From Labs to Markets: The Commerce of Nanotechnologies

Transcription

1 From Labs to Markets: The Commerce of Nanotechnologies Dr Michael Knowles VP, Global Scientific and Regulatory Affairs for The Coca-Cola Company, Chairman of the CIAA Nanotechnology Task Force CONFERENCE ON THE GLOBAL REGULATION OF NANOTECHNOLOGIES Boston, Massachusetts May 7-8, 2010

2 Contents Overview of potential applications EU Regulations covering food/packaging Requirements for food additives Requirements for food packaging EFSA Guidance on Risk Assessment Consumer Communications US EU Regulatory Convergence

3 From International Risk Governance Council, Geneva 2009

4 EU Regulations covering Engineered Nanomaterials Novel Food (EC 258/1997) Food additives (EC 1333/2008) Flavourings (EC 1334/2008) Food contact materials (EC 1935/2004) Active and Intelligent Packaging (EC 450/2009) Commission Communication: Regulatory Aspects of Nanomaterials COM (2008) 355 Final.

5 New Food additive in nano scale Approved Food additive Evaluation by EFSA + Additional data Case-by case evaluation by EFSA Change in manufacturing process or in the raw materials including nanotechnology No (or inconclusive opinion) Substance not authorised Favourable Opinion? Yes Substance authorised with specifications ( including particle size) and conditions of use No (or inconclusive opinion) Substance not authorised New Evaluation by EFSA Favourable Opinion? Yes Substance authorised with specifications ( including particle size) and conditions of use

6 New substance in plastic FCM An Example in Practise in nano scale Approved substance in plastic FCM Evaluation by EFSA + Additional data Case-by case evaluation by EFSA any new scientific or technical information, which might affect the safety assessment No (or inconclusive opinion) Substance not authorised Favourable Opinion? Yes Substance proposed for authorisation with specifications No (or inconclusive opinion) Substance not authorised New Evaluation by EFSA Favourable Opinion? Substance proposed for authorisation with specifications Yes

7 Opinion published 5 th March

8 31 March 2009 CIAA 2 nd Nanotechnology Dialogue SCIENTIFIC OPINION The Potential Risks Arising from Nanoscience and Nanotechnologies on Food and Feed Safety Dr David Carlander Scientific Officer Scientific Committee and Advisory Forum Unit 1

9 Recommendations in the Opinion Include into the current definition of nanoscale materials, which is now solely based on size metric, the additional metric of specific surface area. Investigate the interaction and stability of ENMs in food and feed, in the gastro-intestinal tract and in biological tissues Development and validation of routine methods to detect, characterise and quantify ENMs in food contact materials, food and feed Development and validation of test methodologies to assess toxicity of ENMs (including reliability and relevance of test methods)

10 FCP/NANO/001/10E Brussels, 22 March RD CIAA NANOTECHNOLOGY DIALOGUE MEETING Brussels, 23 rd March 2010 Hotel Marriott Renaissance Rue Parnasse Brussels Agenda Time Title Registration and Coffee Welcome and introduction to the 3rd Nanotechnology Dialogue Review of CIAA activities Dr. Mike Knowles Presentations and Discussion Time Title Presenter Regulatory update Novel food Safety assessment Filling the knowledge gaps General discussion Food Contact Material Safety assessment of nanomaterials, testing Update nanotechnology expert group ILSI Latest developments EFSA Towards the safe use of nanomaterials (20 ) Risk assessment SEAC 1 Dr Jean-François Roche, European Commission Dr Annette Schaefer, European Commission Dr Stamm, JRC Dr Anne Constable, ILSI Dr David Carlander, EFSA Dr Georgios Katalagarianakis, DG Research Dr Bobby Bradford, SEAC Lunch

11 Applications Potential applications in the food chain General Discussion Food contact material Food packaging material Active silver and antimicrobial coatings Diagnostics Anticaking agents Professor Schalkhammer, Attophotonics, Biosciences GmbH Austria Dr Ian Appleyard ColorMatrix Dr Richard Hastings, BioCote Ltd Dr David Sarphie, CEO BIO Nano Consulting Dr Monika Maier, Cefic/ASASP coffee break National activities UK Consumer attitudes General discussion the way forward Concluding remarks France, Germany, The Netherlands) (30 ) Consumer expectations from Nanotechnology Consumer attitudes towards the Technology Peter Hatto, Director Research IonBond Limited ANIA, BLL, FNLI Sue Davies, Which Dr Jo Wills, Eufic Dr Mike Knowles, CIAA end of the meeting 1 Association of Synthetic Amorphous Silica Producers

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