First Nanotechnology Stakeholder Dialogue

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1 First Nanotechnology Stakeholder Dialogue 19 September 2008, Programme Morning session The food industry and nanotechnology - the future Introduction Mike Knowles, Chairman CIAA Nanotechnology taskforce Presentations 1. DG Research - Domenico de Martinis 2. Joint industry presentation 3. Academia - Prof Richard A.L. Jones, Senior Strategic Advisor for Nanotechnology, Dept of Physics and Astronomy, University of Sheffield Lunch Afternoon session The food industry and nanotechnology - today Presentations 1. Friends of the Earth - David Azoulay, FoE, Europe 2. Ingredients supplier, Maryse Herve, ELC 3. CEFIC food contact material, Madeleine Lafont, CEFIC 4. Food supplement industry Patrick Coppens, EAS 5. DG SANCO, Philippe Martin 6. DG Enterprise, Cornelius Brekelmans 7. EFSA, David Carlander 8. BEUC representative Final panel debate with all speakers - Moderated by Dr Antje Grobe, Risk Dialogue Foundation Closing remarks - Mike Knowles

2 List of participants Richard A.J. Jones Philippe Martin Maryse Hervé Lorene Courrege David Azoulay Jurek Vengels Laurent Bontoux Dr Antje Grobe David Carlander Steffi Friedrichs Jean François Roche Madeleine Laffont Marc Vermeulen Domenico De Martinis Cornelis Brekelmans Maila Puolamaa Rocio Salvador Rolan Federico Morais Pauline Raust Erika Mink Gabi Pieper Hugo Byrnes Alexander Döring Teresa Babuscio Bernd Gruner Fatma Sahin Reinder Sijtsma Henry Uitslag Sophie Holm Agnes Davi Anna-Maria De Smedt Truus Huismann Lynn Insall Michael Knowles Sieglinde Stähle Dominique Taeymans Susana Navarro-Brown Rocio Salvador Roldan University of Sheffield DG SANCO ELC EHPM FoE Europe FoE Europe DG Research Risk Dialogue Foundation EFSA Nanotechnoly Ind Association CEFIC CEFIC DG Research DG Enterprise FIAB ANIA TETRA PACK TETRA PACK Royal Ahold FEFAC COCERAL CELCAA EUROCOMMERCE NUTRECO BEUC BEUC DANONE THE BREWERS OF EUROPE UNILEVER FDF COCA-COLA BLL NESTLE KRAFT FOODS DG Enterprise

3 On 19 September 2008, CIAA held a stakeholder meeting on nanotechnology and its applications in the food industry. Participants included representatives from the European Commission (DGs SANCO, Research and Enterprise), CEFIC (the chemicals industry), BEUC (European consumer organisation), EFSA (European Food Safety Authority), academia, Friends of the Earth (FoE) and others. To launch the debate, the Chair of the CIAA Nanotechnology Task Force, M. Knowles, outlined the formation and work of this Task Force, presenting early drafts of the CIAA Code of Practice on Nanotechnology and the CIAA working definition of nanomaterial for initial feedback. The definition in particular generated much discussion: FoE and BEUC both found the definition too restrictive 1. Others, such as Professor Richard Jones of Sheffield University, observed that food itself is a naturally structured nanomaterial, and that too broad a definition could lead to a significant amount of traditional food processing (e.g. the production of ricotta cheese or low-fat ice-cream) being categorised as nanotechnology. He nevertheless called for a distinction to be made between engineered nanoparticles, broken down by milling, for example, and self-assembled nanoparticles. Meanwhile, CEFIC advocated using the ISO definition (not yet final), which did not have an absolute cut-off size. DG SANCO argued that size was immaterial from a legislative point of view, and DG Enterprise advocated making a distinction between a legal definition, which it considered to be unnecessary, and a working definition. ELC, the additives industry, on the other hand, supported the CIAA definition. Although the diverse views expressed served to underline the need in the eyes of many for a common definition, Friends of the Earth expressed the need for complete transparency, especially from industry. FoE expressed concerns about the knowledge gap which existed surrounding nanotechnology, particularly in relation to risk assessment. They stressed that a prudent and transparent approach by industry was necessary in order to bolster consumer confidence, and that if risks surrounding a product could not be characterised, the product should simply not be permitted on the market. In response, M. Knowles affirmed that the workshop was an indication of industry s willingness to be as open as possible on this subject. He emphasised that consumers response to real or perceived food safety issues was of prime important for the competitiveness of the European food industry, and industry is committed to providing the highest standards of food safety. In addition, he underlined that while the food industry was certainly undertaking research into the potential benefits of nanotechnology, as highlighted within the European Technology Platform Food for Life Strategic Research Agenda for , the industry was simply not permitted to place any products with new properties created using nanotechnologies on the market without prior approval. Food companies would not jeopardise their valuable reputations by placing products on the market which were the subject of any doubt by risk managers. He therefore emphasised the importance of appropriate risk assessment procedures designed for nanomaterials before applications are placed on the market, and noted that research institutes could play a vital role in this respect. FoE insisted, nevertheless, that such products were not only available on the market, but were even being openly advertised as such, and cited the food, food packaging and agricultural products listed within its recent study Out of the Laboratory and onto our Plates 2 as examples. DG SANCO also took the floor to reassure FoE and BEUC that, while there was indeed a knowledge gap, a knowledge base does currently exist. It is because of the knowledge that we have that we would like to acquire more knowledge, the DG SANCO representative stated, adding that a sufficient 1 FoE considered 300 nanometers to be a more acceptable size, but agreed however that the scope of the definition should be limited to manufactured materials which exhibit properties different to those which it would have in its original form. 2

4 regulatory framework was already in place to address potential health and environmental risks in relation to nanotechnology in foods, a view firmly supported by the DG Enterprise representatives present. DG SANCO also stated that the European Medicines Evaluation Agency (EMEA) had experienced no difficulties with the risk assessment of non-food nano-products to date, all of which had been easily identified as having been produced using nanotechnology. Nevertheless, Commission representatives acknowledged that where food was concerned, there was still a lot of work to be done at the implementation level (e.g. the gathering of further exposure data and the development of methodology, etc). EFSA informed participants that it intended to adopt its draft Opinion on nanotechnology the following week, cautioning that it may be subject to change prior to publication. Stakeholders would have the opportunity to comment on the draft during a six-week public consultation, with a view to publication of the final draft by the end of the year. The representative explained that although EFSA considered that nanotechnology is also applicable to the general risk analysis paradigm, a case-by-case approach was still needed, given that data needs may completely change over time. In addition, he highlighted that some nanoparticles would be impossible to even detect, given the current shortage in reference materials and validated methods, and agreed with Commission officials that little was known about exposure. The EFSA representative also noted that there was also a general lack of data on toxicokinetics. He was reasonably confident, however, that standard toxicology tests would have a good chance of determining toxicity. In response to a request by BEUC for guidance on product safety assessment and rapid testing methods, EFSA noted that it could provide general guidance based on the knowledge available. Stakeholders were also informed of recent initiatives by CEFIC to improve transparency and build trust with stakeholders. For example, a workshop was organised in June on non-food nanomaterials and there are plans to host a series of workshops with stakeholders in the first half of 2009, the themes for which would be decided on the basis of consultations with stakeholders. ELC informed stakeholders that although it could not rule out that additives produced using nanotechnology could be placed on the market in future, such additives would have to undergo an EFSA safety assessment and meet very specific requirements for origin, purity, etc, and their use should not mislead the consumer. DG SANCO representatives present confirmed this point. ELC pointed out that, if there were any concerns surrounding a new additive, the risk could not be appropriately assessed, and EFSA could not deliver an Opinion, the additive could therefore not be placed on the market. In addition, other legitimate factors, including environmental factors, would have to be taken into account in future following the adoption of the new Additives Regulation (Council adoption on 18 November with an expected publication at the end of the year). Nevertheless, ELC acknowledged that there were indeed some nano-additives on the European market which had been imported from the U.S., and that the additives industry recognised that more scientific certainty was needed on the potential risks involved with nanotechnology. CEFIC informed stakeholders that although no additives produced using nanotechnology had been placed on the European market by any of its members, applications had been made to EFSA. The European Health Product Manufacturers association, EHPM, expressed concern at the fact that it was not always clear to manufacturers, when purchasing an ingredient, whether it is made of nanomaterials, but noted that the supplements producers trusted that European operators were compliant with European legislation. Stakeholders also learned that the International Life Sciences Institute (ILSI) was working on a globalscale nanotechnology project with a specific focus on nanoparticles. The project will involve information sessions on nanotechnology, the creation an expert group to investigate the safety

5 assessment of nanoparticles and nanotechnology in food applications, and close monitoring of developments throughout Europe in the risk assessment of nanoparticles via networking activities. The Organisation for Economic Cooperation and Development (OECD) is also very active in the area of nanotechnology. In addition, the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) was expected to shortly issue a report on the safety of nanotechnology, from the chemicals industry s point of view. The potential benefits and disadvantages of nanotechnology were also discussed. Professor Jones recognised the potential for flavours and, and noted that increasing numbers of micronutrients with positive health benefits were also being discovered. BEUC, meanwhile, acknowledged that nanotechnology could be beneficial to consumers and society in general, but stressed the need for safety regulation in a transparent manner. In response to concerns raised by BEUC with regard to the use of nanometals in packaging, Professor Jones agreed that regulation was potentially an issue, but that larger packaging companies were trying to proactively engage with regulators on this matter. M. Knowles added that as was the case with nanofoods, any nanomaterials would have to first be assessed by EFSA. The labelling of nanotechnology products was also briefly discussed. BEUC proposed that reference be made within an ingredients list as to whether a product/ingredient was in nano-form, while FoE suggested that the information be made available on the product s website instead. It was also suggested to develop a register of nanotech products. Professor Jones reported that pilot work was underway on an online registry in the UK. Companies would be asked for information on their products and, in the absence of such information, educated guesses would be made. The stakeholder debate was welcomed as a useful initiative and starting-point for future dialogue. All stakeholders agreed in conclusion that better communication was needed on this subject, and that an environment of trust and mutual confidence must be established. CIAA agreed that consumers required clear messages, presented in simple language, but that in turn, EFSA assessments and scientific recommendations must be undisputed and give rise to consistent policy decisions. As a first gesture of transparency, CIAA offered to circulate the principles contained within its draft Code of Practice to all stakeholders for more extensive comment.

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