The Toys and Cosmetic Products (Restriction of Chemical Substances) Regulations 2022 No. 659

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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 1223/2009of 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 1223/2009of 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 1223/2009of 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 atwww.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. 2019/696in 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. 2019/696as that instrument was itself amended by S.I. 2019/1246. Other relevant amendments were made by S.I. 2019/696and 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.


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