COMMISSION REGULATION (EU) No /.. of XXX
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1 EUROPEAN COMMISSION Brussels, XXX [ ](2012) XXX draft COMMISSION REGULATION (EU) No /.. of XXX amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (Text with EEA relevance) EN EN
2 COMMISSION REGULATION (EU) No /.. of XXX amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 1, and in particular Article 37(5) thereof, Whereas: (1) Part 3 of Annex VI to Regulation (EC) No 1272/2008 contains two lists of harmonised classification and labelling of hazardous substances. Table 3.1 lists the harmonised classification and labelling of hazardous substances based on the criteria set out in Parts 2 to 5 of Annex I to Regulation (EC) No 1272/2008. Table 3.2 lists the harmonised classification and labelling of hazardous substances based on the criteria set out in Annex VI to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances 2. Those two lists need to be amended to include updated classifications for substances already subject to those harmonised classifications and to include new harmonised classifications. (2) The Committee for Risk Assessment (RAC) of the European Chemicals Agency (ECHA) has issued opinions on proposals for harmonised classification and labelling of substances which had been submitted to ECHA pursuant to Article 37 of Regulation (EC) No 1272/2008. Based on those opinions, as well as on the comments received from the parties concerned, it is appropriate to amend Annex VI to Regulation (EC) No 1272/2008 in order to harmonise the classification and labelling of certain substances. (3) The harmonised classifications set out in Part 3 of Annex VI to Regulation (EC) No 1272/2008, as amended by this Regulation, should not apply immediately, as a certain period of time will be necessary to allow operators to adapt the labelling and packaging of substances and mixtures to the new classifications and to sell existing stocks. In addition, a certain period of time will be necessary to allow operators to comply with the registration obligations resulting from the new harmonised classifications for substances classified as carcinogenic, mutagenic or toxic to reproduction, categories 1A and 1B (Table 3.1) and categories 1 and 2 (Table 3.2), or 1 2 OJ L 353, , p. 1. OJ 196, , p. 1. EN 2 EN
3 as very toxic to aquatic organisms which may cause long term effects in the aquatic environment, in particular with those set out in Article 23 of 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, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC 3. (4) With regard to the substance 'pitch, coal tar, high-temp.; pitch' (EC Number: ), an extended period of time will be necessary to allow operators to comply with the obligations resulting from the new harmonised classification for substances classified as very toxic to aquatic organisms which may cause long term effects in the aquatic environment, in particular with those set out in Article 6 of Council Directive 96/82/EC of 9 December 1996 on the control of major-accident hazards involving dangerous substances 4, in Article 7 of Directive 2012/18/EU of the European Parliament and of the Council of 4 July 2012 on the control of major-accident hazards involving dangerous substances, amending and subsequently repealing Council Directive 96/82/EC 5, and in Article 3 and Annex III of Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods 6. Therefore, a longer transition time should be foreseen before the harmonised classification has to be applied. (5) With regard to the substance gallium arsenide (EC Number: ), the RAC is in the process of adopting a new opinion for the hazard class 'toxicity to reproduction'. Therefore, this hazard class should not be included in Annex VI to Regulation (EC) No 1272/2008 until that opinion is finalised. (6) With regard to the substance polyhexamethylene biguanide hydrochloride PHMB (CAS number or ), new scientific data has been made available for the hazard class 'acute toxicity (inhalation)', which suggests that the classification for this hazard class as recommended in the RAC opinion, which is based on older data, might not be appropriate. Therefore, this hazard class should not be included in Annex VI to Regulation (EC) No 1272/2008 until RAC has had the opportunity to deliver an opinion on the new information, while all other hazard classes covered by the earlier RAC opinion should be included. (7) In line with the transitional provisions of Regulation (EC) No 1272/2008 which allow the application of the new provisions at an earlier stage on a voluntary basis, suppliers should have the possibility of applying the harmonised classifications set out in Part 3 of Annex VI to Regulation (EC) No 1272/2008, as amended by this Regulation, and of adapting the labelling and packaging accordingly on a voluntary basis before the dates by which the harmonised classifications will become mandatory. (8) The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006, OJ L 396, , p. 1. OJ L 10, , p. 13. OJ L 197, , p. 1. OJ L 260, , p. 13. EN 3 EN
4 HAS ADOPTED THIS REGULATION: Article 1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 is amended as follows: (1) Table 3.1 is amended as follows: (a) The entries set out in Annex VI to Regulation (EC) No 1272/2008 corresponding to the entries set out in Annex I to this Regulation are replaced by the entries set out in Annex I to this Regulation; (b) The entries set out in Annex II to this Regulation are inserted in accordance with the order of the entries set out in Table 3.1. (2) Table 3.2 is amended as follows: (a) The entries set out in Annex VI to Regulation (EC) No 1272/2008 corresponding to the entries set out in Annex III to this Regulation are replaced by the entries set out in in Annex III to this Regulation; (b) The entries set out in Annex IV to this Regulation are inserted in accordance with the order of the entries set out in Table 3.2. Article 2 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. Article 1 shall apply from 1 January 2015 for all entries except for the entry 'pitch, coal tar, high-temp.; pitch' (EC Number ), for which Article 1 shall apply from 1 April The harmonised classifications set out in Part 3 of Annex VI to Regulation (EC) No 1272/2008, as amended by this Regulation, may be applied before the dates referred to in Article 2(2). This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, For the Commission The President José Manuel BARROSO EN 4 EN
5 ANNEX I Index No International Chemical Identification EC No CAS No Classification Hazard Class and Category Code(s) Hazard statement Code(s) Pictogram, Signal Word Code(s) Labelling Hazard statement Code(s) Suppl. Hazard statement Code(s) Specific Conc. Limits, M - Factors Notes aluminium phosphide Water-react. 1 Acute Tox. 2 Acute Tox. 3 Acute Tox. 1 Acute 1 H260 H300 H311 H330 GHS02 GHS06 H260 H300 H311 H330 EUH029 EUH magnesium phosphide; trimagnesium diphosphide Water-react. 1 Acute Tox. 2 Acute Tox. 3 Acute Tox. 1 Acute 1 H260 H300 H311 H330 GHS02 GHS06 H260 H300 H311 H330 EUH029 EUH fenamiphos (ISO); ethyl-4-methylthio-m-tolyl isopropyl phosphoramidate Acute Tox. 2 Acute Tox. 2 Acute Tox. 2 Eye Irrit. 2 Acute 1 H300 H310 H330 H319 GHS06 H300 H310 H330 H aluminium-magnesium-zinc-carbonatehydroxide Chronic 4 H413 H chloroform; trichloromethane Carc. 2 Repr. 2 Acute Tox. 3 Acute Tox. 4 STOT RE 1 Eye Irrit. 2 Skin Irrit. 2 H361d H331 H319 H315 GHS06 H361d H331 H319 H ,1',1''-nitrilotripropan-2-ol; triisopropanolamine Eye Irrit. 2 H319 GHS07 Wng H319 EN 5 EN
6 acrolein; prop-2-enal; acrylaldehyde Flam. Liq. 2 Acute Tox. 1 Acute Tox. 2 Acute Tox. 3 Skin Corr. 1 Acute 1 H225 H330 H300 H311 H314 GHS02 GHS06 GHS05 H225 H330 H300 H311 H314 EUH071 Skin Corr. 1; H314: C 0.1 % 0 M =1 D vinyl acetate Flam. Liq. 2 Carc. 2 Acute Tox. 4 STOT SE 3 H225 H335 GHS02 GHS07 H225 H335 D reaction mass of; succinic acid monopersuccinic acid dipersuccinic acid monomethyl ester of succinic acid monomethyl ester of persuccinic acid dimethyl succinate glutaric acid monoperglutaric acid diperglutaric acid monomethyl ester of glutaric acid monomethyl ester of perglutaric acid dimethyl glutarate adipic acid monoperadipic acid diperadipic acid monomethyl ester of adipic acid monomethyl ester of peradipic acid dimethyl adipate hydrogen peroxide methanol water Acute Tox. 4* Acute Tox. 4* Acute Tox. 4* Skin Corr. 1B STOT SE 2 H312 H314 H371 (eyes) GHS07 GHS05 H312 H314 H371 (eyes) Nitrobenzene Carc. 2. Repr. 1B Acute Tox. 3 Acute Tox. 3 Acute Tox. 3 STOT RE 1 Chronic 3 H360F H301 H331 H311 (blood) H412 GHS06 H360F H301 H331 H311 (blood) H412 EN 6 EN
7 aclonifen (ISO); 2-chloro-6-nitro-3-phenoxyaniline Carc. 2 Skin Sens. 1A Acute 1 GHS07 Wng epoxiconazole (ISO); (2RS,3SR)-3-(2-chlorophenyl)-2-(4- fluorophenyl)-[( 1H-1,2,4-triazol-1-yl)methyl]oxirane Carc. 2 Repr. 1B Chronic 2 H360Df H411 H360Df H reaction mass of N,N'-ethane-1,2- diylbis(hexanamide) and 12-hydroxy-N-[2- [(1-oxyhexyl)amino]ethyl]octadecanamide and N,N'-ethane-1,2-diylbis(12- hydroxyoctadecan amide) Chronic 4 H413 H pitch, coal tar, high-temp.; pitch; [The residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 30 C to 180 C (86 F to 356 F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.] Carc. 1A Muta. 1B Repr. 1B Acute 1 H350 H340 H360FD H350 H340 H360FD naphtha (petroleum), hydrodesulphurized heavy; Low boiling point hydrogen treated naphtha; [A complex combination of hydrocarbons obtained from a catalytic hydrodesulfurization process. It consists of hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 90 C to 230 C (194 F to 446 F).] Carc. 1B Muta. 1B STOT RE 1 Asp. Tox. 1 H350 H340 (central nervous H350 H340 (central nervous P X solvent naphtha (petroleum), medium aliph.; Straight run kerosine; [A complex combination of hydrocarbons obtained from the distillation of crude oil or natural gasoline. It consists predominantly of STOT RE 1 Asp. Tox. 1 (central nervous (central nervous EN 7 EN
8 saturated hydrocarbons having carbon numbers predominantly in the range of C9 through C12 and boiling in the range of approximately 140 C to 220 C (284 F to 428 F).] stoddard solvent; Low boiling point naphtha unspecified; [A colourless, refined petroleum distillate that is free from rancid or objectionable odours and that boils in a range of approximately 148,8 C to 204,4 C (300 F to 400 F).] Carc. 1B Muta. 1B STOT RE 1 Asp. Tox. 1 H350 H340 (central nervous H350 H340 (central nervous P EN 8 EN
9 ANNEX II Index No International Chemical Identification EC No CAS No Classification Hazard Class and Category Code(s) Hazard statement Code(s) Pictogram, Signal Word Code(s) Labelling Hazard statement Code(s) Suppl. Hazard statement Code(s) Specific Conc. Limits, M - Factors Notes gallium arsenide Carc. 1B STOT RE 1 H350 (respiratory and haematopoieti c systems) H350 (respiratory and haematopoieti c systems) trichloromethylstannane Repr. 2 H361d Wng H361d ethylhexyl 10-ethyl-4-[[2-[(2- ethylhexyl)oxy]-2-oxoethyl]thio]-4-methyl- 7-oxo-8-oxa-3,5-dithia-4- stannatetradecanoate Repr. 2 H361d Wng H361d ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8- oxa-3,5-dithia-4-stannatetradecanoate Repr. 1B H360D H360D ,4,4-trimethylpentene Flam. Liq. 2 Asp. Tox. 1 STOT SE 3 H225 H336 GHS02 GHS07 H225 H336 D sulcotrione (ISO); 2-[2-chloro-4- (methylsulfonyl)benzoyl]cyclohexane-1,3- dione Repr. 2 STOT RE 2 Skin Sens. 1A Acute 1 H361d H373 (kidneys) GHS07 Wng H361d H373 (kidneys) M = bifenthrin (ISO); (2-methylbiphenyl-3-yl)methyl rel-(1r,3r)- 3-[(1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1- yl]-2,2-dimethylcyclopropanecarboxylate Carc. 2 Acute Tox. 3 Acute Tox. 2 STOT RE 1 Skin Sens. 1B Acute 1 H331 H300 (nervous GHS06 H331 H300 (nervous EN 9 EN
10 ammoniumpentadecafluorooctanoate Carc. 2 Repr. 1B Lact. Acute Tox. 4 Acute Tox. 4 STOT RE 1 Eye dam.1 H360D H362 (liver) H318 GHS07 GHS05 H360D H362 (liver) H perfluorooctanoic acid Carc. 2 Repr. 1B Lact. Acute Tox. 4 Acute Tox. 4 STOT RE 1 Eye Dam. 1 H360D H362 (liver) H318 GHS07 GHS05 H360D H362 (liver) H indoxacarb (ISO); methyl (4aS)-7-chloro-2- {(methoxycarbonyl)[4- (trifluoromethoxy)phenyl]carbamoyl}-2,5- dihydroindeno[1,2-e][1,3,4]oxadiazine- 4a(3H)-carboxylate [1] reaction mass of (S)- Indoxacarb and (R)- Indoxacarb 75:25; methyl 7-chloro-2-{(methoxycarbonyl)[4- (trifluoromethoxy)phenyl]carbamoyl}-2,5- dihydroindeno[1,2-e][1,3,4]oxadiazine- 4a(3H)-carboxylate [2] [1] [2] Acute Tox. 3 Acute Tox. 4 STOT RE 1 Skin Sens. 1B Acute 1 H301 GHS06 H301 M =1 M = dihexyl phthalate Repr. 1B H360FD H360FD octadecylamine Asp. Tox. 1 STOT RE 2 Skin Irrit. 2 Eye Dam. 1 Acute 1 H373 (gastrointestinal tract, liver, immune H315 H318 GHS05 H373 (gastrointestinal tract, liver, immune H315 H318 EN 10 EN
11 (Z)-octadec-9-enylamine Acute Tox. 4 Asp Tox. 1 STOT SE 3 STOT RE 2 Skin Corr. 1B Acute 1 H335 H373 (gastrointestinal tract, liver, immune H314 GHS05 GHS07 H335 H373 (gastrointestinal tract, liver, immune H amines, hydrogenated tallow alkyl Asp Tox. 1 STOT RE 2 Skin Irrit. 2 Eye Dam. 1 Acute 1 H373 (gastrointestinal tract, liver, immune H315 H318 GHS05 H373 (gastrointestinal tract, liver, immune H315 H amines, coco alkyl Acute Tox. 4 Asp. Tox. 1 STOT SE3 STOT RE 2 Skin Corr. 1B Acute 1 H335 H373 (gastrointestinal tract, liver, immune H314 GHS05 GHS07 H335 H373 (gastrointestinal tract, liver, immune H X amines, tallow alkyl Acute Tox. 4 Asp. Tox. 1 STOT RE 2 Skin Corr. 1B Acute 1 H373 (gastrointestinal tract, liver, immune GHS05 GHS07 H373 (gastrointestinal tract, liver, immune EN 11 EN
12 H314 H flufenoxuron (ISO); 1-(4-(2-cloro-α,α,α-p-trifluorotolyloxy)-2- fluorophenyl)-3-(2,6-difluorobenzolyl)urea Lact. Acute 1 H362 Wng H X polyhexamethylene biguanide hydrochloride or N-ethyl-2-pyrrolidone; 1-ethylpyrrolidin-2-one Carc. 2 Acute Tox. 4 STOT RE 1 Eye Dam. 1 Skin Sens. 1B Acute 1 (respiratory tract) (inhalation) H318 GHS Repr. 1B H360D (respiratory tract) (inhalation) H318 H360D amidosulfuron (ISO); 3-(4,6-dimethoxypyrimidin-2-yl)-1-((Nmethyl-Nmethylsulfonylamino)sulfonyl)urea Acute 1 Wng tebufenpyrad (ISO); N-(4-tertbutylbenzyl)- 4-chloro-3-ethyl-1-methyl-1Hpyrazole-5- carboxamide Acute Tox. 3 Acute Tox. 4 STOT RE 2 Skin Sens. 1B Acute 1 H301 (Gastrointesti nal tract) (Oral) GHS06 H301 (Gastrointesti nal tract) (Oral) proquinazid (ISO); 6-iodo-2-propoxy-3-propylquinazolin-4(3H)- one Carc. 2 Acute 1 Wng M =1 EN 12 EN
13 ANNEX III Index No International Chemical Identification EC No CAS No Classification Labelling Concentration Limits Notes aluminium phosphide F; R15/29 T+; R26/28 Xn; R21 R32 N; R magnesium phosphide; trimagnesium diphosphide fenamiphos (ISO); ethyl-4-methylthio-m-tolyl isopropyl phosphoramidate aluminium-magnesium-zinc-carbonatehydroxide F; R15/29 T+; R26/28 Xn; R21 R32 N; R T+; R26/28 T; R24 Xi; R R53 R: 53 S: 61 F; T+; N R: 15/ / S: (1/2-)3/9/14/ / F; T+; N R: 15/ / S: (1/2-)3/9/14/ / T+; N R: 24-26/ /53 S: (1/2-) / N; R50: C 0.25 % N; R50: C 0.25% : C 0.25 % N; R51-53: % C < 0.25 % R52-53: % C < % chloroform; trichloromethane Carc. Cat. 3; R40 Repr. Cat. 3; R63 Xn; R20/22-48/20 Xi; R36/38 Xn R: 20/22-36/ /20-63 S: (2-)36/ ,1',1''-nitrilotripropan-2-ol; triisopropanolamine Xi; R36 Xi R: 36 S: (2-) acrolein; prop-2-enal; acrylaldehyde F; R11 T+; R26/28 T; R24 C; R34 F; T+; C; N R: / S: (1/2-) C; R34: C 0.1% N; R50: C 0.25% D EN 13 EN
14 N; R /37/ vinyl acetate F; R11 Carc. Cat. 3; R40 Xn; R20 Xi; R37 F; Xn R: S: /37 D reaction mass of; succinic acid monopersuccinic acid dipersuccinic acid monomethyl ester of succinic acid monomethyl ester of persuccinic acid dimethyl succinate glutaric acid monoperglutaric acid diperglutaric acid monomethyl ester of glutaric acid monomethyl ester of perglutaric acid dimethyl glutarate adipic acid monoperadipic acid diperadipic acid monomethyl ester of adipic acid monomethyl ester of peradipic acid dimethyl adipate hydrogen peroxide methanol water C; R34 Xn; R20/21/22-68/20/21/22 C R: 20/21/ /20/21/22 S: (1/2-) /37/ Nitrobenzene Carc. Cat. 3; R40 Repr. Cat. 2; R60 T; R23/24/25-48/23/24/25 R aclonifen (ISO); 2-chloro-6-nitro-3-phenoxyaniline Carc. Cat. 3; R40 R43 T R: 23/24/25-48/23/24/ /53 S: (1/2-)27-36/ Xn; N R: /53 S: (2-)36/ R43: C 0.1% : C 0.25 % N; R51-53: % C < 0.25 % R52-53: % C < % EN 14 EN
15 epoxiconazole (ISO); (2RS,3SR)-3-(2-chlorophenyl)-2-(4- fluorophenyl)-[(1h-1,2,4-triazol-1- yl)methyl]oxirane Carc. Cat. 3; R40 Repr. Cat. 2; R61 Repr. Cat. 3; R62 N; R51-53 T; N R: /53 S: reaction mass of N,N'-ethane-1,2- diylbis(hexanamide) and 12-hydroxy-N-[2- [(1-oxyhexyl)amino]ethyl]octadecanamide and N,N'-ethane-1,2-diylbis(12- hydroxyoctadecan amide) R53 R: 53 S: pitch, coal tar, high-temp.; pitch; [The residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 30 C to 180 C (86 F to 356 F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.] Carc. Cat. 1; R45 Muta. Cat. 2; R46 Repr. Cat. 2; R60-61 T; N R: /53 S: : C % N; R51-53: % C < % R52-53: % C < % naphtha (petroleum), hydrodesulphurized heavy; Low boiling point hydrogen treated naphtha; [A complex combination of hydrocarbons obtained from a catalytic hydrodesulfurization process. It consists of hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 90 C to 230 C (194 F to 446 F).] Carc. Cat. 2; R45 Muta. Cat. 2; R46 Xn; R48/20-65 T R: /20-65 S: P stoddard solvent; Low boiling point naphtha unspecified; [A colourless, refined petroleum distillate that is free from rancid or objectionable odours and that boils in a range of approximately 148,8 C to 204,4 C (300 F to 400 F).] Carc. Cat. 2; R45 Muta. Cat. 2; R46 Xn; R48/20-65 T R: /20-65 S: P X solvent naphtha (petroleum), medium aliph.; Xn; R48/20-65 Xn EN 15 EN
16 Straight run kerosine; [A complex combination of hydrocarbons obtained from the distillation of crude oil or natural gasoline. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C9 through C12 and boiling in the range of approximately 140 C to 220 C (284 F to 428 F).] R: 48/20-65 S: (2-) EN 16 EN
17 ANNEX IV Index No International Chemical Identification EC No CAS No Classification Labelling Concentration Limits Notes gallium arsenide Carc. Cat. 2; R45 T; R48/23 T R: 45-48/23 S: trichloromethylstannane Repr. Cat. 3; R63 Xn R: 63 S: (2-)22-36/ ethylhexyl 10-ethyl-4-[[2-[(2- ethylhexyl)oxy]-2-oxoethyl]thio]-4-methyl- 7-oxo-8-oxa-3,5-dithia-4- stannatetradecanoate Repr. Cat. 3; R63 Xn R: 63 S: (2-)22-36/37 E ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8- oxa-3,5-dithia-4-stannatetradecanoate Repr. Cat. 2; R61 T R: 61 S: ,4,4-trimethylpentene F; R11 Xn; R65 R sulcotrione (ISO); 2-[2-chloro-4- (methylsulfonyl)benzoyl]cyclohexane-1,3- dione bifenthrin (ISO); (2-methylbiphenyl-3-yl)methyl rel-(1r,3r)- 3-[(1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1- yl]-2,2-dimethylcyclopropanecarboxylate Repr. Cat. 3; R63 Xn; R48/22 R Carc. Cat 3; R40 T; R23/25 Xn; R48/22 R43 F; Xn R: S: Xn; N R: 43-48/ /53 S: (2-)22-36/ T; N R: 23/ /22-50/53 S: (1/2-) / : C 25 % N; R51-53: 2.5 % C < 25 % R52-53: 0.25 % C< 2.5 % R43: C 0.1% : C % N; R51-53: % C< % R52-53: % C < % D EN 17 EN
18 indoxacarb (ISO); methyl (4aS)-7-chloro-2- {(methoxycarbonyl)[4- (trifluoromethoxy)phenyl]carbamoyl}-2,5- dihydroindeno[1,2-e][1,3,4]oxadiazine- 4a(3H)-carboxylate T; R25-48/25 Xn; R20 R43 T; N R: /25-50/53 S: (1/2-) : C 25 % N; R51-53: 2.5 % C < 25 % R52-53: 0.25 % C < 2.5 % reaction mass of (S)- Indoxacarb and (R)- Indoxacarb 75:25; methyl 7-chloro-2-{(methoxycarbonyl)[4- (trifluoromethoxy)phenyl]carbamoyl}-2,5- dihydroindeno[1,2-e][1,3,4]oxadiazine- 4a(3H)-carboxylate dihexyl phthalate T; R48/25 Xn; R20/22 R43 T; N R: 20/ /25-50/53 S: (1/2-) Repr. Cat. 2; R60-61 T R: S: : C 25 % N; R51-53: 2.5 % C < 25 % R52-53: 0.25 % C < 2.5 % ammoniumpentade cafluorooctanoate perfluorooctanoic acid Carc. Cat. 3; R40 Repr. Cat. 2; R61 R64 T; R48/23 Xn; R20/22-48/21/22 Xi; R Carc. Cat. 3; R40 Repr. Cat. 2; R61 R64 T; R48/23 Xn; R20/22-48/21/22 Xi; R41 T; Xn R: 61-20/ /23-48/21/22-64 S: T; Xn R: 61-20/ /23-48/21/22-64 S: octadecylamine Xn; R48/22-65 Xi; R (Z)-octadec-9-enylamine Xn; R22-48/22-65 C; R34 Xn; N R: / /53 S: (2-)26-36/37/ C; N R: / /53 S: (1/2-) /37/ : C 2.5 % N; R51-53: 0.25 % C < 2.5 % R52-53: % C < 0.25 % C; R34: C 10% Xi; R36/37/38: 5 % C < 10% : C 2.5 % N; R51-53: 0.25 % C < 2.5 % R52-53: % C < 0.25 % EN 18 EN
19 amines, hydrogenated tallow alkyl Xn; R48/22-65 Xi; R amines, coco alkyl Xn; R22-48/22-65 C; R X amines, tallow alkyl Xn; R22-48/22-65 C; R35 N; flufenoxuron (ISO); 1-(4-(2-cloro-α,α,α-p-trifluorotolyloxy)-2- fluorophenyl)-3-(2,6-difluorobenzolyl)urea R64 R33 Xn; N R: / /53 S: (2-)26-36/37/ C; N R: / /53 S: (1/2-) /37/ C; N R: / /53 S: (1/2-)26-36/37/ N R: /53 S: (2-)22-36/ : C 2.5 % N; R51-53: 0.25 % C < 2.5 % R52-53: % C < 0.25 % C; R35: C 10% C; R34: 5 % C < 10% Xi; R36/37/38: 1% C < 5 % : C 2.5 % N; R51-53: 0.25 % C < 2.5 % R52-53: % C < 0.25 % : C 2.5 % N; R51-53: 0.25 % C < 2.5 % R52-53: % C < 0.25 % C > % N; R % < C < % R % < C < % X polyhexamethylene biguanide hydrochloride or N-ethyl-2-pyrrolidone; 1-ethylpyrrolidin-2-one Carc. Cat 3; R40 Xn; R22 T; R48/23 Xi; R41-43 T; N R: /23-50/53 S: (1/2-)22-36/37/ Repr. Cat. 2; R61 T R: 61 S: : C 2.5 % N; R51-53: 0.25 % C 2.5 R52-53: % C 0.25 % amidosulfuron (ISO); 3-(4,6-dimethoxypyrimidin-2-yl)-1-((Nmethyl-Nmethylsulfonylamino)sulfonyl)urea N R: 50/53 : C 0.25% N; R51-53: 0.025% C <0.25% R52-53: % C <0.025% tebufenpyrad (ISO); N-(4-tertbutylbenzyl)- 4-chloro-3-ethyl-1-methyl-1Hpyrazole Xn; R20/22 R43 Xn; N R: 20/ : C 2.5 % N; R51-53: 0.25 % C < 2.5 % EN 19 EN
20 carboxamide 50/53 S: (2-) R52-53: % C < 0.25 % proquinazid (ISO); 6-iodo-2-propoxy-3-propylquinazolin- 4(3H)-one Carc. Cat. 3; R40 Xn; N R: 40-50/53 S: (2-)36/ EN 20 EN
COMMISSIO REGULATIO (EU) o /.. of XXX
EUROPEAN COMMISSION Brussels, XXX [ ](2011) XXX draft COMMISSIO REGULATIO (EU) o /.. of XXX amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) o 1272/2008
COMMISSION REGULATION (EU)
EN 11.7.2012 Official Journal of the European Union L 179/3 COMMISSION REGULATION (EU) No 618/2012 of 10 July 2012 amending, for the purposes of its adaptation to technical and scientific progress, Regulation
12 th Meeting of Competent Authorities for REACH and CLP March 2013
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