Delegated powers
1. The Commission is empowered to adopt delegated acts in accordance with Article 50 to supplement this Regulation by determining the technical requirements related to the digital product passport for toys. Those requirements shall cover, in particular, the following:
(a)
one or more data carriers that are to be used;
(b)
the layout in which the data carrier is to be presented and its positioning;
(c)
the technical elements of the digital product passport for which defined European or international standards are to be used;
(d)
the actors that are to have access to data in the digital product passport and to what data they are to have access;
(e)
the actors that are to create a digital product passport or update the data in a digital product passport and what data they may introduce or update; and
(f)
the detailed arrangements for introducing or updating data referred to in point (e).
When determining the access rights referred to in the first subparagraph, point (d), the Commission shall take into account the need to protect confidential business information and trade secrets in accordance with Directive (EU) 2016/943 of the European Parliament and of the Council ( 30 ) , as well as the need to ensure that consumers can easily access the information that is relevant to them.
The actors that update data in a digital product passport in accordance with the first subparagraph, point (e), shall be responsible for the accuracy of the data they provide, except where they act on behalf of the manufacturer.
The date of application of delegated acts referred to in the first subparagraph shall not be earlier than 18 months from their entry into force, except in duly justified cases for the whole act or for some specific requirements, or except in cases of partial repeal or amendment of delegated acts, where an earlier date of application may be set.
2. The Commission is empowered to adopt delegated acts in accordance with Article 50 to amend Annex VI as regards the data to be provided in the digital 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.
3. The Commission is empowered to adopt delegated acts in accordance with Article 50 to amend Article 22(1) by setting out that the additional information among the information listed in Annex VI or that the information on the non-compliance of the toy when measures are taken in accordance with Article 45(2) or (4) is to be stored in the registry.
When adopting the delegated acts referred to in the first subparagraph, the Commission shall take into account the following criteria:
(a)
consistency with other applicable Union acts, where relevant;
(b)
the need to allow for the verification of the authenticity of the digital product passport;
(c)
the relevance of the information for improving the efficiency and effectiveness of market surveillance checks and customs controls for toys; and
(d)
the need to avoid a disproportionate administrative burden for economic operators and national authorities, including customs authorities.
4. The Commission is empowered to adopt delegated acts in accordance with Article 50 of this Regulation 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 23(6) of this Regulation. 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 50 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 50 to amend Part C of the Appendix to Annex II, while taking into account the conditions set out in Part III, point 10, of Annex II, in order to permit a certain presence in toys of a specific substance or mixture that is prohibited pursuant to Part III, point 4, 5 or 6, of Annex II, or to amend or withdraw the permission of the presence of a certain substance or mixture. The Commission shall justify any exemption granted and make this publicly available in an easily accessible and user-friendly manner.
7. The Commission is empowered to adopt delegated acts in accordance with Article 50 to amend Parts A, B and D 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 the non-intended presence of prohibited substances or mixtures as referred to in Part III, point 7, of Annex II; or
(b)
modifying the conditions or limit values for the presence of substances and mixtures in toys.
8. The Commission shall request an opinion from the European Chemicals Agency (ECHA) pursuant to Article 52(7) on the safety of nitrosamines and nitrosatable substances in toys, in view of the overall exposure. The Commission shall evaluate the opinion and, where necessary, in view of that opinion, adopt delegated acts in accordance with Article 50 in order to adapt the limit values for those substances in toys listed in Part A of the Appendix to Annex II.
9. The Commission shall request an opinion from ECHA pursuant to Article 52(7) on the safety of lead, cadmium, mercury and chromium (VI) in toys, in view of the overall exposure. The Commission shall evaluate the opinion and, where necessary, in view of that opinion, adopt delegated acts in accordance with Article 50 in order to adapt the limit values for those substances in toys listed in Part A of the Appendix to Annex II.
10. 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.
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 49 shall be conferred on the Commission for a period of five years from 1 January 2026. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
3. The delegation of powers referred to in Article 49 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. A delegated act adopted pursuant to Article 49 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of three 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 three months at the initiative of the European Parliament or of the Council.
Requests for assessment for the purposes of Article 49(6)
1. Requests for an assessment of a substance or mixture prohibited pursuant to Part III, point 4, 5 or 6, of Annex II for the purposes of Article 49(6) shall be submitted to ECHA using the format referred to in paragraph 3 of this Article. The requests shall be made publicly available in an easily accessible and user-friendly manner.
2. Without prejudice to the second subparagraph of this paragraph, any person submitting a request for assessment pursuant to paragraph 1 may request that certain confidential information is not to be made publicly available in accordance with the applicable Union law. 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.
The following information held by ECHA shall be made publicly available, free of charge, in a user-friendly format:
(a)
the name of the legal person making the request;
(b)
the name of the substance or mixture for which there is a request for an exemption and, where appropriate, the hazard class as referred to in Part III, point 4, of Annex II; and
(c)
the type of toy or toy component.
3. Before 2 February 2027, ECHA shall draw up and make publicly available a format for the submission of requests for assessment referred to in paragraph 1. Before that date, ECHA shall also draw up and make publicly available technical and scientific guidance on how to submit such requests and on how the analysis supporting such requests is to be conducted, including as regards the availability of alternatives to the substances or mixtures and how to address, pursuant to this Regulation, the known additional hazards from the combined exposure to the different substances and mixtures present in the toy.
Opinions from ECHA
1. For the purposes of Article 49(6), ECHA shall provide opinions to the Commission on the presence in toys of substances or mixtures that are prohibited pursuant to Part III, point 4, 5 or 6, of Annex II, where a request for an assessment is submitted to it in accordance with Article 51(1). ECHA shall assess in its opinions whether the criteria set out in Part III, point 10, points (a) and (b), of Annex II 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 and made publicly available in an easily accessible and user-friendly manner within a period of 12 months from the receipt of the request for an assessment.
4. The period referred to in paragraph 3 of this Article 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 pursuant to Article 51(1).
5. ECHA shall re-evaluate its opinions on the presence 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 49(6). For the purposes of carrying out this re-evaluation, ECHA shall request the person submitting the original request to provide within a specified period the necessary information and documentation demonstrating that the conditions justifying the presence of the substance in toys set out in Part III, point 10, of Annex II continue to be met. ECHA may also request any third party to submit additional information within a specified period.
6. The Commission shall request an opinion from ECHA on the presence in toys of substances or mixtures listed in Part C of the Appendix to Annex II as soon as new scientific information or technological progress 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 49(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 known additional hazards from the combined exposure to the different substances and mixtures present in the toy, as well as the vulnerability of children.
8. When preparing an opinion in accordance with 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.
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. Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and Article 5(4), third subparagraph, 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.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
