当地时间2021年12月14日,欧盟在其官方公报上发布(EU)2021/2204法规,更新REACH法规附录XVII中的CMR(carcinogenic, mutagenic or reproductive toxicant ,致癌,致畸或生殖毒性)物质清单,将限制的CMR物质清单再次扩大范围。
欧盟REACH法规附录XVII中的第28、29和30项规定,任何人禁止(规定了特定的浓度范围)向市场投放和使用,或向公众供应被分类为1A或1B类的CMR物质。具体的CMR物质被列入该附录的附件表格1至表格6中。这些物质也同步列于(EC) No 1272/2008法规的附件VI的第三部分。
本次更新具有整体约束力,自公布在官方公报之日起第20天开始生效,并直接适用于所有欧盟成员国。
附表2中罗列了附录XVII中第28项管控的1B类的致癌物质(Carcinogens: Category 1 B),现增加如下物质:
Substances | EC No | CAS No |
‘silicon carbide fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1) | 206-991-8 | 409-21-2 308076-74-6’ |
‘dibenzo[def,p]chrysene; dibenzo[a,l]pyrene | 205-886-4 | 191-30-0’ |
‘tetrafluoroethylene | 204-126-9 | 116-14-3’ |
‘1,4-dioxane | 204-661-8 | 123-91-1’ |
‘m-bis(2,3-epoxypropoxy)benzene; resorcinol diglycidyl ether | 202-987-5 | 101-90-6’ |
‘7-oxa-3-oxiranylbicyclo[4.1.0]heptane; 1,2-epoxy-4-epoxyethylcyclohexane; 4-vinylcyclohexene diepoxide | 203-437-7 | 106-87-6’ |
‘2,2-bis(bromomethyl)propane-1,3-diol | 221-967-7 | 3296-90-0’ |
‘sodium N-(hydroxymethyl)glycinate; [formaldehyde released from sodium N-(hydroxymethyl)glycinate] | 274-357-8 | 70161-44-3’ |
‘butanone oxime; ethyl methyl ketoxime; ethyl methyl ketone oxime | 202-496-6 | 96-29-7’ |
‘N-(hydroxymethyl)acrylamide; methylolacrylamide; [NMA] | 213-103-2 | 924-42-5’; |
附表4中罗列了附录XVII中第29项管控的1B类致基因突变物质(Germ cell mutagens: Category 1 B),现增加如下物质:
Substances | EC No | CAS No |
‘2,2-bis(bromomethyl)propane-1,3-diol | 221-967-7 | 3296-90-0’ |
‘N-(hydroxymethyl)acrylamide; methylolacrylamide; [NMA] | 213-103-2 | 924-42-5’; |
附表6中罗列了附录XVII中第30项管控的1B类生殖毒性物质(Reproductive toxicants: Category 1 B),现增加如下物质:
Substances | EC No | CAS No |
‘mancozeb (ISO); manganese ethylenebis(dithiocarbamate) (polymeric) complex with zinc salt | - | 8018-01-7’ |
‘tris(2-methoxyethoxy)vinylsilane; 6-(2-methoxyethoxy)-6-vinyl-2,5,7,10-tetraoxa-6-silaundecane | 213-934-0 | 1067-53-4’ |
‘dichlorodioctylstannane | 222-583-2 | 3542-36-7’ |
‘dioctyltin dilaurate; [1] stannane, dioctyl-, bis(coco acyloxy) derivs. [2] | 222-883-3 [1] 293-901-5 [2] | 3648-18-8 [1] 91648-39-4 [2]’ |
‘7-oxa-3-oxiranylbicyclo[4.1.0]heptane; 1,2-epoxy-4-epoxyethylcyclohexane; 4-vinylcyclohexene diepoxide | 203-437-7 | 106-87-6’ |
‘ipconazole (ISO); (1RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl)-5-isopropyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol | - | 125225-28-7 115850-69-6 115937-89-8’ |
‘bis(2-(2-methoxyethoxy)ethyl)ether; tetraglyme | 205-594-7 | 143-24-8’ |
‘6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol; [DBMC] | 204-327-1 | 119-47-1’ |
‘2-(4-tert-butylbenzyl)propionaldehyde | 201-289-8 | 80-54-6’ |
‘diisooctyl phthalate | 248-523-5 | 27554-26-3’ |
‘2-methoxyethyl acrylate | 221-499-3 | 3121-61-7’ |
‘dimethomorph (ISO); (E,Z)-4-(3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl)morpholine | 404-200-2 | 110488-70-5’ |
‘1,2,4-triazole | 206-022-9 | 288-88-0’ |
‘pyrithione zinc; (T-4)-bis[1-(hydroxy-.kappa.O)pyridine-2(1H)-thionato-.kappa.S]zinc | 236-671-3 | 13463-41-7’ |
‘flurochloridone (ISO); 3-chloro-4-(chloromethyl)-1-[3-(trifluoromethyl)phenyl]pyrrolidin-2-one | 262-661-3 | 61213-25-0’ |
‘3-methylpyrazole | 215-925-7 | 1453-58-3’ |
‘bis(α,α-dimethylbenzyl) peroxide | 201-279-3 | 80-43-3’ |
对于上述这类物质,需要满足欧盟(EC) No 1272/2008法规规定的物质分类、包装和标签要求,同时需要满足(EC) No 1272/2008法规的附件VI的第三部分制定的特定限量要求,此外这些物质或混合物的包装上还需要以不可磨灭的方式标注如下字样“仅限专业人员使用”(Restricted to professional users)。