Dear Ms Smith, Linda Smith Assistant Clerk to the Public Health Petitions Committee TG.01 EDINBURGH EH99 1SP

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1 Linda Smith Assistant Clerk to the Public Health Petitions Committee TG.01 EDINBURGH EH99 1SP 7 th September 2009 Our reference: FSA OR 897 Dear Ms Smith, RE: Consideration of Petition PE1259 Thank you for your letter to Dr George Paterson dated 18 June As the recently appointed Director of the Food Standards Agency in Scotland (FSAS), I am pleased to reply to your letter and welcome the chance to respond to petition PE1259. Current FSA and UK Government recommendations for dietary vitamin D intakes, supplementation and fortification are based on the 1991 Committee on Medical Aspects of Food Policy report Dietary Reference Values for Food Energy and Nutrients for the United Kingdom 1, the 2007 Update on Vitamin D- Position Statement by the Scientific Advisory Committee on Nutrition (SACN) 2 and the findings of the 2003 Report of the Expert Group on Vitamins and Minerals (EVM) 3. Further information on FSAS, SACN and EVM is included in Annex 2. In 2007, SACN stated that currently available data was insufficient to clarify relationships between biochemical vitamin D status and chronic disease outcomes, and that further risk assessment of vitamin D supplementation and fortification would be warranted when additional evidence had become available. FSA have commissioned several studies, one of which is based in Aberdeen (project code N05062), to clarify uncertainties in the evidence base on vitamin D. The results of the research will be discussed by invited experts, including UK Health Departments and Directorates and SACN representatives, at an FSA workshop in November This research will be used together with other emerging evidence if SACN undertake further review of vitamin D recommendations in future. Vitamin D Vitamin D is primarily obtained by synthesis in the skin on exposure to sunlight. Synthesis occurs between April and September in the UK and vitamin D is stored in body fat until it is required. In 2007, SACN noted that it is important to clearly state the requirement for sunlight exposure required for vitamin D synthesis, so that adequate stores of vitamin D could be achieved during the summer months and risk of sun damage to skin could be avoided 2. There is no risk of toxicity from vitamin D created from sunlight as manufacture by the skin is tightly controlled by the body s internal mechanisms. Most people should be able to get enough vitamin D from sun exposure. Vitamin D is found in a few foods, such as oily fish, fortified margarines and some fortified breakfast cereals. There are smaller amounts in red meat and egg yolk. Turning to the specific questions asked of FSAS, it is necessary to first distinguish between dietary supplements and food fortification. Vitamin D supplementation refers to vitamin D taken by individuals (as pills, tablets or capsules) to increase their vitamin D intake. Vitamin D fortification is where vitamin D is added to specific foods to increase their nutritional value.

2 Vitamin D supplementation 1) What is the current advice regarding vitamin D supplements to food? Is this likely to change? Current UK government policy recommends dietary supplements of vitamin D to a limited number of population subgroups that may be at risk of vitamin D deficiency: 10 µg (micrograms) per day for pregnant and breast-feeding women; to ensure their requirement for vitamin D is met and to build adequate fetal stores for early infancy; µg per day for children up to the age of five years; supplementation is recommended for all children under 5 years to safeguard infant health; 10 µg vitamin D per day for people aged over 65 years or confined indoors, particularly for vulnerable may have limited exposure to sunlight or wear concealing clothing. In 2007, SACN recommended that a clear public health strategy and guidance on vitamin D supplementation be implemented to overcome poor understanding and advice surrounding vitamin D supplements among health professionals and at risk groups of the population 2. The lead for this work would lie with the Scottish Government Chief Medical Officer and Public Health Directorate. Based on the current evidence, we cannot recommend any changes to the current policy on vitamin D supplementation. Governments would make further policy decisions based on any new evidence and advice from a SACN review. Vitamin D fortification 2) Does it (FSAS) think that vitamin D should be added to more food products (such as milk)? If not, why not? In the UK, fortification of margarine with vitamin D (and A) is mandatory. According to The Spreadable Fats, Milk and Milk Products (Scotland) Regulations 2008 (SSI 2008 No. 216) 4, any margarine sold by retail must contain no less than 7.05 µg and no more than 8.82 µg of vitamin D in every 100 g end product. Vitamin D is also mandated as part of the compositional criteria of infant formula and follow-on formula: 1 to 2.5 µg per 100 kcal in infant formula. These criteria are set out in accordance with The Infant Formula and Follow-on Formula (Scotland) Regulations which implements European Commission Directive 2006/141/EC 6. Vitamin D can be added voluntarily to foods in accordance with European Regulation (EC) 1925/2006 on the addition of vitamins and minerals and of certain other substances to food. Foods which are voluntarily fortified are required to provide mandatory nutrition labelling, including the total amounts of the vitamins and minerals with which the food has been fortified. In Finland, where milk is fortified with vitamin D, studies have shown that fortification safely improved the vitamin D status of children. However, fortification could pose the risk of vitamin D toxicity in some groups of the population. For example, in the USA, it was reported that inadvertent over-fortification of milk with vitamin D had led to cases of vitamin D poisoning 2. In 2003, EVM concluded that, for guidance purposes only, a level of 25 µg/day supplementary vitamin D would not be expected to cause adverse effects in the general population when consumed regularly over a long period 3.

3 SACN did not make any recommendation on voluntary fortification of foods with vitamin D. FSAS cannot recommend mandatory fortification of a wider range of foods without careful assessment of the effects on the population. In summary Advice from the FSA in Scotland is based on recommendations from our relevant Expert Scientific Advisory Committees, SACN and EVM. As such, we cannot presently recommend additional mandatory fortification of foods with Vitamin D. Vitamin D supplements are already recommended for vulnerable groups, including pregnant women and children up to age five years. It is important that healthcare professionals are aware of the guidance on vitamin D supplementation for vulnerable groups, so that deficiency can be avoided. Ongoing FSA funded research will assist SACN when undertaking a further review of vitamin D recommendations when sufficient new evidence becomes available. Thank you again for the opportunity to comment on this petition. I hope that our response has addressed the specific issues you raised in your letter, but should you require any clarification or any further information, please do not hesitate to contact me. Yours sincerely, Professor Charles Milne Director, Scotland Cc: Fergus Millan, Scottish Government Anne Corbett, Scottish Government Elaine Stone, Food Standards Agency

4 Annex 1 References 1 DoH (UK Department of Health), 1991, Dietary Reference Values for Food Energy and Nutrients for the United Kingdom: Report of the Panel on Dietary Reference Values of the Committee on Medical Aspects of Food Policy, 1 st Edition, The Stationary Office, Norwich 2 SACN, 2007, Update on vitamin D- Position Statement by the Scientific Advisory Committee on Nutrition, 3 EVM, 2003, Safe Upper Levels for Vitamins and Minerals- Report of the Expert Group on Vitamins and Minerals, 4 Spreadable Fats, Milk and Milk Products (Scotland) Regulations The Infant Formula and Follow-on Formula (Scotland) Regulations Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC Text with EEA relevance

5 Annex 2- The role of the FSA in Scotland, the Scientific Advisory Committee on Nutrition and the Expert Group on Vitamins and Minerals The Food Standards Agency is an independent, non-ministerial Government department set up by an Act of Parliament in 2000 to protect the public's health and consumer interests in relation to food. We are governed by a Board appointed to act in the public interest, with the task of protecting consumers in relation to food. We are a UK-wide body with our main offices in London, Aberdeen, Cardiff, Belfast and York, employing over 2000 staff. Our 2008/09 budget was 162 million (for 2008/09), of which 10.6 million was spent in Scotland. We are accountable to the Westminster Parliament through the Secretary of State for Health and to the Scottish Parliament, Welsh Assembly Government and the Northern Ireland administration through their health ministers or equivalent. Food safety and standards are devolved matters and each of our offices in the devolved countries are headed by a Director who is directly accountable to our Chief Executive. The Agency s core values are key to our success and these will continue within our new strategy Our core values are: putting the consumer first openness independence science and evidence-based The Agency has a unique role and contributes to UK-wide food policy. The work of the Agency in Scotland reflects the different priorities and arrangements in Scotland and the Agency as a whole works closely with the four Governments in order that local needs are met within a wider UK strategic framework. The FSA is committed to providing evidence-based advice and our recommendations are based on work undertaken by our Expert Scientific Advisory Committees; in the case of vitamin D, the relevant committees are the Scientific Advisory Committee on Nutrition and the Expert Group on Vitamins and Minerals. The Scientific Advisory Committee on Nutrition (SACN) is a UK-wide Scientific Advisory Committee which was set up in 2001 to replace the Committee on Medical Aspects of Food and Nutrition Policy (COMA). It advises the UK Health Departments and Directorates as well as the FSA and its remit includes the nutrient content of individual foods, advice on diet and the nutritional status of people. The Expert Group on Vitamins and Minerals (EVM) was set up in 1998, solely to evaluate the safety of all the vitamins and minerals essential to health plus those currently available as food supplements or used in fortified foods. The group carried out a detailed toxicological review, including thorough risk assessments, with particular reference to safety for long-term use. The terms of reference were to establish principles on which controls for ensuring the safety of vitamin and mineral supplements sold under food law can be based; to review the levels of individual vitamins and minerals associated with adverse effects; to recommend maximum levels of intakes of vitamins and minerals from supplements; to advise on the levels of vitamins and minerals in fortified foods. As part of a UK-wide organisation, the Food Standards Agency in Scotland has access to the advice from SACN and EVM.