Erhvervsudvalget 2007-08 (2. samling)
KOM (2008) 0009 Bilag 4
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ANEC-CHILD-2008-G-036
12 June 2008
ANEC/BEUC Fact sheet
Chemical requirements in toys ought to be strengthened
Background
Lead, phthalates, nitrosamines, volatile organic compounds such as formaldehyde or
phenol - a mixture of problematic chemicals, of which some can present risks to
children’s health and the environment, is contained in all toys: from wooden toys to
dolls, rubber ducks to beach toys. Phthalates in soft plastic toys made of PVC can
represent up to 30, even 50% of the weight of the toy. All these substances have the
potential to migrate or emit out of toys.
Children have increased vulnerability to chemical harms due to their young age. In
addition, they have potential exposure to chemicals through play with toys (sucking,
biting, chewing, manipulating) as these behaviours can extract chemicals from toys
and lead to ingestion, inhalation, entry in contact with the skin, eyes and mucous
membranes with a certain amount of the chemicals.
Unfortunately, even if only a small number of emergency room visits for chemical
injury related to toys has been reported by hospitals across the EU, this does not
necessarily mean that there are effective mechanisms in place to protect children
from most acute chemical harms. In addition, uncertainty and data gaps remain
about possible non-acute health harms to children from dangerous chemicals used in
toys.
There is therefore clearly a need to apply a precautionary approach to children’s
safety legislation by minimising the use of dangerous chemical substances. In this
repect, the Commission’s proposal contains many shortcomings. Although it foresees
a prohibition of CMRs (substances which are carcinogenic, mutagenic or reprotoxic)
it only refers to the accessible parts of toys, with exemptions which would make it
easy to get around this prohibition. We also consider that the proposed list of
allergens to be prohibited in toys is not exhaustive: it only covers some fragrances,
despite the fact that many other substances can also provoke allergies. Finally, it is
not acceptable that no measures are foreseen for other problematic substances,
such as endocrine disruptors.
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Our proposal for amendments
CHAPTER I
GENERAL PROVISIONS
Article 2
Definitions
(13) “harm” means the physical injury or damage to health,
including long term
health effects;
Justification:
This wording clarifies that the term ‘damage to health’ includes long term health
effects such as carcinogenic and endocrine disrupting effects.
ANNEX II
PARTICULAR SAFETY REQUIREMENTS
III. CHEMICAL PROPERTIES
1. Toys shall be so designed and constructed that there are no risks of adverse effects
on human health or the environment due to exposure to the chemical substances or
preparations of which the toys are composed or which they contain, when the toys
are used as specified in the first subparagraph of Article 9 (2).
Justification:
Even though the Toy Safety Directive is meant to regulate the safety of toys for
children, it should also be stated that toys should not present risks to the environment.
One should not forget that a toy generally has a very short lifespan because the child
gets tired of it or because the toy is old fashioned or even breaks. Toys therefore
generate an enormous amount of waste in the EU every year.
2. Toys shall comply with relevant Community legislation relating to certain
categories of products or to the prohibition of use of certain dangerous substances
and preparations. Toys that are themselves substances or preparations must
comply also with Directives 67/548/EEC and 1999/45/EC25 relating to the
classification, packaging and labelling of dangerous substances and dangerous
preparations.
3.
The use in toys of substances that are classified as carcinogenic, mutagenic or
toxic for reproduction (CMR) according to Directive 67/548/EEC in individual
concentrations equal to or greater than 0.01% shall be prohibited. Where
appropriate, a lower limit shall be stipulated for certain CMR substances based
upon advice of the relevant Scientific Committee and following a Decision as
referred to in Article 45 (2).
Justification:
The concentration limits for CMR substances (i.e. 0,1% for CMR category 1 and 2,
1% for category 3) established in the EU Directive 1999/45/EC on dangerous
substances and preparations are too high to be applied in toys. Only very low trace
levels of CMR substances should be allowed in toys. In addition, the Comitology
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procedure should be introduced in order to allow for a re-evaluation of these
concentration limits if necessary to protect children’s health.
4. Substances or preparations classified as CMR category 1, 2 and 3 according to
Directive 67/548/EEC may be used in one particular toy provided that all the
following conditions are met:
Justification:
The precautionary principle needs to be applied when addressing the risks posed by
CMR in toys. The same provisions should therefore be foreseen for both CMR 1-2 and
CMR 3. Indeed, CMR Category 3 are substances which are suspected from being
carcinogenic to man on the basis of available evidence but the evidence is not yet
sufficient to classify them in category 2.
4.1. use of the substance in this particular toy has been evaluated by the relevant
Scientific Committee and found to be safe, in particular in view of exposure, and a
Decision as referred to in Article 45 (2) has been taken;
4.2.there are no suitable alternative substances or materials available, as documented
in an analysis of alternatives,
4.3.they are not prohibited for uses in consumer articles under Regulation (EC) No
1907/2006 (REACH).
The Commission shall mandate the relevant Scientific Committee to re-evaluate
those substances or preparations as soon as safety concerns arise and at the latest
every 3 years from the date that a decision in accordance with Article 45 (2) was
taken.
Justification:
Considering the fact that only a limited number of CMR substances will be exempted
from the prohibition and that new scientific evidence arises almost everyday, three
years appears a reasonable period for the SCCP to re-evaluate the safety of the
substances.
5. The Commission shall establish a program to systematically and regularly
evaluate the occurrence of dangerous substances in toys, other than CMR
substances, and including endocrine disrupters, PBT and vPvB, sensitisers other
than allergenic fragrances, substances classified e.g. as “very toxic”, “toxic”,
“harmful”, “corrosive”, “irritant” or non-classified (or not yet classified)
substances which pose health hazards. The program shall take into account reports
of market surveillance bodies and concerns expressed by Member States and
stakeholders. Appropriate measures shall be taken based upon advice of the
relevant Scientific Committee and following a Decision as referred to in Article
45 (2).
Justification:
The precautionary principle needs to be applied in order to allow for quick
adaptation of the Toy Safety Directive to new evidence or new risks related to one
individual chemical substance. This only will ensure a high level of protection for
children.
6. Cosmetic toys, such as play cosmetics for dolls, shall comply with the
compositional and labelling requirements provided for in Directive 76/768/EEC.
7. Toys shall not contain the following allergenic fragrances:
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(1) Alanroot (Inula helenium)
(2) Allylisothiocyanate
(3) Benzyl cyanide
(4) 4 tert-Butylphenol
(5) Chenopodium oil
(6) Cyclamen alcohol
(7) Diethyl maleate
(8) Dihydrocoumarin
(9) 2,4-Dihydroxy-3-methylbenzaldehyde
(10) 3,7-Dimethyl-2-octen-1-ol (6,7-Dihydrogeraniol)
(11) 4,6-Dimethyl-8-tert-butylcoumarin
(12) Dimethyl citraconate
(13) 7,11-Dimethyl-4,6,10-dodecatrien-3-one
(14) 6,10-Dimethyl-3,5,9-undecatrien-2-one
(15) Diphenylamine
(16) Ethyl acrylate
(17) Fig leaf, fresh and preparations
(18) trans-2-Heptenal
(19) trans-2-Hexenal diethyl acetal
(20) trans-2-Hexenal dimethyl acetal
(21) Hydroabietyl alcohol
(22) 4-Ethoxy-phenol
(23) 6-lsopropyl-2-decahydronaphthalenol
(24) 7-Methoxycoumarin
(25) 4-Methoxyphenol
(26) 4-(p-Methoxyphenyl)-3-butene-2-one
(27) 1-(p-Methoxyphenyl)-1-penten-3-one
(28) Methyl trans-2-butenoate
(29) 6-Methylcoumarin
(30) 7-Methylcoumarin
(31) 5-Methyl-2,3-hexanedione
(32) Costus root oil (Saussurea lappa Clarke)
(33) 7-Ethoxy-4-methylcoumarin
(34) Hexahydrocoumarin
(35) Peru balsam (Myroxylonpereirae Klotzsch)
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(36) 2-Pentylidene-cyclohexanone
(37) 3,6,10-Trimethyl-3,5,9-undecatrien-2-one
(38) Verbana oil (Lippia citriodora Kunth).
(39) Amyl cinnamal
(40) Amylcinnamyl alcohol
(41) Anisyl alcohol
(42) Benzyl alcohol
(43) Benzyl benzoate
(44) Benzyl cinnamate
(45) Benzyl salicylate
(46) Cinnamal
(47) Cinnamyl alcohol
(48) Citral
(49) Citronellol
(50) Coumarin
(51) Eugenol
(52) Farnesol
(53) Geraniol
(54) Hexyl cinnamaldehyde
(55) Hydroxy-citronellal
(56) Hydroxy-methylpentylcyclohexenecarboxaldehyde
(57) Isoeugenol
(58) Lilial (referred to in the Cosmetics Directive in entry 83 as: 2-(4-tert-
Butylbenzyl) propionaldehyde
(59) d-Limonene
(60) Linalool
(61) Methyl heptine carbonate
(62) 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one
(63) Oakmoss extracts
(64) Treemoss extracts
However, the presence of traces of these substances shall be allowed provided that
such presence is technically unavoidable in good manufacturing practice.
Justification:
Fragrances are recognised as one of the leading causes of allergies. As allergies can
start at any age but the majority of people develop the first symptoms before the age
of ten, the use of fragrances that are recognized as allergenic should be prohibited in
toys.
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8. The following migration limits, from all parts and components of toys shall not be
exceeded:
Element
mg/kg in solid, dry, brittle, powder-like or
pliable toy material
mg/kg
in liquid or sticky toy
material
1406
11.3
1.9
1125
300
0.9
9.4
Aluminium
Antimony
Arsenic
Barium
Boron
Cadmium
Chromium
(III)
Chromium
(VI)
Cobalt
Copper
Lead
Manganese
Mercury
Nickel
Selenium
Strontium
Tin
Organic tin
Zinc
5625
45
7.5
4500
1200
3.8
37.5
0.04
10.5
622.5
27
1200
15
75
37.5
4500
15000
1.9
3750
0.01
2.6
156
6.8
300
3.8
18.8
9.4
1125
3750
0.5
938
These limit values do not apply to 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 9 (2).
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Justification:
The notion "dry, brittle, powder-like or pliable material" does not necessarily include
"solid materials" (see the background study carried out by RIVM and proposing 3
sets of limit values depending on the material). Hence, the headline must be changed
to "solid, dry, brittle, powder-like or pliable materials".
9.
Specific requirements shall be adopted for toys or parts thereof that are designed
to be placed in the mouth, regardless of the age group for which the toy is
intended, based on the requirements for packaging for food as laid down in
Regulation (EC) No 1935/2004 of the European Parliament and of the Council
of 27 October 2004 on materials and articles intended to come into contact with
food and its related specific measures for particular materials. Such
requirements shall be taken based upon advice of the relevant Scientific
Committee and following a Decision as referred to in Article 45 (2) taking into
account the differences between toys and food contact materials (e.g. migration
conditions).
Justification:
The Comitology procedure should be used for the establishment of limit values that
have a direct impact on children’s health and safety. Indeed, setting limit values is a
highly political issue which should be solved at political level and not shifted to
standardisation bodies. This is particularly true for the establishment of limit values
for chemicals, and other limits that are directly linked to the health and safety of
children, such as noise or speed limits.
ANNEX IV
TECHNICAL DOCUMENTATION
The technical documentation referred to in Article 20 shall contain, in particular, so
far as relevant for assessment:
a) a detailed description of the design and manufacture, including a list of
components and materials used in toys as well as
detailed information on the
chemical composition of the toy or the substances used in the manufacture of
the toy as well as on the amount of the individual substances used in the toy or
parts of it;
END.
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