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Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (Text with EEA relevance)
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Toys and their parts must not present a risk of strangulation.
Toys and their parts must not present a risk of asphyxiation by closing off the flow of air as a result of airway obstruction external to the mouth and nose.
Toys and their parts must be of such dimensions as to not present a risk of asphyxiation by closing off the flow of air as a result of internal airway obstruction by objects wedged in the mouth or pharynx or lodged over the entrance to the lower airways.
Toys, which are clearly intended for use by children under 36 months, and their component parts and any of their detachable parts must be of such dimensions as to prevent their being swallowed or inhaled. This also applies to other toys which are intended to be put in the mouth, and to their component parts and any of their detachable parts.
The packaging in which toys are contained for retail sale must not present a risk of strangulation or asphyxiation caused by airway obstruction external to the mouth and nose.
Toys contained within food or co-mingled with food must have their own packaging. This packaging, as it is supplied, must be of such dimensions as to prevent its being swallowed and/or inhaled.
Toy packaging, as referred to in points (e) and (f), which is spherical, egg-shaped or ellipsoidal, and any detachable parts of this or of cylindrical toy packaging with rounded ends, must be of such dimensions as to prevent it from causing airway obstruction by being wedged in the mouth or pharynx or lodged over the entrance to the lower airways.
Toys firmly attached to a food product at the moment of consumption, in such a way that the food product needs to be consumed in order to get direct access to the toy, shall be prohibited. Parts of toys otherwise directly attached to a food product shall fulfil the requirements set out in points (c) and (d).
The maximum design speed of electrically driven ride-on toys must be limited so as to minimise the risk of injury.
the maximum and minimum temperature of any accessible surfaces does not cause injury when touched; and
liquids and gases contained within the toy do not reach temperatures or pressures which are such that their escape from the toy, other than for reasons essential to the proper functioning of the toy, might cause burns, scalds or other physical injury.
they do not burn if directly exposed to a flame or spark or other potential source of fire;
they are not readily flammable (the flame goes out as soon as the fire cause disappears);
if they do ignite, they burn slowly and present a low rate of spread of the flame;
irrespective of the toy’s chemical composition, they are designed so as to mechanically delay the combustion process.
Such combustible materials must not constitute a risk of ignition for other materials used in the toy.
which, when mixed together, may explode through chemical reaction or through heating;
which may explode when mixed with oxidizing substances; or
which contain volatile components which are flammable in air and liable to form a flammable or explosive vapour/air mixture.
Toys shall comply with the relevant Community legislation relating to certain categories of products or to restrictions for certain substances and mixtures.
these substances and mixtures are contained in individual concentrations equal to or smaller than the relevant concentrations established in the Community legal acts referred to in Section 2 of Appendix B for the classification of mixtures containing these substances;
these substances and mixtures are inaccessible to children in any form, including inhalation, when the toy is used as specified in the first subparagraph of Article 10(2);
a decision in accordance with Article 46(3) has been taken to permit the substance or mixture and its use, and the substance or mixture and its permitted uses have been listed in Appendix A.
That decision may be taken if the following conditions are met:
the use of the substance or mixture has been evaluated by the relevant Scientific Committee and found to be safe, in particular in view of exposure;
there are no suitable alternative substances or mixtures available, as documented in an analysis of alternatives; and
the substance or mixture is not prohibited for use in consumer articles under Regulation (EC) No 1907/2006.
The Commission shall mandate the relevant Scientific Committee to re-evaluate those substances or mixtures as soon as safety concerns arise and at the latest every five years from the date that a decision in accordance with Article 46(3) was taken.
these substances and mixtures are contained in individual concentrations equal to or smaller than the relevant concentrations established in the Community legal acts referred to in Section 2 of Appendix B for the classification of mixtures containing these substances;
these substances and mixtures are inaccessible to children in any form, including inhalation, when the toy is used as specified in the first subparagraph of Article 10(2); or
a decision in accordance with Article 46(3) has been taken to permit the substance or mixture and its use, and the substance or mixture and its permitted uses have been listed in Appendix A.
That decision may be taken if the following conditions are met:
the use of the substance or mixture has been evaluated by the relevant Scientific Committee and found to be safe, in particular in view of exposure; and
the substance or mixture is not prohibited for use in consumer articles under Regulation (EC) No 1907/2006.
The Commission shall mandate the relevant Scientific Committee to re-evaluate those substances or mixtures as soon as safety concerns arise and at the latest every five years from the date that a decision in accordance with Article 46(3) was taken.
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 |
However, the presence of traces of these fragrances shall be allowed provided that such presence is technically unavoidable under good manufacturing practice and does not exceed 100 mg/kg.
In addition, the names of the following allergenic fragrances shall be listed on the toy, on an affixed label, on the packaging or in an accompanying leaflet, if added to a toy, as such, at concentrations exceeding 100 mg/kg in the toy or components thereof:
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 |
(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) | Methyl heptine carbonate | 111-12-6 |
(11) | 3-methyl-4-(2.6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one | 127-51-5 |
those fragrances are clearly labelled on the packaging, and the packaging contains the warning set out in point 10 of Part B of Annex V;
if applicable, the resulting products made by the child in accordance with the instructions comply with the requirements of Directive 76/768/EEC; and
if applicable, those fragrances comply with the relevant 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 1 of Part B of Annex V.
Element | mg/kgin dry, brittle, powder-like or pliable toy material | mg/kgin liquid or sticky toy material | mg/kgin scraped-off toy material |
---|---|---|---|
Aluminium | 5 625 | 1 406 | 70 000 |
Antimony | 45 | 11,3 | 560 |
Arsenic | 3,8 | 0,9 | 47 |
[F1Barium | 1 500 | 375 | 18 750] |
Boron | 1 200 | 300 | 15 000 |
[F2Cadmium | 1,3 | 0,3 | 17] |
Chromium (III) | 37,5 | 9,4 | 460 |
[F3Chromium (VI) | 0,02 | 0,005 | 0,053] |
Cobalt | 10,5 | 2,6 | 130 |
Copper | 622,5 | 156 | 7 700 |
[F4Lead | 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 |
Textual Amendments
F1 Substituted by Commission Regulation (EU) No 681/2013 of 17 July 2013 amending part III of Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys (Text with EEA relevance).
F2 Substituted by Commission Directive 2012/7/EU of 2 March 2012 amending, for the purpose of adaptation to technical progress, part III of Annex II to Directive 2009/48/EC of the European Parliament and of the Council relating to toy safety (Text with EEA relevance).
These limit values shall not apply to toys or components of toys which, due to their accessibility, function, volume or mass, clearly exclude any hazard due to sucking, licking, swallowing or prolonged contact with skin when used as specified in the first subparagraph of Article 10(2).
Internal voltages shall not exceed 24 volts DC or the equivalent AC voltage unless it is ensured that the voltage and the current combination generated do not lead to any risk or harmful electric shock, even when the toy is broken.
Toys shall comply with all relevant measures adopted under Chapter III of the Treaty establishing the European Atomic Community.
Textual Amendments
Substance | Classification | Permitted use |
---|---|---|
Nickel | CMR 2 | In toys and toy components made of stainless steel. In toy components which are intended to conduct an electric current.] |
As a result of the timing of the application of Regulation (EC) No 1272/2008, there are equivalent ways of referring to a given classification that should be used at different points in time.
The substance fulfils the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:
hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;
hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;
hazard class 4.1;
hazard class 5.1.
The mixture is dangerous within the meaning of Directive 67/548/EEC.
The substance or mixture fulfils the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:
hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;
hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;
hazard class 4.1;
hazard class 5.1.
From 20 July 2011 until 31 May 2015, the relevant concentrations for the classification of mixtures containing the substances shall be those established in accordance with Directive 1999/45/EC.
From 1 June 2015, the relevant concentrations for the classification of mixtures containing the substances shall be those established in accordance with Regulation (EC) No 1272/2008.
Point 4 of Part III concerns substances classified as CMR category 1A and 1B under Regulation (EC) No 1272/2008.
From 20 July 2011 until 31 May 2015, point 4 of Part III concerns mixtures classified as CMR category 1 and 2 under Directive 1999/45/EC and Directive 67/548/EEC as applicable.
From 1 June 2015, point 4 of Part III concerns mixtures classified as CMR category 1A and 1B under Regulation (EC) No 1272/2008.
Point 5 of Part III concerns substances classified as CMR category 2 under Regulation (EC) No 1272/2008.
From 20 July 2011 until 31 May 2015, point 5 of Part III concerns mixtures classified as CMR category 3 under Directive 1999/45/EC and Directive 67/548/EEC as applicable.
From 1 June 2015, point 5 of Part III concerns mixtures classified as CMR category 2 under Regulation (EC) No 1272/2008.
Article 46(3) concerns substances classified as CMR category 1A, 1B and 2 under Regulation (EC) No 1272/2008.
From 20 July 2011 until 31 May 2015, Article 46(3) concerns mixtures classified as CMR category 1, 21999 and 3 under Directive 1999/45/EC and Directive 67/548/EEC as applicable.
From 1 June 2015, Article 46(3) concerns mixtures classified as CMR category 1A, 1B and 2 under Regulation (EC) No 1272/2008.
Textual Amendments
Substance | CAS No | Limit value |
---|---|---|
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) |
[F7Bisphenol A | 80-05-7 | 0,04 mg/l (migration limit) in accordance with the methods laid down in EN 71-10:2005 and EN 71-11:2005] |
[F8Formamide | 75-12-7 | 20 μg/m 3 (emission limit) after a maximum of 28 days from commencement of the emission testing of foam toy materials containing more than 200 mg/kg (cut-off limit based on content)] |
[F91,2-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] |
[F10Reaction 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] |
[F11Phenol | 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.] ] |
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