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Fifth Standing Committee
on Delegated Legislation
The Committee consisted of the following Members:
Chairman:
Mr. Martyn Jones
†Bailey, Mr. Adrian (West Bromwich, West) (Lab/Co-op)
†Blunt, Mr. Crispin (Reigate) (Con)
†Burns, Mr. Simon (West Chelmsford) (Con)
†Campbell, Mr. Ronnie (Blyth Valley) (Lab)
†Flint, Caroline (Parliamentary Under-Secretary of State for Health)
†Hoyle, Mr. Lindsay (Chorley) (Lab)
†Marris, Rob (Wolverhampton, South-West) (Lab)
†McCarthy-Fry, Sarah (Portsmouth, North) (Lab)
†Merron, Gillian (Lord Commissioner of Her Majesty’s Treasury)
†Murphy, Mr. Denis (Wansbeck) (Lab)
†Newmark, Mr. Brooks (Braintree) (Con)
†Pelling, Mr. Andrew (Croydon, Central) (Con)
Penrose, John (Weston-super-Mare) (Con)
†Snelgrove, Anne (South Swindon) (Lab)
†Webb, Steve (Northavon) (LD)
Williams, Stephen (Bristol, West) (LD)
Emily Commander, Committee Clerk
† attended the Committee
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Wednesday 16 November 2005
[Mr. Martyn Jones in the Chair]
Tryptophan in Food (England) Regulations 2005
2.30 pm
Mr. Simon Burns (West Chelmsford) (Con): I beg to move,
That the Committee has considered the Tryptophan in Food (England) Regulations 2005 (S.I., 2005, No. 2630).
I am grateful that we have this opportunity to discuss the regulations as a result of the official Opposition’s prayer against them. The issue does not divide us along party political lines, and we do not intend to press for a Division. However, it is important that we be able to raise issues that have arisen over the past 15 years as a result of the banning of tryptophan in 1990.
As the Minister will be aware, tryptophan was a popular ingredient in supplements until 1990, but the Government of the day decided to ban its use following a serious epidemic of an illness that is probably best referred to by the acronym EMS. The regulations will slightly reverse that decision in the light of time and experience, and will allow tryptophan to be reintroduced and used in amounts up to 220 mg.
There is some controversy about whether the ban was absolutely necessary in the first place. Regardless of that, however, I would like to know whether, in the light of experience and of further scientific testing and evidence over the past 15 years, it is realistic for the Government to produce regulations that restrict the levels, rather than returning to the pre-1990 status quo.
The Minister will be aware that studies are being carried out, and I believe that a result is expected early in the new year. If that is correct and a report based on scientific evidence were published in the new year suggesting that 1,000 mg—the original amount—is in no way a threat to the health or well-being of individuals, would the Government come back to the House with further regulations to replace those before us, and return to the pre-1990 status quo?
I understand that this is a difficult issue for the Minister in one way, because neither she nor her party were in office when the original decision was made. That decision was taken in good faith to protect citizens from what was considered a potential problem. Has any work been done on the testing and evidence that were used in deciding to ban tryptophan? Many people will argue that that decision was perhaps hasty, and not necessarily relevant in terms of protecting people’s health.
In the light of that, why have the Government opted for 220 mg, rather than 1,000 mg or a figure in between, given that they have accepted the principle
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that tryptophan can be reintroduced and are therefore convinced that it is safe at a certain level? What was the scientific evidence that the Government received and studied that made them decide that 220 mg is the most appropriate level? On the same point but from a different angle, will the Minister share with the Committee the reasons why the Government regard 1,000 mg as the wrong level? If they did not regard it as the wrong level, we would not have regulations before us restricting the amount to 220 mg.
Will the Minister also tell us how many representations the Government received before and after the regulations were laid before Parliament, since which time people have had the opportunity to see the Government’s proposals? How many representations did they receive agreeing with 220 mg, and how many disagreeing? What evidence made them take such a step?
The Minister will correct me if I am wrong, but I understand that the submissions that the Government received in response to their consultation have not been circulated. If I am right, will they circulate those submissions, so that interested parties can see what people and organisations have been saying on both sides of the argument—assuming that both sides of the argument were presented in the submissions received by the Department of Health?
I shall be extremely glad to hear the Minister’s comments. If she is unable for the best of reasons to respond to any of my questions today, I would appreciate it if she wrote to me, so that we can get to the bottom of the matter.
2.37 pm
Steve Webb (Northavon) (LD): I am grateful to the Conservative party for giving us the opportunity to debate the regulations. I know that the hon. Member for West Chelmsford (Mr. Burns) has been pursuing this subject and that he has tabled written questions on it; in doing so, he performs an important function. It is good to have the opportunity to debate what is a small but nonetheless important change for those affected who want to use the supplement.
The hon. Gentleman was a little harsh on his party. I understand that 37 deaths arose from EMS in 1989. That is a significant number of deaths linked to a supplement, and it led to some caution. We can debate whether 15 years was too long a period, but withdrawing and banning the supplement while further evidence was taken seems a proportionate response.
Mr. Burns: I am grateful to the hon. Gentleman for his possibly justified criticism of me; I am not often described as being harshly critical of a Conservative Government. I said what I said only because there is a great deal of dispute and contestation among interested parties about the extent of the impact of EMS on individuals as a result of taking the supplement. I was hoping that the Minister would elucidate on the matter. It is not naturally and automatically accepted by everyone that that was the cause of those deaths.
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Steve Webb: I accept that there is still uncertainty, but the Minister will doubtless enlighten us on the latest thinking. Nevertheless, the proportionate approach seems appropriate.
The regulations propose a limit of 220 mg. What is the process for reviewing that figure? Is it planned in a year’s time to raise the limit to 500 mg if no one appears to have suffered any ill effects? The hon. Member for West Chelmsford was right to say that further work will be done in the coming months, but what is the Government’s thinking on the subject? Shall we be back here in a year’s time considering a 500 mg limit? What is in the Minister’s mind? Where do we go from here?
I did not know the tryptophan limit in the Netherlands until a moment ago. However, I now understand that the proposed maximum level for the United Kingdom is only a third of that in the Netherlands—a substantial difference. Why are we being more cautious than the Dutch? The level showing the lowest observed adverse effect is probably 20 times the figure that we are debating today, so this seems an extremely cautious approach. The estimated average tryptophan requirement in adults is greater than the figure that we are debating today. Tryptophan can be obtained in other ways. I am reliably informed that 220 mg is less than one would consume if one had a baked potato with cottage cheese and tuna salad for lunch. I do not know whether you had such a lunch, Mr. Jones, but if you did, you exceeded the tryptophan level that we are talking about today.
The Chairman: That is far too healthy for me.
Steve Webb: The fact that a normal diet and a regular lunch would take us above this limit shows just how cautious we are being today. Are we being excessively cautious?
As the hon. Member for West Chelmsford said, the usual supplement intake is about 500 mg or 1,000 mg. People have taken such amounts quite happily and successfully for long periods without any obvious adverse effects.
Rob Marris (Wolverhampton, South-West) (Lab): Welcome to the Chair, Mr. Jones. If you had such a lunch but also took supplements, would that not risk putting you above a safe limit? Is that not the point?
Steve Webb: I am querying the amount of 220 mg, which appears to be a tenth of a magic number that was picked. I simply ask whether dividing that magic number by 10 to get 220 mg, for the sake of caution, is overly cautious. I hope that the Minister will tell us, among other things, what she understands the potential health benefits of 220 mg to be. In other words, is there any evidence that some people lost out when the supplement was banned in 1990? Did certain people with particular conditions for which the supplement is helpful report adverse effects as a result of the ban? Do we know what happened when the ban was introduced? To the extent that we know what happened—I assume that the Government have done such research—we know the potential loss involved in
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restricting the dose to perhaps a fifth of what people typically take. Will the Minister say what research has been done?
Will the Minister also say something about the Food Standards Agency’s ad hoc expert advisory committee on vitamins and minerals? I appreciate that tryptophan is not a vitamin or a mineral—I understand the distinction—but the dosage is lower than the amount that the committee tends to recommend. It is a question of consistency. The FSA has a policy not to impose so-called safe upper limits on supplements of vitamins and minerals, but opts instead for warnings.
I read the Minister’s written answer to the hon. Member for West Chelmsford, suggesting that the matter is so serious that the Government had to go further, but I am unclear why they are being so cautious, given that we are talking about a one-off, isolated—albeit very serious—incident of some 15 years ago. That is the thrust of my argument.
Academic studies have found no dose-risk relationship. In other words, there is no obvious link between taking significant amounts of tryptophan within reasonable tolerance levels—even in amounts that greatly exceed the dosage that we are discussing today—and the adverse effects being much worse. So far as we can tell, the people affected probably consumed contaminated materials and suffered as a result. Whether they took a little or a lot seems not to have made a great deal of difference.
Are there alternatives to tryptophan? Could other food supplements have similar beneficial effects? Could the people who used to take tryptophan have taken other supplements with no adverse effects? In other words, is part of the reason for the Government’s caution the fact that, frankly, they do not believe that it matters very much whether people have this supplement or not? That would be one way of reading a 15-year ban. Could tryptophan’s beneficial effects be gained in other ways—from simply a better diet, or from other supplements that have the same effect?
If we are to decide whether caution in respect of this supplement is appropriate, it would be useful to know whether we are depriving people of something that they cannot get elsewhere, or whether the Government believe that this issue does not matter very much because there are other things that people can do, and that the health benefits are not clearly proven. I hope that the Minister can clarify those points, so that we can assess the adequacy of the limit that has been set.
2.44 pm
Rob Marris: I have one simple question. Why, as we are dealing with safety and so on, will the regulations apply only to England, particularly given that the European Union is involved? I am sure that there is a simple answer, and I presume that it has something to do with devolved powers.
2.45 pm
The Parliamentary Under-Secretary of State for Health (Caroline Flint): I hope that I will be able to answer all the questions.
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First, no EC legislation governs the use of tryptophan in food supplements. It is up to national authorities to make decisions based on their own risk assessment. One of the interesting aspects of the case, which I have explored in some depth over the past few months, is that the Netherlands, for example, allows tryptophan to be provided in its markets but has not notified the Commission. Our officials look to the Commission for examples across Europe, so it is unfortunate that some countries do not go through that procedure. I am not having a go at the Dutch, but it would help us all to share scientific evidence bases if, as a point of courtesy, that notification occurred. It is helpful that the Health Food Manufacturers Association and others, through their market knowledge, have brought to our attention the fact that tryptophan is available in some European countries, although it is not widespread throughout Europe.
In answer to my hon. Friend the Member for Wolverhampton, South-West (Rob Marris), I can say that the changes that allow tryptophan on to the UK market mean that it can be provided in Scotland, Wales and Northern Ireland. I hope that that will be an important consideration for hon. Members and that they will not vote against the regulations because that would mean England having a policy different from that in other parts of the United Kingdom. There are some important issues about the sharing of evidence base sites and so on.
I think it would be nice for everybody if we knew what we were talking about. I certainly found it comforting to have some information. Some hon. Members may know more than I did before my involvement. Basically, L-tryptophan is an essential amino acid that cannot be made by the body and must therefore be included in the diet. As humans, we need protein because it contributes to creating, for example, the serotonin that transmits messages in the brain and nervous system. We need it to enable us to walk down the street—the brain tells us to put one foot in front of the other. It is readily available in the UK diet, provided by food sources high in protein such as meat, cheese, fish, milk and eggs. In 1991, the Committee on Medical Aspects of Food and Nutrition Policy concluded that the protein quality of the UK diet was sufficient not to set recommendations for the intake of individual amino acids in our diet.
We are all eating enough meat, cheese, eggs and milk to supply adequate amounts of essential amino acids. We are therefore talking about people who, for one reason or another, want to add to what they are getting from their diets. In answer to the question posed by the hon. Member for Northavon (Steve Webb), I can say that there are already arrangements for GPs to prescribe supplements that are important for certain conditions, and those arrangements allow for registration and monitoring of the effect. That was important in the late 1980s when what was happening in the United States gave cause for concern.
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The average dietary intake of L-tryptophan in 1974 was estimated to be 890 mg a day. That exceeds the recommended adult requirement of 360 mg a day. I would like to think that there has been a significant shift away from eating too much milk, cheese, eggs and meat but, dealing as I do with healthy eating, I am not sure that there has been a huge change. Prior to the 1990 ban, the dietary supplements were typically used for insomnia, depression and premenstrual syndrome, as well as by body builders. In the UK at that time, users typically took one to two 500 mg tablets a day.
For individuals with a medical requirement, L-tryptophan has always been available in the UK as a prescription drug. It is used for the treatment of depression. GPs can prescribe 2,000 mg or thereabouts, but they have to register, survey and monitor usage. I can see the expression on the face of the hon. Member for West Chelmsford—I will come to why there is such a difference between the recommended amount and the amount that GPs can prescribe.
GPs are, as I said, advised regularly to survey and monitor for symptoms associated with eosinophilia myalgia syndrome, which led to the ban in 1990. In 1989, more than 1,500 cases of EMS were reported in the United States of America and, as the hon. Member for Northavon said, there were at least 37 deaths. It is difficult to estimate the exact numbers, because, since the product was available on the market, there was no clear-cut monitoring. For all we know, there could be people with a mild form of EMS of whom we are not aware. There were also reported cases in the UK, Germany, Canada, Belgium, France, Israel and Japan. In the United States at the time of the EMS outbreak it was reported that people were taking up to 8,000 mg a day of the supplement. The Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment, or COT, was asked in 2002 to consider the available data and to advise further on the risks to health.
Mr. Brooks Newmark (Braintree) (Con): I am as new to this as anyone else, and I seem to have missed the link between the people who take the product and the reaction that occurs. It would be helpful if the Minister explained where the problem is occurring. Are there a few people who cannot metabolise the product properly when they ingest it and therefore suffer a reaction? What percentage are affected?
Caroline Flint: The hon. Gentleman’s question is appropriate, but difficult to answer, because it is not easy to monitor the effects on individuals of products offered on the open market. An individual may have symptoms of which their GP is unaware. That is the problem we have in deciding, with respect to vitamins, minerals and supplements, the safety threshold that we think in good faith will protect people. Action could also include advisory statements. We must concede that an element of the situation is people doing the right thing, because there are so many substances on the market and irresponsible people could do themselves a great deal of harm.
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Prescribed supplements make it possible to register and monitor individuals and watch a path of change. Someone presenting with depression and being prescribed tryptophan by their GP can be monitored. As far as I am aware, because of monitoring, there have been no undue effects where GPs are involved. Because of the difficulty that I have outlined with the market we need to decide on the best way to provide something that need not be monitored and is available in health food stores and chemists. I shall touch later on how COT arrived at the level that it suggests.
Evidence from the Institute for Optimum Nutrition was considered, and information was provided about the use of tryptophan in other member states. I shall, in my closing remarks, provide some reassurance about how to make progress in relation to other evidence. A statement by COT published in June 2004 agreed—in line with much of what has been said in Committee this afternoon—that tryptophan was not causal to EMS and that the condition was probably due to one or more contaminants present in certain batches of food supplements. However, COT noted uncertainties in the scientific data.
It is worth reading COT’s statement on tryptophan, which, in paragraphs 36 to 39 on page 8, outlines some of the issues. One problem is that it has been difficult to isolate what causes EMS. Animal studies have been unable to provide a comparator to show what happens to create the syndrome. Without that comparator it is difficult to exclude possible contributors to the syndrome.
There are no reliable data on the prevalence of EMS. The supplement was available on the open market, and it is possible that in the 1990s some people had a mild form of EMS and were unaware of it. It may have caused no problems in their general life; they may have had a headache and not worried about it. It is therefore a difficult condition to define. It has a variety of non-specific symptoms, and, as I said, data from animal studies are limited, so it has not been possible to reproduce successfully all the features of the syndrome. Neither has it been possible to determine completely the specific contaminants that cause EMS. When the epidemic emerged, some contaminants were identified but others were not, which is a problem. COT felt, therefore, that there were still some uncertainties surrounding EMS, such as why it happens and under what conditions, so it took a precautionary approach in determining the safety level. I am happy to raise the issue of further evidence as and when necessary.
COT used the same approach as the expert group on vitamins and minerals to identify possible hazards and determine, in its best judgment, the safest level. It decided that an uncertainty factor of 10 should be applied to derive a dose that should not pose a risk to the health of the general population.
In answer to the question about consultation, I can tell the Committee that the Government received six representations on consultation, of which two objected to the 220 mg level, three did not comment on it particularly, and one thought that it might be too low. A wide body of scientific information was
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considered, which is listed in the statement on the Food Standards Agency website. I hope that that is available to all. Responses to the consultation have now been forwarded to those who responded, and published on the website. There were some concerns about the process and about when people were getting that information, for which I apologise. We have discussed the problem with the FSA and will ensure, as far as possible, that it will not happen again. We want people to feel that their views are being taken on board and that the process is transparent.
The hon. Member for Northavon asked about the alternatives to setting a level, and about the possibility of having advisory statements—as with vitamins and minerals, I think he meant. That expert group on vitamins and minerals has a voluntary agreement with industry—the FSA—to make an advisory statement where levels exceed those advised by the group. The substance that we are discussing is not a vitamin or mineral, so it does not fall into the same category. The FSA has asked COT to consider, at its next meeting, the decisions of other European member states to allow tryptophan on to the market, the level at which it is set and the scientific basis on which it is set, in comparison to the UK, so I am happy to ask that it should also consider advisory statements. Obviously, I cannot tell it to do so, but I can ask it to consider them while it considers those issues.
Rob Marris: My hon. Friend is being generous in giving way. We have been talking about the safe level, which is, I believe, 220 mg. There might be a slight gloss on my reading of the regulations, so I hope that the Minister will correct me if I am wrong, but it seems that laevorotatory tryptophan is banned from food, except infant formula. That is not the precise wording, but I think that I am reading the regulations right. It seems strange to me that we should protect adults more than children.
Caroline Flint: Baby food is covered by Europe-wide regulations, and that includes baby milk, formula and other baby food, such as that contained in little jars. Humans need certain levels of some substances. There is a special arrangement for babies who do not have access to meat and other protein-building foods, and for individuals with special needs, such as those on an organised nutritional diet that requires the addition of tryptophan. Nutritional diet supplements are covered by the same purity criteria that apply to the tryptophan that we are saying should be available on the open market. Baby milk and baby food are covered by equally stringent regulations on purity levels.
Rob Marris: I appreciate that the added substance has to comply with the purity criteria specified for infant formula in the European pharmacopoeia. I do not have a scientific background and the Minister has obviously studied the matter, but to me, purity is a relative concept, whereas percentage is a different issue; one is relative and the other is absolute. Something could be very pure, but it could be purely bad—one might have pure arsenic, for example. Purity is a different issue from quantity, and the subject under consideration is a limit of 220 mg. The European
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purity criteria may protect infants from having impure L-tryptophan in their formula, but they do not necessarily protect them in relation to volume or quantity.
Caroline Flint: My hon. Friend makes some important points. I shall be happy to write to him with further details on how the European regulations relate to volume. However, I can say with my hand on my heart that I am not trying to create a back door through which we might somehow poison the babies of our nation—that would be a very unpopular thing for a Minister to do.
Rob Marris: I am not trying to suggest—
Caroline Flint: I did not want my hon. Friend to think that anything sinister was going on; I attended a Committee only yesterday to talk about our healthy start programme.
Mr. Newmark: I am not a scientist either, but perhaps I can help out both the Minister and the hon. Member for Wolverhampton, South-West (Rob Marris). From what little I have read, I understand that the source of the problem was a bad batch that contained certain toxins. Tryptophan does not necessarily pose a great danger in itself to those who ingest it. My understanding is that ensuring that there are no toxins in baby formula does not negate the fact that tryptophan helps babies to absorb those proteins that they do not get naturally. What counts is the amount. Purity is important in ensuring that there are no toxins, but a small amount can be ingested without posing any of the dangers that the Minister might suggest.
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