European Council rejects Parliament Proposal for Labelling of Nanomaterials in Food

Published: Saturday 20 March 2010

The European Council has adopted its 1^st-Reading position on a draft regulation concerning Novel Foods. The decision, which was taken, without discussion, at the Environment Council in Brussels on the 15^th March 2010, reflects the Council’s political agreement approved on 22 June 2009.

According to the Consilium Press release (15^th March 2010), ‘[t]he definition of novel food and the scope of the regulation are clarified. [...] ‘food containing or consisting of engineered nanomaterials is explicitly included in the scope of the regulation. The general definition of novel food remains unchanged, i.e. food not used for human consumption to a significant degree within the Community before 15 May 1997 (when the current regulation 258/97 entered into force).’

The Position of the Council at 1^st Reading (with a view to adopting a Regulation of the European Parliament and of the Council on novel foods) specifically mentions nanotechnologies and nanomaterials (5^th March 2010, 11261/2/09 REV 2):

• Novel food should therefore include [...] foods produced by new production processes which might have an impact on food, and foods containing or consisting of engineered nanomaterials.
• The use of engineered nanomaterials in food production might increase with the further development of technology. In order to ensure a high level of protection of human health, free movement of goods and legal certainty for manufacturers, it is necessary to develop a uniform definition for engineered nanomaterial at international level. The Union should endeavour to reach an agreement on a definition in appropriate international fora. Should such an agreement be reached, the definition of engineered nanomaterial in this Regulation should be adapted accordingly.
• At present, there is inadequate information on the risks associated with engineered nanomaterials. In order to better assess their safety the Commission, in cooperation with the Authority, should develop test methodologies which take into account specific characteristics of engineered nanomaterials.
• In particular, the Commission should be empowered to clarify certain definitions in order to ensure a harmonised implementation of these provisions by the Member States on the basis of relevant criteria, including the definition of "engineered nanomaterial", taking into account the technical and scientific developments and the non-traditional animal breeding technique that includes techniques used for asexual reproduction of genetically identical animals not used for food production within the Union before 15 May 1997. Furthermore, the Commission should be empowered to adopt any appropriate transitional measures and to update the list of traditional foods from third countries and the Union list.
• [...] "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 [...].

The Council introduced the following modifications with regard to the amendments proposed by the European Parliament (1^st Reading position, 25^th March 2009) (see Council Statement, 2^nd March 2010, 11261/09 ADD 1 REV 1):

• ‘[T]he Council recognized the need for systematic safety evaluation and authorisation of foods containing or consisting of engineered nanomaterials irrespective of any changes that the nanomaterials might cause in the properties of such foods.
• Therefore, the Council made clear that such foods are considered to be novel (Article 3(2)(a)(iv)) and added the definition of "engineered nanomaterial" (Article 3(2)(c)). The Council thus closed the gap that might have been created if the use of nanotechnologies would have not given rise to significant changes in the composition or structure of the food as defined by Article 3(2)(a)(iii), but the food would have still contained engineered nanomaterials.’

The Council rejected the following amendments proposed by the European Parliament (1^st Reading position, 25^th March 2009) (see Council Statement, 2^nd March 2010, 11261/09 ADD 1 REV 1):

• An amendment demanding that ‘[N]anomaterials present in food packaging should be entered on a list of approved nanomaterials, accompanied by a limit on migration into or onto the food products contained in such packaging’  was rejected on the grounds that ‘[this amendment] does not fall under the scope of novel foods Regulation; Regulation (EC) 1935/2004 on materials and articles intended to come into contact with food applies.’
• An amendment demanding that ‘[p]roducts produced with the aid of nanotechnologies and food produced from animals fed with genetically modified feeding stuffs must be labelled as such’ was rejected on the grounds that ‘systematic specific labelling of ingredients in the form of nanomaterials is excessive; there is a requirement to consider specific labelling requirements on a case-by-case basis according to Article 9(2).’
•  An amendment demanding that ‘[f]oods to which production processes have been applied that require specific risk assessment methods (e.g. foods produced using nanotechnologies) may not be included in the Community list until such specific methods have been approved for use, and an adequate safety assessment on the basis of these methods has shown that the use of the respective foods is safe’ on the grounds that ‘in case of doubt concerning the safety of foods containing nanomaterials the precautionary principle would apply. In addition, the date of application of the Regulation has been prolonged to 24 months, thus leaving additional time for the development of risk assessment methods for engineered nanomaterials.’

Two of these amendments had previously been rejected by the European Commission, as stated in its Commission Communication (4^th June 2009; SP(2009)3060):
Excerpts:

• The Commission agrees with the inclusion of the definition of "engineered nanomaterials" [...] which could be modified afterwards through comitology with scrutiny. It also agrees with the inclusion of a provision which clarifies that all the "engineered nanomaterials" used in foods and food ingredients need a pre-marketing authorization.
• The Commission does not agree with the assumption that the general methodology used for the risk assessment of foodstuffs would not apply for the risk assessment of nanomaterials in food [...]. However, as underlined in the EFSA opinion on nanotechnologies, additional tests and control measures need still to be developed.
• The Commission does not also agree with a systematic labelling [...] of all foods produced with the aid of nanotechnology. As defined in the common authorization procedure, labelling must be decided on a case by case basis, following the scientific assessment and after consideration of other relevant factors.

Follow these links to find out more about the Review of the Novel Foods Regulation, to find out more about the European Parliament’s position on Novel Foods, to download the European Commission Communication on the 1^st Reading (4^th June 2009),  or to download the European Council draft Statements (5^th March 2010 and 2^nd March 2010).

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