Food Supplements (Scotland)<br />Regulations 2003
Good morning. I open the third meeting of the Health Committee this year. I welcome to the committee petitioners John McKee and Helen McDade. Thank you for your written submission. We shall move straight to questions.
Under European law, the United Kingdom is obliged to implement the Food Supplements (Scotland) Regulations 2003. In fact, the advice that the committee has received is that we have no option but to implement these technical measures. As a committee, we could send the regulations back to the Scottish Executive if we felt that it was not implementing the European directive properly—in other words, if it was not using all the derogations that could be used under the directive—but our advice is that the Executive is using every derogation that is available to it. What do the witnesses think the committee can and should do about that, given that the regulations are technical measures?
The other question is whether it is legal in Scottish law to pass the regulations. I understand that all law that is passed by the Scottish Parliament must comply with the European convention on human rights, which gives people the right to health. We argue that the regulations will adversely affect our health, so surely it would not be legal to pass the regulations.
Any regulation or law that is passed by the Scottish Parliament has to be examined by the Scottish Parliament's lawyers. The lawyers feel that the regulations are appropriate. Of course, anything that the Scottish Parliament does can be challenged in law, but that is a rather legal point.
It is hard to accept that your lawyers have considered whether the regulations are legal when nobody has examined whether the implementation of the regulations will affect our health. It is not for me to sit here and argue with you. The point is that nobody has considered that. The regulations are predicated on advice on the toxicity of vitamins and minerals, but the remit of the expert group on vitamins and minerals, which considered the levels that should be set for substances, did not allow it to determine whether such substances provide non-nutritional or nutritional benefits. The issue of whether the regulations will adversely affect people's health has not been considered, so I do not see how your lawyers can have addressed our legal point. Obviously, I am not a lawyer, and I cannot sit here and debate the issue, but how can the legality in relation to the effect on our health have been considered?
I am trying to get away from the legal argument, because that is best dealt with by lawyers. I am trying to get from you a response that I have not had. What should the Scottish Executive do that it is not doing in implementing the EU directive?
In its report, the European and External Relations Committee asked that the potency and range of supplements that are currently available in Scotland should be available at the end of the negotiations with the European Food Safety Authority. If that is not achieved, the committee stated that the Scottish Executive should repeal the regulations. Therefore, the first thing that we ask for is a cast-iron guarantee from the Executive that it will seek to achieve that situation through the Food Standards Agency and the UK Government.
For clarification, I asked whether the Scottish Executive should be doing anything else in making the regulations. You have not said that it should be doing anything else, except to say that we should repeal the regulations at the appropriate point.
The Scottish Executive should consider the European and External Relations Committee's report. A report from a committee of this Parliament suggested four things, none of which the Scottish Executive will do. The simple answer is that the Scottish Executive should revisit those options.
I will take that up with the minister later if I get the chance.
Do the public understand the concept of passing potentially bad law into Scots law for technical reasons?
I do not think that the public are interested. They are interested in whether the system appears to work for them. The UK has a fairly unique market in vitamins and minerals within the European Union. Any decision that redesigns that market to set up an internal market with common standards will always have to dance to the tune of the other 14 member states, and that enrages people. They do not feel that the UK Government should even have opened up discussions on the issue, because it was bound to lose.
Many of the products that the petitioners are seeking to keep on open sale are approved by the FSA, which is an agency of the Scottish Executive and Westminster. Are the petitioners asking why, if the current safety mechanisms are good enough for a Government agency in this country, we should change them because of an arbitrary comment from outside, without any scientific evidence of harm and toxicity? Is that where the petitioners are coming from in challenging the regulations?
Yes, that is entirely the point. People use supplements, and many of them believe that they are essential to their families' well-being. They will wonder how on earth it can be that food supplements are being removed from them. It is not as if they will be able to get them on prescription; they will not be available at all. There are supplements that people whose children have attention deficit hyperactivity disorder, autism or ME, like my daughter, believe are important. The argument is not whether the medical profession accepts that; the point is whether the supplements are safe.
The committee's remit is to consider the health care of the people of Scotland. As you rightly said, such products are not medicinal—they come under food regulations—and the Food Standards Agency has cleared them. Can you produce evidence that individuals in Scotland will experience substantial difficulties if many of the products are no longer available because of the way in which the directive is implemented?
I believe that we can, but we would need more time to gather that evidence for the committee. We only had a week to get our submission together.
How long have you had? How long has the directive been bubbling away? Can you give the committee an idea of when you were first told about it and of the time you have had to respond?
As a consumer, I first heard of the directive last summer. Health food retailers have known about it for slightly longer. Consumers have had very little consultation on the matter. I rang the Food Standards Agency and asked whom it consulted. It says that it consulted consumers, but I know a lot of the people who are involved in health campaigning in different areas and they were astonished when I told them that the directive was going through. Realistically, the consumer has known about the directive since last autumn.
I have a supplementary question on your point about the adverse effects of some of the supplements that we are talking about. I understand that there is a mandatory system under which doctors have to record the adverse effects of medicinal substances. Is that the case for vitamins and minerals?
No, they have not sought to introduce a yellow-card reporting system for vitamins and minerals. There are a few reasons why they might not have done that, but the main reason seems to be that food supplements are patently safe and that is accepted.
Is it fair to say that if there is no mandatory system for recording such results, there are very few recorded adverse effects?
My store has been in business for 70 years and we have been selling high-strength food supplements in quite large quantities for 30 years. We have quite a successful business. In that 30 years, we have never been contacted by a doctor, trading standards officer or hospital to complain about an adverse reaction suffered by a customer.
Do you think that that is perhaps because people perceive supplements to be safe and so do not understand that there are side effects, particularly if they take excessive dosages or take them along with prescribed medication?
Doctors have a voluntary reporting system. Dr Turner will be able to answer better, but I am sure that all doctors would report anything that they thought had caused a problem. As I said, there are some reports and those are what the Food Standards Agency figure is based on. If a doctor thought that there was a suggestion of an adverse effect from a food supplement, I am sure that they would feel that it was their responsibility to report it. I do not think for a minute that such a report would not be made. There is the question whether a reaction is always recognised, but that question exists for drugs as well. There is massive underreporting in relation to drugs, so the same argument applies.
When I was driving through to Edinburgh this morning, I heard someone from the Royal College of Physicians talking on the radio about the increase in allergies, particularly those that can be linked to peanut butter. Do you believe that there is a need for scientifically based evidence in this area, particularly in relation to children and the elderly?
You are quite right. We are asking the Scottish Parliament to put money into research. Research in the area exists—we could produce lots of it—but the trouble is that there is no scientific research.
From a consumer's point of view, do you accept that some vitamins and minerals can cause harm? The figures that we have do not reflect the problem as you have described it. There is a problem.
Is there a problem? We have asked for proof.
You suggested in earlier evidence that the problem is minute—only one incident is reported a year. Would a study and scientific evidence highlight a genuine problem? Can vitamins cause harm?
Who knows what research would show? We are certainly confident that it would show that vitamins are of great benefit. We are all for research. Should politicians be introducing legislation to stop selling something before finding a problem or doing research to discover the benefits? It is ludicrous to legislate before examining the evidence.
You might not be able to answer this, but do you know whether professional bodies such as the British Medical Association were consulted on the directive?
I am sure that it was. The Food Standards Agency would probably consult all the usual suspects on legislation such as this.
Perhaps we should check that out. Can you answer that question, Helen?
No. However, I should have added in my response to Mr McNeil that the trouble about the evidence is that there is not much experience in nutrition in the establishment. A lot of the experience is in the private sector.
I would like to move on after Mike Rumbles speaks.
The briefing paper that members received tells us that there were 431 consultees in 2000, 957 consultees in 2001, and 409 consultees in 2002. That should be recorded.
The paper is a public document so it should be in the public domain.
Will the witnesses explain their views on the probable impact of the regulations, not only at a local level, but at a wider Scottish level?
There is a particular Scottish issue, although we are told that there are no Scottish differences. We are continually told that Scotland has particularly poor health: we have high levels of chronic illness and very high levels of multiple sclerosis and other illnesses for which data might not have been collected. Many of the people who will be affected by the regulations will be older people, women and the disabled—people with chronic illnesses. Having done the research for themselves, those people are going off and finding the products. I was speaking to just such a person before the meeting. People are enraged that the supplements will be taken away. On the one hand, the First Minister tells us that we must do something about Scotland's health and, on the other hand, we are told that there is no specific Scottish issue. A specific Scottish issue is involved.
You say that the supplements will be taken away, but we must be clear that people will not be unable to buy any of the items that they can buy at the moment. The concern is that there is a school of thought that says that people will never be able to buy any vitamins or minerals ever again if the regulations are passed.
The situation will change. Many supplements are not available on prescription, but doctors still say, "If that supplement helps you, perhaps you should take it."
Is it not the case that those minerals might be included on the positive list if a safety dossier were provided and they were deemed safe?
So what are people who have a deficiency supposed to do in the meantime? The question is: how many people are expendable for EU legislation? Some people who have a gut problem or particular needs will be deficient in those three minerals. What is to happen to them while the issue is discussed and before someone adds the minerals to the list in 10 years?
In 10 years, someone could say that taking those supplements has a detrimental side effect that we have only just discovered. If I were taking supplements, I would rather know that proper research had been undertaken into their safety. I would rather know now if I were taking something that I thought was beneficial but which might be unsafe in the longer term, instead of discovering in 10 years' time that I am suffering detrimental side effects.
What will you say to the parents of children with autism or of children with attention deficit hyperactivity disorder who are following a nutritional path to help their children? That is the question that the committee must address. What will members say to people who cannot have the supplements in the meantime? Nobody will pay for research, because it would not benefit a pharmaceutical company, so the research will never be done, but that is all right, because the committee is considering people's health interests. It is fair enough to hold that opinion, but what will you say to people such as me, who have sick children with no avenue of help from the medical profession and the national health service? If we believe that supplements help our children and us, and if nobody has proved them to be unsafe, why on earth will we not be allowed to give them to our children?
As a mother, I would rather know that something was safe in the long term before I gave it to my child, even if it had short-term benefits. I would not like to give my child something that had longer term detrimental effects and I would like to know that full research had been undertaken before I gave anything to my child.
Janis Hughes is right to say that the mechanism for dossier submission would allow manufacturers to present evidence for safety. Unfortunately, the problem is that the rationale that the European Food Safety Authority uses is too strict and too narrow. For example, a form of selenium—a trace mineral that is essential in Scotland because its level is low in the soil—that is called selenomethionine and which occurs naturally in broccoli is not found on the positive list, because the previous European Scientific Committee on Food had no information about where selenomethionine ends up in the body when it is taken. The committee accepted that it is safer than some other forms of selenium on the list, such as sodium selenite, but because of the lack of one piece of evidence, selenomethionine is not on the list, which seems silly when the committee accepts that it is safe. There are similar examples.
I want the witnesses to expand on that.
Selenium is on the positive list. The report of the Food Standards Agency expert group on vitamins and minerals set the recommended level for toxicity at something like 500 or 600 micrograms. Northern Europe has a real problem with a lack of selenium in the soil. Selenium is very important because it stimulates liver enzymes and helps to recycle antioxidants. Through research, it is well known that antioxidants are important in stopping low-density and maintaining high-density cholesterol, and in preventing gene damage that might lead to cancer in the long run.
I want to ask Helen McDade and John McKee about the implications for people such as themselves who are very well informed about this subject—better informed than are many of us round the table. If the legislation goes through, it will be on the assumption that a reduced potency is safer, allowing us all to sit back and think that everything is fine. However, I know that you folks will continue to try to access your product. I have been reading all the information that I have been given and I want to ask, does the reduced potency mean that some people will buy double the quantity? Will the price stay the same if the potency is reduced? Will it rise? Will people stock up on the product? Are people already planning to buy the product via the internet, from America or anywhere else? If we bring in this legislation, will you still be able to get your products by other means?
This is the moral hazard that faces the Parliament with the legislation. We have customers—some of whom are in this room—who are extremely passionate about the supplements that they take to benefit their health. In many cases, they have been taking the supplements for decades. Whatever happens here today, and whatever happens on 1 August 2005 when the legislation comes into effect, those people are not going to stop wanting the supplements. Dr Turner will not be able to prescribe the supplements for them, and they will not be able to go to a pharmacist to buy them, so they will resort to mail order, perhaps from the Channel Islands or the Isle of Man—which are nominally in Europe but seem to escape all the bits that they do not agree with, which does not seem quite right. Alternatively, people will get the products via the internet. If they got the products from America, they would be ecstatic, because the chances of the product being of a better quality would be quite good. However, they could get them from any offshore place around the world, or from Russia, and the standard could be extremely variable.
Given that we are told that the legislation will come into force anyway, do you have plans to monitor the situation among your consumers?
John McKee's plan will be to look for a job because all health food retail shops—or at least the vast majority of them—will be shut. I do not think that anybody will monitor them.
Will you sum up briefly your argument on the inclusion and exclusion of certain vitamins and minerals from the positive lists and give your view on the projected costs of submitting dossiers in support of ingredients that are not on the positive lists?
As I said to Janis Hughes, there is an established mechanism for submitting dossiers. The UK Government argued for an extension of the submission period from 18 months to 36 months—the period will end in three years. However, between only 10 and 20 dossiers are in production, whereas about 300 nutrient forms are missing from the positive lists. All the companies involved have complained about the cost of creating dossiers and the FSA admits that the cost could be up to £250,000 per nutrient form. I understand that even Roche Pharmaceuticals Ltd, which manufactures one ingredient that is missing from the lists, cannot afford to produce a dossier and has pulled out of producing that ingredient. The European Food Safety Authority has admitted that animal testing will be required for nutrients that we have all been happy to take for decades.
I understand the industry's concerns about the cost of producing dossiers. Would it be realistic for the industry collectively to finance dossiers? As I understand it, once the dossiers have been agreed, they are agreed for all time and the exercise does not have to be repeated.
I will confess to ignorance on the subject. There is a real lack of clarity about whether a dossier gets confirmed for all time. There is the extension to 2009, but the only way to get an extension for all time is for the European scientific committee for foods to add substances to the positive lists. The assumption in some of the Scottish Executive answers is that that would happen automatically if a dossier were to be accepted. It might be that I have misunderstood what the Executive has said on the matter, but I do not think that I am the only person to be confused by the lack of clarity on the subject.
Is it not the case that, if the associations were to form a legal entity—I am thinking of some sort of association co-operative—that legal entity could register for the copyright? Surely the dossier would become the property of the business entity and not of those who had not financed it?
That is not the way in which it works. It is not possible to copyright natural substances, which is what these things are. They are freely available to all.
I want to ask John McKee what might seem to be a simplistic question, but it follows on from something that Helen McDade said earlier. I want people to get a sense of what the effect will be on your shop. Helen McDade said earlier that, if the regulations go through, people like you will be looking for a job. What is the percentage of goods that are sold in the shop at the moment that are not included on the positive list? I am looking for a ballpark figure—I do not expect you to have an inventory.
I am glad that you asked that question. I did an impact assessment about a year ago. I took account of the positive list—as it stood a year ago; it will not change substantially over the next two years—and used a potency level of about 1 x RDA. Hazel Blears, the Parliamentary Under-Secretary of State for Public Health, admitted at the beginning of this month that that was the way that it was going and that we should get used to that. Based on the ingredients that are missing from the positive list, I calculated that I would lose about 300 products, which amounts to about 25 per cent of my annual turnover. Taking the RDA basis into account, I calculated that I would lose about another 12 per cent. There is, however, some overlap, so about 30 per cent of my annual turnover would be lost as a result of the directive.
If you were not able to sell 1,000mg of vitamin C, you could still sell 500mg. Is that correct?
The amount would be much lower. The likelihood is that the maximum amount of vitamin C that we will be able to sell will probably be between 100mg and 200mg.
I was referring to your inventory: you just took these—
You are absolutely right. I took them out of the equation. The implications of the directive mean that only so many 200mg vitamin C products can be on the market. I am sure that Sainsbury's or Boots could sell it a lot cheaper than we could, albeit without the advice that we give. The effect would be to genericise the market. People with specialist needs who go to specialist health food shops would no longer be able to get the products, which would be gone. They would be left with buying low-potency, low-effectiveness products from multiple retailers.
Let us return to the dossier. It seems that the emphasis has been on putting in the money to publish a dossier. Once the status of an item has been decided upon, other people can benefit from that. If small companies have paid for a dossier, the bigger manufacturers can take over and benefit. To some extent, that happens with the pharmaceutical industry. Licences are held for, say, 10 years for a particular drug that has been developed. Then, everybody moves in and can sell that drug. It would seem unfair if the smaller companies that seem to be affected had to put up the money, only for the bigger companies to take advantage later. That is what I have understood from the information that I have been given.
That is broadly right.
You mentioned a directive on herbal remedies. I am not sure what stage that is at. What are your views on that? Does it flow on from the food supplements directive?
I would rather you had not asked me about that—I have not done my homework on it that well. The effect of the herbal medicines directive will be quite catastrophic, too. There are two reasons for that. First, there is a 30-year rule. If a product has not been around for 30 years—if it was not available in 1973—then it will not be permitted to sell it. For example, a perfectly safe combination of bilberry and lutein, which a lot of people currently take for macular degeneration, would not be available. It would not be possible to get glucosamine sulphate with ginger.
What legislative stage has the herbal medicines directive reached?
I cannot remember exactly.
Is it just at the consultation stage?
I think that it is coming up for a second go-round. It is at some stage of consultation. I think that it has been through one stage and that it is now back in committee, but I am not sure.
I will ask a final short question, because we should not really be talking about the herbal medicines directive. When the Parliament deals with the herbal medicines directive, will that reopen consideration of the food supplements directive?
There is a bit of a link with combinations, but the herbal medicines directive falls within the scope of medicines licensing, so it is reserved to Westminster.
John McKee mentioned essential fatty acids and amino acids, which are planned to be dealt with and are linked more directly with vitamins and minerals. It is clear from several replies from the UK Government and the Scottish Government, which say that they will consider in a few years how the food supplements directive is working, that they mean to consider the legislation with a view to extending it to those substances. That is in writing.
David Davidson can ask a very brief question, as I want to move on to questioning the minister.
John McKee talked about the number of people in Scotland who use food supplements and the low incidence of problems. Do you know what percentage of the population in Scotland uses supplements? I do not mean only those who tell me that they depend on supplements, but those who use supplements generally. Do genuinely few reactions occur?
The Food Standards Agency conducted a UK-wide study of 22,000 people, of whom, on average, 40 per cent took supplements. More women than men take supplements, so about 47 per cent of women take something.
What is the incidence of problems?
If there are any problems, the incidence is very low, and in many cases, effects are reversible.
I thank both witnesses for their evidence.
I understand that UK members of the European Parliament secured derogations during discussions on the food supplements directive. Will the minister explain the rationale behind the Executive's using those derogations when it compiled the regulations? Are any other derogations available to the Parliament to deal with the petitioners' concerns?
I am sorry; I should have referred members to the Executive's response in committee paper HC/S2/03/03/2, of which I am sure they are aware.
Good morning, everyone. The threads that ran through the United Kingdom's approach to the negotiations were those of the protection of public health and consumer safety, accompanied by a desire to eliminate any unnecessary restriction on trade and to promote the maximum consumer choice.
Are you satisfied that no other derogations are available to the Parliament that would enable it to address some of the concerns raised by the petitioners?
I do not believe that there are. I return to the point that I made earlier: further derogations could be secured only by reopening negotiations. As I said, the negotiations were very difficult and the United Kingdom view was not in the ascendant. There is a real risk that if negotiations were reopened we might end up with a more restrictive set of regulations.
You have described the actions of the UK Government. What has the Scottish Government done? Have you or the Minister for Health and Community Care had any direct contact with Brussels in response to the concerns that were raised previously, as well as those expressed recently by the European and External Relations Committee? Did officials from the Health Department have any input into discussions on the directive at the time when it was possible to influence those discussions?
Discussions were taken forward on behalf of the United Kingdom through the Food Standards Agency. As members know, the Food Standards Agency is a UK-wide Government body. Officials from the Health Department have discussions with the people from the Food Standards Agency who conduct negotiations.
It is important to remember that the FSA is a separate Government department. It is not part of the Executive and it is not an agency. We were involved in the very difficult negotiations to which the minister referred. We will now negotiate on a case-by-case basis on the safe levels for vitamins and minerals. We will also negotiate on the basis of recommendations by the expert committee on vitamins and minerals. We know that those negotiations will be very difficult because of the attitudes of some other member states.
You said that you were involved in negotiations. To what extent was Scottish expert advice sought to influence the discussions? We have heard about the particular Scottish perspective on this issue, because of public health concerns and so on. I am trying to tease out the extent to which the Scottish perspective influenced the negotiations.
I think that the negotiations were mainly guided by the recommendations in the report by the expert group on vitamins and minerals. I have no doubt that the group took account of the situation not only in Scotland, but throughout the United Kingdom.
Did it?
Yes. My information is that it did.
Did the expert group take evidence from Scottish experts?
I think that the group arrived at its conclusions by using all relevant available data.
The FSA was set up on a UK basis to reflect the need for the best scientific advice to support the raft of issues covered by our remit. We have a nutrition committee that is UK in nature. We do not specifically seek to have proportional representation for any UK country. We seek the best scientific advice. We also ensure that we have full consultation throughout each UK country. The paper that is before the committee has figures that show the number of consultations that took place from 2000 to this year and the number of consultees in Scotland.
In your letter to us yesterday, minister, you said that the UK is obliged, under European law, to implement the directive. You also said, regarding the regulations that you have presented to Parliament, that we must implement the directive's provisions and have the regulations in place by 31 July. It seems to me that the key question is not about the rights and wrongs of the detail. The issue that faces the Health Committee is whether the Executive has produced regulations that implement the directive appropriately for Scotland. My understanding of the advice that was given to the committee is that the Executive used every possible derogation. Is that the case?
Yes.
It strikes me that, if you are presenting to us the best possible regulations—perhaps you will confirm whether that is the case—there is no point in the Health Committee delaying or throwing out the regulations and asking you to return with different regulations.
I believe that we have produced the best possible regulations. I reiterate the point that I made earlier, which is that the Parliament has the right and the opportunity to make its own decisions. However, if the Scottish statutory instrument were not confirmed and the UK Parliament did not pass similar regulations into UK law, our firm view is that renegotiation could place us in a far more restrictive position than that provided by the current regulations.
I will follow up Shona Robison's questions. Is there a specifically Scottish dimension in terms of products that might be more popular in Scotland and which might have different dosage levels compared with levels in other parts of the UK? Are Scottish consumers of such products losing out? Is there a Scottish impact?
I am not aware of a particularly Scottish dimension. The supplements industry is a substantial one. I think that, at 2000 prices, the industry was worth around £335 million in the UK. Surveys show a substantial rise from 1996 to 2002 in the number of people—men and women—who take supplements. Those are UK rather than Scotland statistics.
During our consultations, we also went to the consumer associations. We got a response from the National Consumers Council, which has supported the general terms of the directive as far as mandatory labelling and clarifying issues for consumers is concerned. We did not get a separate response from the Scottish Consumers Council.
I will ask the minister a simple question. Do you have any concerns about the directive?
As I said, the United Kingdom worked hard to achieve a position that ensured that the directive focused as much as we could possibly achieve on public health, public safety, minimum restrictions on trade and maximum consumer choice. The negotiations have achieved the best possible situation relative to all those matters.
Do you still have concerns that this may not be best law to introduce in Scotland?
No, I do not.
You have no concerns.
No.
We heard earlier from the petitioners that glucosamine sulphate is one of the items with which there will be a problem. Like many people throughout the UK, I am concerned about that, as I am a user of glucosamine sulphate. Any arthritis sufferer would tell you about the result of the evaluation that was carried out at St Thomas' hospital in London. It is a major product and has a real impact on us. I wanted you to hear that comment from me.
I will comment first on the substance that you mentioned. My information is that that is not a mineral or vitamin and that it is therefore not affected at this time.
Any of us would be able to buy substances over the internet. For example, we cannot buy melatonin in this country, but we can buy it from America.
The technological development of tools such as the internet has impacted on many aspects of life, from highly undesirable activities, such as child pornography, through to being able to source different items that one can purchase from different countries. The fact that that happens does not necessarily make the case for avoiding the proper regulation of particular products or services through the retail sector in our country. It is an unfortunate situation, and it is clear that there are developing issues. The wider global community is still spending time thinking about how to develop a response to those issues, but that would not necessarily negate our proper desire to ensure that proper regulation and proper levels of consumer safety and choice exist in Scotland.
I will take the minister up on his use of the phrase "consumer safety and choice". I understand from the Food Standards Agency presentation that we had recently that manufacturers of the products that we are discussing have a duty of care under law anyway. Those products are not medicines. As far as medicines are concerned, the Medicines Commission is rigorous in putting safety first. If it finds signs that a product that has been on general sale as a medicine is causing side effects it reinvestigates the product. In this case, regulations are being proposed that seem to restrict choice without dealing with safety.
Under general food law, we do not licence or positively approve foods. It is up to the manufacturers and the retailers, through due diligence, to ensure that they are selling something that will not be harmful. That is the current situation.
So the agency, under its current remit, was going to take action that is separate from any European-led initiative. You were dealing with those products and were going to come back with recommendations about levels of specific substances.
I go back to the expert group on vitamins and minerals, which predates the agency. The developments that were taking place in Europe and the UK—using expert scientific advice to set recommended safety levels for the raft of vitamins and minerals that have come on to the market—have been running hand in hand. The expert group's report, which was published earlier this year, raised concerns about the safety levels of certain products. Therefore, on a precautionary basis and in accordance with its duty and remit, the agency will discuss those concerns with the manufacturers.
Does that mean that you would be doing independent scientific research on individual items? Does it also mean that there would not be a blanket ban, as appears to be proposed by Europe, but that any ban would be specific to products that may have a problem?
Yes.
I am trying to clarify the matter. I am not being hostile.
That is okay.
You are operating on the same basis as the Medicines Commission operates, but for different product ranges.
It might be helpful if I say that the way that the expert group operated was that it looked at individual vitamins and minerals in turn and negotiated with and consulted industry and other experts over the five years. It took each one in turn and examined the scientific advice that was available. My colleague may be able to help me on that point.
The expert group considered as much evidence as it could on each vitamin and mineral. That evidence is presented in its report. As has been said, where concerns have been raised over particular vitamins and minerals, we will meet manufacturers shortly to discuss the concerns and the measures that we can take in the interim before the EU proposes to set limits. Where there are concerns about public health, we will have discussions on the specific limits that are available for those particular vitamins and minerals.
The limits are possibly going to be different from those in other countries, as you are using UK-based evidence and UK-based population requirements.
The evidence considered would be internationally based. The report lists the evidence that was considered for each vitamin and mineral. Our report will be used in the UK's negotiations when it comes to discussions on vitamins and minerals. Some other member states have set up similar groups to present evidence on the matter; however, that is not a requirement and not all member states have done so. As was mentioned earlier, the Scientific Committee on Food considered a number of vitamins and minerals, but now that that committee no longer exists a new scientific panel of the European Food Safety Authority will continue with the rest of the considerations. Once those are complete, the Commission will be in a position to draw up proposals for maximum limits, which will involve a whole new set of negotiations.
Could you move your microphone slightly? You have a very gentle voice and we are not used to that. No politicians have gentle voices.
Can I ask a brief question of the minister? We have heard in evidence—
The minister was wanting to speak anyway. Do you want to come in first, minister?
On a point of information for Mr Davidson, it may be helpful if I inform him of the terms of reference of the expert group on vitamins and minerals. There are essentially three parts to its remit. First, the group was to establish principles on which controls for ensuring the safety of vitamin and mineral supplements that are sold under food law can be based. Secondly, the group was to review the levels of individual vitamins and minerals that are associated with adverse health effects. Thirdly, the group was to recommend maximum levels of intakes of vitamins and minerals from supplements, if appropriate. The group's recommendations will, in large part, guide the UK's approach in any future negotiations.
I am grateful for that clarification from the minister, which is the sort of comment that I was hoping to hear. It shows that the Government has a mind of its own and is looking at the issue from a UK perspective.
Several issues impact on that specific area. It would be possible, under a de minimis rule relative to state aid, to provide some assistance to certain small and medium-sized enterprises. However, there is some debate over what the cost of dossiers may be. The figures that have been quoted range from £80,000 to £250,000, but those are industry figures, not Government figures. It is important to remember that there could be issues of market distortion relative to the European Union and the open market if Government aid was made available, depending on how much an individual dossier cost.
Is the Executive worried that this is a first step towards controlling alternative therapies?
We are dealing with a specific directive, and the Executive has not expressed a view on what you suggest.
I am sorry, David, but can we move on? I feel that this is becoming a conversation at the far end of the room.
We consulted on the regulatory impact assessment and we received no information to indicate a specific impact on Scotland.
Should you have received such information?
One can only ask for information, not demand it.
Apart from considering the physical impact of changing food additives, one might consider also the financial implications, as has been suggested by the petitioners. Why was that not done for Scotland?
The consultation was UK-wide. We heard earlier that, although the Consumers Council for the UK responded, the Scottish Consumers Council did not.
So are we to blame it?
Those are your words, convener.
Perhaps we should ask the council why it did not respond.
Again, convener, it is for you, not me, to decide the list of people from whom you take evidence.
I want to ask about positive and negative lists. Is the minister happy with the positive list model as opposed to the negative list model?
My understanding is that there is no negative list. There is a positive list that remains open and can be added to on the production of safety dossiers.
Let me then ask you about what is not on the positive list. Your letter to the committee dated 24 June states:
Scientists tell us that there is no known human deficiency in those three minerals.
That runs counter to evidence that we have heard from people who use food supplements. Some of those products have been used for decades to control epilepsy. Have you any information on that?
That is a medical condition and not one that we would expect people to buy supplements to treat.
Do you not accept that people with conditions such as multiple sclerosis use food supplements to alleviate their condition?
I do not accept that it is appropriate to make claims about what these products can do to cure particular medical conditions. That would be dangerous.
Nobody is making that claim.
I thought that that was what you were saying, but if I misunderstood you, I misunderstood you. It would be dangerous if someone with epilepsy who was being treated by their general practitioner for their condition was adding to their treatment without knowing the effect of combining the treatments.
For the record, I am not saying that food supplements would cure a condition; I am saying that people have found over the decades that certain minerals help to alleviate the symptoms of their condition. Do you dispute that?
It is not for me to dispute that, but my view and, I think, the view of the Executive would be that, if an individual felt that a particular supplement added to the alleviation of a medical condition, they should take advice from their GP.
I think that we have already touched on it, but I was wondering about monitoring. Are mechanisms in place, or planned, to monitor the impact of the regulations locally and nationally, and to consider options—such as financial assistance—for those who might be disadvantaged by implementation of the regulations? It seems that small businesses, especially in Scotland, will be well and truly damaged by the regulations—although I am trying not to look at this from a doctor's point of view.
Dr Turner made two points; I think that I have already addressed the second one on financial assistance. I hope that I explained it earlier.
What about monitoring? Have you thought about how you will approach it and about how you will acquire research evidence?
Research continues in the scientific community on the impacts of different nutrients, minerals and vitamins. That work continues to inform the work of the Food Standards Agency. That has always gone on, and will continue to go on in the future.
Does Lydia Wilkie of the Food Standards Agency have anything to add?
We always welcome new scientific evidence's being brought to our attention. We take such evidence to our expert scientific committees in order for them to take a position on it. Where necessary, we take evidence to Europe for discussions to be held at that level.
So—you have no plans to get involved with consumers to find out about how things develop. It seems that there will be a large number of consumers who will no longer be able to access the products that they have been accessing. Either the products will be changed, or they will have to access them in different ways. It might even mean that they will not get them.
We do not know what the end effect will be. A lot depends on what dossiers are brought forward, on which are accepted and on where the European negotiations go on the various individual levels. Our stance is clear; we will—in order to ensure maximum consumer choice—push for the levels to be set according to the safety levels that have been provided to us.
Some claims have been made this morning about the impacts of the directive on the industry and on the consumer. In line with the answer that has just been given, I would say that such claims are difficult to make at the moment, mainly because negotiations on maximum limits are still to take place. I hope that I have reassured the committee that the UK's approach is guided by the recommendations from the expert group on minerals and vitamins. The utmost will be done to try to restrict any regulations that would restrict trade or consumer choice, as long as that is guided by the overriding principle of consumer safety.
It seems as if you are already restricting choice by accepting the European legislation.
That is not our view. Much has been made of the 300 nutrient sources that are used in the UK and are not on the positive lists. Those sources are mainly different sources of 19 vitamins and minerals that are on the positive list. There has been a fair amount of speculation and allegation with which we do not necessarily agree. Perhaps a parliamentary committee has a job to do—although it is not for me to suggest which committee should monitor the impact of the regulations and inform itself about the claims that have been made.
I return to consultation through the Food Standards Agency. Our previous witnesses' view is that consultation was lacking, but our briefing note says that three tranches of consultation took place in 2000, 2001 and 2002 and involved 1,797 individual consultees. We were told that the Consumers Association in Scotland did not reply to the consultation, but that the UK Consumers Association did. Will the Food Standards Agency confirm that? The Executive's paper says:
I should clarify that we are a UK agency with four distinct arms, including the Food Standards Agency Scotland, which is based in Aberdeen. On such issues and on most food matters, we issue consultations from Aberdeen in order to ensure that we pick up any Scottish nuances and feed them into the UK picture. We also have two Scottish members of our independent board and there is an independent Scottish Food Advisory Committee. The figures are on consultations that were issued in Scotland from the arm of the agency's office that is based in Scotland.
Therefore, you are content that the Scottish perspective was covered adequately in the three consultation phases.
Our list of consultees was as wide as we could make it and was on our website. We make information as open as we can and we are always prepared to go out to speak to groups, which is one reason why we spoke to MSPs earlier this year.
I ask the minister to clarify his answer about nutrients. Much of the correspondence that we have received from individuals and businesses has said that about 300 nutrients will no longer be available, but the minister gave the impression that the nutrient sources will not be available. How many nutrients are not on the positive list?
The concise answer is that six minerals are missing. The 300 nutrient sources that have been mentioned are mainly different sources of 19 vitamins and minerals that are on the positive list. I am sure that that is pretty confusing, but the point is important.
That clarifies the matter.
Lydia Wilkie said that she spoke about the directive to MSPs earlier this year. Was that evidence to the then European Committee? We are a new Health Committee, but to the best of my knowledge, our predecessor committee did not take evidence on the issue. Is that correct?
The Food Standards Agency and ministers provided evidence to the then European Committee. I was referring to a letter—which we issued to all MSPs following the elections—that gave a factual briefing on the directive. We received a reasonable response at the time.
With respect, I would not say that sending a letter that would have come in with a batch of others soon after the election means that you "spoke to MSPs".
A specific briefing session for MSPs was held in the past week or so.
Fine—I was seeking clarification.
With the greatest respect, I disagree with you on your first point about committees of the Parliament being railroaded.
I said that that was a personal view.
Yes; we will agree to differ on that.
That will not be the case in relation to herbal medicines.
I am sorry. The FSA will not be the lead negotiator on herbal medicines. The relevant parts of the UK Government that deal with herbal medicines could receive a request from a parliamentary committee to give evidence. However, I stress that, as that particular issue is a reserved matter, it would be for United Kingdom ministers to decide whether they or their civil servants would give evidence.
With respect, my point is that the committee could be part of the consultation procedure. I understand the point about reserved and devolved matters, but committees of this Parliament should—as part of the consultation procedure—be involved earlier. Do you agree that they should give a view, if there is a Scottish dimension that could be absorbed or otherwise or taken in in part by UK ministers?
The consultations are now regularly placed on the worldwide web so that people from round the globe can view them and comment if they so choose. I am sure that the clerks to this or any other parliamentary committee would, if they felt that it was appropriate, bring a consultation to the notice of members and invite them to consider whether they want to make a response.
I was pushing you on the issue because you have responsibility for health matters in Scotland, which are fully devolved. In those circumstances, I would have thought that when a directive impacts on health matters—as this one has and as will the next one, on herbal remedies—you would be a prime mover on the issue and might want to bring the matter before the committees in order to assist you.
You tread a dangerous line—far be it from me or any other minister to suggest what the work programme of this or any other committee should be.
That is not what I was suggesting. It might be of interest to you to pursue the issue of herbal remedies along a line that conjoins with ours—there is an issue that requires to be addressed.
Convener, may I interrupt this private conversation? This is meant to be an evidence session for the committee, not a discussion between the convener and the minister.
With respect, Mr Rumbles, the discussion reflects the subject that we are moving on to, which is consideration of European legislation.
You seem to be making statements that represent the views of the committee, but they do not.
I beg your pardon. I stated at the beginning of the discussion of this point that I am expressing a personal view. I think that you will accept that; it is on the record. I am pursuing in my questioning the issues that come before the committee, although I am expressing personal views.
I think that I have made my point about how such consultations are brought to the attention of a wide audience in this day and age. All consultations are also forwarded to the Scottish Parliament information centre. I am sure that the clerks of this and other committees will consider that information and decide whether they wish to discuss the matter with the relevant politicians.
The evidence that you and the FSA have given this morning suggests that a lot of work is being carried out, although we are nowhere near receiving any outcomes. Indeed, we have heard that products are being considered individually and so on. Did the Scottish Executive appeal to Europe for more time to consider the matter, given that work had already been commissioned in Scotland and was, I presume, being co-ordinated throughout the UK? It appears to be the case that Government bodies and agencies are working to establish where we need to go on the matter and what the safety issues are, but the European directive has, in effect, railroaded the Executive into an early decision before it has reached any conclusions. Can any evidence be sent to Europe on that basis?
With respect, I disagree again: we have not been railroaded in any way, shape or form. At the start of this evidence session I mentioned some of the very significant derogations that we had achieved. For example, some of the timelines for implementation in relation to the submission of safety dossiers, and the final timeline for maximum implementation of the directive were a result of the negotiations that the UK delegation pursued.
Does that mean that the work that is being carried out by the FSA has almost been discounted in Europe?
No, I would say that the exact opposite is the case. The FSA has played a very important and full part in the UK negotiating team and has managed to secure the derogations.
But we are still where we are.
As far as the directive is concerned, we might not have secured the derogations and timelines that we have secured had the FSA—on behalf of the UK—not made certain representations.
I agree with the minister. The European Committee flagged up the issue more than 18 months ago, which has given the public a lot of time to become involved. After all, we are now inquiring into the matter and, as the committee knows, I have done some in-depth work on the subject.
Yes. It has already been made clear that negotiations on maximum limits have still to take place. I mentioned earlier that the UK's position will be pushed on the basis of public safety, minimum restriction on trade and maximum consumer choice. Some of the current speculation, on, for example, the maximum levels of vitamin C does not reflect the UK's position, which is that 1,000mg is acceptable. I know that some people have alleged that the eventual figure will be much lower than that; however, that will be our negotiating stance on this particular issue.
How might the committee play a role in that process? I am very heartened that the minister appears to be taking on board the concerns of the people of Scotland on the matter. However, you said earlier that it was not up to you to determine which monitoring committee ought to examine the impact of the directive. Will you expand on that important comment? After all, Parliament's committees have a monitoring role.
Again, I stress strongly that it is not for me to suggest how the committee should go about its business. However, both the committee and the Executive are aware of the negotiations that will take place on the setting of maximum limits. The Food Standards Agency will play a major part in those negotiations. It is, of course, open to this or any other parliamentary committee to invite the people who will be involved in the negotiations to explain the approach that they will take, and perhaps to say what the views of politicians are on the various different approaches that they might wish to be taken during those negotiations.
Thank you—that is helpful. Irrespective of which committee it is, there is a role for a committee of the Parliament to do as you suggest.
It appears that there are no further questions. I wish to ask the committee whether it now wishes to move to the debate, or whether members wish to take further evidence—as is open to the committee—and postpone the debate on the regulations until after the summer recess, which would still be within the stipulated time limits. I think that members will probably have made up their minds on the matter, but I will allow a short debate.
There is little point in delaying further what we are here to do—the regulations are on our agenda for today. The key point is that we are obliged under EU law to implement the directive. The simple question is whether the Executive is doing what it can. Is it using all the derogations that it can? The evidence suggests that it is. If we took more evidence and decided to throw out the regulations, it would simply not be possible to ask the Scottish Executive to come up with better ones. There is absolutely no point in delaying what we are doing; we must really get on with it.
I disagree fundamentally with that. I do not think that we have done justice to the directive. There is an issue of credibility for the Health Committee: our role is to scrutinise adequately and to report on the health impacts of the regulations. Our role is not to tie ourselves up with the technicalities. I do not think that we have given the matter adequate scrutiny and I do not think that we have done our job.
I spoke to you before the meeting, convener, about the fact that some of the papers came into my possession only this morning, which did not give me an opportunity to look at them carefully or—had it been necessary—to carry out any research, follow-up library work and so on. I do not think that the committee should be seen to be operating in that way. In the first session of Parliament, committees had cut-off lines for information, which only in an emergency did not apply. As the regulations are very important and will affect preparations that are used by a large—and increasing—number of people, and because there is a lack of evidence of their harm, I think that we need to consider the matter more carefully.
We have a number of roles as politicians. We have the role of passing legislation and we have the role of monitoring legislation. We also have the role of listening to what the public are saying. We have a duty this morning to ensure that we do not raise public expectations to the extent that we cannot deliver on them. We must take that on board.
I support Helen Eadie's view. We have a responsibility to be honest with people when they challenge us on our role. We are in a difficult situation and we have no right to raise people's expectations. As Helen said, we must be honest. However, I take comfort from the remarks of the minister and of the representatives of the Food Standards Agency. We can commit ourselves to continuing to look into the differences between the different sets of evidence that we have heard this morning.
I agree. I do not like the directive; personally, I am very much in favour of food supplements. However, if we decide to take more evidence and to continue discussions until after the summer recess, we will be misleading people and putting individuals and organisations to some bother and expense—through their putting together submissions and coming here to give more evidence—when we know that we are obliged to implement the directive. That would not be fair; rather, it would be patronising and unhelpful. We have to decide today, one way or the other.
Speaking as an individual and not on behalf of the committee, I do not think that there is a conflict between the inevitability of the implementation of the directive and our taking further evidence. Our doing so would not raise expectations; it would allow us to comment on the health issues that arise from the directive, which is within our remit. Whether that would be procedurally competent is another matter, but I feel that it would be possible for us to do both things. The petitioners and others are well aware that the directive is inevitable, but the Parliament, through this committee, may want to comment on the health implications. I do not think that there is a conflict.
I agree, convener. I am new to the Parliament and the committee and it astonished me that we were to have a say on what seemed to be a foregone conclusion. There was very little time in which to gather good evidence and do good research. My background is as a doctor, and I would like to have delved into many matters and spoken to an awful lot more people. We do not seem to be listening to our constituents. Why are we here?
After I call Janis Hughes, I will not call anyone else to speak, as we will all have had our say.
I agree with some of Jean Turner's comments, but I disagree with the suggestion that we would not raise expectations by pursuing the matter. We must acknowledge that the regulations are intended to implement a European directive, which was not made in this Parliament. I say with all due respect to Jean Turner that she talked about our scrutiny of and full investigation into legislation, but that relates to legislation that is initiated by this Parliament. The regulations implement European legislation and we are being asked to consider whether the Scottish Executive has complied with the European legislation.
I thank everybody for their interesting comments. I suggest that Mike Rumbles should make a formal proposal.
I am keen for us to stick to procedures. I do not advocate changing the agenda—that is what other people advocate. Agenda item 1 is evidence on food supplements, which we have heard, and item 2 is Shona Robison's motion that nothing further be done, which we are supposed to debate and then agree or disagree to. I thought that that was what we would do.
The committee has the right to decide whether to continue the debate. We have been informed of the procedural options. To be clear about what we are doing, I seek a formal proposal from someone who supports the idea that we should take no further evidence and move straight to the debate. Will you make such a proposal?
I am happy to make that proposal, if that is what you would prefer. I just want to get on with the debate. The proposal would be that we should take no further evidence on the regulations and do what we are expected to do, which is to recommend that Parliament should implement the regulations. Everybody in the room has problems with the regulations, but we cannot do anything practical about them. We should get on with the debate.
We have a motion to annul the regulations, so we must debate that, if Shona Robison insists on it.
Shona Robison might not move her motion.
Does Shona Robison want to reserve her position or make a decision now?
We should debate the motion.
In that case, the proposal must be decided on.
I still do not understand. If Shona Robison wants to continue with agenda item 2, surely we must proceed with it—the situation is as simple as that.
It is open to Shona Robison to postpone the debate on the motion.
I do not know how we have managed to become so tied up. I understood that we would decide first whether to have the debate now or after the summer and I do not see why we cannot take that decision.
That is the point of the proposal, which I would be happy for someone to put.
I am happy to propose that we take no further evidence and stick to the agenda.
The question is, that the committee agrees to take no further evidence on the Food Supplements (Scotland) Regulations 2003 and to move to item 2. Are we agreed?
No.
There will be a division
For
The result of the division is: For 5, Against 4, Abstentions 0.
I am sure that members will not want me to go over exactly the same arguments that we have heard all morning, and I will try not to do so.
On a point of clarification, I did not say that people would feel patronised if we asked them to give more evidence. I said that it would be patronising of us to do that.
If a thing is patronising, someone has to feel patronised.
That the Health Committee recommends that nothing further be done under the Food Supplements (Scotland) Regulations 2003 (SSI 2003/278).
Thank you. Whom were you quoting?
John Home Robertson.
Helen Eadie will be the first to speak in the open debate after the minister has responded, then David Davidson will be able to pitch in.
I will be brief. I have listened to the comments that have been made on the committee's approach. I hope that, both this morning and beforehand, the committee will have taken cognisance of the view that there is a danger and a difficulty in reopening the negotiations. If the committee feels strongly that the industry is being disadvantaged by the regulations as they stand—I am not necessarily saying that that is the case—our advice is that there is a danger that reopening the negotiations might further disadvantage the industry. I have already tried to stress that the negotiations were very difficult and that the United Kingdom's view on how to approach the issue was not in the ascendancy. That should indicate to members that reopening the negotiations would present a danger.
I was not here last week, but I know from my work on the previous session's European Committee that the Executive was advised that simply ignoring the directive was not an option, as we have an obligation to transpose and implement its provisions. We must also bear in mind the fact that if Scotland failed to transpose the directive, the UK would have the right to do that in any case, which would mean that we would not have a basis for taking the matter forward.
I remind the committee that, as a pharmacist, I am committed professionally to patient safety and consumer care. Those are the issues on which we need to focus this morning.
Should you not have made a declaration of interest at the beginning?
I have made all my declarations. I am not a practising pharmacist, so I am not involved. I have some expertise, albeit a bit faded.
Like the rest of us.
We are dealing with a measure that would create consumer disadvantage and that is not backed up by evidence. It would remove choice, but there is no evidence before us about safety. We have heard that again this morning. There is no reason for the legislation to be agreed to now, because research is still under way. The minister said that safety levels are not set. We expect to have that sort of information before we agree to any piece of legislation, regardless of whether it is a member's bill, an Executive bill or legislation from Europe.
I listened carefully to what David Davidson said. His line sounds like his line last week, when he was the only Health Committee member to oppose the Food Protection (Emergency Prohibitions) (Amnesic Shellfish Poisoning) (Orkney) (Scotland) Order 2003, on which he forced a vote in the chamber. He takes the same view about the regulations.
No.
That is not really the debate.
Unless I misunderstood him, that is what David Davidson was saying.
I support most of that. We are debating Shona Robison's motion, which says:
Speaking once more as an individual member, I say that I am not posturing. I have serious concerns about—
You are not moving the motion.
As a member of the committee, I support Shona Robison because I am not satisfied that I have had the opportunity to consider the health implications. Mike Rumbles is right to say that there is no debate about the legal procedures, but there are other issues that this committee could address. Those were perhaps lost in my previous submissions about why I want to take more evidence.
I will be brief because, when I spoke to Shona Robison, I summarised many of the points that have been made around the table.
Do you want to respond to any other points that were made? This is a debate and you are summing up for the Executive.
Mr Davidson made a point about the levels in the UK differing from the levels that apply across the European Union. We have an open and regulated market. That sort of arrangement would contradict the rationale behind having an open and regulated market. I have already made the point strongly that negotiations will take place about the maximum permitted levels.
I call Shona Robison to sum up.
Mike Rumbles made an interesting comment. He said that we have to show that we are "doing our duty" in relation to our European responsibilities. I think that our role should be to do our duty by the Scottish public and to listen to their concerns first and foremost. I do not think that the Scottish public will understand the concept of passing potentially bad law into Scots law for technical reasons. I do not think that they will get that at all and I can see why they would not, because it seems bizarre.
The question is, that motion S2M-118, in the name of Shona Robison, that the Health Committee recommends that nothing further be done under the Food Supplements (Scotland) Regulations 2003 (SSI 2003/278), be agreed to. Are we agreed?
No.
There will be a division.
For
The result of the division is: For 4, Against 5, Abstentions 0.
Motion disagreed to.
I thank the minister for his contribution, and committee members for their robust contributions, which, I am sure, will continue.
I hope that they do.