The Cosmetic Products (Safety) Regulations 1996

(1)	(2)	(3)	(4)	(5)	(6)	(7)
Reference Number	Name of Substance	Purpose of substance or type of product	Maximum concentration of substance in product	Other requirements	Required information	Permitted for use until
NOTE—There are presently no entries in this Part. Combination Rules A. Where a cosmetic product contains two or more substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 1. B. Where a cosmetic product contains the substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 2; but the concentration of each substance shall not in any event exceed the limit specified for the substance in respect of the product in column 4 above. C. The relevant quotient for each substance is the actual concentration of the substance in the product divided by the maximum concentration specified for the substance in respect of the product in Column 4 of this Schedule.	NOTE—There are presently no entries in this Part. Combination Rules A. Where a cosmetic product contains two or more substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 1. B. Where a cosmetic product contains the substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 2; but the concentration of each substance shall not in any event exceed the limit specified for the substance in respect of the product in column 4 above. C. The relevant quotient for each substance is the actual concentration of the substance in the product divided by the maximum concentration specified for the substance in respect of the product in Column 4 of this Schedule.	NOTE—There are presently no entries in this Part. Combination Rules A. Where a cosmetic product contains two or more substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 1. B. Where a cosmetic product contains the substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 2; but the concentration of each substance shall not in any event exceed the limit specified for the substance in respect of the product in column 4 above. C. The relevant quotient for each substance is the actual concentration of the substance in the product divided by the maximum concentration specified for the substance in respect of the product in Column 4 of this Schedule.	NOTE—There are presently no entries in this Part. Combination Rules A. Where a cosmetic product contains two or more substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 1. B. Where a cosmetic product contains the substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 2; but the concentration of each substance shall not in any event exceed the limit specified for the substance in respect of the product in column 4 above. C. The relevant quotient for each substance is the actual concentration of the substance in the product divided by the maximum concentration specified for the substance in respect of the product in Column 4 of this Schedule.	NOTE—There are presently no entries in this Part. Combination Rules A. Where a cosmetic product contains two or more substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 1. B. Where a cosmetic product contains the substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 2; but the concentration of each substance shall not in any event exceed the limit specified for the substance in respect of the product in column 4 above. C. The relevant quotient for each substance is the actual concentration of the substance in the product divided by the maximum concentration specified for the substance in respect of the product in Column 4 of this Schedule.	NOTE—There are presently no entries in this Part. Combination Rules A. Where a cosmetic product contains two or more substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 1. B. Where a cosmetic product contains the substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 2; but the concentration of each substance shall not in any event exceed the limit specified for the substance in respect of the product in column 4 above. C. The relevant quotient for each substance is the actual concentration of the substance in the product divided by the maximum concentration specified for the substance in respect of the product in Column 4 of this Schedule.	NOTE—There are presently no entries in this Part. Combination Rules A. Where a cosmetic product contains two or more substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 1. B. Where a cosmetic product contains the substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 2; but the concentration of each substance shall not in any event exceed the limit specified for the substance in respect of the product in column 4 above. C. The relevant quotient for each substance is the actual concentration of the substance in the product divided by the maximum concentration specified for the substance in respect of the product in Column 4 of this Schedule.

SCHEDULE 3 — LIST OF COLOURING AGENTS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS AND EXCEPT COLOURING AGENTS INTENDED SOLELY TO COLOUR HAIR

In this Schedule the colouring agents referred to in regulation 4(2)(c) are—

• (i) those identified in column 1 either by name or by colour index number (the colour index numbers being those specified in the third edition of The Colour Index published in 1971 by the Society of Dyers and Colourists);

• (ii) lakes or salts of these colouring agents which do not use substances prohibited under Schedule 1.

In the case of colouring agents identified by the addition of (*) to the name or colour index number, the insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolubility which will be determined by the procedure laid down in Article 8 of the Directive.

Colouring agents whose number is preceded by the letter ‘E’ in accordance with the EEC Directive of 23 October 1962 on the approximation of the rules of member States concerning foodstuffs and colouring matter[^f00042], as amended[^f00043], adapted[^f00044] and replaced in part[^f00045] must fulfil the purity requirements laid down in those Directives.

PART I — COLOURING AGENTS LISTED IN ANNEX IV PART 1 (FORMERLY ANNEX III PART 2) OF THE DIRECTIVE AS COLOURING AGENTS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN

Field of application

In column 3 of this Schedule, the entry “X” in a sub-column means that the colouring agent must not be used other than as follows—

• Sub-column 1 = Colouring agents allowed in all cosmetic products;

• Sub-column 2 = Colouring agents allowed in all cosmetic products except those intended to be applied in the vicinity of the eyes, in particular eye make-up and eye make-up remover;

• Sub-column 3 = Colouring agents allowed exclusively in cosmetic products except cosmetic products intended to come into contact with the mucous membranes;

• Sub-column 4 = Colouring agents allowed exclusively in cosmetic products intended to come into contact only briefly with the skin. (1)(2)(3)(4)Name or colour index numberColourType of product Field of applicationOther requirements1234 10006GreenX10020GreenX10316YellowX11680YellowX11710YellowX11725OrangeX11920OrangeX12010RedX12085RedX3 per cent maximum concentration in the finished product12120RedX12150RedX12370RedX12420RedX12480BrownX12490RedX12700YellowX13015YellowXE 10514270OrangeXE 10314700RedX14720RedXE 12214815RedXE 12515510OrangeX15525RedX15580RedX15620RedX15630RedX3 per cent maximum concentration in the finished product15800RedX15850RedX15865RedX15880RedX15980OrangeXE 11115985YellowXE 11016035RedX16185RedXE 12316230OrangeX16255RedXE 12416290RedXE 12617200RedX18050RedX18130RedX18690YellowX18736RedX18820YellowX18965YellowX19140YellowXE 10220040YellowXMaximum 3,3'-dimethyl-benzidine concentration in the colouring agent: 5 mg/kg20170OrangeX20470BlackX21100YellowXMaximum 3,3'-dichloro-benzidine concentration in the colouring agent: 5 mg/kg21108YellowXMaximum 3,3'-dichloro-benzidine concentration in the colouring agent: 5 mg/kg21230YellowX24790RedX26100RedXPurity criteria: aniline ≤0.2 per cent, 2-naphthol ≤0.2 per cent, azobenzen-4-amine ≤0.1 per cent, 1-phenylazo-2-naphthol ≤3 per cent, 1-[2-(phenylazo)phenylazo]-2-naphthol ≤2 per cent27290RedX27755BlackXE 15228440BlackXE 15140215OrangeX40800OrangeX40820OrangeXE 160e40825OrangeXE 160f40850OrangeXE 161g42045BlueX42051BlueXE 13142053GreenX42080BlueX42090BlueX42100GreenX42170GreenX42510VioletX42520VioletXMaximum concentration in the finished product: 5 mg/kg42735BlueX44045BlueX44090GreenXE 14245100RedX45190VioletX45220RedX45350YellowX6 per cent maximum concentration in the finished product45370OrangeXNot more than 1 per cent 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid and 2 per cent 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid45380RedXas immediately above45396OrangeXWhen used in lipstick, the colouring agent is allowed only in free acid form and in a maximum concentration of 1 per cent45405RedXNot more than 1 per cent 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid and 2 per cent 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid45410RedXas immediately above45425RedXNot more than 1 per cent 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid and 3 per cent 2-(iodo-6-hydroxyl-3-oxo-3H-xanthen-9-yl)benzoic acid45430RedXas immediately above, E 12747000YellowX47005YellowXE 10450325VioletX50420BlackX51319VioletX58000RedX59040GreenX60724VioletX60725VioletX60730VioletX61565GreenX61570GreenX61585BlueX62045BlueX69800BlueXE 13069825BlueX71105OrangeX73000BlueX73015BlueXE 13273360RedX73385VioletX73900VioletX73915RedX74100BlueX74160BlueX74180BlueX74260GreenX75100YellowX75120OrangeXE 160b75125YellowXE 160d75130OrangeXE 160a75135YellowXE 161d75170WhiteX75300YellowXE 10075470RedXE 12075810GreenXE 140 and E 14177000WhiteXE 17377002WhiteX77004WhiteX77007BlueX77015RedX77120WhiteX77163WhiteX77220WhiteXE 17077231WhiteX77266BlackX77267BlackX77268:1BlackXE 15377288GreenXFree from chromate ions77289GreenXFree from chromate ions77346GreenX77400BrownX77480BrownXE 17577489OrangeXE 17277491RedXE 17277492YellowXE 17277499BlackXE 17277510BlueXFree from cyanide ions77713WhiteX77742VioletX77745RedX77820WhiteXE 17477891WhiteXE 17177947WhiteXAcid red 195RedXAluminium, zinc, magnesium and calcium stearatesWhiteXAnthocyaninsRedXE 163Beetroot redRedXE 162Bromocresol greenGreenXBromothymol blueBlueXCaramelBrownXE 150Capsanthin, capsorubinOrangeXE 160cLactoflavinYellowXE 101

PART II — COLOURING AGENTS LISTED IN ANNEX IV OF PART 2 OF THE DIRECTIVE AS COLOURING AGENTS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN AND WHERE COSMETIC PRODUCT SUPPLIED BEFORE A CERTAIN DATE

Field of application

NOTE: There are presently no entries in this part.

SCHEDULE 4 — LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS

In this Schedule, the matters specified in columns 3, 4, 5 and 6 which apply to a particular substance are those set out to the right of its name as mentioned in column 2; and the matters specified in columns 4, 5 and 6 which apply in any particular case are those set out to the right of the matter specified in column 3 which applies in that case. The substance may not be used or contained other than in the types of product specified in column 3. The concentration of the substance, when it is used as a preservative, in a product may not exceed the limit set out in column 4. Where a product is intended to be mixed with another product in specified proportions before use, the level of concentration shall be calculated by reference to the mixture. Other requirements are specified in column 5.

In column 4 of this Schedule, “A” indicates that the concentration of the substance in a product may exceed the limit set out in that column provided that—

• (a) the presence of any excess of the substance in a product over the concentration so set out is not for the primary purpose of inhibiting the development of micro-organisms; and

• (b) the purpose for which any such excess is present in the product is apparent from the labelling of the product.

In this Schedule—

• “salts” means salts of the cations sodium, potassium, calcium, magnesium, ammonium and ethanolamines and of the anions chloride, bromide, sulphate and acetate;

• “esters” means esters of methyl, ethyl, propyl, isopropyl, butyl, isobutyl and phenyl.

In column 4 of this Schedule, the percentage concentration is measured by reference to mass (m/m) unless a contrary intention appears.

All preservative substances containing formaldehyde or any substances named in this Schedule which release formaldehyde must be labelled with the warning “contains formaldehyde” when the concentration of formaldehyde in the final product exceeds 0.05 per cent.

Names which appear in square brackets in column 2 of this Schedule are the International Nomenclature Cosmetic Ingredient names of the substances in question given in the inventory of ingredients employed in cosmetic products drawn up in accordance with the provisions of the Directive and contained in Commission Decision 96/335/EC[^f00048].

PART I — PRESERVATIVES LISTED IN ANNEX VI, PART I OF THE DIRECTIVE AS PRESERVATIVES WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN

(1)	(2)	(3)	(4)		(5)	(6)
Reference Number	Name of substance	Purpose of substance or type of product	Maximum concentration of substance in product		Other requirements	Required information
1	Benzoic acid, its salts and esters	All products	0.5 per cent (acid)	A	—	—
2	Propionic acid and its salts	All products	2 per cent (acid)	A	—	—
3	Salicylic acid and its salts	All products	0.5 per cent (acid)	A	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 (Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin)
4	Sorbic acid (hexa-2,4-dienoic acid) and its salts	All products	0.6 per cent (acid)	A	—	—
5	Formaldehyde and paraformaldehyde	For oral hygiene	0.1 per cent (expressed as free formaldehyde)		Not to be used in aerosol dispensers (sprays)	—
		Except for oral hygiene (see also Part I of Schedule 2)	0.2 per cent (expressed as free formaldehyde)
6	ENTRY DELETED
7	Biphenyl-2-ol [o-phenylphenol] and its salts	All products	0.2 per cent (expressed as the phenol)	A	—	—
8	Pyrithione zinc (INN) [Zinc pyrithione]	Products rinsed off after use	0.5 per cent	A	Not to be used in oral hygiene products	—
9	Inorganic sulphites and hydrogen sulphites	All products	0.2 per cent (expressed as free SO₂)	A	—	—
10	Sodium iodate	Products rinsed off after use	0.1 per cent		—	—
11	Chlorobutanol (INN)	All products	0.5 per cent		Not to be used in aerosol dispensers (sprays)	Contains chlorobutanol
12	4-Hydroxybenzoic acid and its salts and esters [the Parabens]	All products	0.4 per cent (acid) for 1 ester, 0.8 per cent (acid) for mixtures of esters	A	—	—
13	3-Acetyl-6-methylpyran-2,4(3H)-dione [Dehydroacetic acid] and its salts	All products	0.6 per cent (acid)		Not to be used in aerosol dispensers (sprays)	—
14	Formic acid and its sodium salt	All products	0.5 per cent (expressed as acid)	A	—	—
15	3,3'-Dibromo-4,4'-hexamethylene-dioxydibenzamidine [Dibromohexamidine] and its salts (including isethionate)	All products	0.1 per cent		—	—
16	Thiomersal (INN) [Thimerosal]	Eye make-up and eye make-up remover	0.007 per cent calculated as mercury. When mixed with other authorised mercury compounds total mercury concentration must not exceed 0.007 per cent		—	Contains thiomersal
17	Phenylmercuric salts (including borate)	Eye make-up and eye make-up remover	0.007 per cent calculated as mercury. When mixed with other authorised mercury compounds total mercury concentration must not exceed 0.007 per cent		—	Contains phenylmercuric compounds
18	Undec-10-enoic acid [Undecylenic acid] and its salts	All products	0.2 per cent (acid)	A	—	—
19	Hexetidine (INN)	Products rinsed off after use	0.1 per cent	A	—	—
20	5-Bromo-5-nitro-1,3-dioxane	Products rinsed off after use	0.1 per cent		Avoid formation of nitrosamines	—
21	Bronopol (INN) [2-Bromo-2-nitropropane-1,3-diol]	All products	0.1 per cent	A	Avoid formation of nitrosamines	—
22	2,4-Dichlorobenzyl alcohol [Dichlorobenzyl alcohol]	All products	0.15 per cent	A	—	—
23	Triclocarban (INN)	All products	0.2 per cent	A	Purity criteria: 3,3'4,4'-tetrachloro-azobenzene<1 mg/kg 3,3',4,4'-tetrachloro-azoxybenzene<1 mg/kg	—
24	4-Chloro-m-cresol [p-Chloro-m-cresol]	Not to be used in products intended to come into contact with mucous membranes	0.2 per cent	A	—	—
25	Triclosan (INN)	All products	0.3 per cent	A	—	—
26	4-Chloro-3,5-xylenol [Chloroxylenol]	All products	0.5 per cent	A	—	—
27	3,3'-Bis(1-hydroxymethyl-2,5-dioxoimidazolidin-4-yl)-1,1'-methylenediurea [Imidazolidinyl urea]	All products	0.6 per cent	A	—	—
28	Poly(1-hexamethylene-biguanide hydrochloride) [Polyaminopropyl biguanide]	All products	0.3 per cent	A	—	—
29	2-Phenoxyethanol [Phenoxyethanol]	All products	1.0 per cent	A	—	—
30	Hexamethylenetetramine (Methenamine (INN)) [Methenamine]	All products	0.15 per cent	A	—	—
31	Methenamine 3-chloroallylochloride (INNM) [Quaternium-15]	All products	0.2 per cent		—	—
32	1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one (Climbazole (INN)) [Climbazole]	All products	0.5 per cent	A	—	—
33	1,3-Bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione [DMDM Hydantoin]	All products	0.6 per cent	A	—	—
34	Benzyl alcohol (See also Part I of Schedule 2)	All products	1.0 per cent	A	—	—
35	1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone and its monoethanolamine salt [Piroctone olamine]	Products rinsed off after use Other products	1.0 per cent 0.5 per cent	A A	— —	— —
36	1,2-Dibromo-2,4-dicyanobutane [Methyldibromo glutaronitrile]	All products	0.1 per cent		Not to be used in cosmetic sunscreen products at a concentration exceeding 0.025 per cent	—
37	6,6-Dibromo-4,4-dichloro-2,2'-methylenediphenol [Bromochlorophen]	All products	0.1 per cent	A	—	—
38	4-Isopropyl-m-cresol [o-Cymen-5-ol]	All products	0.1 per cent		—	—
39	Mixture of 5-chloro-2-methylisothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one with magnesium chloride and magnesium nitrate [Methylchloroisothiazolinone and Methylisothiazolinone]	All products	0.0015 per cent of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol-3(2H)-one to 2-methylisothiazol-3(2H)-one		—	—
40	2-Benzyl-4-chlorophenol [Chlorophene]	All products	0.2 per cent		—	—
41	2-Chloroacetamide [Chloroacetamide]	All products	0.3 per cent		—	Contains chloroacetamide
42	Chlorhexidine (INN) and its digluconate, diacetate and dihydrochloride	All products	0.3 per cent	A	—	—
43	1-Phenoxypropan-2-ol [Phenoxyisopropanol] (see also Part I of Schedule 2)	Products rinsed off after use	1.0 per cent		—	—
44	Alkyl (C12-C22)-trimethylammonium bromide and chloride (Cetrimonium bromide (INN) and Cetrimonium chloride (INNM))	All products	0.1 per cent	A	—	—
45	4,4-Dimethyl-1,3-oxazolidine [Dimethyl oxazolidine]	All products	0.1 per cent		The pH of the finished product must not be lower than 6	—
46	1-[1,3-Bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea [Diazolidinyl urea]	All products	0.5 per cent		—	—
47	Hexamidine (INN) (4,4'-(Hexamethylene-dioxy)dibenzamidine) and its salts, including isethionate and p-hydroxybenzoate	All products	0.1 per cent	A	—	—
48	Glutaraldehyde (pentane-1,5-dial) [Glutaral]	All products	0.1 per cent		Prohibited in aerosols (sprays)	Contains glutaraldehyde (where glutaraldehyde concentration in the finished product exceeds 0.05 per cent)
49	5-Ethyl-3,7-dioxa-1-azabicyclo[3.3.0]octane[7-Ethylbicyclooxazolidine]	All products	0.3 per cent		Prohibited in oral hygiene products and in products intended to come into contact with mucous membranes	—
50	Chlorphenesin (INN) [Chlorphenesin]	All products	0.3 per cent		—	—
51	Sodium N-hydroxymethylglycinate [Sodium hydroxymethyl-glycinate]	All products	0.5 per cent		—	—
52	Silver chloride deposited on titanium dioxide	Not to be used in products for children under three years of age, in oral hygiene products and in products intended for application around the eyes and on the lips	0.004 per cent calculated as silver chloride		The ratio of titanium dioxide to silver chloride shall be 4:1 by mass	—

PART II — PRESERVATIVES LISTED IN ANNEX VI PART 2 OF THE DIRECTIVE AS PRESERVATIVES WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN AND WHERE SUPPLIED BEFORE A CERTAIN DATE

(1)	(2)	(3)	(4)	(5)	(6)	(7)
Reference Number in Annex VI Part 2 of the Directive	Name of substance	Purpose of substance or type of product	Maximum concentration of substance in product	Other requirements	Required information	Preservative supplied until
Note: Entry number 15 is deleted with effect from the dates specified in regulation 1(4) and entry numbers 2 and 30 are deleted with effect from the dates specified in regulation 1(6). Until then entry number 15 in Part II of Schedule 4 to S.I. 1989/2233 (as amended by S.I. 1995/1478 but not by S.I. 1996/1446) and entry numbers 2 and 30 in Part II of Schedule 4 to S.I. 1989/2233 (amended most recently by S.I. 1996/1446) continue in force.	Note: Entry number 15 is deleted with effect from the dates specified in regulation 1(4) and entry numbers 2 and 30 are deleted with effect from the dates specified in regulation 1(6). Until then entry number 15 in Part II of Schedule 4 to S.I. 1989/2233 (as amended by S.I. 1995/1478 but not by S.I. 1996/1446) and entry numbers 2 and 30 in Part II of Schedule 4 to S.I. 1989/2233 (amended most recently by S.I. 1996/1446) continue in force.	Note: Entry number 15 is deleted with effect from the dates specified in regulation 1(4) and entry numbers 2 and 30 are deleted with effect from the dates specified in regulation 1(6). Until then entry number 15 in Part II of Schedule 4 to S.I. 1989/2233 (as amended by S.I. 1995/1478 but not by S.I. 1996/1446) and entry numbers 2 and 30 in Part II of Schedule 4 to S.I. 1989/2233 (amended most recently by S.I. 1996/1446) continue in force.	Note: Entry number 15 is deleted with effect from the dates specified in regulation 1(4) and entry numbers 2 and 30 are deleted with effect from the dates specified in regulation 1(6). Until then entry number 15 in Part II of Schedule 4 to S.I. 1989/2233 (as amended by S.I. 1995/1478 but not by S.I. 1996/1446) and entry numbers 2 and 30 in Part II of Schedule 4 to S.I. 1989/2233 (amended most recently by S.I. 1996/1446) continue in force.	Note: Entry number 15 is deleted with effect from the dates specified in regulation 1(4) and entry numbers 2 and 30 are deleted with effect from the dates specified in regulation 1(6). Until then entry number 15 in Part II of Schedule 4 to S.I. 1989/2233 (as amended by S.I. 1995/1478 but not by S.I. 1996/1446) and entry numbers 2 and 30 in Part II of Schedule 4 to S.I. 1989/2233 (amended most recently by S.I. 1996/1446) continue in force.	Note: Entry number 15 is deleted with effect from the dates specified in regulation 1(4) and entry numbers 2 and 30 are deleted with effect from the dates specified in regulation 1(6). Until then entry number 15 in Part II of Schedule 4 to S.I. 1989/2233 (as amended by S.I. 1995/1478 but not by S.I. 1996/1446) and entry numbers 2 and 30 in Part II of Schedule 4 to S.I. 1989/2233 (amended most recently by S.I. 1996/1446) continue in force.	Note: Entry number 15 is deleted with effect from the dates specified in regulation 1(4) and entry numbers 2 and 30 are deleted with effect from the dates specified in regulation 1(6). Until then entry number 15 in Part II of Schedule 4 to S.I. 1989/2233 (as amended by S.I. 1995/1478 but not by S.I. 1996/1446) and entry numbers 2 and 30 in Part II of Schedule 4 to S.I. 1989/2233 (amended most recently by S.I. 1996/1446) continue in force.
1 to 15	ENTRIES DELETED (see Note)
16	Benzalkonium chloride (INN), bromide and saccharinate (Alkyl(C8-C18) benzyldimethyl-ammonium chloride, bromide and saccharinate)	All products	0.1 per cent A	—	—	30.06.1997
17 to 20	ENTRIES DELETED
21	Benzylhemiformal (a 1:1 mixture of benzyloxymethanol and benzyloxy-methoxymethanol)	Products rinsed off after use	0.03 per cent	—	—	30.06.1997
22 to 28	ENTRIES DELETED
29	3-lodoprop-2-ynyl butylcarbamate	All products	0.1 per cent	—	—	30.06.1997
30	ENTRY DELETED (see Note)

SCHEDULE 5 — LIST OF UV FILTERS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS

In this Schedule, the matters specified in columns 3, 4 and 5 which apply to a particular substance are those set out to the right of its name as mentioned in column 2. The concentration of the substance in a product may not exceed the limit specified in column 3. Where a product is intended to be mixed with another product in specified proportions before use, the level of concentration shall be calculated by reference to the mixture. Other requirements are specified in column 4. In column 3 of this Schedule, the percentage concentration is measured by reference to mass (m/m) unless a contrary intention appears.

Names which appear in square brackets in column 2 are the International Nomenclature Cosmetic Ingredient names of the substances in question given in the inventory of ingredients employed in cosmetic products drawn up in accordance with the provisions of the Directive and contained in Commission Decision 96/335/EC[^f00051]

PART I — UV FILTERS LISTED IN ANNEX VII PART I OF THE DIRECTIVE AS UV FILTERS WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN

(1)	(2)	(3)	(4)	(5)
Reference Number	Name of substance	Maximum concentration of substance in product	Other requirements	Required information
1	4-Aminobenzoic acid [PABA]	5 per cent	—	—
2	N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl)anilinium methyl sulphate [Camphor benzalkonium methosulfate]	6 per cent	—	—
3	Homosalate (INN)	10 per cent	—	—
4	Oxybenzone (INN) [Benzophenone-3]	10 per cent	—	Contains oxybenzone. (Not required when concentration is not more than 0.5 per cent, and when the substance is only intended to protect the product.)
5	ENTRY DELETED
6	2-Phenylbenzimidazole-5-sulphonic acid [Phenylbenzimidazole sulfonic acid] and its potassium, sodium and triethanolamine salts	8 per cent (expressed as acid)	—	—
7	3,3'-(1,4-Phenylenedimethylene)bis(7,7-dimethyl-2-oxo-bicyclo[2.2.1]hept-1-ylmethanesulfonic acid) [Terephthalylidene dicamphor sulfonic acid] and its salts	10 per cent (expressed as acid)	—	—
8	1-(4-tert-Butylphenyl)-3-(4-methoxyphenyl) propane-1,3-dione (Avobenzone (INN)) [Butyl methoxy dibenzoylmethane]	5 per cent	—	—
9	α-(2-Oxoborn-3-ylidene)toluene-4-sulphonic acid [Benzylidene camphor sulfonic acid] and its salts	6 per cent (expressed as acid)	—	—
10	2-Ethylhexyl-2-cyano-3,3-diphenylacrylate [Octocrylene]	10 per cent (expressed as acid)	—	—
11	Polymer of N-{(2 and 4)-[2-oxoborn-3-ylidene)methyl]benzyl}acrylamide [Polyacrylamidomethyl benzylidene camphor]	6 per cent	—	—

PART II — UV FILTERS LISTED IN ANNEX VII PART 2 OF THE DIRECTIVE AS UV FILTERS WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN AND WHERE SUPPLIED BEFORE A CERTAIN DATE

(1)	(2)	(3)	(4)	(5)	(6)
Reference Number	Name of substance	Maximum concentration of substance in product	Other requirements	Required information	UV filter supplied until
Note: Entry numbers 33 and 34 are deleted with effect from the dates specified in regulation 1(6). Until then the corresponding entries in Part II of Schedule 5 to S.I. 1989/2233 (amended most recently by S.I. 1996/1446) continue in force.	Note: Entry numbers 33 and 34 are deleted with effect from the dates specified in regulation 1(6). Until then the corresponding entries in Part II of Schedule 5 to S.I. 1989/2233 (amended most recently by S.I. 1996/1446) continue in force.	Note: Entry numbers 33 and 34 are deleted with effect from the dates specified in regulation 1(6). Until then the corresponding entries in Part II of Schedule 5 to S.I. 1989/2233 (amended most recently by S.I. 1996/1446) continue in force.	Note: Entry numbers 33 and 34 are deleted with effect from the dates specified in regulation 1(6). Until then the corresponding entries in Part II of Schedule 5 to S.I. 1989/2233 (amended most recently by S.I. 1996/1446) continue in force.	Note: Entry numbers 33 and 34 are deleted with effect from the dates specified in regulation 1(6). Until then the corresponding entries in Part II of Schedule 5 to S.I. 1989/2233 (amended most recently by S.I. 1996/1446) continue in force.	Note: Entry numbers 33 and 34 are deleted with effect from the dates specified in regulation 1(6). Until then the corresponding entries in Part II of Schedule 5 to S.I. 1989/2233 (amended most recently by S.I. 1996/1446) continue in force.
1	ENTRY DELETED
2	Ethoxylated ethyl 4-aminobenzoate [PEG-25 PABA]	10 per cent	—	—	30.6.1997
3–4	ENTRIES DELETED
5	2-Ethylhexyl 4-dimethylamino-benzoate [Octyl dimethyl PABA]	8 per cent	—	—	30.6.1997
6	2-Ethylhexyl salicylate [Octyl salicylate]	5 per cent	—	—	30.6.1997
7–11	ENTRIES DELETED
12	Isopentyl 4-methoxycinnamate, mixed isomers [Isoamyl p-methoxycinnamate]	10 per cent	—	—	30.6.1997
13	2-Ethylhexyl 4-methoxycinnamate [Octyl methoxycinnamate]	10 per cent	—	—	30.6.1997
14–16	ENTRIES DELETED
17	2-Hydroxy-4-methoxybenzo-phenone-5-sulphonic acid [Benzophenone-4] and its sodium salt [Benzophenone-5] (Sulisobenzone (INN) and Sulisobenzone sodium (INNM))	5 per cent (expressed as acid)	—	—	30.6.1997
18–24	ENTRIES DELETED
25	3-(4-Methylbenzyl-idene)bornan-2-one [4-Methylbenzylidene camphor]	6 per cent	—	—	30.6.1997
26	3-Benzylidenebornan-2-one [3-Benzylidene camphor]	6 per cent	—	—	30.6.1997
27–28	ENTRIES DELETED
29	4-Isopropylbenzyl salicylate [Isopropylbenzyl salicylate]	4 per cent	—	—	30.6.1997
30–31	ENTRIES DELETED
32	Tris(2-ethylhexyl) 4,4',4"-(1,3,5-triazin-2,4,6-triyltriimino)- tribenzoate [Octyl triazone]	5 per cent	—	—	30.6.1997
33–34	ENTRIES DELETED (see Note)

SCHEDULE 6 — SYMBOL IN ANNEX VIII OF THE DIRECTIVE WHICH IS REQUIRED FOR THE PURPOSES OF REGULATIONS 6(6) AND 6(11)

SCHEDULE 7

PART I — PARTICULARS TO BE INCLUDED WITH A REQUEST FOR CONFIDENTIALITY

1

The name or trade name and address or registered office of the applicant.

2

Precise identification of the cosmetic ingredient for which confidentiality is requested, namely—

• (a) where they exist, the CAS, EINECS and colour index numbers, the chemical name, the IUPAC name, the INCI name, the European Pharmacopoeia name, the International Non-proprietary Name as recommended by the World Health Organization and the common name as provided for in the common ingredients nomenclature;

• (b) the Elincs name and the official number allocated to it if it has been notified pursuant to Council Directive 67/548/EEC and an indication of the decision to approve or refuse any request for confidentiality made under Article 19 of that Directive;

• (c) where the names or numbers referred to in sub-paragraphs (a) and (b) above do not exist, for example in the case of certain ingredients of natural origin, the name of the base material, the name of the part of the plant or animal used and the names of the cosmetic ingredient’s compounds, such as solvents.

3

The evaluation of the safety for human health of the cosmetic ingredient as used in the finished cosmetic product or products taking into account the cosmetic ingredient’s toxicological profile, chemical structure and the level of exposure as specified in regulation 8(1)(d) and carried out in accordance with the requirements of regulations 8(2) and (3).

4

The envisaged use of the cosmetic ingredient and in particular the different categories of cosmetic products in which it will be used.

5

A detailed justification of why confidentiality is sought addressing for example—

• (a) the fact that the identity of the cosmetic ingredient or its function in the cosmetic product to be supplied has not been described in the literature accompanying the cosmetic product and is unknown to other manufacturers or suppliers of cosmetic products;

• (b) the fact that the information is not yet in the public domain even though a patent application has been lodged for the cosmetic ingredient or its use;

• (c) the fact that if the information were known it would be easily reproducible, to the detriment of the applicant.

6

• (a) If known, the name of each cosmetic product which is to contain the cosmetic ingredient and if different names are to be used in other member States, precise details of each one of them.

• (b) If the name of a cosmetic product is not yet known, it may be communicated at a later date, but at least 15 days before the cosmetic product is supplied.

• (c) If the cosmetic ingredient is used in several products, one request shall suffice, provided that the cosmetic products are clearly indicated to the competent authority.

7

A statement setting out whether a request has been submitted to the competent authority of any other member State in respect of the cosmetic ingredient for which confidentiality is sought and particulars on the outcome of any such request.

PART II — PROCEDURE FOR GRANT OF REGISTRATION NUMBER

SCHEDULE 8 — SAMPLING AND TESTING

1

In this Schedule—

• “Annex A” means the Annex to Commission Directive No. 80/1335/EEC[^f00054] as amended by Commission Directive No. 87/143/EEC[^f00055];

• “Annex B” means the Annex to Commission Directive No. 82/434/EEC[^f00056] as amended by Commission Directive No. 90/207/EEC[^f00057];

• “Annex C” means the Annex to Commission Directive No. 83/514/EEC[^f00058];

• “Annex D” means the Annex to Commission Directive No. 85/490/EEC[^f00059];

• “Annex E” means the Annex to Commission Directive No. 93/73/EEC[^f00060];

• “Annex F” means the Annex to Commission Directive No. 95/32/EC[^f00061];

• “Annex G” means the Annex to Commission Directive No. 96/45/EC[^f00062];

• “purchase” means purchase for the purpose of carrying out a test.

2

An enforcement authority intending to purchase a cosmetic product shall purchase a sufficient laboratory sample, as defined in paragraph 2.3 of Part I of Annex A, for the purpose of Annex A; and, for the purposes of the definition of “total sample” in paragraph 2.2 of Part I of Annex A, samples shall be regarded as having the same batch number if—

• (a) the means of identifying the batch referred to in regulation 6(2)(g) above shows that they were manufactured in the same batch; or

• (b) in the case of a product not manufactured in a batch, the reference referred to in regulation 6(2)(g) above shows that they are derived from the same unit of production; or

• (c) in the case of a product which does not comply with the requirements of regulation 6(2)(g) above, the officer effecting the purchase has reasonable cause to believe that they were manufactured in the same batch or are derived from the same unit of production, as the case may be.

3

The immediate container, if any, of a cosmetic product purchased by an enforcement authority shall not have been opened by, on behalf of or at the request of the enforcement authority before the purchase takes place and the container shall not thereafter be opened except in accordance with paragraph 5.3 of Part I of Annex A and paragraph 1.2 of Part II of Annex A.

4

As soon as an enforcement authority has purchased a cosmetic product, the officer effecting the purchase shall—

• (a) either—

• (i) place a seal on the product’s container or outer packaging, or

• (ii) place the product in a container and forthwith place a seal on that container, in such a way that the product’s immediate container cannot be opened or (in the case of a product which was not in a container when it was purchased) the product cannot be touched without (in either case) the seal being broken in such a manner that it would be apparent thereafter that it had been broken, and

• (b) attach to the product a label indicating—

• (i) the name of the product,

• (ii) the date, time and place at which the product was purchased,

• (iii) his own name, and

• (iv) the name of the enforcement authority making the purchase.

5

• (1) Subject to sub-paragraph (2) below, the provisions of Part I of Annex A, other than paragraphs 3.1, 3.2 and 4, and of Part II of Annex A, other than paragraph 1.4, shall be complied with in the sampling of cosmetic products and the laboratory preparation of test portions.

• (2) Where, because of the way in which a cosmetic product is put up for sale, it is not practicable for Part II of Annex A to be complied with, it shall be prepared for testing in accordance with good analytical practice, and the person so preparing it shall record in writing the method of preparation which he has used.

6

• (1) Any test to determine whether a cosmetic product contains a significant amount of free sodium hydroxide or free potassium hydroxide shall be carried out in accordance with paragraphs 1 to 4 of Part III of Annex A.

• (2) Any test to determine the amount of free sodium hydroxide or free potassium hydroxide in a hair straightener product or a nail cuticle solvent product shall be carried out in accordance with paragraphs 1, 2, 3 and 5 of Part III of Annex A.

• (3) Any test to determine whether a hair-care product contains oxalic acid or any alkaline salt of oxalic acid or to determine the amount of such a substance in a hair-care product shall, subject to the limitation specified in the second sentence of paragraph 1 of Part IV of Annex A, be carried out in accordance with the said Part IV.

• (4) Any test to determine the amount of chloroform in toothpaste shall, subject to the limitation specified in the second sentence of paragraph 1 of Part V of Annex A, be carried out in accordance with the said Part V.

• (5) Any test to determine the amount of zinc chloride, zinc sulphate or zinc 4-hydroxybenzenesulphonate by virtue of their zinc contents in a cosmetic product shall be carried out in accordance with Part VI of Annex A and Commission Directive 87/143/EEC[^f00063], and shall take into account paragraph 11 of Part VII of Annex A.

• (6) Any test to determine whether a cosmetic product contained in an aerosol dispenser or a cream, emulsion, lotion, gel or oil intended to be applied to the skin contains 4-hydroxybenzenesulphonic acid, or to determine the amount of that acid in such a product, shall be carried out in accordance with Part VII of Annex A.

• (7) Any test to determine whether a hair-care product contains persulphate, bromate or hydrogen peroxide shall be carried out in accordance with Part A of Part I of Annex B.

• (8) Any test to determine whether a hair-care product contains barium peroxide shall be carried out in accordance with Part B of Part I of Annex B.

• (9) Any test to determine the amount of hydrogen peroxide in a hair-care product shall be carried out in accordance with Part C of Part I of Annex B.

• (10) Any test to determine whether a hair-dye contains any of the oxidation colourants specified in paragraph 1 of Part II of Annex B, or to determine the amount of such a substance in a hair-dye, shall be carried out in accordance with the said Part II.

• (11) Any test to determine whether a cosmetic product contains nitrite, or to determine the amount of that substance in a cosmetic product, shall be carried out in accordance with Part III of Annex B.

• (12) Any test to determine whether a cosmetic product contains free formaldehyde, or to determine the amount of that substance in a cosmetic product, shall be carried out in accordance with Part IV of Annex B.

• (13) Any test to determine the amount of resorcinol in a shampoo or hair lotion shall, subject to the limitation specified in the second sentence of paragraph 1 of Part V of Annex B, be carried out in accordance with the said Part V.

• (14) Any test to determine the amount of methanol in relation to ethanol or propan-2-ol in a cosmetic product shall be carried out in accordance with Part VI of Annex B.

• (15) Any test to determine the amount of dichloromethane or 1,1,1-trichloroethane in a cosmetic product shall be carried out in accordance with paragraphs 1 to 10 of that part of Annex C which is headed “Determination of dichloromethane and 1,1,1-trichloroethane”.

• (16) Any test to determine whether a cosmetic product contains quinolin-8-ol or bis(8-hydroxyquinolinium) sulphate, or to determine the amount of such a substance in a cosmetic product, shall be carried out in accordance with paragraphs 1 to 9 of that part of Annex C which is headed “Identification and determination of quinolin-8-ol and bis(8-hydroxyquinolinium) sulphate”.

• (17) Any test to determine the amount of ammonia in a cosmetic product shall be carried out in accordance with paragraphs 1 to 8 of that part of Annex C which is headed “Determination of ammonia”.

• (18) Any test to determine whether a cosmetic product contains nitromethane, or to determine the amount of that substance in a cosmetic product, shall be carried out in accordance with paragraphs 1 to 7 of that part of Annex C which is headed “Identification and determination of nitromethane”.

• (19) Any test to determine whether a hair waving, hair straightening or depilatory product contains mercaptoacetic acid (thioglycolic acid), or to determine the amount of that substance in such a product, shall be carried out in accordance with paragraphs 1 to 6 of that part of Annex C which is headed “Identification and determination of mercaptoacetic acid in hair-waving, hair-straightening and depilatory products”.

• (20) Any test to determine whether a cosmetic product contains hexachlorophene (INN) shall be carried out in accordance with paragraphs 1 to 7 of Part A of that part of Annex C which is headed “Identification and determination of hexachlorophene”.

• (21) Any test to determine the amount of hexachlorophene (INN) in a cosmetic product shall be carried out in accordance with paragraphs 1 to 9 of Part B of that part of Annex C which is headed “Identification and determination of hexachlorophene”.

• (22) Any test to determine the amount of tosylchloramide sodium (INN) in a cosmetic product shall be carried out in accordance with paragraphs 1 to 9 of that part of Annex C which is headed “Quantitative determination of tosylchloramide sodium (INN) (chloramine-T)”.

• (23) Any test to determine the total amount of fluorine in dental creams shall be carried out in accordance with paragraphs 1 to 8 of that part of Annex C which is headed “Determination of total fluorine in dental creams”.

• (24) Any test to determine whether a cosmetic product contains organomercury compounds shall be carried out in accordance with paragraphs 1 to 4 of Part A of that part of Annex C which is headed “Identification and determination of organomercury compounds”.

• (25) Any test to determine the amount of organomercury compounds in a cosmetic product shall be carried out in accordance with paragraphs 1 to 7 of Part B of that part of Annex C which is headed “Identification and determination of organomercury compounds”.

• (26) Any test to determine the amount of alkali sulphides or alkaline earth sulphides in a cosmetic product shall be carried out in accordance with paragraphs 1 to 8 of that part of Annex C which is headed “Determination of alkali and alkaline earth sulphides”.

• (27) Any test for the identification and determination of the amount of glycerol 1-(4-aminobenzoate) in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of glycerol 1-(4-aminobenzoate)”.

• (28) Any test to determine the amount of chlorobutanol (INN) in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Determination of chlorobutanol”.

• (29) Any test for the identification and determination of the amount of quinine in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of quinine”.

• (30) Any test for the identification and determination of inorganic sulphites and hydrogen sulphites in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of inorganic sulphites and hydrogen sulphites”.

• (31) Any test for the identification and determination of chlorates of the alkali metals in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of chlorates of the alkali metals”.

• (32) Any test for the identification and determination of sodium iodate in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of sodium iodate”.

• (33) Any test for the identification and determination of silver nitrate in a cosmetic product shall be carried out in accordance with that part of Annex E which is headed “Identification and determination of silver nitrate in cosmetic products”.

• (34) Any test for the identification and determination of selenium disulphide in anti-dandruff shampoos shall be carried out in accordance with that part of Annex E which is headed “Identification and determination of selenium disulphide in anti-dandruff shampoos”.

• (35) Any test for the determination of soluble barium and soluble strontium in pigments in the form of salts or lakes shall be carried out in accordance with that part of Annex E which is headed “Determination of soluble barium and strontium in pigments in the form of salts or lakes”.

• (36) Any test for the identification and determination of benzyl alcohol in a cosmetic product shall be carried out in accordance with that part of Annex E which is headed “Identification and determination of benzyl alcohol in cosmetic products”.

• (37) Any test for the identification of zirconium and the determination of zirconium, aluminium and chlorine in non-aerosol anti-perspirants shall be carried out in accordance with that part of Annex E which is headed “Identification of zirconium, and determination of zirconium, aluminium and chlorine in non-aerosol anti-perspirants”.

• (38) Any test for the identification and determination of hexamidine, dibromohexamidine, dibromopropamidine and chlorhexidine in a cosmetic product shall be carried out in accordance with that part of Annex E which is headed “Identification and determination of hexamidine, dibromohexamidine, dibromopropamidine and chlorhexidine”.

• (39) Any test for the identification and determination of benzoic acid, 4-hydroxybenzoic acid, sorbic acid, salicylic acid and propionic acid in a cosmetic product shall be carried out in accordance with that part of Annex F which is headed “Identification and determination of benzoic acid, 4-hydroxybenzoic acid, sorbic acid, salicylic acid and propionic acid in cosmetic products”.

• (40) Any test for the identification and determination of hydroquinone, hydroquinone monomethylether, hydroquinone monoethylether and hydroquinone monobenzylether (monobenzone) in a cosmetic product shall be carried out in accordance with that part of Annex F which is headed “Identification and determination of hydroquinone, hydroquinone monomethylether, hydroquinone monoethylether and hydroquinone monobenzylether in cosmetic products”.

• (41) Any test for the identification and determination of 2-phenoxyethanol, 1-phenoxypropan-2-ol, and methyl, ethyl, propyl, butyl and benzyl 4-hydroxybenzoate in a cosmetic product shall be carried out in accordance with Annex G.

SCHEDULE 9 — REVOCATIONS

(1)	(2)
Regulations revoked	References
The Cosmetic Products (Safety) Regulations 1989	S.I. 1989/2233
The Cosmetic Products (Safety) (Amendment) Regulations 1990	S.I. 1990/1812
The Cosmetic Products (Safety) (Amendment) Regulations 1991	S.I. 1991/447
The Cosmetic Products (Safety) (Amendment) Regulations 1992	S.I. 1992/1525
The Cosmetic Products (Safety) (Amendment) Regulations 1993	S.I. 1993/1539
The Cosmetic Products (Safety) (Amendment) Regulations 1994	S.I. 1994/1529
The Cosmetic Products (Safety) (Amendment) Regulations 1995	S.I. 1995/1478
The Cosmetic Products (Safety) (Amendment) Regulations 1996	S.I. 1996/1446

Signed

John M Taylor — Parliamentary Under-Secretary of State for Corporate and Consumer Affairs, — Department of Trade and Industry — 21st November 1996

Explanatory note

(This note is not part of the Regulations)

These Regulations consolidate with amendments the Cosmetic Products (Safety) Regulations 1989 as amended. They implement Council Directive 76/768/EEC (O.J. No. L262, 27.9.1976, p.169) on the approximation of the laws of the member States relating to cosmetic products, as amended (“the Cosmetics Directive”). They implement for the first time the amendments made to the Cosmetics Directive by Council Directive 93/35/EEC (O.J. No. L151, 23.6.1993, p.32) and Commission Directive 96/41/EC (O.J. No. L198, 8.8.1996, p.36). They also implement Commission Directives 95/32/EC (O.J. No. L178, 28.7.1995, p.20) and 96/45/EC (O.J. No. L213, 2.7.1996, p.8) relating to methods of analysis necessary for checking the composition of cosmetic products. Further, they implement Commission Directive 95/17/EC (O.J. No. L140, 23.6.1995, p.26) laying down detailed rules for the application of the Cosmetics Directive as regards the non-inclusion of one or more ingredients on the list used for the labelling of cosmetic products.

These Regulations give effect to Council Directive 93/35/EEC and Commission Directive 96/41/EC as follows—

• (1) they contain an amended definition of “cosmetic product”(regulation 2(1));

• (2) they contain an expanded general safety requirement for cosmetic products (regulation 3(1));

• (3) they prohibit the use of urocanic acid and its ethyl ester in cosmetic products (regulation 4(2)(a) and Schedule 1, entry numbers 342, 405 and 751);

• (4) they permit the use in certain cosmetic products of potassium hydroxide, sodium hydroxide, lithium hydroxide and calcium hydroxide, subject to restrictions (regulation 4(2)(b) and Schedule 2, Part I, entry numbers 15a, 15b and 15c);

• (5) they permit the use as preservatives in cosmetic products of chlorphenesin, sodium hydroxymethylglycinate and silver chloride deposited on titanium dioxide, subject to restrictions (regulations 4(2)(e)(i) and 4(2)(f) and Schedule 4, Part I, entry numbers 50, 51 and 52);

• (6) they permit, subject to restrictions, the use in cosmetic products until 30 June 1997 of three preservatives listed as entry numbers 16, 21 and 29 in Schedule 4, Part II (regulation 4(2)(e)(ii) and Schedule 4, Part II);

• (7) they permit the use as a UV filter in cosmetic products of polymer N-{(2 and 4)-[(2-oxoborn-3-ylidene)methyl]benzyl}acrylamide, subject to a restriction (regulation 4(2)(h)(i) and 4(2)(i) and Schedule 5, Part I, entry number 11);

• (8) they permit the use in cosmetic products until 30 June 1997 of 10 UV filters listed as entry numbers 2, 5, 6, 12, 13, 17, 25, 26, 29 and 32 in Schedule 5, Part II, subject to restrictions (regulation 4(2)(h)(ii) and Schedule 5, Part II);

• (9) they prohibit the use in cosmetic products of any ingredients which have been tested on animals after 1st January 1998 (regulation 4(3));

• (10) they provide that any reference to testing on animals in the labelling, putting up for sale or advertising of a cosmetic product must state clearly whether the tests carried out involved the cosmetic product itself or its ingredients (regulation 4(4) and (5));

• (11) they require cosmetic products to be labelled with information about their function, unless this is clear from their presentation (regulation 6(2)(h));

• (12) they require cosmetic products to be labelled with details of their ingredients, identified by their common names as provided for in the common ingredients nomenclature (an inventory of ingredients compiled by the Commission and contained in Commission Decision 96/335/EC (O.J. No. L132, 1.6.1996, p.1), and they make provision for the manner of labelling required and for cases where ingredients are not listed in the common ingredients nomenclature (regulation 6(1), (5)(b) and (9) to (12));

• (13) they require manufacturers, their agents, persons to whose order cosmetic products are manufactured and (in certain circumstances) persons responsible for supplying cosmetic products for the first time in the Community to keep for control purposes detailed information (which must be readily accessible to a United Kingdom competent authority) bearing on the composition, ingredients, method of manufacture, safety and effect of the cosmetic products in question (regulation 8);

• (14) they require manufacturers, their agents, persons to whose order cosmetic products are manufactured and (in certain circumstances) persons responsible for supplying cosmetic products for the first time in the Community to notify a United Kingdom competent authority of the address of the place of manufacture or initial importation into the Community of a type of cosmetic product before that type of product is first supplied in the Community, where the place of manufacture or initial importation is within the United Kingdom (regulation 9); and

• (15) they enable United Kingdom competent authorities to require that any holder of information on substances used in cosmetic products must make that information available where this may overcome or ease any difficulties encountered in providing prompt and appropriate medical treatment (regulation 10).

These Regulations give effect to the requirements of Commission Directives 95/32/EC and 96/45/EC by introducing procedures for the identification and determination of benzoic acid, 4-hydroxybenzoic acid, sorbic acid, salicylic acid, propionic acid, hydroquinone, hydroquinone monomethylether, hydroquinone monoethylether, hydroquinone monobenzylether (monobenzone), 2-phenoxyethanol, 1-phenoxypropan-2-ol, and methyl, ethyl, propyl, butyl and benzyl 4-hydrozybenzoate in cosmetic products (regulation 14 and Schedule 8, paragraph 6(39), (40) and (41)).

Finally, these Regulations give effect to the requirements of Commission Directive 95/17/EEC by providing that manufacturers, their agents, persons to whose order cosmetic products are manufactured and (in certain circumstances) persons responsible for supplying cosmetic products for the first time in the Community may, if for reasons of trade secrecy they do not wish to include a particular cosmetic ingredient in the list of cosmetic ingredients required for labelling purposes, apply to a competent authority for approval to use a reference number in that list rather than the ingredient’s name. Provision is made for the particulars which must accompany such an application and for the procedures which apply to applications and to the withdrawal of any approval (regulation 11 and Schedule 7).

The Colour Index referred to in these Regulations may be obtained from the Society of Dyers and Colourists, PO Box No. 244, 82 Grattan Road, Bradford BD1 2JB.

The International Cosmetic Ingredient Dictionary referred to in these Regulations may be obtained from Micelle Press, 12 Ullswater Crescent, Weymouth, Dorset DT3 5HE.

A Compliance Cost Assessment is available, copies of which have been placed in the libraries of both Houses of Parliament. Copies are also available from the Consumer Affairs and Competition Policy Directorate of the Department of Trade and Industry, Room 4.D.2, 1 Victoria Street, London SW1H 0ET.

Footnotes

[^f00001]: 1987 c. 43.

[^f00002]: S.I. 1972/1811, 1975/1707, 1993/2661.

[^f00003]: 1972 c. 68.

[^f00004]: S.I. 1989/2233, amended by S.I. 1990/1812, 1991/447, 1992/1525, 1993/1539, 1994/1529, 1995/1478, 1996/1446.

[^f00005]: O.J. No. L132, 1.6.1996, p.1.

[^f00006]: O.J. No. L140, 23.6.1995, p.26.

[^f00007]: O.J. No. L262, 27.9.1976, p.169.

[^f00008]: O.J. No. L167, 15.6.1982, p.1.

[^f00009]: O.J. No. L63, 6.3.1982, p.26.

[^f00010]: O.J. No. L109, 26.4.1983, p.25.

[^f00011]: O.J. No. L188, 13.7.1983, p.15.

[^f00012]: O.J. No. L332, 28.11.1983, p.38.

[^f00013]: O.J. No. L275, 8.10.1983, p.20.

[^f00014]: O.J. No. L228, 25.8.1984, p.31.

[^f00015]: O.J. No. L224, 22.8.1985, p.40.

[^f00016]: O.J. No. L138, 24.5.1986, p.40.

[^f00017]: O.J. No. L149, 3.6.1986, p.38.

[^f00018]: O.J. No. L56, 26.2.1987, p.20.

[^f00019]: O.J. No. L105, 26.4.1988, p.11.

[^f00020]: O.J. No. L382, 31.12.1988, p.46.

[^f00021]: O.J. No. L64, 8.3.1989, p.10.

[^f00022]: O.J. No. L398, 30.12.1989, p.25.

[^f00023]: O.J. No. L71, 17.3.1990, p.40.

[^f00024]: O.J. No. L91, 12.4.1991, p.59.

[^f00025]: O.J. No. L70, 17.3.1992, p.23.

[^f00026]: O.J. No. L325, 11.11.1992, p.18.

[^f00027]: O.J. No. L203, 13.8.1993, p.24.

[^f00028]: O.J. No. L151, 23.6.1993, p.32.

[^f00029]: O.J. No. L181, 15.7.1994, p.31.

[^f00030]: O.J. No. L167, 18.7.1995, p.19.

[^f00031]: O.J. No. L198, 8.8.1996, p.36..

[^f00032]: The Directive is within the scope of the EEA Agreement by virtue of Chapter XVI of Annex II to that Agreement.

[^f00033]: An ingredient’s CTFA name is the name given to it by the Cosmetics Toiletries and Fragrances Association and listed in the sixth edition of the International Cosmetic Ingredient Dictionary published in 1995. Its EINECS identification reference is the reference given in the European Inventory of Existing Commercial Chemical Substances. Its IUPAC identification reference is the reference given by the International Union of Pure and Applied Chemistry. Its CAS identification reference is the reference assigned by the Chemical Abstracts Service. An ingredient’s colour index number is the number specified in the third edition of The Colour Index published in 1971 by the Society of Dyers and Colourists. European Pharmacopoeia names, International Non-proprietary Names and EINECS, IUPAC and CAS identification references are listed in Commission Decision 96/335/EC (O.J. No. L132, 1.6.1996, p.1).

[^f00034]: O.J. No. L15, 17.1.87, p.29.

[^f00035]: 1954 c. 61.

[^f00036]: 1983 c. 54.

[^f00037]: 1987 c. 43.

[^f00038]: O.J. No. L187, 12.7.76, p.1.

[^f00039]: O.J. No. L147, 9.6.75, p.13.

[^f00040]: O.J. No. L132, 1.6.1996, p.1.

[^f00041]: See Directives 86/199/EEC, 87/137/EEC, 88/233/EEC, 88/667/EEC, 89/174/EEC, 90/121/EEC, 91/184/EEC, 92/8/EEC, 92/86/EEC, 93/47/EEC, 94/32/EC, 95/34/EC.

[^f00042]: O.J. No. 115, 11.11.62, p.2645.

[^f00043]: Council Directives Nos. 65/469/EEC, 67/653/EEC, 68/419/EEC, 70/358/EEC, 76/399/EEC, 78/144/EEC, 81/20/EEC and 85/7/EEC (O.J. Nos. L178, 26.10.65, p.2793; L263, 30.10.67, p.4; L309, 24.12.68, p.24; L157, 18.7.70, p.36; L108, 26.4.76, p.19; L44, 15.2.78, p.20; L43, 14.2.81, p.11; L2, 3.1.85, p.22).

[^f00044]: Annexes I and VII to the Act of Accession of 22 January 1972, as adjusted by the Council Decision of 1 January 1973 (O.J. No. L2, 1.1.73, p.1).

[^f00045]: Council Directive 94/36/EC (O.J. No. L237, 10.9.1994, p.13) and Commission Directive 95/45/EC (O.J. No. L226, 22.9.1995, p.1).