Nanotechnologies and Food - Science and Technology Committee Contents

Examination of Witnesses (Questions 40 - 59)


Dr Andrew Wadge, Dr Stephen Axford and Mr John Roberts

  Q40  Lord Crickhowell: You made exactly the point I was going to put to you. Is there not a real problem here because with the best will in the world I am sure many of the best companies are doing some very serious research and very responsible research and we have had an account of one company doing just that. But one is extremely sceptical about their willingness to reveal what they are doing, if it is going to make a difference to them in the competitive market if they suddenly have a smoother ice cream or dressing using much less fat or whatever they are seeking to achieve and want to show that it is of benefit to the customer and not just for themselves, which is the big lesson learned from the GM disaster. So you have quite a problem, have you not, in getting real material out of companies about the research they are doing?

  Dr Wadge: There is a genuine tension there is there not? However, we do have regular dialogue, for example we talk with beverage manufacturers around possible use of micelles to put colours in and so forth so there are technical developments which they are happy to discuss with us but they would not necessarily want to discuss more widely because of commercial pressures. The fundamental safeguard here is that these companies know and are very familiar with the need to make sure that their products fall within the requirements of general food safety and even wider than that the general requirements of the public acceptability. There will be a real caution amongst these companies about learning the lessons from the GM experience in terms of simply thinking that because they have some new bit of technical kit, somehow this will be broadly welcomed by the public at large. They are very, very cautious on that point.

  Q41  Chairman: In the evidence that DIUS submitted it mentions that in Germany it appears from the table that there are 17 products on the market which use nanotechnologies. Presumably de facto those are also on the market in Britain because Europe operates as a single market? What kind of approval process have they been through?

  Dr Wadge: I am not sure. They would be permitted under EU law but I am not sure whether they would be on sale in the UK. I am not sure what 17 products are being referred to there. I can refer to one specific product, which is the co-enzyme Q10, where we had quite detailed conversations with our counterparts in Germany around whether that particular product should fall within the novel food requirements and they were quite clear that the micelles which were being used were not changing the nature of the properties of the coenzyme Q10 so it did not need to go through that additional safety assessment. In a way that shows the ability of regulatory bodies such as ourselves to communicate, as we do regularly with counterparts across Europe, so that where there are products on sale in one Member State we will talk and discuss as to why those products are on sale and whether they should or should not need to go through further assessments.

  Q42  Lord O'Neill of Clackmannan: In the case of the Federal Republic there are two quite substantial supermarket chains, German owned and German directed. Has nobody thought of looking at their range of products and sending anybody to do that? This is quite a sizeable part of the supermarket market share in the UK. I would have thought that major players like that might well have been taking advantage of nanotechnology on some of their products.

  Dr Wadge: You referred earlier on to the reviews that we are doing and two of the reviews were looking at the use of nanomaterials, food contact materials and food ingredients more generally and that showed very little is currently in use in the UK market, but we fully expect that to change and that is why we are so concerned about getting the regulatory framework and the risk assessment frameworks right in anticipation of that change.

  Q43  Baroness O'Neill of Bengarve: Do you have a sense of the timeframe? How urgent is it? It is rather a different story, requiring the withdrawal of a large number of products which have been on the shelves and would have had bad effects on public confidence in the technology and preventing them getting on the shelves until the assessment has been done. How much time do you think you have to get this regulatory framework in place?

  Dr Wadge: The particular silver product that we talked about earlier is an anomaly in the sense that it is a product which has been around for some time, it is a rather niche product, as a food supplement it will fall from the permitted list and no longer be permitted. What I was trying to explain earlier is that the regulatory framework is such that any nanoparticle that is either changing the size or the nature of the property of the material will need to go through additional safety checks so that we will not be in a situation where we have lots and lots of products out there on the market which then have to be withdrawn.

  Q44  Baroness O'Neill of Bengarve: The "we" there is European, is it?

  Dr Wadge: Yes.

  Q45  Baroness O'Neill of Bengarve: So there is an expectation that a number of these products on the market in Germany will quietly be withdrawn because they will need to go through additional checks before they come back on the shelves.

  Dr Wadge: I would be very happy to look into that and provide some additional information because I am not familiar with the particular products that you are talking about. I would rather not comment without being familiar with what they are.

  Q46  Chairman: Perhaps you could follow that up. They were listed in an annex to the DIUS submission in a table produced by the German Federal Risk Assessment Institute.

  Dr Wadge: Yes; okay.

  Q47  Earl of Selborne: I should like to take us back to the European regulatory framework and in answer to Lord Haskel's question Dr Wadge helpfully referred to the review which the FSA had conducted on the European regulatory framework. I think you referred to the general safety requirements of the EU food law regulation which would be the same whether the food was nano-engineered or not. You referred to novel food and food ingredients and noted that this is in course of revision. The regulation for food additives has already been added. Then there is provision under packaging regulations which presumably are relevant, animal feed and the like. Would you like to comment on whether you are satisfied that the amendments either in progress or already in place put the regulatory framework in a fit-for-purpose state?

  Dr Wadge: I think that they do. I think that they do provide the necessary regulatory framework. Where the challenges and difficulties will lie will be far more around the precise nature of the risk assessment and the toxicological testing rather than the regulatory framework. It is there that more work is needed. I feel reasonably confident around the regulatory framework that products would need to go through additional safety testing. Once a product has been developed then the nature of that safety testing will be adapted on a case by case basis according to the properties of the particular material that is being looked at and that is one of the very specific bits of advice that we have received from the independent toxicological experts.

  Q48  Earl of Selborne: You refer to the problem about the adequacy of current test methods. In your evidence you refer to the International Risk Governance Council's report which says that whether you are looking at Japan, America, European Union, all seem to be approaching this in roughly the same way but you point out that questions have been raised about the adequacy of current test methods and the ability of regulatory bodies to monitor and control measurements and risk assessments. In other words, the technology does not appear to be there to give the sort of assessments which are clearly going to be needed. You have identified the problem. How do you see this being resolved?

  Dr Wadge: It is an area where we clearly have a part to play and we have just put the call out for our first particular project looking at toxicokinetics which will really address one specific part of that. The MRC is starting to fund projects and there is an international programme which is being coordinated through OECD of risk assessment work. If I were a budding young toxicologist then that is an area I would be getting into because I think there will be considerable research funding in that area over the next ten to 15 years and that is what is required.

  Q49  Earl of Selborne: We have already talked about colloidal silver which has been around for a long time. We are now realising that the EFSA is not likely to list it as an approved supplement. At what moment does the precautionary principle rear its head? Do we just wait until the final review is listed and presumably there will be other such products coming forward which eventually will be withdrawn but meanwhile they could or could not be cumulatively toxic. Why do we not take the precautionary principle seriously?

  Dr Wadge: The precautionary principle is what is going to lead to the colloidal silver being withdrawn because the company has not produced the safety data to support the sale of that particular product. The regulatory framework that is set out requires a pre-market assessment of safety that would be approved by independent experts on scientific committees. That is a precautionary basis; it is one where the onus is on the manufacturer, the food business, to demonstrate safety before it is put on the market.

  Q50  Earl of Selborne: It just seems surprising, as you can already anticipate that in a year or so this will be withdrawn, that you do not enact the principle sooner rather than later. Precaution usually means you take it sooner rather than later, rather than just allow the process to continue.

  Dr Wadge: The area of food supplements is quite a specific area apart and the UK in particular compared to other Member States has a long history of quite large consumption of a range of food supplements which are perhaps not consumed in other parts of Europe and there are current measures under way to bring the sale of those products under greater control and assessment of safety. This particular product and a number of other supplements have been on the market for a while and manufacturers now have to provide the safety data to support their continued use. These are not nanotechnology supplements in general but it is just the nature of that area of legislation in relation to supplements. In relation to food more generally, we have been able to demonstrate that there is not currently a range of nanotechnology materials on the UK market and that food businesses would need to go through a pre-market assessment of safety that would be considered by independent experts.

  Q51  Earl of Selborne: On the revision of the novel foods regulation, a 1997 regulation which is to be updated, the European Parliament has proposed that any new regulation should explicitly apply to all nanomaterials. I gather that is under discussion by Member States and the European Parliament. What is our position on this?

  Dr Wadge: We support the additional controls and requirements to assess safety of nanomaterials which would have a different size or a different property compared with the existing foods that are on the market. The whole way the novel foods regulation works is that it makes a comparison and sets a date back in 1997 where, if a food has been in continued use for a period of time within Europe then it is not considered to be novel. What this change in the legislation is ensuring is that a change in the size or the properties due to nanotechnology would make that a novel product and would require further assessment before it is used.

  Q52  Chairman: Presumably that is going to involve a definition of nanotechnology. You said earlier on that the definition is a bit woolly. So when we talk about a new product being defined as a novel product, I assume there will have to be a precise definition.

  Dr Wadge: Yes.

  Q53  Chairman: As a related question, you talked about this product involving a co-enzyme which was deemed not to be a novel product even though it had nanotechnology in it. How does that square? Is that the current situation which will change in future and will not be able to slip under the radar screen in future?

  Dr Wadge: In the end the debate was around the properties of that particular material and although it was produced by nanotechnology, under the current novel food regulations the properties were not considered different, therefore it was not considered novel. If the regulations are changed to include anything produced by nanotechnology methods, then perhaps it may come under that requirement in future.

  Q54  Baroness O'Neill of Bengarve: You have been telling us about the likely shape that the European regulation will have. Will that put the European regulation on a different track from the Japanese or US regulation? We have been there before in other areas and it does create difficulties.

  Dr Wadge: There are very specific differences of approach and we have seen that clearly in relation to GM between North America and Europe. In a sense that reflects the different political and social environments that the regulations are derived from. Probably what is most important from a scientific point of view is that we have international agreement on the risk assessment procedures and that is where the OECD work has a really important part to play. There will always be an opportunity for a much wider socio-political layer which is then put on top of the science in terms of the types of controls which are required in one part of the world compared with another part of the world. That is just the nature of the differences between different parts of the world.

  Q55  Lord O'Neill of Clackmannan: In your evidence in relation to project A03063 you give a helpful description of the proposed changes to the food packaging regulations. What is the attitude of the Government to this? You are rather coy. I realise this is just a résumé of the regulations but what is the Government's attitude to that? How do you envisage implementing this on labels which are small enough to be acceptable to the packaging requirements?

  Dr Wadge: There are two questions there. One is: what are the changes required to make sure that nanomaterials are properly assessed and need to be assessed before they are permitted for use such as nanoclays for example. Then the second question is the question of labelling. At the moment labelling is something which in broad terms is required where consumers need information that is meaningful to them. The priority has always been around information on safety and nutritional composition. For genetically modified materials there is a requirement for safety assessment and also labelling. Given that we are at such an early stage in nanotechnology we have not had that debate yet around what the nature of the labelling might be and how useful it would be for consumers to have the word "nano" put on one part of the label. That is certainly something where we would be engaging with consumers to find what type of information they would find useful. Once we get to a position where there are very specific products which are much closer to coming onto the market, of course we are in a position there where there are competing demands of clarity and useful information and a very small space on particular products to provide information around safety and use-by dates and nutritional composition, some environmental factors and possibly also information about the nanotechnology as well. It is something we are going to need to engage in and that is something we have done in the past. We will engage with consumers quite broadly with deliberative research to find out what sort of information they need and what is actually useful. There is no point putting "nano" on a label if it does not actually mean anything to anybody.

  Q56  Lord O'Neill of Clackmannan: One of the problems we have had so far is the debate about nutritional information and whether it should be something which is imposed or be the right of the manufacturer or provider of the food to put down with their own particular spin. I find I am an avid reader of breakfast cereal nutritional values and if there are more than two cereals on the table I get totally bewildered. I understand the problem and I wish you well in your endeavours.

  Dr Wadge: Thank you.

  Q57  Lord Haskel: We have had a fair bit of discussion about the draft report on Regulatory Aspects of Nanomaterials by the European Parliament and indeed I think you told us you are conducting a review about this. Can you tell us whether you think that this is going to be a basis for having the same risk assessment procedures throughout Europe? Are you working with your counterparts in Europe on this? What is your general view about this draft report?

  Mr Roberts: On many products we have European-wide systems. If you look at chemicals generally, for example, we have just introduced a major new regulation, which is European-wide, to identify the risks around chemicals generally. If I may, I will explain how I think that relates to nano which is why I think some of the comments the European Parliament rapporteur has been making are perhaps misfounded. REACH regulates substances other than those which are regulated by other regimes such as the food regime, the pesticide regime or the pharmaceuticals regime. Nanoparticles are substances so they therefore fall within the scope of the general European regulation. The question that we need to work through is how we should apply that regime in the circumstances of nanomaterials. The first question you have to ask is whether a nanomaterial is the same substance as a larger material or not. We are quite clear across Europe, both the Commission and the Member States, that if someone is producing a nanomaterial then the risk assessments they have to do under REACH would have to deal with the risks which might be associated with the nanomaterial. There are still big issues which we have to deal with because the testing regime associated with chemicals was designed for chemicals rather than nanotechnology. It may pick up many of the risks but it may not pick up all of the risks and therefore we do need to review how the tests are done to see whether there are new risks or new tests which need to be added to the suite to make sure we do capture the risks. We may also need to deal with some of the issues such as the fact that for registration under REACH there is a threshold of one tonne before a manufacturer has to go to Europe. For most chemicals that is fine; for nanomaterials a tonne may be rather a lot. It does not necessarily mean that nanomaterials are exempt, because if a manufacturer produces, for example, bulk titanium oxide and nano titanium dioxide, then they have to register the whole of their production, so the nanomaterial would be included. The principles which underlie general regulation of chemicals, similarly pharmaceuticals or pesticides, that you have to provide information, that you have to provide information through the supply chain so they can be used safely and the regulator has the opportunity to restrict the manufacturing use if there are proven risks, apply to both bulk materials and nanomaterials in the same way. The way I would see the regulatory regime going forward is amendment of some of the detail to make sure the tests are sufficiently comprehensive and any criteria in terms of thresholds and so on may need to be adapted to reflect nano. However, the principles that we use for regulation of chemicals, of foods, of pesticides should apply to nano in the same way they apply to the products generally.

  Q58  Lord Haskel: That is very helpful. Do you think that will be adopted throughout Europe? REACH is a European system so we are working on this together and whatever rules we come up with will apply throughout the market; it will be part of REACH.

  Mr Roberts: It will be part of the REACH system.

  Q59  Chairman: Just to be clear, in this report to which Lord Haskel is referring from the Committee on the Environment, Public Health and Food Safety, the European Parliament says in paragraph E " ... in the context of REACH, it has so far not even been possible to agree on guidance on the identification of nanomaterials, leaving important decisions in the context of registration to economic operators". I am assuming translated into English that means that nanomaterials could slip through the net under REACH. Are you saying that is wrong, that this committee are wrong?

  Mr Roberts: It is more subtle than that. Some guidance was published by the European Commission after agreement with Member States a couple of weeks ago about how far we have got in terms of the application of REACH to nanomaterial. I can happily provide a copy of that, if that would be helpful; that analyses the issue in rather more detail. What it says is that if the nanomaterial is a new substance, if, for example, it is a fullerene, then it is clearly a substance on its own and REACH would apply to that substance. If it is the same as a bulk form, then it is probably the same substance as the bulk form but the chemical assessments and the safety data sheets would have to reflect any particular risks that arise in the nanomaterial and in terms of classification and labelling, the hazard symbols which are put on products, if the nanoform has different risks, then it might merit a different hazard symbol to the same chemical in bulk form. The draft report from the rapporteur is an over-simplification of a rather more complex situation.

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