1. Alexandra Nikolakopoulou Directorate General for Health and Consumers
"Nanomaterials in foods -Information to consumers in the context of Regulation (EU) 1169/2011"
Alexandra Nikolakopoulou
Unit E.4, Nutrition, food composition and information
Directorate General for Health and Consumers
19 October 2012,
5th annual Nanotechnology Stakeholder Dialogue

2. Outline Some history (setting the scene)
Provisions of Regulation (EU) 1169/2011
Current state of thinking
Future steps

3. 1. Some history
No nano labelling in the Commission proposal on Food Information
1st reading EP amendment –
Labelling requirement but no definition
accepted in principle by the Commission
1st reading Council Common Position
Labelling requirement
Cross reference to the definition of the "future novel food Regulation"
Second reading negotiation
(failure of novel food – draft interservice definition of nanomateraterial)
Definition and labelling as agreed in the novel food
Recital

4. 2. Nano provisions in the Regulation 1169/2011
Article 18 (the labelling requirement)
"All ingredients present in the form of engineered nanomaterials shall be clearly? indicated in the list of ingredients. The names of such ingredients shall be followed by the word ‘nano’ in brackets. "
In accordance with the rules on ingredient listing!
Entry into application: 13 December 2014

5. Nano provisions in the Regulation 1169/2011
The definition(Art. 2.(t))- Legally binding for labelling purposes
‘engineered nanomaterial’ means 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, 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;

6. Nano provisions in the Regulation 1169/2011
Adaptation of the definition (Article 18.5)
"For the purposes of achieving the objectives of this Regulation, the Commission shall, by means of delegated acts in accordance with Article 51, adjust and adapt the definition of engineered nanomaterials referred to in point (t) of Article 2(2) to technical and scientific progress or to definitions agreed at international level. "

7. Nano provisions in the Regulation 1169/2011
The Recital!
"In order to inform consumers of the presence of engineered nanomaterials in food, it is appropriate to provide for a definition of engineered nanomaterials.!! !!
Taking into account the possibility of food containing or consisting of engineered nanomaterials being a novel food, the appropriate legislative framework for that definition should be considered in the context of the upcoming review of Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients "

8. Current state of thinking

9. Future steps Considering the change of the definition
Appropriate legal framework?
Time wise amending the FIC