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Nanotechnologies and Novel Foods in European Law

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Abstract

Food is a big business in the EU and nanofood products are beginning to be placed on the market. It is still unclear whether the absence of minimum regulation at a global level promotes or prevents the growth of a market in nanofood. However, the development of an adequate risk management policy in relation to food safety is a key concern for consumers. Importantly, the European Parliament in its 2009 Resolution on “Legal aspects on nanomaterials” called for more in-depth scientific research on the toxicity of compounds in nanomaterials, and for the adoption of an EU definition of nanomaterials for regulatory purposes. Unfortunately, in 2011, nanotechnology led to inconclusive debates in the context of the revision of Novel Food Regulation. General Food Law applies to nanofood in terms of safety requirements, and specific rules also apply to food contact materials containing nanoparticles as well as to to additives, vitamins and minerals. The EU legislator also introduced mandatory labelling in respect of products derived from nanotechnologies. The legal framework is evolving according to the so-called “incremental approach”, a governance model that creates the risk of fragmentation. But the main problem is the inconsistent definition of the terms “nanotechnology” and “nanomaterials” when looking at the enforcement of regulations and the provision of a wide range of specific tools for different nanofoods: for example the use of positive lists of authorised substances applying only to food contact materials, additives and supplements. This contribution aims to review the regulations in force in respect to nanofood and novel foods and to highlight the problems that are still unresolved.

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Notes

  1. The Commission has identified nanotechnology as a key enabling technology (KET) providing the basis for further innovation and new products. See the Communication “A European strategy for Key Enabling Technologies – A bridge to growth and jobs” of 26 June 2012, COM (2012) 341 final, where the Commission outlines a single strategy for KETs, built upon three pillars: technological research, product demonstration and competitive manufacturing activities. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0341:FIN:EN:PDF

  2. A radical new approach in managing food safety was proposed by the European Commission in the White Paper on Food Safety of 12 January 2000, Brussels, COM (1999) 719 final.

  3. This concept was developed under the World Health Organization (WHO) legal framework. Further information is available on the institutional website at: http://www.who.int.

  4. Regulation (EC) 1223/2009 on cosmetic products provides a definition of «nanomaterial » as an « insoluble or biopersistent and intentionally manufactured material with one or more external dimensions or an internal structure from 1 to 100 nm ». However this definition will be adapted « to technical and scientific progress and to definitions subsequently agreed at international level. » In addition, certain requirements relating to notifications to the Commission were introduced on 11 January 2011.

  5. See Regulation (EU) 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products. Importantly, recital 66 of the Regulation establishes that “there is scientific uncertainty about the safety of nanomaterials for human health, animal health and the environment. In order to ensure a high level of consumer protection, free movement of goods and legal certainty for manufacturers, it is necessary to develop a uniform definition for nanomaterials […]. The Commission should regularly review the provisions on nanomaterials in the light of scientific progress”. Following the same approach Article 4(4) provides that “the approval of an active substance shall not cover nanomaterials except where explicitly mentioned.”

  6. Directive 2011/65 of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment, recital 16, establishes that: “as soon as scientific evidence is available, and taking into account the precautionary principle, the restriction of other hazardous substances, including any substances of very small size or a very small internal or surface structure (nanomaterials) which may be hazardous due to properties relating to their size or structure, and their substitution by more environmentally friendly alternatives which ensure at least the same level of protection of consumers should be examined.” Similarly, Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on waste electrical and electronic equipment (WEEE), recital 18, establishes that: “to control possible risks to human health and the environment from the treatment of WEEE that contains nanomaterials, it is appropriate for the Commission to assess whether specific treatment may be necessary” and Article 7(4) provides that: “The Commission is invited to evaluate whether amendments to Annex VII are necessary to address nanomaterials contained in EEE.”

  7. See G. van Calster, Simply Swallow? – The Application of Nanotechnologies in European Food Law, in EFFL, n. 3, 2009, p. 169

  8. Some guidance is provided by the EU authorities and consultative bodies. See, in particular, EFSA (2011): Opinion on the Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain. EFSA Journal 9 (2011), 2140; SCENIHR (2007): Opinion on the appropriateness of the risk assessment methodology in accordance with the technical guidance documents for new and existing substances for assessing the risk of nanomaterials. http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_010.pdf; SCENIHR (2009): Opinion on risk assessment of products of nanotechnologies. http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_023.pdf.

  9. COM(2008)366 final.

  10. Commission staff working document accompanying document to the communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee - Regulatory aspects of nanomaterials - Summary of legislation in relation to health, safety and environment aspects of nanomaterials, regulatory research needs and related measures.

  11. See the Scientific Opinion of the Scientific Committee, The Potential Risks Arising from Nanoscience and Nanotechnologies on Food and Feed Safety, in The EFSA Journal (2009) 958, 1–39.

  12. Food additives are regulated under Directive 89/107/EC and associated legislation. The Directive is based on the principle that only additives which are explicitly authorised may be used in food. In December 2008, a new Regulation was passed (Regulation EC/1333/2008) which set out a common authorisation procedure for additives, enzymes and flavourings. The system is based on a list of approved additives, including vitamins and minerals; the inclusion of additives on the list is decided by the Commission on the basis of an opinion from the EFSA.

  13. The general legal framework for FCMs is embedded in Regulation (EC) 1935/2004. The European Commission or Member States may request the EFSA to conduct a safety evaluation of any substance or compound used in the manufacture of a FCM. In addition, “intelligent materials” (see further in the text) are governed by Regulation (EC) 450/2009 which considers nanoparticles requiring a case by case evaluation. Certain nanomaterials, in particular, plastic, are subject to additional measures, as provided by the Commission Regulation (EU) 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food.

  14. Panel on Food Additives and Nutrient Sources Added to Food.

  15. Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids.

  16. Further information is available on the EFSA institutional website at http://www.efsa.europa.eu/.

  17. See ENDS Report, National – Government rejects nanofood database, April 30, 2010.

  18. European Parliament legislative resolution of 24 March 2009 on the proposal for a regulation on novel foods, Position of the European Parliament adopted at first reading, A6-0512/208, in OJEU n. C 117 E, 6 May 2010, pp. 236–254. The European Parliament adopted also a proposal at second reading on 7 July 2010. See P7_TA(2010)0266, in OJEU n. C 351E, 2 December 2011, pp. 174–193.

  19. “Engineered nanomaterials” is defined by Parliament as “any intentionally produced material that has one or more dimensions of the order of 100 nm or less or 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 to the nanoscale. Properties that are characteristic to 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.”

  20. The definition of “novel food” provided by the Regulation is food that “has not been used for human consumption to a significant degree within the Community before 15 May 1997”.

  21. European Commission, Proposal for a Regulation of the European Parliament and of the Council on novel foods and amending Regulation (EC) No XXX/XXXX [common procedure], COM/2007/0872 final, Brussels, 14 January 2008.

  22. Regulation 178/2002, Article 1.

  23. See D. Marrani, Nanofoods e Novel foods nella legislazione alimentare dell'Unione europea, in Diritto Comunitario e Degli Scambi Internazionali, vol. 3, 2012, p. 557–571.

  24. Judgment of the Court (Second Chamber) of 15 January 2009. Case C-383/07, M-K Europa GmbH & Co. KG v Stadt Regensburg, in Reports of Cases 2009 I, p. 115.

  25. On the 12th May 2004, the European Commission adopted the Communication “Towards a European Strategy for Nanotechnology” COM(2004) 338. On the 7th June 2005, the European Commission adopted the Action Plan "Nanosciences and nanotechnologies: An action plan for Europe 2005–2009" (COM(2005) 243). On 6 September 2007, the European Commission adopted the Communication "Nanosciences and Nanotechnologies: an action plan for Europe 2005–2009. First Implementation Report 2005–2007", COM(2007)505 final. On 29 October 2009, the European Commission adopted the Communication “Nanosciences and Nanotechnologies: an Action Plan for Europe 2005–2009. Second Implementation Report 2007–2009”, COM(2009)607 final. The further soft law instruments are focused on “nanomaterials” and lead to the Commission/Parliament divergence on the market- oriented strategy and on the pre-market risk assessment. See footnotes 6, 7.

  26. European Commission, Recommendation on a code of conduct for responsible nanosciences and nanotechnologies research, Brussels, 7 February 2008, C(2008)424 final, in OJEU n. L 116, 30 April 2008, pp. 46–52.

  27. The public consultation ended on 19 November 2010.

  28. European Commission, Recommendation of 18 October 2011 on the definition of nanomaterial (2011/696/EU), in OJEU n. L 275 of 20 October 2011, pp. 38–40. The public consultation ended on 19 November 2010.

  29. SCENIHR (2010): Scientific Basis for the Definition of the Term “nanomaterial” http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_032.pdf

  30. See in particular the initiatives and working groups on nanotechnologies established by OECD, CEN, ISO.

  31. COM(2012)572 final and SWD(2012)288 final.

  32. See Regulation (EC) N. 1223/2009 on Cosmetics Products, Article 19(1)(g).

  33. Regulation (EC) N. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures, Title III. It should be noted, however, that where a nanomaterial is thought to be more hazardous than a bulk version of the material for which registration documentation has already been submitted, REACH requires the submission of additional hazard information, Article 22.

  34. Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, in OJEU n. L 304, 22 November 2011, pp. 18–63.

  35. See Food and Drug Administration (FDA), Nanotechnology: A Report of the US Food and Drug Administration Nanotechnology Task Force (FDA, Rockville 2007) at 34–5, especially 35.

  36. European Commission, From Farm to Fork: Safe Food for Europe’s Consumers (Office for Official Publications of the European Communities, Luxembourg, 2004) at 14.

  37. Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives, in OJEU n. L 354, 31 December 2008, pp. 16–33.

  38. Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, in OJEU n. L 304, 22 November 2011, pp. 64–88.

  39. Law n. 2010–788 of 12 July 2010, so-called Grenelle II, which adds to the Code of the environment a Section specifically devoted to nanotechnologies: « Prévention des risques pour la santé et l'environnement résultant de l'exposition aux substances à l'état nanoparticulaire ».

  40. House of Lords Science and Technology Committee report of session 2009–10 'Nanotechnologies and Food' published 7 January 2012.

  41. Under the old Sixth Framework Programme, between 2002 and 2006 more than 1.3 billion euros was spent on more than 550 projects related to nanotechnology R&D. Under the current programme, the Seventh Framework Programme, running from 2007 to 2013, funding for nanotechnology projects is expected to reach 3.5 billion euros, out of a budget of 50.5 billion.

  42. Horizon 2020 – The Framework Programme for Research and Innovation – COM (2011) 808 to run from 2013 to 2020. The proposal was submitted to the European Parliament on 30 November 2011. The proposal includes a budget of EUR 6.663 billion for Key Enabling Technologies of photonic, micro- and nanoelectronics, advanced materials, biotechnology and advance manufacturing and processing.

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Authors and Affiliations

  1. University of Salerno, via Ponte don Melillo, 84084, Fisciano, Salerno, Italy

    Daniela Marrani

  2. Italian National Bioethics Committee, Rome, Italy

    Daniela Marrani

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Marrani, D. Nanotechnologies and Novel Foods in European Law. Nanoethics 7, 177–188 (2013). https://doi.org/10.1007/s11569-013-0176-4

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