EN 1  EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, 14.3.2024  
C(2024) 1612 final  
 
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’  
(Text with EEA relevance)   EN 2  EN 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’  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to 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 /20011, 
and in particular Article  31 thereof , 
Whereas:  
(1) Taking into account the possibility of food consisting of engineered nanomaterials 
being a novel food, Article 3(2), point (f), of Regulation (EU) 2015/2283 provides for 
a definition of engineered  nanomaterial. Article 2(1) , point (h), of Regulation (EU) No 
1169/2011 of the European Parliament and of the Council2 refers to the definition of 
‘engineered nanomaterials’ as established by point (f) of Article 3(2) of Regulation 
(EU) 2015/2283 , in orde r to inform consumers of the presence of engineered 
nanomaterials in food . 
(2) On 10 June 2022, Commission Recommendation 2022/C 229/013 was adopted, 
updating the definition of nanomaterial set out in Commission Recommendation 
2011/696/EU4, in light of experience and technical and scientific progress. 
Recommendation 2022/C 229/01  takes into account the European Commission Joint 
Research Centre’s Science for Policy Reports “ Towards a review of the EC 
Recommendation for a definition of the te rm “nanomaterial” Parts 15, 26, and 37 on the 
 
1 OJ L 327, 11.12.2015, p. 1.   
2 Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on 
the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) 
No 1925/2006 of the European Parliament and of the Council, and  repealing Commission Directive 
87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC 
of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and 
Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, p.18).  
3 Commission Recommendation of 10 June 2022  on the definition of nanomaterial 2022/C 229/01 (OJ C 
229, 14.6.2022, p.1).   
4 Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomaterial (OJ  
L 275, 20.10.2011, p. 38).   
5 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).   
6 Towards a r eview 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).    EN 3  EN experience of stakeholders with the implementation of the definition and with the 
identification of possible points of revision , and two reports providing guidance on the 
implementation of the definition8,9.  It also takes into account relevant developments in 
standardisation by the International Organization for Standardization (ISO) and the 
European Committee for Standardisation (CEN), results of the NanoDefine project of 
the Commission’s 7th Framework Pr ogramme for Research10, and the opinion of the 
Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) 
concerning the ‘Scientific basis for the definition of the term “Nanomaterial”11.  
(3) It is therefore, appropriate to adapt the def inition of engineered nanomaterial laid 
down in Regulation (EU) 2015/2283 taking into consideration Recommendation 
2022/C 229/01 , which reflects the latest  technical and scientific updates in this area . 
(4) Experience with the current definition of engineered nanomaterial has shown 
difficulties in its implementation for both food business operators and enforcement 
authorities , as it allows for different interpretations as to whether a material is 
intentionally produced to be a n engineered  nanomateria l. The implementation of the 
current definition was hindered also  by the lack of a default threshold value of 
particles with external dimensions in the nanoscale. It is therefore appropriate that the 
definition  of engineered nanomaterial  is adapted to incl ude a default threshold of 
particles in the number -based size distribution with external dimensions in the 
nanoscale , present in a manufactured material , above which the material would be 
considered to have acquired specific functional properties and would  therefore be 
considered as an engineered nanomaterial.     
(5) The technical and scientific elements underpinning the nanomaterial definition 
contained in Recommendation  2022/C 229/01 did not provide  scientific evidence that 
the default threshold of 50% of particles with external dimensions at the nanoscale 
pursuant to  Recommendation 2011/696/EU should be changed. It is therefore 
appropriate that this default threshold is included in the definition of engineered 
nanomaterial to ensure regulatory consistency and coherence, to avoid the possibility 
that a specific material could be considered a nanomaterial under one regulatory 
framework but not under another, and to provide objectivity and clarity in the  
implementation of the definition of engineered nanomaterial for the economic 
operators, consumers , and enforcement authorities . 
(6) Since the definition laid down in Regulation (EU) 2015/2283 refers to engineered 
nanomaterials and not to natural and/or in cidental nanomaterials, only manufactured 
materials consisting of at least 50% of particles in the nanoscale should be included in 
that definition .  
(7) For the purpose s of defini ng engineered nanomaterial s, and to address the inherent 
subjectivity of the current definition in interpreting whether a material is intentionally 
produced to be a n engineered  nanomaterial or not , a description of the term 
‘manufactured’  should be included in the definition to introduce existing objective 
technical elements that encompass  the processes of manufacturing nano materials 
 
7 Towards a review of the EC Recommendation fo r 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:10.2788/770401 (2015).    
8 An overview of concepts and terms used in the Europea n Commission’s definition of nanomaterial; 
EUR 29647 EN; doi:10.2760/459136 (2019).  
9 Identification of nanomaterials through measurements; EUR 29942 EN; doi:10.2760/053982 (2019).  
10 The NanoDefine Methods Manual; EUR 29876 EN; doi:10.2760/79490 (2020).  
11  http://ec.europa.eu/health/scientific_committees/emerging/docs/ scenihr_o_032.pdf  EN 4  EN which  are produced, synthesised or generated by physical /mechanical , and/or 
biological , and/or chemical processing, formulation  and/or transformation of raw 
and/or sta rting materials . 
(8) The definition and its core terms should, where applicable, be based on existing 
scientifically defined and standardised terms adopted by the international communities 
(ISO, CEN). The core terms used in the definition should remain suf ficiently specific 
and should enable the practical implementation of the definition within the context of 
Regulation (EU) 2015/2283. I ts implementation should be supported, where 
applicable, by the guidance prepared  by the European Commission Joint Research 
Centre (‘JRC’) in the context of the implementation of the definition in 
Recommendation  2022/C 229/0112,  by the guidance  documents  of the European Food 
Safety Authority (‘the Authority’) on the risk assessment of nanomaterials to be 
applied in the food and feed  chain : human and animal health13 and on technical 
requirements for regulated food and feed applications to establish the presence of 
small particles including nanoparticles14. These guidance documents may be  further 
updated  as a result of the evolving scien tific and technical progress .  
(9) The definition  of ‘engineered nanomaterial’  should cover both “particles on their own ” 
and “identifiable constituent particles in agglomerates or aggregates ”. The 
identification and measurement of constituent particles in agglomerates or aggregates 
can be very challenging . Thus, the 'identifiable' qualifier is bound by practical 
considerations pertaining to their identification.  
(10) The term ‘particle’ should be defined as a minute piece of matter with defined physical 
boundaries  in line  with the definition of ‘particle’ adopted in ISO 26824:2022 .  
(11) As the external dimension of the constituent particles of a material is the only common 
feature of all nanomaterials, t he definition  of engineered nanomateri al should be based 
on the relat ive fraction of particles in a defined range within the particle number -based 
distribution of the external dimension of the constituent particles of a material .   
(12) A single molecule, including a macromolecule such as a protein that may be larger 
than 1 nm, should not be considered as a particle. In very specific cases, the distinction 
may depend on a precise understanding of the term ‘single molecule’ .  
(13) Recommen dation  2022/C 229/01 refers  to materials consisting of particles in solid 
state. It is therefore appropriate that the definition of engineered nanomaterial would 
also refer to materials consisting of particles in solid state to exclude particles with 
highl y dynamic external dimensions such as micelles, liposomes, or nanoscale droplets 
in emulsions .  
(14) The NanoDefine15 project demonstrated that , in a broad range of materials tested,  there 
were no inconsistencies in classification of non -nanomaterials, based on the median 
 
12 Guidance on the implementation of the Commission Recommendation 2022/C 229/01 on the definition 
of nanomaterial EUR 31452 EN, doi.org/10.2760/1 43118.  
13 Guidance on risk assessment of nanomaterials to be applied  in the food and feed chain: human and 
animal health . (EFSA Journal 2021;19(8):6768 ). https://doi.org/10.2903/j.efsa.2021.6768  
14 Guidance on technical requirements for  regulated food and feed product applications to establish the 
presence of small particles including nanoparticles. EFSA Journal 2021;19(8):6769 
https://doi.org/ 10.2903/j.efsa.2021.6769 . 
15 NanoDefine, “Evaluation report on the applicability ranges of the volume specific surface area (VSSA) 
method and the quantitative relation to particle number -based size distribution for real world samples, 
Deliverable number 3.5 , 2015 , and, Wohlleben, W., Mielke, J., Bianchin, A. et al.  Reliable EN 5  EN value determined from the particle number -based size distributions and on the volume 
specific surface area being less than 6  m2/cm3 (even if particle shape is unknow n), 
respectively. Therefore, a  material with a volume specific surface area less than 
6 m2/cm3 should not be considered  a nanomaterial .   
(15) In its guidance documents on risk assessment of nanomaterials to be applied in the 
food and feed chain: human and  animal health, and on technical requirements for 
regulated food and feed applications to establish the presence of small particles 
including nanoparticles , the Authority stated  that materials  should  be also considered  
on the basis  of their solubility  and/or dissolution/degradation  properties  in water  and 
not solely  on the basis  of their physical  form . The Authority  also identified  flexible  
approaches,  and the technical  conditions  that allow  for a proper  evaluation  of the 
solubility  and/or  dissolution/degradation  properties  of materials  in water  and defined  
cut-off thresholds  above  which  materials  should  not be considered  to be 
nanomaterials . It is therefore  appropriate  that material s which  exhibit  solubility  and/or  
dissolution/degradatio n properties  in water , measured  according  to the approach  and 
technical  elements  set out by the Authority  guidance  documents , above  the thresholds  
establishe d by the Authority , should not be considered engineered nanomaterials.   
(16) In order to provide business operators with sufficient time to comply with the 
requirements of this Regulation, the applicability of this Regulation should be 
deferred. Transitional measure s for foods  lawfully placed on the market  and labelled  
before the d ate of application of this Regulation should be also provided in order to 
avoid any unnecessary food waste.  Furthermore, a food lawfully placed on the market 
before the date of application of this Regulation and which falls within the scope of 
this Regula tion, should in principle be allowed to continue to be placed on the market 
until the risk assessment and authorization procedures taking into account the 
definition laid down in this Regulation , have been concluded. The applications  under 
Regulation (EU) 2015/2283 for foods falling within the scope of this Regulation for 
which a final decision has not been taken before the date of application of this 
Regulation, should be updated  by the applicant in order to allow for appropriate risk 
assessment.  Therefore, transitional provisions should be laid down to ensure a smooth 
transition to the application of the definition laid down in this Regulation.  
(17) Regulation (EU) 2015/2283 should therefore be amended accordingly , 
 
HAS ADOPTED THIS RE GULATION:  
Article 1  
Amendment of the definition of the engineered nanomaterial  
Point (f) of Article 3(2) of Regulation (EU) 2015/2283 is replaced by the following:  
 
‘(f) 
(1) ‘Engineered nanomaterial ’ means a manufactured  material , consisting of solid 
particles that are present, either on their own or as identifiable constituent particles in 
aggregates or agglomerates, and where 50 % or more of these particles in the 
number -based size distribution fulfil at least one of the following conditions:  
 
nanomaterial classification of powders using the volume -specific surface area method. J Nanopart Res  
19, 61 (2017). https://doi.org/10.1007/s11051 -017-3741 -x. EN 6  EN (a) one or more external dimensions of the particle are in the size range 1 nm to 
100 nm;  
(b) the particle has an elongated shape, such as a rod, fibre or tube, where two 
external dimensions are smaller than 1 nm and the other dimension is larger 
than 100 nm;  
(c) the particle has a plate -like shape, where one external dimension is smaller 
than 1 nm and the other dimensions are larger than 100 nm ; 
In the determination of the particle number -based size distribution, particles with at 
least two orthogonal external dimensions larger than 100 μm shall not be considered .  
(2)  For the purposes of point (1), the following appl y: 
(a) ‘manufactured material ’ means a material produced, synthesised or generated 
from physical /mechanical , and/or biological and/or  chemical processing, 
and/or formulation, and/or transformation , of raw and/or starting materials;  
(b) ‘particle’ means a minute piece of matter with defined physical boundaries.  
Single molecules are not considered ‘particles’;  
(c) ‘aggregate’ means a particle comprising of strongly bound or fused particles;  
(d) ‘agglomerate’ means a collection of weakly  bound particles or aggregates 
where the resulting external surface area is similar to the sum of the surface 
areas of the individual components.  
(3) A manufactured material with a specific surface area by volume of < 6 m2/cm3, 
and/or with high solubility  and/or dissolution/degradation rate values in water as 
determined using the thresholds  andmethodologies identified by the Authority shall 
not be considered an engineered nanomaterial. ’ 
 
Article 2  
Transitional measures  
Foods  lawfully placed on the market or labelled prior to [the date of application of this 
Regulation ], which fall within the scope of this Regulation may be marketed until their date of 
minimum durability or use by  date.   
Authorised novel foods that were lawful ly placed on the market before [the date of 
application of this Regulation] and fall within the scope of this Regulation may continue to be 
placed on the market until a decision is taken in accordance with Article s 10 to 12 of t he 
Regulation (EU) 2015/2283 following an application for authorization of novel food 
submitted no later than [24 months after the date of application of this Regulation ]. 
The applications  submitted under Regulation (EU) 2015/2283 for which a final decisio n has 
not been taken before [the date of application of this Regulation]  and which concern food 
falling within the scope of this Regulation , shall be updated by the applicant no later than  [24 
months after the date of application of this Regulation ]. 
Article 3  
Entry into force and application  EN 7  EN 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] . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels, 14.3.2024  
 For the Commission  
 The President  
 Ursula VON DER LEYEN  
 