COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT pursuant to Article 294(6) of the Treaty on the Functioning of the European Union concerning the position of the Council on the adoption of a regulation of the European Parliament and of the Council on the safety of toys and repealing Directive 2009/48/EC
Date: 2025-10-14
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: EC conformity marking, European standard, child, free movement of goods, market approval, product safety, safety standard, technical standard, toy industry

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   EUROPEAN COMMISSION  Brussels, 14.10.2025  COM(2025) 635 final 2023/0290 (COD)  COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT  pursuant to Article 294(6) of the Treaty on the Functioning of the European Union  concerning the position of the Council on the adoption of a regulation of the European Parliament and of the Council on the safety of toys and repealing Directive 2009/48/EC  
 
2023/0290 (COD) 

COMMUNICATION FROM THE COMMISSION 
TO THE EUROPEAN PARLIAMENT 

pursuant to Article 294(6) of the Treaty on the Functioning of the European Union 

concerning the 

position of the Council on the adoption of a regulation of the European Parliament and 
of the Council on the safety of toys and repealing Directive 2009/48/EC 

1. 

BACKGROUND 

Date of transmission of the proposal to the European Parliament and 
to the Council (document COM(2023) 462  – 2023/0290 COD): 

28 July 2023 

Date  of  the  opinion  of  the  European  Economic  and  Social 
Committee: 

13 December 2023 

Date of the position of the European Parliament, first reading: 

13 March 2024 

Date of transmission of the amended proposal: 

N/A 

Date of adoption of the position of the Council: 

13 October 2025  

2. 

OBJECTIVE OF THE PROPOSAL FROM THE COMMISSION 

The  Commission  proposal  pursues  two  objectives:  (i)  to  improve  the  protection  of  children 
from  harmful  chemicals  when  playing  with  toys;  and  (ii)  to  reduce  the  number  of  non-
compliant  toys  which  can  still  be  found  on  the  Union  market,  in  particular  through  online 
sales. 

3. 

COMMENTS ON THE POSITION OF THE COUNCIL 

The  position  of  the Council  as  adopted  at  first  reading  fully  reflects  the  political  agreement 
reached  between  the  European  Parliament  and  the  Council  on  10  April  2025.  The 
Commission supports this agreement, the main points of which are set out below. 

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Precautionary  principle:  The  co-legislators  have  agreed  to  introduce  a  reference  to 
the  precautionary  principle  in  Article  1  of  the  regulation,  as  an  inspirational 
principle, which is acceptable to the Commission. 

Mental health of  children: The  co-legislators have agreed  to  enlarge the  concept  of 
toy safety to include mental health and well being of children for digitally connected 
toys. Article 21 concerning the safety assessment of toys will require that toys within 
the scope of the Radio Equipment  Directive 2014/53/EU, the Cyber Resilience Act 
Regulation (EU) 2024/2847 or Regulation (EU) 2024/1689 on Artificial Intelligence 
take account of the vulnerabilities of children when assessing under the Toy Safety 
Regulation  the  hazards  they  present.  This  is  in  line  with  the  objective  of  the 
Commission proposal and is acceptable to the Commission. 

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The  Digital  Product  Passport  was  agreed  by  the  co-legislators,  and  it  may  also  be 
used to replace the declaration of conformity under other legislation applicable to the 
toy. This will lead to simplification in case of toys within the scope of other Union 
law requiring a declaration of conformity. The technical requirements for the digital 
product  passport  supplementing  the  regulation  (Article  17)  will  be  established  via 
delegated acts,  in  line with the provisions on the digital product  passport set  out  in 
Regulation  (EU)  2024/1781  on  ecodesign  requirements  for  sustainable  products 
(ESPR). 

Online  sales  of  toys:  The  co-legislators  agreed  to  introduce  in  the  regulation 
provisions  on  fulfilment  service  providers  and  on  the  online  sale  of  toys.  These 
provisions intend to “plug in” into Regulation 2022/2065 (the Digital Services Act) 
and converge with the General Product Safety Regulation, by specifying information 
requirements  to  be  included  in  offers  through  marketplaces.  Thus,  these  provisions 
respect  the  enforcement  structure  between  consumer´s  law  (mainly  based  on  the 
country of destination principle) and the Digital Services Act (based on the country 
of establishment/ origin principle). 

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Chemicals in toys: The following provisions were agreed by the co-legislators: 

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The  generic  ban  of  harmful  substances  in  toys  will  include  carcinogenic, 
mutagenic or toxic for reproduction substances (CMRs), endocrine disruptors, 
respiratory sensitisers and substances toxic to a specific organ, as proposed by 
the Commission. In addition, it was agreed to include substances classified as 
skin  sensitisers  category  1A  in  the  generic  ban,  as  set  out  in  the  Council 
mandate.  This  is  a  limited  category  of  substances,  presenting  the  highest 
potential for sensitisation, and excluding substances showing a low to moderate 
frequency of occurrence in humans, or a probability of occurrence of a low to 
moderate sensitisation rate in humans. Therefore, this addition is acceptable to 
the  Commission.  The  generic  ban  relies  on  the  harmonised  classification  of 
chemical  substances  as  set  out  under  Regulation  (EC)  No  1272/2008  on 
classification,  labelling  and  packaging  of  substances  and  mixtures  (the  CLP 
Regulation)1, as proposed by the Commission.   

A ban on the intentional use of per- and polyfluoroalkyl substances (PFAS) in 
toys  was  included,  as  included  in  the  European  Parliament  position,  until  the 
universal  restriction  on  PFAS  under  Regulation  (EC)  No  1907/2006 
concerning  the  Registration,  Evaluation,  Authorisation  and  Restriction  of 
Chemicals (REACH) becomes applicable. 

A  ban  on  the  presence  of  ten  bisphenols  for  which  the  European  Chemicals 
Agency  (ECHA)  recommended  regulatory  measures,  and  which  are  not 
otherwise banned under other provisions of the regulation. This is acceptable to 
the Commission as these substances can be harmful for children. 

All allergenic fragrances will be banned in toys intended for children under 36 
months and for toys to be put in the mouth.  This provision is acceptable as it 
targets  the  younger  children;  exposure  to  allergenic  fragrances  can  cause 
sensitisation and lead to allergy outbreaks. 

On  nitrosamines,  the  co-legislators  agreed  to  keep  different  limit  values  for 
different types of toys, which are based on the current scientific evidence and 

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OJ L 353, 31.12.2008, p. 1.  

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available  testing  methods.  For  heavy  metals  (lead,  cadmium,  mercury  and 
chromium  vi),  the  migration  limits  proposed  by  the  Commission  were 
maintained.  In  both  cases,  to  facilitate  an  agreement,  the  co-legislators 
requested  that  the  Commission  issue  a  statement  indicating  that  it  would 
request ECHA to provide a new scientific assessment on nitrosamines in toys 
within 12 months of the entry into force of the regulation and, on heavy metals 
in toys, within 24 months. 

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Transition  period:  The  co-legislators  agreed  to  include  a  transition  period  of  54 
months. 

4. 

CONCLUSION 

The  Commission  supports  the  results  of  the  interinstitutional  negotiations  and  can  therefore 
accept the Council’s position at first reading.  

5.  

DECLARATIONS FROM THE COMMISSION 

The Commission has prepared one unilateral declaration which can be found in the appendix. 

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Appendix 

Declarations from the Commission 

Commission declaration: 

“The  Commission  regularly  and  systematically  evaluates  the  occurrence  of 
hazardous chemicals in toys, taking into account available scientific evidence, with a 
view  to  adapting  the  limit  values  or  the  conditions  for  the  presence  of  specific 
chemical substances or mixtures in toys in accordance with Article 46 of Regulation 
2025/…  on  the  safety  of  toys.  For  that  purpose,  the  Commission  will  request  an 
opinion  from  the  European  Chemicals  Agency  on  the  safety  of  nitrosamines  and 
nitrosatable substances in toys, in view of the overall exposure, within 12 months of 
the entry into force of  this  Regulation.  For the same purpose, the Commission  will 
request  an  opinion  from  the  European  Chemicals  Agency  on  the  safety  of  lead, 
cadmium, mercury and chromium vi in toys, in view of the overall exposure, within 
24 months of the entry into force of this Regulation.” 

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