August 31, 2017, official journal of the European Commission published the amending the Appendices to Annex XVII to Regulation (EU) No 1907/2006 of REACH. The prohibitive substances that are classified as carcinogenic, mutagenic or reproductive toxicant (CRM) have been added to 23 and the previous 2 kinds of CMR also get their updates. This amendment will take into force on the 20th day.
Entries 28, 29 and 30 of Annex XVII to Regulation (EC) No 1907/2006 prohibit the placing on the market or use for supply to the general public of substances that are classified as carcinogenic, mutagenic or reproductive toxicant (CMR), category 1A or 1B, and of mixtures containing such substances in specified concentrations. The substances concerned are listed in Appendices 1 to 6 to that Annex.
Annex XVII to Regulation (EC) No 1907/2006 is amended as follows:
(1) in Appendix 2, the following entries are inserted in the table in order of the index numbers set out therein:
‘1,2-dichloropropane; propylene dichloride | 602-020-00-0 | 201-152-2 | 78-87-5 |
e-glass microfibers of representative composition; [Calcium-aluminium-silicate fibres with random orientation with the following representative composition (% given by weight): SiO2 50,0-56,0 %, Al2O3 13,0-16,0 %, B2O3 5,8-10,0 %, Na2O < 0,6 %, K2O < 0,4 %, CaO 15,0-24,0 %, MgO < 5,5 %, Fe2O3 < 0,5 %, F2 < 1,0 %. Process: typically produced by flame attenuation and rotary process. (Additional individual elements may be present at low levels; the process list does not preclude innovation).] | 014-046-00-4 |
(2) in Appendix 4, the following entry is inserted in the table in order of the index number set out therein:
‘3,7-dimethylocta-2,6-dienenitrile | 608-067-00-3 | 225-918-0 | 5146-66-7’ |
(3) in Appendix 5,
(a) the following entries are inserted in the table in order of the index numbers set out therein:
‘brodifacoum (ISO); 4-hydroxy-3-(3-(4′-bromo-4-biphenylyl)-1,2,3,4- tetrahydro-1-naphthyl)coumarin | 607-172-00-1 | 259-980-5 | 56073-10-0 |
lead powder; [particle diameter < 1 mm] | 082-013-00-1 | 231-100-4 | 7439-92-1 |
lead massive: [particle diameter≥1 mm] | 082-014-00-7 | 231-100-4 | 7439-92-1’ |
(b) the entry relating to warfarin; 4-hydroxy-3-(3-oxo-1- phenylbutyl)-coumarin is replaced by the following entry:
‘warfarin (ISO); 4-hydroxy-3-(3-oxo-1- phenylbutyl)-2H-chromen- 2-one; [1] (S)-4-hydroxy-3-(3-oxo- 1-phenylbutyl)-2-benzopyrone; [2] (R)-4-hydroxy-3-(3-oxo- 1-phenylbutyl)-2-benzopyrone [3] | 607-056-00-0 | 201-377-6 [1] 226-907-3 [2] 226-908-9 [3] | 81-81-2 [1] 5543-57-7 [2] 5543-58-8 [3]’ |
(4) in Appendix 6,
(a) the following entries are inserted in the table in order of the index numbers set out therein:
‘tetrahydro-2-furyl-methanol; tetrahydrofurfuryl alcohol | 603-061-00-7 | 202-625-6 | 97-99-4 |
gallium arsenide | 031-001-00-4 | 215-114-8 | 1303-00-0 |
Tributyltin compounds, with the exception of those specified elsewhere in this Annex | 050-008-00-3 | - | - |
1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear | 607-710-00-5 | 271-093-5 | 68515-50-4 |
imidazole | 613-319-00-0 | 206-019-2 | 288-32-4 |
bisphenol A; 4,4′-isopropylidenediphenol | 604-030-00-0 | 201-245-8 | 80-05-7 |
phenol, dodecyl-, branched; [1] phenol, 2-dodecyl-, branched; [2] phenol, 3-dodecyl-, branched; [3] phenol, 4-dodecyl-, branched; [4] phenol, (tetrapropenyl) derivatives [5] | 604-092-00-9 | 310-154-3 [1] - [2] - [3] - [4] - [5] | 121158-58-5 [1] - [2] - [3] 210555-94-5 [4] 74499-35-7 [5] |
chlorophacinone (ISO);2-[(4-chlorophenyl)(pheenyl)acetyl]-1H-indene-1,3(2H)-dione | 606-014-00-9 | 223-003-0 | 3691-35-8 |
coumatetralyl (ISO); 4-hydroxy-3-(1,2,3,4-tetrahydro-1-naphthyl)coumarin | 607-059-00-7 | 227-424-0 | 5836-29-3 |
difenacoum (ISO); 3-(3-biphenyl-4-yl-1,2,3,4-tetrahydro-1-naphthyl)-4-hydroxycoumarin | 607-157-00-X | 259-978-4 | 56073-07-5 |
flocoumafen (ISO); reaction mass of: cis-4-hydroxy-3-(1,2,3,4-tetrahydro-3-(4-(4-trifluoromethylbenzyloxy)phenyl)-1-naphthyl)coumarin and trans-4-hydroxy-3-(1,2,3,4-tetrahydro- 3-(4-(4-trifluoromethylbenzyloxy)phenyl)-1- naphthyl)coumarin | 607-375-00-5 | 421-960-0 | 90035-08-8 |
disodium octaborate anhydrous; [1] disodium octaborate tetrahydrate [2] | 005-020-00-3 | 234-541-0 [1] 234-541-0 [2] | 12008-41-2 [1] 12280-03-4 [2] |
bromadiolone (ISO); 3-[3-(4′-bromobiphenyl-4- yl)-3-hydroxy-1-phenylpropyl]-4-hydroxy-2H- chromen-2-one | 607-716-00-8 | 249-205-9 | 28772-56-7 |
difethialone (ISO); 3-[3-(4′-bromobiphenyl-4-yl)-1,2,3,4-tetrahydronaphthalen-1-yl]-4-hydroxy-2H-1-benzothiopyran-2-one | 607-717-00-3 | - | 104653-34-1 |
perfluorononan-1-oic acid [1] and its sodium [2] and ammonium [3] salts | 607-718-00-9 | 206-801-3 [1] - [2] - [3] | 375-95-1 [1] 21049-39-8 [2] 4149-60-4 [3] |
dicyclohexyl phthalate | 607-719-00-4 | 201-545-9 | 84-61-7 |
triflumizole (ISO); (1E)-N-[4-chloro-2-(trifluoromethyl)phenyl]- 1-(1H-imidazol-1-yl)-2-propoxyethanimine | 612-289-00-6 | - | 68694-11-1’ |
(b) the entry relating to flumioxazin (ISO); N-(7-fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl)—2,H 1,4-benzoxazin-6-yl)
cyclohex-1-ene-1,2dicarboxamide is replaced by the following entry:
‘flumioxazin (ISO); 2-[7-fluoro-3-oxo-4- (prop-2- yn-1-yl)-3,4-dihydro-2H-1,4-benzoxazin-6-yl]- 4,5,6,7-tetrahydro-1H-isoindole-1,3 (2H)-dione | 613-166-00-X | - | 103361-09-7’ |
C&K Testing reminds, CMRs are going to be prohibited placing on the market or use for supply to the general public. So the compounds containing CMRs also should meet the specific limits under (EC) No 1272/2008 and its requirement which regulates label shall mark “professional user application” applies to CMRs or their compounds.
|Further Information:
1. the amending the Appendices to Annex XVII to Regulation
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