Nanotechnologies and Food - Science and Technology Committee Contents

CHAPTER 6: Regulatory Enforcement

6.1.  To be effective, regulations must have appropriate scope and must be enforceable. We have described how the scope of the current regulatory framework appears to be sufficiently broad to address the use of nanotechnologies in the food sector. We now turn to enforceability, which is carried out by individual Members States within the European Union (p 300). On this aspect, two issues of concern were drawn to our attention: risk assessment, and imports and products sold over the internet. In addition we consider government guidance to industry on the implementation of legislation; regulation in an international context; and the provision of information to the public about food products containing nanomaterials.

6.2.  We have concluded that legislation needs to define nanomaterials used in the food sector and to require that all nanomaterials undergo a risk assessment by the EFSA before they are approved for human consumption. By the same token, a definition is an important precondition to the enforcement of that legislation. Without a clear definition regulators will find it hard to determine companies' compliance with legislation. Dr Falkner told us: "if you have no means to distinguish clearly between a nanomaterial and a non-nanomaterial, and if you are therefore uncertain whether existing laws apply, that restricts the application of the [regulatory] framework" (Q 317).

Risk assessment

6.3.  Our witnesses assured us that consumer safety is of paramount importance to both industry and Government, and that until products can be adequately risk assessed they will not be brought to market (QQ 3, 156). The only food company to give written evidence to the Committee, Cargill, told us that until there was a "clear science-based regulatory regime" that could properly assess the potential environmental, health and safety impact of nanomaterials, "Cargill will not incorporate intentionally-engineered nano-materials into its products"(p 294).

6.4.  As with many new technologies, long-term risks can be hard to assess. Insurance can play an important role in ensuring that companies are willing to explore the potential of new technologies. Yet Lloyd's told us that the difficulty in quantifying some risks associated with nanotechnologies has lead to some insurers withdrawing cover: "at least one US company … has excluded all aspects of nanotechnology; others are actively avoiding providing direct cover to this industry" (p 223). There is, therefore, a clear need for effective risk assessment frameworks to be put in place. Until this is done, not only will products be unable to play a significant role in the food market, but research into their potential applications may be affected.

6.5.  At present, food products must be assessed as safe before they can be approved for use (see paragraph 5.2). Where food products contain nanomaterials, data have to be presented to the relevant authority (usually the EFSA) and that authority carries out a risk assessment. There are two components to the effectiveness of risk assessment of food products: first, whether the risk assessment framework correctly determines when a product poses a threat to human health; and, secondly, whether the organisation carrying out the risk assessment is able to apply the framework effectively.


6.6.  The risk assessment process will usually include the following elements:

  • Hazard identification (recognition of what the nanomaterials is capable of doing at any dose)
  • Hazard characterisation (assessment of the relevance to humans of each adverse effect including dose-response analysis for relevant effects in order to predict safe intake levels for humans)
  • Intake assessment (estimation of potential human exposures and intakes based on real data or predictions)
  • Risk characterisation (comparison of the potential human exposure with the predicted safe intake for humans)

6.7.  The EFSA's scientific opinion found that this risk assessment paradigm is "considered applicable for ENMs [Engineered Nanomaterials]".[74] Similarly, in 2005, COT, COM and COC concluded that "current approaches to risk assessment should be appropriate for nanomaterials".[75]


6.8.  Whatever the applicability of standard risk assessment frameworks to nanomaterials, some witnesses questioned whether the risk assessment process worked in practice given the knowledge gaps in the scientific understanding (see Chapter 4). The FSA, for example, cited the following problems: difficulties in characterising, detecting and measuring engineered nanomaterials in food; limited data on exposure analysis; and limited data on oral exposure and toxicity (pp 3-4). Dr Wadge told us: "the challenges and difficulties will lie … around the precise nature of risk assessment and the toxicological testing" (Q 47). The EFSA has concluded that, although the framework is theoretically appropriate, "the adequacy of currently existing toxicological tests to detect all aspects of potential toxicity of ENMs has yet to be established" and "any individual risk assessment is likely to be subject to a high degree of uncertainty"[76], while the 2005 joint statement by COT, COM and COC said that: "in the absence of [hazard identification data] it was not possible to derive conclusions about the spectrum of toxicological effects which might be associated with nanomaterials".[77] Similar points were made in the RCEP report[78] and the EMERGNANO report[79]. The European Parliament Committee on the Environment, Public Health and Food Safety has recently concluded in its report on Regulatory Aspects of Nanomaterials that:

"[The Committee] does not agree, in the absence of any nano-specific provisions in Community law, with the Commission's conclusion that current legislation covers in principle the relevant risks relating to nanomaterials, when due to a lack of appropriate data and methods to assess the risks relating to nanomaterials it is effectively unable to address their risks".[80]

6.9.  Given doubts about the workability of the risk assessment process, Friends of the Earth Australia and the Soil Association have called for a moratorium on the use of nanotechnologies and nanomaterials in food. Others are against this. Ms Sue Davies of Which? said: "we do not think a moratorium is very meaningful. We have issues around definition, it is very difficult to find out what is actually happening, so even if we thought that a moratorium was useful we do not understand how it would practically be enforced and applied" (Q 287). Dr Falkner told us that to be effective any moratorium would have to be a "broad-brush instrument" and so cover a "wide range of nanomaterials that perhaps do not deserve to be covered under a moratorium" (Q 319).

6.10.  We also have doubts about imposing a moratorium. In Chapter 5 we referred to potential gaps in regulatory coverage as a result of difficulties in defining nanomaterials. In the absence of an agreed definition, a moratorium would present similar problems. If, however, a workable definition were formulated (thereby making a moratorium practicable), then a moratorium would be unnecessary since the definition could be used within food legislation to ensure that any products containing nanotechnologies would have to go through mandatory pre-market approval processes.

6.11.  EFSA assesses products on a case-by-case basis. Where there is a lack of information about the risk a product may pose to human health, that product will not receive approval. Nanosilver supplements have failed to obtain approval from the EFSA on these grounds (p 3). David Carlander, Scientific Officer at the EFSA, told us that EFSA was not able to make a decision on the risk posed by nanosilver because the uncertainties were "so clear" that "additional information would have been needed to perform the risk assessment". He concluded that consumers' safety was protected because "if there is no data we cannot perform a risk assessment … such products would then not be risk assessed and therefore in future would likely not be on the market" (Q 520).

6.12.  We endorse the case-by-case approach taken by the European Food Safety Authority in assessing the safety of products. It allows the responsible development of low-risk products where safety data are available and is, in effect, a selective moratorium on products where safety data are not available. It provides consumers with the greatest security and ensures that unless a product can be fully safety assessed, on its own merits, it will not be allowed on to the market.


6.13.  Products imported into the European Union can only be marketed within Member States if they meet food safety requirements which are equivalent to those in the European Union. Companies have a legal duty to ensure that all food products they import meet these requirements (p 5, Q 8). Whilst this provides a level of protection against the importation of unsafe food products, there are weaknesses.

6.14.  The first concerns the internet. According to the FSA, "food products ordered from a non-EU country by members of the public in limited quantities for their personal use, for example over the Internet, may not be subject to the protection of UK food safety requirements" (p 5). Professor Morris agreed: "the worry is about what is available on the Internet" since in many cases it "is not regulated" (Q 114). In these circumstances, we consider that providing consumers with information about products containing nanomaterials, and their potential risks, is the only practical action the Government can take to help protect the public. We consider this further in Chapter 7.

6.15.  A second problem area relates to the capability of the enforcement authorities. In the United Kingdom, local authorities and port health authorities have power to check all imported food for compliance with food safety requirements. But inspectors do not, at present, have the means to detect the use of nanomaterials in imported food (QQ 346, 504, 673, p 300). The European Commission Directorate General for Health and Consumers (DG SANCO) told us that "as there are currently no validated … methods to detect nanomaterials in food, the possibility for Member States to control imported foods … is limited" (p 300). Although it is unlikely that food containing nanomaterials is being imported into the United Kingdom, the possibility cannot be ruled out (QQ 505-506, 675). DG SANCO told us that, on different occasions, Finnish border control officers stopped "a product that contained vitamin C in nanoform and a product that contained nanosilver, both on the basis of non-compliance with the Novel Foods legislation" (p 300). Given this, we welcome the participation of the Food Standards Agency in a European Union project which will investigate methods for detecting and measuring nanomaterials in the food (Q 672). Ensuring that this research results in practical tests that can be used by enforcement agents will be an important step in securing the safety of food imports.

6.16.  Which? expressed some doubt about whether enforcement authorities regarded nanomaterials as a particular priority at the moment (Q 291). Ms Merron agreed, although she added: "that is the result of being at a very early stage. I can assure the Committee that we will have in process the necessary alerts to those said authorities" (Q 676). We welcome this assurance.

6.17.  We recommend that the Government should ensure that research into methods of measuring nanomaterials in food results in the development of practical tests for enforcement authorities to use on imported food, and develop a plan to inform and educate enforcement authorities once such tests have been developed.

Guidance for companies

6.18.  A number of witnesses, including Dr Knowles and the NIA, called for the Government to provide guidance to industry on the legislative meaning of the term "nanomaterials" and on the tests required by EFSA for the safety assessment of nanomaterials (Q 170). Campden BRI, an independent membership-based organisation carrying out research and development for the food and drinks industry, told us: "questions from industry indicate a difficulty in understanding the meaning of the term 'nanotechnologies'… there is confusion over whether … [certain] products are to be considered as 'nano-products'" (p 292). Dr Friedrichs thought that small companies were in particular need of guidance (Q 488) and said that uncertainty about the current (and future) regulatory burden creates a fear that they will be faced with "the introduction of a demanding and costly approval process [which] will render their … core technologies non-viable" (p 242). Dr John Wand, Head of the EPSRC's Nanotechnology Programme, also felt that uncertainty over how regulation will operate may cause companies to be "cautious" when they consider "investing potentially large sums of money" in developing new products (Q 429).

6.19.  Dr Knowles stressed that industry and the academic community should contribute to the development of guidance: "It is nothing that the Government in itself can do alone. It needs to work with all of the stakeholders to provide that guidance. All of the regulators and academics need to work together with the Government to provide that information to allow suppliers and manufacturers of nanomaterials to carry out the appropriate safety testing" (Q 211). We agree. The FSA argued that it was "the responsibility of food businesses to ensure that the products they market are safe, and this includes considering the effect of changes to manufacturing processes and reformulation of existing ingredients, even where such changes do not trigger a formal regulatory review" (p 42). While this responsibility lies with industry, the FSA should make every effort to assist industry in ensuring that they have as much information as possible to help them fulfil this responsibility.

6.20.  In view of these calls for guidance, we were pleased to be told by the Minister, Ms Merron, that the European Commission would be providing more formal guidance to companies on the application of current food laws to nanotechnologies and that if revisions to food legislation included a special category in respect of nanomaterials, then the FSA would publishing that in its formal guidance (Q 671). The EFSA has set up a working group on nanotechnologies, which will be looking specifically at the guidance to provide to companies (Q 525). This guidance will cover not only situations where engineered nanomaterials have been added to products by manufacturers, but also those where nanomaterials result from the production process (p 298).

6.21.  We recommend that the Government work with the European Food Safety Authority as it develops guidance on the implementation of the Novel Foods Regulation and other relevant legislation. We urge the Government to state what steps they will take to ensure that industry and academia are involved in the development of this guidance.

International harmonisation

6.22.  The food industry is a global market, and many new products containing nanomaterials will be developed outside the United Kingdom. Dr Falkner reminded us that "we approach many of these issues from a national or European perspective, but any regulatory system that we end up with for nanotech food will have an impact on the global food trade" (Q 343). Some witnesses argued in favour of trying to harmonise regulations governing these technologies with other nations to ensure a consistent approach to risk assessment and reporting. Which?, for example, said "it is essential that there is international co-operation on this issue"—although it warned that the process might be slow: "experience from the development of standards for other emerging technologies has been that these bodies can take many years to reach agreement" (p 137)

6.23.  The relevant body for converging international regulation is the Codex Alimentarius, an intergovernmental agency created by the Food and Agriculture Organisation (FAO) and the World Health Organisation (WHO) to help develop and promote the coordination of food standards and guidelines. Ms Merron said that any efforts at the international harmonisation of food safety legislation would be through this body. The Codex Alimentarius held an expert consultation on the food safety implications of nanomaterial use in agriculture and food sectors in June 2009, and is due to report in the near future (Q 651).

6.24.  Other witnesses stressed the need for informed discussion and knowledge transfer between nations, rather than looking for international harmonisation of regulations. Mr Roberts, for example, told us that, "it would be wrong to say there is scope for international global regulation of nanotechnology in the immediate term. We are trying to raise awareness of the issues in countries, not only those producing nanotechnologies but those which may also import products containing nanotechnologies and therefore have to deal with waste streams that may require specialist handling; at least raise awareness, spread the science and begin to get cooperative action going" (Q 73). The recent report by Chatham House on transatlantic regulatory cooperation (see paragraph 4.55) supported this view, stating that there is "little if any interest in pursuing the more ambitious objective of creating an international treaty on nanomaterials regulation".[81] Ms Merron told us that "there have not been [any] moves really at an international level to harmonise regulations for nanotechnologies and nanomaterials"; at present efforts were instead focused on securing a better common understanding of nanomaterials before moving on to look at possible areas of harmonisation (Q 651).

6.25.  Dr Falkner felt that at this early stage the emphasis should be on preventing regulatory approaches diverging, rather than trying to develop an international set of regulations:

"If existing national regulations in the US and in Europe—but also think of the emerging economies (Brazil, China)—go in different directions, there will be a need for harmonisation. We are not at that point yet. I think much more needs to be done there to, in a sense, prevent regulatory divergence" (Q 345).

6.26.  The OECD plays an important role in coordinating the characterisation and risk assessment of nanomaterials (see Chapter 4). Dr Falkner described the OECD as "a bit of a gentlemen's club for intergovernmental co-operation. It works well, in the sense that it creates space for regulators to talk to each other and to learn from each other, but it certainly will not be the main platform for developing internationally harmonised regulations" (Q 345). Friends of the Earth Australia pointed out that many countries are not represented at the OECD, in particular developing nations (Q 304).

6.27.  International bodies are beginning to address common policy issues arising from the commercialisation of nanotechnologies. The United Nations Environmental Programme (UNEP) and the WHO may yet play an important role in their respective areas of responsibility, but the Chatham House report noted that "they are only just beginning to identify the EHS [environmental, health and safety] risks of nanomaterials as emerging areas of concern".[82] Which? mentioned the Transatlantic Economic Council (TEC), established in 2007 to strengthen transatlantic economic integration. The framework for the TEC, setting out a multi-year programme of cooperation, includes a commitment to "exchange views on policy options for emerging technologies ... in particular in the field of nanotechnology"[83]. The framework applies to the United States and European Union only.

6.28.  We agree that it is too early for serious attempts to be made to harmonise legislation across the international community in this area, and that at present the Government should focus their efforts on coordinating with the international community on areas of common concern such as risk assessment and standards.

6.29.  We recommend that the Government continue to push for continued international dialogue and information exchange on appropriate approaches to regulating the applications of nanotechnologies in the food sector, and seek to ensure that all relevant international organisations are aware of the emerging implications of the development of nanotechnologies.

A register of applications of nanotechnologies in the food sector

6.30.  A number of witnesses raised the question of the establishment of a register or database of food products containing nanomaterials, and the FSA told us they were considering various options for developing a UK-based register of nano-derived foods and food contact materials (p 2).

6.31.  Which? and Lloyd's informed us that such a register could be used as an information tool to help clarify the state of the market (QQ 298, 445). Ms Davies thought that it would be "essential because at the moment … it is very difficult to get a sense of exactly what is happening in this area" (Q 298). Dr Wadge agreed that "in terms of really understanding what is happening in the market, a register clearly could be very useful" (Q 37). Mr Simon Burall, Director of Involve, felt "the last thing you want is rumours about nanotechnology in this or that food" so a register would be "a sensible idea" (Q 378). Professor Pidgeon, considered that a register would be "a good thing to have" (Q 376). Ms Davies, Ms Miller and Professor Howard, agreed (QQ 300, 301, 302). Dr Kellie also thought that a register was an important way of building public confidence in the technology (Q 182).

6.32.  Industry appeared to be less enthusiastic. Dr Knowles said a register would be "premature" given that most products were still at the development stage. He also questioned whether a register would have any value. Products had to go through a safety evaluation by the EFSA before being allowed on to the market and, at that point, the information would be in the public domain in any event (Q 183). Mr Opie took the same view: "if all the products have been through the regulatory framework, the products are safe for the market. … Why would we then need a subsequent register on top of that?"(Q 184) Mr Opie also feared that a register might become a "blacklist" for consumers (Q 185). Ms Davies disagreed: "we do not think that would be the case. The danger is more in not being open about what is happening in relation to nanotechnologies" (Q 300). Ms Miller went further, suggesting that, even if a register were to become a "blacklist", that was no reason not to have one given that people had a right to choose not to buy food containing nanotechnologies (Q 302). Professor Morris agreed (Q 93).

6.33.  Some witnesses proposed that a register could hold a greater range of information—such as covering details of nanomaterials used through the food chain rather than simply the final products. Dr Falkner thought that "we need to move in the direction of greater transparency in global food chains", not only in terms of products on the market but also in terms of food ingredients and materials (Q 332), a point echoed by Mr Maynard who thought a register "should include the companies involved in the full supply chain, including those outside the UK or EU" (Q 445). Ms Davies also supported a register which did more than set out a simple list of marketed products: "we think the regulators … need to be much more proactive in actually going out and seeking the information … including talking to the chemical companies who are producing food additives or food pesticides and understanding exactly how much they are producing and who they are supplying" (Q 298).

6.34.  Industry representatives were not convinced of the need for regulators to monitor the food chain. They were clear that if their suppliers used nanomaterials, they would be informed (QQ 189,190). Although they conceded that "no system is 100 per cent perfect", they argued that nanotechnologies were still novel and that the chance of them being used in the supply chain without food companies being aware of it was "remote" (Q 193). Dr Friedrichs said that, since nanomaterials were expensive to produce, it was unlikely that they would be used in the food chain without companies "wanting to cash in on the benefits claimed" (Q 506).

6.35.  The European Commission has announced that work would begin in 2009 on a European Union inventory of nanomaterials (p 2). According to the FSA, however, "they have taken no action to date and officials understand from their Commission contacts that nothing is currently planned, at least in the food area" (p 291). Ms Merron said:

"our view is that it would be useful to have an inventory. We need to clarify what is or is not on the market and so if it is not going to happen at an EU level then we want to do it at a UK level. The FSA is going to be working on this in the next few months … but I think it is important that we do have this before others who have more vested interests do so, so I am keen that we get on with this area of work" (Q 647).

6.36.  Dr Clair Baynton, Head of Novel Foods, Additives and Supplements at the Food Standards Agency, was not willing to say what type of register it would be—whether it would simply provide information to the public about marketed products or whether it would seek more detailed information from industry (Q 648). Dr Lawrie thought that designing a register should wait until the FSA had a "clearer idea of the range of so-called nanomaterials" (Q 650). Some witnesses, such as Dr Friedrichs (Q 507) and Mr Opie (Q 184), argued that developing a register would run into practical difficulties because of the absence, at present, of an appropriate definition of nanomaterials. We acknowledge these concerns, but we consider that compiling a list of marketed products containing nanomaterials should not prove too difficult given that these products will have been identified by the EFSA during the pre-market risk assessment process.

6.37.  In Chapter 4 we recommended that the FSA develop a confidential database of information on nanomaterials in development in the food sector to assist in the development of appropriate risk assessment procedures. This would not monitor the use of nanomaterials throughout the supply chain, but at present the likelihood of nanomaterials entering the food chain without the knowledge of the industry is remote. We therefore do not feel it is necessary for the FSA to monitor the presence of nanomaterials throughout the food chain. We judge, however, that a register of publicly available products containing nanomaterials would be valuable, both to clarify the state of the market and to build public confidence by ensuring that information is freely available. This information will be made publicly available through the EFSA as products go through pre-market approval processes, but in the interests of transparency and accessibility we believe this information should be gathered together into a single source for consumers to access. We recommend therefore that the Food Standards Agency create and maintain an accessible list of publicly-available food and food packaging products containing nanomaterials that have been approved by the European Food Safety Authority.

74   EFSA, Scientific Opinion, op. cit., p 2. Back

75   COT, COM, COC, Joint Statement, op. cit., p 6. Back

76   EFSA, Scientific Opinion, op. cit., p 2. Back

77   COT, COM, COC, Joint Statement, op. cit., p 4. Back

78   RCEP, Novel Materiols, op. cit., p 48. Back

79   Aitken et al., EMERGNANO, op. cit., p 146. Back

80   European Parliament, Report on regulatory aspects of nanomaterials, (2008/2208(INI), p 10, para 3. Back

81   Falkner R et al., Securing the Promise of Nanotechnologies, op. cit., p xiii. Back

82   Ibid., Falkner et al., Securing the Promise of Nanotechnologies, p xiii. Back

83   See Back

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