CELEX: 32019R1966
Language: en
Date: 2019-11-27 00:00:00
Title: Commission Regulation (EU) 2019/1966 of 27 November 2019 amending and correcting Annexes II, III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance)

28.11.2019   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 307/15
               
            
         COMMISSION REGULATION (EU) 2019/1966
         of 27 November 2019
         amending and correcting Annexes II, III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
         (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 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (1), and in particular Article 15(1) and the fourth subparagraph of Article 15(2) thereof,
         Whereas:
         
                     (1)
                  
                  
                     Regulation (EC) No 1272/2008 of the European Parliament and of the Council (2) provides for a harmonised classification of substances as carcinogenic, mutagenic or toxic for reproduction (CMR) based on a scientific assessment by the Risk Assessment Committee of the European Chemicals Agency. The substances are classified as CMR substances of category 1A, CMR substances of category 1B or CMR substances of category 2 depending on the level of evidence of their CMR properties.
                  
               
                     (2)
                  
                  
                     Article 15 of Regulation (EC) No 1223/2009 provides that substances which have been classified as CMR substances of category 1A, category 1B or category 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 (CMR substances) are prohibited from use in cosmetic products. A CMR substance may however be used in cosmetic products where the conditions laid down in the second sentence of Article 15(1) or in the second subparagraph of Article 15(2) of Regulation (EC) No 1223/2009 are fulfilled.
                  
               
                     (3)
                  
                  
                     In order to uniformly implement the prohibition of CMR substances within the internal market, to ensure legal certainty, in particular for economic operators and national competent authorities and to ensure a high level of protection of human health, all CMR substances should be included in the list of prohibited substances in Annex II to Regulation (EC) No 1223/2009 and, where relevant, deleted from the lists of restricted or authorised substances in Annexes III and V to that Regulation. Where the conditions laid down in the second sentence of Article 15(1) or the second subparagraph of Article 15(2) of Regulation (EC) No 1223/2009 are fulfilled, the lists of restricted or authorised substances in Annexes III and V to that Regulation should be amended accordingly.
                  
               
                     (4)
                  
                  
                     All substances which were classified as CMR substances pursuant to Regulation (EC) No 1272/2008 as at 1 December 2018, when Commission Regulation (EU) 2017/776 (3) became applicable, were intended to be covered by Commission Regulation (EU) 2019/831 (4). This Regulation covers the substances classified as CMR substances by Commission Regulation (EU) 2018/1480 (5), which will apply from 1 May 2020.
                  
               
                     (5)
                  
                  
                     With regard to the substance 2-hydroxy-benzoic acid, with the International Nomenclature of Cosmetic Ingredients (INCI) name Salicylic acid, which has been classified as a CMR substance of category 2, a request for the application of the second sentence of Article 15(1) of Regulation (EC) No 1223/2009 has been submitted and it has been established that the condition provided for in that provision is fulfilled.
                  
               
                     (6)
                  
                  
                     Salicylic acid and its salts are currently listed in entry 3 of Annex V to Regulation (EC) No 1223/2009 as preservatives allowed in cosmetic products in a concentration of up to 0,5 % (acid).
                  
               
                     (7)
                  
                  
                     Salicylic acid is also listed in entry 98 of Annex III to Regulation (EC) No 1223/2009 as a restricted substance only allowed, when used for purposes other than preservative, in rinse-off hair products in a concentration of up to 3,0 % and in other products in a concentration of up to 2,0 %.
                  
               
                     (8)
                  
                  
                     In accordance with the second sentence of Article 15(1) of Regulation (EC) No 1223/2009, a substance classified as a CMR substance of category 2 may be used in cosmetic products where the substance has been evaluated by the Scientific Committee on Consumer Safety (SCCS) and found safe for use in such products.
                  
               
                     (9)
                  
                  
                     On 21 December 2018, the SCCS issued a scientific opinion on Salicylic acid (6) (‘the SCCS opinion’) which concluded that, on the basis of the available data, the substance is safe for consumers when used as a preservative in cosmetic products in a concentration of up to 0,5 % (acid) considering its current restrictions in place. The SCCS opinion is not applicable to any oral products, nor to sprayable products that could lead to exposure of the consumer’s lungs by inhalation.
                  
               
                     (10)
                  
                  
                     The SCCS also concluded that Salicylic acid is safe when used for purposes other than preservative in a concentration of up to 3,0 % for rinse-off hair products and up to 2,0 % for other products, considering its current restrictions in place, except for body lotion, eye shadow, mascara, eyeliner, lipstick and roll-on deodorant applications. The SCCS opinion is not applicable to any oral products, nor to sprayable products that could lead to exposure of the consumer’s lungs by inhalation.
                  
               
                     (11)
                  
                  
                     Finally, the SCCS concluded that Salicylic acid is an eye irritant with the potential to cause serious damage to the eyes and pointed out that specific tests are currently on-going to assess whether salicylic acid has endocrine disrupting properties and that depending the outcome of these tests, the potential endocrine disrupting properties of salicylic acid in cosmetics may need to be considered.
                  
               
                     (12)
                  
                  
                     In light of the classification of Salicylic acid as a CMR substance of category 2 and as an eye irritant which may cause serious eye damage and of the SCCS opinion, the substance should be authorised as a preservative in cosmetic products in a concentration of up to 0,5 % (acid), considering its current restrictions, except for oral products and for applications that may lead to exposure of the end-user’s lungs by inhalation. It should also be authorised, with regard to non-preservative use, in rinse-off hair products in a concentration of up to 3,0 % and in other products except for body lotion, eye shadow, mascara, eyeliner, lipstick and roll-on deodorant applications, in a concentration of up to 2,0 %. It should not, in any case, be authorised in applications that may lead to exposure of the end-user’s lungs by inhalation. Considering the conclusion of the SCCS that Salicylic acid is an eye irritant, the current restriction and condition stating that the substance is not to be used in products for children under 3 years of age, except for shampoos, should be modified so that they cover all products for children under 3 years of age. The restrictions set out in Annex III to Regulation (EC) No 1223/2009 and the conditions set out in Annex V to that Regulation should be adapted accordingly.
                  
               
                     (13)
                  
                  
                     With regard to all other substances than Salicylic acid which were classified as CMR substances pursuant to Regulation (EC) No 1272/2008 by Regulation (EU) 2018/1480, no request for use in cosmetic products by way of exception has been submitted. None of those substances are currently restricted or authorised in Annexes III or V to Regulation (EC) No 1223/2009. Four of those substances are currently listed in Annex II to that Regulation. The substances that are not already listed in Annex II to Regulation (EC) No 1223/2009 should be added to the list of substances prohibited in cosmetic products in that Annex.
                  
               
                     (14)
                  
                  
                     The substance 8-hydroxyquinoline; quinolin-8-ol, with the INCI name Oxyquinoline, has been classified as a CMR substance of category 1B by Regulation (EU) 2017/776 while its sulphate form, the substance Bis(8-hydroxyquinolinium) sulphate, with the INCI name Oxyquinoline sulphate, has not been classified as a CMR substance. Both substances were listed in entry 395 of Annex II to Regulation (EC) No 1223/2009 at the time when the classification of Oxyquinoline as a CMR substance started to apply and were prohibited for use in cosmetic products except under the conditions laid down in entry 51 of Annex III to that Regulation. Having being classified as a CMR substance, Oxyquinoline should have been removed from entry 51 of Annex III to Regulation (EC) No 1223/2009. By Regulation (EU) 2019/831, entry 51 was however erroneously deleted in its entirety, including the reference to that entry in entry 395 of Annex II to Regulation (EC) No 1223/2009. In order to correctly reflect the prohibition of Oxyquinoline in cosmetic products on the basis of its classification as a CMR substance, entry 51 should be re-introduced for Oxyquinoline sulphate in Annex III to Regulation (EC) No 1223/2009 and entry 395 in Annex II to that Regulation should be adapted accordingly.
                  
               
                     (15)
                  
                  
                     The substance methyl-phenylene diamine, with the INCI name Diaminotoluene, has been added to the list of prohibited substances in Annex II to Regulation (EC) No 1223/2009 by Regulation (EU) 2019/831 as entry 1507. However, that entry does not correspond to a specific substance but to a group of substances among which only 4-methyl-m-phenylene diamine and 2-methyl-m-phenylene diamine, the mixture and the reaction mass of those two substances have been classified as CMR substances under Regulation (EC) No 1272/2008. Among those CMR substances, 4-methyl-m-phenylenediamine, 2-methyl-m-phenylenediamine and mixture of those two substances are already listed as entries 364, 413 and 1144 in Annex II to Regulation (EC) No 1223/2009 while the substance reaction mass of 4-methyl-m-phenylenediamine and 2-methyl-m-phenylenediamine has not yet been banned for use in cosmetics. Therefore, entry 1507 in Annex II to Regulation (EC) No 1223/2009 should be amended and cover only that substance. Since the CMR substances 4-methyl-m-phenylenediamine and 2-methyl-m-phenylenediamine as well as the mixture and the reaction mass of those substances are also part of the wider group of restricted substances listed as entry 9 of Annex III to Regulation (EC) No 1223/2009, the corresponding entries in Annex II, including entry 1507 as amended, should have been excluded from entry 9. Therefore, entry 9 of Annex III to Regulation (EC) No 1223/2009 should be adapted accordingly.
                  
               
                     (16)
                  
                  
                     Moreover, 19 substances or groups of substances classified as CMR substances by Commission Regulation (EU) 2016/1179 (7), which became applicable on 1 March 2018, have by error not been included in Regulation (EU) 2019/831, despite the fact that no request for use in cosmetic products has been submitted for those substances or groups of substances. None of those substances or groups of substances are currently restricted or authorised in Annexes III or V to Regulation (EC) No 1223/2009. 18 of those substances or groups of substances are currently not listed in Annex II to Regulation (EC) No 1223/2009 and should therefore be included in the list of substances prohibited in cosmetic products in that Annex II. One of the substances, i.e. disodium octaborate anhydrous, belongs to the group of substances already listed as entry 1396 in Annex II to Regulation (EC) No 1223/2009 and should be included in that entry. Entry 1396 should therefore be adapted accordingly.
                  
               
                     (17)
                  
                  
                     Regulation (EC) No 1223/2009 should therefore be amended and corrected accordingly.
                  
               
                     (18)
                  
                  
                     The amendments to Regulation (EC) No 1223/2009 are based on the classifications of the relevant substances as CMR substances by Regulation (EU) 2018/1480 and should therefore apply from the same date as those classifications.
                  
               
                     (19)
                  
                  
                     In order to avoid any discontinuity and legal uncertainty for economic operators, the correction of the error introduced by Regulation (EU) 2019/831 with regard to the substance Oxyquinoline sulphate should apply retroactively from the date of entry into force of that Regulation.
                  
               
                     (20)
                  
                  
                     The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products,
                  
               HAS ADOPTED THIS REGULATION:
         
            Article 1
            Annexes II, III and V to Regulation (EC) No 1223/2009 are amended in accordance with Annex I to this Regulation.
         
         
            Article 2
            Annexes II and III to Regulation (EC) No 1223/2009 are corrected in accordance with Annex II to this Regulation.
         
         
            Article 3
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
            Article 1 shall apply from 1 May 2020.
            Points (1)(a) and (2)(b) of Annex II shall apply from 11 June 2019.
         
         
            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 27 November 2019.
            
               
                  For the Commission
               
               
                  The President
               
               Jean-Claude JUNCKER
            
         
         
            (1)  OJ L 342, 22.12.2009, p. 59.
         
            (2)  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 (OJ L 353, 31.12.2008, p. 1).
         
            (3)  Commission Regulation (EU) 2017/776 of 4 May 2017 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 (OJ L 116, 5.5.2017, p. 1).
         
            (4)  Commission Regulation (EU) 2019/831 of 22 May 2019 amending Annexes II, III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (OJ L 137, 23.5.2019, p. 29).
         
            (5)  Commission Regulation (EU) 2018/1480 of 4 October 2018 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 and correcting Commission Regulation (EU) 2017/776 (OJ L 251, 5.10.2018, p. 1).
         
            (6)  SCCS/1601/18, http://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_223.pdf
         
            (7)  Commission Regulation (EU) 2016/1179 of 19 July 2016 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 (OJ L 195, 20.7.2016, p. 11).
      
      
         
            ANNEX I
            
               (1)   
               Annex II to Regulation (EC) No 1223/2009 is amended as follows:
               The following entries are added:
            
            
                        Reference number
                     
                     
                        Substance identification
                     
                  
                        Chemical name/INN
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                  
                        a
                     
                     
                        b
                     
                     
                        c
                     
                     
                        d
                     
                  
                        ‘1612
                     
                     
                        Phosmet (ISO); S-[(1,3-dioxo-1,3-dihydro-2H- isoindol-2-yl)methyl]-O,O-dimethyl phosphorodithioate;
                        
                           O,O-dimethyl-S-phthalimidomethyl phosphorodithioate
                     
                     
                        732-11-6
                     
                     
                        211-987-4
                     
                  
                        1613
                     
                     
                        Potassium permanganate
                     
                     
                        7722-64-7
                     
                     
                        231-760-3
                     
                  
                        1614
                     
                     
                        2-Benzyl-2-dimethylamino-4′- morpholinobutyrophenone
                     
                     
                        119313-12-1
                     
                     
                        404-360-3
                     
                  
                        1615
                     
                     
                        Quizalofop-p-tefuryl (ISO);
                        (+/–) tetrahydrofurfuryl (R)-2-[4-(6- chloroquinoxalin-2-
                        yloxy)phenyloxy]propionate
                     
                     
                        200509-41-7
                     
                     
                        414-200-4
                     
                  
                        1616
                     
                     
                        Propiconazole (ISO); (2RS,4RS;2RS,4SR)-1-{[2-(2,4- dichlorophenyl)-4-propyl-1,3- dioxolan-2-yl]methyl}-1H- 1,2,4-triazole
                     
                     
                        60207-90-1
                     
                     
                        262-104-4
                     
                  
                        1617
                     
                     
                        Pinoxaden (ISO); 8-(2,6-diethyl-4-methylphenyl)-7-oxo-1,2,4,5-tetrahydro-7H-pyrazolo[1,2-d][1,4,5]oxadiazepin-9-yl 2,2-dimethylpropanoate
                     
                     
                        243973-20-8
                     
                     
                        635-361-9
                     
                  
                        1618
                     
                     
                        Tetramethrin (ISO);
                        (1,3-dioxo-1,3,4,5,6,7-hexahydro-2H-isoindol-2-yl)methyl 2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate
                     
                     
                        7696-12-0
                     
                     
                        231-711-6
                     
                  
                        1619
                     
                     
                        (1,3,4,5,6,7-Hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl (1R-trans)-2,2-dimethyl-3-(2- methylprop-1-enyl)cyclopropanecarboxylate
                     
                     
                        1166-46-7
                     
                     
                        214-619-0
                     
                  
                        1620
                     
                     
                        Spirodiclofen (ISO);
                        3-(2,4-dichlorophenyl)-2-oxo- 1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutyrate
                     
                     
                        148477-71-8
                     
                     
                        604-636-5
                     
                  
                        1621
                     
                     
                        Reaction mass of 1-[2-(2-aminobutoxy)ethoxy]but-2-ylamine and 1-({[2-(2-aminobutoxy)ethoxy]methyl}propoxy) but-2-ylamine
                     
                     
                        897393-42-9
                     
                     
                        447-920-2
                     
                  
                        1622
                     
                     
                        1-Vinylimidazole
                     
                     
                        1072-63-5
                     
                     
                        214-012-0
                     
                  
                        1623
                     
                     
                        Amisulbrom (ISO)3-(3-bromo-6-fluoro-2-methylindol-1-ylsulfonyl)-N,N-dimethyl-1H-1,2,4-triazole-1-sulfonamide
                     
                     
                        348635-87-0
                     
                     
                        672-776-4’
                     
                  
               (2)   
               Annex III to Regulation (EC) No 1223/2009 is amended as follows:
               Entry 98 is replaced by the following:
            
            
                        ‘98
                     
                     
                        Benzoic acid, 2-hydroxy-  (1)
                        
                     
                     
                        Salicylic acid
                     
                     
                        69-72-7
                     
                     
                        200-712-3
                     
                     
                        (a) Rinse-off hair products
                        (b) Other products except body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant
                     
                     
                        (a) 3,0 %
                        (b) 2,0 %
                     
                     
                        Not to be used in preparations for children under 3 years of age.
                        Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation.
                        Not to be used in oral products.
                        For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product.
                     
                     
                        Not to be used for children under 3 years of age  (2)
                        
                     
                  
               (3)   
               Annex V to Regulation (EC) No 1223/2009 is amended as follows:
               Entry 3 is replaced by the following:
            
            
                        Reference number
                     
                     
                        Substance Identification
                     
                     
                        Conditions
                     
                     
                        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
                     
                  
                        ‘3
                     
                     
                        Salicylic acid  (3) and its salts
                     
                     
                        Salicylic acid
                        Calcium salicylate, magnesium salicylate, MEA- salicylate, sodium salicylate, potassium salicylate, TEA- salicylate
                     
                     
                        69-72-7
                        824-35-1, 18917-89-0, 59866- 70-5, 54-21-7, 578-36-9, 2174-16-5
                     
                     
                        200-712-3
                        212-525-4, 242-669-3, 261-963-2, 200-198-0, 209-421-6, 218-531-3
                     
                     
                         
                     
                     
                        0,5 % (acid)
                        0,5 % (acid)
                     
                     
                        Not to be used in products for children under 3 years of age.
                        Not to be used in oral products.
                        Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation.
                        Not to be used in products for children under 3 years of age, except for shampoos.
                     
                     
                        Not to be used for children under 3 years of age  (4)
                        
                        Not to be used for children under 3 years of age  (5)
                        
                     
                  
               (1)  For use as a preservative see Annex V, No 3.
            
               (2)  Solely for products which might be used for children under 3 years of age.’
            
               (3)  For uses other than preservative, see Annex III, No 98.
            
               (4)  Solely for products which might be used for children under 3 years of age
            
               (5)  Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin.’
         
      
      
         
            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- 2H-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-2H-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); (1E)-N-[4-chloro-2-(trifluoromethyl)phenyl]-1- (1H-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)’