New Chemical Legislation on Toy Safety
Added: (Mon Feb 01 2010)
Pressbox (Press Release) -
Author: Luisa Marín
AIJU Laboratory
Abstract
The new legislation on Toy safety has introduced several innovations, especially regarding chemical requirements. The document forecasted a period of enlistment that, in the longest case, will be four years. During this time new rules must be created or adapted taking into account all the aspects of toy safety.
History
The first directive relating to toy safety (88/378/CEE) was the first considered with the “new approach”. This means that the document establishes the essential safety requirements while the harmonised standards are focused on technical specifications and requirements that toys have to comply with. (Series EN71).
The reasons that have led to the review of the previous toy safety directive are based on the clarification of concepts based on new knowledge: to update and complete new requirements due to new safety problems, clarification of the field of application, improvements in this field and to guarantee the consistency of its application. All this means that the general objective of the review is to improve the quality and the efficiency of toy safety rules and at the same time simplify the current legislation, both for the economic agents and the market surveillance authorities [1].
Consequently, the Directive has been adapted to strengthen toy safety requirements and to establish rules for its improved compliance and efficiency.
New Chemical Requirements
Annex II, in chapter III relating to the chemical properties of the directive 2009/48/CE the requirements, in relation to chemical substances that toys must accomplish, are specified. The main incorporations are:
1) Prohibition of CMR substances (carcinogenic, mutagenic or toxic for reproduction) categorized as 1A, 1B o 2.
2) Prohibition of the use of certain allergenic fragrances (Table 1)
3) More restrictive limitations with respect to migration and the inclusion of new elements (Table 2).
The classification of the substances is based on the Regulation (CE) nº 1272/2008. Nevertheless, currently there is an exception to this ban and it relates to nickel, which in spite of being classified as CMR2, its use is allowed when it is in a stainless steel format.
On the other hand, regulations relating to the presence of CMR are not applied as long as they comply with the specific regulations relating to foodstuff materials according to Regulation (CE) nº 1935/2004.
Additionally, nitrosamines and nitrosatable substances are forbidden in toys for infants under 3 years old or toys destined to be put in the mouth if their migration is equal or superior to 0.05 mg/kg for nitrosamines and 1mg/kg for nitrosatable substances.
Other considerations have been expressly mentioned in the new document of the Directive as this complementary legislation must be complied with, particularly the REACH Regulation and, on the other hand, toy cosmetics must obey the legislation relating to cosmetics (Directive 76/768/CEE)
Table 1: Allergenic fragrances forbidden in toys by Directive 2009/48/CE
No. Name of the allergenic substance CAS No. Name of the allergenic substance CAS
(1) Alanroot oil (Inula helenium) 97676-35-2 (28) Methyl trans-2-butenoate 623-43-8
(2) Allylisothiocyanate 57-06-7 (29) 6-Methylcoumarin 92-48-8
(3) Benzyl cyanide 140-29-4 (30) 7-Methylcoumarin 2445-83-2
(4) 4 tert-Butylphenol 98-54-4 (31) 5-Methyl-2,3-hexanedione 13706-86-0
(5) Chenopodium oil 8006-99-3 (32) Costus root oil (Saussurea lappa Clarke) 8023-88-9
(6) Cyclamen alcohol 4756-19-8 (33) 7-Ethoxy-4-methylcoumarin 87-05-8
(7) Diethyl maleate 141-05-9 (34) Hexahydrocoumarin 700-82-3
(8) Dihydrocoumarin 119-84-6 (35) Peru balsam, crude (Exudation of Myroxylon pereirae (Royle) Klotzsch) 8007-00-9
(9) 2,4-Dihydroxy-3-methylbenzaldehyde 6248-20-0 (36) 2-Pentylidene-cyclohexanone 25677-40-1
(10)
3,7-Dimethyl-2-octen-1-ol (6,7-Dihydrogeraniol) 40607-48-5 (37) 3,6,10-Trimethyl-3,5,9-undecatrien-2-one 1117-41-5
(11) 4,6-Dimethyl-8-tert-butylcoumarin 17874-34-9 (38) Verbena oil (Lippia citriodora Kunth) 8024-12-2
(12) Dimethyl citraconate 617-54-9 (39) Musk ambrette (4-tert-Butyl-3-methoxy-2,6-dinitrotoluene) 83-66-9
(13) 7,11-Dimethyl-4,6,10-dodecatrien-3-one 26651-96-7 (40) 4-Phenyl-3-buten-2-one 122-57-6
(14) 6,10-Dimethyl-3,5,9-undecatrien-2-one 141-10-6 (41) Amyl cinnamal 122-40-7
(15) Diphenylamine 122-39-4 (42) Amylcinnamyl alcohol 101-85-9
(16) Ethyl acrylate 140-88-5 (43) Benzyl alcohol 100-51-6
(17) Fig leaf, fresh and preparations 68916-52-9 (44) Benzyl salicylate 118-58-1
(18) trans-2-Heptenal 18829-55-5 (45) Cinnamyl alcohol 104-54-1
(19) trans-2-Hexenal diethyl acetal 67746-30-9 (46) Cinnamal 104-55-2
(20) trans-2-Hexenal dimethyl acetal 18318-83-7 (47) Citral 5392-40-5
(21) Hydroabietyl alcohol 13393-93-6 (48) Coumarin 91-64-5
(22) 4-Ethoxy-phenol 622-62-8 (49) Eugenol 97-53-0
(23) 6-lsopropyl-2-decahydronaphthalenol 34131-99-2 (50) Geraniol 106-24-1
(24) 7-Methoxycoumarin 531-59-9 (51) Hydroxy-citronellal 107-75-5
(25) 4-Methoxyphenol 150-76-5 (52) Hydroxy-methylpentylcyclohexenecarboxaldehyde 31906-04-4
(26) 4-(p-Methoxyphenyl)-3-butene-2-one 943-88-4 (53)
Isoeugenol 97-54-1
(27) 1-(p-Methoxyphenyl)-1-penten-3-one 104-27-8 (54) Oakmoss extracts 90028-68-5
(55) Treemoss extracts 90028-67-4
Table 2: Limit values by element
Element Directive 2009/48/CE Directive 88/378/CEE
Limit mg/kg
( in liquid or sticky toy material) limit mg/kg
(in dry, brittle, powder-like or pliable toy material) limit mg/kg
(in scraped-off toy material) limit mg/kg (any material) limit mg/kg (modelling pastes) limit mg/kg (finger painting)
Al 1406 5625 70000
Sb 11,3 45 560 60 60 10
As 0,9 3,8 47 25 25 10
Ba 1125 4500 56000 1000 250 350
B 300 1200 15000
Cd 0,5 1,9 23 75 50 15
Cr (III) 9,4 37,5 460 60 25 25
Cr (VI) 0,005 0,02 0,2
Co 2,6 10,5 130
Cu 156 622,5 7700
Pb 3,4 13,5 160 90 90 25
Mn 300 1200 15000
Hg 1,9 7,5 94 60 25 10
Ni 18,8 75 930
Se 9,4 37,5 460 500 500 50
Sr 1125 4500 56000
Sn 3750 15000 180000
Sn organic 0,2 0,9 12
Zn 938 3750 46000
Complementary Requirements
The Directive already expresses the compulsory need to obey the complementary legislation that is applicable, specially the REACH Regulation. From the processes derived from REACH, it can be concluded that non-authorized substances will not be used. That is why special attention must be paid to toy production so as to only use substances which have been authorized for this purpose. Moreover, the restrictions in Annex XVII of the Regulation must be observed. This annex belongs to the already repealed directive regarding dangerous substances and preparations in which the presence of benzene, ftalatos, cadmium, azo dyes, etc. to be used in the manufacturing of toys or the materials that form a part of them.
The Regulation on substance classification deserves special attention as it will determine CMR substances.
Other requirements could also be applied depending on the nature and/or use of the toy. For example, if it is a sweet container in toy form, this must comply with all the regulations relating to foodstuff materials. If it is an electric toy, it must also comply with RoHS.
Changes in the Chemical Rules EN 71
The regulations that establish the technical requirements for the compliance of the Directive make up the series EN71, “Toy Safety”. Currently, the series has the following parts (parts having chemical requirements are in bold):
Part 1: Mechanical and physical properties.
Part 2: Inflammability.
Part 3: Migration of certain elements.
Part 4: Experimental games and related activities.
Part 5: Chemical games different to the experimental games.
Part 6: Graphic Signs (cancelled).
Part 7: Finger painting. Requirements and test methods.
Part 8: Swings, slides and similar activity toys for inside and outside family domestic use.
Part 9: Organic Chemical Compounds. Requirements.
Part 10: Organic Chemical Compounds. Sample preparation and extraction.
Part 11: Organic Chemical Compounds. Test Methodology.
All these parts are harmonized with the exception of the serie relating to Organic Chemical Compounds (Parts 9, 10 y 11).
Till the present it is not clear if the rules will be modified to include the new requirements or if new rules will be created. Nevertheless it is clear that there will be changes, especially in part 3, due to the inclusion of new elements as well as the decrease in the limit of many of them (table 2). That will make it necessary to determine if the sample preparation is valid and, on the other hand, it requires the inclusion of new analysis techniques, as is the case of the organic tin determination, which is usually done by cromatographic techniques.
The parts of the standard referring to chemical experiments will be modified, to include the new requirements relating to elements and to consider new substance classifications.
In the case of finger painting, apart from the new composition requirements, those relating to nitrosamines will be included as it is a product for children under 3 years old.
Finally, the most uncertain situation is that referring to the serie of organic chemical compounds. The reasons that prevent their harmonization will be reviewed as well as the standards with the objective of complying with the essential requirements of the new directive.
Bibliography
Explanatory Memorandum. Proposal for Directive of the European Parliament and the Council.
Council Directive 88/378/CEE relating to the approach of the legislation in the EU Members States on toy safety.
Directive 2009/48/CE of the European Parliament and the Toy Safety Council.
Regulation CE nº 1272/2008 of the European Parliament and the Council for the classification, labelling and packing of substances and mixtures.
Regulation CE nº 1935/2004 of the European Parliament and the Council for materials and object destined to be in contact with foodstuffs, and which repeals Directives 80/590/CEE and 89/109/CEE.
Reglament CE nº 1907/2006 of the European Parliament and Council for the registration, evaluation, authorization and restriction of chemical substances and preparations (REACH).
Directive of the Council 76/768/CEE relating to the approach of the EU Members States in cosmetic product matters.
Directive 2002/95/CE on the restrictions and use of certain dangerous substances in electrical and electronic equipment.
Sponsoring:
IMPIVA - GENERALITAT VALENCIANA
FONDO EUROPEO DE DESARROLLO REGIONAL
MINISTERIO DE INDUSTRIA, TURISMO Y COMERCIO (GOBIERNO DE ESPAÑA)