Activities of Anna HEDH related to 2008/0018(COD)
Plenary speeches (1)
Toys Directive (debate)
Amendments (55)
Amendment 104 #
Proposal for a directive
Recital 3 a (new)
Recital 3 a (new)
Amendment 106 #
Proposal for a directive
Recital 8
Recital 8
(8) All economic operators intervening in the supply and distribution chain should exercise the responsibility and vigilance required to ensure that under normal and reasonably foreseeable conditions of use the toys they place on the market do not jeopardise the safety and health of children. Economic operators should take the appropriate measures to ensure that they make available on the market only toys which are in conformity with the applicable legislation. This Directive provides a clear and proportionate distribution of obligations which correspond to the respective role of each operator in the supply and distribution process.
Amendment 124 #
Proposal for a directive
Recital 17
Recital 17
(17) The general and specific chemical requirements in this Directive should aim at protecting the health of children from dangerous substances in toys, while environmental concerns presented by toys are addressed in horizontal environmental legislation applying also to toys, in particular in Directive 2006/12/EC of the European Parliament and of the Council of 5 April 2006 on waste,to electrical and electronic toys, namely Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the restriction of the use of certain hazardous substances in electrical and electronic equipment, in and Directive 2002/96/EC of the European Parliament and of the Council of 27 January 2003 on waste electrical and electronic equipment, in. In addition, environmental issues concerning waste are regulated by Directive 2006/12/EC of the European Parliament and of the Council of 5 April 2006 on waste, those concerning packaging by Directive 94/62/EC of the European Parliament and of the Council of 20 December 1994 on packaging and packaging waste, and inthose concerning batteries and accumulators by Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators and repealing Directive 91/157/EEC.
Amendment 127 #
Proposal for a directive
Recital 18
Recital 18
(18) It is appropriate to lay down specific safety requirements to cover the potential specific hazard presented by toys inside food in line with the precautionary principle, since the association of a toy and food could be the cause of a risk of choking that is distinct from the risks presented by the toy alone and which is, therefore, not covered by any specific measures at Community level.
Amendment 130 #
Proposal for a directive
Recital 19
Recital 19
(19) Since toys may exist or be developed which present hazards which are not covered by a particular safety requirement laid down in this Directive, it is necessary to set a general requirement of safety as the legal base for taking action against such toys. In this respect safety of toys should be determined by reference to the intended use of the product while taking into account the reasonably foreseeable use, bearing in mind behaviour of children, who do not generally show the same degree of care as the average adult user.
Amendment 131 #
Proposal for a directive
Recital 19
Recital 19
(19) Since toys may exist or be developed which present hazards which are not covered by a particular safety requirement laid down in this Directive, it is necessary to set a general requirement of safety as the legal base for taking action against such toys. In this respect safety of toys should be determined by reference to the intended use of the product while taking into account the foreseeable use, bearing in mind behaviour of children, who do not generally show the same degree of care as the average adult user.Does not affect English version.)
Amendment 132 #
Proposal for a directive
Recital 22
Recital 22
(22) It is crucial to make clear to both manufacturers and users that by affixing the CE marking to the toy the manufacturer declares that the product is in conformity with all applicable requirements and that he takes full responsibility thereof.
Amendment 138 #
Proposal for a directive
Article 1 – paragraph 1 − subparagraph 1
Article 1 – paragraph 1 − subparagraph 1
1. This Directive lays down rules on the safety, and the free movement in the Community, of products designed or by virtue of their functions, dimensions and characteristics intended, whether or not exclusively, for use in play by children under 14 years of age, hereinafter "“toys"”.
Amendment 142 #
Proposal for a directive
Article 1 – paragraph 1 a (new)
Article 1 – paragraph 1 a (new)
1a. This Directive is based on the principle that manufacturers, importers and other economic operators guarantee that the manufacture or marketing of toys, and any chemicals they contain, are not harmful or toxic to children's health and the environment. These measures are based on the precautionary principle.
Amendment 143 #
Proposal for a directive
Article 2 – point 12 a (new)
Article 2 – point 12 a (new)
(12a) “could cause suffocation” means any object which, by virtue of its shape or size, could, in the absence of any force other than that exerted by the object itself, completely cover the mouth, nose or lower airways;
Amendment 147 #
Proposal for a directive
Article 2 – point 16 a (new)
Article 2 – point 16 a (new)
(16a) "soft filled toy" means a toy, clothed or unclothed, with soft body surfaces and filled with soft materials, readily allowing compression of the main part of the toy with the hand.
Amendment 148 #
Proposal for a directive
Article 2 – point 16 b (new)
Article 2 – point 16 b (new)
(16b) ”packaging” means any material accompanying the toy when purchased, which may not be defined as a toy or any other product sold together with the toy.
Amendment 151 #
Proposal for a directive
Article 3 – paragraph 4
Article 3 – paragraph 4
4. Manufacturers shall ensure that procedures are in place to ensure the continued conformity of series production to the model or prototype of the toy and its component parts having been used in the various evaluation and conformity procedures for the toy in question and its compliance with the standards and the basic requirements laid down in Article 9 and Annex II. Changes in the product design or characteristics and changes in the harmonised standards by reference to which conformity of a toy is stated shall also be adequately taken into account by manufacturers. Manufacturers shall, in all cases whe carry out sample testing of manufactured appropriate, carry out sample testing of marketed toys, investigating, and, if necessary,nd marketed toys, including the component parts thereof. Such testing shall be performed at least once a year, without prejudice to Article 38. Manufacturers shall investigate complaints received from economic operators and end users and respond to these within two weeks. They shall keeping a register of those complaints, and keeping distributorsin accordance with Article 7a, and shall keep the economic operators and end users who contacted them informed of such monitoring.
Amendment 154 #
Proposal for a directive
Article 3 – paragraph 7
Article 3 – paragraph 7
7. Manufacturers who consider or haveIf there is a reason to believe that a toy which theymanufacturers have placed on the market poses in any way a health risk to children or is not in conformity with the applicable Community legislation shall, the manufacturer shall immediately take the necessary corrective measures to bring that toy into conformity or withdraw it from the market and recall it from end users, if appropriate. They shall immediately inform the national authorities of the Member States where they made the toy available to this effect, giving detailsan accurate description, in particular, of the non- compliance and of the corrective, withdrawal or recall measures taken.
Amendment 157 #
Proposal for a directive
Article 3 – paragraph 8
Article 3 – paragraph 8
8. Manufacturers shall, on request from the competent national authorities, provide them, within seven days, with all the information and documentation necessary to demonstrate the conformity of the toy. They shall cooperate with those authorities, at the request of the latter, on any action to avoid the risks posed by toys which they have placed on the market.
Amendment 158 #
Proposal for a directive
Article 4 – paragraph 1 a (new)
Article 4 – paragraph 1 a (new)
1a. Manufacturers who appoint an authorised representative shall notify that appointment to the competent national authorities of the territory in which their toys are made available on the market not later than four weeks after the date on which the appointment was made.
Amendment 159 #
Proposal for a directive
Article 4 – paragraph 1 b (new)
Article 4 – paragraph 1 b (new)
1b. Such notification shall, as a minimum requirement, include the authorised representative's particulars (name, postal address, telephone number, e-mail address, web site address), details of the toys in respect of which the authorised representative is subject to the obligations set out in paragraph 3, and the unique identification numbers of those toys.
Amendment 161 #
Proposal for a directive
Article 4 – paragraph 3 – point b
Article 4 – paragraph 3 – point b
(b) on request from the competent national authorities, provide them, within seven days, with all the information and documentation necessary to demonstrate the conformity of the toy;
Amendment 162 #
Proposal for a directive
Article 5 – paragraph 1
Article 5 – paragraph 1
1. When placing a toy on the market, importers shall act with due care in relation to the applicable requirements and ensure that the toys they place on the market comply with this Directive and are safe.
Amendment 163 #
Proposal for a directive
Article 5 – paragraph 3
Article 5 – paragraph 3
3. Importers shall indicate their name and the, in a visible and clearly legible manner, their name and the address, telephone number and e-mail address at which they can be contacted on the toy or, where the size or nature of the toy does not allow it, on its packaging or in a document accompanying the toy, in such a way that it is visible and distinct from the description of the toy.
Amendment 164 #
Proposal for a directive
Article 5 – paragraph 5
Article 5 – paragraph 5
5. Importers who consider or havef there is a reason to believe that a toy which theyimporters have placed on the market poses in any way a health risk to children or is not in conformity with the applicable Community legislation shall, importers shall immediately take the necessary corrective measures to bring that toy into conformity or withdraw it from the market and recall it from end users, if appropriate. They shall immediately inform the national authorities of the Member States where they made the toy available to this effect, giving detailsan accurate description, in particular, of the non- compliance and of the corrective, withdrawal or recall measures taken.
Amendment 166 #
Proposal for a directive
Article 5 – paragraph 7
Article 5 – paragraph 7
7. Importers shall, on request from the competent national authorities, provide them, within seven days, with all the information and documentation necessary to demonstrate the conformity of the toy. They shall cooperate with those authorities, at the request of the latter, on any action to avoid the risks posed by toys which they have placed on the market.
Amendment 167 #
Proposal for a directive
Article 6 – paragraph 1
Article 6 – paragraph 1
1. When makplacing a toy available on the market, distributors shall act with due care in relation to the applicable requirements and ensure that the toys they place on the market comply with this Directive, in order to ensure that the toys they place on the market are safe.
Amendment 168 #
Proposal for a directive
Article 6 – paragraph 4
Article 6 – paragraph 4
4. Distributors who consider or haveIf there is a reason to believe that a toy which theydistributors have placed on the market poses in any way a health risk to children or is not in conformity with the applicable Community legislation shall, the distributor shall immediately take the necessary corrective measures to bring that toy into conformity, or withdraw it from the market and recall it from end users, if appropriate. They shall immediately inform the other economic operators concerned and the national authorities of the Member States where they made the toy available to this effect, giving detailsan accurate description, in particular, of the non- compliance and of the corrective, withdrawal or recall measures taken.
Amendment 169 #
Proposal for a directive
Article 6 – paragraph 5
Article 6 – paragraph 5
5. Distributors shall, on request from the competent national authorities, provide them, within seven days, with all the information and documentation necessary to demonstrate the conformity of the toy. They shall cooperate with those authorities, at the request of the latter, on any action to avoid the risks posed by toys which they have made available on the market.
Amendment 170 #
Proposal for a directive
Article 7 a (new)
Article 7 a (new)
Amendment 173 #
Proposal for a directive
Article 8 – subparagraph 2
Article 8 – subparagraph 2
They shall have in place appropriate systems and procedures which allow for this information to be made available within seven days to the market surveillance authorities on request, for a period of 10 years.
Amendment 175 #
Proposal for a directive
Article 9 – paragraph 1
Article 9 – paragraph 1
1. Member States shall take all measures necessary to ensure that toys may not be placed on the market unless they comply with the essential safety requirements set out, as far as the general safety requirement is concerned, in paragraph 2, and, as far as the particular safety requirements are concerned, in Annex II. These measures shall take due account of the precautionary principle.
Amendment 183 #
Proposal for a directive
Article 10 – paragraph 2 – subparagraph 1
Article 10 – paragraph 2 – subparagraph 1
2. The manufacturer shall mark the warnings in a visible, clearly legible and accurate manner, so that they are conspicuously displayed on the toy, on an affixed label or on the consumer packaging and, if appropriate, on the instructions for use which accompany the toy. Small toys that are sold without packaging shall have appropriate warnings affixed to them.
Amendment 185 #
Proposal for a directive
Article 10 – paragraph 2 – subparagraph 1 a (new)
Article 10 – paragraph 2 – subparagraph 1 a (new)
When appearing on the package or on the label attached thereto, the warnings shall be printed on the package or on the label in characters of a font size of at least 3 mm and shall be presented in such a way as to ensure a significant contrast between the print and the background.
Amendment 186 #
Proposal for a directive
Article 10 – paragraph 2 – subparagraph 2
Article 10 – paragraph 2 – subparagraph 2
Warnings specifying ththat are necessary for a choice of toy that is safe minimum and maximum ages f connection with the intended use or users shall be visible, legible andappear on the consumer packaging or be otherwise attached to the toy in such a way that the consumer can read it before purchase. If purchased online the warning should be conspicuously displayed aton the point of salwebpage.
Amendment 192 #
Proposal for a directive
Article 10 – paragraph 2 – subparagraph 2 a (new)
Article 10 – paragraph 2 – subparagraph 2 a (new)
Warning of hazards that occur every time the toy is used or of unsafe behaviour that is likely to occur after some time of use shall be permanently marked on the toy
Amendment 199 #
Proposal for a directive
Article 13 – paragraph 2 a (new)
Article 13 – paragraph 2 a (new)
2a. If the references in the Official Journal of the European Union to a harmonised standard as referred to in Article 13 are published with restriction or maintained with restriction, the Commission may, in accordance with the regulatory procedure with scrutiny referred to in Article 46(2), adopt a decision indicating the reasons for the restriction. The Decision may specify threshold limits and other criteria corresponding to the specific safety requirements in question. The Decision shall make clear whether a toy complying with the harmonised standard as completed by the Decision shall be presumed to be in conformity with the requirements covered by the standard and the Decision.
Amendment 203 #
Proposal for a directive
Article 14 – paragraph 3
Article 14 – paragraph 3
3. By drawing up the EC declaration of conformity, the manufacturer shall assume the responsibility for the compliance of the toy. A copy of the declaration of conformity shall be made available to the relevant authorities, as well as economic operators in the supply chain, upon request.
Amendment 207 #
Proposal for a directive
Article 15 – paragraph 7
Article 15 – paragraph 7
7. Toys not bearing a CE-marking andor which do not otherwise comply with the provisions of this Directive may feature in trade fairs and exhibitions, provided that they are accompanied by a sign which clearly indicates that the toys do not comply with the requirements of this Directive and are not for sale or for distribution free of charge.
Amendment 212 #
Proposal for a directive
Article 17 − subparagraph 1 a (new)
Article 17 − subparagraph 1 a (new)
The absence of an accident history may not automatically be taken as indicating a low presumption of risk.
Amendment 225 #
Proposal for a directive
Article 45 - paragraph 1 - subparagraph 2
Article 45 - paragraph 1 - subparagraph 2
Those measures, designed to amend non- essential elements of this RegulationDirective, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 46 (2).
Amendment 229 #
Proposal for a directive
Article 45 - paragraph 2
Article 45 - paragraph 2
Amendment 235 #
Proposal for a directive
Article 45 - paragraph 2 a (new)
Article 45 - paragraph 2 a (new)
2a. The Commission may, for the purpose of enhancing the standardisation process, amend the mandate for a standard not adopted within the given time frame, specifying threshold limits and the other criteria necessary for the compliance of the standard with the essential safety requirements set out in Article 9(2) and in Annex II. Those measures shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 46(2).
Amendment 238 #
Proposal for a directive
Article 45 - paragraph 2 a (new)
Article 45 - paragraph 2 a (new)
2a. The Commission may, for the purpose of addressing hazards not covered by any specific safety requirement, amend Annex II by adding specific safety requirements. Those measures, designed to amend non- essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 46(2).
Amendment 257 #
Proposal for a directive
Annex II – Part I – point 4 – subparagraph 1
Annex II – Part I – point 4 – subparagraph 1
4. Toys and their parts must not present risk of asphyxiation caused, in particular, by strangulation or suffocstrangulation.
Amendment 259 #
Proposal for a directive
Annex II – Part I – point 4 – subparagraph 2
Annex II – Part I – point 4 – subparagraph 2
The packaging in which toys are contained for retail sale must not present risk of strangulation or asphyxiation caused byof closing off the flow of air as a result of airway obstruction external to the mouth and nose. Spherical, egg shaped or ellipsoidal packaging may not have dimensions that can cause internal airways obstruction by being wedged in the mouth or pharynx.
Amendment 262 #
Proposal for a directive
Annex II – Part I – point 4 - subparagraph 2 a (new)
Annex II – Part I – point 4 - subparagraph 2 a (new)
Toys and their parts must not present any risk of closing off the flow of air as a result of airway obstruction external to the mouth and nose.
Amendment 263 #
Proposal for a directive
Annex II – Part I – point 4 – subparagraph 2 b (new)
Annex II – Part I – point 4 – subparagraph 2 b (new)
Toys and their parts must be of such dimensions as not to present any risk of closing off the flow of air as a result of airway obstruction by objects wedged in the mouth or pharynx or lodged over the entrance to the lower airways.
Amendment 264 #
Proposal for a directive
Annex II – Part I – point 4 – subparagraph 3
Annex II – Part I – point 4 – subparagraph 3
Toys, which are clearlyby virtue of their functions, dimensions and characteristics, are 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 and/or inhaled. This also applies to other toys which by virtue of their functions, dimensions and characteristics are intended to be put in the mouth, and to their component parts and any of their detachable parts.
Amendment 270 #
Proposal for a directive
Annex II – Part I – point 4 – subparagraph 4
Annex II – Part I – point 4 – subparagraph 4
Toys contained within food or co-mingled with a food must have their own packaging. This packaging, in its supplied condition, must be of such dimensions as to prevent it being swallowed and/or inhaled, and must fulfil the other requirements for toy packaging in 4e. Cylindrical inner packaging with rounded ends that as supplied can be divided in two individual halves may not have dimensions that can cause internal airways obstruction.
Amendment 277 #
Proposal for a directive
Annex II – Part I – point 4 – subparagraph 5
Annex II – Part I – point 4 – subparagraph 5
Toys firmly attached to a food product at the moment of consumption, in such a way that the food products 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 4c and 4d.
Amendment 291 #
Proposal for a directive
Annex II – Part I – point 10
Annex II – Part I – point 10
10. Toys which are designed to emit a sound should be so designed and constructed so that the sound from them is not able to impair children’s hearing. This shall apply to all toys irrespective of the age group targeted. The limit for impulse noise should be 135 dB LpC peak at the ear. Limits for continuous noise shall be set on the basis of the sensitivity of the ear of an infant under 36 months of age.
Amendment 294 #
Proposal for a directive
Annex II – Part I – point 11 a (new)
Annex II – Part I – point 11 a (new)
11a.Toys and their parts which can be swallowed by children, in particular magnets or magnetic components, expanding parts or button batteries, must not present risks of harming the gastric channels or the intestines,
Amendment 312 #
Proposal for a directive
Annex II – Part III – point 4
Annex II – Part III – point 4
Amendment 321 #
Proposal for a directive
Annex II – Part III – point 5
Annex II – Part III – point 5
Amendment 338 #
Proposal for a directive
Annex II – Part III – point 7
Annex II – Part III – point 7
7. Toys shall not contain the following allergenic fragrances: (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) (36) 2-Pentylidene-cyclohexanone (37) 3,6,10-Trimethyl-3,5,9-undecatrien- 2-one (38) Verbana oil (Lippia citriodora Kunth). However, the presence of traces of these substances shall be allowed provided that such presence is technically unavoidable in good manufacturing practice. In addition the following allergenic fragrances shall be listed if added to toys, as such, at concentrations exceeding 0,01 % by weight: (1) Amyl cinnamal (2) Amylcinnamyl alcohol (3) Anisyl alcohol (4) Benzyl alcohol (5) Benzyl benzoate (6) Benzyl cinnamate (7) Benzyl salicylate (8) Cinnamal (9) Cinnamyl alcohol (10) Citral (11) Citronellol (12) Coumarin (13) Eugenol (14) Farnesol (15) Geraniol (16) Hexyl cinnamaldehyde (17) Hydroxy-citronellal (18) Hydroxy- methylpentylcyclohexenecarboxaldehyde (19) Isoeugenol (20) Lilial (referred to in the Cosmetics Directive in entry 83 as: 2-(4-tert- Butylbenzyl) propionaldehyde (21) d-Limonene (22) Linalool (23) Methyl heptine carbonate (24) 3-methyl-4-(2,6,6-trimethyl-2- cyclohexen-1-yl)-3-buten-2-one (25) Oakmoss extracts (26) Treemoss extractOnly fragrances which are found not to be allergenic in accordance with to the Regulation on Classification, Labelling and Packaging of Substances and Mixtures may be used in toys
Amendment 349 #
Proposal for a directive
Annex II – Part III – point 8
Annex II – Part III – point 8
8. The following migration limits, from toys or components of toys that are accessible to children during use as specified in the first subparagraph of Article 9 (2), shall not be exceeded: Element mg/kg in mg/kg dry, brittle, in liquid or dry, brittle, in liquid or powder-like sticky powder-like sticky or toy material or toy material pliable toy pliable toy material material Aluminium 5625 1406 Antimony 45 11.3 Arsenic 7.51.9 Barium 4500 1125 Boron 1200 300 Cadmium 3.8 Chromium 37.5 (III) Chromium 0.04 (VI) Cobalt 10.50.9 9.4 0.01 2.6 Copper 622.5 156 Lead 276.8 Manganese 1200 300 Mercury 15 Nickel 753.8 18.8 Selenium 37.5 9.4 Strontium 4500 1125 Tin 15000 3750 Organic tin 1.9 Zinc 3750 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).0.5 Zinc 3750 938 deleted
Amendment 364 #
Proposal for a directive
Annex V - Part A - subparagraph 1 a (new)
Annex V - Part A - subparagraph 1 a (new)
All warnings, by phrases or pictogram, shall be preceded by the word “Warning”.
Amendment 367 #
Proposal for a directive
Annex V - Part B - Point 1
Annex V - Part B - Point 1
1.Toys which might be dangerous for children under 36 months of age shall bear a warning, for example: 'Warning: Not suitable for children under 36 months' or 'Warning: Not suitable for children under three years' or the word “Warning” together with the following graphic: [Pictogram] These warnings shall be accompanied with a brief indication, which may appear in the instructions for use, of the specific hazard calling for this restriction. Such a warning may not be used for toys designed or, by virtue of their function, dimensions and characteristics, intended for use by children of under 36 months. In particular, all soft-filled toys are considered as toys intended for children under 36 months. This provision does not apply to toys which, on account of their function, dimensions, characteristics, properties or other cogent grounds, are manifestly unsuitable for children under 36 months.