Regulation of
Nanotechnology in Food
Craig Simpson, Attorney
14 June 2007
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?
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
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 nanotechnology 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)
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)
PROBLEMS WITH CURRENT LAW
Summary of Conclusions of Report of UK FSA Regulatory Review
EU Legislation
Gaps in Regulation
Novel Foods (Regulation 258/97)
– Adequate for new nanomaterials: measures
– mandatory pre-market approval for all novel toxicology and considers manufacturing process
foods and processes
– 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)
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)
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...’
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
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
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
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
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 counterproductive’ (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 ECBiotech 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...’
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)
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)
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)
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)
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.