Legal provisions of COM(2023)462 - Safety of toys - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2023)462 - Safety of toys. |
|---|---|
| document | COM(2023)462 |
| date | July 28, 2023 |
Contents
CHAPTER - I
GENERAL PROVISIONS
Article 1
Subject matter
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 Union.
Article 2
Scope
1. This Regulation applies to products which are designed or intended, whether or not exclusively, for use in play by children under 14 years of age (‘toys’).
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 relevant age group.
2. This Regulation does not apply to the products listed in Annex I.
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).
Article 3
Definitions
For the purposes of this Regulation the following definitions apply:
(1) ‘making available on the market’ means any supply of a toy for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
(2) ‘placing on the market’ means the first making available of a toy on the Union market;
(3) ‘manufacturer’ means any natural or legal person who manufactures a toy or has a toy designed or manufactured, and markets that toy under that person’s name or trademark;
(4) ‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on that person’s behalf in relation to specified tasks;
(5) ‘importer’ means any natural or legal person established within the Union who places a toy from a third country on the Union market;
(6) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a toy available on the market;
(7) ‘fulfilment service provider’ means fulfilment service provider as defined in Article 2, point 11, of Regulation (EU) 2019/1020;
(8) ‘economic operator’ means the manufacturer, the authorised representative, the importer, the distributor and the fulfilment service provider;
(9) ‘online marketplace’ means online marketplace as defined in Article 3, point (14), of Regulation (EU) 2023/988;
(10) ‘harmonised standard’ means a harmonised standard as defined in Article 2, point (1), of Regulation (EU) No 1025/2012;
(11) ‘Union harmonisation legislation’ means Union legislation listed in Annex I to Regulation (EU) 2019/1020 and any other Union legislation harmonising the conditions for the marketing of products to which that Regulation applies;
(12) ‘CE marking’ means a marking by which the manufacturer indicates that the toy is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing;
(13) ‘toy model’ means a group of toys that meet the following conditions:
(a) they are under the responsibility of the same manufacturer,
(b) they have uniform design and technical characteristics,
(c) they are manufactured using uniform materials and manufacturing processes,
(d) they are defined by a type number or other element allowing them to be identified as a group;
(14) ‘data carrier’ means a linear bar code symbol, a two-dimensional symbol or other automatic identification data capture medium that can be read by a device;
(15) ‘unique product identifier’ means unique string of characters for the identification of toys that also enables a web link to the product passport;
(16) ‘unique operator identifier’ means a unique string of characters for the identification of actors involved in the value chain of toys;
(17) ‘release for free circulation’ means the customs procedure laid down in Article 201 of Regulation (EU) No 952/2013;
(18) ‘customs authorities’ means customs authorities as defined in Article 5, point (1), of Regulation (EU) No 952/2013;
(19) ‘EU Customs Single Window Certificates Exchange System’ means the system referred to in Article 4 of Regulation (EU) 2022/2399 of the European Parliament and of the Council42;
(20) ‘conformity assessment’ means the process demonstrating whether the essential requirements relating to a toy have been fulfilled;
(21) ‘conformity assessment body’ means a body that performs conformity assessment activities, including calibration, testing, certification and inspection;
(22) ‘accreditation’ means accreditation as defined in Article 2, point (10), of Regulation (EC) No 765/2008;
(23) ‘national accreditation body’ means a national accreditation body as defined in Article 2, point (11), of Regulation (EC) No 765/2008;
(24) ‘hazard’ means a potential source of harm;
(25) ‘risk’ means the combination of the probability of an occurrence of a hazard and the degree of severity of the harm caused by that hazard;
(26) ‘recall’ means any measure aimed at achieving the return of a toy that has already been made available to the end user;
(27) ‘withdrawal’ means any measure aimed at preventing a toy in the supply chain from being made available on the market;
(28) ‘market surveillance authority’ means a market surveillance authority as defined in Article 3, point (4), of Regulation (EU) 2019/1020;
(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;
(30) ‘aquatic toy’ means a toy that is intended for use in shallow water and which is capable of carrying or supporting a child in the water;
(31) ‘activity toy’ means a toy for domestic use in which the support structure remains stationary while the activity is taking place and which is intended for climbing, jumping, swinging, sliding, rocking, spinning, crawling, creeping, or any combination thereof;
(32) ‘chemical toy’ means a toy intended for the direct handling of chemical substances and mixtures;
(33) ‘olfactory board game’ means a toy the purpose of which is to assist a child to learn to recognise different odours or flavours;
(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;
(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;
(36) ‘substance of concern’ means substance of concern as defined in Article 2, point (28), of Regulation (EU) …/… [on Ecodesign Requirements for Sustainable Products].
Article 4
Free movement
1. Member States shall not impede, for reasons relating to health and safety or other aspects covered by this Regulation, the making available on the market of toys which comply with this Regulation.
2. 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 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.
During fairs, exhibitions and demonstrations, adequate measures shall be taken by economic operators to ensure the protection of persons.
Article 5
Product requirements
1. Toys shall only be placed on the market if they comply with the essential safety requirements which include the safety requirement set out in paragraph 2 (the ‘general safety requirement’) and the safety requirements set out in Annex II (the ‘particular safety requirements’).
2. 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 children, when they are used as intended or in a foreseeable way, bearing in mind the behaviour of children.
When assessing the risk referred to in the first subparagraph, the ability of the 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.
3. Toys placed on the market shall comply with the essential safety requirements during their foreseeable period of use.
Article 6
Warnings
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.
2. The following categories of toys shall bear warnings in accordance with the rules for each category set out in Annex III:
(a) toys not intended for use by children under 36 months;
(b) activity toys;
(c) functional toys;
(d) chemical toys;
(e) skater, roller skates, inline skates, skateboards, scooters and toy bicycles;
(f) aquatic toys;
(g) toys in food;
(h) imitations of protective masks and helmets;
(i) toys intended to be strung across a cradle, cot or perambulator by means of strings, cords, elastics or straps;
(j) packaging for fragrances in olfactory board games, cosmetic kits and gustative games.
Toys shall not bear one or more of the warnings set out in Annex III where such warnings conflict with the intended use of the toy, as determined by virtue of its function, dimension and characteristics.
3. 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 toys which are sold without packaging shall have appropriate warnings affixed to them.
Warnings 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.
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 toys, and to the ways of avoiding such hazards and risks.
CHAPTER II
OBLIGATIONS OF ECONOMIC OPERATORS
Article 7
Obligations of manufacturers
1. When placing toys on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with the essential safety requirements.
2. Before placing toys on the market, manufacturers shall draw up the required technical documentation in accordance with Article 23 and carry out the applicable conformity assessment procedure in accordance with Article 22 or have it carried out.
Where compliance of a toy with the applicable requirements laid down in this Regulation has been demonstrated by the procedure referred to in the first subparagraph, manufacturers shall, before the toy is placed on the market:
(a) create a product passport for the toy in accordance with Article 17;
(b) affix the data carrier to the toy or to a label attached to the toy, in accordance with Article 17(5);
(c) affix the CE marking in accordance with Article 16(1);
(d) upload the unique product identifier and the unique operator identifier of the toy in the product passport registry referred to in Article 19(1), as well as any other additional information determined by a delegated act adopted in accordance with Article 46(2).
3. Manufacturers shall keep the technical documentation and the product passport for a period of 10 years after the toy covered by that documentation and product passport has been placed on the market.
4. Manufacturers shall ensure that procedures are in place for toys that are part of a series production to remain in conformity with this Regulation. Changes in the design or characteristics of toys, and changes in the harmonised standards referred to in Article 13 or the common specifications referred to in Article 14 by reference to which conformity of a toy is declared or by application of which its conformity is verified, shall be adequately taken into account.
When manufacturers, with regard to the risks presented by a toy, consider it necessary for the protection of health and safety of consumers, manufacturers shall, carry out sample testing of marketed toys.
5. Manufacturers shall ensure that toys bear a type, batch, serial or model number or other element allowing their identification, or, where the size or nature of the toy does not allow it, that the required information is provided on the packaging or in a document accompanying the toy.
6. Manufacturers 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 packaging or in a document accompanying the toy. Manufacturers shall indicate a single point at which they can be contacted.
7. Manufacturers shall ensure that the toy is accompanied by instructions and safety information in a language or languages easily understood by consumers and other end-users, as determined by the Member State concerned. Such instructions and information shall be clear, understandable and legible.
8. Where manufacturers consider, or have reason to believe, that a toy which they have placed on the market is not in conformity with this Regulation, they shall immediately take the corrective measures necessary to bring that toy into conformity, withdraw it or recall it, as appropriate.
Where manufacturers consider, or have reason to believe, that a toy presents a risk, they shall immediately provide information thereof to:
(a) the market surveillance authorities of the Member States in which they have made the toy available, via the Safety Business Gateway referred to in Article 26 of Regulation (EU) 2023/988, giving details, in particular, of any non-compliance and of any corrective measures taken; and
(b) the consumers or other end-users, in accordance with Article 35 or 36 of Regulation (EU) 2023/988, or both.
9. Manufacturers shall, further to a reasoned request from a competent national authority, provide it, with all the information and documentation necessary to demonstrate the conformity of the toy, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, as regards any action taken to eliminate the risks posed by toys which they have placed on the market.
10. Manufacturers shall ensure that other economic operators, the economic operator referred to in Article 4(1) of Regulation (EU) 2019/1020, and online marketplaces, in the supply chain concerned, are kept informed in a timely manner of any non-conformity that the manufacturers have identified.
11. Manufacturers shall make publicly available a telephone number, an electronic address, a dedicated section of their website or another communication channel, allowing consumers or other end-users to file complaints concerning the safety of toys and to inform the manufacturers of any accident or safety issue they have experienced with such toys. In doing so, the manufacturers shall take into account the accessibility needs for persons with disabilities.
12. Manufacturers shall investigate complaints and information referred to in paragraph 11 and shall keep an internal register of those complaints and that information, as well as of recalls and any other corrective measures taken to bring the toys into conformity with this Regulation.
13. The internal register referred to in paragraph 12 shall only contain personal data that are necessary for the manufacturer to investigate the complaint or the information referred to in paragraph 11. Such data shall only be kept as long as is necessary for the purpose of the investigation and, in any event, no longer than 5 years after the data have been entered in the register.
Article 8
Authorised representatives
1. A manufacturer may appoint an authorised representative by written mandate.
2. The obligations laid down in Article 7(1), and the obligation to draw up technical documentation referred to in Article 7(2), shall not form part of the authorised representative’s mandate.
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 allow the authorised representative to do at least the following:
(a) keep the technical documentation at the disposal of national surveillance authorities and ensure that the product passport is available, in accordance with Article 17(2), for a period of 10 years after the toy covered by those documents has been placed on the market;
(b) further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a toy;
(c) cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by toys covered by the mandate.
4. Where a manufacturer not established in the Union appoints an authorised representative as referred to in paragraph 1 of this Article, the written mandate shall include the tasks set out in Article 4(3) of Regulation (EU) 2019/1020.
Article 9
Obligations of importers
1. Importers shall only place on the market toys complying with this Regulation.
2. Before placing toys on the market, importers shall ensure the following:
(a) the manufacturer has carried out the appropriate conformity assessment procedure and drawn up the technical documentation referred to in Article 7(2);
(b) the toy is accompanied by instructions of use and safety information in accordance with in Article 7(7) in a language or languages which can be easily understood by consumers or other end-users, as determined by the Member State concerned;
(c) the manufacturer has created a product passport for the toy in accordance with Article 7(2);
(d) the toy bears a data carrier in accordance with Article 17(5);
(e) the relevant information in the product passport has been included in the product passport registry in accordance with Article 19(1);
(f) the toy bears the CE marking in accordance with Article 16;
(g) the manufacturer has complied with the requirements set out in Article 7(5) and (6).
Where importers consider, or have reason to believe, that a toy is not in conformity with the essential safety requirements, they shall not place the toy on the market until it has been brought into conformity.
Where importers consider, or have reason to believe, that the toy presents a risk, they shall immediately provide information thereof to:
(a) the manufacturer;
(b) the market surveillance authorities, via the Safety Business Gateway referred to in Article 26 of Regulation (EU) 2023/988 ;
(c) consumers or other end-users, in accordance with Article 35 or 36 of Regulation (EU) 2023/988, or both.
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 packaging or in a document accompanying the toy.
4. Importers shall ensure that, while a toy is under their responsibility, their storage or transport conditions do not jeopardise the toy’s compliance with the essential safety requirements.
5. When importers, with regard to the risks presented by a toy, consider it necessary for the protection of health and safety of consumers or other end-users, they shall carry out sample testing of marketed toys.
6. Where importers consider, or have reason to believe, that a toy which they have placed on the market is not in conformity with the relevant Union harmonisation legislation, they shall immediately take the corrective measures necessary to bring that toy into conformity, withdraw it or recall it, as appropriate.
Where importers consider, or have reason to believe, that a toy that they have placed on the market presents a risk to health and safety of consumers and other end-users, they shall immediately inform the competent national authorities of the Member States in which they made the toy available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.
7. Importers shall, for a period of 10 years after the toy has been placed on the market, keep the unique product identifier of the toy at the disposal of the market surveillance authorities and ensure that the technical documentation referred to in Article 23 can be made available to those authorities, upon request.
8. Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the toy in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, as regards any action taken to eliminate the risks posed by toys which they have placed on the market.
9. Importers shall verify whether the manufacturer has made a communication channel as referred to in Article 7(11) publicly available to consumers or other end-users, allowing them to present complaints concerning the safety of toys and provide information on any accident or safety issue they have experienced with the toy. If a communication channel is not available, importers shall provide for such a channel, taking into account accessibility needs for persons with disabilities.
10. Importers shall investigate complaints and information referred to in paragraph 9 of this Article that they have received via a communication channel made available by the manufacturer, or via a communication channel made available by the importers themselves, and that concern the toys which they have made available on the market. Importers shall file those complaints, as well as recalls and any other corrective measures taken to bring the toys into conformity with this Regulation, in the register referred to in Article 7(12), or in their own internal register.
Importers shall keep the manufacturer, distributors and, where relevant, online marketplaces informed in a timely manner of the investigation performed and of the results of the investigation.
11. Personal data contained in the internal register of the importers referred to in paragraph 10 shall only be those personal data that are necessary for the importer to investigate the complaint or the information referred to in paragraph 9. Such data shall only be kept as long as is necessary for the purpose of the investigation and, in any event, no longer than 5 years after the data have been entered in the register.
Article 10
Obligations of distributors
1. When making a toy available on the market, distributors shall act with due care in relation to the requirements of this Regulation.
2. Before making a toy available on the market, distributors shall verify that the following conditions have been met:
(a) the toy is accompanied by instructions and safety information in a language or languages which can be easily understood by consumers or other end-users as determined by the Member State in which the toy is to be made available on the market;
(b) the toy bears a data carrier in accordance with Article 17(5) and the CE marking in accordance with Article 16 and
(c) the manufacturer and the importer have complied with the requirements set out in Article 7(2), second subparagraph, Article 7(5), (6) and (11) and Article 9(3) respectively.
Where distributors consider, or have reason to believe, that a toy is not in conformity with the essential safety requirements, they shall not make the toy available on the market until it has been brought into conformity.
Where distributors consider, or have reason to believe, that the toy presents a risk, they shall immediately provide information thereof to:
(a) the manufacturer or the importer;
(b) the market surveillance authorities through the Safety Business Gateway referred to in Article 26 of Regulation (EU) 2023/988;
(c) consumers or other end-users, in accordance with Article 35 or 36 of Regulation (EU) 2023/988, or both.
3. Distributors shall ensure that, while a toy is under their responsibility, storage or transport conditions do not jeopardise its compliance with the essential safety requirement.
4. Where distributors consider, or have reason to believe, that a toy which they have made available on the market is not in conformity with this Regulation, they shall ensure that the corrective measures necessary to bring that toy into conformity, to withdraw it or recall it, if appropriate, are taken.
Where distributors consider, or have reason to believe, that a toy that they have made available on the market presents a risk, they shall immediately inform the market surveillance authorities of the Member States in which they made the toy available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.
5. Distributors shall, further to a reasoned request from a competent national authority, provide it, with all the information and documentation necessary to demonstrate the conformity of the toy, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, as regards any action taken to eliminate the risks posed by toys which they have made available on the market.
Article 11
Cases in which obligations of manufacturers apply to importers and distributors
An importer or a distributor shall be considered a manufacturer for the purposes of this Regulation, and shall be subject to the obligations of the manufacturer under Article 7, where such importer or distributor places a toy on the market under its name or trademark or modifies a toy already placed on the market in such a way that compliance with the applicable requirements of this Regulation may be affected.
Article 12
Identification of economic operators
1. Economic operators shall, on request, identify the following to the market surveillance authorities:
(a) any economic operator who has supplied them with a toy;
(b) any economic operator to whom they have supplied a toy.
2. Economic operators shall be able to present the information referred to in the paragraph 1 for a period of 10 years after the toy has been placed on the market, in the case of the manufacturer, and for a period of 10 years after they have been supplied with the toy, in the case of other economic operators.
CHAPTER III
CONFORMITY OF TOYS
Article 13
Presumption of conformity
Toys which are in conformity with harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the essential safety requirements to the extent that those requirements are covered by those standards or parts thereof.
Article 14
Common specifications
1. Toys which are in conformity with the common specifications referred to in paragraph 2 of this Article or parts thereof shall be presumed to be in conformity with the essential safety requirements to the extent that those requirements are covered by those common specifications or parts thereof.
2. The Commission may, by means of implementing acts, establish common specifications for the essential safety requirements where the following conditions are fulfilled:
(a) there is no harmonised standard covering those requirements the reference of which is published in the Official Journal of the European Union or the standard does not satisfy the requirements it aims to cover;
(b) the Commission has requested, pursuant to Article 10(1) of Regulation 1025/2012, one or more European standardisation organisations to draft or to revise European standards for those requirements and either of the following conditions is fulfilled:
(1) the request has not been accepted by any of the European standardisation organisations to which the request was addressed;
(2) the request has been accepted by at least one of the European standardisation organisations to which the request was addressed, but the European standards requested:
(a) have not been adopted within the deadline set in the request;
(b) do not comply with the request; or
(c) do not satisfy the requirements they aim to cover.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 50(3).
3. When references of a harmonised standard are published in the Official Journal of the European Union, the Commission shall assess whether the implementing acts referred to in paragraph 2 of this Article which cover the same essential safety requirement need to be repealed or amended.
Article 15
General principles of the CE marking
Toys made available on the market shall bear the CE marking.
The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
Article 16
Rules and conditions for affixing the CE marking
1. The CE marking shall be affixed visibly, legibly and indelibly to the toy, to a label attached to the toy or to the packaging of the toy.
By way of derogation from the first subparagraph, in the case of small toys and toys consisting of small parts, the CE marking may be affixed to a leaflet accompanying the toy.
By way of derogation from the first subparagraph, in the case of toys sold in counter displays where it is not technically possible to affix the CE marking to each individual toy, the CE marking may be affixed to the counter display on the condition that the counter display was originally used as packaging for the toy.
Where the CE marking affixed to the toy is not visible from outside the packaging, it shall also be affixed to the packaging.
2. The CE marking shall be affixed before the toy is placed on the market.
3. The CE marking shall, where applicable in accordance with Article 6, be followed by a pictogram or any other warning indicating a special risk or use.
4. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.
CHAPTER IV
PRODUCT PASSPORT
Article 17
Product passport
1. Before placing a toy on the market, manufacturers shall create a product passport for that toy. The product passport shall meet the requirements laid down in this Article and Article 18.
2. The product passport shall:
(a) correspond to a specific toy model;
(b) state that compliance of the toy with the requirements set out in this Regulation and, in particular, the essential safety requirements, has been demonstrated;
(c) contain at least the information set out in Part I of Annex VI;
(d) be up to date;
(e) be available in the language or languages required by the Member State where the toy is made available on the market;
(f) be accessible to consumers or other end-users, market surveillance authorities, customs authorities, notified bodies, the Commission and other economic operators;
(g) be available for a period of 10 years after the toy is placed on the market, also in cases of insolvency, a liquidation or a cessation of activity in the Union of the economic operator that created the product passport;
(h) be accessible through a data carrier;
(i) fulfil the specific and technical requirements laid down pursuant to paragraph 10.
3. In addition to the information referred to in paragraph 2, the product passport may contain the information set out in Part II of Annex VI.
4. By creating the product passport, the manufacturer shall assume responsibility for the compliance of the toy with this Regulation.
5. The data carrier shall be physically present on the toy or on a label attached to the toy, in accordance with the implementing act adopted in accordance with paragraph 10. In the case of small toys and toys consisting of small parts, the data carrier may alternatively be affixed to its packaging. It shall be clearly visible to the consumer before any purchase and to market surveillance authorities, including in cases where the toy is made available through distance sales.
6. Where other Union legislation requires information on the toy to be available via a data carrier, a single data carrier shall be used to provide the information required under this Regulation and such other Union legislation.
7. Where other Union legislation applying to toys requires a product passport, a single product passport shall be created for toys containing the information required under this Regulation as well as any other information required for the product passport by that other Union legislation.
8. By way of derogation from paragraph 2, point (c), where information requirements relating to substances of concern in toys are established in a delegated act adopted in accordance with Article 4 of Regulation …/… [OP please insert: the Ecodesign for Sustainable Products Regulation], the information referred to in Part I, point (k), of Annex VI to this Regulation is no longer required.
9. Economic operators may, in addition to the information referred to in paragraphs 6 and 7, make other information accessible through the data carrier referred to in paragraph 5. Where this is the case, that information shall be clearly separated from the information required under this Regulation and, where relevant, under other Union legislation.
10. The Commission shall adopt implementing acts determining the specific and technical requirements related to the product passport for toys. Those requirements shall cover in particular the following:
(a) the types of data carrier to be used;
(b) the layout in which the data carrier is to be presented and its positioning;
(c) the technical elements of the passport for which defined European or international standards are to be used;
(d) the actors that may introduce or update the information in the product passport, including where needed the creation of a new passport, including manufacturers, notified bodies, competent national authorities, and the Commission, or any organisation acting on their behalf, and the types of information they may introduce or update.
Those implementing acts shall be adopted in accordance with the procedure set out in Article 50(3).
Article 18
Technical design and operation of the product passport
1. The product passport shall be fully interoperable with product passports required by other Union legislation in relation to the technical, semantic and organisational aspects of end-to-end communication and data exchange.
2. All information included in the product passport shall be based on open standards developed with an interoperable format and shall be machine readable, structured and searchable.
3. Consumers or other end-users, economic operators and other relevant actors shall have access to the product passport free of charge.
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.
5. Where the data included in the product passport is stored or otherwise processed by an operator authorised to act on behalf of the economic operators placing the toy on the market, that other operator shall not be allowed to sell, re-use or process such data, in whole or in part, beyond what is necessary for the provision of the relevant storing or processing services.
6. Economic operators may not track, analyse or use any usage information for purposes other than what is absolutely necessary for providing the information on the product passport online.
Article 19
Product passport registry
1. Before placing a toy on the market, economic operators shall upload, in the registry established under Article 12(1) of Regulation (EU) …/… [PO insert serial number for Ecodesign Requirements for Sustainable Products] (the ‘registry’), the unique product identifier and unique operator identifier for that toy.
2. The Commission, market surveillance authorities and customs authorities shall have access to the information stored in the registry referred to in paragraph 1 for carrying out their duties pursuant to this Regulation.
Article 20
Customs controls relating to the product passport
1. Toys entering the Union market shall be subject to verifications and other measures laid down in this Article.
2. Declarants as defined in Article 5, point (15), of Regulation (EU) No 952/2013 shall include the unique product identifier in the customs declaration for release for free circulation of any toy.
3. Customs authorities shall verify whether the unique product identifier indicated by the declarant in accordance with paragraph 2 of this Article corresponds to a unique product identifier included in the registry in accordance with Article 19(1).
4. In addition to the verification referred to in paragraph 3 of this Article, customs authorities shall verify the consistency of information made available to customs by declarants with other information stored in the registry and listed in the delegated act referred to in Article 46(3).
5. The verifications referred to in paragraphs 3 and 4 of this Article shall take place electronically and automatically using the interconnection between the registry referred to in Article 19(1) and the EU Customs Single Window Certificates Exchange System referred to in [Article 13 of [P.O. insert serial number for Regulation (EU) …/… on Ecodesign Requirements for Sustainable Products]].
6. Paragraphs 3, 4 and 5 of this Article shall apply from the day when the interconnection between the registry and the EU Customs Single Window Certificates Exchange System referred to in [Article 13 of [P.O. insert serial number for Regulation (EU) …/… on Ecodesign Requirements for Sustainable Products]] becomes operational.
The Commission shall publish a notice in the Official Journal of the European Union to that effect indicating the date when the interconnection is operational.
7. Customs authorities may retrieve and use the information on toys included in the product passport and in the registry for carrying out their duties pursuant to Union legislation, including for risk management in accordance with Articles 46 and 47 of Regulation (EU) No 952/2013.
8. The verifications and other measures laid down in this Article shall be carried out on the basis of the list of commodity codes and product descriptions set out in Annex VII.
9. The verifications and measures laid down in this Article shall not affect the application of other Union legal acts governing the release for free circulation of products, including Articles 46, 47 and 134 of Regulation (EU) No 952/2013, and the controls referred to in Chapter VII of Regulation (EU) 2019/1020.
CHAPTER V
CONFORMITY ASSESSMENT
Article 21
Safety assessment
1. In order to demonstrate that a toy complies with the essential safety requirements, manufacturers shall, before placing a toy on the market, carry out a safety assessment including an analysis of the hazards that the toy may present, as well as an assessment of the potential exposure to such hazards.
2. The safety assessment shall in particular :
(a) cover all the chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards and the potential exposure to such hazards;
(b) in relation to chemical hazards, take account of the possible exposure to individual chemicals, and any known additional hazards from combined exposure to the different chemicals present in the toy, taking into account the obligations under Regulation (EC) No 1907/2006 and the conditions set out therein;
(c) be updated whenever additional relevant information is available.
The safety assessment shall be included in the technical documentation referred to in Article 23.
Article 22
Conformity assessment procedures
1. Manufacturers shall use the conformity assessment procedures referred to in paragraphs 2 and 3.
2. If the manufacturer has applied harmonised standards, the reference of which has been published in the Official Journal of the European Union, or common specifications covering all relevant safety requirements for the toy, the manufacturer shall use the internal production control procedure set out in Part I of Annex IV.
3. In the following cases, the manufacturer shall use the EU-type examination procedure set out in Part II of Annex IV together with the conformity to type procedure set out in Part III of that Annex:
(a) where harmonised standards, the reference of which has been published in the Official Journal of the European Union, or common specifications covering all relevant safety requirements for the toy, do not exist;
(b) where harmonised standards or common specifications referred to in point (a) exist but the manufacturer has not applied them or has applied them only in part;
(c) where one or more of the harmonised standards referred to in point (a) has been published with a restriction;
(d) where the manufacturer considers that the nature, design, construction or purpose of the toy necessitates third party verification.
4. The EU-type examination certificate issued in accordance with Part II, point 6, of Annex IV shall be reviewed whenever necessary, in particular in case of a change to the manufacturing process, the raw materials or the components of the toy, and, in any case, every five years.
Article 23
Technical documentation
1. The technical documentation shall contain all relevant data or details of the means used by the manufacturer to ensure that the toy complies with the essential safety requirements. It shall, in particular, contain the documents listed in Annex V.
2. The technical documentation shall be drawn up in one of the official languages of the Union.
3. Following a reasoned request from the market surveillance authority of a Member State, the manufacturer shall provide a translation of the relevant parts of the technical documentation into the language of that Member State.
When a market surveillance authority requests the technical documentation or a translation of parts thereof from a manufacturer, it may fix a deadline for receipt of such file or translation, which shall be 30 days, unless a shorter deadline is justified in the case of serious and immediate risk to health and safety.
4. If the manufacturer does not comply with the requirements set out in paragraphs 1, 2 and 3, the market surveillance authority may require the manufacturer to have a test performed by a notified body at its own expense within a specified period in order to verify compliance with the essential safety requirements.
CHAPTER VI
NOTIFICATION OF CONFORMITY ASSESSMENT BODIES
Article 24
Notification
Member States shall notify the Commission and the other Member States of bodies authorised to carry out third-party conformity assessment tasks under this Regulation.
Article 25
Notifying authorities
1. Member States shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies for the purposes of this Regulation, and for the monitoring of notified bodies, including compliance with Article 30.
2. Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.
3. Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1 of this Article to a body which is not a governmental entity, that body shall be a legal entity and shall comply mutatis mutandis with the requirements laid down in Article 26. In addition, that body shall have arrangements to cover liabilities arising out of its activities.
4. The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraph 3.
Article 26
Requirements relating to notifying authorities
1. A notifying authority shall be established in such a way that no conflict of interest with conformity assessment bodies occurs.
2. A notifying authority shall be organised and operated so as to safeguard the objectivity and impartiality of their activities.
3. A notifying authority shall be organised in such a way that each decision relating to notification of a conformity assessment body is taken by competent persons different from those who carried out the assessment.
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.
5. A notifying authority shall safeguard the confidentiality of the information they obtain.
6. A notifying authority shall have a sufficient number of competent personnel at their disposal for the proper performance of their tasks.
7. A notifying authority shall monitor the nature and amount of tasks performed by subsidiaries of or subcontractors to notified bodies in accordance with Article 30.
Article 27
Information obligation of notifying authorities
Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto.
The Commission shall make that information publicly available.
Article 28
Requirements relating to notified bodies
1. For the purposes of notification under this Regulation, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11. It shall be accredited in accordance with Regulation (EC) No 765/2008.
2. Conformity assessment bodies shall be established under the national law of a Member State and shall have legal personality.
3. A conformity assessment body shall be a third-party body independent of the organisation or the toy it assesses.
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 a third-party body for the purposes of the first subparagraph.
4. A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the toys which they assess, nor the authorised representative of any of those parties. This shall not preclude use of the assessed toys that is necessary for the operations of the conformity assessment body or the use of those toys for personal purposes.
A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture, marketing, installation, use or maintenance of those toys, or represent the parties engaged in those activities. 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.
Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.
5. Conformity assessment bodies and their personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities.
6. A conformity assessment body shall be capable of carrying out the conformity assessment tasks assigned to it by Annex IV and in relation to which it has been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.
At all times and for each conformity assessment procedure and each kind or category of toy in relation to which it has been notified, a conformity assessment body shall have at its disposal, or in place, the following:
(a) personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;
(b) descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and ability of reproduction of those procedures;
(c) appropriate policies and procedures that distinguish between tasks it carries out as a notified body and other activities;
(d) procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the technology of the toy in question and the mass or serial nature of the production process.
A conformity assessment body shall have the means 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.
7. The personnel responsible for carrying out the conformity assessment activities (the ‘assessment personnel’) shall have the following:
(a) sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;
(b) satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;
(c) appropriate 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;
(d) the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.
8. The impartiality of conformity assessment bodies, their top level management and assessment personnel shall be ensured.
The remuneration of the top level management and assessment personnel of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments.
9. Conformity assessment bodies shall take out liability insurance unless liability is assumed by the Member State in accordance with its national law, or the Member State itself is directly responsible for the conformity assessment.
10. The personnel of a conformity assessment body shall observe 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. Intellectual property rights shall be protected.
11. Conformity assessment bodies shall participate in, or ensure that their assessment personnel are informed of, the relevant standardisation activities and the activities of the notified body coordination group established under Article 40, and shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group.
Article 29
Presumption of conformity of notified bodies
Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, it shall be presumed to comply with the requirements set out in Article 28 insofar as the applicable harmonised standards cover those requirements.
Article 30
Subsidiaries of and subcontracting by notified bodies
1. Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 28, and shall inform the notifying authority accordingly.
2. Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries, wherever these are established.
3. Notified bodies shall be capable of reviewing the tasks performed by the subcontractors or subsidiaries in all their elements.
4. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client.
5. Notified bodies shall keep at the disposal of the notifying authority the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under Annex IV.
Article 31
Application for notification
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.
2. The application referred to in paragraph 1 shall be accompanied by a description of the conformity assessment activities and the toys for which that body claims to be competent, as well as by an accreditation certificate issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 28.
Article 32
Notification procedure
1. Notifying authorities may only notify conformity assessment bodies which have satisfied the requirements laid down in Article 28.
2. Notifying authorities shall notify conformity assessment bodies to the Commission and the other Member States using the electronic notification tool developed and managed by the Commission.
3. The notification shall include full details of the conformity assessment activities and the relevant accreditation certificate. The notification shall also include information on any tasks to be performed by subsidiaries and subcontractors.
4. The body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two months of a notification.
Only such a body shall be considered a notified body for the purposes of this Regulation.
5. The notifying authority shall inform the Commission and the other Member States of any subsequent relevant changes to the notification.
Article 33
Identification numbers and lists of notified bodies
1. The Commission shall assign an identification number to each notified body.
It shall assign a single identification number even where the same body is notified under several Union acts.
2. The Commission shall make publicly available a list of bodies notified under this Regulation, including the identification numbers that have been assigned to them and the activities for which they have been notified.
The Commission shall ensure that the list is kept up to date.
Article 34
Changes to notifications
1. Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 28, or that it is failing to fulfil its obligations, the notifying authority shall restrict, suspend or withdraw the notification as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly.
2. In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the notifying Member State shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available to the responsible notifying authorities and market surveillance authorities, at their request.
Article 35
Challenge to the competence of notified bodies
1. The Commission shall investigate all cases where it doubts, or doubt is brought to its attention regarding, the competence of a notified body or the continued fulfilment by a notified body of the requirements and responsibilities to which it is subject.
2. The notifying authority shall provide the Commission, on request, with all information relating to the basis for the notification or the maintenance of the competence of the body concerned.
3. The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially.
4. Where the Commission ascertains that a notified body does not meet the requirements for notification, it shall, by means of an implementing act, request the notifying authority to take the necessary corrective measures, including the withdrawal of the notification if necessary.
Article 36
Operational obligations of notified bodies
1. A notified body shall carry out conformity assessments in accordance with the conformity assessment procedure provided for in Annex IV.
2. Notified bodies shall carry out the conformity assessment activities set out in this Regulation in a proportionate manner, avoiding unnecessary burdens for economic operators. They shall perform their activities under this Regulation taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the technology of the toy in question and the mass or serial nature of the production process.
When performing their activities, the notified bodies shall respect the degree of rigour and the level of protection required for the compliance of the toy with this Regulation.
3. Where a notified body finds that the toy does not meet the essential safety requirements, the requirements in corresponding harmonised standards, where such standards are applied or the requirements in corresponding common specifications referred to in Article 14, where such specifications are applied, it shall require that manufacturer to take appropriate corrective measures and shall not issue an EU-type examination certificate as referred to in Part II, point 6, of Annex IV.
4. Where, in the course of the monitoring of conformity following the issue of a EU-type examination certificate, a notified body finds that a toy is no longer in compliance, it shall require the manufacturer to take appropriate corrective measures, and shall suspend or withdraw the EU-type examination certificate if necessary.
5. Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw any EU-type examination certificates, as appropriate.
6. Where a notified body is informed by a market surveillance authority that a toy for which the notified body has issued a EU-type examination certificate is not in conformity with the essential safety requirements, it shall withdraw the EU-type examination certificate in respect of that toy.
Article 37
Appeals against decisions of notified bodies
A notified body shall ensure that a transparent and accessible appeals procedure against its decisions is available.
Article 38
Information obligation of notified bodies
1. Notified bodies shall inform the notifying authority of the following:
(a) any refusal, restriction, suspension or withdrawal of an EU-type examination certificate;
(b) any circumstances affecting the scope of and conditions for their notification;
(c) any request for information which they have received from market surveillance authorities regarding conformity assessment activities;
(d) on request, conformity assessment activities performed within the scope of their notification, and any other activity performed, including cross-border activities and subcontracting.
2. Notified bodies shall provide the other bodies notified under this Regulation which carry out similar conformity assessment activities covering the same toys with relevant information on issues relating to negative and, on request, positive conformity assessment results.
3. Notified bodies shall, further to a reasoned request from a market surveillance authority, provide it with all the information and documentation that relates to any EU-type examination certificate which they have issued or withdrawn, or that relates to any refusal to issue such a certificate, including test reports, and the technical documentation referred to in Article 23.
Article 39
Exchange of experience
The Commission shall provide for the organisation of exchange of experience between the Member States' national authorities responsible for notification policy.
Article 40
Coordination of notified bodies
The Commission shall ensure that appropriate coordination and cooperation between bodies notified under this Regulation are put in place and properly operated in the form of a sectoral group or groups of notified bodies.
Notified bodies shall participate in the work of that group or groups, directly or by means of designated representatives.
CHAPTER VII
MARKET SURVEILLANCE
Article 41
Procedure for dealing with toys presenting a risk at national level
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 persons, they shall carry out an evaluation in relation to the toy concerned covering all the requirements laid down in this Regulation. The relevant economic operators shall cooperate, as necessary, with the market surveillance authorities for that purpose.
Where, in the course of that evaluation, a market surveillance authority finds that a toy does not comply with the requirements laid down in this Regulation, it shall without delay require the relevant economic operator to take appropriate corrective action in accordance with Article 16(3) of Regulation (EU) 2019/1020 within a reasonable period of time prescribed by the market surveillance authority and taking into account the nature of the risk.
The market surveillance authorities shall inform the relevant notified body accordingly.
2. Where the market surveillance authorities consider that non-compliance is not restricted to their 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 relevant economic operator to take.
3. The economic operator shall ensure that appropriate corrective action is taken in respect of all the concerned toys that the economic operator has made available on the market throughout the Union.
4. Where the relevant economic operator does not take adequate corrective action within the period referred to in paragraph 1, second subparagraph, the market surveillance authorities shall take appropriate provisional measures to prohibit or restrict the toy being made available on their national market, to withdraw the toy from that market or to recall it.
The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures.
5. The information referred to in paragraph 4, second subparagraph, shall include all available details, in particular the data necessary for the identification of the non-compliant toy including the unique product identifier, the origin of that toy, the nature of the alleged non-compliance and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to any of the following:
(a) failure of the toy to meet the essential safety requirements;
(b) shortcomings in the harmonised standards referred to in Article 13;
(c) shortcomings in the common specifications referred to in Article 14.
6. Market surveillance authorities of Member States other than the Member State initiating the procedure under this Article shall without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the toy concerned, and, in the event of disagreement with the notified national measure, of their objections.
7. Where, within 3 months of receipt of the information referred to in paragraph 4, second subparagraph, no objection has been raised by either a market surveillance authority of a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed to be justified.
8. Market surveillance authorities of other Member States shall ensure that appropriate restrictive measures, such as withdrawal of the toy from their market, are taken without delay in respect of the toy concerned, and shall inform the Commission and the other Member States of those measures.
9. The information referred to in paragraphs 2, 4, 6 and 8 of this Article shall be communicated through the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020. That communication shall not affect the obligation on market surveillance authorities to notify measures taken against products presenting a serious risk in accordance with Article 20 of Regulation (EU) 2019/1020.
Article 42
Union safeguard procedure
1. Where, on completion of the procedure set out in Article 41(3) and (4), objections are raised against a measure taken by a Member State, or where the Commission has reasons to believe that a national measure could be contrary to Union legislation, the Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measure.
On the basis of the results of that evaluation, the Commission shall adopt an implementing act determining whether the national measure is justified or not.
The Commission shall address its decision to all Member States and shall without delay communicate it to them and the relevant economic operator or operators.
2. If the national measure is considered justified, all Member States shall take the measures necessary to ensure that the non-compliant toy is withdrawn or recalled from their market, and shall inform the Commission accordingly.
If the national measure is considered unjustified, the Member State concerned shall withdraw it.
3. Where the national measure is considered to be justified and the non-compliance of the toy is attributed to shortcomings in the harmonised standards referred to in Article 13 of this Regulation or the common specifications referred to in Article 14 of this Regulation, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012 or amend the common specifications as appropriate.
Article 43
Formal non-compliance
1. Without prejudice to Article 41, where a market surveillance authority makes one of the following findings with regard to a toy, it shall require the relevant economic operator to put an end to the non-compliance concerned:
(a) the CE marking has been affixed in violation of Article 15 or 16;
(b) the CE marking has not been affixed;
(c) the product passport has not been drawn up in accordance with Article 17;
(d) the data carrier through which the product passport is accessible has not been affixed in accordance with Article 17(5);
(e) the technical documentation referred to in Article 23 is either not available or not complete.
2. Where the non-compliance referred to in paragraph 1 persists, the market surveillance authority concerned shall take appropriate measures to restrict or prohibit the making available on the market of the toy, or ensure that the toy is recalled or withdrawn from the market.
Article 44
National measures concerning toys which are compliant with the particular safety requirements but which present a risk
1. Where, having carried out an evaluation under Article 41(1), a market surveillance authority finds that, although a toy made available on the market is in compliance with the particular safety requirements it poses a risk to the health and safety of persons, it shall require the relevant economic operator to take all appropriate measures, within a reasonable period of time prescribed by the market surveillance authority taking into account the nature of the risk to ensure that the toy, when made available on the market, no longer presents that risk, to withdraw the toy from the market or to recall it.
2. The economic operator shall ensure that corrective action is taken in respect of all the toys concerned that the economic operator has made available on the market throughout the Union.
3. The market surveillance authority of the Member State shall immediately inform the Commission and the other Member States of its findings and any subsequent actions taken by the economic operator. That information shall include all available details, in particular the data necessary for the identification of the toy concerned including the unique product identifier, the origin and the supply chain of the toy, the nature of the risk involved and the nature and duration of the national measures taken.
4. The Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall adopt an implementing act determining whether the national measure is justified or not and, where necessary, propose appropriate measures.
The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators.
5. The information referred to in paragraph 3 of this Article shall be communicated through the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020. That communication shall not affect the obligation on market surveillance authorities to notify measures taken against products presenting a serious risk in accordance with Article 20 of Regulation (EU) 2019/1020.
Article 45
Commission action concerning toys that present a risk
1. Where the Commission becomes aware of a toy or a specific category of toys made available on the market which presents a risk to the health and safety of persons but is nonetheless either in compliance with the particular safety requirements or raising doubts about such compliance, it is empowered to adopt implementing acts setting out measures to ensure that the toy or category of toys, when made available on the market, no longer presents that risk, to withdraw it from the market or to recall it where all of the following conditions are met:
(a) it emerges from prior consultations with the market surveillance authorities that their approaches to dealing with the risk differ from one market surveillance authority to another;
(b) the risk cannot, in view of its nature, be dealt with under other procedures laid down by this Regulation.
2. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 50(3). On duly justified imperative grounds of urgency relating to the protection of the health and safety of persons, the Commission is empowered to adopt an immediately applicable implementing act in accordance with the procedure referred to in Article 50(4).
CHAPTER VII - I
DELEGATED POWERS AND COMMITTEE PROCEDURE
Article 46
Delegated powers
1. The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Annex VI as regards the information to be provided in the product passport, in order to adapt it to technical and scientific progress and to the level of digital readiness of market surveillance authorities and of users and their supervisors.
2. The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Article 19(1) by setting out that additional information among the information listed in Annex VI or that information on the non-compliance of the toy when measures are taken in accordance with Articles 41(2) or (4) and Article 44(1) is to be stored in the registry.
When adopting the delegated acts in accordance with the first subparagraph, the Commission shall take into account the following criteria:
(a) coherence with other relevant Union acts, where relevant;
(b) the need to allow for the verification of the authenticity of the product passport;
(c) the relevance of the information for improving the efficiency and effectiveness of market surveillance checks and customs controls for toys;
(d) the need to avoid disproportionate administrative burden for economic operators.
3. The Commission is empowered to adopt delegated acts in accordance with Article 47 to supplement this Regulation by determining which of the information stored in the registry is to be controlled by customs authorities, in addition to the information set out in Article 20(3).
4. The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Annex VII to this Regulation in order to adapt the list of commodity codes and product descriptions to be used for the purposes of Article 20(8). Those adaptations shall be based on the list set out in Annex I to Regulation (EEC) No 2658/87.
5. The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Annex III in order to adapt it to technical and scientific progress.
6. The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Part C of the Appendix to Annex II in order to permit a certain use in toys of a specific substance or mixture that is prohibited under Part III, point 4, of Annex II, or to limit a certain use that has been permitted.
7. The use in toys of a substance or mixture prohibited under Part III, point 4, of Annex II may only be permitted when all of the following conditions are met:
(a) it has been found to be safe by the European Chemicals Agency (ECHA), in particular in view of exposure, including the overall exposure from other sources, and taking particular account of the vulnerability of children;
(b) there are no suitable alternative substances or mixtures available, as established by ECHA based on an analysis of alternatives;
(c) the substance or mixture is not prohibited for use in consumer articles under Regulation (EC) No 1907/2006.
8. The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Parts A and B of the Appendix to Annex II in order to adapt them to technical and scientific progress, by :
(a) introducing conditions for the presence of substances or mixtures in toys and, in particular, limit values for specific substances or mixtures in toys, including limit values for traces of prohibited substances or mixtures as referred to in Part III, point 4, of Annex II;
(b) modifying the conditions or limit values for the presence of substances and mixtures in toys.
9. For the purposes of paragraphs 6 and 7, the Commission shall systematically and regularly evaluate the occurrence of hazardous chemical substances or mixtures in toys. In those evaluations, the Commission shall take into account reports of market surveillance bodies and scientific evidence presented by Member States and stakeholders.
Article 47
Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The power to adopt delegated acts referred to in Article 46 shall be conferred on the Commission for an indeterminate period of time.
3. The delegation of powers referred to in Article 46 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
6. Delegated acts adopted pursuant to Article 46 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Article 48
Requests for assessment for the purposes of Article 46(6)
1. Requests for an assessment of a substance or mixture prohibited under Part III, point 4, of Annex II for the purposes of Article 46(6) shall be submitted to ECHA using the format and submission tools referred to in paragraph 3 of this Article.
2. Any person submitting a request for assessment under paragraph 1 may request that certain information is not to be made publicly available. The request for confidentiality shall be accompanied by a justification as to why the disclosure of the information could be harmful to the commercial interests of the person submitting the request for assessment or of any other party concerned.
3. ECHA shall draw up and make publicly available a format and tools for the submission of requests for assessment referred to in paragraph 1 as well as technical and scientific guidance on how to submit such requests.
Article 49
Opinions from ECHA
1. For the purposes of Article 46(6), ECHA shall provide opinions to the Commission on the use in toys of substances or mixtures that are prohibited under Part III, point 4 of Annex II, where a request for an assessment is submitted to it in accordance with Article 48(1). ECHA shall assess in its opinions whether the criteria set out in Article 46(6), second subparagraph, points (a) and (b), are met for a specific use.
2. ECHA may request the person submitting the request for assessment or any third party to submit additional information within a specified period. ECHA shall take into account any information submitted by third parties.
3. The opinions referred to in paragraph 1 shall be sent to the Commission within a period of 12 months from the receipt of the request for an assessment.
4. That period may be extended once by a period of up to 6 months if ECHA needs to request information from a third party or if a high number of requests for assessment are submitted to ECHA under Article 48(1).
5. ECHA shall re-evaluate its opinions on the use in toys of substances or mixtures listed in Part C of the Appendix to Annex II at least every 5 years from the date of entry into force of a delegated act adopted in accordance with Article 46(6).
6. The Commission shall request an opinion from ECHA on the use in toys of substances or mixtures listed in Part C of the Appendix to Annex II as soon as new scientific information that may affect the permitted use of a specific substance or mixture in toys becomes known to the Commission.
7. For the purposes of Article 46(7), the Commission may request an opinion from ECHA on the safety of a specific substance or mixture in toys, which shall take into consideration the overall exposure to the substance or mixture from other sources and the vulnerability of children.
8. When preparing an opinion in accordance with the provisions set out in this Article, ECHA shall make publicly available the information on the start of the assessment, the adoption of the opinion as well as any intermediate steps in the assessment procedure. In particular, ECHA shall make the draft opinions publicly available and provide an opportunity for any interested party to comment on those opinions within a period of at least 4 weeks.
Article 50
Committee procedure
1. The Commission shall be assisted by a Committee on Toy Safety. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.
CHAPTER I - X
CONFIDENTIALITY AND PENALTIES
Article 51
Confidentiality
1. Competent national authorities, notified bodies and the Commission shall respect the confidentiality of the following information and data obtained in carrying out their tasks in accordance with this Regulation:
(a) personal data;
(b) commercially confidential information and trade secrets of a natural or legal person, including intellectual property rights, unless disclosure is in the public interest.
2. Without prejudice to paragraph 1, information exchanged on a confidential basis between the competent national authorities and between competent national authorities and the Commission shall not be disclosed without taking into account the opinion of the originating competent national authority.
3. Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member States and notified bodies with regard to the exchange of information and the dissemination of warnings, or the obligations of the persons concerned to provide information under criminal law.
4. Member States and the Commission may exchange confidential information with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements.
Article 52
Penalties
Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive.. Member States by … [P.O. insert date: the first day of the month following 30 months after the date of entry into force of this Regulation] notify the Commission of those rules and shall notify it without delay of any subsequent amendment affecting them.
CHAPTER X
FINAL PROVISIONS
Article 53
Repeal
Directive 2009/48/EC is repealed with effect from … [OP: please insert the date = the first day of the month following 30 months after the date of entry into force of this Regulation].
References to the repealed Directive 2009/48/EC shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex VIII.
Article 54
Transitional provisions
1. Toys placed on the market in conformity with Directive 2009/48/EC before … [OP please insert the date = the first day of the month following 30 months after the date of entry into force of this Regulation] may continue to be made available on the market until … [OP please insert the date = the first day of the month following 42 months after the date of entry into force of this Regulation].
2. Chapter VII of this Regulation shall apply mutatis mutandis instead of Article 42, 43 and 45 of Directive 2009/48/EC to toys which were placed on the market in conformity with that Directive before … [PO insert date: the first day of the month following 30 months after the date of entry into force of this Regulation], including toys for which a procedure has already been initiated under Article 42 or 43 of Directive 2009/48/EC before … [PO insert date: the first day of the month following 30 months after the date of entry into force of this Regulation].
3. EC type-examination certificates issued in accordance with Article 20 of Directive 2009/48/EC shall remain valid until … [PO insert date: the first day of the month following 42 months after the date of entry into force of this Regulation], unless they expire before that date.
Article 55
Evaluation and review
1. By … [OP please insert the date = the first day of the month following 60 months after the date of entry into force of this Regulation] and every 5 years thereafter, the Commission shall carry out an evaluation of this Regulation. The Commission shall submit a report to the European Parliament and to the Council on the main findings.
2. Where the Commission finds it appropriate, the report shall be accompanied by a legislative proposal for amendment of the relevant provisions of this Regulation.
Article 56
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from … [OP please insert the date = the first day of the month following 30 months after the date of entry into force of this Regulation].
However, Articles 17(10), 24 to 40, and 46 to 52, shall apply from … [OP: please insert the date of entry into force of this Regulation].
This Regulation shall be binding in its entirety and directly applicable in all Member States.