Nanotechnology The Regulatory Landscape for the Food Industry

1. Nanotechnology The Regulatory Landscape for the Food Industry Dr. Anna Gergely, Director EHS Regulatory agergely@steptoe.com Leatherhead Food Research 18 November 2010

2. CONTENTS 1. Examples of Nanotechnologies in Food • Current Regulatory Framework • Emergence of Regulation of Nanotechnology 4. Risk Assessment of Products enabled by Nanotechnologies 5. Reporting/Labelling 6. Conclusions

3. SOME POSSIBILITIES FOR THE USE OF NANOTECHNOLOGIES IN FOOD • Food Packaging ‘Active’ and ‘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. LEGAL FRAMEWORK • Horizontal Legislation: (applicable, but pre-nano) • General Product Safety and Product Liability Legislation • Workers’ Protection Legislation • Environmental Legislation • Chemicals Legislation (REACH and CLP) • Vertical (Application Specific) Legislation: (nano-specific) Food / Novel Food / Food-contact / Cosmetics / Biocides/ RoHS/ Medical Devices etc.

5. EXISTING FRAMEWORK – POSITIONS OF INSTITUTIONS • EU Commission: June 2008 Communication on Regulatory Aspect of Nanomaterials/Staff Working Document: • ‘Current legislation covers in principle the potential health, safety and environmental risks in relation to nanomaterials. Protection ... needs to be enhanced by improving implementation of current legislation. ‘Specially mentions: • Regulation 258/97 (Novel Foods) • Regulation 1935/2004 (Food Contact Materials) • Directive 89/107 (Food Additives – now repealed) • Directive 2002/46 (Food Supplements). • Directive 1925/2006 (Fortification/Addition of vitamins and minerals)

6. EXISTING FRAMEWORK – POSITIONS OF INSTITUTIONS • European Parliament: April 2009 Resolution on regulatory aspects of nanomaterials; among others: • Call on Commission to review all relevant legislation within 2 years (2011) • Introduce comprehensive definition of nanomaterials into relevant Community legislation • Duty of care on manufacturers placing nanomaterials on the market • Commission to compile before June 2011 publicly available inventory (respecting CBI) of different types/uses of nanomaterials in EU • Labelling of nano ingredients • Urgent development of adequate testing protocols to assess hazards of and exposure to nanomaterials

7. EXISTING LEGAL FRAMEWORK - FOOD • General principle of Regulation 178/2002 (Food law): ‘Food shall not be placed on the market if it is unsafe’ (Article 14(1)) • Regulation of products or processes incorporating nanotechnology, not of nano-technology itself • For example: • (Existing) Novel Foods (Regulation 258/97) • Food supplements (Directive 2002/46) • Fortification (Regulation 1925/2006) • New food additives Regulation 1333/2008 • Existing ‘precautionary approach’ prior approval (process/product specific)

8. EXISTING LEGAL FRAMEWORK - FOOD CONTACT • Regulation 1935/2004 (Framework Regulation): Article 3: specific provisions on safety – also applies for nanomaterials • Directive 2002/72 (Plastics Directive): • the establishment of a list of approved substances (the positive list) is sufficient to demonstrate the achievement of safety • provided the relevant restrictions are met • No restrictions on particle size; hence the positive listing of a substance could be claimed to also cover its nano-form (this has been changed with PIM!)

9. EXISTING LEGAL FRAMEWORK - FOOD CONTACT • However, the Framework Regulation also provides, that: • …the applicant or any business operator using the authorized substance shall immediately inform the Commission of any new scientific or technical information, which might affect the safety assessment of the authorized substance in relation to human health. • What “might” affect the safety assessment is left for the business operator to judge • Can be claimed to cover nanomaterials with potential health hazard

10. EXISTING LEGAL FRAMEWORK - FOOD CONTACT • Safety demonstrated on a case-by-case basis: • With sufficient toxicological information • With demonstrating the lack of any exposure; i.e. no migration • All the above implies that the individual authorization of the nano-form is required by the Authority. This calls for: • Clarifying the confusion of relying on existing authorization for bulk substances – see PIM • Developing proper criteria for the safety evaluation of nanomaterials, allowing their petitioning and appropriate listing as authorized substances in their nano-forms

11. EXISTING LEGAL FRAMEWORK - FOOD CONTACT • Active and Intelligent Packaging Regulation (EC No. 450/2009) • Excludes “nanoparticles” (“substances deliberately engineered to particle size which exhibit functional physical and chemical properties that significantly differ from those at a larger scale”) from the exemption to authorize substances behind a Functional Barrier • Different definition than in other regulatory areas (cosmetics, novel foods, etc.)

12. EMERGENCE OF REGULATIONOF NANOTECHNOLOGY IN FOOD • Need for ‘systematic’ evaluation of food containing engineered nanomaterials, irrespective of whether nanomaterials thought to cause changes in food properties (Council) • Recognition of need for adaptation of comprehensive, internationally agreed definition to technical and scientific progress (EP) • Urgent need for appropriate and specific risk assessment test methods for engineered nanomaterials (EP, Council) • UK House of Lords Select Committee Report on Nanotechnologies and Food (January 2010): engineered nanomaterials used in food must be subject to a formal EFSA risk assessment • Labelling (see infra)

13. WORKING DEFINITIONS I • European level Opinion of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) Joint Research Center Reference Report Scientific Committee on Consumer Products (SCCS) Definitions adopted in EU law (Cosmetics, Novel Food …) • International level ISO OECD Working Party on Manufactured Nanomaterials (WPMN) • National level US, Australia, Canada, UK, Germany • Definitions are not based on the same elements

14. WORKING DEFINITIONS II • UK House of Lords Select Committee Report on Nanotechnologies and Food (January 2010): • change in functionality (how substance interacts with the body) and not size range should be the key   • detailed list of 'properties that are characteristic of the nanoscale' • distinguish between naturally occurring and engineered nanoparticles • SCENIHR opinion on the scientific basis for the definition of the term “nanomaterial” (July 2010): • Size-driven definition with a two-tier approach (upper size threshold and lower, critical size threshold) • Overarching definition with case-by-case exclusion criteria • JRC Reference Report “Considerations on a definition of nanomaterial for regulatory purposes” (June 2010): • Exclude properties other than size in a basic definition • Focus on “particulate nanomaterials”

15. WORKING DEFINITIONS III • European Commission Draft Recommendation (open for consultation until 19 November 2010!): • Consists of particles, with one or more external dimensions in the size range 1nm – 100nm for more than 1% of their number size distribution • Has internal or surface structures in one or more dimensions in the size range 1nm-100nm • Has a specific surface area by volume greater than 60m²/cm³, excluding materials consisting of particles with a size lower than 1nm • Particle: means a minute piece of matter with defined physical boundaries (ISO 146446:2007)

16. DEFINITION FOR COSMETIC USE • Cosmetics Regulation (EC) No 1223/2009 • Amended to specifically address nano materials • Intention to place a product containing nanomaterials on the market must be notified to the Commission 6 months in advance (no obligatory assessment by the SCCS) • Definition for nanomaterials as “insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure on the scale of 1 to 100 nm” • while “moving” definition; it creates difficulties in interpretation and enforcement

17. DRAFT DEFINITION FOR NOVEL FOOD USE • Council Common Position Article 3(2)(c): • ‘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’

18. NEW FOOD ADDITIVES REGULATION 1333/2008 • In conjunction with the Regulations on food enzymes (No. 1334/2008) and on food flavourings (No. 1334/2008) a common authorization system is introduced and a common basis of controls is established • Food additives produced through nanotechnology requires separate new entry in positive list from non-nano version already on list (Article 12) • Producers or users of a food additive are obliged to inform the Commission of any new scientific or technical information that may affect the safety-assessment of the food additive (Article 26)

19. DRAFT NOVEL FOODS REGULATION • Recast of Regulation No. 258/97 • Current and proposed Regulation apply only, if the food’s nutritional value, its metabolism profile or its level of undesirable substances is significantly changed in relation to its macroscale counterpart • EP Plenary Sitting 2nd Reading, July 2010: • ‘Novel food should include foods modified by new production processes, such as nanotechnology and nanoscience, which might have an impact on food’ (Recital 6, Art. 3(2)(a)(iii) Proposal)

20. EMERGENCE OF REGULATION - FOOD CONTACT Draft Plastics Implementation Measure (PIM): • Whereas (23): “substances deliberately engineered in particle sizes that significantly differ from those at larger scale, e.g. nanoparticles”. Further: “…authorizations which are based on the risk assessment of the conventional particle size of a substance do not cover engineered nanoparticles.” • Article 9 of draft PIM provides: • “Unless explicitly mentioned in the specifications […of the positive list] the use of substances in nano-form shall not be authorized” • “nano-form” is not defined

21. EMERGENCE OF REGULATION - FOOD CONTACT • To date: EFSA has published a positive opinion on TiN nanoparticles in PET bottles. Basis of no concern: lack of any detectable migration into food. • BUT: Commission didn’t act on this opinion to include TiN in the positive list of permitted food contact additives • nTiN is listed in the EU Provisional List and can be used on the basis of this listing subject to national law • Annex 13 of the German BGVo has listed nTiN (in effect since September 2009) • Other Member States: nTiN can be used on the basis of Mutual Recognition

22. RISK ASSESSMENT OF PRODUCTS ENABLED BY NANOTECHNOLOGY • February 2009 EFSA opinion on the Potential Risk Arising from nanoscience and nanotechnologies on Food and Feed Safety: • ‘The risk assessment of ENMs must be performed on a case-by-case basis’ • ‘The available data on oral exposure to specific ENMs and any consequent toxicity are extremely limited’ • Under these circumstances, any individual risk assessment is likely to be subject to a high degree of uncertainty. This situation will remain so until more data or and experience with testing of ENMs becomes available • House of Lords Report: • Urgent need for behaviour of nanomaterials in gut

23. REPORTING/INVENTORIES • Belgian Presidency proposes to establish nanomaterials register under REACH • mandatory to label nanomaterials in consumer products • 2009 Milieu Report commissioned by Commission proposes Commission mandatory nanomaterials register • information from producers/importers required to understand what is on market and assess exposure  • UK Food Standards Agency propose (follow House of Lords recommendation): • mandatory confidential database of nanomaterials researched in food industry • crucial information for risk assessment of nanomaterials • legislation required

24. REPORTING/INVENTORIES (cont.) • Publicly available (online) list of foods and food packaging containing nanomaterials (those given positive Opinion by EFSA and other foods which appear to have nanoscale elements • Difficult to gauge precisely extent of nanotechnology use in food sector – definition? • Food industry should avoid secrecy: GMO comparison - ‘exactly the type of behaviour that may bring about the public reaction [industry] is trying to avert’ - secrecy breeds mistrust • Balance industry confidentiality concerns with need to gain consumer confidence

25. LABELLING • Labelling: • Novel Foods Regulation Proposal: • Labelling stipulated in authorisation decision – case by case (Council) • Labelling to state produced with nanotechnology (EP) • ‘(nano)’ to appear next to nanomaterial ingredient on label (EP) • will consumer understand significance?  • perceived as mandatory warning or marketing claim

26. CONCLUSIONS • Regulatory framework need to balance economic potential with both ensuring safety and gaining public trust (avoid GMO backlash) • Existing food legislative framework being extended to cover nanotechnologies specifics • For nano-specific risk assessment, verify or develop: • adequate risk assessment tools • ability to know what nanotechnology is being used in food • Development of agreed definition and adopted amendments of revised Novel Food Regulation a crucial next step

27. THANK YOU http://www.steptoe.com/nanoresourcecenter Dr. Anna Gergely, Director EHS Regulatory agergely@steptoe.com