Cosmetics Regulation

02009R1223-20191218 → 02009R1223-20200501

ANNEX I COSMETIC PRODUCT SAFETY REPORT The cosmetic product safety report shall, as a minimum, contain the following: PART A – Cosmetic product safety information 1. Quantitative and qualitative composition of the cosmetic product The qualitative and quantitative composition of the cosmetic product, including chemical identity of the substances (incl. chemical name, INCI, CAS, EINECS/ELINCS, where possible) and their intended function. In the case of perfume and aromatic compositions, description of the name and code number of the composition and the identity of the supplier. 2. Physical/chemical Physical/chěmical characteristics and stability of the cosmetic product The physical and chemical characteristics of the substances or mixtures, as well as the cosmetic product. The stability of the cosmetics product under reasonably foreseeable storage conditions. 3. Microbiological quality The microbiological specifications of the substance or … 612 unchanged words … be duly justified. Impacts of the stability on the safety of the cosmetic product shall be duly considered. 4. Assessor's credentials and approval of part B Name and address of the safety assessor. Proof of qualification of safety assessor. Date and signature of safety assessor.

02009R1223-20191218 → 02009R1223-20200501

ANNEX II LIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS OJ L 159, 29.6.1996, p. 1Modified INNM-name.OJ L 273, 10.10.2002, p. 1.for the individual ingredient see reference number 364 in Annex II.for the individual ingredient see reference number 413 in Annex II.From 23 … 16,424 unchanged words … the source, in the mixture as placed on the market is ≥ 0,1 % w/w — — 1608 Methylhydrazine 60-34-4 200-471-4 1609 Triadimenol (ISO); (1RS,2RS;1RS,2SR)-1-(4-chlorophenoxy)-3,3-dimethyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol; α-tert-butyl-β-(4-chlorophenoxy)-1H-1,2,4-triazole-1-ethanol 55219-65-3 259-537-6 1610 Thiacloprid (ISO); (Z)-3-(6-chloro-3-pyridyl-methyl)-1-3-thiazolidin-2-ylidenecyanamide; {(2Z)-3-[(6-chloropyridin-3-yl)methyl]-1,3-thiazolidin-2-ylidene}cyanamide 111988-49-9 601-147-9 1611 Carbetamide (ISO); (R)-1-(ethylcarbamoyl) ethyl-carbanilate; (2R)-1-(ethylamino) -1-oxopro-pan-2-yl-phenylcarbamate 16118-49-3 240-286-6 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 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] 121158-58-5 [1] 310-154-3 [1] Phenol, 2-dodecyl-, branched [2] 1801269-80-6 [2] - [2] Phenol, 3-dodecyl-, branched [3] 1801269-77-1 [3] - [3] Phenol, 4-dodecyl-, branched [4] 210555-94-5 [4] 640-104-9 [4] Phenol, (tetrapropenyl) derivatives [5] 74499-35-7 [5] 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] 375-95-1 [1] 206-801-3 [1] and its sodium [2] 21049-39-8 [2] - [2] and ammonium [3] salts 4149-60-4 [3] - [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

02009R1223-20191218 → 02009R1223-20200501

compared line by line: this provision is too large to compare word by word, so a marked line is a line that changed somewhere

ANNEX III LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorised for each of them does not exceed 1.For use as a preservative, see Annex V, No. 5.Only if the concentration exceeds 0,05 %.These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorised for each of them does not exceed 2.The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In cases of mixtures, the sum should not exceed the limits given in column g.The concentration of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In case of mixtures, the sum should not exceed the limits given in column g.For use as a preservative, see Annex V, No. 34.For use as a preservative, see Annex V, No 43.For use as a preservative, see Annex V, No. 54.For use as a preservative, see Annex V, No 3.Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin.For use as a preservative, see Annex V, No 9.For use as a preservative, see AnnexV, No 23.For use as a preservative, see Annex V, No 8.Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (OJ L 255, 30.9.2005, p. 22).This limit applies to the substance and not to the finished cosmetic product.The sum of those substances used in combination should not exceed the limits given as Maximum concentration in ready for use preparation.The free base and salts of this hair colouring ingredient, unless prohibited under Annex II, are permitted for use.For use as a preservative, see Annex V, No 58.For use as a preservative, see Annex V, entry No 44.For other uses of potassium hydroxide, see Annex III, No 15d.For other uses of potassium hydroxide, see Annex III, No 15a.From 25 September 2018 cosmetic products containing peanut oil, extracts and derivatives and not complying with that restriction shall not be placed on the Union market. From 25 December 2018 cosmetic products containing peanut oil, extracts and derivatives and not complying with that restriction shall not be made available on the Union market.From 25 September 2018 cosmetic products containing hydrolyzed wheat proteins and not complying with that restriction shall not be placed on the Union market. From 25 December 2018 cosmetic products containing hydrolyzed wheat proteins and not complying with that restriction shall not be made available on the Union market.From 1 May 2019 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 August 2019 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.From 1 May 2019 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 August 2019 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.From 1 May 2019 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 August 2019 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.From 1 May 2019 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 August 2019 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.For use as a preservative, see Annex V, entry 32.From 27 November 2019 cosmetic products containing 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one and not complying with those restrictions shall not be placed on the Union market. These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorised for each of them does not exceed 1.For use as a preservative, see Annex V, No. 5.Only if the concentration exceeds 0,05 %.These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorised for each of them does not exceed 2.The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In cases of mixtures, the sum should not exceed the limits given in column g.The concentration of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In case of mixtures, the sum should not exceed the limits given in column g.For use as a preservative, see Annex V, No. 34.For use as a preservative, see Annex V, No 43.For use as a preservative, see Annex V, No. 54.For use as a preservative see Annex V, No 3.Solely for products which might be used for children under 3 years of age.For use as a preservative, see Annex V, No 9.For use as a preservative, see AnnexV, No 23.For use as a preservative, see Annex V, No 8.Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (OJ L 255, 30.9.2005, p. 22).This limit applies to the substance and not to the finished cosmetic product.The sum of those substances used in combination should not exceed the limits given as Maximum concentration in ready for use preparation.The free base and salts of this hair colouring ingredient, unless prohibited under Annex II, are permitted for use.For use as a preservative, see Annex V, No 58.For use as a preservative, see Annex V, entry No 44.For other uses of potassium hydroxide, see Annex III, No 15d.For other uses of potassium hydroxide, see Annex III, No 15a.From 25 September 2018 cosmetic products containing peanut oil, extracts and derivatives and not complying with that restriction shall not be placed on the Union market. From 25 December 2018 cosmetic products containing peanut oil, extracts and derivatives and not complying with that restriction shall not be made available on the Union market.From 25 September 2018 cosmetic products containing hydrolyzed wheat proteins and not complying with that restriction shall not be placed on the Union market. From 25 December 2018 cosmetic products containing hydrolyzed wheat proteins and not complying with that restriction shall not be made available on the Union market.From 1 May 2019 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 August 2019 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.From 1 May 2019 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 August 2019 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.From 1 May 2019 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 August 2019 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.From 1 May 2019 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 August 2019 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.For use as a preservative, see Annex V, entry 32.From 27 November 2019 cosmetic products containing 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one and not complying with those restrictions shall not be placed on the Union market. From 27 February 2020 cosmetic products containing 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one and not complying with those restrictions shall not be made available on the Union market. 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 … 473 unchanged lines … (c) 0,03 % in other products 97 4'-tert-Butyl-2',6'-dimethyl-3',5'-dinitroacetophenone Musk ketone 81-14-1 201-328-9 All cosmetic products, with the exception of oral products (a) 1,4 % in fine fragrance (b) 0,56 % in eau de toilette (c) 0,042 % in other products 98 Benzoic acid, 2-hydroxy- Salicylic acid 69-72-7 200-712-3 (a) Rinse-off hair products (b) Other products (a) 3,0 % (b) 2,0 % Not to be used in preparations for children under 3 years of age, except for shampoos 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 (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 99 Inorganic sulfites and bisulfites (a) Oxidative hair dye products (a) 0,67 % (as free SO2) 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 (b) Hair straightening products (b) 6,7 % (as free SO2) (c) Self-tanning products for the face (c) 0,45 % (as free SO2) (d) Other self-tanning products (d) 0,40 % (as free SO2) … 1,216 unchanged lines … Avoid skin contact Read directions for use carefully 312 2-Furaldehyde Furfural 98-01-1 202-627-7 0,001 %

02009R1223-20191218 → 02009R1223-20200501

ANNEX V LIST OF PRESERVATIVES ALLOWED IN COSMETIC PRODUCTS Preamble 1. For the purposes of this list: Salts is taken to mean: salts of the cations sodium, potassium, calcium, magnesium, ammonium and ethanolamines; salts of the anions chloride, bromide, sulphate, acetate. Esters is taken to mean: esters of methyl, ethyl, propyl, isopropyl, butyl, isobutyl, phenyl. 2. All finished products containing substances in this Annex and which release formaldehyde must be labelled with the warning contains formaldehyde where the concentration of formaldehyde in the finished product exceeds 0,05 % For use uses other than as a preservative, see Annex III, No. No 98.Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin.For use other than as a preservative, see Annex III, No. 13.For use other than as a preservative, … 451 unchanged words … 2 Propionic acid and its salts Propionic acid, ammonium propionate, calcium propionate, magnesium propionate, potassium propionate, sodium propionate 79-09-4, 17496-08-1, 4075-81-4, 557-27-7, 327-62-8, 137-40-6 201-176-3, 241-503-7, 223-795-8, 209-166-0, 206-323-5, 205-290-4 2 % (acid) 3 Salicylic acid and its salts Salicylic acid, calcium acid 69-72-7 200-712-3 0,5 % (acid) Not to be used in products for children under 3 years of age. Not to be used 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. Calcium salicylate, magnesium salicylate, MEA-salicylate, MEA- salicylate, sodium salicylate, potassium salicylate, TEA-salicylate 69-72-7, TEA- salicylate 824-35-1, 18917-89-0, 59866-70-5, 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) Not to be used in products for children under 3 years of age, except for shampoos shampoos. Not to be used for children under 3 years of age 4 Hexa-2,4-dienoic acid and its salts Sorbic acid, calcium sorbate, sodium sorbate, potassium sorbate 110-44-1, 7492-55-9, 7757-81-5, 24634-61-5 203-768-7, 231-321-6, 231-819-3, 246-376-1 0,6 % (acid) 5 Formal-dehyde, paraformaldehyde Formaldehyde Paraformaldehyde 50-00-0, … 1,184 unchanged words … and 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, silver(1+) salt, monohydrate Citric acid (and) Silver citrate — 460-890-5 0,2 %, corresponding to 0,0024 % of silver Not to be used in oral products and eye products 60 4-(3-ethoxy-4-hydroxyphenyl)butan-2-one Hydroxyethoxyphenyl Butanone 569646-79-3 933-435-8 0,7 %