Nanomaterials in Foods: Consumer Information in the Context of Regulation (EU) 1169/2011

1. "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 novelfoodRegulation" • Second readingnegotiation (failure of novelfood – draftinterservicedefinition of nanomateraterial) • Definition and labelling as agreed in the novelfood • 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 legalframework? • Time wise amending the FIC