   
  
G/SPS/N/EU/747  
4 April 2024  
(24-2877) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION  
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved:   
2. Agency responsible:  European Commission, Health and Food Safety Directorate -General  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Novel foods  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Draft Commission Delegated Regulation amending 
Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods 
as regards the definition of 'engineered  nanomaterials' (Text with EEA relevance) . 
Language(s):  English, French and Spanish . Number of pages:  7 
https://members.wto.org/crnattachments/2024/SPS/EEC/24_02425_00_e.pdf  
https://members.wto.org/crnattachments/2024/SPS/EEC/24_02425_00_f.pdf  
https://members.wto.org/crnattachments/2024/SPS/EEC/24_02425_00_s.pdf  
6. Description of content:  The measure updates the definition of 'engineered 
nanomaterials' of Regulation (EU ) 2015/2263 on novel foods in line with technical and 
scientific progress. The measure transposes the main elements of the general 
nanomaterial definition of Commission Recommendation 2022/C 229/01 which is in turn 
underpinned by extensive technical and sc ientific elements and developments. The act 
maintains the current definition size limit (< 100 nm) below which a material would be 
considered as a nanomaterial; 2) introduces a default threshold value of 50% of particles 
(by number) being at the nanoscale for a material to be considered a nanomaterial; 
3) includes provisions on its applicability taking into account the external dimension and 
shape of the material; 4) excludes from the definition single molecules and materials with 
a surface to volume ratio below a certain value; 5) defines the terms 'particle', 'aggregate' 
and 'agglomerate'; and 6) includes only materials in solid state to exclude particles with 
highly dynamic external dimensions such as micelles, liposomes, or nanoscale droplets in 
emulsion s. 
In addition, the Regulation includes elements specifically aimed to address the subjectivity 
elements in interpreting the 'intentionally produced' notion of the current definition which 
have hampered its implementation.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territory from 
other damage from pests.   G/SPS/N/EU/747  
 
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  8. Is there a relevant international standard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) :  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  
Does this proposed regulation conform to the relevant international standard?  
[ ] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international stand ard:  
9. Other relevant documents and language(s) in which these are available:   
− Guidance on the implementation of the Commission Recommendation 2022/C 229/01 
on the definition of nanomaterial  
https://publications.jrc.ec.europa.eu/repository/handle/JRC132102  
− Guidance on risk assessment of nanomaterials to be applied in the food and f eed 
chain: human and animal health  
https://www.efsa.europa.eu/en/efsajournal/pub/6768  
− Guidance on technical requirements for regulated food and feed product  applications to 
establish the presence of small particles including nanoparticles  
https://efsa.onlinelibrary.wiley.com/doi/pdf/10.2903/j.efsa.2021.6769  
10. Proposed date of adoption (dd/mm/yy) : 11 June 2024  
Proposed date of publication (dd/mm/yy) : 12 June 2024  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : 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 18 months 
following the entry into force of this Regulation.  
[ ] Trade facilitating measure   
12. Final date for comm ents: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 3 June 2024  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address (if 
available) of other body:   
European Commission  
DG Health and Food Safety, Unit A4 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
E-mail: sps@ec.europa.eu  
13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
European Commission  
DG Health and Food Safety, Unit A4-Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
E-mail: sps@ec.europa.eu  
 