83 Amendments of Vlad-Marius BOTOŞ related to 2023/0290(COD)
Amendment 80 #
Proposal for a regulation
Recital 2
Recital 2
(2) Children are a particularly vulnerable group. It is essential to ensure a high level of safety of children when playing with toys. Children should be adequately protected from possible risks stemming from toys, in particularcluding from the chemical substances that toys may contain. At the same time, compliant toys should be able to move freely across the internal market without additional requirements.
Amendment 88 #
Proposal for a regulation
Recital 12
Recital 12
(12) To ensure adequate protection of children and other persons, this Regulation should apply to all forms of supply of toys, including distance sales as referred to in Article 6 of Regulation (EU) 2019/1020 of the European Parliament and of the Council29 . _________________ 29 Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1).
Amendment 90 #
Proposal for a regulation
Recital 13
Recital 13
(13) Essential safety requirements for toys should ensure protection from all relevant health and safety hazards posed by toys, for children whether they are the users or a third partiesy. Particular safety requirements should cover the physical and mechanical properties, flammability, chemical properties, electrical properties, hygiene and radioactivity to ensure that the safety of children is adequately protected against those specific hazards. Since it is possible that toys which present hazards that are not covered by a particular safety requirement might exist or be developed, it is necessary to maintain a general requirement of safety to ensure protection of children in respect of such toys. The safety of toys should be determined by reference to the intended use, while taking into account also the foreseeable use, and bearing in mind the behaviour of children, who do not generally show the same degree of care as the average adult user. Together, the general safety requirement and the particular safety requirements should form the essential safety requirements for toys.
Amendment 99 #
Proposal for a regulation
Recital 14
Recital 14
(14) Relying on digital technologies has led to new hazards in toys. Radio toys are to comply with essential requirements for the protection of privacy and internet- connected toys are to incorporate safeguards towards cybersecurity and protection from fraud in accordance with Directive 2014/53/EU of the European Parliament and of the Council30 . Toys which include artificial intelligence are to comply with Regulation (EU) …/…[P.O. insert serial number for Regulation laying down harmonised rules on artificial intelligence]31 . Therefore, particular safety requirements regarding cybersecurity, protection of personal data and privacy or other hazards stemming from the incorporation of artificial intelligence in toys should not be set out. However, protecting the health of children should not merely ensure the absence of disease or infirmity and relying on digital technologies may pose risks to children which go beyond their physical health. To ensure that children are protected from any risk coming from the use of digital technologies and artificial inteligence in toys, the general safety requirement should ensure the psychological and mental health, as well as the well-being and cognitive development, of children. _________________ 30 Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62). 31 PO: Please insert in the text the number of the Regulation and insert the number, date, title and OJ reference of that Regulation in the footnote.
Amendment 105 #
Proposal for a regulation
Recital 15
Recital 15
(15) Toys should comply with physical and mechanical requirements that prevent children from getting physically injured when playing with toys and should not pose a risk of choking or suffocation to children. In order to protect children from the risk of impaired hearing, maximum values should be set out taking into account the scientific studies and medical experts recomendations for both impulse noise and continuous noise emitted by toys intended to emit sounds. Toys or their parts and their packaging which can be reasonably expected to be brought into contact with food or to transfer their constituents to food under normal or foreseeable conditions of use are subject to Regulation (EC) No 1935/2004 of the European Parliament and of the Council32 . In addition, it is appropriate to lay down specific safety requirements to cover the potential specific hazard presented by toys in food, since the association of a toy and food could cause a risk of choking which is distinct from the risks presented by the toy alone and which is, therefore, not covered by any specific measure at Union level. Toys should also ensure sufficient protection as regards flammability or electric properties, in particular to prevent burns or electric shocks. Moreover, toys should meet certain hygiene standards to avoid microbiological risks or other risks of infection or contamination. _________________ 32 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 repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).
Amendment 110 #
Proposal for a regulation
Recital 20
Recital 20
(20) As batteries are regulated by Regulation (EU) …/…[P.O. insert serial number for Regulation on batteries and waste batteries]35 , the requirements regarding chemical substances in toys should not apply to the batteries included in toys. However, toys that include batteries should be designed in such a way that the batteries are difficult for children to access. In situations where, due to the nature, size or form factor of the toy, or of the small electronics contained within, it would not be possible to design the toy where the internal battery is removable and replaceable by the end-user while also ensuring the safety of the child and the safe continued use of the toy, the toy may be designed in such a way as to make the battery removable and replaceable only by independent operators. _________________ 35 PO: Please insert in the text the number of the Regulation …. and insert the number, date, title and OJ reference of that Regulation in the footnote.
Amendment 140 #
Proposal for a regulation
Recital 67 a (new)
Recital 67 a (new)
(67 a) Data on injuries are scarce and unevenly collected across the EU, making it hard to assess the effect of the toy safety regulatory framework on the protection of childrens’ health and safety. A Pan- European data base would allow for proper monitoring of the impact and effectiveness of EU safety rules. Injury related data could also bring relevant information to the manufacturers, standardisers and future decision makers on design, safety features and other elements needed to imporve the safety of toys. When setting up such data base the Commission should closely cooperate with the experts in the field and draw inspiration from similar data bases that are already existing and helping the industry in third countries.
Amendment 147 #
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
This Regulation lays down rules on the safety of toys, ensuring a high level of protection of health and safety of children and other persons, and on the free movement of toys in the Unioe objective of this Regulation is to improve the functionning of the internal market while providing for a high level of consumer protection and ahigh level of protection of health and safety of children.
Amendment 150 #
Proposal for a regulation
Article 1 – paragraph 1 a (new)
Article 1 – paragraph 1 a (new)
This Regulation lays down rules on the safety of toys and on the free movement of toys in the Union, contributing to strenghtening of the Single Market.
Amendment 153 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 2
Article 2 – paragraph 1 – subparagraph 2
For the purposes of this Regulation, a product shall be considered to be intended for use in play by children under 14 years of age, or by children of any other specific age group below 14 years, where a parent or supervisor can reasonably assume, by virtue of the functions, dimensions and characteristics of that product, that it is intended for use in play by children of the relevantvarious age groups.
Amendment 155 #
Proposal for a regulation
Article 2 – paragraph 3
Article 2 – paragraph 3
3. The Commission shall be empowered to adopt implementing acts determining whether or not specific products or categories of products fulfil the criteria set out in paragraph 1 of this Article and therefore can or cannot be considered toys within the meaning of this Regulation. Those implementing acts shall be adopted in accordance with the procedure set out in Article 50(2).
Amendment 166 #
Proposal for a regulation
Article 3 – paragraph 1 – point 12 a (new)
Article 3 – paragraph 1 – point 12 a (new)
(12 a) 'intended for the use by' means that the economic operator manufactured that product with a specific intention explicitly mentioned in the instructions of the product or in any other documents of that product;
Amendment 167 #
Proposal for a regulation
Article 3 – paragraph 1 – point 12 b (new)
Article 3 – paragraph 1 – point 12 b (new)
(12 b) 'reasonably forseable' means that an average consumer whether parent or supervisor, shall reasonably be able to assume by the virtue of the functions, dimensions and characteristics of a product that it is intended for the use by children of various ages;
Amendment 174 #
Proposal for a regulation
Article 3 – paragraph 1 – point 29
Article 3 – paragraph 1 – point 29
(29) ‘functional toy’ means a toy which performs and is used in the same way as a product, appliance or installation intended for use by adults, and which may be a scale model of such product, appliance or installation, if that toy brings similar level of risk for children as the real model produces for adults;
Amendment 176 #
Proposal for a regulation
Article 3 – paragraph 1 – point 33
Article 3 – paragraph 1 – point 33
(33) ‘olfactory board game’ means a toy the purpose of which is to assist a child to learn to recognise or combine different odours or flavours;
Amendment 177 #
Proposal for a regulation
Article 3 – paragraph 1 – point 34
Article 3 – paragraph 1 – point 34
(34) ‘cosmetic kit’ means a toy the purpose of which is to assist a child to learn to make cosmetic products such as fragrances, soaps, creams, shampoos, conditioners, bath foams, tooth pastes as well as glosses, lipsticks and other make- up or to use them on dolls and action figures or on their own body;
Amendment 178 #
Proposal for a regulation
Article 3 – paragraph 1 – point 35
Article 3 – paragraph 1 – point 35
(35) ‘gustative game’ means a toy the purpose of which is to allow children to make sweets or dishes through the use of food ingredients, including liquids, powders and aromas without using any heat source;
Amendment 182 #
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 1
Article 4 – paragraph 2 – subparagraph 1
At trade fairs, exhibitions and demonstrations or similar events, Member States shall not prevent the display of a toy which does not comply with this Regulation, provided that a visible sign, either on the packaging or on the exhibition stand, that clearly indicates that the toy does not comply with this Regulation and will not be available on the market until it has been brought into conformity.
Amendment 185 #
Proposal for a regulation
Article 5 – paragraph 2 – subparagraph 1
Article 5 – paragraph 2 – subparagraph 1
Toys shall not present a risk to the safety or health of users or third parties, including the psychological and mental health, well- being and cognitive development of childrenchildren, whether they are the users or the third party, when they are used as intended or in a foreseeable way, also bearing in mind the behaviour of childrenpsychological and mental health, the cognitive development and the behaviour of children in specific age groups.
Amendment 189 #
Proposal for a regulation
Article 5 – paragraph 2 – subparagraph 2
Article 5 – paragraph 2 – subparagraph 2
When assessing the risk referred to in the first subparagraph, the ability of the intended group of users and, where appropriate, their supervisors shall be taken into account. Where a toy is intended for use by children under 36 months or by another specified age groups, the ability of users in that specific age group shall be taken into account.
Amendment 191 #
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Where necessary to ensure their safe use, toys shall bear a general warning specifying appropriate user limitations. The user limitations shall include at least the minimum or maximum age of the user and, where appropriate, the required abilities of the user, the maximum or minimum weight of the user and the need to ensure that the toy is used only under adult supervision.
Amendment 193 #
Proposal for a regulation
Article 6 – paragraph 3 – subparagraph 1
Article 6 – paragraph 3 – subparagraph 1
The manufacturer shall mark 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 tToys which are sold without packaging shall have appropriate warnings affixed to them, if the surface of the toy allows, if not, the warnings should be placed on the label.
Amendment 200 #
Proposal for a regulation
Article 6 – paragraph 3 – subparagraph 2
Article 6 – paragraph 3 – subparagraph 2
Warnings that might determine the decision to purchase a toy shall be clearly visible to the consumer before the purchase, including in cases where the purchase is made through distance sales. Warnings shall be of sufficient size to ensure their visibility.
Amendment 201 #
Proposal for a regulation
Article 6 – paragraph 4
Article 6 – paragraph 4
4. Labels and instructions for use shall draw the attention of children or their supervisors to the inherent hazards and risks to the health and safety of children involved in using the toysconsidering the age group of children for which the toys are intended, and to the ways of avoiding such hazards and risks.
Amendment 224 #
Proposal for a regulation
Article 8 – paragraph 3 – introductory part
Article 8 – paragraph 3 – introductory part
3. An authorised representative shall perform the tasks specified in the mandate received from the manufacturer and shall provide a copy of the mandate to the market surveillance authorities upon their request. The mandate shall allowempower the authorised representative to doperform at least the following tasks:
Amendment 231 #
Proposal for a regulation
Article 8 – paragraph 3 – point c
Article 8 – paragraph 3 – point c
(c) cooperate with the competent national authorities, at their request, on any action taken to eliminate in an efective manner the risks posed by toys covered by the written mandate.
Amendment 238 #
Proposal for a regulation
Article 8 – paragraph 4 a (new)
Article 8 – paragraph 4 a (new)
4 a. When an appointed authorised representative ends its mandate it shall inform the market surveillance authority and shall provide the information regarding the name of the company they represented, registered trade name or registered trade mark and the postal and electronic address at which the manufacturer can be contacted.
Amendment 245 #
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. Importers shall indicate their name, registered trade name or registered trade mark and the postal and electronic address at which they can be contacted, on the toy or, where that is not possible, on its packagingpackaging of the toy or in a document accompanying the toy.
Amendment 249 #
Proposal for a regulation
Article 9 – paragraph 7 a (new)
Article 9 – paragraph 7 a (new)
7 a. Where the importer suspends its activity for various reasons it will notify the market surveillance authorities and makes available to those authorities all the technical documentations referred to in Article 23.
Amendment 272 #
Proposal for a regulation
Chapter II a (new)
Chapter II a (new)
II a Providers of online marketplaces
Amendment 272 #
Proposal for a regulation
Chapter II a (new)
Chapter II a (new)
II a Providers of online marketplaces
Amendment 275 #
Proposal for a regulation
Article 12 b (new)
Article 12 b (new)
Article 12b Providers of online marketplaces to which Section 4 of Regulation (EU) 2022/2065 applies, shall make reasonable efforts to randomly check before and after they allow a trader to offer a product on the online marketplace, whether it has been identified as being dangerous in any official, freely accessible and machine- readable online database or online interface, made available in a Member State or in the Union, in particular the Safety Gate Portal. The Commission shall provide guidelines on the practicalities of such random checks.
Amendment 275 #
Proposal for a regulation
Article 12 b (new)
Article 12 b (new)
Article 12b Providers of online marketplaces to which Section 4 of Regulation (EU) 2022/2065 applies, shall make reasonable efforts to randomly check before and after they allow a trader to offer a product on the online marketplace, whether it has been identified as being dangerous in any official, freely accessible and machine- readable online database or online interface, made available in a Member State or in the Union, in particular the Safety Gate Portal. The Commission shall provide guidelines on the practicalities of such random checks.
Amendment 282 #
Proposal for a regulation
Article 17 – title
Article 17 – title
Amendment 282 #
Proposal for a regulation
Article 17 – title
Article 17 – title
Amendment 283 #
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
1. Before placing a toy on the market, manufacturers shall create a digital product passport for that toy. The digital product passport shall meet the requirements laid down in this Article and Article 18.
Amendment 283 #
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
1. Before placing a toy on the market, manufacturers shall create a digital product passport for that toy. The digital product passport shall meet the requirements laid down in this Article and Article 18.
Amendment 290 #
Proposal for a regulation
Article 17 – paragraph 2 – point f
Article 17 – paragraph 2 – point f
(f) be accessible to consumers or other end-users, market surveillance authorities, customs authorities, notified bodies, the Commission and other economic operators in accordance with the Directive (EU) 2016/943;
Amendment 290 #
Proposal for a regulation
Article 17 – paragraph 2 – point f
Article 17 – paragraph 2 – point f
(f) be accessible to consumers or other end-users, market surveillance authorities, customs authorities, notified bodies, the Commission and other economic operators in accordance with the Directive (EU) 2016/943;
Amendment 304 #
Proposal for a regulation
Article 17 – paragraph 10 – subparagraph 1 – introductory part
Article 17 – paragraph 10 – subparagraph 1 – introductory part
The Commission shall adopt implementingdelegated acts determining the specific and technical requirements related to the product passport for toys. Those requirements shall cover in particular the following:
Amendment 304 #
Proposal for a regulation
Article 17 – paragraph 10 – subparagraph 1 – introductory part
Article 17 – paragraph 10 – subparagraph 1 – introductory part
The Commission shall adopt implementingdelegated acts determining the specific and technical requirements related to the product passport for toys. Those requirements shall cover in particular the following:
Amendment 305 #
Proposal for a regulation
Article 17 – paragraph 10 – subparagraph 1 – point d
Article 17 – paragraph 10 – subparagraph 1 – point d
Amendment 305 #
Proposal for a regulation
Article 17 – paragraph 10 – subparagraph 1 – point d
Article 17 – paragraph 10 – subparagraph 1 – point d
Amendment 308 #
Proposal for a regulation
Article 17 – paragraph 10 – subparagraph 2
Article 17 – paragraph 10 – subparagraph 2
Those implementingdelegated acts shall be adopted in accordance with the procedure set out in Article 50(3).
Amendment 308 #
Proposal for a regulation
Article 17 – paragraph 10 – subparagraph 2
Article 17 – paragraph 10 – subparagraph 2
Those implementingdelegated acts shall be adopted in accordance with the procedure set out in Article 50(3).
Amendment 310 #
Proposal for a regulation
Article 18 – title
Article 18 – title
Technical design and operation of the digital product passport
Amendment 310 #
Proposal for a regulation
Article 18 – title
Article 18 – title
Technical design and operation of the digital product passport
Amendment 312 #
Proposal for a regulation
Article 18 – paragraph 3
Article 18 – paragraph 3
3. Consumers or other end-users, economic operators and other relevant actors shall have access to the product passport, in accordance with the Union legislation, free of charge.
Amendment 312 #
Proposal for a regulation
Article 18 – paragraph 3
Article 18 – paragraph 3
3. Consumers or other end-users, economic operators and other relevant actors shall have access to the product passport, in accordance with the Union legislation, free of charge.
Amendment 317 #
Proposal for a regulation
Article 18 – paragraph 4
Article 18 – paragraph 4
4. The data included in the product passport shall be stored by the economic operator responsible for its creation or by operators authorised to act on their behalf or by competent authorities.
Amendment 317 #
Proposal for a regulation
Article 18 – paragraph 4
Article 18 – paragraph 4
4. The data included in the product passport shall be stored by the economic operator responsible for its creation or by operators authorised to act on their behalf or by competent authorities.
Amendment 324 #
Proposal for a regulation
Article 19 – title
Article 19 – title
Amendment 324 #
Proposal for a regulation
Article 19 – title
Article 19 – title
Amendment 326 #
Proposal for a regulation
Article 20 – title
Article 20 – title
Customs controls relating to the digital product passport
Amendment 326 #
Proposal for a regulation
Article 20 – title
Article 20 – title
Customs controls relating to the digital product passport
Amendment 336 #
Proposal for a regulation
Article 22 – paragraph 3 – point c
Article 22 – paragraph 3 – point c
(c) where one or more of the harmonised standards referred to in point (a) has been published with a restriction that is relevant for the toy to be examined ;
Amendment 336 #
Proposal for a regulation
Article 22 – paragraph 3 – point c
Article 22 – paragraph 3 – point c
(c) where one or more of the harmonised standards referred to in point (a) has been published with a restriction that is relevant for the toy to be examined ;
Amendment 343 #
Proposal for a regulation
Article 26 – paragraph 4
Article 26 – paragraph 4
4. A notifying authority shall not offer or provide any activities that conformity assessment bodies perform, nor shall they offer or provide consultancy services on a commercial or competitive basis, however the notifying authority shall provide information to the economic operators about the procedures for the assessment and the conformity assessment bodies if so requested.
Amendment 343 #
Proposal for a regulation
Article 26 – paragraph 4
Article 26 – paragraph 4
4. A notifying authority shall not offer or provide any activities that conformity assessment bodies perform, nor shall they offer or provide consultancy services on a commercial or competitive basis, however the notifying authority shall provide information to the economic operators about the procedures for the assessment and the conformity assessment bodies if so requested.
Amendment 344 #
Proposal for a regulation
Article 26 – paragraph 6
Article 26 – paragraph 6
6. A notifying authority shall have a sufficient number of competent personnel and adequate resources at their disposal for the properefficient performance of their tasks.
Amendment 344 #
Proposal for a regulation
Article 26 – paragraph 6
Article 26 – paragraph 6
6. A notifying authority shall have a sufficient number of competent personnel and adequate resources at their disposal for the properefficient performance of their tasks.
Amendment 345 #
Proposal for a regulation
Article 28 – paragraph 6 – subparagraph 3
Article 28 – paragraph 6 – subparagraph 3
A conformity assessment body shall have the meanresources necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities.
Amendment 345 #
Proposal for a regulation
Article 28 – paragraph 6 – subparagraph 3
Article 28 – paragraph 6 – subparagraph 3
A conformity assessment body shall have the meanresources necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities.
Amendment 346 #
Proposal for a regulation
Article 28 – paragraph 7 – point b
Article 28 – paragraph 7 – point b
(b) satisfactoryvery good knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;
Amendment 346 #
Proposal for a regulation
Article 28 – paragraph 7 – point b
Article 28 – paragraph 7 – point b
(b) satisfactoryvery good knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;
Amendment 347 #
Proposal for a regulation
Article 28 – paragraph 7 – point c
Article 28 – paragraph 7 – point c
(c) appropriatevery good knowledge and understanding of the requirements set out in this Regulation, of the applicable harmonised standards referred to in Article 13 of this Regulation and the common specifications referred to in Article 14 of this Regulation;
Amendment 347 #
Proposal for a regulation
Article 28 – paragraph 7 – point c
Article 28 – paragraph 7 – point c
(c) appropriatevery good knowledge and understanding of the requirements set out in this Regulation, of the applicable harmonised standards referred to in Article 13 of this Regulation and the common specifications referred to in Article 14 of this Regulation;
Amendment 348 #
Proposal for a regulation
Article 28 – paragraph 10
Article 28 – paragraph 10
10. The personnel of a conformity assessment body shall observerespect professional secrecy with regard to all information obtained in carrying out their tasks under Annex IV, except in relation to the competent authorities of the Member State in which its activities are carried out or to the competent authorities of the European Union. Intellectual property rights shall be protected.
Amendment 348 #
Proposal for a regulation
Article 28 – paragraph 10
Article 28 – paragraph 10
10. The personnel of a conformity assessment body shall observerespect professional secrecy with regard to all information obtained in carrying out their tasks under Annex IV, except in relation to the competent authorities of the Member State in which its activities are carried out or to the competent authorities of the European Union. Intellectual property rights shall be protected.
Amendment 350 #
Proposal for a regulation
Article 31 – paragraph 1
Article 31 – paragraph 1
1. A conformity assessment body shall submit an application for notification under this Regulation to the notifying authority of the Member State in which it is established or in any other Member State where he wants to perform his activity.
Amendment 350 #
Proposal for a regulation
Article 31 – paragraph 1
Article 31 – paragraph 1
1. A conformity assessment body shall submit an application for notification under this Regulation to the notifying authority of the Member State in which it is established or in any other Member State where he wants to perform his activity.
Amendment 353 #
Proposal for a regulation
Article 41 – paragraph 1 – subparagraph 1
Article 41 – paragraph 1 – subparagraph 1
Where the market surveillance authorities of one Member State have sufficient reason to believe that a toy covered by this Regulation presents a risk to the health or safety of personschildren, they shall carry out an evaluation in relation to the toy concerned covering all the requirements laid down in this Regulation. TUpon dully motivated request from the market surveillance authorities the relevant economic operators shall cooperate, as necessary, with the market surveillance authorities for that purpose.
Amendment 353 #
Proposal for a regulation
Article 41 – paragraph 1 – subparagraph 1
Article 41 – paragraph 1 – subparagraph 1
Where the market surveillance authorities of one Member State have sufficient reason to believe that a toy covered by this Regulation presents a risk to the health or safety of personschildren, they shall carry out an evaluation in relation to the toy concerned covering all the requirements laid down in this Regulation. TUpon dully motivated request from the market surveillance authorities the relevant economic operators shall cooperate, as necessary, with the market surveillance authorities for that purpose.
Amendment 355 #
Proposal for a regulation
Article 41 – paragraph 4 – subparagraph 2
Article 41 – paragraph 4 – subparagraph 2
The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures. Based on the information of the Member State who took the provisional measures to prohibit or restrict the toy, other Member States may decide to take appropriate provisional measures.
Amendment 355 #
Proposal for a regulation
Article 41 – paragraph 4 – subparagraph 2
Article 41 – paragraph 4 – subparagraph 2
The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures. Based on the information of the Member State who took the provisional measures to prohibit or restrict the toy, other Member States may decide to take appropriate provisional measures.
Amendment 369 #
Proposal for a regulation
Article 45 a (new)
Article 45 a (new)
Article45a Pan -European Injury Database 1. A Pan-European Injury Database covering all types of injuries caused by toys shall be set up and coordinated by the European Commission. 2. The relevant market surveillance authorities established by the Member States shall contribute to the establishment of the database and deliver injury data to the database, based on a common methodology, comprehensive and in accordance with European and national laws on data protection. 3. The Commission shall support the co- ordination of the collection of data from Member States and the operation of the database.
Amendment 369 #
Proposal for a regulation
Article 45 a (new)
Article 45 a (new)
Article45a Pan -European Injury Database 1. A Pan-European Injury Database covering all types of injuries caused by toys shall be set up and coordinated by the European Commission. 2. The relevant market surveillance authorities established by the Member States shall contribute to the establishment of the database and deliver injury data to the database, based on a common methodology, comprehensive and in accordance with European and national laws on data protection. 3. The Commission shall support the co- ordination of the collection of data from Member States and the operation of the database.
Amendment 413 #
Proposal for a regulation
Annex II – Part I – point 9
Annex II – Part I – point 9
9. Toys that are intended to emit sounds shall be designed and manufactured in such a way, in terms of the maximum values for impulse noise and continuous noise, that the sound from them is not able to impair children’s hearing. The limit values shall be set through a delegated act considering age cathegories after consultations with medical experts.
Amendment 413 #
Proposal for a regulation
Annex II – Part I – point 9
Annex II – Part I – point 9
9. Toys that are intended to emit sounds shall be designed and manufactured in such a way, in terms of the maximum values for impulse noise and continuous noise, that the sound from them is not able to impair children’s hearing. The limit values shall be set through a delegated act considering age cathegories after consultations with medical experts.
Amendment 422 #
Proposal for a regulation
Annex II – Part III – point 7 – point c
Annex II – Part III – point 7 – point c
(c) toy components necessary for electronic or electric functions of the toy where the substance or mixture is fully inaccessible to children, including by inhalation.
Amendment 422 #
Proposal for a regulation
Annex II – Part III – point 7 – point c
Annex II – Part III – point 7 – point c
(c) toy components necessary for electronic or electric functions of the toy where the substance or mixture is fully inaccessible to children, including by inhalation.
Amendment 429 #
Proposal for a regulation
Annex II – Part A – point 2
Annex II – Part A – point 2
2. N-nitrosamines and N-nitrosatable substances are prohibited in toys where the migration of those substances is equal to or higher than: Table - Limit values for elastomers PRODUCT TYPE a) toys intended for use by children under 36 months or in other toys intendedand intended or likely to be placed into the mouth where the migration of those substances is equal to or higher than 0,01 mg/kg for nitrosamines and 0,1 N-nitrosamines mg/kg: 0,01 N-nitrosatable substances mg/kg: 0,1 b) toys intended for use by children under 36 months not covered by a) N-nitrosamines mg/kg: 0,05 N-nitrosatable substances mg/kg: 1 c) toys intended for use by children of 36 months and over and intended to be placed into the mouth N-nitrosamines mg/kg: 0,05 N-nitrosatable substances mg/kg: 1 d) balloons N-nitrosamines mg/kg: 0,05 N-nitrosatable substances mg/k:g for nitros1 e) finger paints N-nitrosamines mg/kg: 0,02 N-nitrosatable substances. mg/kg: 1
Amendment 429 #
Proposal for a regulation
Annex II – Part A – point 2
Annex II – Part A – point 2
2. N-nitrosamines and N-nitrosatable substances are prohibited in toys where the migration of those substances is equal to or higher than: Table - Limit values for elastomers PRODUCT TYPE a) toys intended for use by children under 36 months or in other toys intendedand intended or likely to be placed into the mouth where the migration of those substances is equal to or higher than 0,01 mg/kg for nitrosamines and 0,1 N-nitrosamines mg/kg: 0,01 N-nitrosatable substances mg/kg: 0,1 b) toys intended for use by children under 36 months not covered by a) N-nitrosamines mg/kg: 0,05 N-nitrosatable substances mg/kg: 1 c) toys intended for use by children of 36 months and over and intended to be placed into the mouth N-nitrosamines mg/kg: 0,05 N-nitrosatable substances mg/kg: 1 d) balloons N-nitrosamines mg/kg: 0,05 N-nitrosatable substances mg/k:g for nitros1 e) finger paints N-nitrosamines mg/kg: 0,02 N-nitrosatable substances. mg/kg: 1