1. Regulation of Nanotechnology in Food Craig Simpson, Attorney 14 June 2007

2. OUTLINE 1.Applications of Nanotechnology in the Food Area 2.Current EU Regulation of Nanotechnology in Food 3.Problems with Current Regulatory Framework 4.The Problem of Risk Assessment 5.Options for Future Regulation 6.The US Perspective – Potential for a Trade Dispute à la GMO?

3. APPLICATIONS OF NANOTECHNOLOGY IN FOOD  Food Packaging ‘Active’ or ‘intelligent’ packaging  Food Processing: Taste and Texture For example, nanoparticle emulsions to improve texture (trickling agents) and reduce fat content  Functional Foods Nanocapsules enclosing nutrients such as vitamins or Omega 3 fatty acids (‘nanoceuticals’) for release into body when required

4. CURRENT REGULATION OF NANOTECHNOLOGY IN FOOD  No dedicated EU or US legislation (for food or otherwise)  Indirect regulation of products or processes incorporating nanotechnology, not of nano- technology component itself  Existing ‘precautionary approach’ prior approval food legislation (process/product specific) For example: Novel Foods (Regulation 258/97) Food Additives (Directive 89/107, and daughter directives on specific purity criteria)

5. CURRENT REGULATION OF NANOTECHNOLOGY IN FOOD Food contact materials (Regulation 1935/2004 and daughter Directives on specific materials) Food supplements (Directive 2002/46) Fortification (Regulation 1925/2006)  Non-food specific chemicals prior approval legislation: REACH (Regulation 1907/2006) since 1 June 2007 Dangerous Substances Directive (Directive 67/548) (largely replaced by REACH)  General principle of food law: ‘Food shall not be placed on the market if it is unsafe’ (Article 14(1), Regulation 178/2002)

6. PROBLEMS WITH CURRENT LAW Summary of Conclusions of Report of UK FSA Regulatory Review EU LegislationGaps in Regulation Novel Foods (Regulation 258/97) – mandatory pre-market approval for all novel foods and processes – Adequate for new nanomaterials: measures toxicology and considers manufacturing process – Inadequate for new nanoversions of ingredients Food Additives (Directive 89/107 and implementing legislation) – Positive lists, maximum levels, specific purity criteria – Inadequate since generally no control of particle size – Purity criteria Directives could be easily amended by comitology to include minimum particle size provision Food Contact Materials (Regulation 1935/2004 and implementing legislation) – Controls migration of chemicals from materials into food – Inadequate: no differentiation between ‘routine’ chemicals and those produced by nanotechnology – Suggests amending Regulation 1935/2004 to require nanocomponents to be subject to own risk assessment (regardless of the material incorporated into)

7. PROBLEMS WITH CURRENT LAW  Prior Approval Legislation: Report of UK FSA Regulatory Review re current regulation of nanotechnology in food (March 2006) Does not cover all nanotechnology uses: ‘most potential uses of nanotechnologies that could affect the food area would come under some form of approval process before being permitted for use’ (para. 62) Does not require testing of new nanotechnology versions of ingredients/ materials already on positive list (not previously checked for particle size): ‘uncertainty in some areas whether application of nanotechnologies would be picked up consistently’ (para. 63)

8. PROBLEMS WITH CURRENT LAW  REACH Substances used in foods (including additives and flavourings) largely exempted (Article 2(5)(b) Substances in food contact materials and food additives and flavourings preparations sold as such to final user covered (Articles 2(6)(d) and 14(5)(a)) 1 ton threshold suitable for nanoparticles? Lack of risk assessment method?: ‘...methodologies for identifying hazards and evaluating risks of substances at the nano-scale need to be further refined over the next few years...’

9. PROBLEMS WITH CURRENT LAW ‘It will also be necessary to carefully monitor over the next few years whether the 1t threshold for registration and the information requirements under REACH are adequate to address potential risk from particles on a nano-scale’ (REACH Q&A)  No marketing of unsafe food ‘Unsafe’ subjective decision of food business operator When is duty to recall (Article 19) triggered?  General Conclusion: Current legislation unsuited to specifics of nanotechnology and rarely used Significant that no notification for nanotechnology applications made under Directive 67/548

10. RISK ASSESSMENT OF NANOTECHNOLOGY  Clear that not yet possible to carry out a risk assessment of nanoparticles Commission Communication on Nanotechnology (May 2004): need to ‘generate the data needed for risk assessment.’ SCENIHR Opinion on Nanotechnology (September 2005): ‘major gaps in the knowledge necessary for risk assessment’. EFSA Note on Nanoscience (March 2006): ‘It is clear that for future risk assessment of nanoparticles additional information, knowledge and tools are needed, e.g. –investigation of the mechanism and toxicological potential –reconsideration of the currently applied paradigms for risk assessment in the light of the altered properties of nanoparticles –development and allocation of analytical tools to monitor the occurrence and distribution of nanoparticles’. EFSA 2007 Management Plan: develop harmonised risk assessment approaches and gather more data for further analysis

11. HOW TO REGULATE NANOTECHNOLOGY IN THE EU IN THE FUTURE  EFSA State of Play (2006): ‘most countries are still in the phase of raising awareness and investigating what the regulated topics should be’.  Commission favours proactive amendment of existing EU prior approval Regulations only Communication (2004): ‘Maximum use should be made of existing regulation. However, the particular nature of nanotechnologies requires their re-examination and possible revision.’ (para. 3.4.4.) Action Plan (2005): ‘propose adaptations of EU regulations in relevant sectors...’ (para. 6.1(d))  Amend specific additive purity criteria Directives through comitology to include minimum particle size

12. HOW TO REGULATE NANOTECHNOLOGY IN THE EU IN THE FUTURE  Food Additives Proposal Evaluation of new nanotechnology versions of additive already approved (Recital 13) EP ENVI Committee Report on Proposal: separate limit values for nanoparticles in additives and treat separately on positive list (Amendment 35) Faster authorisation procedure for new additives: Commission decision based on EFSA risk assessment and technological need/ consumer interest assessment of SCFAH

13. HOW TO REGULATE NANOTECHNOLOGY IN THE EU IN THE FUTURE  Moratorium/Ban on nanotechnology products Green support: Australian lobby group, Greenpeace Communication (2004): moratorium ‘severely counter- productive’ (para. 3.5.1.) Breach of Article 5.1 of WTO SPS Agreement if prior to full risk assessment (WTO Beef Hormones ruling 1999 and EC- Biotech Products ruling 2006 re safeguard measures)  Ban based on precautionary principle? Communication (2004): ‘The Precautionary Principle... could be applied in the event that realistic and serious risks are identified.’ (para. 3.5.1.) Article 5.7 SPS: ‘...on the basis of available pertinent information, including that from the relevant international organisations...’

14. HOW TO REGULATE NANOTECHNOLOGY IN THE EU IN THE FUTURE Article 7 Regulation 178/2002: ‘the possibility of harmful effects on health if identified but scientific uncertainty persists...’ German Federal Institute for Risk Assessment (BfR) Draft Nanotechnology Research Strategy August 2006: –‘the risks have not yet been characterised’ –‘we do not know whether there are any risks involved in the uptake of nanoparticles from the gastro-intestinal tract’ (Reported in EU Food Law, November 24, 2006) Alpharma case (T-70/99): ‘a preventive measure [based on the precautionary principle] cannot be based on a purely hypothetical approach to risk, founded on mere conjecture which has not been verified’ (para. 156)

15. THE NEXT TRANSATLANTIC TRADE DISPUTE?  Inevitable comparisons to GMO US-EU trade dispute: strategic economic value v. societal fears  Current regulatory position in EU and US very similar: indirect regulation only, in practice none  FDA more defensive ‘head in sand’ approach than EU, reactive not proactive: ‘FDA believes that the existing battery of pharmatoxicity tests is probably adequate for most nanotechnology products that we will regulate. Particle size is not the issue... FDA regulates products, not technology.’ (FDA and Nanotechnology Products FAQs)

16. THE NEXT TRANSATLANTIC TRADE DISPUTE? International Centre for Technology Assessment (CTA) petitions FDA May 2006: Amendment of regulations to require new nano-specific testing and mandatory product labelling  Likelihood of EU-US trade dispute? Future EU moratorium or national safeguard measures? Will US follow ‘non-product incorporated’ product distinction approach in GMO debate? (does not recognise product distinctions based on production processes and methods (‘PPMs’) not reflected in the final characteristics of a good)

17. THE NEXT TRANSATLANTIC TRADE DISPUTE?  Difference may be real health risk: US may take process based approach in common with EU Avoid conflict over EU precautionary measures based mainly on societal considerations –‘Scientific risk assessment alone cannot, in some cases, provide all the information on which a risk management decision should be based, and other factors relevant to the matter under consideration should be legitimately be taken into account including societal [and] ethical factors’ (Regulation 178/2002, Recital (19), Article 7.2)

18. CONCLUSIONS 1.EU Regulation currently insufficient and not used in practice. Lack of risk assessment capabilities a major reason for this. 2.Commission proactive approach to amendment of current food safety legislation. No dedicated GMO style legislation anticipated. 3.Precautionary measures possible but seem unlikely, and not legally justifiable, for the moment. 4.US position less proactive, more reactive product based approach – but public pressure to fill regulatory void. 5.Likelihood of a trade dispute low: –Commission’s wish to avoid repeat of GMO; and –real risks more likely to be identified.