Nanotechnology in Food & Agriculture - denix

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nano form in food ingredients, additives
or packaging. This means that in practice
many nanomaterials could be used as
additives in foods and food packaging
without legally requiring new safety
assessment.
EU novel foods regulation needs
to cover nanofoods
The EU novel foods regulation 258/
requires mandatory pre-market approval
of all new ingredients and products
(introduced after May 1997), including
product safety assessments carried out
by the EFSA. The regulation requires
assessments on the composition,
nutritional value, metabolism, intended
use and the level of microbiological and
chemical contaminants. Studies on the
toxicology, allergenicity and details of
the manufacturing process may also be
considered. However, once again, as
the regulation makes no distinction in
relation to particle size, nanoparticles will
not require new safety assessments if the
substance has already been approved in
bulk form.
EU Regulation 258/97 is currently
under revision and this may provide an
opportunity to change the legislation
to cover nanofoods properly. In a
review of this legislation the U.K. Food
Standards Agency (FSA) stated that the
regulation appears to be adequate
for most products. However as the FSA
acknowledged, nano forms of substances
that have a history of use are exempt
and would escape additional safety
requirements.
EU Food Additive Use Directive needs
to be expanded to include nano-sized
additives
The EU Food Additive Use Directive
lists all permitted food additives, the
maximum level of their use and the foods
in which they can be used (EU directive
89/107). All additives on this list have
been assessed for safety by the Scientific
Committees which advise the European
| NANOTECHNOLOGY IN FOOD & AGRICULTURE
Commission, via the EFSA. Currently the
minimum particle size is only prescribed
in the case of microcrystalline cellulose
(E460) and minimum molecular weight
distribution in the case of carrageenan
(E407, a chemical extracted from red
algae that is added to commercial ice
creams as an emulsifying agent). Size is
not specified in relation to any of the other
permitted additives on the above list, and
nanomaterials are not recognised to be
new substances. In its 2006 review the UK
FSA reported that there are no immediate
plans to redress this regulatory gap (U.K.
FSA 2006).
EU food packaging regulation is under
review, but will it cover nano ingredients?
EU Food Packaging Regulation (EC
1935/2004) covers all materials that
come into contact with food such as a
packaging, bottles (plastic and glass),
cutlery, domestic appliances and even
adhesives and inks for printing labels.
Similarly to the regulation on novel foods,
it requires the establishment of a positive
list of authorised food contact materials,
and an assessment of their potential
toxicity or safety. However its weakness
is that once again, the failure to identify
nanomaterials as new substances means
that nanomaterials of substances which
are already authorised in bulk form for
use in food contact materials will not be
subject to new safety assessments.
This regulation also requires that
authorised food contact materials
must be traceable. The Institute of
Food Science and Technology (IFST),
the leading European independent
professional qualifying body for food
scientists and technologists, have argued
that “traceability should include a
specific reference to the presence of
nanoparticles and should, ultimately,
enable the relevant safety dossiers for
these materials to be accessed” (IFST
2006).
Interestingly the special case of active
packaging is covered in some detail
in this framework, requiring that active