ANNEX IISupplementary provisions
ANNEX II (1) Annex II to Regulation (EC) No 1223/2009 is corrected as follows: (a) entry 395 is replaced by the following: Reference number Substance identification Chemical name/INN CAS number EC number ‘395 Hydroxy-8-quinoline and its sulphate bis(8-hydroxyquinolinium) sulphate, except for the uses of the sulphate provided for in entry 51 of Annex III 148-24-3 134-31-6 205-711-1 205-137-1’ (b) entry 1396 is replaced by the following: Reference number Substance identification Chemical name/INN CAS number EC number a b c d ‘1396 Borates, tetraborates, octaborates and boric acid salts and esters, including: Disodium octaborate anhydrous [1] Disodium octaborate tetrahydrate [2] 2-Aminoethanol, monoester with boric acid [3] 2-Hydroxypropyl ammonium dihydrogen orthoborate [4] Potassium borate, boric acid potassium salt [5] Trioctyldodecyl borate [6] Zinc borate [7] Sodium borate, disodium tetraborate anhydrous; boric acid, sodium salt [8] Tetraboron disodium heptaoxide, hydrate [9] Orthoboric acid, sodium salt [10] Disodium tetraborate decahydrate; borax decahydrate [11] Disodium tetraborate pentahydrate; borax pentahydrate [12] 12008-41-2 [1] 12280-03-4 [2] 10377-81-8 [3] 68003-13-4 [4] 12712-38-8 [5] - [6] 1332-07-6 [7] 1330-43-4 [8] 12267-73-1 [9] 13840-56-7 [10] 1303-96-4 [11] 12179-04-3 [12] 234-541-0 [1] 234-541-0 [2] 233-829-3 [3] 268-109-8 [4] 603-184-6 [5] - [6] 215-566-6 [7] 215-540-4 [8] 235-541-3 [9] 237-560-2 [10] 215-540-4 [11] 215-540-4 [12]’ (c) entry 1507 is replaced by the following: Reference number Substance identification Chemical name/INN CAS number EC number ‘1507 Diaminotoluene, methyl-phenylenediamine, technical product-reaction mass of [4-methyl-m-phenylenediamine and 2-methyl-m-phenylenediamine] – –’ (d) the following entries are added: Reference number Substance identification Chemical name/INN CAS number EC number a b c d ‘1624 Pirimicarb (ISO); 2-(dimethylamino)-5,6-dimethylpyrimidin-4-yl dimethylcarbamate 23103-98-2 245-430-1 1625 1,2-Dichloropropane; propylene dichloride 78-87-5 201-152-2 1626 Phenol, dodecyl-, branched [1] Phenol, 2-dodecyl-, branched [2] Phenol, 3-dodecyl-, branched [3] Phenol, 4-dodecyl-, branched [4] Phenol, (tetrapropenyl) derivatives [5] 121158-58-5 [1] 1801269-80-6 [2] 1801269-77-1 [3] 210555-94-5 [4] 74499-35-7 [5] 310-154-3 [1] — [2] — [3] 640-104-9 [4] 616-100-8 [5] 1627 Coumatetralyl (ISO); 4- hydroxy-3-(1,2,3,4-tetrahydro-1-naphthyl) coumarin 5836-29-3 227-424-0 1628 Difenacoum (ISO); 3-(3- biphenyl-4-yl-1,2,3,4- tetrahydro-1-naphthyl)- 4-hydroxycoumarin 56073-07-5 259-978-4 1629 Brodifacoum (ISO); 4-hydroxy-3-(3-(4′-bromo-4-biphenylyl)-1,2,3,4-tetrahydro-1-naphthyl)coumarin 56073-10-0 259-980-5 1630 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 90035-08-8 421-960-0 1631 Acetochlor (ISO); 2- chloro- N -(ethoxymethyl)- N -(2-ethyl-6- methylphenyl)acetamide 34256-82-1 251-899-3 1632 e-Glass microfibres of representative composition - - 1633 Glass microfibres of representative composition - - 1634 Bromadiolone (ISO); 3- [3-(4′-bromobiphenyl- 4-yl)-3-hydroxy-1-phenylpropyl]-4-hydroxy- 2 H -chromen-2-one 28772-56-7 249-205-9 1635 Difethialone (ISO); 3-[3-(4′-bromobiphenyl-4-yl)-1,2,3,4-tetrahydronaphthalen-1-yl]- 4-hydroxy-2 H -1-benzothiopyran-2-one 104653-34-1 600-594-7 1636 Perfluorononan-1-oic acid [1] and its sodium [2] and ammonium [3] salts 375-95-1 [1] 21049-39-8 [2] 4149-60-4 [3] 206-801-3 [1] - [2] - [3] 1637 Dicyclohexyl phthalate 84-61-7 201-545-9 1638 3,7-Dimethylocta-2,6- dienenitrile 5146-66-7 225-918-0 1639 Bupirimate (ISO); 5-butyl-2-ethylamino-6- methylpyrimidin-4-yl dimethylsulfamate 41483-43-6 255-391-2 1640 Triflumizole (ISO); (1 E )- N -[4-chloro-2-(trifluoromethyl)phenyl]-1- (1 H -imidazol-1-yl)-2- propoxyethanimine 68694-11-1 604-708-8 1641 tert -Butyl hydroperoxide 75-91-2 200-915-7’ (2) Annex III to Regulation (EC) No 1223/2009 is corrected as follows: (a) entry 9 is replaced by the following: Ref No. Substance identification Restrictions Wording of conditions of use and warnings Chemical name/ INN Name of Common Ingredients Glossary CAS number EC number Product type, body parts Maximum concentration in ready for use preparation Other a b c d e f g h i ‘9 Methylphenylenediamines, their N- substituted derivatives and their salts (1), with the exception of the substance listed under reference numbers 9 a and 9 b of this Annex and the substances listed under reference numbers 364, 413, 1144, 1310, 1313 and 1507 of Annex II Hair dye substance in oxidative hair dye products (a) General use (b) Professional use For (a) and (b): After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 5 % calculated as free base (a) To be printed on the label: The mixing ratio. ‘ Hair colourants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irritated and damaged scalp, — you have ever experienced any reaction after colouring your hair, — you have experienced a reaction to a temporary ‘black henna’ tattoo in the past. Contains phenylenediamines (toluenediamines). Do not use to dye eyelashes or eyebrows.’ (b) To be printed on the label: The mixing ratio. ‘For professional use only. Hair colourants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary “black henna” tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irritated and damaged scalp, — you have ever experienced any reaction after colouring your hair, — you have experienced a reaction to a temporary “black henna” tattoo in the past. Contains phenylenediamines (toluenediamines). Wear suitable gloves.’ (b) the following entry is added: Reference number Substance identification Restrictions Wording of conditions of use and warnings Chemical name/INN Name of Common Ingredients Glossary CAS number EC number Product type, body parts Maximum concentration in ready for use preparation Other a b c d e f g h i ‘51 Bis(8-hydroxyquinolinium) sulphate Oxyqui-noline sulphate 134-31-6 205-137-1 Stabilizer for hydrogen peroxide in rinse-off hair products Stabilizer for hydrogen peroxide in leave-on hair products (0,3 % as base) (0,03 % as base)’