EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
SANCO/11616/2013 
(POOL/E4/2013/11616/11616-EN.doc) […](2013) XXX  draft 
  
COMMISSION DELEGATED REGULATION (EU) No …/.. 
of XXX  
amendin g Regulation (EU) No 1169/2011 of the Euro pean Parliament a nd 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 Europe an Parliament and of the Council of 
25 October 2011 on the provision of food information to consumers1 establishes the 
general principles, requirements and res ponsibilities governing food information, and 
in particular food labelling. It lays dow n 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 
may be adjusted and adapted 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 the Regulation. 
On 18 October 2011, the Commission a dopted Recommendation 2011/696/EU on 
the definition of nanomaterial
2. According to the Commi ssion Communication to the 
European Parliament, the Council and the European Economic and Social Committee 
on the Second Regulatory Re view on Nanomaterials3, the Commission intends to use 
the definition of 'nanomaterial' se t out in the Commission Recommendation 
2011/696/EU in EU legislation and in struments of implementation, where 
appropriate. Where other definitions are used in EU legislation, provisions will be adapted in order to ensure a consistent approach, although sector specific solutions 
may remain necessary. 
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 durin g the preparation of this delegated act 
on the basis of Working Document prepared  by the Commission services in four 
meetings that took place on 5 Febr uary 2013, 6 March 2013, 12 April 2013 and 
24 May 2013. A subsequent consultation of the Expert Group by means of written 
communication also took place on 11 June 2013.  
A further consultation of stakeholders took place on 23 May 2013 in the context of a 
working group 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 
                                                 
1 OJ L 304, 22.11.2011, p. 18. 
2 OJ L 275, 20.10.2011, p. 38.  
3 COM (2012)573 final, dated 3.10.2012. EN 3   EN 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 necessary 
sector specific considerations. 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
4, 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, Regulation (EU) No 1169/2011 provides for a 
definition of 'engineered nanomaterials'. 
(2) Article 18(5) of that Regulation empowers the Commission to adjust and adapt the 
definition of 'engineered nano materials' referred therein to technical and scientific 
progress or to definitions agr eed at international level, by means of delegated acts, for 
the purposes of achieving the objectives of that Regulation. 
(3) On 18 October 2011, Commission Reco mmendation 2011/696/EU was adopted
5, 
responding, amongst others, to a request from the European Parliament for the 
introduction of a comprehensive science-ba sed 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 ma terial and covers natural, incidental and 
manufactured materials. It takes into  account, amongst others, the European 
Commission Joint Research Centre's Refere nce Report 'Considerations on a Definition 
of Nanomaterial for Regulatory purposes'6, the opinion of the Scientific Committee on 
Emerging and Newly Identified Health Risk s (SCENIHR) concerning the 'Scientific 
basis for the definition of the term "Nanomaterial"'7 and the definition of 
'nanomaterial' developed by the International Organizati on for Standardization (ISO)8. 
                                                 
4 OJ L 304, 22.11.2011, p. 18.  
5 Commission Recommendation of 18 October 2011 on the definition of nanomaterial (OJ L 275, 
20.10.2011, p. 38).  
6 EUR 24403 EN, June 2010. 
7 http://ec.europa.eu/health/scientific_co mmittees/emerging/docs/scenihr_o_032.pdf . 
8 http://cdb.iso.org. EN 5   EN (4) According to the Commission Recomme ndation 2011/696/EU, the definition of 
'nanomaterial' set out therein does not prejudge , nor reflect the scope  of application of 
any piece of Union legislation.  
(5) In a Communication to the European Pa rliament, the Council and the European 
Economic and Social Committee on the Second Regulatory Review on 
Nanomaterials9, 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 EU legislation, provision s will be adapted in order 
to ensure a consistent approach, alt hough sector specific 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 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'10. 
(9) Pursuant to Article 4 of Regulation (EC) No 1333/2008 of the European Parliament 
and of the Council11, only approved food additives includ ed in the Union lists may be 
placed on the market as such and used in foods, in food additives, in food enzymes and 
in food flavourings under the conditions of us e specified therein and following a safety 
assessment.  
(10) Those Union lists were established by Commission Regulations (EU) No 1129/201112 
and (EU) No 1130/201113. These lists, as established, set out the food additives that 
were permitted for use prior to the entr y into force of Regulation (EU) No 1333/2008 
after a review of their compliance with th e provisions thereof. All these authorised 
food additives are currently subject to a re-evaluation programme by the European 
Food Safety Authority (hereinafter 'the Authority') in accordance with Commission 
Regulation (EU) No 257/201014. The re-evaluation of food additives is being carried 
out in accordance with the priorities laid down in that Regulation, and it also covers 
                                                 
9 COM (2012)573 final, dated 3.10.2012. 
10 http://cdb.iso.org. 
11 Regulation (EC) No 1333/2008 of the European Parliament and of hte Council of 16 December 2008 on 
food additives (OJ L 354,  31.12.2008, p. 16). 
12 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). 
13 Commission Regulation (EU) No 1130/2011 of 11 November 2011 amending Annex III to Regulation 
(EU) 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). 
14 Commission Regulation (EU) No 257/2010 of 25 March 2010 setting up a programme for the re-
evaluation of approved food additiv es in accordance with Regulati on (EC) No 1333/2008 of the 
European Parliament and of the Council on food additives (OJ L 80, 26.3.2010, p. 19). EN 6   EN any nano-related issues, which may be addresse d in a revision of the conditions of use, 
where appropriate.   
(11) Certain food additives included in the Union lists as established by Commission 
Regulations (EU) No 1129/2011 and (EU) No 1130/2011 could be in the form of 
'engineered nanomaterial' in the final food. Ho wever, indicating such food additives in 
the list of ingredients preceded by the word 'nano' may confuse the consumers as it 
may suggest that those additives are new while in reality they have been used in foods 
in that form for decades. 
(12) Taking into account the potential risk of c onfusing consumers, food additives included 
in the Union lists by Regulations (E U) no 1129/2011 and (EU) No 1130/2011 should 
not be mandatorily qualified as 'nano' in th e list of ingredients a nd should therefore not 
be covered by the definition of engineered nanomaterials. The need for specific nano-
related labelling requirements relating to those additives should be addressed in the 
context of the re-evaluation programme, by amending, if necessar y, the conditions of 
use in Annex II to Regulation (EC) No 1333/ 2008 and the specifications of those food 
additives, set out in Commi ssion Regulation (EU) No 231/201215. That exception 
should not apply to food additi ves inserted in those lists at a later date, including new 
entries pursuant to Article 12 of Regulation (EC) No 1333/2008.  
(13) The number based size distribution thre shold of 50% should be replaced by a 
threshold between 1% and 50% in the future in light of  technological developments 
concerning detection and quantification met hods and where warranted by concerns for 
health and safety.  
(14) 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:  (a) food additives covered by the definition set out in the first paragraph shall not 
be considered as engineered nanomaterial s, if they have been included in the 
Union lists referred to in Article 4 of Regulation (EC) No 1333/2008 by 
Commission Regulations (EU) No 1129/2011* and (EU) No 1130/2011**; 
(b) fullerenes, graphene flakes and singl e wall carbon nanotubes with one or more 
external dimensions below 1 nm sh all be considered as engineered 
nanomaterials. 
For the purposes of the definition set out in the first paragraph: 
i. "particle" means a minute piece of matter with defined physical boundaries; 
                                                
 
15 Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food 
additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and 
of the Council (OJ L 83, 22.3.2012, p. 1). EN 7   EN 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 individual components; 
iii. "aggregate" means a particle comprisi ng of strongly bound or fused particles;  
iv. "intentionally manufactured" means that the material is manufactured  to 
perform/fulfil a specific function or purpose;". 
________________________________ * 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). 
** 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 establishi ng 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). 
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union . 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President  José Manuel BARROSO