The Toys and Cosmetic Products (Restriction of Chemical Substances) Regulations 2022

Statutory Instruments

2022 No. 659

Consumer Protection

The Toys and Cosmetic Products (Restriction of Chemical Substances) Regulations 2022

Made

14th June 2022

Laid before Parliament

15th June 2022

Coming into force in accordance with regulation 1

The Secretary of State makes the following Regulations in exercise of the powers conferred by regulation 39B(1) and 39C(1) of the Toys (Safety) Regulations 2011(1) and Article 31(1)(f) and 31(1)(g)(i) of Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products(2).

Citation, commencement and extent

1.—(1) These Regulations may be cited as the Toys and Cosmetic Products (Restriction of Chemical Substances) Regulations 2022.

(2) These Regulations, except for regulations 2(3)(c), 2(4), 3(2) and 3(6) come into force on 15th October 2022.

(3) Regulations 2(3)(c), 2(4), 3(2) and 3(6) come into force on 15th December 2022.

(4) These Regulations extend to England and Wales and Scotland.

Amendment to the Toys (Safety) Regulations 2011

2.—(1) The Toys (Safety) Regulations 2011 are amended as follows.

(2) In regulation 3, for the definition of “the Directive” substitute—

““the Directive” means Directive 2009/48/EC of the European Parliament and of the Council of 18th June 2009 on the safety of toys(3);”.

(3) In Part 3 (chemical properties) of Schedule 2 (particular safety requirements)—

(a) in the first table at point 11 (prohibited allergenic fragrances) after row 55 (treemoss extracts), insert—

“(56)	Atranol (2,6-Dihydroxy-4-methyl-benzaldehyde)	526-37-4
(57)	Chloroatranol (3-Chloro-2,6-Dihydroxy-4-methyl-benzaldehyde)	57074-21-2
(58)	Methyl heptine carbonate	111-12-6”.

(b) in the second table at point 11 (permitted allergenic fragrances), omit entry 10 (Methyl heptine carbonate);

(c) in the table at point 13, for the element in the first row (aluminium), substitute—

“Aluminium

2 250

560

28 130”.

(4) At the end of the table in Appendix C to Schedule 2 (limit values for chemicals used in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth) insert the following entries—

“Aniline	62-53-3	30 mg/kg after reductive cleavage in textile and leather materials
		30 mg/kg after reductive cleavage in finger paints
		10 mg/kg as free aniline in finger paints
Formaldehyde	50-00-0	Polymeric 1.5 mg/l (migration limit)
		Resin-bonded wood 0.1 ml/m3 (emission limit)
		Textile 30 mg/kg
		Leather 30 mg/kg
		Paper 30 mg/kg
		Water-based 10 mg/kg”.

Amendment to Regulation (EC) No 1223/2009

3.—(1) Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products is amended as follows.

(2) At the end of the table in Annex 2 (list of substances prohibited in cosmetic products), before the entries to be added by virtue of paragraph (3) insert—

“1645

4-[(tetrahydro-2H-pyran-2-yl)oxy]phenol

53936-56-4

800-360-6”.

(3) At the end of the table in Annex 2, insert the entries set out in the Schedule to these regulations.

(4) In the table in Annex 3 (list of substances which cosmetic products must not contain except subject to the restrictions laid down), omit the following entries—

(a) entry 83 (2-(4-tert-Butylben-zyl)propionaldehyde);

(b) entry 101 (Pyrithione zinc).

(5) In the table in Annex 3 at entry 24, for the text in column b (name of common ingredients glossary) substitute—

“Water-soluble zinc salts with the exception of zinc 4- hydroxy-benzenesulphonate (entry 25) and Pyrithione zinc (Annex 2, entry 1669)”.

(6) In the table in Annex 3, at entry 98 (Benzoic acid, 2-hydroxy (salicylic acid))—

(a) for the text in column f (product type, body parts), after “(b) Other products except body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant” insert—

“(c) Body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant”;

(b) for the text in column g (maximum concentration in ready for use preparation), after “(b) 2.0 %” insert—

“(c) 0.5%”.

(7) In the table in Annex 5 (list of preservatives allowed in cosmetic products) omit entry 8 (Pyrithione zinc).

(8) In the table in Annex 5 at entry 51 (Sodium hydroxymethylamino acetate), in column h (other) insert—

“Not to be used if the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is ≥ 0,1 % w/w”.

Transitional Provisions

4.—(1) Regulation 2(3)(a) and (b) do not apply to toys that are placed on the market on the market prior to 15th October 2022.

(2) Regulation 2(3)(c) and (4) do not apply to toys that are placed on the market prior to 15th December 2022.

(3) Notwithstanding the amendments in regulation 3(3), (4), (5), (7) and (8) cosmetic products that are placed on the market prior to 15th October 2022 can be made available on the market until 15th December 2022.

(4) Notwithstanding the amendments in regulation 3(2) and (6) cosmetic products that are placed on the market prior to 15th December 2022 can be made available on the market until 15th March 2023.

Paul Scully

Minister for Small Business, Consumers and Labour Markets

Department for Business, Energy and Industrial Strategy

14th June 2022

Regulation 3(3)

SCHEDULE Amendments to Annex 2 (prohibited substances)

“1646	Cobalt	7440-48-4	231-158-0
1647	Metaldehyde (ISO); 2,4,6,8-tetramethyl- 1,3,5,7-tetraoxacyclooctane	108-62-3	203-600-2
1648	Methylmercuric chloride	115-09-3	204-064-2
1649	Benzo[rst]pentaphene	189-55-9	205-877-5
1650	Dibenzo[b,def]chrysene; dibenzo[a,h]pyrene	189-64-0	205-878-0
1651	Ethanol, 2,2’-iminobis-, N- (C13-15-branched and linear alkyl) derivs.	97925-95-6	308-208-6
1652	Cyflumetofen (ISO); 2-methoxyethyl (RS)-2- (4-tert-butylphenyl)-2-cyano-3-oxo-3-(α,α,α-trifluoro-o-tolyl)propionate	400882-07-7	—
1653	Diisohexyl phthalate	71850-09-4	276-090-2
1654	halosulfuron-methyl (ISO); methyl 3-chloro-5-{[(4,6- dimethoxypyrimidin-2-yl) carbamoyl]sulfamoyl}-1- methyl-1H-pyrazole-4- carboxylate	100784-20-1	—
1655	2-methylimidazole	693-98-1	211-765-7
1656	Metaflumizone (ISO);	—	—
	(EZ)-2’-[2-(4-cyanophenyl)-1-(α,α,α -trifluoro-m- tolyl)ethylidene]-[4-(trifluoromethoxy)phenyl] carbanilohydrazide [E-isomer ≥ 90 %, Z-isomer ≤ 10 % relative content]; [1]	139968-49-3 [1]	604-167-6 [1]
	(E)-2’-[2-(4-cyanophenyl)- 1-(α,α,α -trifluoro-m-tolyl) ethylidene]-[4-(trifluoromethoxy)phenyl]carbanilohydrazide [2]	852403-68-0 [2]
1657	Dibutylbis(pentane-2,4- dionato-O,O’)tin	22673-19-4	245-152-0’;
1658	Silicon carbide fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1)	409-21-2 308076-74-6	206-991-8
1659	Tris(2-methoxyethoxy) vinylsilane; 6-(2-methoxyethoxy)- 6-vinyl-2,5,7,10-tetraoxa-6-silaundecane	1067-53-4	213-934-0
1660	Dioctyltin dilaurate; [1]	3648-18-8 [1]	222-883-3 [1]
	Stannane, dioctyl-, bis (coco acyloxy) derivs. [2]	91648- 39-4 [2]	293-901-5 [2]
1661	Dibenzo[def,p]chrysene; dibenzo[a,l]pyrene	191-30-0	205-886-4
1662	Ipconazole (ISO); (1RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl)-5-isopropyl-1- (1H-1,2,4-triazol-1-ylmethyl) cyclopentanol	125225-28-7	—
		115850-69-6
		115937-89-8
1663	Bis(2-(2-methoxyethoxy)ethyl)ether; tetraglyme	143-24-8	205-594-7
1664	Paclobutrazol (ISO); (2RS,3RS)-1-(4-chlorophenyl)-4,4-dimethyl- 2-(1H-1,2,4-triazol-1- yl)pentan-3-ol	76738-62-0	—
1665	2,2-bis(bromomethyl) propane-1,3-diol	3296-90-0	221-967-7
1666	2-(4-tert-butylbenzyl) propionaldehyde	80-54-6	201-289-8
1667	Diisooctyl phthalate	27554-26-3	248-523-5
1668	2-methoxyethyl acrylate	3121-61-7	221-499-3
1669	Pyrithione zinc; (T-4)- bis[1-(hydroxy-.kappa.O)pyridine-2(1H)- thionato-.kappa.S]zinc	13463-41-7	236-671-3
1670	Flurochloridone (ISO); 3-chloro-4-(chloromethyl)-1-[3-(trifluoromethyl)phenyl]pyrrolidin-2-one	61213-25-0	262-661-3
1671	3-(difluoromethyl)-1- methyl-N-(3’,4’,5’-trifluorobiphenyl-2-yl) pyrazole-4-carboxamide; fluxapyroxad	907204-31-3	—
1672	N-(hydroxymethyl)acrylamide; methylolacrylamide; [NMA]	924-42-5	213-103-2
1673	5-fluoro-1,3-dimethyl-N-[2-(4- methylpentan-2-yl) phenyl]-1H-pyrazole- 4-carboxamide; 2’- [(RS)-1,3-dimethylbutyl]-5-fluoro-1,3-dimethylpyrazole-4-carboxanilide; penflufen	494793-67-8	—
1674	Iprovalicarb (ISO); isopropyl [(2S)-3- methyl-1-{[1-(4- methylphenyl)ethyl] amino}-1-oxobutan-2- yl]carbamate	140923-17-7	—
1675	Dichlorodioctylstannane	3542-36-7	222-583-2
1676	Mesotrione (ISO); 2-[4-(methylsulfonyl)- 2-nitrobenzoyl]-1,3- cyclohexanedione	104206-82-8	—
1677	Hymexazol (ISO); 3-hydroxy-5-methylisoxazole	10004-44-1	233-000-6
1678	Imiprothrin (ISO); reaction mass of: [2,4- dioxo-(2-propyn-1-yl) imidazolidin-3-yl] methyl(1R)-cis-chrysanthemate; [2,4-dioxo-(2-propyn-1-yl) imidazolidin-3-yl] methyl(1R)-trans-chrysanthemate	72963-72-5	428-790-6
1679	Bis(α,α-dimethylbenzyl) peroxide	80-43-3	201-279-3”

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations amend the Toys (Safety) Regulations 2011 and Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products to restrict or prohibit the use of certain chemical substances in toys and cosmetic products.

Regulation 2(3)(a) amends Part 3 of Schedule 2 to the Toys (Safety) Regulations 2011 to prohibit the use of specified allergenic fragrances in toys to which the Regulations apply. Regulation 2(3)(c) and (4) restricts the permitted levels of aluminium in toys and restricts the use of aniline, and formaldehyde in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth.

Regulation 3 amends technical annexes to the retained EU legislation, Regulation (EC) No 1223/2009 (“the Cosmetics Regulation”) to prohibit or restrict the use of chemicals following advice from the Scientific Advisory Group on Chemical Safety. Regulation 3(3) prohibits the use of the chemicals listed in the Schedule to the Regulations following their classification as carcinogenic, mutagenic or reprotoxic under the retained EU legislation, Regulation (EC) No 1272/2008, and regulation 3(4), (5), (7) and (8) make consequential amendments to the technical annexes of the Cosmetics Regulation.

Regulation 4 provides for transitional arrangements allowing toys and cosmetics products containing chemical substances detailed in the Regulations to be made available on the market after the coming into force of the Regulations, subject to certain limitations in relation to cosmetics.

A full impact assessment has not been produced for this instrument as no, or no significant, impact on the private, voluntary or business sectors is foreseen. An Explanatory Memorandum has been published alongside these Regulations and is available at www.legislation.gov.uk.

(1)

S.I. 2011/1881. The instrument was made in part under section 2(2) of the European Communities Act (c. 68) and saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018 (c. 16), as that section was amended by section 25(1) of the European Union (Withdrawal) Act 2020 (c. 1). The powers provided for in regulations 39B(1) and 39C(1) were inserted by regulation 18 of and paragraphs 1 and 27 of Schedule 15 to S.I. 2019/696 in respect of England and Wales and Scotland. There are other amending instruments that are not relevant to this instrument.

(2)

EUR 1223/2009 was incorporated by virtue of section 3(1) of the the European Union (Withdrawal) Act 2018 (c. 16). The powers provided for in Article 31(1)(f) and 31(1)(g)(i) were inserted by S.I. 2019/696 as that instrument was itself amended by S.I. 2019/1246. Other relevant amendments were made by S.I. 2019/696 and 1246.

(3)

OJ No. L 170, 30.6.2009, p. 1, relevant amendments to which were made by Commission Directive (EU) No. 2019/1922, Commission Directive (EU) No. 2019/1929, Commission Directive (EU) No. 2020/2089, Commission Directive (EU) No. 2021/903.