00-6 | 18 June 2010 | Carcinogen Mutagen |
- | - | ||
| Ammonium dichromate Ammonium dichromate Ammonium dichromate is the inorganic compound with the formula 2Cr2O7. In this compound, as in all chromates and dichromates, chromium is in a +6 oxidation state, commonly known as hexavalent chromium... |
7789-09-5 | 18 June 2010 | Carcinogen Mutagen Toxic for reproduction |
- | - | ||
| Potassium dichromate | 7778-50-9 | 18 June 2010 | Carcinogen Mutagen Toxic for reproduction |
- | - | ||
| Tetraboron disodium heptaoxide, hydrate Hydrate Hydrate is a term used in inorganic chemistry and organic chemistry to indicate that a substance contains water. The chemical state of the water varies widely between hydrates, some of which were so labeled before their chemical structure was understood.... |
12267-73-1 | 18 June 2010 | Toxic for reproduction | - | - | ||
| Disodium tetraborate, anhydrous Anhydrous As a general term, a substance is said to be anhydrous if it contains no water. The way of achieving the anhydrous form differs from one substance to another... |
1303-96-4/1330-43-4/12179-04-3 | 18 June 2010 | Toxic for reproduction | - | - | ||
| Boric acid Boric acid Boric acid, also called hydrogen borate or boracic acid or orthoboric acid or acidum boricum, is a weak acid of boron often used as an antiseptic, insecticide, flame retardant, as a neutron absorber, and as a precursor of other chemical compounds. It exists in the form of colorless crystals or a... |
/ | 10043-35-3/11113-50-1 | 18 June 2010 | Toxic for reproduction | - | - | |
| Trichloroethylene Trichloroethylene The chemical compound trichloroethylene is a chlorinated hydrocarbon commonly used as an industrial solvent. It is a clear non-flammable liquid with a sweet smell. It should not be confused with the similar 1,1,1-trichloroethane, which is commonly known as chlorothene.The IUPAC name is... |
79-01-6 | 18 June 2010 | Carcinogen | - | - | ||
| Acrylamide Acrylamide Acrylamide is a chemical compound with the chemical formula C3H5NO. Its IUPAC name is prop-2-enamide. It is a white odourless crystalline solid, soluble in water, ethanol, ether, and chloroform. Acrylamide is incompatible with acids, bases, oxidizing agents, iron, and iron salts... |
79-06-1 | 30 March 2010 | Carcinogen Mutagen |
- | - | ||
| Aluminosilicate Aluminosilicate Aluminosilicate minerals are minerals composed of aluminium, silicon, and oxygen, plus countercations. They are a major component of kaolin and other clay minerals.... Refractory Ceramic Fibres |
- | Extracted from Index no. 650-017-00-8 | 13 January 2010 | Carcinogen | - | - | |
| Zirconia Aluminosilicate Aluminosilicate Aluminosilicate minerals are minerals composed of aluminium, silicon, and oxygen, plus countercations. They are a major component of kaolin and other clay minerals.... Refractory Ceramic Fibres |
- | Extracted from Index no. 650-017-00-8 | 13 January 2010 | Carcinogen | - | - | |
| Tris(2-chloroethyl)phosphate | 115-96-8 | 13 January 2010 | Toxic for reproduction | - | - | ||
| Pitch Pitch (resin) Pitch is the name for any of a number of viscoelastic, solid polymers. Pitch can be made from petroleum products or plants. Petroleum-derived pitch is also called bitumen. Pitch produced from plants is also known as resin. Products made from plant resin are also known as rosin.Pitch was... , coal tar Coal tar Coal tar is a brown or black liquid of extremely high viscosity, which smells of naphthalene and aromatic hydrocarbons. Coal tar is among the by-products when coal iscarbonized to make coke or gasified to make coal gas... , high temp. |
65996-93-2 | 13 January 2010 | Carcinogen PBT vPvB |
- | - | ||
| 2,4-Dinitrotoluene | 121-14-2 | 13 January 2010 | carcinogen | - | - | ||
| Anthracene oil | 90640-80-5 | 13 January 2010 | carcinogen PBT, vPvB |
- | - | ||
| Anthracene oil, anthracene paste | 90640-81-6 | 13 January 2010 | carcinogen mutagen PBT, vPvB |
- | - | ||
| Anthracene oil, anthracene paste, anthracene fraction | 91995-15-2 | 13 January 2010 | carcinogen mutagen PBT, vPvB |
- | - | ||
| Anthracene oil, anthracene paste, distillation lights | 91995-17-4 | 13 January 2010 | carcinogen mutagen PBT, vPvB |
- | - | ||
| Anthracene oil, anthracene-low | 90640-82-7 | 13 January 2010 | carcinogen mutagen PBT, vPvB |
- | - | ||
| Diisobutyl phthalate Diisobutyl phthalate Diisobutyl Phthalate is prepared by esterification process of isobutanol and phthalic anhydride. Its structural formula is C6H42. Refractive index is 1.488 - 1.492 .... (DIBP) |
84-69-5 | 13 January 2010 | toxic for reproduction | - | - | ||
| Lead chromate | 7758-97-6 | 13 January 2010 | carcinogen toxic for reproduction |
- | - | ||
| Lead chromate molybdate sulfate red (C.I. Pigment Red 104) | 12656-85-8 | 13 January 2010 | carcinogen toxic for reproduction |
- | - | ||
| Lead sulfochromate yellow (C.I. Pigment Yellow 34) | 1344-37-2 | 13 January 2010 | carcinogen toxic for reproduction |
- | - | ||
| Arsenic pentoxide Arsenic pentoxide Arsenic pentoxide is the inorganic compound with the formula As2O5. This glassy, white solid is relatively unstable, consistent with the rarity of the As oxidation state. More common, and far more important commercially, is arsenic oxide .... (diarsenic pentaoxide) |
1303-28-2 | 28 October 2008 | carcinogen | no | - | - | |
| Arsenic trioxide Arsenic trioxide Arsenic trioxide is the inorganic compound with the formula As2O3. This commercially important oxide of arsenic is the main precursor to other arsenic compounds, including organoarsenic compounds. Approximately 50,000 tonnes are produced annually... (diarsenic trioxide) |
1327-53-3 | 28 October 2008 | carcinogen | no | - | - | |
| 4,4'-Diaminodiphenylmethane (MDA) | 101-77-9 | 28 October 2008 | carcinogen | YES | 21 February 2013 | 21 August 2014 | |
| Lead hydrogen arsenate Lead hydrogen arsenate Lead hydrogen arsenate, also called lead arsenate, acid lead arsenate or LA, chemical formula PbHAsO4, is an inorganic insecticide used primarily against the potato beetle.-Chemistry:It is usually produced using the following reaction:... |
7784-40-9 | 28 October 2008 | carcinogen toxic for reproduction |
no | - | - | |
| Sodium dichromate Sodium dichromate Sodium dichromate is the chemical compound with the formula Na2Cr2O7. Usually, however, the salt is handled as its dihydrate Na2Cr2O7·2H2O. Virtually all chromium ore is processed via conversion to sodium dichromate. In this way, many millions of kilograms of sodium dichromate are produced... |
7789-12-0 10588-01-9 |
28 October 2008 | carcinogen mutagen toxic for reproduction |
no | - | - | |
| Triethyl arsenate | 15606-95-8 | 28 October 2008 | carcinogen | no | - | - | |
| Benzyl butyl phthalate Benzyl butyl phthalate Benzylbutylphthalate , also called n-butyl benzyl phthalate or benzyl butyl phthalate, is a phthalate, an ester of phthalic acid, benzyl alcohol and n-butanol. It comes under trade names e.g. Palatinol BB, Unimoll BB, Sicol 160, or Santicizer 160. It is mostly used as a plasticizer for PVC... (BBP) |
85-68-7 | 28 October 2008 | toxic for reproduction | YES | 21 August 2013 | 21 February 2015 | |
| Bis(2-ethylhexyl) phthalate Bis(2-ethylhexyl) phthalate Bisphthalate, commonly abbreviated DEHP, is an organic compound with the formula C6H42. It is sometimes called dioctyl phthalate and abbreviated DOP. It is the most important "phthalate," being the diester of phthalic acid and the branched-chain 2-ethylhexanol. This colourless viscous liquid is... (DEHP) |
117-81-7 | 28 October 2008 | toxic for reproduction | YES | 21 August 2013 | 21 February 2015 | |
| Dibutyl phthalate Dibutyl phthalate Dibutyl phthalate is a commonly used plasticizer. It is also used as an additive to adhesives or printing inks. It is soluble in various organic solvents, e.g. in alcohol, ether and benzene... (DBP) |
84-74-2 | 28 October 2008 | toxic for reproduction | YES | 21 August 2013 | 21 February 2015 | |
| Anthracene Anthracene Anthracene is a solid polycyclic aromatic hydrocarbon consisting of three fused benzene rings. It is a component of coal-tar. Anthracene is used in the production of the red dye alizarin and other dyes... |
120-12-7 | 28 October 2008 | PBT | no | - | - | |
| Hexabromocyclododecane Hexabromocyclododecane Hexabromocyclododecane is a brominated flame retardant. It consists of twelve carbon, eighteen hydrogen, and six bromine atoms tied to the ring. Its primary application is in extruded and expanded polystyrene foam that is used as thermal insulation in the building industry... (HBCDD), including all major diastereomers |
|
134237-50-6 134237-51-7 134237-52-8 |
28 October 2008 | PBT | YES | 21 February 2014 | 21 August 2015 |
| Short chain chlorinated paraffins (C10–C13 chloroalkanes, SCCP) |
85535-84-8 | 28 October 2008 | PBT vPvB |
YES | - | - | |
| Tributyltin oxide Tributyltin oxide Tributyltin oxide , or bisoxide, is an organotin compound chiefly used as a biocide , especially a wood preservative. Its chemical formula is C24H54OSn2. It has the form of a thin, colorless to pale yellow liquid with melting point -45 °C, boiling point 180 °C, and slight water solubility... (Bis(tributyltin) oxide, TBTO) |
56-35-9 | 28 October 2008 | PBT | no | - | - | |
| Musk xylene Musk xylene Musk xylene was the most widely used of the "nitro-musks", a type of synthetic musk fragrance, which mimic natural musk. It has been used as a perfume fixative in a wide variety of consumer products, and is still used in some cosmetics and fragrances.... (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
External links
- List of substances from ECHA
- Products' Management SVHCs consultancy
- Obligations Linked to the Candidate List of Substances of Very High Concern from ECHA