The Cosmetic Products (Safety) (Amendment) Regulations 1992

Statutory Instruments

1992 No. 1525

CONSUMER PROTECTION

The Cosmetic Products (Safety) (Amendment) Regulations 1992

Made

25th June 1992

Laid before Parliament

26th June 1992

Coming into force

29th June 1992 (except as provided in regulation 1(2), (3) and (4))

Whereas the Secretary of State is a Minister designated(1) for the purposes of section 2 of the European Communities Act 1972(2) in relation to measures for safety and consumer protection as respects cosmetic products and any provisions concerning the composition, labelling, marketing, classification or description of cosmetic products and in relation to indication of origin on imported goods:

Now, therefore, the Secretary of State in exercise of powers conferred on him by section 2 of the said Act of 1972 hereby makes the following Regulations:—

1.—(1) These Regulations may be cited as the Cosmetic Products (Safety) (Amendment) Regulations 1992 and except as provided by paragraphs 2, 3 and 4 below shall come into force on 29 June 1992.

(2) Regulation 2(b), regulation 2(d)(i) and regulation 2(f) in so far as it relates only to the deletion of colour index numbers 12075, 45170 and 45170:1 and the entries relating thereto from Schedule 3 Part I shall come into force—

(a) on 29 June 1992 in relation to the supply of cosmetic products by the manufacturer or importer into the United Kingdom, or in the case of cosmetic products manufactured or imported into the United Kingdom on behalf of another person, by that other person, except where the cosmetic products are supplied by retail in which case it shall come into force on 1st January 1993; and

(b) in all other cases on 1st January 1993.

(3) Regulation 2(c), regulation 2(f), in so far as it relates only to the deletion of colour index number 15585 and the entries relating thereto from Schedule 3 Part I, regulation 2(h), regulation 2(i)(iii) and regulation 2(j) shall come into force—

(a) on 1st January 1993 in relation to the supply of cosmetic products by the manufacturer or importer into the United Kingdom, or in the case of cosmetic products manufactured or imported into the United Kingdom on behalf of another person, by that other person, except where the cosmetic products are supplied by retail in which case they shall come into force on 1st January 1995; and

(b) in all other cases, on 1st January 1995.

(4) (a) Regulation 2(d)(ii), regulation 2(g)(i), (g)(ii), regulation 2(i)(i), (i)(ii) and regulation 2(k) shall come into force on 1st July 1992 in relation to the supply of cosmetic products by the manufacturer or importer into the United Kingdom or in the case of cosmetic products manufactured or imported into the United Kingdom on behalf of another person, by that other person except, where the cosmetic products are supplied by retail in which case they shall come into force on 1st July 1993;

(b) and in all other cases, on 1st July 1993.

2.  The Cosmetic Products (Safety) Regulations 1989(3) are hereby amended—

(a) in regulation 2(1) in the definition of “the Directive” by the substitution for “and” of “,” between the words “Council Directive No. 89/679/EEC(h)” and “Commission Directive No. 90/121/EEC (i)” and by the addition of the words “and Commission Directives Nos. 91/184/EEC (j) and 92/8/EEC(k)” and by the insertion as a footnote at the foot of the relevant page the following—

“(j) O.J. L91 12.4.91, p.59.

(k) O.J. L70 17.3.92, p.23”;

(b) in Schedule 1—

(i) by the insertion after entry number 187 of the following—

“187A

Colouring agent CI 12075 and its lakes, pigments and salts

— 397”;

(ii) by the insertion after entry number 190B of the following—

“190C

Colouring agent CI 45170 and CI 4517:1

— 398”;

(iii) by the insertion after entry number 289 of the following—

“289A

Dithio-2,2' bispyridine- dioxide 1,1' (additive with trihydrated magnesium sulphate) − (pyrithione disulphide + magnesium sulphate)

— 396”;

(iv) by the insertion after entry number 400 of the following—

“400A

Lidocaine (INN)

— 399”;

(v) by the insertion after entry number 583 of the following—

“583A

Quinolin-8-ol and bis (8-hydroxy-quinolinium) sulphate except for the uses provided for in entry number 51 of Schedule 2 Part I

— 395”;

(vi) in entry number 414 by the deletion of “in Part III of Schedule 2 or”;

(c) in Schedule 2 Part I—

(i) in entry number 15 by the deletion of “keep out of reach of children. Avoid contact with eyes”, where this appears in the final two lines of column 6.

(ii) by the insertion after entry number 55 of the following—

56

Magnesium Fluoride

Dental hygiene products

0.15 per cent calculated as fluorine. When mixed with other fluorine compounds the total fluorine concentration must not exceed 0.15 per cent

— Contains magnesium fluoride

(d) in Schedule 2 Part II—

(i) by the deletion of entry numbers 1 and 4;

(ii) by the substitution for “31.12.1990” of “30.6.1992” in column 7 relating to reference number 2.

(e) in Schedule 2 Part III — by the deletion of entry number 2;

(f) in Schedule 3 Part I by the deletion of colour index numbers 12075, 15585, 45170, 45170:1 and the entries relating thereto;

(g) in Schedule 3 Part II—

(i) by the substitution for “31.12.1990” of “30.6.1992” in column 5 relating respectively to colour index numbers 26100, 73900, 74189 and Solvent Yellow 98;

(ii) by the insertion after the entry in respect of colour index number 15800 of the following—

15585(*)

Red

— X — —

Maximum 3 per cent in products intended to come into contact with mucous membranes

30.6.1992

(h) in Schedule 4 Part I—

(i) in column 4 of entry number 27 by the substitution for “0.3 per cent” of “0.6 per cent”.

(ii) by the insertion after entry number 43 of the following—

“44	Alkyl (C12-C22) trimethylammonium bromide and chlorine	All products	0.1 per cent A	—	—
45	4,4-dimethyl-1,3- oxazolidine	All products	0.1 per cent	The pH of the finished product must not be lower than 6
46	1-[1,3-Bis (hydroxmethyl)-2, 5-dioxoimidazolidin -4-yl]-1,3-bis (hyroxymethyl) urea	All products	0.5 per cent	—	—”;

(i) in Schedule 4 Part II—

(i) in entry numbers 2, 15, 16, 20, 21 and 27 by the substitution for “31.12.1990” of “30.6.1992”;

(ii) in entry number 26 by the substitution for “31.12.1991” of “30.6.1992”

(iii) by the deletion of entry numbers 4, 6 and 17;

(iv) by the insertion after entry number 27 of the following—

“28

5-Ethyl-3, 7-dioxa-1- azabicyclo [3.3.0]octane

—

not to be used in dental hygiene products and in products intended to come into contact with mucous membranes

0.3 per cent

—

—

31.12.1992”

(j) in Schedule 5 Part I by the insertion after entry number 6 of the following—

7

2,2'-Dioxo-3,3' (ρ-xylene-α-α' — diylidene) dibornane-10- sulphonic acid and its salts

— All products

10 per cent (expressed as acid)

not to be used in aerosol dispensers (sprays)

(k) in Schedule 5 Part II in entry numbers 1, 2, 4, 5, 6, 12, 13, 16, 17, 24, 25, 26, 28, 29, 31 and 32 of the substitution for “31.12.1991” of “30.6.1992”.

Denton of Wakefield

Parliamentary Under Secretary of State

Department of Trade and Industry

25th June 1992

Explanatory Note

(This note is not part of the Regulations)

These Regulations amend the Cosmetic Products (Safety) Regulations 1989 ( “the principal regulations”) as amended by the Cosmetic Products (Safety) (Amendment) Regulations 1990 and the Cosmetic Products (Safety) (Amendment) Regulations 1991.

They implement Commission Directives 91/184/EEC and 92/8/EEC by—

1.  Prohibiting 6 substances for use in cosmetic products, the substances being colouring agent CI 12075 and its lakes, pigments and salts; colouring agents CI 45170 and 45170.1; Dithio-2,2' bispyridine-dioxide 1,1' (additive with trihydrated magnesium sulphate)-(pyrithione disulphate + magnesium sulphate); Quinolin-8-ol and bis (8-hydroxy-quinolinium) sulphate (except for use as a stabiliser for hydrogen peroxide in rinse off and non rinse off hair care products); and Lidocaine (INN) (regulations 2(b), 2(d)(i) and 2(f)).

2.  Extending the prohibition on the use of mercury and its compounds in cosmetic products to include the use of thiomersal and phenylmercunic compounds (regulations 2(b)(vi) and 2(e)).

3.  Deleting the warning labelling requirements for the use of potassium and sodium hydroxide as a pH adjuster in uses other than for depilatories (regulation 2(c)(i)).

4.  Permitting, subject to restrictions, the use of magnesium fluoride in dental hygiene products (regulation 2(c)(ii)).

5.  Extending the allowed use of 1,1 1-tricholoroethane (methyl chloroform) in aerosol sprays until 30 June 1992 (regulation 2(d)(ii)).

6.  Extending the periods of authorisation for provisionally approved colouring agents CI 26100, CI 73900, CI 74189 and Solvent Yellow 98 to 30 June 1992 (regulation 2(g)(i)).

7.  Permitting provisionally and subject to restrictions the use of colouring agent 15585 in cosmetic products until 30 June 1992 (regulation 2(g)(ii)).

8.  Increasing the maximum concentration allowed in cosmetic products of 3,3'-Bis(1-hyroxymethyl-2,5- dioxoimidazolidin-4-yl)-1,1'- methylenediurea to 0,6 per cent (regulation 2(h)(i)).

9.  Permitting the continued use, subject to restrictions, of 3 preservatives in cosmetic products, the substances being Alkyl (C12-C22) trimethylammonium; bromide and chloride, 4,4- dimethyl-1,3-oxazolidine and 1-[1,3-Bis (hydroxymethyl)-2, 5-dioxoimidazolidin -4-y1]-1,3-bis (hydroxymethyl) urea (regulations 2(h)(ii) and 2(i)(iii)).

10.  Permitting the continued use, subject to restrictions, in cosmetic products of the preservatives listed as entries 2, 15, 16, 20 , 21, 26 and 27 in Schedule 4 Part II to the principal regulations until 30 June 1992 (regulations 2(i)(i) and 2(i)(ii)).

11.  Permitting subject to restrictions, the use until 31 December 1992 of 5-Ethyl-3,7-dioxa-1 -azabicyclo[3.3.0.]octane as a preservative in certain cosmetic products (regulation 2(i)(iv)).

12.  Permitting, subject to restrictions, the use of 2,2' Dioxio-3,3' (ρ-xylene-α,α' diylidene) dibornane-10-sulphonic acid and its salts as a UV filter in cosmetic products (regulation 2(j)).

13.  Extending, subject to restrictions, the permitted use of 16 UV filters in cosmetic products until 30 June 1992, those UV filters being listed as entries 1, 2, 4, 5, 6, 12, 13, 16, 17, 24, 25, 26, 28, 29, 31 and 32 of Schedule 5 Part II to the principal regulations (regulation 2(k)).

The Colour Index referred to in these Regulations may be obtained from the Society of Dyers and Colourists, PO Box No 224, 82 Grafton Road, Bradford BD1 2JB.

(1)

S.I. 1972/1811, 1975/1707.

(2)

1972 c. 68.

(3)

S.I. 1989/2233, amended by S.I. 1990/1812, S.I. 1991/447.