ECHA launches a public consultation on 54 potential Substances of Very High Concern

The European Commission has requested the European Chemicals Agency (ECHA) to prepare Annex XV dossiers for 37 substances on their behalf. In addition, Austria, Germany, the Netherlands, Poland, Slovakia, Sweden and the United Kingdom have put forward proposals for the identification of 17 substances. Amongst the substances, 44 are proposed to be identified as SVHCs on the basis of their classifications as carcinogenic, mutagenic and/or toxic for reproduction (REACH Article 57(a–c)). One of these substances is also suggested as being of equivalent concern in accordance with Article 57(f) based on its endocrine disrupting properties. Five further substances are proposed to be of equivalent concern. In particular, three of those are respiratory sensitisers and proposed to be of equivalent level of concern for human health. Two further proposals comprise substances proposed to be of equivalent concern for the environment due to endocrine disrupting properties or because they are degrading to the already identified endocrine disruptor (1,1,3,3-tetramethylbutyl)phenol. Finally, five substances are proposed to be identified as being persistent, bioaccumulative and toxic (PBT) and/or very persistent and very bioaccumulative (vPvB) in accordance with Article 57(d) and/or (e). Comments should provide information concerning the identity of the substances or on their PBT/vPvB or “equivalent concern” properties. The Member State Committee will take these comments into account when seeking agreement on the identification of all proposed substances as SVHCs. No account will, however, be taken by the Committee of comments on CMR properties where harmonised classification is laid down in Annex VI of the regulation on classification, labelling and packaging of hazardous substances and mixtures (CLP Regulation). Furthermore, ECHA invites the submission of information on the uses of the substances. This would include data on tonnages per use and exposures or releases resulting from these uses. Information on the availability of safer alternative substances and techniques as well as the structure of supply chains is also welcome. ECHA will consider this information when recommending SVHCs for inclusion in the Authorisation List (Annex XIV). Information on the identity of the substances and the reasons for their proposal as SVHCs is available at ECHA’s consultation web pages and on their uses in the registered substances database. Comments should be submitted using the dedicated webform available on the ECHA website. Currently, 84 SVHCs have been included in the Candidate List. The current set of candidate SVHCs may take the total number above the policy target of 136 set for the end of 2012. Inclusion on this list imposes new information requirements on manufacturers and importers of listed substances and on suppliers of preparations and articles containing the substances. Substances proposed for identification as SVHC and reasons for their proposal Substance name EC number CAS number Proposed SVHC property Bis(pentabromophenyl) ether (DecaBDE) 214-604-9 1163-19-5 PBT (Article 57 d); vPvB (Article 57 e) Pentacosafluorotridecanoic acid 276-745-2 72629-94-8 vPvB (Article 57 e) Tricosafluorododecanoic acid 206-203-2 307-55-1 vPvB (Article 57 e) Henicosafluoroundecanoic acid 218-165-4 2058-94-8 vPvB (Article 57 e) Heptacosafluorotetradecanoic acid 206-803-4 376-06-7 vPvB (Article 57 e) 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated – covering well-defined substances and UVCB substances, polymers and homologues – – Equivalent level of concern – probable serious effects on the environment (Article 57 f) 4-Nonylphenol, branched and linear – substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, covering also UVCB- and well-defined substances which include any of the individual isomers or a combination thereof – – Equivalent level of concern – probable serious effects on the environment (Article 57 f) Diazene-1,2-dicarboxamide (C,C’-azodi(formamide)) 204-650-8 123-77-3 Equivalent level of concern – probable serious effects on human health (Article 57 f) Cyclohexane-1,2-dicarboxylic anhydride (Hexahydrophthalic anhydride – HHPA) 201-604-9 85-42-7 Equivalent level of concern – probable serious effects on human health (Article 57 f) Hexahydromethylphathalic anhydride, Hexahydro-4-methylphathalic anhydride, Hexahydro-1-methylphathalic anhydride, Hexahydro-3-methylphathalic anhydride 247-094-1, 243-072-0, 256-356-4, 260-566-1 25550-51-0, 19438-60-9, 48122-14-1, 57110-29-9 Equivalent level of concern – probable serious effects on human health (Article 57 f) Methoxy acetic acid 210-894-6 625-45-6 Toxic for reproduction (Article 57 c); equivalent level of concern -probable serious effects on human health and the environment (Article 57 f) 1,2-Benzenedicarboxylic acid, dipentylester, branched and linear 284-032-2 84777-06-0 Toxic for reproduction (Article 57 c) Diisopentylphthalate (DIPP) 210-088-4 605-50-5 Toxic for reproduction (Article 57 c) N-pentyl-isopentylphtalate – – Toxic for reproduction (Article 57 c) 1,2-Diethoxyethane 211-076-1 629-14-1 Toxic for reproduction (Article 57 c) N,N-dimethylformamide; dimethyl formamide 200-679-5 68-12-2 Toxic for reproduction (Article 57 c) Dibutyltin dichloride (DBT) 211-670-0 683-18-1 Toxic for reproduction (Article 57 c) Acetic acid, lead salt, basic 257-175-3 51404-69-4 Toxic for reproduction (Article 57 c) Basic lead carbonate (trilead bis(carbonate)dihydroxide) 215-290-6 1319-46-6 Toxic for reproduction (Article 57 c) Lead oxide sulfate (basic lead sulfate) 234-853-7 12036-76-9 Toxic for reproduction (Article 57 c) [fusion_builder_container hundred_percent=”yes” overflow=”visible”][fusion_builder_row][fusion_builder_column type=”1_1″ background_position=”left top” background_color=”” border_size=”” border_color=”” border_style=”solid” spacing=”yes” background_image=”” background_repeat=”no-repeat” padding=”” margin_top=”0px” margin_bottom=”0px” class=”” id=”” animation_type=”” animation_speed=”0.3″ animation_direction=”left” hide_on_mobile=”no” center_content=”no” min_height=”none”][Phthalato(2-)]dioxotrilead (dibasic lead phthalate) 273-688-5 69011-06-9 Toxic for reproduction (Article 57 c) Dioxobis(stearato)trilead 235-702-8 12578-12-0 Toxic for reproduction (Article 57 c) Fatty acids, C16-18, lead salts 292-966-7 91031-62-8 Toxic for reproduction (Article 57 c) Lead bis(tetrafluoroborate) 237-486-0 13814-96-5 Toxic for reproduction (Article 57 c) Lead cynamidate 244-073-9 20837-86-9 Toxic for reproduction (Article 57 c) Lead dinitrate 233-245-9 10099-74-8 Toxic for reproduction (Article 57 c) Lead oxide (lead monoxide) 215-267-0 1317-36-8 Toxic for reproduction (Article 57 c) Lead tetroxide (orange lead) 215-235-6 1314-41-6 Toxic for reproduction (Article 57 c) Lead titanium trioxide 235-038-9 12060-00-3 Toxic for reproduction (Article 57 c) Lead Titanium Zirconium Oxide 235-727-4 12626-81-2 Toxic for reproduction (Article 57 c) Pentalead tetraoxide sulphate 235-067-7 12065-90-6 Toxic for reproduction (Article 57 c) Pyrochlore, antimony lead yellow 232-382-1 8012-00-8 Toxic for reproduction (Article 57 c) Silicic acid, barium salt, lead-doped 272-271-5 68784-75-8 Toxic for reproduction (Article 57 c) Silicic acid, lead salt 234-363-3 11120-22-2 Toxic for reproduction (Article 57 c) Sulfurous acid, lead salt, dibasic 263-467-1 62229-08-7 Toxic for reproduction (Article 57 c) Tetraethyllead 201-075-4 78-00-2 Toxic for reproduction (Article 57 c) Tetralead trioxide sulphate 235-380-9 12202-17-4 Toxic for reproduction (Article 57 c) Trilead dioxide phosphonate 235-252-2 12141-20-7 Toxic for reproduction (Article 57 c) Furan 203-727-3 110-00-9 Carcinogenic (Article 57a) Propylene oxide; 1,2-epoxypropane; methyloxirane 200-879-2 75-56-9 Carcinogenic (Article 57 a); Mutagenic (Article 57 b) Diethyl sulphate 200-589-6 64-67-5 Carcinogenic (Article 57 a); Mutagenic (Article 57 b) Dimethyl sulphate 201-058-1 77-78-1 Carcinogenic (Article 57 a) 3-ethyl-2-methyl-2-(3-methylbutyl)-1,3-oxazolidine 421-150-7 143860-04-2 Toxic for reproduction (Article 57 c) Dinoseb 201-861-7 88-85-7 Toxic for reproduction (Article 57 c) 4,4′-methylenedi-o-toluidine 212-658-8 838-88-0 Carcinogenic (Article 57 a) 4,4′-oxydianiline and its salts 202-977-0 101-80-4 Carcinogenic (Article 57 a); Mutagenic (Article 57 b) 4-Aminoazobenzene; 4-Phenylazoaniline 200-453-6 60-09-3 Carcinogenic (Article 57 a) 4-methyl-m-phenylenediamine (2,4-toluene-diamine) 202-453-1 95-80-7 Carcinogenic (Article 57 a) 6-methoxy-m-toluidine (p-cresidine) 204-419-1 120-71-8 Carcinogenic (Article 57 a) Biphenyl-4-ylamine 202-177-1 92-67-1 Carcinogenic (Article 57 a) o-aminoazotoluene 202-591-2 97-56-3 Carcinogenic (Article 57 a) o-Toluidine; 2-Aminotoluene 202-429-0 95-53-4 Carcinogenic (Article 57 a) N-methylacetamide 201-182-6 79-16-3 Toxic for reproduction (Article 57 c) 1-bromopropane; n-propyl bromide 203-445-0 106-94-5 Toxic for reproduction (Article 57 c)

ECHA, 3 September 2012 ;http://echa.europa.eu ;

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