The Cosmetic Products (Safety) Regulations 1995

Statutory Instruments

1995 No. 1478

CONSUMER PROTECTION

The Cosmetic Products (Safety) Regulations 1995

Made

7th June 1995

Laid before Parliament

8th June 1995

coming into force (except as provided in regulation 1(2))

30th June 1995

Whereas the Secretary of State is a Minister designated(1) for the purpose 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 1995 and except as provided by paragraph (2) below shall come into force on 30th June 1995.

(2) Regulations 2(b), 2(c), 2(e), 2(f)(ii), 2(g) and 2(h)(ii) shall come into force—

(a) on 1st July 1995 in relation to the supply of cosmetic products by the manufacturer in 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 30th June 1996; and

(b) in all other cases on 30th June 1996.

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 “92/86/EEC(1)” and “Commission Directive No. 93/37/EEC(m)” and by the addition of the words “and Commission Directive No. 94/32/EC(n)” at the end of the definition and by the insertion as a footnote at the foot of the relevant page the following—

“(n) O.J. No. L181, 15.7.1994, p.31.”;

(b) in Schedule 1 by the insertion after entry number 446 of the following—

“446A

2-Methyl-m-phenylenediamine

—

413”;

(c) in Schedule 2, Part I—

(i) by the substitution for entry number 59 of the following—

“59 Talc: hydrated magnesium silicate	(a) Powdery products intended to be used for children under three years of age	—	—	(a) Keep powder away from children’s nose and mouth
	(b) Other products	—	—	—”;

(ii) by the insertion after entry number 62 of the following—

“63 Strontium hydroxide	pH-regulator in depilatory products	3.5 per cent calculated as strotium	pH value not to exceed 12.7	Keep out of reach of children. Avoid contact with the eyes
64 Strontium peroxide	Rinse-off hair care preparations professional use	4.5 per cent calculated as strontium in the ready-for-use preparation	All products must meet the hydrogen peroxide release requirements	Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them. For professional use only. Wear suitable gloves”;

(d) in Schedule 2, Part II—

(i) by the deletion of entry number 6;

(ii) in entry number 7 by the substitution for “30.6.1994” of “30.6.1995”;

(e) in Schedule 4, Part I—

(i) by the substitution for entry number 14 of the following—

“14 Formic acid and its sodium salt

All products

0.5 per cent (expressed as acid) A

—

—”;

(ii) by the insertion after entry number 47 of the following—

“48 Glutaraldehyde (Pentane-1,5-dial)	All products	0.1 per cent	Prohibited in aerosols (sprays)	Contain glutaraldehyde (where glutaraldehyde concentration in the finished product exceeds 0.05 per cent)
49 5-Ethyl-3,7-dioxa-l-azabicyclo-[3.3.0]octane	All products	0.3 per cent	Prohibited in oral hygiene products and in products intended to come into contact with mucous membranes	—”;

(f) in Schedule 4, Part II—

(i) by the deletion of entry numbers 26, 27 and 28;

(ii) by the substitution for entry number 21 of the following—

“21 Benzylhemiformal (a 1:1 mixture of benzyloxymethanol and benzyloxymethoxymethanol)

Products rinsed-off after use

0.03 per cent

—

30.6.1995”;

(iii) in entry numbers 2, 15, 16, 29 and 30 by the substitution for “30.6.1994” of “30.6.1995”;

(g) in Schedule 5, Part I—

(i) by the insertion for entry number 7 of the following—

“7 3,3-(l,4-Phenylenedimethylene) bis(7,7-dimethyl-2-oxo-bicyclo[2.2.l]hept-l-ylmethanesulfonic acid) and its salts

10 per cent (expressed as acid)

—

—”

(ii) by the insertion after entry number 8 of the following—

“9 α-(2-Oxoborn-3-ylidene)toluene-4-sulphonic acid and its salts

6 per cent (expressed as acid)

—

—”

(h) in Schedule 5, Part II—

(i) by the deletion of entry numbers 24 and 28;

(ii) by the insertion after entry number 33 of the following—

“34 Polymer of N-{(2 and 4)-[2-oxoborn-3-ylidene)methyl]benzyl}acrylamide

6 per cent

—

—

30.6.1995”;

(iii) in entry numbers 2, 5, 6, 12, 13, 17, 25, 26, 29, 32 and 33 by the substitution for “30.6.1994” of “30.6.1995”.

Ferrers

Minister of State for Small Firms and Consumer Affairs,

Department of Trade and Industry.

7th June 1995

Explanatory Note

(This note is not part of the Regulations)

These Regulations amend the Cosmetic Products (Safety) Regulations 1989 (S.I. 1989/2233) (“the Principal Regulations”) as amended by 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), and the Cosmetic Products (Safety) (Amendment) Regulations 1994 (S.I. 1994/1529).

They implement Commission Directive 94/32/EC (O.J. No. L181, 15.7.1994, p. 31) by amending the Principal Regulations to—

1. prohibit the use of 2-Methyl-m-phenylenediamine in cosmetic products (regulation 2(b));

2. amend the description of the purpose of Talc: hydrated magnesium silicate to refer to powdery products and its labelling requirements for use to refer to children (regulation 2(c)(i));

3. permit, subject to restrictions and certain labelling requirements, the use of Strontium hydroxide in depilatory products and Strontium peroxide in rinse-off hair care preparations for professional use (regulation 2(c)(ii)) and deleting the latter from the list of substances provisionally allowed to be used in cosmetic products (regulation 2(d)(i));

4. extend the provisionally allowed use of Phenolphthalein (INN) [3,3-Bis(4-hydroxyphenyl)-phthalide] until 30th June 1995;

5. include in the description of the substance Formic acid reference to its sodium salt and to amend the maximum concentration of the substance as a preservative in a cosmetic product to 0.5 per cent (expressed as acid) (regulation 2(e)(i)) and permit as a preservative Glutaraldehyde (pentene-1,5-dial) at a maximum concentration of 0.1 per cent save in aerosols (sprays) subject to a labelling requirement and 5-Ethyl-3,7-dioxa-I-azabicyclo-[3.3.0]octane at a maximum concentration of 0.3 per cent save in oral hygiene products and in products intended to come into contact with mucous membranes (regulation 2(e)(ii)), and deleting these preservatives and Glutaraldehyde from the list of provisionslly permitted preservatives (regulation 2(f)(i));

6. restrict the provisional use of the preservative Benzylhemiformal to rinse-off products only until 30th June 1995 and to decrease the maximum concentration permitted of that preservative to 0.03 per cent (regulation 2(f)(ii));

7. extend the permitted use of the five preservatives listed as entry numbers 2, 15, 16, 29 and 30 of Schedule 4 Part II to the Principal Regulations until 30th June 1995 (regulation 2(f)(iii));

8. substitute 3,3-(l,4-phenylenedimethylene)bis(7,7-dimethyl-2-oxo-bicyclo[2,2,l]hept-l-ylmethanesulfonic acid) and its salts at a maximum concentration of 10 per cent (expressed as acid) as a permitted UV filter in cosmetic products for 2,2'-Dioxo-3,3'(p-xylene-α-α'-diylidene)diborname-10-sulphonic acid and its salts (regulation 2(g)(i)) and by adding α-(2-Oxoborn-3-ylidene)toluene-4-sulphonic acid and its salts to the list of permitted UV filters subject to a maximum concentration of 6 per cent (expressed as acid) (regulation 2(g)(ii)); delete the latter and 3-Benzylidenecamphor from the list of UV filters provisionally permitted for use (regulation 2(h)(i));

9. permit, subject to a maximum concentration of 6 per cent, the use of Polymer of N-{(2 and 4)-[2-oxoborn-3-ylidene)methyl]benzyl}acrylamide as a UV filter in cosmetic products until 30th June 1995 (regulation 2(h)(ii));

10. extend, subject to restrictions, the permitted use of 11 UV filters in cosmetic products until 30th June 1995, those UV flters being listed as entry numbers 2, 5, 6, 12, 13, 17, 25, 26, 29, 32 and 33 of Schedule 5 Part II to the Principal Regulations (regulation 2(h)(iii)).

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 Division of the Department of Trade and Industry, Room 4.D.2, 1 Victoria Street, London, SW1H 0ET.

(1)

S.I. 1972/1811, 1975/1707, 1993/2661.

(2)

1972 c. 68.

(3)

S.I. 1989/2233, amended by S.I. 1990/1812, S.I. 1991/447, S.I. 1992/1525, S.I. 1993/1539, S.I. 1994/1529.