The UK food safety regulator is worried that harmonised EU-wide legislation to fill in the gaps could take years to come into force, and calls for a speeded up process to ensure food safety. A potential solution would be to amend legislation to require that all nanocomponents be subject to their own risk assessment, the review document suggests as a way forward.
Nanotechnology has been touted as the next revolution in many industries, including food manufacturing. It is a sector for which the topic is likely to become a hot consumer issue due to fears over the unknown consequences of digesting particles designed to behave in specific way in the body.
"The future success of nanotechnology will depend on rational and informed work to understand and minimize these potential adverse effects on health and the environment," the Food Standards Agency (FSA) said yesterday in its regulatory review of the topic.
The report provides manufacturers with an outline of potential areas for future regulation relating to the use of nanotechnology and nanomaterials in foods. It finds that the existing regulatory model for risk assessment is applicable to nanomaterials, although there are gaps in the information needed to identifying potential environmental and health hazards.
"This review has not identified any major gaps in regulations but there is uncertainty in some areas whether applications of nanotechnologies would be picked up consistently," the FSA stated.
Most potential uses of nanotechnologies that could affect the food area would come under some form of approval process before being permitted for use. On the whole the process is adequate to identify any potential risk associated with the presence of newly designed nanomaterials that might be used as food ingredients, the FSA stated.
"It is less certain that this regulatory framework would apply to ingredients that have a history of use and which might in future be marketed in smaller particle sizes of 100nm or below," the FSA stated.
In such cases, the general safety articles of the EU Food Law Regulation would apply. The law requires that food placed on the market should be safe to eat. Other applications of nanotechnology in food processing would require evaluation under the novel foods law only if they significantly affect the properties of the final product.
The use of food additives in the EU falls under legislation that sets out lists of permitted additives, the foods in which they can be used, and maximum levels of use. All current permitted additives were previously assessed for safety by independent scientific committees advises the European Commission. Assessments are now carried out for the EU by a recently created European Food Safety Authority.
Each additive must also comply with specific purity criteria laid down in related European Commission directives. The criteria dictate the chemical structure and purity of each additive.
Any new nanomaterials would need to undergo safety assessments by EFSA before they were included on the relevant positive list and so be permitted in foods. For the majority of additives, specifications have also been elaborated for the material as used.
The only examples in the food additives area that specifically limits the presence of small particles is the specification for microcrystalline cellulose, where the presence of small particles below five microns is limited because of uncertainties over their safety.
There is also a limit on the molecular weight distribution of carrageenan, which the FSA said could be regarded as a size limitation. The limit is based on concerns over the potential toxicity in the gut associated with the smaller “degraded” components of carrageenan.
"As none of the other permitted additives include limitation on the size of particles, it could be argued that in principle there are gaps in the legislation," the FSA stated. "The European Commission has no plans, as far as we are aware, to address these gaps."
The regulator suggests that individual specifications, which are set out in Commission directives, could be amended at the committee level.
"Therefore, action could be taken fairly quickly if EFSA recommended that amendments were required to address the issue of particle size, whether as a result of its own assessment or on the basis of information or a request from member states," the FSA stated.
In relation to fixing the gaps the agency has issued a call for research proposals to assess the potential applications of nanotechnology for food additives and other novel ingredients. The research will consider consumer safety and the regulatory implications of their possible use.
The review also covered current controls relating to egulation (EC) 1935/2004, which covers materials, such as packaging, that come into contact with foods.
The regulation is drawn widely enough to deal with the potential migration of ‘nanocomponents’ into food from contact materials. It requires that such materials should not transfer their constituents to foods in quantities that could endanger human health, or bring about an unacceptable change in the composition of the food or a deterioration in its sensory properties.
Where the ‘nanocomponent’ might be intended to migrate into the food as part of an ‘active’ packaging system, it must only do so to improve the shelf life or to maintain or improve the condition of the food.
However, any change to the food must comply with EC provisions applicable to food. Where that ‘nanocomponent’ is part of an ‘intelligent’ packaging system the material or article may only monitor the condition of the food in the packaging or the environment around the food.
Furthermore it may not give information to the consumer that could mislead them about the condition of the food. Both types of material or article must be labelled to say that they are ‘active’ or ‘intelligent’, under current law.
A provision within the law allows the European Commission, acting on its own or in response to a member state request, to ask EFSA to conduct an independent health risk assessment of any substance or compound used in the manufacture of a food contact material or article.
Under the law some materials and articles are subject to specific measures. Different requirements may apply to ‘nanocomponents’ incorporated into these materials or articles.
In relation to plastic materials and articles, provisions in Commission directive 2002/72/EC do not yet differentiate between nanoscale components and others, the FSA found.
A previous report by the Royal Society that these components should be treated as new chemicals is not yet covered by the legislation, the FSA noted.
Otherwise, monomers or starting substances have to be included in a positive list and if they aren’t on that list they cannot be used. Additives to the polymer in order to achieve a technical effect are currently subject to an open list system. This will change in the future but the Commission has not set a date for this.
Ceramic materials and articles are covered by legislation that is currently being reviewed and amended, although the sole subject of that legislation will remain the control of migration of lead and cadmium into foodstuffs. Other issues affecting the safety, quality and nature of food with which these materials come into contact are covered by the provisions of the Regulation No. (EC) 1935/2004.
In the future the food safety aspects of rules on food contact ceramics will be the responsibility of the FSA. As is the case for other food contact materials, food contact ceramics may only be manufactured from substances on a positive list.
Regenerated cellulose film materials are subject to manufacture only from substances on a positive list, with the exception of colorants and adhesives, but these must be non-detectable in the food using a validated method.
Any plastic coating of regenerated cellulose film on the food contact side may only be manufactured using substances listed in Directive 2002/72/EC on food contact plastics. The legislation as it stands does not differentiate between chemicals produced routinely by current methods and those that may be developed by nanotechnology, the FSA stated.
There is currently no scope in the European legal framework for food contact materials and articles to develop specific measures to deal with ‘nanocomponents’ on their own, the FSA noted. However the European Commission and other member states are currently debating a working document on the subject, that could go on to become a proposal for rules on substances and materials that are problematic and not dealt with elsewhere in the legislation on food contact materials.
Until that working document completes its passage through the European procedure for adopting rules on food contact materials, the products of nanotechnology would have to be dealt with by the specific controls on particular materials and articles.
"The negotiation and adoption of all th specific measures on all the materials and articles for which harmonised EU legislation is envisaged could take many years," the FSA stated.
The FSA plans to work with the European Commission and other member states to develop harmonised EU controls on food contact materials in relation to nanotechnology.
"The European Commission has informally declared its intention to develop controls for the application of nanotechnology in the manufacture of food contact materials and articles, although unless a real problem arises from the use of this technology, specific rules are likely to take some time to put in place," the FSA stated.
A potential solution would be to amend the legislation to require that all nanocomponents be subject to their own risk assessment, the FSA suggests.
This would bring all nanocomponents within scope of the requirement regardless of the material they are incorporated into. The solution would also apply to those materials and articles not already covered by the specific measures currently in place.
Nanoscale technology offers new opportunities for the packaging industries, and various potential food contact applications have been suggested, including improved barrier properties, better temperature performance, thinner films for flexible packaging, and nanoscale pigments for inks.
"However, little is known about the impact on chemical migration into food from such applications," the FSA stated. The agency has issued a call for research proposals to "assess new and potential applications of nanotechnology for food contact materials in the UK, considering the consumer safety and regulatory implications of their possible use."
The review considered areas where regulations require some form of formalised ‘prior approval’ or ‘positive list’ of permitted products or processes as well as those relying on case-by-case assessment, including deliberate use or adventitious or accidental presence of nanomaterials.
The review also considered wider issues of openness and transparency of regulation and risk assessment in an area where high technical innovation may give rise to competing demands for commercial confidentiality for new nano-materials or nanotechnology.
Regulation in the food area is largely decided at European Union level, and UK food law generally implements in the UK the measures that have been agreed at the bloc level.
The review is an outcome of a June 2003 government-commissioned report by the Royal Society and the Royal Academy of Engineering. The report raised concerns about exposure to manufactured nano-sized particles and the possible harmful effects on human health.
The report made a number of recommendations, many centering on the need for a programme of research and public engagement to better understand the potential risks.
The government published its response to the report in February 2005. This included a commitment to a number of actions, including a review of existing regulations to identify any gaps to ensure that human health and the environment are adequately protected from any potential risks.
The European Commission published a regulatory action plan relating to nanotechnology in June 2005.
Consumer groups and some scientists have have also called for increased regulator supervision and transparency as the technology is developed.