Progress: Procedure completed
Role | Committee | Rapporteur | Shadows |
---|---|---|---|
Lead | IMCO | THYSSEN Marianne ( PPE-DE) | |
Committee Opinion | ENVI | FERREIRA Anne ( PSE) | |
Committee Opinion | ITRE | HAMMERSTEIN David ( Verts/ALE) |
Lead committee dossier:
Legal Basis:
EC Treaty (after Amsterdam) EC 095
Legal Basis:
EC Treaty (after Amsterdam) EC 095Subjects
Events
PURPOSE: to lay down rules on the safety of toys and on their free movement in the Community, and to repeal Directive 88/378/EEC.
PROPOSED ACT: Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys (text with EEA relevance).
CONTENT: following a first reading agreement reached with the European Parliament, the Council adopted a directive aimed at reinforcing the safety of toys in the internal market. The new directive, which replaces directive 88/378/EEC, updates and completes current Community rules to take account of technological developments of toys and new scientific knowledge, in particular as concerns safety issues that were unknown when the original Toys Safety Directive was adopted. In accordance with the existing legislation on marketing of products, economic operators placing toys on the EU market will have responsibility of ensuring that these toys comply with Community legislation in order to ensure a high level of protection of consumers and of the environment. The new legislation reinforces market surveillance and essential safety requirements for toys, in order to ensure that toys sold to consumers in the EU are safe.
This directive is the first specific directive following the principles of the new legislative framework for market surveillance and CE marking agreed last year. The provisions on chemicals are adapted to meet the requirements of the regulation on the classification, labelling and packaging of chemical substances and mixtures.
The main elements of the Directive are as follows:
Scope : the Directive shall apply to products designed or intended, whether or not exclusively, for use in play by children under 14 years of age . The products listed in Annex I shall not be considered as toys within the meaning of this Directive. Moreover, it shall not apply to: (i) playground equipment intended for public use; (ii) automatic playing machines, whether coin operated or not, intended for public use; (iii) toy vehicles equipped with combustion engines; (iv) toy steam engines; (v) slings and catapults.
Obligations of manufacturers : manufacturers shall, inter alia: (i) ensure that toys have been designed and manufactured in accordance with the requirements of this Directive; (ii) draw up the required technical documentation and carry out the applicable conformity assessment procedure; (iii) keep the technical documentation and the EC declaration of conformity for a period of 10 years after the toy has been placed on the market; (iv) ensure that their toys bear a type, batch, serial or model number or other element allowing their identification; (v) indicate their name, registered trade name and the address at which they can be contacted on the toy; (vi) ensure that the toy is accompanied by instructions and safety information in a language or languages easily understood by consumers; (vii) immediately take the corrective measures necessary to bring a non-conforming toy into conformity, to withdraw it or recall it and immediately inform the competent national authorities of the Member States in which they made the toy available.
Obligations of importers and distributors : they shall, inter alia: (i) ensure/verify that the toy bears the required conformity marking, that it is accompanied by the required documents and by instructions and safety information in a language or languages easily understood by consumers in the Member State in which the toy is to be made available on the market, and that the manufacturer has complied with the requirements set out in the Directive; (ii) ensure that, while a toy is under their responsibility, storage or transport conditions do not jeopardise its compliance; (iii) immediately take the corrective measures necessary to bring a non-conforming toy into conformity, to withdraw it or recall it.
In particular, importers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the toy and carry out sample testing of marketed toys, investigate, and, if necessary, keep a register of complaints, of non-conforming toys and toy recalls.
Essential safety requirements : Member States shall take all measures necessary to ensure that toys are not placed on the market unless they comply with the essential safety requirements as regards physical and mechanical properties, flammability, chemical properties, electrical properties, hygiene and radioactivity. Manufacturers shall, before placing a toy on the market, carry out an analysis of these requirements and an assessment of the potential exposure to the hazards that the toy may present.
In particular, stricter rules , responding to consumer concerns, will apply as regards hazards caused by certain chemical substances (in particular carcinogenic, mutagenic or toxic for reproduction (CMR) substances and fragrances used in toys, as well as noise from toys. The Directive also restricts the use of heavy metals in toys and strengthens the measures to prevent chocking and suffocation.
Warnings : the directive also complements and reinforces existing provisions on clearly legible warnings for toys in order to reduce inherent risks when they are used. The warnings shall be preceded by the words ‘Warning’ or ‘Warnings’, as the case may be. The manufacturer shall mark the warnings in a clearly visible, easily legible and understandable and accurate manner on the toy, on an affixed label or on the packaging. A Member State may, within its territory, stipulate that those warnings and the safety instructions be written in a language or languages easily understood by consumers. Toys shall not bear one or more of the specific warnings set out in Part B of Annex V where that warning conflicts with the intended use of the toy, as determined by virtue of its function, dimension and characteristics.
Toys which might be dangerous for children under 36 months of age shall bear a warning such as ‘Not suitable for children under 36 months’ or ‘Not suitable for children under three years’ or a warning in the form of a graphic.
CE marking : this directive is the first specific directive following the principles of the new legislative framework for market surveillance and CE marking agreed in 2008. Member States shall presume that toys bearing the CE marking comply with this Directive. The manufacturer shall mark the warnings in a clearly visible, easily legible and understandable and accurate manner on the toy, on an affixed label or on the packaging and, if appropriate, on the instructions for use which accompany the toy. Small toys which are sold without packaging shall have appropriate warnings affixed to them. Where, in the case of toys sold in counter displays, that is not technically possible, and on condition that the counter display was originally used as packaging for the toy, the CE marking may be affixed to the counter display. Where the CE marking is not visible from outside the packaging, if any, it shall as a minimum be affixed to the packaging.
Notification : Member States shall notify the Commission and the other Member States of bodies authorised to carry out third-party conformity assessment tasks. They shall designate a notifying authority responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies. The Directive sets out the requirements relating to notifying authorities and to notified bodies, as well as the notification procedure.
Market surveillance : Member States shall organise and perform surveillance of toys placed on the market. Where, in the course of their evaluation, the market surveillance authorities find that a toy does not comply with the requirements laid down in this Directive, they shall without delay require the relevant economic operator to take appropriate corrective action to bring the toy into compliance with those requirements, to withdraw the toy from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as they may prescribe.
Penalties : Member States shall lay down rules on penalties for economic operators, which may include criminal sanctions for serious infringements, applicable to infringements of the national provisions adopted pursuant to this Directive, and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive and may be increased if the relevant economic operator has previously committed a similar infringement of this Directive.
Reporting : by 20 July 2014 and every five years thereafter, Member States shall send the Commission a report on the application of this Directive. The report shall contain an evaluation of the situation concerning the safety of toys and of the effectiveness of this Directive, as well as a presentation of the market surveillance activities performed by that Member State.
ENTRY INTO FORCE: 20/07/2009.
TRANSPOSITION: 20/01/2011.
APPLICATION: 20/07/2011.
The European Parliament adopted by 481 votes to 73 with 40 abstentions, a legislative resolution amending the proposal for a directive of the European Parliament and of the Council on the safety of toys. The report had been tabled for consideration in plenary by Marianne THYSSEN (EPP-ED, BE), on behalf of the Committee on the Internal Market and Consumer Protection. The amendments were the result of a compromise between the Council and the Parliament. The main amendments - adopted under the 1st reading of the codecision procedure - were as follows:
Subject-matter: the compromise text simply states that this Directive lays down rules on the safety of toys, and on their free movement in the Community
Scope: Parliament confirms that the Directive applies to products designed or intended, whether or not exclusively, for use in play by children under 14 years of age. A list of products not regarded as toys is annexed to the text. It includes party decorations, collectors' items clearly intended for people aged fourteen or over (including reproductions of real firearms or faithful scale models), puzzles with more than 500 pieces, fireworks, and fashion accessories for children, which are not for use in play.
Safety: manufacturers and importers shall ensure that the toy is accompanied by instructions and safety information in a language or languages easily understood by consumers, as determined by the Member State concerned. Distributors must ensure that toys are accompanied by the required documents and by instructions and safety information in a language or languages easily understood by consumers in the Member State in which the toy is to be made available on the market.
Importers' obligations : amongst importers' obligations, the compromise text states that, when deemed appropriate with regard to the risks presented by a toy, importers shall, to protect the health and safety of consumers, carry out sample testing of marketed toys, investigate, and, if necessary, keep a register of complaints, of non-conforming toys and toy recalls, and shall keep distributors informed of such monitoring.
Economic operators : economic operators shall be able to present prescribed information for a period of 10 years after the toy has been placed on the market, in the case of the manufacturer, and 10 years after they have been supplied with the toy, in the case of other economic operators.
Warnings: Parliament clarified and strengthened the rules regarding warnings on packaging and on toys themselves. The warnings shall be preceded by the words "Warning" or "Warnings", as the case may be. With regard to the specific warnings listed in the Annex, such as those required on toys for children under 36 months, the compromise text stipulates that toys shall not bear one or more of these specific warnings, if they contradict the intended use of the toy, as determined by virtue of their function, dimension and characteristics. The manufacturer shall mark the warnings in a clearly visible and easily legible, easily understandable and accurate manner on the toy, on an affixed label or on the 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.
Warnings, which determine the decision to purchase the toy, such as those specifying the minimum and maximum ages for users and the other applicable warnings set out in Annex V, must appear on the consumer packaging or be otherwise clearly visible to the consumer before the purchase, including when the purchase is made on-line.
A Member State may, within its territory, stipulate that those warnings and safety instructions shall be written in one or more languages, easily understood by consumers, which it shall determine.
CE marking : the CE marking shall be affixed visibly, legibly and indelibly to the toy, or to an affixed label, or to the packaging. In the case of small toys and toys consisting of small parts the CE marking may alternatively be affixed on a label or an accompanying leaflet. If that is not technically possible in the case of toys sold in counter displays, and on the condition that the counter display was originally used as packaging for the toys, the CE marking shall be affixed to the counter display.
If the CE marking is not visible from outside the packaging, if any, it shall at least be affixed on the packaging.
Conformity assessment body : Parliament specified that A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of toys which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.
Chemicals: limit values for certain metals, namely arsenic, cadmium, chromium VI, lead, mercury and organic tin, which are particularly toxic, and which should therefore not be intentionally used in those parts of toys that are accessible to children, should be set at levels that are half of those considered safe according to the criteria of the Commission's scientific committee, in order to ensure that only traces that are compatible with good manufacturing practice will be present. The text states that nickel in stainless steel has proven to be safe and consequently it is appropriate to provide that it can be used in toys.
The Commission may adopt specific limit values for chemicals used in toys intended for children under 36 months or in other toys intended to be placed in the mouth taking into account the packaging requirements for food as laid down in Regulation (EC) No 1935/2004 and the related specific measures for particular materials, and the differences between toys and materials which come into contact with food. The Commission shall amend Appendix C to Annex II accordingly. Those measures will be adopted in accordance with the regulatory procedure with scrutiny.
CMR: substances that are classified as carcinogenic, mutagenic or toxic for reproduction (CMR), category 1A, 1B or 2 according to Regulation (EC) No .../... [on classification, labelling and packaging of substances and mixtures] shall not be used in toys, in components of toys or in micro-structurally distinct parts of toys. The compromise text contains derogations to this prohibition, with the proviso that certain prescribed conditions must be met. Nitrosamines and nitrosable substances are prohibited for use in toys intended for children under 36 months or in other toys intended to be placed in the mouth if the migration of the substances is equal to or higher than 0,05 mg/kg for nitrosamines and 1 mg/kg for nitrosable substances. The Commission shall systematically and regularly evaluate the occurrence of hazardous substances of materials in toys. These evaluations shall take into account reports of market surveillance bodies and concerns expressed by Member States and stakeholders.
Allergenic fragrances : the Commission proposal contained a list of prohibited allergenic fragrances and a list of fragrances subject to labelling. Parliament added to the first list of banned substances 17 more substances including musk ambrette and treemoss extracts. However, the presence of traces of these substances shall be allowed provided that such presence is technically unavoidable in good manufacturing practice and does not exceed 100 ppm.
In addition there are now 11 substances in the list of allergenic fragrances which, if added to toys, as such, at concentrations exceeding 0,01 % by weight, might be listed on the packaging and in instructions attached to the toy. However, the use of certain of these fragrances from both lists shall be allowed in olfactory board games, cosmetic kits and gustative games under certain circumstances, which include the requirement that those fragrances must be clearly labelled on the packaging and the packaging contain the warning: "contains fragrances that may cause allergies". Such olfactory board games, cosmetic kits and gustative games shall not be permitted to be used by children under 36 months and must comply with provisions on specific warnings.
Risk of choking : toys and their parts must not present risk of asphyxiation by closing off the flow of air as a result of airway obstruction external to the mouth and nose. They must be of such dimensions as not to present 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. Toy packaging 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.
Noise: the compromise text does not follow the Parliament's competent committee's recommendation on noise limit figures. The text follows the commission's proposal and states that toys which are designed to emit a sound should be so designed and manufactured in terms of the peak values for impulse noise and prolonged noise so that the sound from them is not able to impair children's hearing.
Precautionary principle : when competent authorities of the Member States take measures as provided for in this Directive, and in particular measures under the provisions on their general obligation to organise market surveillance, they shall take due account of the precautionary principle.
Transitional periods : in order to allow toy manufacturers and other economic operators sufficient time to adapt to the new requirements, Members provides for a transitional period of two years after the entry into force of the Directive during which toys which comply with Directive 88/378/EEC may be placed on the market. In the case of chemical requirements, this period is set at four years so as to allow the development of the harmonised standards which are necessary for compliance with those requirements.
Penalties: these may be increased if the relevant economic operator has previously committed a similar infringement of this Directive.
The Committee on the Internal Market and Consumer Protection adopted a report drafted by Marianne THYSSEN (EPP-ED, BE), and amended the proposal for a directive of the European Parliament and of the Council on the safety of toys. The amendments seek to tighten restrictions on the use of chemicals and perfumes, clarifying the rules on warnings and totally banning the use of heavy metals in toy manufacture.
The main amendments – adopted in the framework of the consultation procedure – are as follows:
General purpose : a new clause clarifies that the Directive is based on the principle that manufacturers are obliged to ensure that toys, and any chemicals they contain, are neither harmful to children's health nor toxic, in accordance with the provisions of the Directive.
Scope : Annex I is amended so that children's books designed or clearly intended for use by children that are made only of cardboard or paper and that do not contain any elements other than those made of cardboard or paper, are not regarded as toys.
Precautionary principle : Members inserted a clause stating that when competent authorities of the Member States take measures as provided for in this Directive they shall take due account of the precautionary principle.
Safety: manufacturers, importers and distributors must ensure that the toy is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. Members added that the lack of a history of accidents shall not automatically be considered as evidence of low risk.
Importers' obligations : when deemed appropriate with regard to the risks presented by a toy, importers shall, to protect the health and safety of consumers, carry out sample testing of marketed toys, investigate, and, if necessary, keep a register of complaints, non-conforming toys and toy recalls, and shall keep distributors informed of such monitoring.
Warnings: Members clarified and strengthened the rules regarding warnings on packaging and on toys themselves: warnings on packaging must be preceded by the word "Warning". Toys for children under 36 months must meet higher safety standards. The warnings must not be used for toys which, by virtue of their functions, dimensions or other characteristics, with the exception of weight, are intended for use by children of under 36 months. Members also inserted a definition of the term "warning" which means special wording drawing the end user's or a supervisor's attention to the conditions for use or assembly of a toy. Warnings shall be worded in an accurate, visible, clearly legible and easy to- read manner so that they may be understood by the users or their supervisors and shall be affixed to the toy or, where this is impossible for technical reasons, on a label affixed to the toy or on the consumer packaging. They shall also appear on the instructions for use which accompany the toy. Warnings shall be written in the official language or languages of the Member State where the toy is placed on the market.
Safety Notification Points : the notifying authority shall establish Safety Notification Points at which childcare professionals and consumers may report the non-conformity of toys or accidents related to the use of a toy.
Allergenic fragrances : the Commission proposal contained a list of prohibited allergenic fragrances and a list of fragrances subject to labelling. The committee added to the first list of banned substances 17 more substances including musk ambrette and treemoss extracts. However, the presence of traces of these substances shall be allowed provided that such presence is technically unavoidable in good manufacturing practice and does not exceed 10 ppm. In addition the committee added certain substances to the list of allergenic fragrances which, if added to toys, as such, at concentrations exceeding 0,01 % by weight, shall be listed on the packaging and in instructions attached to the toy. However, the use of certain of these fragrances from both lists shall be allowed in olfactory board games, cosmetic kits and gustative games under certain circumstances. Such olfactory board games, cosmetic kits and gustative games shall not be permitted to be used by children under 36 months.
Chemicals : the use of arsenic, cadmium, chromium (VI), lead, mercury and organic tin in toys will be prohibited. Traces of those substances may be allowed unless their presence is technically unavoidable in accordance with good manufacturing practice.
CMR: certain uses of substances or preparations shall be exempt from the prohibition on CMR category 1 and 2 under Directive 67/548/EEC. The Commission will mandate the relevant Scientific Committee to re-evaluate these substances or preparations as soon as safety concerns arise and at the latest every 5 years. Toys or parts of toys, irrespective of the age of the children for which they are intended, must comply with the provisions on the release of nitrosamines and nitrosatable substances from elastomer or rubber teats set out in Commission Directive 93/11/EEC.
Risk of choking : 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. Specific requirements shall be adopted for toys or toy parts that are designed to be placed in the mouth, regardless of the age group for which the toy is intended, based upon the packaging requirements for food as laid down in Regulation (EC) No 1935/2004.
Hazardous substances : the Commission shall establish a programme aimed at systematically and regularly evaluating the occurrence of hazardous substances or materials in toys. The programme shall take into account reports of market surveillance bodies and concerns expressed by Member States and stakeholders. The committee noted that the use of hazardous substances in toys is not limited to CMR substances, fragrances or substances containing certain elements. All hazardous substances should be subject to regular evaluation by the Commission. In case this evaluation reveals an unacceptable risk, the Commission should be empowered to take appropriate action in comitology.
Noise: the Commission proposal had stated that 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. The committee added that this shall apply to all toys irrespective of the age group targeted. The limit for toys with impulse noise should be 115 dB LpC peak at the ear. The limit for toys with prolonged noise should be 80 dB LpC peak at the ear. Transitional periods : in order to allow toy manufacturers and other economic operators sufficient time to adapt to the new requirements, Members provides for a transitional period of two years after the entry into force of the Directive during which toys which comply with Directive 88/378/EEC may be placed on the market. In the case of chemical requirements, this period is set at four years so as to allow the development of the harmonized standards which are necessary for compliance with those requirements.
Lastly, the committee amended the provisions of the text so that the latter conformed with the good package.
PURPOSE: to repeal the 1988 Toy Safety Directive.
PROPOSED ACT: Directive of the European Parliament and of the Council.
CONTENT: one of the first new approach Directives to be adopted, the 1988 Directive on the approximation of the laws of the Member States concerning the safety of toys (88/378/EEC) has proven, by and large, to be a success. It is, however, in need of updating.
Adopted in the context of the Internal Market the main objective of the Toy Safety Directive is twofold. Firstly, to offer consumers, especially children, safe products and secondly, to remove a plethora of national rules and regulations that stifle free trade across the Community. One of the key concepts of the New Approach Directives is to lay down, in legislation, the essential safety requirements. The technical product specifications are left to the standardisation bodies CEN and CENELEC to regulate.
Since its adoption, however, a number of deficiencies have been identified, which have triggered the need to assess the existing legal framework. The most pressing needs are to:
update and complete existing provisions; address safety issues that were unknown at the time of the TSD adoption; improve implementation and enforcement; clarify the Directive’s scope; and offer greater consistency with provisions set out in other legislative acts concerning the marketing of goods
The purpose of this proposal, therefore, is to repeal the 1988 Toy Safety Directive and to replace it with a more updated version. The overall objective is to improve the quality and efficiency of toy safety regulations and to simplify current legislation for both economic operators and market surveillance authorities.
The main elements of the proposal, in summary, are as follows:
Chemical substances used in toys: Current provisions require that toys must comply with the Community’s general chemicals legislation, including Regulation EC N° 1907/2006 (REACH). This will remain the same particularly as far as CMRs 1 or 2 are concerned. One of the main innovations of the revised Directive will be the introduction of specific rules on CMR (carcinogenic, mutagenic, or toxic for reproduction) in toys. Further, in order to take account of new scientific knowledge, the Directive provides for an update of certain chemical substances to be used in toys and to raise the limit values for these substances.
Warnings: The proposed revision will require warnings to specify, where appropriate, user limitations (such as minimum and maximum ages) the maximum or minimum weight of users, and whether or not a toy is to be used under adult supervision.
Choking and suffocation: The revised Directive will extend provisions on “toys placed in the mouth” (such as toy instruments) to children above 36 months. Similarly, the revised Directive, will extend provisions concerning the external and internal obstruction of the mouth and/or nose (suffocation risk) to cover all toys – and not just toys intended for children under 36 months, as is currently the case.
Toys in food: Currently no specific provisions exist for toys in food. The revised Directive proposes a set of new requirements: i) toys should be marketed in a package separating them from the food items they are attached to, ii) the packaging itself should not present any choking hazard (namely that it passes the safety ‘small parts cylinder test’) and iii) to ban toys that are firmly coupled with foodstuffs in such a way that prior consumption of the food item is necessary to access to the toy itself.
Definition of the general safety requirement: Clarifying the general safety requirement is essential because it is the only legal basis for taking dangerous toys out of the market in cases were a new risk is discovered, that is, a risk which was previously unknown and which is therefore, not covered by specific standards. The Commission proposes to amend the general safety requirement to refer to the "behaviour" of children to take account of their, often unpredictable, behaviour.
Reinforcement of the Member States market surveillance measures : The proposal reinforces market surveillance obligations under the General Product Safety Directive by granting certain specific powers to the market surveillance authorities such as: the right of access to the premises of economic operators; the right to request information from Notified bodies; the right to give instructions to the Notified bodies; and the right to obtain mutual assistance from other Member States.
Information on chemicals in the technical file : The proposal contains an update of the documentation which toy manufacturers and importers have to keep available for inspection purposes.
Information on chemicals in the technical file: A completely new provision requires that the CE mark must always be affixed on the packaging even if the marking on the toy is not visible from outside the packaging.
Safety assessmen t: A new obligation will require an analysis of the hazards that the toy may present, and to make it available - as part of the toy’s technical file - to the market surveillance authorities for inspection.
Clarifying scope and definitions: The scope of the Directive has been clarified, by completing the list of products which are not within its scope. This concerns, in particular, certain new products, such as videogames and peripherals. Certain new definitions are also foreseen specific to the toys sector including: functional toys, activity toys, trampolines, hazard, risk, harm, suffocation and design speed.
PURPOSE: to repeal the 1988 Toy Safety Directive.
PROPOSED ACT: Directive of the European Parliament and of the Council.
CONTENT: one of the first new approach Directives to be adopted, the 1988 Directive on the approximation of the laws of the Member States concerning the safety of toys (88/378/EEC) has proven, by and large, to be a success. It is, however, in need of updating.
Adopted in the context of the Internal Market the main objective of the Toy Safety Directive is twofold. Firstly, to offer consumers, especially children, safe products and secondly, to remove a plethora of national rules and regulations that stifle free trade across the Community. One of the key concepts of the New Approach Directives is to lay down, in legislation, the essential safety requirements. The technical product specifications are left to the standardisation bodies CEN and CENELEC to regulate.
Since its adoption, however, a number of deficiencies have been identified, which have triggered the need to assess the existing legal framework. The most pressing needs are to:
update and complete existing provisions; address safety issues that were unknown at the time of the TSD adoption; improve implementation and enforcement; clarify the Directive’s scope; and offer greater consistency with provisions set out in other legislative acts concerning the marketing of goods
The purpose of this proposal, therefore, is to repeal the 1988 Toy Safety Directive and to replace it with a more updated version. The overall objective is to improve the quality and efficiency of toy safety regulations and to simplify current legislation for both economic operators and market surveillance authorities.
The main elements of the proposal, in summary, are as follows:
Chemical substances used in toys: Current provisions require that toys must comply with the Community’s general chemicals legislation, including Regulation EC N° 1907/2006 (REACH). This will remain the same particularly as far as CMRs 1 or 2 are concerned. One of the main innovations of the revised Directive will be the introduction of specific rules on CMR (carcinogenic, mutagenic, or toxic for reproduction) in toys. Further, in order to take account of new scientific knowledge, the Directive provides for an update of certain chemical substances to be used in toys and to raise the limit values for these substances.
Warnings: The proposed revision will require warnings to specify, where appropriate, user limitations (such as minimum and maximum ages) the maximum or minimum weight of users, and whether or not a toy is to be used under adult supervision.
Choking and suffocation: The revised Directive will extend provisions on “toys placed in the mouth” (such as toy instruments) to children above 36 months. Similarly, the revised Directive, will extend provisions concerning the external and internal obstruction of the mouth and/or nose (suffocation risk) to cover all toys – and not just toys intended for children under 36 months, as is currently the case.
Toys in food: Currently no specific provisions exist for toys in food. The revised Directive proposes a set of new requirements: i) toys should be marketed in a package separating them from the food items they are attached to, ii) the packaging itself should not present any choking hazard (namely that it passes the safety ‘small parts cylinder test’) and iii) to ban toys that are firmly coupled with foodstuffs in such a way that prior consumption of the food item is necessary to access to the toy itself.
Definition of the general safety requirement: Clarifying the general safety requirement is essential because it is the only legal basis for taking dangerous toys out of the market in cases were a new risk is discovered, that is, a risk which was previously unknown and which is therefore, not covered by specific standards. The Commission proposes to amend the general safety requirement to refer to the "behaviour" of children to take account of their, often unpredictable, behaviour.
Reinforcement of the Member States market surveillance measures : The proposal reinforces market surveillance obligations under the General Product Safety Directive by granting certain specific powers to the market surveillance authorities such as: the right of access to the premises of economic operators; the right to request information from Notified bodies; the right to give instructions to the Notified bodies; and the right to obtain mutual assistance from other Member States.
Information on chemicals in the technical file : The proposal contains an update of the documentation which toy manufacturers and importers have to keep available for inspection purposes.
Information on chemicals in the technical file: A completely new provision requires that the CE mark must always be affixed on the packaging even if the marking on the toy is not visible from outside the packaging.
Safety assessmen t: A new obligation will require an analysis of the hazards that the toy may present, and to make it available - as part of the toy’s technical file - to the market surveillance authorities for inspection.
Clarifying scope and definitions: The scope of the Directive has been clarified, by completing the list of products which are not within its scope. This concerns, in particular, certain new products, such as videogames and peripherals. Certain new definitions are also foreseen specific to the toys sector including: functional toys, activity toys, trampolines, hazard, risk, harm, suffocation and design speed.
Documents
- For information: COM(2016)0560
- For information: EUR-Lex
- For information: EUR-Lex
- For information: SWD(2016)0289
- For information: EUR-Lex
- For information: SWD(2016)0290
- Final act published in Official Journal: Directive 2009/48
- Final act published in Official Journal: OJ L 170 30.06.2009, p. 0001
- Final act published in Official Journal: Corrigendum to final act 32009L0048R(01)
- Final act published in Official Journal: OJ L 355 31.12.2013, p. 0092
- Draft final act: 03744/2008/LEX
- Commission response to text adopted in plenary: SP(2009)402
- Results of vote in Parliament: Results of vote in Parliament
- Decision by Parliament, 1st reading: T6-0626/2008
- Debate in Parliament: Debate in Parliament
- Debate in Council: 2910
- Committee report tabled for plenary, 1st reading/single reading: A6-0441/2008
- Committee report tabled for plenary, 1st reading: A6-0441/2008
- Committee opinion: PE409.407
- Committee opinion: PE409.475
- Debate in Council: 2891
- Amendments tabled in committee: PE412.121
- Committee draft report: PE407.804
- Debate in Council: 2871
- Legislative proposal: COM(2008)0009
- Legislative proposal: EUR-Lex
- Document attached to the procedure: SEC(2008)0038
- Document attached to the procedure: EUR-Lex
- Document attached to the procedure: SEC(2008)0039
- Document attached to the procedure: EUR-Lex
- Legislative proposal published: COM(2008)0009
- Legislative proposal published: EUR-Lex
- Legislative proposal: COM(2008)0009 EUR-Lex
- Document attached to the procedure: SEC(2008)0038 EUR-Lex
- Document attached to the procedure: SEC(2008)0039 EUR-Lex
- Committee draft report: PE407.804
- Amendments tabled in committee: PE412.121
- Committee opinion: PE409.475
- Committee opinion: PE409.407
- Committee report tabled for plenary, 1st reading/single reading: A6-0441/2008
- Commission response to text adopted in plenary: SP(2009)402
- Draft final act: 03744/2008/LEX
- For information: COM(2016)0560 EUR-Lex
- For information: EUR-Lex SWD(2016)0289
- For information: EUR-Lex SWD(2016)0290
Activities
- Hans-Gert PÖTTERING
Plenary Speeches (9)
- 2016/11/22 Safety of Toys (A6-0441/2008, Marianne Thyssen) (vote)
- 2016/11/22 Safety of Toys (A6-0441/2008, Marianne Thyssen) (vote)
- 2016/11/22 Safety of Toys (A6-0441/2008, Marianne Thyssen) (vote)
- 2016/11/22 Safety of Toys (A6-0441/2008, Marianne Thyssen) (vote)
- 2016/11/22 Safety of Toys (A6-0441/2008, Marianne Thyssen) (vote)
- 2016/11/22 Safety of Toys (A6-0441/2008, Marianne Thyssen) (vote)
- 2016/11/22 Safety of Toys (A6-0441/2008, Marianne Thyssen) (vote)
- 2016/11/22 Safety of Toys (A6-0441/2008, Marianne Thyssen) (vote)
- 2016/11/22 Safety of Toys (A6-0441/2008, Marianne Thyssen) (vote)
- Hannes SWOBODA
Plenary Speeches (2)
- Marianne THYSSEN
Plenary Speeches (2)
- 2016/11/22 Toys Directive (debate)
- 2016/11/22 Toys Directive (debate)
- Jacques TOUBON
Plenary Speeches (2)
- 2016/11/22 Safety of Toys (A6-0441/2008, Marianne Thyssen) (vote)
- 2016/11/22 Toys Directive (debate)
- Emmanouil ANGELAKAS
Plenary Speeches (1)
- 2016/11/22 Toys Directive (debate)
- Šarūnas BIRUTIS
Plenary Speeches (1)
- 2016/11/22 Toys Directive (debate)
- Hiltrud BREYER
Plenary Speeches (1)
- 2016/11/22 Toys Directive (debate)
- Colm BURKE
Plenary Speeches (1)
- 2016/11/22 Toys Directive (debate)
- Luigi COCILOVO
Plenary Speeches (1)
- 2016/11/22 Toys Directive (debate)
- Anne FERREIRA
Plenary Speeches (1)
- 2016/11/22 Toys Directive (debate)
- Hélène GOUDIN
Plenary Speeches (1)
- 2016/11/22 Toys Directive (debate)
- David HAMMERSTEIN
Plenary Speeches (1)
- 2016/11/22 Toys Directive (debate)
- Małgorzata HANDZLIK
Plenary Speeches (1)
- 2016/11/22 Toys Directive (debate)
- Anna HEDH
Plenary Speeches (1)
- 2016/11/22 Toys Directive (debate)
- Arlene McCARTHY
Plenary Speeches (1)
- 2016/11/22 Toys Directive (debate)
- Seán Ó NEACHTAIN
Plenary Speeches (1)
- 2016/11/22 Toys Directive (debate)
- Gérard ONESTA
Plenary Speeches (1)
- 2016/11/22 Toys Directive (debate)
- Zita PLEŠTINSKÁ
Plenary Speeches (1)
- 2016/11/22 Toys Directive (debate)
- Bernd POSSELT
Plenary Speeches (1)
- Herbert REUL
Plenary Speeches (1)
- Karin RIIS-JØRGENSEN
Plenary Speeches (1)
- 2016/11/22 Toys Directive (debate)
- Zuzana ROITHOVÁ
Plenary Speeches (1)
- 2016/11/22 Toys Directive (debate)
- Heide RÜHLE
Plenary Speeches (1)
- 2016/11/22 Toys Directive (debate)
- Katrin SAKS
Plenary Speeches (1)
- 2016/11/22 Toys Directive (debate)
- Richard SEEBER
Plenary Speeches (1)
- 2016/11/22 Toys Directive (debate)
- Eva-Britt SVENSSON
Plenary Speeches (1)
- 2016/11/22 Toys Directive (debate)
- MARIAN ZLOTEA
Plenary Speeches (1)
- 2016/11/22 Toys Directive (debate)
Votes
Rapport Thyssen A6-0441/2008 - am. 142 #
Rapport Thyssen A6-0441/2008 - résolution #
Amendments | Dossier |
378 |
2008/0018(COD)
2008/07/25
ENVI
50 amendments...
Amendment 105 #
Proposal for a directive 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
Amendment 106 #
Proposal for a directive Recital 32 (32) In particular
Amendment 107 #
Proposal for a directive Recital 32 (32) In particular
Amendment 108 #
Proposal for a directive Article 2 – point 15 a (new) (15a) 'Specifically designed or intended for children of the age group x': a term that means that children must possess the dexterity and mental abilities corresponding to this particular age group.
Amendment 109 #
Proposal for a directive Article 10 – paragraph 1 – subparagraph 2 Amendment 110 #
Proposal for a directive Article 10 – paragraph 2 – subparagraph 1 2. The
Amendment 111 #
Proposal for a directive Article 10 – paragraph 2 – subparagraph 1 Amendment 112 #
Proposal for a directive Article 10 – paragraph 2 – subparagraph 1 2. The manufacturer shall mark the warnings in an accurate, clearly visible,
Amendment 113 #
Proposal for a directive Article 10 – paragraph 2 – subparagraph 2 Warnings specifying the minimum and maximum ages for users shall be visible,
Amendment 114 #
Proposal for a directive Article 10 – paragraph 2 – subparagraph 2 Warnings specifying the minimum and maximum ages for users shall be visible,
Amendment 115 #
Proposal for a directive Article 10 – paragraph 2 – subparagraph 2 Warnings specifying the minimum and maximum ages for users shall be visible, legible and conspicuously displayed on the packaging of toys and at the point of sale.
Amendment 116 #
Proposal for a directive Article 10 – paragraph 2 – subparagraph 2 a (new) Amendment 117 #
Proposal for a directive Article 10 – paragraph 2 – subparagraph 2 a (new) Warnings must alternate so that they appear regularly. Warnings shall be printed on the most visible surface of the unit packet and on all external packaging, with the exception of transparent packaging, used for the retail sale of the toy in question.
Amendment 118 #
Proposal for a directive Article 10 – paragraph 2 – subparagraph 2 a (new) The Commission shall prepare guidelines concerning the way the warnings should be presented. These guidelines shall be drawn up together with the various stakeholders and Member State authorities taking into account developments in scientific and technical knowledge.
Amendment 119 #
Proposal for a directive Article 10 – paragraph 2 – subparagraph 2 b (new) Member States may determine the location of the warnings to appear on the surfaces in question in the light of linguistic requirements.
Amendment 120 #
Proposal for a directive Article 10 – paragraph 2 –subparagraph 2 b (new) Member States may determine the location of the warnings to appear on the surfaces in question in the light of linguistic requirements.
Amendment 121 #
Proposal for a directive Article 10 – paragraph 3 3.
Amendment 122 #
Proposal for a directive Article 22 – paragraph 3 a (new) 3a. Notifying authorities shall establish Safety Notification Points at which childcare professionals and consumers may report the non-conformity of toys or accidents related to the use of a toy.
Amendment 123 #
Proposal for a directive Article 41 – paragraph 1 – subparagraph 2 Where, in the course of that evaluation, the market surveillance authorities find that the toy does not comply with the requirements laid down by this Directive, they shall require the relevant economic operator, while at the same time notifying consumers, to take all appropriate corrective actions to bring the toy into compliance with those requirements or to withdraw the toy from
Amendment 124 #
Proposal for a directive Article 41 – paragraph 2 2. Where the market surveillance authorities consider that the non- compliance is not limited to the national territory, they shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operator to take. They shall officially notify Member States and the Commission of the answer and the intention to comply or not to comply issued by the economic operator.
Amendment 126 #
Proposal for a directive Article 45 – paragraph 1 – point a (a) Point
Amendment 127 #
Proposal for a directive Article 45 – paragraph 1 – subparagraph 2 Those measures, designed to amend non- essential elements of this
Amendment 128 #
Proposal for a directive Article 45 – paragraph 1 a (new) 1a. Without prejudice to the restrictions laid down in Part III of Annex II, the Commission may, where appropriate and in accordance with the regulatory procedure with scrutiny referred to in Article 46 (2), amend Annex II with a view to: – defining limit values or other restrictions for substances or preparations posing a risk to health other than those listed in points 7 and 8 in Part III of Annex II; – adopting or adapting limit values for noise.
Amendment 129 #
Proposal for a directive Article 45 – paragraph 1 a (new) 1a. The Commission shall, where necessary to ensure the health and safety of children, specify, in detail, the essential safety requirements set out in Annex II (e.g. by establishing limit values or other restrictions for certain chemicals other than those listed in points 7 and 8 of Part III of Annex II, limit values for noise, limit values for speed, etc.) and shall establish a list of toys requiring EC type- examination for the purposes of Part II of Annex I. Those specifications shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 46 (2).
Amendment 130 #
Proposal for a directive Article 45 – paragraph 2 Amendment 131 #
Proposal for a directive Article 52 Member States shall not impede the placing on the market of toys which are in accordance with Directive 88/378/EEC and which were placed on the market before this Directive entered into force or at the latest
Amendment 132 #
Proposal for a directive Article 54 a (new) Article 54a Review The Commission shall review this Directive, based on the evaluations of the relevant Scientific Committee and the opinion of the expert group, every eight years.
Amendment 133 #
Proposal for a directive Annex II – Part I – point 4 – subparagraph 2 2. The packaging in which toys are contained for retail sale must not present risk of strangulation or asphyxiation caused by a
Amendment 134 #
Proposal for a directive Annex II – Part I – point 10 10. Toys which are designed to emit a sound should be so designed and constructed
Amendment 135 #
Proposal for a directive Annex II – Part III – point 3 3. Without prejudice to the application of the restrictions under the first sentence of point 2, the use in toys of substances that are classified as carcinogenic, mutagenic or toxic for reproduction (CMR) according to Directive 67/548/EEC
Amendment 136 #
Proposal for a directive Annex II – Part III – point 3 3. Without prejudice to the application of the restrictions under the first sentence of point 2, the use in toys of substances that are classified as carcinogenic, mutagenic or toxic for reproduction (CMR) category 1 and 2 according to Directive 67/548/EEC in individual concentrations equal to or greater than the relevant concentrations established for the classification of preparations containing
Amendment 137 #
Proposal for a directive Annex II – Part III – point 3 3. Without prejudice to the application of the restrictions under the first sentence of point 2, the use in toys of substances that are classified as carcinogenic, mutagenic or toxic for reproduction (CMR) according to Directive 67/548/EEC in
Amendment 138 #
Proposal for a directive Annex II – Part III – point 4 Amendment 139 #
Proposal for a directive Annex II – Part III – point 4 – introductory part 4. Substances or preparations classified as CMR category
Amendment 140 #
Proposal for a directive Annex II – Part III – point 5 Amendment 141 #
Proposal for a directive Annex II – Part III – point 5 Amendment 142 #
Proposal for a directive Annex II – Part III – point 5 a (new) 5a. The Commission shall establish a programme aimed at systematically and regularly evaluating the occurrence of hazardous substances or materials in toys. The programme shall take into account reports of market surveillance bodies and concerns expressed by Member States and stakeholders. The Commission shall decide, following the opinion of the relevant Scientific Committee, to take appropriate restrictive measures, if necessary. Those measures, designed to amendment 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 143 #
Proposal for a directive Annex II – Part III – point 5 a (new) 5a. Toys or parts of toys which are intended to be placed in the mouth must comply with the provisions for migration limit values for food packaging, irrespective of the age of the children for which they are intended, as set out 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.
Amendment 144 #
Proposal for a directive Annex II – Part III – point 7 7. Toys shall not contain
Amendment 145 #
Proposal for a directive Annex II – Part III – point 7 7. Toys shall not contain
Amendment 146 #
Proposal for a directive 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-
Amendment 147 #
Proposal for a directive Annex II – Part III – point 7 – subparagraph 1 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
Amendment 148 #
Proposal for a directive Annex II – Part III – point 7 – subparagraph 2 Amendment 149 #
Proposal for a directive Annex II – Part III – point 7 – subparagraph 3 Amendment 150 #
Proposal for a directive Annex II – Part III – point 7 – subparagraph 3 Amendment 151 #
Proposal for a directive Annex II – Part III – point 8 – table Element
Amendment 152 #
Proposal for a directive Annex II – Part III – point 8 – table and paragraph 2 Amendment 153 #
Proposal for a directive Annex II – Part III – point 8 – paragraph 2 a (new) Substances or preparations based on any of the following elements shall be prohibited for use in toys or components of toys: (1) Arsenic (2) Cadmium (3) Chromium (V) (4) Lead (5) Mercury (6) Organic tin
Amendment 154 #
Proposal for a directive Annex IV – point (a) (a) a detailed description of the design and manufacture, including a list of components
source: PE-409.734
2008/09/11
IMCO
272 amendments...
Amendment 102 #
Proposal for a directive Recital 2 (2) Directive 88/378/EEC is based on the New Approach principles, as set out in the Council Resolution of 7 May 1985 on a new approach to technical harmonisation and standards. Thus, it sets out
Amendment 103 #
Proposal for a directive Recital 3 a (new) (3a) Another important objective of the new system to be established by this Directive is to encourage and in certain cases to ensure that dangerous substances and materials used in toys are replaced by less dangerous substances or technologies where suitable economically and technically viable alternatives are available.
Amendment 104 #
Proposal for a directive Recital 3 a (new) Amendment 105 #
Proposal for a directive Recital 3 a (new) (3a) The precautionary principle was added to the Treaty in 1992 and the Court of Justice of the European Communities has, on numerous occasions1, clarified the substance and scope of this principle of Community law as one of the foundations of Community protection policy in the environment and health spheres. _________ 1 Judgment of 23 September 2003 in Case C- 192/01, Commission v Denmark, ECR 2003, p. I- 9693; judgment of 7 September 2004 in Case C- 127/02, Landelijke Vereniging tot Behoud vande Waddenzee, Nederlandse Vereniging tot Bescherming van Vogels v Staatssecretaris vanLandbouw, Natuurbeheer en Visserij, ECR 2004, p. I-7405.
Amendment 106 #
Proposal for a directive 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 107 #
Proposal for a directive Recital 8 (8)
Amendment 108 #
Proposal for a directive Recital 13 a (new) (13a) In order to enhance respect for the principles of fair competition in the internal market and to avoid any threat to the safety of children, improvements should be made to the border control mechanisms for toys entering the European market.
Amendment 109 #
Proposal for a directive Recital 16 (16) In order to ensure a high level of protection of children a
Amendment 110 #
Proposal for a directive Recital 16 a (new) Amendment 111 #
Proposal for a directive Recital 16 a (new) Amendment 112 #
Proposal for a directive Recital 16 a (new) Amendment 113 #
Proposal for a directive Recital 16 a (new) (16a) In order to avoid duplication of evaluation under this Directive and Regulation (EC) No 1907/2006 (REACH), CMRs which have been evaluated for use in toys and which have not been prohibited under this Directive should not be proposed for restriction and should not be subject to authorisation under Regulation (EC) No 1907/2006 (REACH) on account of risks to human health in accordance with Article 58(2) thereof.
Amendment 114 #
Proposal for a directive Recital 16 a (new) (16a) The duplication of evaluation by different EU bodies (such as the Scientific Committee on Consumer Products under the future Directive concerning the security of toys and the European Chemicals Agency under REACH) for the use of the same CMR in toys with potentially different outcomes must be avoided.
Amendment 115 #
Proposal for a directive Recital 16 b (new) (16b) It is necessary to apply a harmonised transition period of two years after the entry into force of this directive to provide an opportunity to comply with its provisions. A specific transition period of five years after the publication of the revised safety standards for chemical properties is also needed to enable toy manufacturers and economic operators enough time to adjust to the new technical requirements relating to chemical properties and to ensure uniform application of this directive throughout the European Union.
Amendment 116 #
Proposal for a directive Recital 16 b (new) (16b) It is necessary to apply a harmonized transition period of two years after the entry into force of this Directive for compliance with its provisions and, after that period, an additional transition period of three years to provide toy manufacturers and economic operators with sufficient time to adapt to the new technical requirements on chemicals, and to ensure consistent application of this Directive throughout the EU.
Amendment 117 #
Proposal for a directive Recital 16 b (new) (16b) It is necessary to apply a harmonized transition period of two years after the entry into force of this Directive for compliance with its provisions and a further transition period of three years after the entry into force of this Directive in all Member States to provide toy manufacturers and economic operators with sufficient time to adapt to the new technical requirements on chemicals, and to ensure consistent application of this Directive throughout the EU.
Amendment 118 #
Proposal for a directive Recital 16 b (new) (16b) It is necessary to apply a harmonized transition period of two years after the entry into force of this Directive for compliance with its provisions and a further transition period of three years to provide toy manufacturers and economic operators with the time needed to comply with the new technical requirements on chemicals, and to ensure consistent application of this Directive throughout the EU.
Amendment 119 #
Proposal for a directive Recital 16 b (new) (16b) It is necessary to apply a general harmonized transition period of two years after the entry into force of this Directive for compliance with its provisions, and a specific transition period of three years after publication of the revised harmonized toy safety standard in relation to chemical properties, to provide toy manufacturers and economic operators with sufficient time to adapt to the new technical requirements on chemicals, and to ensure consistent application of this Directive throughout the EU.
Amendment 120 #
Proposal for a directive Recital 16 b (new) (16b) It is necessary to apply a harmonized transition period of two years after the entry into force of this Directive for compliance with its provisions and a further transition period of one year after the revised Toy Standard EN 71-3 on the new chemical requirements of this Directive has entered into force to provide toy manufacturers and economic operators with sufficient time to adapt to the new technical requirements and to ensure consistent application of this Directive throughout the EU.
Amendment 121 #
Proposal for a directive 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
Amendment 122 #
Proposal for a directive 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
Amendment 123 #
Proposal for a directive 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
Amendment 124 #
Proposal for a directive 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
Amendment 125 #
Proposal for a directive Recital 17 (17) The general and specific chemical requirements in this Directive should aim at protecting the health of children from all dangerous substances in toys, while environmental concerns presented by toys are addressed in horizontal environmental legislation applying also to toys, in
Amendment 126 #
Proposal for a directive Recital 17 a (new) (17a) Toys or their parts and packaging that can reasonably be expected to be brought into contact with food should comply with the requirements of Regulation (EC) No 1935/2004 on materials intended to come into contact with food.
Amendment 127 #
Proposal for a directive Recital 18 (18) It is appropriate to lay down specific safety requirements to cover the potential specific hazard presented by toys inside food
Amendment 128 #
Proposal for a directive 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
Amendment 129 #
Proposal for a directive 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 not be determined only by reference to the intended use of the product while taking into account
Amendment 130 #
Proposal for a directive Recital 19 (19) Since toys may exist or be developed
Amendment 131 #
Proposal for a directive Recital 19 (
Amendment 132 #
Proposal for a directive Recital 22 (22) It is crucial to make clear to
Amendment 133 #
Proposal for a directive Recital 27 a (new) (27a) The precautionary principle should be applied where a scientific assessment cannot ascertain the risk with sufficient certainty to ensure a high level of protection of health, particularly that of children.
Amendment 134 #
Proposal for a directive Recital 32 (32) In particular power should be conferred on the Commission
Amendment 135 #
Proposal for a directive Recital 32 (32) In particular power should be conferred on the Commission
Amendment 136 #
Proposal for a directive Recital 32 (32) In particular power should be conferred on the Commission
Amendment 137 #
Proposal for a directive Recital 34 a (new) (34a) A harmonised transition period of up to 5 years after the entry into force of this Directive is necessary in order to give toy manufacturers and other market operators time to adjust to the new technical and especially chemical requirements and in order to guarantee consistent implementation of this Directive throughout the European Union.
Amendment 138 #
Proposal for a directive 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
Amendment 139 #
Proposal for a directive 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 140 #
Proposal for a directive 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 141 #
Proposal for a directive 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 intended, whether or not exclusively, for use in play by children under 14 years of age, hereinafter "toys", in accordance with the precautionary principle.
Amendment 142 #
Proposal for a directive 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) (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 144 #
Proposal for a directive Article 2 – point 13 (13) “harm” means
Amendment 145 #
Proposal for a directive Article 2 – point 13 (13) “harm” means the physical injury or damage to health
Amendment 146 #
Proposal for a directive Article 2 – point 15 a (new) (15a) "intended for use by" means that a parent or supervisor could reasonably assume a toy was intended for use by children of the stated age group. The placing of a warning on a product stating that it is not suitable for a particular age group is not deemed to make the product compliant with the safety requirements of this Directive.
Amendment 147 #
Proposal for a directive 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) (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 149 #
Proposal for a directive Article 3 – paragraph 2 2. Manufacturers shall draw up technical documentation in accordance with Article 20 and carry out or have carried out the conformity assessment procedure applicable in accordance with Article 18. Where the compliance of the toy with the applicable requirements has been demonstrated by such procedure, manufacturers shall draw up an EC declaration of conformity, as referred to in Article 14 and affix the conformity
Amendment 150 #
Proposal for a directive Article 3 – paragraph 3 3. Manufacturers shall keep the technical documentation and the EC declaration of conformity for a period of
Amendment 151 #
Proposal for a directive 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
Amendment 152 #
Proposal for a directive Article 3 – paragraph 4 4. Manufacturers shall ensure that procedures are in place to ensure the continued conformity of series production. Changes in the product design or characteristics and changes in the harmonised standards by reference to which conformity of a toy is stated shall be adequately taken into account. Manufacturers shall, in all cases where appropriate, carry out sample testing of marketed toys, investigating, and, if necessary, keeping a register of complaints, and keeping distributors informed of such monitoring.
Amendment 153 #
Proposal for a directive Article 3 – paragraph 6 6. Manufacturers shall indicate their name and the address at which they can be contacted and, in so far as relevant, the name and address of the independent assessment agency, 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.
Amendment 154 #
Proposal for a directive Article 3 – paragraph 7 7.
Amendment 155 #
Proposal for a directive Article 3 – paragraph 7 7. Manufacturers who consider or have reason to believe that a toy which they have placed on the market is not in conformity with the applicable Community legislation shall 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 details, in particular, of the non- compliance and of the corrective measures taken.
Amendment 156 #
Proposal for a directive Article 3 – paragraph 7 7. Manufacturers who consider or have reason to believe that a toy which they have placed on the market is not in conformity with the applicable Community legislation shall 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,
Amendment 157 #
Proposal for a directive 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) 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) 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 160 #
Proposal for a directive Article 4 – paragraph 3 – point a (a) keep the EC declaration of conformity and the technical documentation at the disposal of national surveillance authorities for a period of
Amendment 161 #
Proposal for a directive 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 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 3. Importers shall indicate
Amendment 164 #
Proposal for a directive Article 5 – paragraph 5 5. I
Amendment 165 #
Proposal for a directive Article 5 – paragraph 6 6. Importers shall, for a period of
Amendment 166 #
Proposal for a directive 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 1. When
Amendment 168 #
Proposal for a directive Article 6 – paragraph 4 4.
Amendment 169 #
Proposal for a directive 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) Amendment 171 #
Proposal for a directive Article 8 – subparagraph 1 – point (b a) (new) (ba) which may have certified the CE+ marking as an independent assessment agency.
Amendment 172 #
Proposal for a directive Article 8 – subparagraph 2 They shall have in place appropriate systems and procedures which allow for this information to be made available to the market surveillance authorities on request, for a period of
Amendment 173 #
Proposal for a directive 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 174 #
Proposal for a directive 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
Amendment 175 #
Proposal for a directive 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 176 #
Proposal for a directive 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. Member States shall duly take account of the precautionary principle.
Amendment 177 #
Proposal for a directive Article 9 – paragraph 1 – subparagraph 1 a (new) In taking such measures, Member States shall take into account the precautionary principle as set out in Article 8 of Directive 2001/95/EC
Amendment 178 #
Proposal for a directive Article 9 – paragraph 2 2. Toys shall not jeopardize the safety or health of users or third parties when they are used as intended or in a foreseeable way, bearing in mind behaviour of children. The ability of the users and where appropriate their supervisors shall be taken into account, in particular, in the case of toys which, by virtue of their functions, dimensions and characteristics, are intended for use by children of under
Amendment 179 #
Proposal for a directive Article 9 – paragraph 2 – subparagraph 1 2. Toys shall not jeopardize the safety or health of users or third parties when they are used as intended
Amendment 180 #
Proposal for a directive Article 9 – paragraph 2 – subparagraph 2 The ability of the users and where appropriate their supervisors shall be taken into account, in particular, in the case of toys which, by virtue of their functions, dimensions and characteristics, are intended for use by children of under 36 months. For specific categories of toys other age limits may be determined in accordance with the safety requirements of the harmonized standards referred to in Article 12.
Amendment 181 #
Proposal for a directive Article 9 – paragraph 2 – subparagraph 3 Labels on toys and/or on their packaging and the instructions for use which accompany them
Amendment 182 #
Proposal for a directive Article 10 – paragraph 2 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
Amendment 183 #
Proposal for a directive Article 10 – paragraph 2 – subparagraph 1 2. The manufacturer shall mark the warnings in
Amendment 184 #
Proposal for a directive Article 10 – paragraph 2– subparagraph 1 2
Amendment 185 #
Proposal for a directive 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 Warnings
Amendment 187 #
Proposal for a directive Article 10 – paragraph 2 – subparagraph 2 When appear
Amendment 188 #
Proposal for a directive Article 10 – paragraph 2 – subparagraph 2 Warnings, specifying the minimum and maximum ages for users shall be visible, legible and conspicuously displayed at the point of sale.
Amendment 189 #
Proposal for a directive Article 10 – paragraph 2 The manufacturer shall mark the warnings in an accurate, clearly visible,
Amendment 190 #
Proposal for a directive Article 10 – paragraph 2 - subparagraph 2 Warnings specifying the minimum and maximum ages for users shall be visible, legible and conspicuously displayed
Amendment 191 #
Proposal for a directive Article 10 – paragraph 2 − subparagraph 2 Warnings specifying the minimum and maximum ages for users shall be visible, legible and conspicuously displayed on the toys' packaging and at the point of sale.
Amendment 192 #
Proposal for a directive 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 193 #
Proposal for a directive Article 10 – paragraph 2 – subparagraph 2 a (new) Warnings of hazards that occur every time the toy is used shall be permanently marked on the toy.
Amendment 194 #
Proposal for a directive Article 10 – paragraph 2 - subparagraph 2 a (new) Warnings which are useful for selecting a safe toy for the intended use or user shall be conspicuously displayed on the toy and/or its packaging so that consumers can read the information before purchasing.
Amendment 195 #
Proposal for a directive Article 10 – paragraph 2 - subparagraph 2 b (new) Warnings which consumers must bear in mind every time the toy is used or for a considerable time after the toy is purchased in order to avoid unsafe or incorrect use thereof shall be permanently affixed to both the toy and its packaging.
Amendment 196 #
Proposal for a directive Article 10 – paragraph 2 - subparagraph 2 a (new) Warnings that should be remembered every time the toy is used, or a long time after the toy has been purchased, in order to avoid unsafe use or misuse, shall be permanently marked on both the toy and its packaging. This applies to the warnings in points 2, 5 and 6 of Annex V, Part B.
Amendment 197 #
Proposal for a directive Article 10 – paragraph 2 - subparagraph 2 b (new) The Commission shall prepare guidelines concerning the way the warnings should be presented. These guidelines shall be drawn up together with the various stakeholders and Member States' authorities taking into account developments in scientific and technical knowledge.
Amendment 198 #
Proposal for a directive Article 13 – paragraph 2 2. I
Amendment 199 #
Proposal for a directive 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 200 #
Proposal for a directive 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 this Article are published or maintained with restrictions, 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 shall make clear whether a toy complying with the harmonised standard as completed by Decision shall be presumed to be in conformity with the requirements covered by the standard and the Decision.
Amendment 201 #
Proposal for a directive Article 14 – paragraph 2 2. The EC declaration of conformity shall as a minimum contain the elements specified in Annex III and shall continuously be updated. The EC declaration of conformity shall have the model structure set out in Annex III. It shall be translated into the language or languages required by the Member State in whose market the toy is placed or made available.
Amendment 202 #
Proposal for a directive Article 14 – paragraph 2 a (new) 2a. The EC declaration of conformity shall, where appropriate, incorporate the declaration by the independent assessment agency performing the assessment.
Amendment 203 #
Proposal for a directive 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 204 #
Proposal for a directive 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 EC Type Certificate shall be made available to the relevant authorities, as well as economic operators in the supply chain, upon request.
Amendment 205 #
Proposal for a directive Article 15 – paragraph 5 a (new) 5a. The CE mark must incorporate an indication of the assessment agency which has certified conformity.
Amendment 206 #
Proposal for a directive Article 15 – paragraph 7 7.
Amendment 207 #
Proposal for a directive Article 15 – paragraph 7 7. Toys not bearing a CE-marking
Amendment 208 #
Proposal for a directive Article 15 – paragraph 7 7. Toys not bearing a CE-marking
Amendment 209 #
Proposal for a directive Article 15 a (new) Article 15a Toys placed on the market which are intended for children under three years of age must bear the CE+ mark. Toys placed on the market which are intended for children of three or more years of age may bear the CE+ mark. In other respects, the provisions of Article 15 shall apply.
Amendment 210 #
Proposal for a directive Article 16 a (new) Article 16a Rules and conditions for the affixing of the CE+ marking 1. The CE+ marking shall consist of the initials 'CE' and the symbol '+' taking the following form: [illustration] 2. In other respects, the provisions of Article 16 shall apply.
Amendment 211 #
Proposal for a directive Article 17 Manufacturers shall, before placing a toy on the market, carry out an analysis of the chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards that the toy may present and an assessment of the potential exposure to them. The lack of a history of accidents shall not automatically be considered as evidence of low risk.
Amendment 212 #
Proposal for a directive 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 213 #
Proposal for a directive Article 18 - paragraph 1 1. Before manufacturers plac
Amendment 214 #
Proposal for a directive Article 18 - paragraph 1 1. Before placing the toys on the market, manufacturers shall use the conformity assessment procedures identified in paragraph
Amendment 215 #
Proposal for a directive Article 18 - paragraph 2 Amendment 216 #
Proposal for a directive Article 18 - paragraph 2 Amendment 217 #
Proposal for a directive Article 18 - paragraph 3 3. The toy shall be submitted for EC-type- examination as referred to in Article 19 combined with the conformity to type procedure set out in Module C of Annex I to Decision […]
Amendment 218 #
Proposal for a directive Article 18 - paragraph 3 - point d a (new) (da) where the toy is intended for children under 36 months old.
Amendment 219 #
Proposal for a directive Article 18 - paragraph 3 a (new) 3a. The products listed in Annex I, Section II, shall be submitted for EC-type- examination.
Amendment 220 #
Proposal for a directive Article 20 - paragraph 4 4. If the manufacturer does not observe the obligations foreseen in paragraphs 1, 2 and 3, the market surveillance authority may require him to have a test performed by a notified body at his own expense within a specified period in order to verify compliance with the harmonised standards and essential safety requirements. In such cases, the market surveillance authority may require that the toy may not be placed on the market until a final decision can be taken on the basis of the test performed.
Amendment 221 #
Proposal for a directive Article 45 - paragraph 1 1. The Commission may, for the purposes of adapting them to technical
Amendment 222 #
Proposal for a directive Article 45 - paragraph 1 - subparagraph 1 1. The Commission
Amendment 223 #
Proposal for a directive Article 45 - paragraph 1 - subparagraph 1 - point -a) (new) -a) Annex I
Amendment 224 #
Proposal for a directive Article 45 - paragraph 1 - subparagraph 2 Those measures, designed to amend non- essential elements of this
Amendment 225 #
Proposal for a directive Article 45 - paragraph 1 - subparagraph 2 Those measures, designed to amend non- essential elements of this
Amendment 226 #
Proposal for a directive Article 45 - paragraph 1 - subparagraph 2 Those measures, designed to amend non- essential elements of this
Amendment 227 #
Proposal for a directive Article 45 - paragraph 1 a (new) Amendment 228 #
Proposal for a directive Article 45 - paragraph 2 Amendment 229 #
Proposal for a directive Article 45 - paragraph 2 Amendment 230 #
Proposal for a directive Article 45 - paragraph 2 2. The Commission
Amendment 231 #
Proposal for a directive Article 45 - paragraph 2 2. The Commission may decide upon the
Amendment 232 #
Proposal for a directive Article 45 - paragraph 2 Amendment 233 #
Proposal for a directive Article 45 - paragraph 2 Amendment 234 #
Proposal for a directive Article 45 - paragraph 2 Amendment 235 #
Proposal for a directive 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 236 #
Proposal for a directive 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 237 #
Proposal for a directive 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) 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 239 #
Proposal for a directive 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 240 #
Proposal for a directive 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 241 #
Proposal for a directive Article 52 Member States shall not impede the placing on the market of toys which are in accordance with Directive 88/378/EEC and which were placed on the market before this Directive entered into force or at the latest
Amendment 242 #
Proposal for a directive Article 52 Member States shall not impede the placing on the market of toys which are in accordance with Directive 88/378/EEC and which were placed on the market before this Directive entered into force or
Amendment 243 #
Proposal for a directive Article 52 Member States shall not impede the placing on the market of toys which are in accordance with Directive 88/378/EEC and which were placed on the market before this Directive entered into force or
Amendment 244 #
Proposal for a directive Article 52 Member States shall not impede the placing on the market of toys which are in accordance with Directive 88/378/EEC and which were placed on the market before this Directive entered into force or
Amendment 245 #
Proposal for a directive Article 52 Member States shall not impede the placing on the market of toys which are in accordance with Directive 88/378/EEC and which
Amendment 246 #
Proposal for a directive Article 52 Member States shall not impede the placing on the market of toys which are in accordance with Directive 88/378/EEC and which were placed on the market before this Directive entered into force or
Amendment 247 #
Proposal for a directive Article 52 Member States shall not impede the placing on the market of toys which are in accordance with Directive 88/378/EEC and which were placed on the market before this Directive entered into force or
Amendment 248 #
Proposal for a directive Article 52 Member States shall not impede the placing on the market of toys which are in accordance with Directive 88/378/EEC and which were placed on the market before this Directive entered into force or
Amendment 249 #
Proposal for a directive Article 52 - paragraph 1 a (new) With regard to Article 3(1), Article 9(1) and point III of Annex II, 'Chemical properties', Member States shall not prohibit the placing on the market of toys in accordance with Directive 88/378/EEC which were placed on the market 1) before this Directive entered into force, or 2) after this Directive entered into force and, at the latest, two years after the publication in the Official Journal of the reference to the corresponding revision of the harmonised standard relating to the same chemical properties of toys.
Amendment 250 #
Proposal for a directive Annex I – title Ι. LIST OF PRODUCTS THAT, IN PARTICULAR, ARE NOT CONSIDERED AS TOYS WITHIN THE MEANING OF THIS DIRECTIVE
Amendment 251 #
Proposal for a directive Annex I – point 17 a (new) 17a. Books that do not contain any elements or added objects others than those in paper or cardboard.
Amendment 252 #
Proposal for a directive Annex I – point 17 a (new) 17a. Cardboard books without a playing purpose
Amendment 253 #
Proposal for a directive Annex I – point 17 a (new) 17a. Books, including children's books, and other printed matter intended for use by children of less than 14 years of age.
Amendment 254 #
Proposal for a directive Annex I – point 17 b (new) 17b. Children’s books designed or clearly intended for use in play by children
Amendment 255 #
Proposal for a directive Annex I – Part I a (new) Ιa. LIST OF TOYS TO BE SUBMITTED FOR EC-TYPE-EXAMINATION 1. Toys intended for children under 3 years. 2. Toys which cannot be designed in a manner which eliminates all risks. 3. Toys which, when not functioning, may have serious effects on the child's health. 4. Toys which have caused serious accidents in the past. The Commission shall draw up a list of the relevant toys for each category in accordance with the regulatory procedure with scrutiny referred to in Article 46 (2).
Amendment 256 #
Proposal for a directive Annex II – Part I – point 4 – subparagraph 1 4a. Toys and their parts must not present risk of asphyxiation caused, in particular, by strangulation or suffocation.
Amendment 257 #
Proposal for a directive Annex II – Part I – point 4 – subparagraph 1 4. Toys and their parts must not present risk of
Amendment 258 #
Proposal for a directive 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 by airway obstruction internal and external to the mouth and nose.
Amendment 259 #
Proposal for a directive 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
Amendment 260 #
Proposal for a directive Annex II – Part I – point 4 – subparagraph 2 T
Amendment 261 #
Proposal for a directive 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 by airway obstruction internal and external to the mouth and nose.
Amendment 262 #
Proposal for a directive 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) 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 Toys, which
Amendment 265 #
Proposal for a directive Annex II – Part I – point 4 – paragraph 3 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
Amendment 266 #
Proposal for a directive Annex II – Part I – point 4 – subparagraph 3 Toys, which by virtue of their functions, dimensions and characteristics, 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 and/or inhaled. This also applies to other toys which by virtue 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 267 #
Proposal for a directive Annex II – Part I – point 4 – subparagraph 3 Toys
Amendment 268 #
Proposal for a directive Annex II – Part I – point 4 – subparagraph 3 a (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 269 #
Proposal for a directive Annex II – Part I – point 4 – subparagraph 3 b (new) The packaging in which toys are contained for retail sale must not present risk of strangulation or of closing off the flow of air as 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 270 #
Proposal for a directive 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 271 #
Proposal for a directive 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 not present any other risk of suffocation, strangulation, external or internal airway obstruction or asphyxiation.
Amendment 272 #
Proposal for a directive Annex II – Part I – point 4 – subparagraph 4 Toys contained within food or co-mingled with a food must
Amendment 273 #
Proposal for a directive 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 not present any other risk of asphyxiation, strangulation, external or internal airway obstruction or choking.
Amendment 274 #
Proposal for a directive 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 can be divided in two individual halves may not have dimensions that can cause internal airways obstruction.
Amendment 275 #
Proposal for a directive Annex II – Part I – point 4 – subparagraph 4 a (new) On the basis of the definition of 'toys' in Article 1, the scope of this Directive does not cover one-piece decorations contained in some traditional foods.
Amendment 276 #
Proposal for a directive Annex II – Part I – point 4 – subparagraph 4 a (new) Toys in food should distinguish themselves clearly by colour, consistency and size from the food. Warning labels on food products containing toys must not be distorted, in particular folded or crumpled, or be easily distorted.
Amendment 277 #
Proposal for a directive 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 278 #
Proposal for a directive Annex II – Part I – point 4 – subparagraph 5 Toys
Amendment 279 #
Proposal for a directive Annex II – Part I – point 4 – subparagraph 5 Toys
Amendment 280 #
Proposal for a directive 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 product needs to be consumed in order to get direct access to the toy,
Amendment 281 #
Proposal for a directive 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 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 4c and 4d.
Amendment 282 #
Proposal for a directive Annex II – Part I – point 4 – subparagraph 5 a (new) Parts of toys attached to a food product which does not need to be consumed in order to get access to the toy should be of such dimensions that they can not be swallowed, inhaled or cause internal airway obstruction.
Amendment 283 #
Proposal for a directive Annex II – Part I – point 4 – subparagraph 5 a (new) Toys in food must be distinguishable from the food by colour, shape and size.
Amendment 284 #
Proposal for a directive Annex II – Part I – point 4 – subparagraph 5 b (new) Warnings on food which contains toys must not be deformed, particularly folded or creased, or be easily deformed.
Amendment 285 #
Proposal for a directive Annex II – Part I – point 4 – subparagraph 5 c (new) Parts of toys attached to food which does not need to be consumed to gain access to the toy must be of such dimensions as to prevent them from being swallowed or inhaled or from obstructing internal airways.
Amendment 286 #
Proposal for a directive Annex II – Part I – point 4 – subparagraph 5 d (new) The hazard inherent in toys in food shall be assessed on the basis of the precautionary principle.
Amendment 287 #
Proposal for a directive Annex II – Part I – point 7 – subparagraph 2a The Commission may lay down the maximum design speed of electrically driven ride-on toys in accordance with the regulatory procedure with scrutiny referred to in Article 46 (2).
Amendment 288 #
Proposal for a directive Annex II – Part I – point 7 – subparagraph 3 Amendment 289 #
Proposal for a directive 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. The Commission may lower the noise limit value for these toys in accordance with the regulatory procedure with scrutiny referred to in Article 46 (2).
Amendment 290 #
Proposal for a directive 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
Amendment 291 #
Proposal for a directive 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 292 #
Proposal for a directive 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 toys with impulse noise should be 115 dB LpC peak at the ear. The limit for toys with prolonged noise should be 80 dB LpC peak at the ear.
Amendment 293 #
Proposal for a directive 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. The Commission may lay down a limit value for such toys in accordance with the regulatory procedure with scrutiny referred to in Article 46 (2).
Amendment 294 #
Proposal for a directive 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 295 #
Proposal for a directive Annex II – Part I – point 11 a (new) 11a. Toys or parts of toys that are accessible to be digested, shall be manufactured in such a manner as not to cause harm when ingested. This applies in particular to risks caused by batteries, magnetism and ability to alter volume or shape.
Amendment 296 #
Proposal for a directive Annex II – Part III – point 1 1. Toys shall be so designed and constructed that there are no risks of adverse effects on human health or on the hormonal system 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).
Amendment 297 #
Proposal for a directive Annex II – Part III – point 3 3. Without prejudice to the application of the restrictions under the first sentence of point 2, the use in toys of substances that are classified as carcinogenic, mutagenic or toxic for reproduction (CMR) according to Directive 67/548/EEC
Amendment 298 #
Proposal for a directive Annex II – Part III – point 3 3. Without prejudice to the application of the restrictions under the first sentence of point 2, the use in toys of substances that are classified as carcinogenic, mutagenic or toxic for reproduction (CMR) a
Amendment 299 #
Proposal for a directive Annex II – Part III – point 3 3. Without prejudice to the application of the restrictions under the first sentence of point 2, the use in toys of substances that are classified as carcinogenic, mutagenic or toxic for reproduction (CMR) a
Amendment 300 #
Proposal for a directive Annex II – Part III – point 3 3. Without prejudice to the application of the restrictions under the first sentence of point 2, the use in toys of substances that are classified as carcinogenic, mutagenic or toxic for reproduction (CMR) according to Directive 67/548/EEC
Amendment 301 #
Proposal for a directive Annex II – Part III – point 3 3. Without prejudice to the application of the restrictions under the first sentence of point 2, the use in toys of substances that are classified as carcinogenic, mutagenic or toxic for reproduction (CMR) according to Directive 67/548/EEC
Amendment 302 #
Proposal for a directive Annex II – Part III – point 3 3. Without prejudice to the application of the restrictions under the first sentence of point 2, 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 the relevant concentrations established for the classification of preparations containing the substances in accordance with the provisions of Directive 1999/45/EC shall be prohibited, except if the substances are contained in components of toys or micro- structurally distinct parts of toys that are not accessible to any physical contact by children if used pursuant to Article 9(2)(1).
Amendment 303 #
Proposal for a directive Annex II – Part III – point 3 3. Without prejudice to the application of the restrictions under the first sentence of point 2, the use in toys of substances that
Amendment 304 #
Proposal for a directive Annex II – Part III – point 3 3. Without prejudice to the application of the restrictions under the first sentence of point 2, the
Amendment 305 #
Proposal for a directive Annex II – Part III – point 3 3. Without prejudice to the application of the restrictions under the first sentence of point 2, t
Amendment 306 #
Proposal for a directive Annex II – Part III – point 3 3. Without prejudice to the application of the restrictions under the first sentence of point 2, t
Amendment 307 #
Proposal for a directive Annex II – Part III – point 3 3. Without prejudice to the application of the restrictions under the first sentence of point 2, t
Amendment 308 #
Proposal for a directive Annex II – Part III – point 4 4. Substances
Amendment 309 #
Proposal for a directive Annex II – Part III – point 4 4. Substances
Amendment 310 #
Proposal for a directive Annex II – Part III – point 4 4. Substances
Amendment 311 #
Proposal for a directive Annex II – Part III – point 4 4. Substances or preparations classified as
Amendment 312 #
Proposal for a directive Annex II – Part III – point 4 Amendment 313 #
Proposal for a directive Annex II – Part III – point 4 Amendment 314 #
Proposal for a directive Annex II – Part III – point 4 Amendment 315 #
Proposal for a directive Annex II – Part III – point 4 Substances or preparations classified as
Amendment 316 #
Proposal for a directive Annex II – Part III – point 4 4. Substances or preparations classified as CMR category 1 and 2 according to Directive 67/548/EEC may not be used in toys
Amendment 317 #
Proposal for a directive Annex II – Part III – point 4 – introductory part 4. Substances or preparations classified as CMR category 1, 2 and
Amendment 318 #
Proposal for a directive Annex II – Part III – point 4 4. Substances or preparations classified as CMR category 1, 2 and
Amendment 319 #
Proposal for a directive Annex II – Part III – point 4.3 – subparagraph 2 The Commission shall mandate the relevant Scientific Committee to re- evaluate those substances or preparations listed in Annex IIa as soon as safety concerns arise and at the latest every 5 years from the date that a decision in accordance with Article 45 (2) was taken.
Amendment 320 #
Proposal for a directive Annex II – Part III – point 4 a (new) 4a. Manufacturers may continue placing toys on the market containing the substances classified as CMRs according to Annex I of Directive 67/548/EEC for which a request has been submitted to the relevant scientific committee in accordance with Paragraph 4.1 until a Decision as referred to in Article 45(2) has been taken.
Amendment 321 #
Proposal for a directive Annex II – Part III – point 5 Amendment 322 #
Proposal for a directive Annex II – Part III – point 5 Amendment 323 #
Proposal for a directive Annex II – Part III – point 5 Amendment 324 #
Proposal for a directive Annex II – Part III – point 5 Amendment 325 #
Proposal for a directive Annex II – Part III – point 5 5. Substances
Amendment 326 #
Proposal for a directive Annex II – Part III – point 5 5.
Amendment 327 #
Proposal for a directive Annex II – Part III – point 5 5.
Amendment 328 #
Proposal for a directive Annex II – Part III – point 5 5.
Amendment 329 #
Proposal for a directive Annex II – Part III – point 5 5.
Amendment 330 #
Proposal for a directive Annex II – Part III – point 5 5.
Amendment 331 #
Proposal for a directive Annex II – Part III – point 5 5. Substances or preparations classified as CMR category 3 according to Directive 67/548/EEC may be used in toys
Amendment 332 #
Proposal for a directive Annex II – Part III – point 5 5. Substances or preparations classified as CMR category 3 according to Directive 67/548/EEC may be used in toys if use of the substance has been evaluated by the relevant Scientific Committee and found to be safe, in particular in view of exposure, and following a Decision as referred to in Article 45 (2) and provided that they are not prohibited for uses in consumer articles under Regulation (EC) No 1907/2006 (REACH). Annex IIb lists the CMR category 3 substances prohibited.
Amendment 333 #
Proposal for a directive Annex II – Part III – point 5 a (new) 5a. Manufacturers may continue placing toys on the market containing the substances classified as CMR according to Directive 67/548/EEC for which a request has been submitted and until a decision is adopted.
Amendment 334 #
Proposal for a directive Annex II – Part III – point 7 Amendment 335 #
Proposal for a directive Annex II – Part III – point 7 Amendment 336 #
Proposal for a directive Annex II – Part III – point 7 7. Toys shall not contain
Amendment 337 #
Proposal for a directive Annex II – Part III – point 7 7.
Amendment 338 #
Proposal for a directive Annex II – Part III – point 7 7.
Amendment 339 #
Proposal for a directive Annex II – Part III – point 7 7. Toys shall not contain the following allergenic fragrances:
Amendment 340 #
Proposal for a directive Annex II – Part III – point 7 7. Toys shall not contain the following
Amendment 341 #
Proposal for a directive Annex II – Part III – point 7 – subparagraph 1 7.7. Toys shall not contain the following
Amendment 342 #
Proposal for a directive Annex II – Part III – point 7 - subparagraph 3 Amendment 343 #
Proposal for a directive Annex II – Part III – point 8 – introductory part 8. The following
Amendment 344 #
Proposal for a directive Annex II – Part III – point 8 8. The
Amendment 345 #
Proposal for a directive Annex II – Part III – point 8 - Table 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
Amendment 346 #
Proposal for a directive 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
Amendment 347 #
Proposal for a directive 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
Amendment 348 #
Proposal for a directive 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 7.5 1.9 Barium 4500 1125 Boron 1200 300
Amendment 349 #
Proposal for a directive 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
Amendment 350 #
Proposal for a directive Annex II – Part III – point 8 - subparagraph 2 a (new) Amendment 351 #
Proposal for a directive Annex II – Part III – point 8 a (new) 8a) Specific requirements shall be adopted for toys or toy parts that are designed to be placed in the mouth, regardless of the age group for which the toy is intended, based upon the packaging requirements 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 the related specific measures for particular materials. These requirements shall be adopted on the basis of the opinion of the competent scientific committee and by decision pursuant to Article 45, paragraph 2, taking account of the differences between toys and materials which come into contact with food.
Amendment 352 #
Proposal for a directive Annex II a - title (new) Annex IIa List of substances or preparations classified as CMR category 1 and 2 according to Annex 1 of Directive 67/548/EEC for which the relevant Scientific Committee granted an exemption following an evaluation in accordance with Annex II, part III, point 4.
Amendment 353 #
Proposal for a directive Annex II a - title (new) Annex IIa List of CMR 1 and 2 substances exempt from the prohibition of Annex II point III (3)
Amendment 354 #
Proposal for a directive Annex II a - title (new) Annex IIa List of CMR 1 and 2 substances and preparations exempt from the prohibition of Annex II part III paragraph 3
Amendment 355 #
Proposal for a directive Annex II a -title (new) Annex IIa List of CMR 1 and 2 substances exempt from the prohibition of Annex II point III (3)
Amendment 356 #
Proposal for a directive Annex II a -title (new) Annex IIa List of CMR 1 and 2 substances exempt from the prohibition of Annex II point III (3)
Amendment 357 #
Proposal for a directive Annex II b -title (new) Annex IIb List of substances or preparations classified as CMR category 3 according to Annex 1 of Directive 67/548/EEC and prohibited in accordance with Annex II, part III, point 5.
Amendment 358 #
Proposal for a directive Annex II b - title (new) Annex IIb List of prohibited CMR 3 substances and preparations
Amendment 359 #
Proposal for a directive Annex II b -title (new) Annex IIb List of prohibited CMR 3 substances
Amendment 360 #
Proposal for a directive Annex II b - title (new) Annex IIb List of prohibited CMR 3 substances
Amendment 361 #
Proposal for a directive Annex II b -title (new) Amendment 362 #
Proposal for a directive Annex IV - paragraph 1 - point a The technical documentation referred to in Article 20 shall contain, in particular, so far as relevant for assessment:
Amendment 363 #
Proposal for a directive Annex IV - paragraph 1 - point a a) a detailed description of the design and manufacture, including a list of components and materials used in toys as well as
Amendment 364 #
Proposal for a directive Annex V - Part A - subparagraph 1 a (new) All warnings, by phrases or pictogram, shall be preceded by the word “Warning”.
Amendment 365 #
Proposal for a directive Annex V - Part A - subparagraph 1 a (new) All warnings, by phrases or pictogram, shall be proceded by the word "Warning."
Amendment 366 #
Proposal for a directive 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 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.
Amendment 368 #
Proposal for a directive 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.
Amendment 369 #
Proposal for a directive Annex V - Part B - Point 5 5. Skates, roller skates, online skates, skateboards, scooters and toy bicycles for children If these toys are offered for sale as toys they shall bear the following markings: 'Warning: protective equipment should be worn. Not to be used
Amendment 370 #
Proposal for a directive Annex V - Part B - Point 7 Toys contained in food or co-mingled with food shall contain the warning:
Amendment 371 #
Proposal for a directive Annex V - Part B - Point 7 Toys contained in food or co-mingled with food shall contain the warning: “Adult supervision recommended”. Food products containing toys must bear the following warning, irrespective of the age of the child: “Warning: contains a toy”, or, in case the toy is packed in a hazardous container: “Warning, contains a toy and a container – choking hazard. Remove these items before giving the product to the child”.
Amendment 372 #
Proposal for a directive Annex V - Part B - Point 7 7. Toys contained in food or co-mingled with food shall contain the warning:
Amendment 373 #
Proposal for a directive Annex V - Part B - Point 7 a (new) (7a) Imitations of protective masks and helmets Imitations of protective masks and helmets shall contain the warning: ‘Warning: this toy does not provide protection.’
source: PE-412.121
2008/09/19
ITRE
56 amendments...
Amendment 25 #
Proposal for a directive Recital 3 a (new) (3a) Another important objective of the new system to be established by this Directive is to encourage and in certain cases to ensure that dangerous substances and materials used in toys are replaced by less dangerous substances or technologies where suitable economically and technically viable alternatives are available.
Amendment 26 #
Proposal for a directive Recital 8 (8)
Amendment 27 #
Proposal for a directive Recital 16 (16) In order to ensure a high level of protection of children a
Amendment 28 #
Proposal for a directive Recital 16 a (new) (16a) In order to avoid any possible duplication of evaluation under this Directive and Regulation (EC) No 1907/2006 concerning REACH, CMRs that have been evaluated and have not been prohibited under this Directive should not be made subject to proposals for restriction under Regulation (EC) No 1907/2006 on the grounds of risks to human health and should not be made subject to authorisation under Regulation (EC) No 1907/2006 on the grounds of risks to human health according to Article 58(2) of that Regulation. In order to avoid similar duplication, CMRs which have been evaluated for use in toys and which have not been prohibited under Regulation (EC) No 1907/2006 should not be made subject to restrictions or evaluation under this Directive.
Amendment 29 #
Proposal for a directive Recital 16 a (new) (16a) In order to avoid duplication of evaluation under this Directive and Regulation (EC) No 1907/2006 concerning REACH, CMRs that have been evaluated and which have not been prohibited under this Directive should not be made subject to proposals for restriction under Regulation (EC) No 1907/2006 on the grounds of risks to human health and should be not be made subject to authorisation under Regulation (EC) No 1907/2006 on the grounds of risks to human health in accordance with Article 58(2) of that Regulation. At the same time, in order to avoid duplication, CMRs that have been evaluated for use in toys and which have not been prohibited under Regulation (EC) No 1907/2006 should not be made subject to restrictions or evaluation under this Directive.
Amendment 30 #
Proposal for a directive Recital 16 a (new) (16a) In order to avoid duplication of evaluation under this Directive and Regulation (EC) No 1907/2006 concerning REACH, CMRs which have been evaluated and which have not been prohibited under this Directive should not be proposed for restriction under Regulation (EC) No 1907/2006 on the grounds of risks to human health and should not be subject to Authorisation under Regulation (EC) No 1907/2006 on the grounds of risks to human health in accordance with Article 58(2) of that Regulation. Therefore, in order to avoid duplication, CMRs which have already been evaluated for use in toys and which have not been prohibited under Regulation (EC) No 1907/2006 should not be made subject to restrictions or evaluations under this Directive.
Amendment 31 #
Proposal for a directive Recital 16 a (new) (16a) In order to avoid any duplication of evaluation under this Directive and Regulation (EC) No 1907/2006 concerning REACH, CMRs which have previously been evaluated and which have not been prohibited under this Directive should not be made subject to proposals for restriction under Regulation (EC) No 1907/2006 on the grounds of risks to human health and should be not be made subject to authorisation under Regulation (EC) No 1907/2006 on the grounds of risks to human health in accordance with Article 58(2) of that Regulation. Consequently, in order to avoid any duplication, CMRs which have been evaluated for use in toys and which have not been prohibited under Regulation (EC) No 1907/2006 should not be made subject to any restrictions or evaluations under this Directive.
Amendment 32 #
Proposal for a directive Recital 16 b (new) (16b) It is necessary to apply a general harmonised transition period of two years after the entry into force of this Directive for compliance with its provisions, and a specific transition period of three years after publication of the revised harmonised toy safety standard in relation to chemical properties, to allow toy manufacturers and economic operators sufficient time to adapt to the new technical requirements on chemicals, and to ensure consistent application of this Directive throughout the European Union.
Amendment 33 #
Proposal for a directive Recital 16 b (new) (16b) It is necessary to apply a harmonised transition period of two years after the entry into force of this Directive for compliance with its provisions and a further transition period of one year after the entry into force of the revised Toy Standard EN 71-3 concerning the new chemical requirements of this Directive, to allow toy manufacturers and economic operators sufficient time to adapt to the new technical requirements and to ensure consistent application of this Directive throughout the European Union.
Amendment 34 #
Proposal for a directive Recital 16 b (new) (16b) It is necessary to apply a harmonised transition period of two years after the entry into force of this Directive for compliance with its provisions and, thereafter, a further transition period of three years to allow toy manufacturers and economic operators sufficient time to adapt to the new technical requirements on chemicals, and to ensure consistent application of this Directive throughout the European Union.
Amendment 35 #
Proposal for a directive Recital 16 b (new) (16b) It is necessary to apply a harmonised transition period of two years after the entry into force of this Directive for compliance with its provisions and a further transition period of three years to allow toy manufacturers and economic operators the time needed to comply with the new technical requirements on chemicals, and to ensure consistent application of this Directive throughout the European Union.
Amendment 36 #
Proposal for a directive Recital 16 b (new) (16b) It is necessary to apply a harmonised transition period of two years after the entry into force of this Directive for compliance with its provisions and a further transition period of three years after the entry into force of this Directive in all Member States to allow toy manufacturers and economic operators sufficient time to adapt to the new technical requirements on chemicals, and to ensure consistent application of this Directive throughout the European Union.
Amendment 37 #
Proposal for a directive Recital 32 (32) In particular power should be conferred on the Commission in order to adapt the chemical requirements in certain well defined cases
Amendment 38 #
Proposal for a directive Recital 32 (32) In particular power should be conferred on the Commission in order to adapt the chemical requirements in certain well defined cases
Amendment 39 #
Proposal for a directive Article 3 – paragraph 7 7. Manufacturers who consider or have reason to believe that a toy which they have placed on the market is not in conformity with the applicable Community legislation shall 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 details, in particular, of the non- compliance and of the corrective measures taken. Manufacturers shall immediately suspend the placing on the market of these toys until they comply with the applicable Community legislation.
Amendment 40 #
Proposal for a directive Article 3 – paragraph 7 7.
Amendment 41 #
Proposal for a directive Article 9 – paragraph 2 – subparagraph 2 The ability of the users and where appropriate their supervisors shall be taken into account, in particular, in the case of toys which, by virtue of their functions, dimensions and characteristics, are intended for use by children of under
Amendment 42 #
Proposal for a directive Article 15 – paragraph 2 – subparagraph 2 a (new) The CE marking shall be randomly checked by an independent market surveillance authority.
Amendment 43 #
Proposal for a directive Article 45 – Paragraph 1 1. The Commission may, for the purposes of adapting them to technical
Amendment 44 #
Proposal for a directive Article 45 – Paragraph 1 1. The Commission may, for the purposes of adapting them to technical
Amendment 45 #
Proposal for a directive Article 45 – Paragraph 2 2. The Commission may decide upon the
Amendment 46 #
Proposal for a directive Article 45 - Paragraph 2 2. The Commission may decide upon the
Amendment 47 #
Proposal for a directive Article 52 Member States shall not impede the placing on the market of toys which are in accordance with Directive 88/378/EEC and which were placed on the market before this Directive entered into force or
Amendment 48 #
Proposal for a directive Article 52 Member States shall not impede the placing on the market of toys which are in accordance with Directive 88/378/EEC and which were placed on the market before this Directive entered into force or
Amendment 49 #
Proposal for a directive Article 52 Member States shall not impede the placing on the market of toys which are in accordance with Directive 88/378/EEC and which were placed on the market before this Directive entered into force or
Amendment 50 #
Proposal for a directive Article 52 Member States shall not impede the placing on the market of toys which are in accordance with Directive 88/378/EEC and which were placed on the market before this Directive entered into force or
Amendment 51 #
Proposal for a directive Article 52 Member States shall not impede the placing on the market of toys which are in accordance with Directive 88/378/EEC and which
Amendment 52 #
Proposal for a directive Article 52 Member States shall not impede the placing on the market of toys which are in accordance with Directive 88/378/EEC and which were placed on the market before this Directive entered into force or at the latest 2 years after this Directive entered into force. This period shall be extended by three years in respect of the requirements laid down in Annex II, section III.
Amendment 53 #
Proposal for a directive Annex I – point 17 a (new) 17a. Books that do not contain any additional elements or objects (except those made of paper or cardboard).
Amendment 54 #
Proposal for a directive Annex II – part I – paragraph 4 – subparagraph 2 The packaging in which toys are contained for retail sale must not present risk of strangulation or asphyxiation caused by airway obstruction internal and external to the mouth
Amendment 55 #
Proposal for a directive Annex II – part I – paragraph 4 – subparagraph 4 Toys contained within food or co-mingled with a food must
Amendment 56 #
Proposal for a directive Annex II – part I – paragraph 4 – subparagraph 5 Toys
Amendment 57 #
Proposal for a directive Annex II – part III – paragraph 3 3. Without prejudice to the application of the restrictions under the first sentence of point 2, t
Amendment 58 #
Proposal for a directive Annex II – part III – paragraph 3 3. Without prejudice to the application of the restrictions under the first sentence of point 2, t
Amendment 59 #
Proposal for a directive Annex II – part III – paragraph 3 3. Without prejudice to the application of the restrictions under the first sentence of point 2, t
Amendment 60 #
Proposal for a directive Annex II – part III – paragraph 4 4. Substances
Amendment 61 #
Proposal for a directive Annex II – part III – paragraph 4 4. Substances
Amendment 62 #
Proposal for a directive Annex II – part III – paragraph 4 4. Substances
Amendment 63 #
Proposal for a directive Annex II – part III – paragraph 4 – subparagraph 4.1 4.1
Amendment 64 #
Proposal for a directive Annex II – part III – paragraph 4 – subparagraph 4.1 4.1
Amendment 65 #
Proposal for a directive Annex II – part III – paragraph 4 – subparagraph 4.1 4.1
Amendment 66 #
Proposal for a directive Annex II – part III – paragraph 4 – subparagraph 4.2 Amendment 67 #
Proposal for a directive Annex II – part III – paragraph 4 – subparagraph 4.2 Amendment 68 #
Proposal for a directive Annex II – part III – paragraph 4 – subparagraph 4.2 Amendment 69 #
Proposal for a directive Annex II – part III – paragraph 5 5.
Amendment 70 #
Proposal for a directive Annex II – part III – paragraph 5 5.
Amendment 71 #
Proposal for a directive Annex II – part III – paragraph 5 5.
Amendment 72 #
Proposal for a directive Annex II – part III – paragraph 5 a (new) 5a. Manufacturers may continue placing toys on the market containing the substances classified as CMR according to Directive 67/548/EEC for which a request has been submitted, until a decision has been adopted.
Amendment 73 #
Proposal for a directive Annex II – part III – paragraph 6 6.
Amendment 74 #
Proposal for a directive Annex II – part III – paragraph 7 – first list of fragrances – new points after point 38 Amendment 75 #
Proposal for a directive Annex II – part III – paragraph 7 – first list of fragrances – new points after point 38 Amendment 76 #
Proposal for a directive Annex II – part III – paragraph 7 – second list of fragrances (
Amendment 77 #
Proposal for a directive Annex II – part III – paragraph 7 – second list of fragrances (
Amendment 78 #
Proposal for a directive Annex II – part III – paragraph 8 – Introductory wording and table Amendment 79 #
Proposal for a directive Annex V – part B – paragraph 7 – subparagraph 2 “Adult supervision strongly recommended”.
Amendment 80 #
Proposal for a directive Annex V – part B – paragraph 7 – subparagraph 2 a (new) Food products containing toys must bear the following warning, irrespective of the age of the child: “Warning: contains a toy”, or, where the toy is packed in a hazardous container: “Warning, contains a toy in a container which may present a choking hazard. Remove these items before giving the food to the child”.
source: PE-412.141
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Committee referral announced in Parliament, 1st reading/single readingNew
Committee referral announced in Parliament, 1st reading |
events/4/type |
Old
Vote in committee, 1st reading/single readingNew
Vote in committee, 1st reading |
events/5 |
|
events/5 |
|
events/7/docs/0/url |
Old
http://www.europarl.europa.eu/sides/getDoc.do?secondRef=TOC&language=EN&reference=20081215&type=CRENew
https://www.europarl.europa.eu/doceo/document/EN&reference=20081215&type=CRE |
events/9 |
|
events/9 |
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procedure/instrument/1 |
Amended by 2017/0353(COD)
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procedure/instrument/1 |
Repealing Directive 88/378/EEC Amended by 2013/0048(COD) Amended by 2017/0353(COD)
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committees/0 |
|
committees/0 |
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committees/1 |
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committees/1 |
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committees/2 |
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committees/2 |
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docs/0/docs/0/url |
Old
http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/sec/2008/0038/COM_SEC(2008)0038_EN.pdfNew
http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/sec/2008/0038/COM_SEC(2008)0038_EN.pdf |
docs/1/docs/0/url |
Old
http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/sec/2008/0039/COM_SEC(2008)0039_EN.pdfNew
http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/sec/2008/0039/COM_SEC(2008)0039_EN.pdf |
docs/6/docs/0/url |
Old
http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A6-2008-441&language=ENNew
http://www.europarl.europa.eu/doceo/document/A-6-2008-0441_EN.html |
docs/7/body |
EC
|
events/0/docs/0/url |
Old
http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2008/0009/COM_COM(2008)0009_EN.pdfNew
http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2008/0009/COM_COM(2008)0009_EN.pdf |
events/5/docs/0/url |
Old
http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A6-2008-441&language=ENNew
http://www.europarl.europa.eu/doceo/document/A-6-2008-0441_EN.html |
events/9/docs/0/url |
Old
http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P6-TA-2008-626New
http://www.europarl.europa.eu/doceo/document/TA-6-2008-0626_EN.html |
docs/0/docs/0/url |
Old
http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/sec/2008/0038/COM_SEC(2008)0038_EN.pdfNew
http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/sec/2008/0038/COM_SEC(2008)0038_EN.pdf |
activities |
|
commission |
|
committees/0 |
|
committees/0 |
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committees/1 |
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committees/1 |
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committees/2 |
|
committees/2 |
|
council |
|
docs |
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events |
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other |
|
procedure/dossier_of_the_committee |
Old
IMCO/6/58655New
|
procedure/final/url |
Old
http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32009L0048New
https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32009L0048 |
procedure/instrument |
Old
DirectiveNew
|
procedure/subject |
Old
New
|
procedure/summary |
|
links/European Commission/title |
Old
PreLexNew
EUR-Lex |
activities/13/docs/1/url |
Old
http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2009:170:TOCNew
http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2009:170:SOM:EN:HTML |
activities |
|
committees |
|
links |
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other |
|
procedure |
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