The Cosmetic Products (Safety) (Amendment) Regulations 1987

Made: 10th November 1987

Laid before Parliament: 23rd November 1987

Coming into force (except as provided in regulation 1): 21st December 1987

Now, therefore, the Secretary of State in exercise of powers conferred on him by section 11 of the said Act of 1987 and by section 2 of the said Act of 1972 and of all other powers enabling him in that behalf hereby makes the following Regulations:

1

• (1) These Regulations may be cited as the Cosmetic Products (Safety) (Amendment) Regulations 1987 and except as provided by paragraph (2) below, shall come into force on 21st December 1987.

• (2) Regulation 2(y), regulation 2(bb) insofar as it relates only to entry Number 52 in Schedule 1 to these Regulations, regulation 2(cc), regulation 2(ee) and regulation 2(ff) shall come into force–

• (a) in relation to the supply, offering to supply, agreeing to supply, exposing for supply or possessing for supply of cosmetic products by the manufacturer in or importer into the United Kingdom or, in the case of cosmetic products, manufactured in or imported into the United Kingdom on behalf of another person, by that other person, on 1st January 1988, except where the cosmetic products are supplied, agreed to be supplied, exposed for supply or possessed for supply by retail in which case they shall come into force on 1st January 1989; and

• (b) in all other cases, on 1st January 1989.

2

The Cosmetic Products (Safety) Regulations 1984[^f00004] are hereby amended–

• (a) in regulation 4(1), in the definition of “the Directive”, by the omission of the word “and” between “Council Directive No. 83/574/EEC” and “Commission Directive No. 83/496/EEC” and by the addition of the words “Commission Directive No. 84/415/EEC(j), Commission Directive No. 85/391/EEC(k), Commission Directive No. 85/490/EEC(l), Commission Directive No. 86/179/EEC(m) and Commission Directive No. 86/199/EEC(n)” and by the insertion as footnotes at the foot of the relevant page of the following–

(j) O.J. L228, 25.8.84, p.31 (k) O.J. L224, 22.8.85, p.40 (l) O.J. L295, 7.11.85, p.30 (m) O.J. L138, 24.5.86, p.40 (n) O.J. L149, 3.6.86, p.38

• (b) in regulation 5(2) by the insertion after the word “manufacturer” of the word “in”;

• (c) in regulation 6(3) by the substitution for the words “3, 4 and 5” of the words “3, 4, 5 and (in the case of Part II) 7”.

• (d) in regulation 6 by the substitution for paragraph (4) of the following paragraph–

(4) A cosmetic product shall not contain– (a) any colouring agent listed in columns 1 and 2 of Schedule 3 unless– (i) the requirements in columns 3 and 4 of Part I of that Schedule in relation to that colouring agent are satisfied; or (ii) the requirements in columns 3 and 4 of Part II of that Schedule in relation to that colouring agent are satisfied and the cosmetic product in question is supplied on or before the date specified in column 5 of that Part; (b) any colouring agent which is not listed in that Schedule and which is intended to come into contact with the mucous membrane;

• (e) in regulation 6 by the omission of paragraph (5);

• (f) in regulation 6(6) by the substitution for sub-paragraph (a) of the following sub-paragraph–

(a) any preservative listed in column 2 of Schedule 5 unless– (i) the requirements in columns 3, 4 and 5 of Part I of that Schedule in relation to that preservative are satisfied; or (ii) the requirements in columns 3, 4 and 5 of Part II of that Schedule in relation to that preservative are satisfied and the preservative in question is supplied on or before the date specified in column 7 of that Part;

• (g) in regulation 6(6) by the omission of the word “and” between sub-paragraphs (a) and (b) and by the addition of the following sub-paragraph–

(c) any preservative listed in column 2 of Part II of Schedule 5 after the date specified in column 7 of that Schedule

• (h) in regulation 6(7) by the omission of the word “and” between sub-paragraphs (a) and (b);

• (i) in regulation 9 by the substitution for paragraph (2) of the following paragraph–

(2) Regulations 5, 6 and 8 above do not apply in any case in which the cosmetic product is supplied, offered for supply, agreed to be supplied, exposed or possessed for supply for the purposes of exporting that product to any country which is not a member State of the European Economic Community

• (j) in Schedule 1 by the substitution for the words in column 2 of entry Number 24 of the words–

“4-(orp-)Aminobenzoic acid esters except glycerol 1-(4-aminobenzoate) when provisionally permitted for use as a UV filter in accordance with the requirements specified at Item 4 of Part II of Schedule 6”;

• (k) in Schedule 1 by the substitution in column 2 of entry Number 64 for the letter “B” of the symbol “*”;

• (l) in Schedule 1 by the substitution for the words in column 2 of entry Number 85 of the words “4-Benzyloxyphenol”;

• (m) in Schedule 1 by the insertion in column 4 of entry Number 148A of the figure “366”;

• (n) in Schedule 1 by the substitution in column 2 of entry Number 212 for the words “column 4 of Part II of Schedule 2” of the words “column 5 of Part II of Schedule 2”;

• (o) in Schedule 1 by the substitution in column 2 of entry Number 213 for the words “column 4 of Part II of Schedule 2” of the words “column 5 of Part II of Schedule 2”;

• (p) in Schedule 1 by the insertion after entry Number 285 of the following entry–

“285A – 4-ethoxyphenol 348 178”;

• (q) in Schedule 1 by the substitution in column 2 of entry Number 348 for the words “Hydroquinone monobenzyl ether” of the words “Hydroquinone monobenzyl, monoethyl and monomethyl ethers”;

• (r) in Schedule 1 by the insertion in column 3 of entry Number 348 after the figure “431” of the figures “285A, 411A”;

• (s) in Schedule 1 by the substitution in column 2 of entry Number 395 for the words “Part II of Schedule 5” of the words “Part I of Schedule 5”;

• (t) in Schedule 1 by the substitution in column 2 of entry Number 397 for the words “column 4 of Part II of Schedule 2” of the words “column 5 of Part II of Schedule 2”;

• (u) in Schedule 1 by the insertion after entry Number 411 of the following entry–

“411A 4-methoxyphenol 348 178”;

• (v) in Schedule 1 by the substitution in column 2 of entry Number 562 for the words “Selenium and its compounds” of the words “Selenium and its compounds except when permitted under the restrictions laid down against entry Number 50 in Part I of Schedule 2”;

• (w) in Schedule 1 by the substitution in column 2 of entry Number 603 for the words “column 4 of Part II of Schedule 2” of the words “column 5 of Part II of Schedule 2”;

• (x) in Schedule 1 entry number 645A by the insertion in column 4 of the figure “366”;

• (y) in Schedule 1 by the renumbering and appropriate relocation in numerical order of entry Number 675 (Aristolochic acid and its salts) as entry Number 56A and by the insertion after entry Number 674 of following–

676 2, 3, 7, 8-Tetrachlorodibenzo-p-dioxin – 367 677 2, 6-Dimethyl-1, 3-dioxan-4-yl acetate (Dimethoxane) – 368 678 Pyrithione sodium (INNM) – 369

• (z) in Part I of Schedule 2 by the substitution in column 3 of entry Number 11 for the words “use other than as a preservative (see also Part II of Schedule 5)” of the words “all purposes and products”;

• (aa) in Part I of Schedule 2 by the substitution for entry Number 45 of the following–

(45) 1, 3-Bis (hydroxymethyl) imidazolidiene-2-thione

• (bb) in Part I of Schedule 2 by the insertion after entry Number 49 of the additional entries set out in Schedule 1 to these Regulations;

• (cc) in Schedule 2 by the substitution for Part II of Schedule 2 of the Part set out in Schedule 2 to these Regulations;

• (dd) in Part III of Schedule 2 by the substitution in column 3 of entry number 4 for the words “(See also Part II of Schedule 5)” of the words “(See also Part I of Schedule 5)”;

• (ee) by the substitution for Schedule 3 of the Schedule set out in Schedule 3 to these Regulations and by the omission of Schedule 4;

• (ff) by the substitution for Schedule 5 of the schedule set out in Schedule 4 to these Regulations;

• (gg) in Schedule 7 by the insertion in paragraph 1 after the words “Commission Directive No. 83/514/EEC;” of the words ““Annex D” means the Annex to Commission Directive No. 85/490/EEC(a)” and by the insertion as a footnote at the foot of the relevant page of “(a) O.J. No. L295, 7.11.85, p.30.”

• (hh) in Schedule 7 by the insertion after entry Number 6(26) of the following–

(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 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”.

SCHEDULE 1

SCHEDULE 2

PART II — Substances listed in Annex IV, Part I of the Directive as substances provisionally allowed

SCHEDULE 3

SCHEDULE 4

Signed

Francis Maude — Parliamentary Under-Secretary of State, — Department of Trade and Industry — 10th November 1987

Explanatory note

(This note is not part of the Regulations)

These Regulations amend the Cosmetic Products (Safety) Regulations 1984 (“the Principal Regulations”) as amended by the Cosmetic Products (Safety) (Amendment) Regulations 1985, and implement Commission Directives No. 85/391/EEC (O.J. L224, 22.8.85, p. 40), No. 85/490/EEC (O.J. L295, 7.11.85, p. 30), No. 86/179/EEC (O.J. L138, 24.5.86 p. 40) and No. 86/199/EEC (O.J. L149, 3.6.86 p. 38) on cosmetic products, and as permitted by the Directives impose certain additional requirements on the composition of cosmetic products. The Regulations are made under the Consumer Protection Act 1987 and the European Communities Act 1972.

The main changes are–

• (1) the deletion of Schedules 3 and 4 of the principal Regulations and their replacement by the Schedule set out in Schedule 3 to these Regulations. The replacement Schedule lists colouring agents which are acceptable throughout the European Community and take account of the review of provisionally approved colourants undertaken to satisfy Article 5 of the Cosmetics Directive (76/768/EEC) (regulation 2(ee));

• (2) the replacement of Schedule 5 of the principal Regulations by the Schedule set out in Schedule 4 to the Regulations. The Schedule lists the preservatives which may be used in cosmetic products and takes account of the review of provisionally approved preservatives undertaken to satisfy Article 5 of the Cosmetics Directive (76/768/EEC) (regulation 2(ff));

• (3) the amendment of the wording of regulations 5(2) and 9(2) to make it clear that the controls over supply also apply to products exported to other member States of the European Economic Community (regulation 2(b) and (i));

• (4) the prohibition of the use of 2,3,7,8–tetrachlorodibenzo–p–dioxin, dimethoxane, pyrithione sodium and heightened versions of hydroquinone (regulation 2 (q) and (y));

• (5) the restriction of the use of selenium disulphide, aluminium zirconium hydroxides, quinolin–8–ol and bis (8–hydroxyquinolinium) sulphate, 2, 2' diothiobis (pyridine 1–oxide), addition product with magnesium sulphate trihydrate and 1–phenoxy-propan–2–ol and the modification of the restriction on the use of 1,3–Bis (Hydroxymethyl) imidazolidene–2–thione (regulation 2(aa) (bb) and (cc));

• (6) the specification of methods in certain cases for identifying and in all cases for determining the presence in cosmetic products of glycerol 1–(4 aminobenzoate);, chlorobutanol, quinine, inorganic sulphites and hydrogen sulphites, chlorates of the alkali metal and sodium iodate (regulation 2(hh)).

Footnotes

[^f00001]: 1987 c. 43.

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

[^f00003]: 1972 c. 68.

[^f00004]: S.I. 1984/1260, amended by S.I. 1985/2045.

[^f00005]: O.J. No. 115, 11.11.1962, p. 2645.

[^f00006]: Council Directives Nos. 65/469/EEC, 67/653/EEC, 68/419/EEC, 70/758/EEC, 76/399/EEC and 78/144/EEC (O.J. Nos. L178, 26.10.1965, p. 2793; L263, 30.10.1967, p. 4; L309, 24.12.1968, p. 24; L157, 18.7.1970, p. 36; L108, 26.4.1976, p. 19; L44, 15.2.1978, p. 20).

[^f00007]: 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, 1.1.1973, p. 1).