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We have not been resting on our laurels since the consultation exercise; a significant amount of work has been done. I realise that my hon. Friend and others who have campaigned in favour of fortification would like to see faster progressparticularly organisations such as the Association for Spina Bifida and Hydrocephalus.
Let me record the Department's apology to ASBAH for the delays in answers to correspondence. Although those oversights are regrettable, I hope that I can reassure my hon. Friend that they were purely administrative, and not due to an unwillingness to communicate. No doubt it will be appreciated that the issue is complex, and that the universal fortification of any foodmainly bread, in this caseis a major public health issue that requires the fullest consultation and consideration.
As my hon. Friend said, during the 1960s it was suggested that the risk of a woman's bearing a child with a neural tube defect might be affected by her intake of the vitamin folate. In 1991, definitive evidence was established in a trial by the Medical Research Council which showed that supplementation with folic acidthe artificial form of the naturally occurring vitamin folatesignificantly reduced the risk of NTDs in women who had already been through a pregnancy affected by NTD.
Following that, the then Government initially issued guidance about supplementation with 5 mg of folic acid to prevent the recurrence of NTDs. The guidance was then expanded to cover the prevention of first-time NTDs, with the recommendation that all women planning pregnancies should take 400 mg as a daily dietary supplement from the time when they began trying to conceive until the 12th week of pregnancy. They were also advised to consume folate-rich foods.
In 1995, the Health Education Authority began a nationally integrated campaign aimed at increasing the average daily intake of folate and folic acid. The key objectives were to increase awareness of the importance of additional folic acid before conception and 12 weeks into pregnancy in the general female population and in health professionals, to encourage fortification to increase the availability of fortified breads and breakfast cereals, and to make fortified products easily identifiable by promoting the use of a logothe folic-acid flashto highlight foods rich in folic acid.
As my hon. Friend suggested, the campaign achieved some success. Spontaneous, unprompted awareness among women increased from 9 per cent. in 1995 to 49 per cent. in 1998, and prompted awareness rose from 51 per cent. to 89 per cent. The percentage of women claiming to take folic acid when trying for a baby had also risen from 24 to 38 per cent.
As my hon. Friend said, although the campaign was generally successful, it had its limitations, as about half of all pregnancies in the United Kingdom are unplanned. Moreover, by the time that a woman knows that she is pregnant it may be too late for folic acid to be effective. Reaching those women remains a challenge. That is why there have been calls for food fortification.
The Department asked its advisory committeethe Committee on Medical Aspects of Food Policyto consider the dietary intakes and nutritional status of the population with regard to folic acid, with particular reference to its contribution to preventing disease, and to make recommendations.
The Government decided to consult on the recommendations in the report, as a number of other options were also outlined. Consultation took place between July and October 2000. Views were sought on whether universal fortification of bread or flour was desirable, whether any such fortification should be mandatory or voluntary, and the practicalities of fortification. That consultation also sought views on wider issues, such as the impact of the recommendations on consumers and consumer choice, food labelling and technical issues for the industry.
A summary of responses to the fortification consultation was posted on the Department of Health website in July 2001. There were 167 respondents to the consultation, including people from academia, consumer and expert groups, trade organisations and individual companies, health authorities, local government and individuals.
The consultation was complex, and the responses raised a number of issues. Although the majority of respondents59 per cent.were in favour of fortification, that was not overwhelming. The most common concerns expressed were about the potential risks of fortification, especially the risk of vitamin B12 deficiency among older adults. A significant number felt that sufficient information was still not available about the possible adverse effects.
Other concerns were about the possible restriction of consumer choice. Almost 80 per cent. of respondents felt that it was important to maintain an element of consumer choice. Another issue was how fortification would be managed, and 85 per cent. felt that there should be restrictions on the level of fortification or the types of foods fortified. Respondents from industry also stated that technical problems may be associated with any mandatory policy.
As with any public health policy, we need to balance benefits against risks. Although the benefits for women of child-bearing age are well established, it is clear that in the opinion of many the potential risks, particularly the risk of B12 deficiency in older people, are not. Therefore, the Government did not feel that it was right to make a decision without further work on this and other issues. I shall explain what we have done in the intervening period and the stage we are at now.
It is known that high levels of folic acid can make it difficult to diagnose vitamin B12 deficiency. Severe deficiency of vitamin B12 has two main effects: it can cause anaemia identical to that of folate deficiency; and, with prolonged deficiency, it can cause damage to the nerves and the spinal cord, leading to severe disability. The anaemia usually appears first, and thus allows early detection of vitamin B12 deficiency before any nerve damage occurs. Older adults are at greatest risk of B12 deficiency as they are less able to absorb the vitamin from foods. There is, therefore, concern that increased
The level of fortification suggested by COMA, at 240 micrograms per 100 g, was designed to minimise the number of older people at risk of having high intakes of folic acid. COMA estimated that approximately 0.6 to 1 per cent. of older people could have intakes of folate high enough to mask B12 deficiency if all flour was fortified. However, information on the true prevalence of B12 deficiency was unknown at the time of the consultation, and it is only with that information that we can estimate how many individuals could be at risk of B12 deficiency. I am pleased to say that research on the prevalence of B12 deficiency and its diagnosis among adults over 65 years of age was commissioned by the Department and has now been completed. The work addressed the prevalence of vitamin B12 deficiency in older people, the most appropriate methods to diagnose it, and the feasibility of its routine identification in older people.
That research is awaiting publication and, as a result, I am unable to release exact details of the findings. However, the results are in line with COMA in as much as that fortification would increase the risk of B12 deficiency among a significant number of older adults. To make full sense of the findings on the prevalence of B12 deficiency, a cost-benefit analysis has been carried out by the Department of Health.
Preserving consumer choice was a significant issue for many peoplealmost 80 per cent. of respondents. Many responses suggested various options for certain types of bread which could remain unfortified. The Food Standards Agency therefore undertook some statistical modelling to look at consumption patterns and what effect those various options might have on folate intakes. The agency has also been addressing other issues of particular concern to consumers, such as the labelling of fortified foods.
Issues have also been raised on the technical aspects of fortification which need consideration. Many responses from industry pointed to the complexity of the technical processes. Folate added to flour is lost to some extent during processing. The amount lost is known to vary substantially between products and, as a result, it could be difficult to achieve a specified target amount in foods
In addition, the Food Standards Agency has assessed various legal aspects of fortification. Those include the public health justification under article 30 of the EC treaty; the terms of the notification under the treaty to the European Commission and member states; the use of powers under the Food Safety Act 1990 to control fortification levels; and issues under the Human Rights Act 1998, relating in particular to consumer choice.
The information gathered from that extra work has now been collated and is being considered. As my hon. Friend may know, that has been a UK-wide exercise carried out jointly between the Health Departments and the Food Standards Agency. Ministers from all the UK Health Departments will therefore need to consider the issue. As part of that, there will also be a formal recommendation from the Food Standards Agency board to Health Ministers. My hon. Friend may be reassured to learn that I understand that the Food Standards Agency board will discuss its possible recommendation at a meeting in the new year.
I hope that I have reassured Members, especially my hon. Friend, that we have been taking the issue seriously and have considered the issues in great depth. I am sure that hon. Members will agree that the issue is complex and it is important to make the right decision on a fortification that could have wide-ranging implications, both beneficial ones and ones that should provoke further consideration.
I remind Members that we continue to encourage women planning to become pregnant to increase their folate intake, including the use of supplements. We also support the folic acid flash scheme which helps consumers to identify foods that have been fortified with folic acid. I am pleased that we have had the opportunity this evening to address the issues, to allow the Government to lay out the action that has been taken and to reassure my hon. Friend that we take the issue very seriously.