Nanosciences and Nanotechnologies in the food sector : state of play of the legislative framework
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First published in Agro FOOD industry hi-tech, September-October 2011, vol.22#5, p. 39-41. By Michela Velardo & Claudio Mereu
THE LINK BETWEEN NANO AND FOOD
It is expected that nanosciences and nanotechnologies will benefit most industries by enabling the marketing of products with new and unusual properties, in particular in the fields of electric and electronic equipment and medical devices.
The use of nanotechnology in food should benefit both consumers and industry with the advent of “light” versions of food with unaltered taste but lower fat, salt and sugar contents, and food with enhanced vitamin and nutrient contents. Other benefits include improved packaging that keeps food fresher for longer and “new materials based on nanotechnology, with increased strength, (that) offer the potential to reduce packaging waste” , which would be thinner and lighter.
Even if nanotechnology is not new to food (for example the production of ricotta cheese and ice cream involves nanoscale alteration to food structure), it is understood that the concept of nanomaterial in food does not cover nanoscale substances naturally present in food or those generated through traditional manufacturing processes.
Despite the potential benefits described above, the Food Standards Agency observed in its April 2011 report that consumers tend to believe that “technological advances in food are developed in the interests of business rather than consumers, and that consumers ultimately bear the costs, either through increased food prices, lower quality produce, or reduced health” .
Particular concern arises in relation to persistent nanomaterials that circulate throughout the body and accumulate in cells, with indeterminate long-term effects. Toxicologists agree that persistent nanoparticles, especially those that are non-biologically degradable, inorganic, the inorganic metal oxides and metals, are the particles that pose the most risk. Persistent nanomaterials are potentially harmful because they may settle in cells and tissues and accumulate over time causing adverse effect in the medium to long term . Attention should also be paid to the use of nanotechnologies in pesticides and fertilisers, which could also lead to the ingestion and accumulation of nanoparticles in the human body.
The missing regulatory link
Even if there is a consensus about the fact that nanoscience in food is thought to involve “the passive observation of food to understand better how it is structured and behaves at nanoscale,” and nanotechnology is thought to be “the more active manipulation of food to produce a desired effect,” the debate on the concept of nanomaterials in food persists.
The European legislator has not yet adopted specific legislation on nanomaterials nor a general, binding definition of nanomaterial despite the fact that food produced through nanotechnologies is already on the market . Industry is no doubt wondering what regulatory framework applies to such products and what steps must be taken before marketing them.
With the exception of the European Parliament , there is consensus among European institutions such that nanoscale chemical substances, including those used in food packaging, fall within the scope of REACH Regulation (EC 1907/2006) whilst all uses of nanotechnologies and nanomaterials in the food sector come within the Novel Food Regulation and related legislation, namely Directive 89/107/EC on food additives, Regulation EC/1935/2004 on food contact materials and Directive 2002/46/EC on food supplements.
However, in our view the existing legislative framework does not fully address issues relating to the safe and responsible use of nanomaterials due to the gaps in the legislative texts in relation to nanomaterials, the absence of a general binding definition of nanomaterials and the uncertainties surrounding the safety of certain products.
For example, requirements under REACH Regulation are triggered by thresholds relating to the tonnage (1-10 depending on the provision considered) of the imported or manufactured substance, which are inappropriate in relation to nanosize substances. Similarly, risk assessment under REACH Regulation as it stands may not enable the identification of all risks associated with nanoscale substances. The review of REACH Regulation scheduled for 2012 may introduce amendments that take into account those issues, reflecting the emerging trend consisting in providing for separate approval of substances in nanoform as evidenced by environmental legislation under discussion.
The possible future framework
The European legislative framework for nanosciences and nanotechnologies in the food sector was to be updated by the introduction of provisions dealing specifically with nanotechnologies in the Novel Foods Regulation EC/258/97, which seeks to ensure that food containing substances that may present a risk to human health is fully assessed before it is placed on the market. This review had been triggered by a proposal made by the European Commission in January 2008. Interestingly, the proposal covered cloning and nanotechnologies, new technologies with applications in the food sector, but not genetically modified organisms, which continue to be governed by a different legislation . The proposal was debated for three years, but failed to be approved due to disagreement in relation to issues unrelated to nanotechnologies, namely mandatory labelling in respect of food derived from the offspring of cloned animals.
As part of the deliberations the following definition of nanomaterials in the food sector was discussed: “any intentionally produced material that has one or more dimensions of 100 nm or less or 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 but retain properties that are characteristic to the nanoscale. Properties that are characteristic to the nanoscale include: (i) those related to a large specific surface area of the materials considered; and for specific physio-chemical properties that are different from those of the non-nanoform of the same material.”
There appeared to be differences of opinion concerning this definition : it was suggested that the size limit of 100nm would not cover all nanomaterials present in food, as some materials with a dimension greater than 100 nm can change in functionality and behaviour inside the human body. It was also pointed out that it is unclear whether the proposed definition also refers to natural food. It should also be noted that the proposed definition differs from the one contained in the Cosmetics Regulation (1223/2009), which refers not only to size but also the biopersistence and solubility of substances . The existence of divergent definitions suggests that the European legislator addresses nanomaterials differently depending on their use.
The proposed review of the Novel Foods Regulation would also have led to the adoption of a European list of authorised food and the centralisation of the pre-marketing procedures for Novel Food at European level. Such changes would have simplified existing procedures, which are complex and in practice require a double evaluation at national and European levels.
Risk control's the main principle for the time being
Notwithstanding the absence of a legal framework dealing specifically with nanotechnologies in the food sector and the fact that European Member States initiatives tend to focus more on transparency and traceability , the European Food Safety Authority has adopted the Guidance on risk assessment concerning potential risks arising from applications of nanosciences and nanotechnologies to food and feed . This guidance applies not only where manufacturers have added engineered nanomaterials to their products, but also where nanomaterials are generated in the course of production.
In essence, the approach adopted is that risk must be assessed on a case-by-case basis and evidenced in safety data provided by applicants. The sophistication of risk analysis in respect of nanotechnologies notwithstanding the regulatory uncertainty surrounding the subject attests to the fact that risk analysis is considered the Grundnorm among the principles governing the European food sector.
For further information please contact Michela Velardo, Associate or Claudio Mereu, Partner, in the Competition and EU Regulatory Team, at Fieldfisher, Brussels office.