Last reviewed 2 October 2023
In this feature Caroline Raine summarises the proposed EU draft Toys Regulation, focusing on the rules for toys containing hazardous substances. Caroline also covers some other key changes relating to the digital passport and labelling requirements.
Introduction
In July 2023 the European Commission published the proposed draft EU Toys Regulation, which convert the existing Toy Safety Directive into a new Toy Safety Regulation. The draft regulation stems from a review of the Toys Directive which was carried out in 2020 where it was identified that there was room to strengthen some of the rules. The new regulation would repeal The Toys Directive 2009/48/EC.
Review of the Toys Directive
The European Commission stated that: “The evaluation of the Toy Safety Directive (TSD) (the Evaluation) identified a number of deficiencies in the TSD in ensuring a high level of protection of children from possible risks in toys, and in particular from risks posed by harmful chemicals. The Evaluation also concluded that there remain many non-compliant and unsafe toys on the EU market.”
The intention of the new regulation: “should achieve a higher level of protection of children from the most harmful substances and reduce the number of non-compliant and unsafe toys on the EU market.”
The review identified a couple of problems:
insufficient protection of children from harmful chemicals
a high number of toys on the Union market do not comply with the Toy Safety Directive and are unsafe
as well as new risks in toys, from emerging digital technologies.
Many of the suggested changes and the review are part of the chemical strategy for sustainability (CSS) which “called for extending the so-called generic approach towards harmful chemicals (based on generic preventive bans) to ensure that consumers, vulnerable groups and the natural environment are more consistently protected. In particular, the CSS called for strengthening the Directive with regard to protection from the risks posed by the most harmful chemicals and with regard to possible combination effects of chemicals. The Directive already contains a general prohibition on substances in toys that are carcinogenic, mutagenic or toxic for reproduction (CMRs). However, it does not refer to other substances of particular concern, such as endocrine disruptors or substances affecting the immune, nervous or respiratory systems.”
The review suggested a few key areas for change.
Policy option 1a — minimum changes to the Directive.
Policy option 1b — Improved protection: generic bans of the most harmful substances with derogations.
Policy option 1c — Maximum protection: generic bans of the most harmful substances without derogations.
Policy option 2a: extending third-party conformity assessment.
Policy option 2b: facilitation of market surveillance through digitalisation.
Policy option 2c: Extending third party conformity assessment and facilitation of market surveillance through digitalisation.
And the European Parliament calls on the Commission to revise the Directive to:
strengthen the protection of children against chemical risks.
ensure that risks posed by internet-connected toys are addressed by EU law.
improve enforcement of the Directive in particular in relation to online sales.
Proposed Draft Regulation
The regulation applies to products which for use in play by children under 14 years of age.
Harmful substances
Substances or mixtures classified in any of the following categories is prohibited:
Carcinogenicity, germ cell mutagenicity or reproductive toxicity (CMR) category 1A, 1B or 2.
Endocrine disruption category 1 or 2.
Specific target organ toxicity category 1, either in single exposure or in repeated exposure.
Respiratory sensitisation category 1.
Cosmetic toys, such as play cosmetics for dolls, shall comply with the compositional and labelling requirements laid down in Regulation (EC) No.1223/2009.
The following migration limits, from toys, components of toys or micro-structurally distinct parts of toys, shall not be exceeded:
Element | mg/kg in dry, brittle, powder-like or pliable toy material | mg/kg in liquid or sticky toy material | mg/kg in scraped-off toy material |
Aluminium | 2250 | 560 | 28130 |
Antimony | 45 | 11,3 | 560 |
Arsenic | 3,8 | 0,9 | 47 |
Barium | 1 500 | 375 | 18750 |
Boron | 1 200 | 300 | 15 000 |
Cadmium | 1,3 | 0,3 | 17 |
Chromium (III) | 37,5 | 9,4 | 460 |
Chromium (VI) | 0,02 | 0,005 | 0,053 |
Cobalt | 10,5 | 2,6 | 130 |
Copper | 622,5 | 156 | 7 700 |
Lead | 2,0 | 0,5 | 23 |
Manganese | 1 200 | 300 | 15 000 |
Mercury | 7,5 | 1,9 | 94 |
Nickel | 75 | 18,8 | 930 |
Selenium | 37,5 | 9,4 | 460 |
Strontium | 4 500 | 1 125 | 56 000 |
Tin | 15 000 | 3 750 | 180 000 |
Organic tin | 0,9 | 0,2 | 12 |
Zinc | 3 750 | 938 | 46 000 |
Nitrosamines and nitrosable substances are prohibited in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth where the migration of those substances is equal to or higher than 0,01 mg/kg for nitrosamines and 0,1 mg/kg for nitrosable substances.
The following limit values, in toys or components of toys or micro-structurally distinct parts of toys, shall not be exceeded:
Substance | CAS No. | Limit value and conditions for application |
TCEP | 115-96-8 | 5 mg/kg (content limit) |
TCPP | 13674-84-5 | 5 mg/kg (content limit) |
TDCP | 13674-87-8 | 5 mg/kg (content limit) |
Formamide | 75-12-7 | 20 μg/m3 (emission limit) after a maximum of 28 days from the start of the emission testing of foam toy materials containing more than 200 mg/kg (cut-off limit based on content) |
1,2-benzisothiazol-3(2H)-one | 2634-33-5 | 5 mg/kg (content limit) in aqueous toy materials, in accordance with the methods laid down in EN 71-10:2005 and EN 71-11:2005 |
Reaction mass of: 5-chloro-2- methyl-4-isothiazolin-3-one [EC no. 247-500-7] and 2-methyl-2H -isothiazol-3-one [EC no.220-239-6] (3:1) | 55965-84-9 | 1 mg/kg (content limit) in aqueous toy materials |
5-Chloro-2-methyl-isothiazolin-3(2H)-one | 26172-55-4 | 0,75 mg/kg (content limit) in aqueous toy materials |
2-methylisothiazolin-3(2H)-one | 2682-20-4 | 0,25 mg/kg (content limit) in aqueous toy materials |
Phenol | 108-95-2 | 5 mg/l (migration limit) in polymeric materials in accordance with the methods laid down in EN 71-10:2005 and EN 71-11:2005. 10 mg/kg (content limit) as a preservative in accordance with the methods laid down in EN 71-10:2005 and EN 71-11:2005. |
Formaldehyde | 50-00-0 | 1,5 mg/l (migration limit) in polymeric toy material 0,062 mg/m3 (emission limit) in wood toy material 30 mg/kg (content limit) in textile toy material 30 mg/kg (content limit) in leather toy material 30 mg/kg (content limit) in paper toy material 10 mg/kg (content limit) in water-based toy material |
Aniline | 62-53-3 | 30 mg/kg (content limit) after reductive cleavage in textile toy material and leather toy material 10 mg/kg (content limit) as free aniline in finger paints 30 mg/kg (content limit) |
Toys shall not contain the following fragrance allergens unless their presence in the toy is technically unavoidable under good manufacturing practice and does not exceed 100 mg/kg:
No. | Name of the allergenic fragrance | CAS number |
(1) | Alanroot oil (Inula helenium) | 97676-35-2 |
(2) | Allylisothiocyanate | 57-06-7 |
(3) | Benzyl cyanide | 140-29-4 |
(4) | 4 tert-Butylphenol | 98-54-4 |
(5) | Chenopodium oil | 8006-99-3 |
(6) | Cyclamen alcohol | 4756-19-8 |
(7) | Diethyl maleate | 141-05-9 |
(8) | Dihydrocoumarin | 119-84-6 |
(9) | 2,4-Dihydroxy-3-methylbenzaldehyde | 6248-20-0 |
(10) | 3,7-Dimethyl-2-octen-1-ol (6,7-Dihydrogeraniol) | 40607-48-5 |
(11) | 4,6-Dimethyl-8-tert-butylcoumarin | 17874-34-9 |
(12) | Dimethyl citraconate | 617-54-9 |
(13) | 7,11-Dimethyl-4.6,10-dodecatrien-3-one | 26651-96-7 |
(14) | 6,10-Dimethyl-3.5,9-undecatrien-2-one | 141-10-6 |
(15) | Diphenylamine | 122-39-4 |
(16) | Ethyl acrylate | 140-88-5 |
(17) | Fig leaf, fresh and preparations | 68916-52-9 |
(18) | trans-2-Heptenal | 18829-55-5 |
(19) | trans-2-Hexenal diethyl acetal | 67746-30-9 |
(20) | trans-2-Hexenal dimethyl acetal | 18318-83-7 |
(21) | Hydroabietyl alcohol | 13393-93-6 |
(22) | 4-Ethoxy-phenol | 622-62-8 |
(23) | 6-lsopropyl-2-decahydronaphthalenol | 34131-99-2 |
(24) | 7-Methoxycoumarin | 531-59-9 |
(25) | 4-Methoxyphenol | 150-76-5 |
(26) | 4-(p-Methoxyphenyl)-3-butene-2-one | 943-88-4 |
(27) | 1-(p-Methoxyphenyl)-1-penten-3-one | 104-27-8 |
(28) | Methyl trans-2-butenoate | 623-43-8 |
(29) | 6-Methylcoumarin | 92-48-8 |
(30) | 7-Methylcoumarin | 2445-83-2 |
(31) | 5-Methyl-2,3-hexanedione | 13706-86-0 |
(32) | Costus root oil (Saussurea lappa Clarke) | 8023-88-9 |
(33) | 7-Ethoxy-4-methylcoumarin | 87-05-8 |
(34) | Hexahydrocoumarin | 700-82-3 |
(35) | Peru balsam, crude (Exudation of Myroxylon pereirae (Royle) Klotzsch) | 8007-00-9 |
(36) | 2-Pentylidene-cyclohexanone | 25677-40-1 |
(37) | 3.6,10-Trimethyl-3.5,9-undecatrien-2-one | 1117-41-5 |
(38) | Verbena oil (Lippia citriodora Kunth) | 8024-12-2 |
(39) | Musk ambrette (4-tert-Butyl-3-methoxy-2,6-dinitrotoluene) | 83-66-9 |
(40) | 4-Phenyl-3-buten-2-one | 122-57-6 |
(41) | Amyl cinnamal | 122-40-7 |
(42) | Amylcinnamyl alcohol | 101-85-9 |
(43) | Benzyl alcohol | 100-51-6 |
(44) | Benzyl salicylate | 118-58-1 |
(45) | Cinnamyl alcohol | 104-54-1 |
(46) | Cinnamal | 104-55-2 |
(47) | Citral | 5392-40-5 |
(48) | Coumarin | 91-64-5 |
(49) | Eugenol | 97-53-0 |
(50) | Geraniol | 106-24-1 |
(51) | Hydroxy-citronellal | 107-75-5 |
(52) | Hydroxy-methylpentylcyclohexenecarboxaldehyde | 31906-04-4 |
(53) | Isoeugenol | 97-54-1 |
(54) | Oakmoss extracts | 90028-68-5 |
(55) | Treemoss extracts | 90028-67-4 |
(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 |
The names of the following fragrance allergens shall be listed on the toy, on an affixed label, on the packaging or in an accompanying leaflet, as well as in the product passport, if those allergens are added to a toy, where they are present in the toy or any component thereof at concentrations exceeding 100 mg/kg:
No. | Name of the allergenic fragrance | CAS number |
(1) | Anisyl alcohol | 105-13-5 |
(2) | Benzyl benzoate | 120-51-4 |
(3) | Benzyl cinnamate | 103-41-3 |
(4) | Citronellol | 106-22-9; 1117-61-9; 7540-51-4 |
(5) | Farnesol | 4602-84-0 |
(6) | Hexyl cinnamaldehyde | 101-86-0 |
(7) | Lilial | 80-54-6 |
(8) | d-Limonene | 5989-27-5 |
(9) | Linalool | 78-70-6 |
(10) | 3-methyl-4-(2.6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one | 127-51-5 |
(11) | Acetylcedrene | 32388-55-9 |
(12) | Amyl salicylate | 2050-08-0 |
(13) | trans-Anethole | 4180-23-8 |
(14) | Benzaldehyde | 100-52-7 |
(15) | Camphor | 76-22-2; 464-49-3 |
(16) | Carvone | 99-49-0; 6485-40-1; 2244-16-8 |
(17) | beta-Caryophyllene (ox.) | 87-44-5 |
(18) | Rose ketone-4 (Damascenone ) | 23696-85-7 |
(19) | alpha-Damascone (TMCHB) | 43052-87-5; 23726-94-5 |
(20) | cis-beta-Damascone | 23726-92-3 |
(21) | delta-Damascone | 57378-68-4 |
(22) | Dimethylbenzyl carbinyl acetate (DMBCA) | 151-05-3 |
(23) | Hexadecanolactone | 109-29-5 |
(24) | Hexamethylindanopyran | 1222-05-5 |
(25) | (DL)-Limonene | 138-86-3 |
(26) | Linayl acetate | 115-95-7 |
(27) | Menthol | 1490-04-6; 89-78-1; 2216-51-5 |
(28) | Methyl salicylate | 119-36-8 |
(29) | 3-Methyl-5-(2,2,3-trimethyl-3-cyclopentelnyl)pent-4-en-2-ol | 67801-20-1 |
(30) | alpha-Pinene | 80-56-8 |
(31) | beta-Pinene | 127-91-3 |
(32) | Propylidene phthalide | 17369-59-4 |
(33) | Salicylaldehyde | 90-02-8 |
(34) | alpha-Santalol | 115-71-9 |
(35) | beta-Santalol | 77-42-9 |
(36) | Sclareol | 515-03-7 |
(37) | alpha-Terpineol | 10482-56-1; 98-55-5 |
(38) | Terpineol (mixture of isomers) | 8000-41-7 |
(39) | Terpinolene | 586-62-9 |
(40) | Tetramethyl acetyloctahydro naphthalenes | 54464-57-2; 54464-59-4; 68155-66-8; 68155-67-9 |
(41) | Trimethyl benzenepropanol (Majantol) | 103694-68-4 |
(42) | Vanillin | 121-33-5 |
(43) | Cananga odorata and Ylang-ylang oil | 83863-30-3; 8006-81-3 |
(44) | Cedrus atlantica bark oil | 92201-55-3; 8000-27-9 |
(45) | Cinnamomum cassia leaf oil | 8007-80-5 |
(46) | Cinnamomum zeylanicum bark oil | 84649-98-9 |
(47) | Citrus aurantium amara flower oil | 8016-38-4 |
(48) | Citrus aurantium amara peel oil | 72968-50-4 |
(49) | Citrus bergamia peel oil expressed | 89957-91-5 |
(50) | Citrus limonum peel oil expressed | 84929-31-7 |
(51) | Citrus sinensis (syn.: Aurantium dulcis) peel oil expressed | 97766-30-8; 8028-48-6 |
(52) | Cymbopogon citratus / schoenanthus oils | 89998-14-1; 8007-02-01; 89998-16-3 |
(53) | Eucalyptus spp. leaf oil | 92502-70-0; 8000-48-4 |
(54) | Eugenia caryophyllus leaf / flower oil | 8000-34-8 |
(55) | Jasminum grandiflorum / officinale | 84776-64-7; 90045-94-6; 8022-96-6 |
(56) | Juniperus virginiana | 8000-27-9; 85085-41-2 |
(57) | Laurus nobilis fruit oil | 8007-48-5 |
(58) | Laurus nobilis leaf oil | 8002-41-3 |
(59) | Laurus nobilis seed oil | 84603-73-6 |
(60) | Lavandula hybrida | 91722-69-9 |
(61) | Lavandula officinalis | 84776-65-8 |
(62) | Mentha piperita | 8006-90-4; 84082-70-2 |
(63) | Mentha spicata | 84696-51-5 |
(64) | Narcissus spp. | diverse |
(65) | Pelargonium graveolens | 90082-51-2; 8000-46-2 |
(66) | Pinus mugo | 90082-72-7 |
(67) | Pinus pumila | 97676-05-6 |
(68) | Pogostemon cablin | 8014-09-03; 84238-39-1 |
(69) | Rose flower oil (Rosa spp.) | Diverse |
(70) | Santalum album | 84787-70-2; 8006-87-9 |
(71) | Turpentine (oil) | 8006-64-2; 9005-90-7; 8052-14-0 |
The use of fragrances referred to in entries 41–55 in the table in Part A, point 4, and of fragrances referred to in points 1–10 in the table in point 1 of this Part shall be allowed in olfactory board games, cosmetic kits and gustative games, under the following conditions.
The fragrances are clearly labelled on the packaging of the toy, and the packaging contains the warning referred to in point 11 of Annex III.
Where applicable, the resulting products made by the child in accordance with the manufacturer’s instructions comply with Regulation (EC) No.1223/2009.
Where applicable, the fragrances comply with the relevant Union legislation on food.
Such olfactory board games, cosmetic kits and gustative games shall not be used by children under 36 months and shall comply with point 2 of Annex III.
There are some permitted uses for Nickel (carc 2) in toys and toy components made of stainless steel and in toy components which are intended to conduct an electric current.
Product Passport
There is a new requirement for digital product passports, this replaces the existing Declaration of Conformity. All toys, including those sold online, are required to have a Digital Product Passport. The regulations specify the information that must be contained within the passport: “the product passport shall;
correspond to a specific toy model;
state that compliance of the toy with the requirements set out in this Regulation and, in particular, the essential safety requirements, has been demonstrated;
contain at least the information set out in Part I of Annex VI;
be up to date;
be available in the language or languages required by the Member State where the toy is made available on the market;
be accessible to consumers or other end-users, market surveillance authorities, customs authorities, notified bodies, the Commission and other economic operators;
be available for a period of 10 years after the toy is placed on the market, also in cases of insolvency, a liquidation or a cessation of activity in the Union of the economic operator that created the product passport;
be accessible through a data carrier;
fulfil the specific and technical requirements laid down pursuant to paragraph 10.”
Mental health risks
Article 5 of the regulations has been expanded to include mental health risks.
“Toys shall only be placed on the market if they comply with the essential safety requirements which include the safety requirement set out in paragraph 2 (the ‘general safety requirement’) and the safety requirements set out in Annex II (the ‘particular safety requirements’).
Toys shall not present a risk to the safety or health of users or third parties, including the psychological and mental health, well-being and cognitive development of children, when they are used as intended or in a foreseeable way, bearing in mind the behaviour of children. When assessing the risk referred to in the first subparagraph, the ability of the users and, where appropriate, their supervisors shall be taken into account. Where a toy is intended for use by children under 36 months or by another specified age groups, the ability of users in that specific age group shall be taken into account.
Toys placed on the market shall comply with the essential safety requirements during their foreseeable period of use.”
Batteries in toys
The draft proposed regulation specifies that “toys that include batteries should be designed in such a way that the batteries are difficult for children to access”. In addition the batteries must comply with other relevant regulations for example The Regulation on the registration, evaluation, authorisation and restriction of chemicals (REACH) and the Batteries Directive.
Labelling changes
In order to help with challenges surrounding translation the review suggested replacing the word “Warning” by a generic pictogram. The report states that this “would lead to simplification for the industry without compromising the protection of children. It would also lead to savings to the industry when producing the labels but these savings cannot be quantified with precision”.
Chemical toys — labels
“Without prejudice to the application of the provisions laid down in applicable Union legislation on the classification, packaging and labelling of certain substances or mixtures, the instructions for use of toys containing inherently dangerous substances or mixtures shall bear a warning of the dangerous nature of those substances or mixtures and an indication of the precautions to be taken by the user in order to avoid hazards associated with them. These precautions shall be specified concisely and shall relate to the type of toy. The first aid to be given in the event of serious accidents resulting from the use of the relevant type of toy shall also be mentioned. It shall also be stated that the toy is to be kept out of reach of children under a certain age, which shall be specified by the manufacturer.”
“In addition to the instructions referred to in the first subparagraph, chemical toys shall bear the following warning on their packaging:
“Not suitable for children under 2 years. For use under adult supervision”.
Timings
A transition period of 30 months has been proposed. It would apply 30 months after the date of entry into force of this regulation. This would apply to all new toys.
Draft Regulation Consultation
The draft legislation is undergoing an eight-week feedback period which closes on 31 October 2023, the consultation can be found here. The new regulation will be evaluated after five years.
Conclusions
If you place toys onto the market, carefully review the proposed regulation and ensure you feed any concerns into the consultation before 31 October 2023. Then start to prepare for the regulation by reviewing your product portfolio and the chemicals you use.