EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANCO/11478/2014 
(POOL/E4/2014/11478/11478-EN.doc) 
[…](2014) XXX  draft 
  
COMMISSION DELEGATED REGULATION (EU) No …/.. 
of XXX  
amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council 
on the provision of food information to consumers as regards the definition of 
'engineered nanomaterials' 
(Text with EEA relevance) 
 EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT OF THE DELEGATED ACT 
Regulation (EU) No 1169/2011 of the Eu ropean Parliament and of the1 establishes 
the general principles, requirements and responsibilities gover ning food information, 
and in particular food labelling. It lays  down the means to guarantee the right of 
consumers to information and procedures  for the provision of food information, 
while providing sufficient flexibility to re spond to future developments and new 
information requirements.  
In order to inform consumers of the pres ence of engineered na nomaterials in food, 
Article 18(3) of Regulation (EU) No 1169/2011 provides that all ingredients present 
in the form of engineered nanomaterials must be clearly indicated in the list of 
ingredients and the names of such ingredients must be followed by the word 'nano' in 
brackets. In addition, it provides a defin ition of engineered nanomaterials, which 
shall be adjusted and adapted to technical and scientific progres s or to definitions 
agreed at international level, by means of delegated acts, for the purposes of 
achieving the objectives of the Regulation. 
On 18 October 2011, the Commission a dopted Recommendation 2011/696/EU as 
regards the definition of nanomaterial2. According to the Commission 
Communication to the European Parlia ment, the Council and the European 
Economic and Social Committee on th e Second Regulatory Review on 
Nanomaterials3, the Commission intends to use the definition of 'nanomaterial' set 
out in the Commission R ecommendation 2011/696/EU in  Union legislation and 
instruments of implementation, where appropr iate. Where other definitions are used 
in Union legislation, provisions will be ad apted in order to ensure a consistent 
approach, although sector specific solutions may remain necessary. 
On 12 December 2013, the Commission adopt ed a Delegated Regulation amending 
Regulation (EU) No 1169/2011 as regard s the definition of ‘engineered 
nanomaterials’. The proposed definition, amongst others, excluded food additives set 
out in the Union lists referred to in Arti cle 4 of Regulation (EC) No 1333/2008 of the 
European Parliament and of the Council4 by Commission Regulations (EU) No 
1129/20115 and (EU) No 1130/20116. 
On 12 March 2014, the European Parliament  objected to the Commission Delegated 
Regulation, by means of Resolution P 7_TA-PROV(2014)0218, as it excluded certain 
food additives from the definition of ‘e ngineered nanomaterials’. The European 
                                                 
1 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 (OJ L 304, 22.11.2011, p. 18). 
2 Commission Recommendation 2011/696/EU on the definition of nanaomaterial (OJ L 275, 20.10.2011, 
p. 38).  
3 COM (2012)572 final, dated 3.10.2012. 
4 Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on 
food additives (OJ L 354,  31.12.2008, p. 16). 
5 Commission Regulation (EU) No 1129/2011 of 11 November 2011 amending Annex II to Regulation 
(EC) No 1333/2008 of the European Parliament and of the Council by establishing a Union list of food 
additives (OJ L 295, 12.11.2011, p. 1). 
6 Commission Regulation (EU) No 1130/2011 of 11 November 2011 amending Annex III to Regulation 
(EC) No 1333/2008 of the European Parliament and of  the Council on food additives by establishing a 
Union list of food additives approved for use in food additives, food enzymes, food flavourings and 
nutrients (OJ L 295, 12.11.2011, p. 178). EN 3   EN Parliament called the Commission to adopt a new delegated act taking into account 
the position of the European Parliament.  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT 
The Expert Group on Regulation (EU) No  1169/2011 on the provision of food 
information to consumers was consulted on 23 June 2014 on a revised draft Commission Regulation, which takes into account the position of the European Parliament.  
Exchange of views with stakeholders took place on 4 July 2014 in  the context of the 
Advisory Group of the Food Chain, Animal and Plant Health. 
3. LEGAL
 ELEMENTS  OF THE  DELEGATED  ACT 
The legal basis for this Delegated Regulati on is Article 18(5) of  Regulation (EU) No 
1169/2011 on the provision of food information to  consumers. According to the latter 
provision, for the purposes  of achieving the objectives  of this Regulation, the 
Commission shall, by means of delegated ac ts, adjust and adapt the definition of 
engineered nanomaterials to te chnical and scientific progress  or to definitions agreed 
at international level. This Delegated Regulation adapts the definition of 'engineered nanomaterials' laid down in Article 2(2)(t ) of Regulation (EU) No 1169/2011 to the 
Commission Recommendation 2011/696/EU, taking into account the position of the 
European Parliament in its Resolution P7_TA-PROV(2014)0218. EN 4   EN COMMISSION DELEGATED REGU LATION (EU) No …/.. 
of XXX  
amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council 
on the provision of food information to consumers 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) No 1169/2011 of the European Parliament and of the 
Council of 25 October 2011 on the provisio n of food information to consumers
7, and in 
particular Article 18(5) thereof, 
Whereas: (1) Article 18(3) of Regulation (EU) No 1169/2011 provides that all food ingredients 
present in the form of engineered nanomaterial s have to be clearly indicated in the list 
of food ingredients to ensure consumer information. In addition, the names of food 
ingredients present in the form of engineer ed nanomaterials have to be followed by the 
word 'nano' in brackets. Accordingly, point (t) of Article 2(2) of Regulation (EU) No 
1169/2011 provides for a definition of  'engineered nanomaterials'). 
(2) Article 18(5) of Regulation (EU) No 1169/ 2011 empowers the Commission to adjust 
and adapt the definition of 'engineered nanomat erials' referred therein to technical and 
scientific progress or to definitions agreed at international level, by means of delegated 
acts, for the purposes of achieving the objectives of that Regulation. 
(3) On 18 October 2011, Commissi on Recommendation 2011/696/EU
8 was adopted, 
responding to a request from the European  Parliament for th e introduction of a 
comprehensive science-based definition of na nomaterials in the Union legislation. The 
definition set out in that Recommendation is based solely on the size of the constituent 
particles of a material  and covers natural, incidental  and manufactured materials. It 
takes into account the European Commissi on Joint Research Centre's Reference 
Report 'Considerations on a Definition of  Nanomaterial for Regulatory purposes'9, the 
opinion of the Scientific Committee on Emer ging and Newly Identified Health Risks 
(SCENIHR) concerning the 'Scientific basis for the definition of the term "Nanomaterial"'
10 and the definition of 'nanomateria l' developed by the International 
Organization for Standardization (ISO)11. 
                                                 
7 OJ L 304, 22.11.2011, p. 18.  
8 Commission Recommendation of 18 October 2011 on the definition of nanomaterial (OJ L 275, 
20.10.2011, p. 38).  
9 EUR 24403 EN, June 2010. 
10 http://ec.europa.eu/health/scientific_co mmittees/emerging/docs/scenihr_o_032.pdf . 
11 http://cdb.iso.org. EN 5   EN (4) Commission Recommendation 2011/696/EU set out that the definition of 
'nanomaterial' neither prejudges, nor reflects  the scope of application of other Union 
acts.  
(5) In a Communication to the European Pa rliament, the Council and the European 
Economic and Social Committee on the Second Regulatory Review on 
Nanomaterials12, the Commission expressed its inte nt to apply the definition of 
'nanomaterial' as set out in Recomme ndation 2011/696/EU to Union legislation. 
Where other definitions are used in Union le gislation, provisions should be adapted in 
order to ensure a consistent  approach, although sector sp ecific solutions may remain 
necessary. 
(6) It is therefore appropriate to adapt the de finition of 'engineered nanomaterials' laid 
down in Regulation (EU) No 1169/2011, for th e purposes of providi ng a high level of 
human health and consumers’ interests,  to that provided in Recommendation 
2011/696/EU, which reflects technical a nd scientific progress to date.  
(7) Since the definition laid dow n in Regulation (EU) No 1169/2011 refers to 'engineered 
nanomaterials' and not to 'nanomaterials ' in general, natural and incidental 
nanomaterials should not be in cluded in the definition.  
(8) Moreover, it is appropriate to link the de finition of 'engineered nanomaterials' to 
intentionally manufactured material, wh ich should be explicitly defined. This 
definition should take into account the defi nition adopted by ISO, according to which 
'engineered nanomaterial' is 'nanomat erial designed for a specific purpose or 
function'13. The notion of 'specific function or purpose' should encompass any function 
or purpose and not be limited to a new or nano-specific function or purpose.  
(9) The number based particle size distribution th reshold of 50% should be reviewed with 
the view to assess whether it should be re placed by a threshold between 1% and 50% 
in the future in light of  technological developments  concerning detection and 
quantification methods and wh ere warranted by concerns for health and safety.  
(10) In order to enable food busine ss operators to adapt the labell ing of their pr oducts to the 
requirements introduced by this Regulation, it is important to provide for an appropriate transitional period. 
(11) Therefore, Regulation (EU) No 1169/2011 should be amended accordingly, 
HAS ADOPTED THIS REGULATION: 
Article 1  
Point (t) of Article 2(2) of  Regulation (EU) No 1169/2011 is  replaced by the following: 
"(t) 'engineered nanomaterial' means any inte ntionally manufactured material, containing 
particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the numbe r size distribution, one or more external 
dimensions is in the size range 1 nm to 100 nm. 
By way of derogation, fullerenes, graphene flakes and single wall carbon nanotubes 
with one or more external dimensions belo w 1 nm shall be considered as engineered 
nanomaterials. 
                                                
 
12 COM (2012)572 final, dated 3.10.2012. 
13 http://cdb.iso.org. EN 6   EN For the purposes of the definition set out in the first paragraph: 
(i) "particle" means a minute piece of matter with defined physical boundaries; 
(ii) "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 indivi dual components;  
(iii) "aggregate" means a particle compri sing of strongly bound or  fused particles;  
(iv) "intentionally manufact ured" means that the material is manufactured to 
perform/fulfil a specific function or purpose;". 
Article 2  
1. Foods placed on the market or labelled before 1 April 2016 which do not comply 
with the requirements of this Regulation may be marketed until the stocks of the 
foods are exhausted.  
2. Foods labelled in accordance with this  Regulation may be placed on the market 
before 1 April 2016. 
Article 3  
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 1 April 2016, with the excepti on of Article 2(2) which shall apply from the 
entry into force of this Regulation. 
It shall be binding in its entirety and di rectly applicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President  Jean-Claude JUNCKER