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EIGHTH COMMISSION DIRECTIVE

of 26 March 1986

adapting to technical progress Annexes II, IV and VI to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products

(86/199/EEC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community,

Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), as last amended by Directive 86/179/EEC (2), and in particular Articles 5 and 8 (2) thereof,

Whereas, in order to protect public health, it is necessary to lay down purity criteria for hexachlorophene and triclocarban;

Whereas, on the basis of the available information, certain provisionally-permitted substances and preservatives may be definitively permitted, while others must be definitively prohibited or be permitted for a further specified period;

Whereas the measures laid down in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Cosmetic Products Sector,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Directive 76/768/EEC is hereby amended as follows:

1. In Annex II, number 221 is replaced by: '221. Mercury and its compounds, except those special cases included in Annexes V and VI, Part 1'.

2. Annex IV, Part 1 and Annex VI, Parts 1 and 2, are replaced by Annexes 1 and 2 to this Directive.

Article 2

1. Member States shall take the necessary measures to ensure that from 1 January 1988 neither manufacturers nor importers, established in the Community, place on the market products which do not satisfy the requirements of this Directive.

2. Member States shall take the necessary measures to ensure that the products referred to in paragraph 1 can no longer be sold or disposed of to the final consumer after 31 December 1989.

Article 3

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the provisions of this Directive not later than 31 December 1986 and shall forthwith inform the Commission thereof.

2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 26 March 1986.

For the Commission

Grigoris VARFIS

Member of the Commission

(1) OJ No L 262, 27. 9. 1976, p. 169.

(2) OJ No L 138, 24. 5. 1986, p. 40.

ANNEX 1

'ANNEX IV

PART ONE

LIST OF SUBSTANCES PROVISIONALLY ALLOWED

1.2.3,5.6.7 // // // // // // Reference number // Substance // Restrictions // Conditions of use and warnings which must be printed on the label // Allowed until // // 1.2.3.4.5.6.7 // // // Field of application and/or use // Maximum authorized concentration in the finished cosmetic product // Other limitations and requirements // // // // // // // // // // a // b // c // d // e // f // g // // // // // // // // 1 // Methanol // Denaturant for ethanol and isopropyl alcohol // 5 % calculated as a % of ethanol and isopropyl alcohol // // // 31. 12. 1987 // // // // // // // // 2 // 1,1,1-Trichloroethane (methyl chloroform) // Aerosol spray // 35 % When mixed with dichloromethane, total concentration must not exceed 35 % // // Do not spray on a naked flame or any incandescent material // 31. 12. 1987 // // // // // // // // 3 // 3,4,5 Tribromosalicylanilide (Tribromsalan (*)) // Deodorant soap // 1 % // Purity criteria: 3,4,5 Tribromosalicylanilide: 98,5 % minimum Other bromosalicylanilides: 1,5 % maximum 4,5 dibromosalicylanilide: 0,1 % maximum Inorganic bromide: 0,1 % maximum expressed as NaBr // Contains tribromosalicylanilide // 31. 12. 1987 // // // // // // // // 4 // 2,2-Dithiobis (pyridine 1-oxide), addition product with magnesium sulphate trihydrate // Only for hair-care products rinse off // 1 % // As preservative, see Annex VI, Part 2, No 13 // // 31. 12. 1986 // // // // // // // // 5 // 1-Phenoxypropan-2-ol // - Rinse-off products only - Prohibited in oral hygiene products // 2 % // As preservative, see Annex VI, Part 2, No 14 // // 31. 12. 1986' // // // // // // //

ANNEX 2

'ANNEX VI

LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MAY CONTAIN

PREAMBLE

1. Preservatives are substances which may be added to cosmetic products for the primary purpose of inhibiting the development of micro-organisms in such products.

2. The substances marked with the symbol (*) may also be added to cosmetic products in concentration other than those laid down in this Annex for other specific purposes apparent from the presentation of the products, e.g. as deodorants in soaps or as anti-dandruff agents in shampoos.

3. Other substances used in the formulation of cosmetic products may also have anti-microbial properties and thus help in the preservation of the products, as, for instance, many essential oils and some alcohols. These substances are not included in this Annex.

4. 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.

5. All finished products containing formaldehyde or 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 %.

PART 1

LIST OF PRESERVATIVES ALLOWED

1.2.3.4.5 // // // // // // Reference number // Substance // Maximum authorized concentration // Limitations and requirements // Conditions of use and warnings which must be printed on the label // // // // // // a // b // c // d // e // // // // // // // // // // // 1 // Benzoic acid, its salts and esters (*) // 0,5 % (acid) // // // // // // // // 2 // Propionic acid and its salts (*) // 2 % (acid) // // // // // // // // 3 // Salicylic acid and its salts (*) // 0,5 % (acid) // Not to be used in preparations for children under three years of age, except for shampoos // Not to be used for children under three years of age (1) // // // // // // 4 // Sorbic acid (hexa-2,4-dienoic acid) and its salts (*) // 0,6 % (acid) // // // // // // // // 5 // Formaldehyde paraformaldehyde // 0,2 % (except for products for oral hygiene) 0,1 % (products for oral hygiene) expressed as free formaldehyde // Prohibited in aerosol dispensers (sprays) // // // // // // // 6 // Hexachlorophene (INN) // 0,1 % // - Prohibited in products for children under three years of age, and intimate hygiene products - Purity criterion: absence of 2,3,7,8-tetrachlorodibenzo-p-dioxin // Not to be used for children under three years of age. Contains hexachlorophene // // // // // // 7 // Biphenyl-2-ol (o-phenylphenol) and its salts (*) // 0,2 % expressed as the phenol // // // // // // // // 8 // Pyrithione zinc (INN) (*) // 0,5 % // Authorized in products rinsed off Forbidden in products for oral hygiene // // // // // // // 9 // Inorganic sulphites and hydrogen- sulphites (*) // 0,2 % expressed as free SO2 // // // // // // // // 10 // Sodium iodate // 0,1 % // Rinse-off products only // // 1,5 // (1) Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin. // // // // 1.2.3.4.5 // // // // // // Reference number // Substance // Maximum authorized concentration // Limitations and requirements // Conditions of use and warnings which must be printed on the label // // // // // // a // b // c // d // e // // // // // // // 11 // Chlorobutanol (INN) // 0,5 % // Prohibited in aerosol dispensers (sprays) // Contains chlorobutanol // // // // // // 12 // 4-Hydroxybenzoic acid and its salts and esters (*) // 0,4 % (acid) for 1 ester, 0,8 % (acid) for mixtures of esters // // // // // // // // 13 // 3-Acetyl-6-methylpyran-2,4 (3H)-dione (Dehydracetic acid) and its salts // 0,6 % (acid) // Prohibited in aerosol dispensers (sprays) // // // // // // // 14 // Formic acid (*) // 0,5 % (acid) // // // // // // // // 15 // 3,3-Dibromo-4,4-hexamethylene-dioxydibenzamidine (Dibromohexamidine) and its salts (including isethionate) // 0,1 % // // // // // // // // 16 // Thiomersal (INN) // 0,007 % (of Hg) If mixed with other mercurial compounds authorized by this Directive, the maximum concentration of Hg remains fixed at 0,007 % // For eye make-up and eye make-up remover only // Contains thiomersal // // // // // // 17 // Phenylmercuric salts (including borate) // Ditto // Ditto // Contains phenylmercuric compounds // // // // // // 18 // Undec-10-enoic acid and salts (*) // 0,2 % (acid) // See Annex VI, Part 2, No 8 // // // // // // // 19 // Hexetidine (INN) (*) // 0,1 % // Rinse-off products only See Annex VI, Part 2, No 18 // // // // // // // 20 // 5-Bromo-5-nitro-1,3-dioxane // 0,1 % // Rinse-off products only Avoid formation of nitrosamines See Annex VI, Part 2, No 7 // // // // // // // 21 // Bronopol (INN) (*) // 0,1 % // Avoid formation of nitrosamines // // // // // // // 22 // 2,4-Dichlorobenzyl alcohol (*) // 0,15 % // // // // // // // // 23 // Triclocarban (INN) (*) // 0,2 % // Purity criteria: 3,3,4,4-Tetrachloroazobenzene <1 ppm 3,3,4,4-Tetrachloroazoxybenzene <1 ppm // // // // // // // // // // // // Reference number // Substance // Maximum authorized concentration // Limitations and requirements // Conditions of use and warnings which must be printed on the label // // // // // // a // b // c // d // e // // // // // // // 24 // 4-Chloro-m-cresol (*) // 0,2 % // Prohibited in the products intended to come into contact with mucous membranes // // // // // // // 25 // Tricolosan (INN) (*) // 0,3 % // // // // // // // // 26 // 4-Chloro-3,5-xylenol (*) // 0,5 % // // // // // // // // 27 // 3,3-Bis (1-hydroxymethyl-2,5-dioxoimida- zolidin-4-yl)-1,1-methylenediurea ("Imidazolidinyl urea") (*) // 0,6 % // // // // // // // // 28 // Poly (1-hexamethylenebiguanide hydrochloride (*) // 0,3 % // // // // // // // // 29 // 2-Phenoxyethanol (*) // 1 % // // // // // // // // 30 // Hexamethylenetetramine (*) (methenamine) (INN) // 0,15 % // // // // // // // // 31 // Methenamine 3-chloroallylochloride (INNM) // 0,2 % // // // // // // // // 32 // 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3- dimethylbutan-2-one (*) // 0,5 % // // // // // // // // 33 // 1,3-Bis (hydroxymethyl)-5,5-dimethylimi- dazolidine-2,4-dione (*) // 0,6 % // // // // // // // // 34 // Benzyl alchohol (*) // 1 % // // // // // // // // 35 // 1-Hydroxy-4-methyl-6(2,4,4-trimethylpentyl) 2-pyridon and its monoethanolamine salt (*) // 1,0 % 0,5 % // Products rinsed off For other products // // // // // // // 36 // 1,2-Dibromo-2,4-dicyanobutane // 0,1 % // // Not to be used in cosmetic sunscreen products // // // // // // 37 // 6,6-Dibromo-4,4-dichloro2,2-methylene- diphenol (Bromochlorophen) (*) // 0,1 % // // // // // // // // 38 // 4-Isopropyl-m-cresol // 0,1 % // // // // // // // // 39 // Mixture of 5-Chloro-2-methyl-isothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one with magnesium chloride and magnesium nitrate // 0,003 % (of a mixture in the ratio 3: 1 of 5-chloro-2-methylisothiazol 3(2H)-one and 2-methylisothiazol-3 (2H)-one // // // // // // //

PART 2

LIST OF PRESERVATIVES PROVISIONALLY ALLOWED

1.2.3.4.5.6 // // // // // // // Reference number // Substance // Maximum authorized concentration // Limitation and requirements // Conditions of use and warnings which must be printed on the label // Allowed until // // // // // // // a // b // c // d // e // f // // // // // // // // // // // // // 1 // Boric acid (*) // (a) 0,5 % // (a) Products for oral hygiene // // 31. 12. 1988 // // // (b) 3 % // (b) Other products // // // // // // // // // 2 // Chlorphenesin (INN) (*) // 0,5 % // // // 31. 12. 1987 // // // // // // // 3 // Dibromopropamidine (INN) and its salts (including isethionate (INN)) // 0,1 % // // // 31. 12. 1988 // // // // // // // 4 // Alkyl (C12-C22) trimethyl-ammonium bromide and chloride (including Cetrimonium bromide (INN) (*)) // 0,1 % // // // 31. 12. 1988 // // // // // // // 5 // 3-Heptyl-2-(3-heptyl-4-methyl-4-thiazolin-2- ylidenemethyl)-4-methyl-thiazolinium iodide // 0,002 % // Creams, toilet lotions, shampoos // // 31. 12. 1988 // // // // // // // 6 // 4,4-Dimethyl-1,3-oxazolidine // 0,1 % // Rinse-off products only. The pH of the finished product shall not be lower than 6 // // 31. 12. 1989 // // // // // // // 7 // 5-Bromo-5-nitro-1,3-dioxane // 0,1 % // Non rinse-off products. Avoid formation of nitrosmaines. See Annex VI, Part 1, No 20 // // 31. 12. 1987 // // // // // // // 8 // Undec-10-enoic acid: esters, the amide, the mono- and bis (2-hydroxethyl) amides and their sulphosuccinates (*) // 0,2 % (acid) // See Annex VI, Part 1, No 18 // // 31. 12. 1987 // // // // // // // 9 // Clorofene (INN) // 0,2 % // // // 31. 12. 1987 // // // // // // // 10 // 2-Chloro-N-(hydroxymethyl) acetamide // 0,3 % expressed as the chloracetamide // Products rinsed off // // 31. 12. 1987 // // // // // // // 11 // Pyrithione aluminium camsilate (INNM) // 0,2 % // // // 31. 12. 1986 // // // // // // // // // // // // // Reference number // Substance // Maximum authorized concentration // Limitation and requirements // Conditions of use and warnings which must be printed on the label // Allowed until // // // // // // // a // b // c // d // e // f // // // // // // // // 12 // N-(Trichloromethylthio) cyclohex-4-ene-1,2- dicarboximide (Captan - ISO)) // 0,06 % // Prohibited in the products intended to come into contact with mucous membranes // // 31. 12. 1986 // // // // // // // 13 // 2,2-Dithiobis (pyridine 1-oxide), addition product with magnesium sulphate trihydrate // 0,2 % // Products rinsed off // // 31. 12. 1986 // // // // // // // 14 // 1-Phenoxypropan-2-ol // 1 % // Rinse-off products only // // 31. 12. 1986 // // // // // // // 15 // Benzethonium chloride (INN) (*) // 0,1 % // Prohibited in the products intended to come into contact with mucous membranes // // 31. 12. 1986 // // // // // // // 16 // Benzalkonium chloride (INN), bromide and saccharinate (*) // 0,25 % // // // 31. 12. 1986 // // // // // // // 17 // 1-[1,3-Bis (hydroxymethyl)-2,5-dioxoimidazoli- din-1-yl]-1,3-bis (hydroxymethyl) urea // 0,5 % // // // 31. 12. 1987 // // // // // // // 18 // Hexetidine (INN) // 0,1 % // See Annex VI, Part I, No 19 // // 31. 12. 1987 // // // // // // // 19 // 4-Hydroxybenzoic acid benzyl ester // 0,1 % (acid) // // // 31. 12. 1988 // // // // // // // 20 // Hexamidine (INN) and its salts (including isethionate and 4-hydroxybenzoate) (*) // 0,1 % // // // 31. 12. 1988 // // // // // // // 21 // Benzylformal (a 1: 1 mixture of benzyloxymethanol and (benzyloxymethoxy) methanol) // 0,2 % // // // 31. 12. 1987 // // // // // // // 22 // 2-Chloroacetamide // 0,3 % // // Contains chloroacetamide // 31. 12. 1987 // // // // // // // 23 // 1-Dodecylguanidinium acetate (Dodine - ISO) (*) // 0,5 % // Products rinsed off // // 31. 12. 1986 // // // 0,1 % // For other products // // // // // // // // // 24 // Chlorhexidine (INN) and its digluconate, diacetate and dihydrochloride (*) // 0,3 % // // // 31. 12. 1987 // // // // // // // 25 // 1,3,5-Tris (2-hydroxyethyl) hexahydro-1,3,5-triasine // 0,2 % // Only for products rinsed off // Contains 1,3,5-Tris (2-hydroxyethyl) hexahydro-1,3,5- triasine // 31. 12. 1988 // // // // // // //

NOT TO BE USED IN COSMETIC SUNSCREEN PRODUCTS // // // // //

37

6,6-DIBROMO-4,4-DICHLORO2,2-METHYLENE - DIPHENOL ( BROMOCHLOROPHEN ) (*)

0,1 % // // // // // // //

38

4-ISOPROPYL-M-CRESOL

0,1 % // // // // // // //

39

MIXTURE OF 5-CHLORO-2-METHYL-ISOTHIAZOL-3(2H)-ONE AND 2-METHYLISOTHIAZOL-3(2H)-ONE WITH MAGNESIUM CHLORIDE AND MAGNESIUM NITRATE

0,003 % ( OF A MIXTURE IN THE RATIO 3 : 1 OF 5-CHLORO-2-METHYLISOTHIAZOL 3(2H)-ONE AND 2-METHYLISOTHIAZOL-3 ( 2H)-ONE // // // // // // //

PART 2

LIST OF PRESERVATIVES PROVISIONALLY ALLOWED

1.2.3.4.5.6REFERENCE NUMBER

SUBSTANCE

MAXIMUM AUTHORIZED CONCENTRATION

LIMITATION AND REQUIREMENTS

CONDITIONS OF USE AND WARNINGS WHICH MUST BE PRINTED ON THE LABEL

ALLOWED UNTIL // // // // // //

A

B

C

D

E

F // // // // // // // // // // // //

1

BORIC ACID (*)

( A ) 0,5 %

( A ) PRODUCTS FOR ORAL HYGIENE //

31 . 12 . 1988 // //

( B ) 3 %

( B ) OTHER PRODUCTS // // // // // // // //

2

CHLORPHENESIN ( INN ) (*)

0,5 % // //

31 . 12 . 1987 // // // // // //

3

DIBROMOPROPAMIDINE ( INN ) AND ITS SALTS ( INCLUDING ISETHIONATE ( INN ))

0,1 % // //

31 . 12 . 1988 // // // // // //

4

ALKYL ( C12-C22 ) TRIMETHYL-AMMONIUM BROMIDE AND CHLORIDE ( INCLUDING CETRIMONIUM BROMIDE ( INN ) (*))

0,1 % // //

31 . 12 . 1988 // // // // // //

5

3-HEPTYL-2-(3-HEPTYL-4-METHYL-4-THIAZOLIN-2 - YLIDENEMETHYL)-4-METHYL-THIAZOLINIUM IODIDE

0,002 %

CREAMS, TOILET LOTIONS, SHAMPOOS //

31 . 12 . 1988 // // // // // //

6

4,4-DIMETHYL-1,3-OXAZOLIDINE

0,1 %

RINSE-OFF PRODUCTS ONLY . THE PH OF THE FINISHED PRODUCT SHALL NOT BE LOWER THAN 6 //

31 . 12 . 1989 // // // // // //

7

5-BROMO-5-NITRO-1,3-DIOXANE

0,1 %

NON RINSE-OFF PRODUCTS . AVOID FORMATION OF NITROSMAINES . SEE ANNEX VI, PART 1, NO 20 //

31 . 12 . 1987 // // // // // //

8

UNDEC-10-ENOIC ACID : ESTERS, THE AMIDE, THE MONO - AND BIS ( 2-HYDROXETHYL ) AMIDES AND THEIR SULPHOSUCCINATES (*)

0,2 % ( ACID )

SEE ANNEX VI, PART 1, NO 18 //

31 . 12 . 1987 // // // // // //

9

CLOROFENE ( INN )

0,2 % // //

31 . 12 . 1987 // // // // // //

10

2-CHLORO-N-(HYDROXYMETHYL ) ACETAMIDE

0,3 % EXPRESSED AS THE CHLORACETAMIDE

PRODUCTS RINSED OFF //

31 . 12 . 1987 // // // // // //

11

PYRITHIONE ALUMINIUM CAMSILATE ( INNM )

0,2 % // //

31 . 12 . 1986 // // // // // //

REFERENCE NUMBER

SUBSTANCE

MAXIMUM AUTHORIZED CONCENTRATION

LIMITATION AND REQUIREMENTS

CONDITIONS OF USE AND WARNINGS WHICH MUST BE PRINTED ON THE LABEL

ALLOWED UNTIL // // // // // //

A

B

C

D

E

F // // // // // // //

12

N-(TRICHLOROMETHYLTHIO ) CYCLOHEX-4-ENE-1,2 - DICARBOXIMIDE ( CAPTAN - ISO ))

0,06 %

PROHIBITED IN THE PRODUCTS INTENDED TO COME INTO CONTACT WITH MUCOUS MEMBRANES //

31 . 12 . 1986 // // // // // //

13

2,2-DITHIOBIS ( PYRIDINE 1-OXIDE ), ADDITION PRODUCT WITH MAGNESIUM SULPHATE TRIHYDRATE

0,2 %

PRODUCTS RINSED OFF //

31 . 12 . 1986 // // // // // //

14

1-PHENOXYPROPAN-2-OL

1 %

RINSE-OFF PRODUCTS ONLY //

31 . 12 . 1986 // // // // // //

15

BENZETHONIUM CHLORIDE ( INN ) (*)

0,1 %

PROHIBITED IN THE PRODUCTS INTENDED TO COME INTO CONTACT WITH MUCOUS MEMBRANES //

31 . 12 . 1986 // // // // // //

16

BENZALKONIUM CHLORIDE ( INN ), BROMIDE AND SACCHARINATE (*)

0,25 % // //

31 . 12 . 1986 // // // // // //

17

1-(1,3-BIS ( HYDROXYMETHYL)-2,5-DIOXOIMIDAZOLI - DIN-1-YL)-1,3-BIS ( HYDROXYMETHYL ) UREA

0,5 % // //

31 . 12 . 1987 // // // // // //

18

HEXETIDINE ( INN )

0,1 %

SEE ANNEX VI, PART I, NO 19 //

31 . 12 . 1987 // // // // // //

19

4-HYDROXYBENZOIC ACID BENZYL ESTER

0,1 % ( ACID ) // //

31 . 12 . 1988 // // // // // //

20

HEXAMIDINE ( INN ) AND ITS SALTS ( INCLUDING ISETHIONATE AND 4-HYDROXYBENZOATE ) (*)

0,1 % // //

31 . 12 . 1988 // // // // // //

21

BENZYLFORMAL ( A 1 : 1 MIXTURE OF BENZYLOXYMETHANOL AND ( BENZYLOXYMETHOXY ) METHANOL )

0,2 % // //

31 . 12 . 1987 // // // // // //

22

2-CHLOROACETAMIDE

0,3 % //

CONTAINS CHLOROACETAMIDE

31 . 12 . 1987 // // // // // //

23

1-DODECYLGUANIDINIUM ACETATE ( DODINE - ISO ) (*)

0,5 %

PRODUCTS RINSED OFF //

31 . 12 . 1986 // //

0,1 %

FOR OTHER PRODUCTS // // // // // // // //

24

CHLORHEXIDINE ( INN ) AND ITS DIGLUCONATE, DIACETATE AND DIHYDROCHLORIDE (*)

0,3 % // //

31 . 12 . 1987 // // // // // //

25

1,3,5-TRIS ( 2-HYDROXYETHYL ) HEXAHYDRO-1,3,5-TRIASINE

0,2 %

ONLY FOR PRODUCTS RINSED OFF

CONTAINS 1,3,5-TRIS ( 2-HYDROXYETHYL ) HEXAHYDRO-1,3,5 - TRIASINE

31 . 12 . 1988 // // // // // //