The Toys and Cosmetic Products (Restriction of Chemical Substances) Regulations 2022
Citation, commencement and extent1.
(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 20112.
(1)
The Toys (Safety) Regulations 2011 are amended as follows.
(2)
““the Directive” means Directive 2009/48/EC of the European Parliament and of the Council of 18th June 2009 on the safety of toys3;”.
(3)
In Part 3 (chemical properties) of Schedule 2 (particular safety requirements)—
(a)
“(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)
“Aluminium
2 250
560
28 130”.
(4)
“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 1223/20093.
(1)
Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products is amended as follows.
(2)
“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)
“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)
“(c)
Body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant”;
(b)
“(c)
0.5%”.
(7)
In the table in Annex 5 (list of preservatives allowed in cosmetic products) omit entry 8 (Pyrithione zinc).
(8)
“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 Provisions4.
(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.
SCHEDULEAmendments 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”
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.