Nanotechnologies and Food - Science and Technology Committee Contents

CHAPTER 5: Regulatory Coverage

5.1.  According to Dr  Falkner, "current regulatory efforts in the UK, the European Union and other industrialised countries are focused on applying existing regulations to nanotechnologies and amending these in order to fill any potential gaps in the covering of nanotechnology risks" (p 176). In this chapter we consider whether the existing law is adequate to the task of regulating current and future applications of nanotechnologies in food in principle. In Chapter 6 we consider whether it can be effectively applied in practice.

Current regulation

5.2.  The food industry in the United Kingdom is regulated by a range of legislation intended to ensure that food products on the market have been appropriately evaluated as to their potential risk to human health. Regulation is largely decided at a European level.[59]

5.3.  All food products have to meet a general safety requirement under the General Principles of Food Law Regulation (EC/178/2002). More specific legislation covers the use of novel foods, food additives and food contact materials (see Box 1). Nanomaterials used in the food sector may also be covered by REACH—European Community legislation concerned with chemicals and their safe use and dealing with the Registration, Evaluation, Authorisation and restriction of CHemical substances.

5.4.  The use of pesticides is regulated by the United Kingdom Plant Protection Products Regulation 1995 (as amended) which implements a two-tier European system: first, any active ingredients used in pesticides have to be agreed at a European level; and, secondly, having gained European approval, individual products are then approved for use in the United Kingdom by the Pesticide Safety Directorate. Fertilisers are covered principally by the EC Fertiliser Regulation 2002/2003 (which specifies the composition and definition of all fertilisers which may be freely sold with the European Union) and the United Kingdom Fertilisers Regulations 1991 (which allow fertilisers which are not covered by the EC Regulation to be sold within the United Kingdom so long as they comply with domestic legislation).


Food sector legislation


Regulation EC/258/97 applies to novel food and food ingredients. Novel foods are defined as foods and food ingredients that have not been used for human consumption to a significant degree in the European Community before 15 May 1997 and the Regulation subjects all novel foods and foods manufactured using novel processes to a mandatory pre-market approval system (p 5). In January 2008, the European Commission published a proposal to revise and update the Novel Foods Regulation. Various proposals have been discussed by the Commission, Parliament and Council. (The draft Regulation is currently going through the co-decision procedure. A definition of nanomaterials has been introduced at the request of the European Parliament, and supported by the Council (see paragraph 5.20 below).) Discussions are continuing on how to bring nanotechnologies specifically into the revised Regulation.


Food additives are regulated under Directive 89/107/EC and associated legislation. The Directive is based on the principle that only additives which are explicitly authorised may be used in food. In the United Kingdom, legislation passed under the Directive includes: the Sweeteners in Food Regulations 1995 (as amended); the Miscellaneous Food Additives Regulations 1995 (as amended) and the Smoke Flavourings (England) Regulations 2005.

In December 2008, a new Regulation was passed (Regulation EC/1333/2008) which set out a common authorisation procedure for additives, enzymes and flavourings. From early 2010, a list of approved additives, including vitamins and minerals, will come into force. Inclusion of additives on the list will be decided by the Commission on the basis of an Opinion from the European Food Safety Authority (EFSA). Those included will often have limits set on their use, for example restrictions on the quantities permitted for use. The new regulations also specify that where the starting material used, or the process by which an additive is produced, is significantly different (for example, through a change in particle size), it must go through a fresh authorisation process, including a new safety evaluation.[60]


Regulation EC/1935/2004 covers all materials which are intended to come into contact with foodstuffs, either directly or indirectly. The Commission or Member States may request the EFSA to conduct a safety evaluation of any substance or compound used in the manufacture of a food contact material. Certain materials, including plastic, are subject to additional measures. The Commission has proposed updating the Regulation governing food contact plastics to specify that a deliberately altered particle size should not be used, even behind a migration barrier, without specific authorisation.


Food supplements are regulated under Directive 2002/46/EC which states that only vitamins and minerals on an approved list may be used as food supplements. New substances may be considered for inclusion on the list, but only after a safety assessment by EFSA.

Adequacy of current legislation

5.5.  In August 2008, the FSA published a report entitled A review of potential implications of nanotechnologies for regulations and risk assessment in relation to food. It considered, among other things, the suitability of current regulations relating to the use of nanotechnologies in the food sector. The report did not identify "any major gaps in regulations", although it noted that there was uncertainly in some areas as to whether applications of nanotechnologies would be picked up consistently. It concluded that "on the basis of current information, most potential uses of nanotechnologies that could affect the food area would come under some form of approval process before being permitted for use".[61] Dr Falkner generally agreed with this conclusion: "we do have a range of laws and regulations in place … that we can use to cover emerging risks from nanomaterials". But he added: "there are some questions about regulatory coverage in certain grey areas" (Q 317). Other witnesses (pp 294-297, 309-315, Q 291) shared Dr Falkner's view.

5.6.  The areas of uncertainty relate to the following:

  • Definitions of nanotechnologies and nanomaterials;
  • Variations in particle size of nanoscale materials;
  • Next generation nanotechnologies and nanomaterials; and
  • The role of REACH.

5.7.  The evidence we received focused mainly on the suitability or otherwise of food legislation, in particular the Novel Foods Regulation. We received less evidence on other areas such as food contact materials, pesticides or fertilisers. For this reason, our comments focus on food legislation—although the issues we raise about variations in particle size (paragraph 5.33) and next generation nanotechnologies (paragraph 5.34) may well have relevance to the regulation of nanomaterials in these areas as well. In addition, our observations about a regulatory definition of nanomaterials, while made in the context of the Novel Foods Regulation, would also apply to any definition that may be may be considered for food additives or food packaging legislation (p 298).

5.8.  While some witnesses (p 77, Q 40) considered that general legislation, such as the General Principles of Food Law Regulation, provided a "safety net" for consumers, others disagreed. Dr Falkner argued that the "uncertainty that exists with regard to definition, methodologies, exposure and hazard types is preventing that general safety provision from working properly" (Q 331). The Economic and Social Research Council Centre for Business Relationships, Accountability, Sustainability and Society (BRASS), agreed (pp 296-297). Scientific uncertainty about the potential health effects of nanomaterials prevents industry from being able to say for certain which are safe and which are not (see Chapter 6). While the general legislation prevents companies from knowingly placing unsafe food on the market, it offers no protection in situations where companies are not aware that their product may be unsafe. (For example, supplements containing nanosilver are likely to be withdrawn from sale in the European Union after several years on the market since EFSA was unable to assess their safety (QQ 27-28)). In the absence of effective protection by such "safety net" legislation, the burden lies on more specific legislation, such as the Novel Foods Regulation, to protect consumers effectively.

Definitions of nanotechnologies and nanomaterials


5.9.  While existing law may, by and large, cover the use of nanotechnologies and nanomaterials in principle, there is no single piece of legislation that specifically defines and regulates nanotechnologies across all sectors, either in the United Kingdom or the European Union (p 295). As a result, nanotechnologies are currently regulated under sector-specific legislation (those relevant to the food sector are listed in Box 1). These regulations are meant to ensure that food containing substances which may present a risk to human health are fully risk-assessed by regulatory authorities before they are permitted on to the market. Witnesses were concerned that, unless a definition of nanomaterials was included in legislation, there might be circumstances where nanomaterials that should be risk-assessed were not recognised as such by companies or regulatory authorities (Q 549, pp 294-297, 313).

5.10.  The FSA, whilst supporting the inclusion of a definition in food regulations (Q 32), took the view that, even without a definition, new applications of nanotechnologies would fall within the Novel Foods Regulation:

"we do not rely on [a definition] … in order to say that new nanomaterials fall within the scope of the novel foods regulation and therefore need to go through the whole requirements of pre-market application, evaluation and … formal authorisation … The inclusion of a new definition in the novel foods regulation provides welcome clarity in saying yes, clearly these materials fall within scope, but I would argue that even if you do not have a definition in that legislation you are still covering virtually all the cases you can imagine" (Q 610).

5.11.  Dr Lawrie pointed out that current regulations trigger pre-market approval and testing based on novelty and changes in the properties of a material. New nanoscale materials would be viewed as "novel ingredients", while familiar materials which had been engineered to the nanoscale would be covered under existing regulations as an example of novel processes causing a change in the properties of an ingredient. Each case, therefore, would be assessed as novel foods by regulatory agencies (Q 611). Mr Roberts also felt that, if products contained nanotechnologies, then there would have to be "an assessment of the nanotechnology component ... you do not have to define nanotechnology is legislative terms to achieve that" (Q 33).

5.12.  A similar view is taken by the FDA in the United States. The FDA does not intend to apply a standard definition of nanotechnologies or nanomaterials because, in their view, the science base is insufficiently complete to provide for a definition of nanotechnologies suitable for the purposes of regulation. Instead they intend to risk-assess nanoscale materials used in the food sector on a case-by-case basis. It appears however that food can bypass the regulatory process in the United States if the manufacturers decide it can be deemed Generally Regarded As Safe (GRAS) (that is, substantially equivalent to an existing, approved food). Given the limitations of current scientific understanding of nanomaterials, this might result in a nanoscale version of an existing food being viewed as safe by the manufacture, thereby bypassing the risk assessment process. The FDA told us that, in situations where manufacturers were uncertain as to whether the GRAS rule applied, they generally asked for an official view before applying the rule. The FDA were confident that this process of dialogue, combined with the power to declare food unlawful if they felt GRAS had been misapplied, would provide consumers with sufficient protection and regulatory coverage (see Appendix 6).

5.13.  Other witnesses, however, saw a definition as essential to ensure that the Novel Foods Regulation was applied to all food products containing nanomaterials. Dr Peter Hatto, Chair of the UK, European and International Standardisation Committees for Nanotechnologies within the ISO, told us bluntly that if "you cannot define it you certainly cannot regulate it" (Q 447), while Professor Richard Owen, Professor of Risk Assessment at the University of Westminster, said: "if you want to ensure that your nanomaterial does not fall through a regulatory gap … you have to be able to identify it as a substance to be risk assessed in a nano form" (Q 459). Other witnesses also supported the introduction of a definition (QQ 160, 481, p 80). In the United Kingdom, although it appears that most uses of nanotechnologies in the food sector are likely to be covered by existing legislation, there are gaps where a definition could clarify whether the Novel Foods Regulation applies. We were surprised to note that, unlike the Food Additives Regulation, foods and ingredients regulated under the Novel Foods Regulation which are already approved for use within the European Union may not necessarily be re-evaluated if they are reformulated at the nano-scale because, in the absence of a legal definition of nanotechnologies or nanomaterials, it is left to industry and the regulators to decide whether new, nano-scale formulations should be subject to a renewed pre-market approval.

5.14.  Under the Regulation pre-market approval is required unless the novel foods are deemed by a national food assessment body to be substantially equivalent to comparable traditional foods (p 295). Substantial equivalence is determined by a range of factors (such as the composition and structure of foods and the nutritional value, metabolism and level of undesirable substances),[62] but there is no explicit reference to particle size or to nanomaterials. This creates the possibility that a national food assessment body may deem a food containing a nanomaterial (for example a nano-sized version of a traditional ingredient) as substantially equivalent to the larger form, even though it may, in fact, demonstrate novel properties (p 295).

5.15.  In 2007 the FSA published a report on the implications of the use of nanomaterials as food additives or food ingredients on consumer safety and regulation which described this risk as follows:

"If a company responsible for placing a nanofood product on the market did not recognise it to be novel (e.g. because the ingredients already have a history of use at the macro-scale), and/or did not consider the properties of the nanofood to be substantially different from its macro-scale counterpart (e.g. because of a lack of information … or the lack of a precise definition of the term "substantially altered") then it is possible that a safety evaluation under EC/258/97 [the novel foods regulation] will not be carried out".[63]

5.16.  A similar issue arises with food supplements. From 2010, vitamins and minerals used as food supplements in the EU will have to come from an approved list. However, individual formulations of those substances are not regulated—so a nano-formulation could alter the way those substances are absorbed or interact with the body and it would be up to the industry to decide whether or not the substance's properties had changed enough for the Government to have to give further approval to it as a novel product (Q 620). Dr Lawrie told us that in the case of vitamins and minerals, "we do not regulate [the] individual formulations of those substances and ... by making a nano-formulation you could certainly alter the bioavailability or the fate of the substance within the gut" (Q 620).

5.17.  The IFST also made this point:

"the legislation is potentially deficient in apparently failing to distinguish ENMs [engineered nanomaterials] of food-approved materials and permitting their use, based on safety guidelines and evaluations produced for macroparticles … [The] replacement of already-permitted macroscopic materials with ENMs of the same chemical composition … appears to have been considered as a simple formulation change" (p 313).

5.18.  Ms Merron recognised that the difficulties caused by the absence of a legal definition impacted on industry as well as consumers: "if we are asking food operators to comply then we have to give them something to comply with that they understand and where they do not find themselves accidentally falling foul of compliance" (Q 609). We agree. We heard an example of this while in the United States, albeit in the agricultural sector. The EPA told us that they had approved a pesticide inadvertently, without realising that it contained nanoscale materials. The manufacturer had not informed them of this since the substance was simply a nano-sized version of an existing, conventional pesticide ingredient.

5.19.  Given the uncertainty about the potential risks of nanomaterials, it is essential that any nanomaterial used in a food product (with the exceptions set out in paragraph 5.32) should to be subject to a formal risk assessment process through the European Food Safety Authority. We recommend, therefore, that the Government should work within the European Union to promote the amendment of current legislation to ensure that all nanomaterials used in food products, additives or supplements fall within the scope of current legislation. We recommend in particular that the legislation should, for the avoidance of uncertainty, include workable definitions of nanomaterials and related concepts.


5.20.  The evidence we received included a number of different definitions of 'nanomaterials' (for example, QQ 149, 160, 219, 481). Although existing legislation does not provide a definition, a draft of the Novel Foods Regulation (which is currently being revised, see Box 1) going through the co-decision procedure and agreed by the Council of the European Union on 22 June 2009, proposed that "engineered nanomaterials" be defined as:

"any intentionally produced material that has one or more dimensions of the order 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 or less, including structures, agglomerates or aggregates, which may have a size above 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 the large specific surface area of the materials considered; and/or (ii) specific physico-chemical properties that are different from those of the non-nanoform of the same material".

5.21.  In formulating a definition, witnesses suggested that two key issues needed to be addressed: the relationship between size and functionality; and, whether 'natural' nanomaterials should be included. Although our comments in this section refer to a definition in European legislation, they are also relevant to definitions at an international level (see paragraph 4.56).


5.22.  The definition of 'nanomaterials' proposed for the Novel Foods Regulation focuses on the quantitative measure of 100 nm. But, as we have already noted (see Chapter 2), the defining feature of the point at which a material can be said to be a "nanomaterial" is not strictly quantitative - it is the point at which a material demonstrates novel properties as a result of its small (nanoscale) size. According to the RCEP, in its report Novel Materials: "it is not the particle size or mode of production of a material that should concern us, but its functionality".[64] Professor Jones told us that the important factor was to consider whether materials were exhibiting "new properties by virtue of their size" (Q 484); and Dr Wadge told us: "from our perspective it is not so much the exact precise cut-off point in terms of size, it is far more around the properties which will have a bearing on the risk assessment" (Q 32). Since a definition in food legislation is used to ensure that relevant nanoscale materials undergo pre-market risk assessment, the meaning of functionality in this context is how a nanomaterial interacts with the body, which is the crucial factor in determining its potential risk.

5.23.  Although nanoscale properties (and as a consequence novel functionality) typically emerge at sizes below 100nm[65] (Q 487), 100nm as such has no toxicological significance—particles larger than this may exhibit novel properties and should therefore be considered nanomaterials for the purposes of risk assessment (QQ 219, 276, 484). Including in a definition phrases such as "of the order of 100nm" does not appear to assist. In Ms Merron's view, using an approximate value of 100nm would create "blurring" for regulators and industry (Q 609).

5.24.  This strongly suggests that any definition of "nanomaterial" should not be limited to an arbitrary dimension of 100nm, but instead focus on any changes in properties that emerge as a result of a material being at the nanoscale (smaller than 1000nm). We recommend that the Government should work towards ensuring that any regulatory definition of nanomaterials proposed at a European level, in particular in the Novel Foods Regulation, should not include a size limit of 100nm but instead refer to 'the nanoscale' to ensure that all materials with a dimension under 1000nm are considered. A change in functionality, meaning how a substance interacts with the body, should be the factor that distinguishes a nanomaterial from its larger form within the nanoscale.

5.25.  The proposed Novel Food Regulation definition also includes materials over 100nm if they "retain properties characteristic of the nanoscale". Ms Merron expressed some concern about this provision on the ground that the state of the science is such that "we do not know enough to say what is characteristic" (Q 609). We recognise this difficulty. However, given how little is known about how nanomaterials interact with the body (see Chapter 4), we take the view that the definition should cover any material that reveals a change in any property that might affect how it behaves in the body as a result of being nanoscale. In Chapter 4 (paragraph 4.2) we referred to a range of physical and chemical properties which SCENIHR describe as "the main parameters of interest with respect to nanoparticle safety".[66] We suggest that these properties should form a basis for a list of properties that may change at the nanoscale, and affect the risk a material may present. A change in any of these properties in a material at the nanoscale should result in it being treated as 'nano' for the purposes of risk assessment. As the scientific community's understanding of nanomaterials increases, this list may need modification to ensure it reflects the full range of properties which should be considered by regulators when determining whether or not a material should be considered as 'nano' by virtue of a change in property at the nanoscale.

5.26.  We recommend that Government should work within the European Union to clarify the phrase "properties that are characteristic to the nanoscale" through the inclusion in the Regulation of a more detailed list of what these properties might comprise. This list should be regularly reviewed, as the understanding of nanomaterials develops, to ensure that it provides comprehensive and up-to-date coverage of relevant properties.


5.27.  Professor Jones described one difficulty encountered when defining nanomaterials in the food sector: "the issue is that food is naturally nano-structured, so that too wide a definition ends up encompassing much of modern food science, and indeed, if you stretch it further, some aspects of traditional food processing" (p 245). The IFST identified three types of nanoscale materials present in food: naturally occurring nanoscale substances (such as nanoscale protein, fat, or sugar molecules or micelles); a proportion of nanosize materials in the distribution of particle sizes derived from conventional processing techniques; and substances deliberately engineered to confer novel properties as a result of their nanoscale size. The IFST told us that attempting to regulate the first two types of nanoscale materials present in food would be difficult: "we consider it is impossible to regulate/legislate for naturally-occurring nanomaterials … and very difficult to legislate where the nanoscale material is adventitious; we question how such presence would be defined/identified/quantified or legal constraints be enforced?" (p 312)

5.28.  In addition to these three types of nanoscale material, we identified a fourth source of nanoscale substances present in food. Nanoscience allows food companies to improve their understanding of the structure of food, and therefore to use conventional processing techniques better to control the formation of foods at the nanoscale, creating nanoscale structures deliberately and not just as part of a distribution curve of particle sizes. Professor Jones told us that while this might be considered to be nanotechnology, it could be argued that, since traditional processing methods are being used, "what makes this nanotechnology ... is simply knowledge" (pp 245-246). He gave the example of ricotta cheese production (which we mention in Chapter 1). If a company uses a new technique to produce ricotta cheese, it could be argued that, given that the cheese contains nanomaterials created during a manufacturing process, it should be assessed under the Novel Foods Regulation.

5.29.  Some witnesses suggested that nanoscale materials created from existing food substances should be treated differently in legislation. LFI argued that there needed to be "a clear distinction" between "nanoparticles naturally and currently present in foods (this will include ones made during manufacture)" and those "not normally expected such as persistent materials" (p 52), adding that naturally-occurring modified materials modified at the nanoscale were unlikely to require further safety or toxicological testing. Professor Morris agreed (QQ 142, 153). The BRC also drew attention to the issue of "whether manipulating existing ingredients such as salt at a nano level is something that would be counted as new technology or simply the better application of a known product" (p 80).

5.30.  However, while nanomaterials created from 'natural' food substances are less likely to pose a threat to human health, Dr Powell told us the possibility cannot be ruled out (Q 276). The Research Councils shared this view: "for manufactured nanomaterials, even when derived from naturally-occurring nanomaterials, appropriate assessments of risk and safety should be made" (p 205). PEN agreed; in its opinion, the question of whether a material was natural or engineered had "no direct bearing on its safety", and the focus should instead be whether the nanomaterials, whether natural or not, demonstrated properties that may raise health and safety concerns. Ms Miller (Q 290) and Professor Jones (Q 479) both argued that scientific understanding of nanomaterials is not yet sufficiently developed that the possibility of some risk from nanomaterials formed from 'natural' food substances, created by conventional food processing techniques, can be excluded.

5.31.  We acknowledge that nanomaterials created from naturally-occurring materials may pose a potential risk to human health. However, we also recognise also that it is impractical to include all natural nanomaterials present in food under the Novel Foods Regulation, and that many natural nanoscale substances have been consumed for many years with no ill affects reported (pp 52, 335). The question is therefore which nanoscale materials created from natural food substances present sufficient risk to mean that they should be treated as engineered nanomaterials and go through a risk assessment before they are allowed on to the market. The EFSA made the following distinction in its Opinion on the risks arising from nanoscience and nanotechnologies: "'Natural' nanoscale materials (e.g. micelles) will be considered if they have been deliberately used e.g. to encapsulate bioactive compounds or further engineered to retain their nanoscale properties" while "'natural nanoscale components present as emulsions (e.g. in homogenised milk, mayonnaise) will not".[67] The FDF said that it: "draws a clear distinction between naturally occurring nanoparticles and the presence of nanoparticles in food from certain conventional processes, and nanoparticles or nanomaterials that that have been deliberately engineered to confer different properties" (p 77).

5.32.  We consider that this is a sensible distinction to make. If regulations are to be workable it is necessary to distinguish nanomaterials that occur naturally in food, or that are created during a conventional manufacturing process, from those that are deliberately selected or engineered to take advantage of properties appearing at the nanoscale. We recommend that, for regulatory purposes, any definition of 'nanomaterials' should exclude those created from natural food substances, except for nanomaterials that have been deliberately chosen or engineered to take advantage of their nanoscale properties. The fact that they have been chosen for their novel properties indicates that they may pose novel risks.

Distribution of particle size

5.33.  A second issue concerning the adequacy of current legislation is the variation of particle sizes within a material. We heard from Dr Peter Hatto, Chair of the UK, European and International Standardisation Committees for Nanotechnologies within the International Organization for Standardization, that nanoparticles cannot, at present, be manufactured uniformly (Q 464) and that there will be a distribution of particle sizes around the intended mean. The FDA raised the same issue (see Appendix 6), as did Dr Knowles (Q 180). This could lead to cases where the mean size of particles may not be considered 'nano', but where a proportion of particles towards the lower end of the size distribution may be small enough to start exhibiting novel properties. As stated above (paragraphs 5.27-5.32), we do not intend for this to apply to a small proportion of nano-sized structures created in natural food substances by traditional manufacturing techniques; but we consider that this may justify a safety assessment where significant proportion of a distribution of inorganic or persistent materials are within the nanoscale. We recommend that the Government should ensure that implementation guidelines for legislation state clearly what proportion of a bulk material has to be at the nanoscale for regulatory oversight to be triggered.

Next generation nanomaterials

5.34.  Even if the current regulatory regime is capable of addressing the current applications of nanotechnologies and nanomaterials in the food sector, some witnesses questioned whether this would remain the case as the science and applications of nanotechnologies and nanomaterials developed. The BRASS centre, for example, anticipated that "gaps in current legislation will only grow to be more pronounced … current regulation will, in our opinion, need to be amended to account for more sophisticated nano-based products and processes" (p 296). Dr Falkner also felt that it was not possible to "establish with any degree of certainty that current regulations will be able adequately to control the next generation of nanotechnologies", and that advances in biotechnology and information technology would create new challenges requiring "more fundamental changes" to existing regulatory frameworks (p 178). The Research Councils commented on the need for regulations to be regularly reviewed to ensure that they remain "fit-for-purpose as new technologies and materials are developed" (p 205). Given the pace at which novel technologies develop we recommend that, in addition to its on-going monitoring of the state of the science, the Food Standards Agency should formally review the suitability of legislation every three years to ensure that regulatory oversight and risk assessment keeps pace with the development of these technologies.


5.35.  REACH—European Community legislation concerned with chemicals and their safe use—plays a role, albeit limited, in regulating nanomaterials. Although materials used solely in food production are excluded (Q 653), nanomaterials used as chemicals in other sectors will fall with the scope of REACH, as will substances used in food packaging (pp 290-291). Some witnesses referred to REACH as an important first stage in risk-assessing nanomaterials. Dr Falkner, for example, said that most nanomaterials enter the regulatory framework when "they are produced by chemical companies for use by other industries, and that is where REACH kicks in … I think any consideration of the food cycle would need to look at the chemical side as well" (Q 318).

5.36.  Concerns about the effectiveness of REACH have, however, been expressed (QQ 318, 549). The RCEP report, Novel Materials, considered the role of REACH and its suitability for regulating nanomaterials in some depth and concluded that, in principle, REACH could adequately regulate nanomaterials, although the report stressed the need for future revisions of REACH to move the focus of regulation from the size of nanomaterials to their functionality.[68] We have reached the same conclusion in relation to defining nanomaterials for the food sector (see paragraph 5.24 above). Therefore, we welcome the Government's decision, in response to the Royal Commission on Environmental Pollution's report, to recognise that functionality, as well as size, should be the focus of required revisions to REACH.[69]

5.37.  The RCEP report also commented on the one-tonne threshold provision within REACH (chemicals produced in smaller quantity than this are not covered by the Regulation). Because of the very large number of particles present "even in tiny quantities of a nanomaterial", one tonne may be "too high a threshold to capture potentially problematic effects".[70] Lord Drayson said that the Government was aware of the problem and that they recognised that the one-tonne threshold was "not … adequate in the case of nanomaterials" (Q 548). It was, he said, a "loophole which needs to be closed" (QQ 549, 550). We commend the Government's commitment to address the issue of the one-tonne threshold for considering the potential toxic effects of a substance under the REACH Regulations. We ask the Government to update the Committee on the progress they have made towards meeting this urgent need.


5.38.  We received evidence about a number of voluntary self-regulation schemes covering nanotechnologies. They included: an in-house initiative by BASF, the world's largest chemical company; a code of conduct for nanoscience and nanotechnology research by the European Commission; and the UK's Responsible Nano Code, a joint initiative by the Royal Society, Insight Investment, and the NIA.[71] These schemes are intended to provide a "private governance mechanism to manage potential risks and promote the technology".[72]

5.39.  RCUK told us that "voluntary codes cannot be considered as adequate replacements for effective regulation" (p 205)—but they may have a role to play in parallel with legislation, particularly where there are gaps in legislation. Professor Pidgeon suggested that voluntary codes were "useful where there is an absence of regulation or where the regulatory framework has taken time to follow developments in industry and elsewhere" (Q 359). Ms Hilary Sutcliffe, Director of the Responsible Nano Forum, also felt that where regulation was not clear or "fit for purpose", voluntary initiatives could help "bridge that gap" (p 368). Dr Friedrichs told us that, alongside regulation, voluntary codes of conduct could help ensure that companies conformed to the same safety requirements even when working across different regulatory regimes (Q 513).

5.40.  Ms Sutcliffe also suggested that the Responsible Nano Code had the potential to be effective in "promoting the issues of responsible nanotechnology" to a range of organisations in "all parts of the supply chain" (p 367). Dr Friedrichs thought that voluntary codes of conduct could help promote awareness of the issues surrounding nanotechnologies even within companies, for example by helping raise the profile of nanotechnology safety issues within management: "the first principle of [the Responsible Nanocode] is that it needs to be signed off by a board or by management, it has to be taken into consideration by all of them and they can all vouch for the fact that it has helped multinational companies to raise the profile of what they are doing in nanotechnology safety" (Q 512). Ms Sutcliffe told us that voluntary codes allowed companies to demonstrate their "compliance with good practice in a transparent and easily understood way for the consumer". Providing the public with information about voluntary initiatives may help "allay concerns" about inadequate regulatory oversight (pp 367-368).

5.41.  Others were less convinced of the effectiveness of voluntary codes. The IFR suggested that it was difficult to assess how well they were followed but "a general observation might be that voluntary self-regulation is often open to abuse" (p 57). Which? felt that it would be a "backward step to rely on a voluntary approach to control the issues raised by manufactured nanomaterials" in this "highly competitive" area (p 137). Ms Sutcliffe also cautioned that the use of voluntary codes of conduct could "provide a sort of 'fig leaf' which is counter-productive to the responsible development of the sector and the perception of responsibility with critical stakeholders" (p 368). An examination of transnational codes by Diana Bowman and Graeme Hodge in a report entitled Counting on codes: An examination of transnational codes as a regulatory mechanism for nanotechnologies concluded that "voluntary nano-codes have weaknesses including a lack of explicit standards … as well as no sanctions for poor compliance"—but despite this, under uncertain regulatory regimes they offered the potential to become the "first cut" of new governance regimes for nanotechnologies.[73]

5.42.  We recommend that the Government, in collaboration with relevant stakeholders, support the development of voluntary codes of conduct for nanotechnologies in order to assist the continuing development of effective legislation for this rapidly emerging technology. The Government should work to ensure that voluntary codes are of a high standard, are subject to effective monitoring processes and are transparent.

59   Food Standards Agency, A review of potential implications of nanotechnologies for regulations and risk assessment in relation to food, 2008, p 4, para 16. Back

60   See 7IPR33563 Back

61   Food Standards Agency, A review of potential implications of nanotechnologies for regulations and risk assessment in relation to food, 2008, p 8. Back

62   Regulation (EC) No 258/97 concerning novel foods and novel foods ingredients, Article 1(2)f. Back

63   Chaudhry et al., Assessment of the potential use of nanomaterials, op. cit., p 20. Back

64   RCEP, Novel Materials, op. cit., p 4, para 1.17. Back

65   RS/RAEng, Nanoscience and nanotechnologies, op. cit., p 5. Back

66   SCENIHR, Risk assessment of the products of nanotechnologies, op. cit., p 15, para 3.2.1. Back

67   EFSA, Scientific Opinion, op. cit., p 7. Back

68   RCEP, Novel Materials, op. cit., p 64. Back

69   Government response to RCEP report Novel Materials, op. cit., p 19, para 2. Back

70   RCEP, Novel Materials, op. cit., p 62, para 4.37. Back

71   Bowman DM and Hodge GA, "Counting on codes: An examination of transnational codes as a regulatory mechanism for nanotechnologies", Regulation and Governance, 2009, 3, pp 145-164. Back

72   Ibid., Bowman, Counting on codes, p 145. Back

73   Ibid., Bowman, Counting on codes, p 145. Back

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