Transcript Alexandra Nikolakopoulou

"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
Health and
Consumers
Outline
1.
2.
3.
4.
Some history (setting the scene)
Provisions of Regulation (EU) 1169/2011
Current state of thinking
Future steps
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Consumers
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1. Some history
 No nano labelling in the Commission proposal on Food
Information
 1st reading EP amendment –
o Labelling requirement but no definition
o accepted in principle by the Commission
 1st reading Council Common Position
o Labelling requirement
o Cross reference to the definition of the "future novel food
Regulation"
 Second reading negotiation
(failure of novel food – draft interservice definition
nanomateraterial)
o Definition and labelling as agreed in the novel food
o Recital
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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
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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;
•
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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. "
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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 "
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Current state of thinking
•
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Future steps
 Considering the change of the definition
 Appropriate legal framework?
 Time wise amending the FIC
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