REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the delegation conferred to the Commission pursuant to Article 31 of Regulation (EU) 2015/2283 on novel foods
Date: 2026-02-04
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: European Commission, consumer protection, delegated legislation, food safety, food standard, market approval, nanotechnology, novel food, powers of the institutions (EU), transfer of competence

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   EUROPEAN COMMISSION  Brussels, 4.2.2026  COM(2026) 60 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the delegation conferred to the Commission pursuant to  Article 31 of Regulation (EU) 2015/2283 on novel foods   
 
 
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
THE COUNCIL 

on the exercise of the delegation conferred to the Commission pursuant to  
Article 31 of Regulation (EU) 2015/2283 on novel foods 

1. 

INTRODUCTION 

This report meets the obligation set for the Commission by Article 32(3) of Regulation (EU) 
2015/2283  of  the  European  Parliament  and  of  the  Council  of  25  November  2015  on  novel 
foods1 (‘the Novel Foods Regulation’). The Novel Foods Regulation establishes the general 
principles, requirements and responsibilities governing the authorisation of novel foods on the 
Union market, ensuring the effective functioning of the internal market while providing a high 
level of protection of human health and consumers’ interests. 

Article 31 of the Novel Foods Regulation empowers the Commission to adopt delegated acts 
to adjust and adapt the definition of engineered nanomaterials referred to in point (f) of Article 
3(2) to technical and scientific progress or to definitions agreed at international level. 

2.  LEGAL BASIS 

According to Article 32(3) of the Novel Foods Regulation, the power to adopt delegated acts 
under Article 31 was conferred on the Commission for an initial period of 5 years from 31 
December  2015.  The  Commission  was  tasked  to  present  a  report  on  the  exercise  of  the 
delegation of power conferred by the Novel Foods Regulation no later than 9 months before 
the end of the 5-year period. The delegation of power was to be extended tacitly for periods of 
5 years, unless the European Parliament or the Council opposes such extension not later than 
3 months before the end of each period.  

3.  EXERCISE OF THE DELEGATION 

In the exercise of the delegation conferred by Article 31 of the Novel Foods Regulation, the 
Commission  has  taken  steps  to  adopt  a  delegated  act  to  adjust  and  adapt  the  definition  of 
engineered nanomaterials.  

Point (f) of Article 3(2) of the Novel Foods Regulation defines ‘engineered nanomaterial’ as  

‘any intentionally produced material that has one or more dimensions of the order of 
100 nm or less or that is composed of discrete functional parts, either internally or at 
the surface, many of which have one or more dimensions of the order of 100 nm or less, 

1 Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel 
foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing 
Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 
1852/2001. OJ L 327, 11.12.2015, p. 1.  

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including  structures,  agglomerates  or  aggregates,  which  may  have  a  size  above  the 
order of 100 nm but retain properties that are characteristic of the nanoscale. 

Properties that are characteristic of the nanoscale include: 

(i) those related to the large specific surface area of the materials considered; and/or 

(ii)  specific  physico-chemical  properties  that  are  different  from  those  of  the  non-
nanoform of the same material.’ 

This  definition  built  on  a  Commission  Recommendation  of  18 October  20112  that  had 
introduced a definition of nanomaterial.  

Subsequently,  on  10  June  2022,  a  new  Commission  Recommendation  on  the  definition  of 
nanomaterials  (‘the  Commission  Recommendation’)  was  adopted  based  on  state-of-the-art 
technical and scientific developments3. The Commission Recommendation was the result of a 
thorough review4 and a targeted stakeholder consultation5 6.  

Taking into account the revised definition introduced by the Commission Recommendation, 
and its call to align existing legislation accordingly, since October 2022 a Commission Expert 
Group7 composed of national experts assisted the Commission in preparing a delegated act to 
adjust and adapt the definition of engineered nanomaterials for the needs of the Novel Foods 
Regulation.  In  that  work,  the  EFSA  “Guidance  on  risk  assessment  of  nanomaterials  to  be 
applied in the food and feed chain: human and animal health”8, adopted on 30 June 2021 and 
published  on  3  August  2021,  was  taken  into  account.  It  was  also  essential  to  draw  on  the 
experience of the stakeholders in order to identify practical issues related to the definition of 

2 Commission Recommendation of 18 October 2011 on the definition of nanomaterial (2011/696/EU). OJ L 275, 
20.10.2011, p. 38. 

3 Commission Recommendation of 10  June 2022 on the definition of nanomaterial (C/2022/3689). OJ C 229, 
14.6.2022, p. 1.  

4 Commission’s Joint Research Centre’s (JRC) Science for Policy reports: 
- ‘Towards a review of the EC Recommendation for a definition of the term “nanomaterial’ - Part 1: Compilation 
of information concerning the experience with the definition’. EUR 26567 EN; doi:10.2788/36237 (2014). 
- ‘Towards a review of the EC Recommendation for a definition of the term “nanomaterial - Part 2: Assessment 
of  collected  information  concerning  the  experience  with  the  definition’.  EUR  26744  EN;  doi:  10.2787/97286 
(2014). 
- ‘Towards a review of the EC Recommendation for a definition of the term “nanomaterial  - Part 3: Scientific-
technical  evaluation  of  options  to  clarify  the  definition  and  to  facilitate  its  implementation’.  EUR  27240  EN; 
doi:10.2788/678452 (2015).  

JRC reports:  
- ‘An overview of concepts and terms used in the European Commission’s definition of nanomaterial’. EUR 29647 
EN; doi:10.2760/459136 (2019). 
- ‘Identification of nanomaterials through measurements’. EUR 29942 EN; doi:10.2760/053982 (2019).  

5 The targeted stakeholder consultation run between 6 May and 30 June 2021.  

6  The  results  of  the  review  and  the  stakeholder  consultation    are  explained  in  the  Commission  staff  working 
document (SWD(2022)150) accompanying the Commission Recommendation. 

7https://ec.europa.eu/transparency/expert-groups-register/screen/expert-
groups/consult?lang=en&do=groupDetail.groupDetail&groupID=3560&Lang=EN  

8 https://www.efsa.europa.eu/en/efsajournal/pub/6768  

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engineered nanomaterials, and their feedback was notably sought alongside the consultation 
that took place between 30 November 2023 and 12 January 20249.  

The  Commission  adopted  a  delegated  regulation  amending  the  Novel  Foods  Regulation  as 
regards the definition of ‘engineered nanomaterials’ (‘the Commission delegated regulation’) 
on  14  March  202410.  It  aimed  at  ensuring  the  coherence  of  the  definition  of  engineered 
nanomaterials in the EU regulatory framework, and at addressing the issues identified in the 
implementation of the definition of ‘engineered nanomaterials’ in the Novel Foods Regulation 
for  the  purposes  of  achieving  the  objectives  of  that  Regulation.  To  do  so,  the  Commission 
delegated  regulation  incorporated  the  main  technical  elements  of  the  general  definition  of 
engineered nanomaterials established in the Commission Recommendation, that included state-
of-the-art technical and scientific developments. In particular, the amended definition included 
the  size  limit  (< 100  nm),  the  exclusion  from  the  definition  of  materials  with  a  surface  to 
volume ratio below a certain value, the definitions of ‘particle’, ‘aggregate’ and ‘agglomerate’, 
and the default threshold value of 50% of particles being at the nanoscale for a material to be 
considered a nanomaterial.  

In line with procedure for adopting delegated acts, the Commission delegated regulation was 
sent  for scrutiny  to  the  European Parliament  and Council. On 24  April  2024, the European 
Parliament objected to the Commission delegated regulation11. In its objection, the European 
Parliament argued that the Commission delegated regulation was not compatible with the aim 
and the content of the Novel Foods Regulation and exceeded the delegated powers conferred 
by Article 31 of that Regulation. On 29 August 2024, the Commission responded officially to 
the European Parliament’s objection12. In view of that objection, the Commission delegated 
regulation did not enter into force. The definition of ‘engineered nanomaterial’ of point (f) of 
Article 3(2) of the Novel Foods Regulation therefore remains unchanged.  

4.  CONCLUSION 

The Commission has over the past years taken steps to exercise the delegated powers conferred 
to it under Article 31 of the Novel Foods Regulation. The Commission sees the need to extend 
the  empowerment  because  it  is  essential  to  ensure  that  the  definition  of  engineered 

9 https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14049-Revision-of-the-definition-of-
engineered-nanomaterial-in-food_en  

10  Commission  delegated  regulation  (EU)  …/…  of  14.3.2024  amending  Regulation  (EU)  2015/2283  of  the 
European Parliament and of the Council on novel foods as regards the definition of ‘engineered nanomaterials’. 
C(2024) 1612 final.  
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=PI_COM:C(2024)1612  

11 Objection to a delegated act: Novel foods - the definition of ‘engineered nanomaterials’. European Parliament 
resolution of 24 April 2024 on the Commission delegated regulation of 14 March 2024 amending Regulation (EU) 
2015/2283 of the European Parliament and of the Council on novel foods as regards the definition of ‘engineered 
nanomaterials’.  C(2024)01612 – 2024/2691(DEA).  
https://www.europarl.europa.eu/doceo/document/TA-9-2024-0316_EN.pdf  

12 Document SP(2024)399. Follow up to the European Parliament non-legislative resolution on the Commission 
delegated regulation of 14 March 2024 amending Regulation (EU) 2015/2283 of the European Parliament and of 
the Council on novel foods as regards the definition of ‘engineered nanomaterials’.  
https://oeil.secure.europarl.europa.eu/oeil/en/procedure-file?reference=2024/2691(DEA) 

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nanomaterials referred to in point (f) of Article 3(2) of the Novel Foods Regulation is adapted 
to technical and scientific progress or to definitions agreed at international level. This technical 
alignment  is  fundamental  to  guarantee  the  level  playing  field  on  internal  market  while 
providing a high level of protection of human health and consumers’ interests, which are the 
purposes of the Novel Foods Regulation. With the continuation of the status quo, materials that 
should  be  defined  as  ‘engineered  nanomaterials’  will  continue  not  being  defined  as  such, 
thereby depriving consumers from receiving the necessary information about their presence in 
products.  

With this report the Commission complies with the reporting requirement under Article 32(3) 
of the Novel Foods Regulation and invites the European Parliament and the Council to take 
note of this report. 

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