In June this year the Government held an informal consultation in order to seek views on possible additions to the exemptions currently allowed under the Bread and Flour Regulations 1998 from the requirement to fortify flour with calcium, iron, niacin, and thiamine. The exemptions that were envisaged would allow more efficient and streamlined manufacturing operations for foods produced for export as well as for the home market, without compromising the public health benefits which accrue from fortification. A range of interested parties were consulted including millers, flour users, retailers, fortificant manufacturers and health professionals.

The options proposed in the consultation would allow millers to produce unfortified flour in England when used as a secondary ingredient which undergoes further processing, or is used in relatively small quantities in products. This approach was welcomed by most consultees and the Government is now considering how to take this forward.

The Department of Health and Public Health England has considered the proposals and concluded that it is unlikely that an exemption from fortification for flour used in such products will have a nutritionally significant impact on the intakes of calcium, iron, thiamine or niacin.

The changes proposed would apply to England only since food legislation is a devolved matter. The devolved administrations are aware of these proposals but have not yet made any decisions on whether to introduce similar changes.

Respondents to the consultation also asked for some additional flexibility around the point at which the fortificants are added to flour. At the moment flour must be fortified at the mill and the four fortificants are added as a premix at the end of the milling process. Many businesses which manufacture foods both for the home market and for export requested the flexibility to be able to add the fortificants at the bakery stage. They highlighted that the requirement for separate storage and handling for, both fortified and unfortified flour (which is used for exported products) was creating significant manufacturing complexities. That resulted in a more restricted product range and is having an adverse effect on their export potential and their ability to diversify into new global markets. The Government is currently considering this.

In June this year the Government held an informal consultation in order to seek views on possible additions to the exemptions currently allowed under the Bread and Flour Regulations 1998 from the requirement to fortify flour with calcium, iron, niacin, and thiamine. The exemptions that were envisaged would allow more efficient and streamlined manufacturing operations for foods produced for export as well as for the home market, without compromising the public health benefits which accrue from fortification. A range of interested parties were consulted including millers, flour users, retailers, fortificant manufacturers and health professionals.

The options proposed in the consultation would allow millers to produce unfortified flour in England when used as a secondary ingredient which undergoes further processing, or is used in relatively small quantities in products. This approach was welcomed by most consultees and the Government is now considering how to take this forward.

The Department of Health and Public Health England has considered the proposals and concluded that it is unlikely that an exemption from fortification for flour used in such products will have a nutritionally significant impact on the intakes of calcium, iron, thiamine or niacin.

The changes proposed would apply to England only since food legislation is a devolved matter. The devolved administrations are aware of these proposals but have not yet made any decisions on whether to introduce similar changes.

Respondents to the consultation also asked for some additional flexibility around the point at which the fortificants are added to flour. At the moment flour must be fortified at the mill and the four fortificants are added as a premix at the end of the milling process. Many businesses which manufacture foods both for the home market and for export requested the flexibility to be able to add the fortificants at the bakery stage. They highlighted that the requirement for separate storage and handling for, both fortified and unfortified flour (which is used for exported products) was creating significant manufacturing complexities. That resulted in a more restricted product range and is having an adverse effect on their export potential and their ability to diversify into new global markets. The Government is currently considering this.

In June this year the Government held an informal consultation in order to seek views on possible additions to the exemptions currently allowed under the Bread and Flour Regulations 1998 from the requirement to fortify flour with calcium, iron, niacin, and thiamine. The exemptions that were envisaged would allow more efficient and streamlined manufacturing operations for foods produced for export as well as for the home market, without compromising the public health benefits which accrue from fortification. A range of interested parties were consulted including millers, flour users, retailers, fortificant manufacturers and health professionals.

The options proposed in the consultation would allow millers to produce unfortified flour in England when used as a secondary ingredient which undergoes further processing, or is used in relatively small quantities in products. This approach was welcomed by most consultees and the Government is now considering how to take this forward.

The Department of Health and Public Health England has considered the proposals and concluded that it is unlikely that an exemption from fortification for flour used in such products will have a nutritionally significant impact on the intakes of calcium, iron, thiamine or niacin.

The changes proposed would apply to England only since food legislation is a devolved matter. The devolved administrations are aware of these proposals but have not yet made any decisions on whether to introduce similar changes.

Respondents to the consultation also asked for some additional flexibility around the point at which the fortificants are added to flour. At the moment flour must be fortified at the mill and the four fortificants are added as a premix at the end of the milling process. Many businesses which manufacture foods both for the home market and for export requested the flexibility to be able to add the fortificants at the bakery stage. They highlighted that the requirement for separate storage and handling for, both fortified and unfortified flour (which is used for exported products) was creating significant manufacturing complexities. That resulted in a more restricted product range and is having an adverse effect on their export potential and their ability to diversify into new global markets. The Government is currently considering this.

In June this year the Government held an informal consultation in order to seek views on possible additions to the exemptions currently allowed under the Bread and Flour Regulations 1998 from the requirement to fortify flour with calcium, iron, niacin, and thiamine. The exemptions that were envisaged would allow more efficient and streamlined manufacturing operations for foods produced for export as well as for the home market, without compromising the public health benefits which accrue from fortification. A range of interested parties were consulted including millers, flour users, retailers, fortificant manufacturers and health professionals.

The options proposed in the consultation would allow millers to produce unfortified flour in England when used as a secondary ingredient which undergoes further processing, or is used in relatively small quantities in products. This approach was welcomed by most consultees and the Government is now considering how to take this forward.

The Department of Health and Public Health England has considered the proposals and concluded that it is unlikely that an exemption from fortification for flour used in such products will have a nutritionally significant impact on the intakes of calcium, iron, thiamine or niacin.

The changes proposed would apply to England only since food legislation is a devolved matter. The devolved administrations are aware of these proposals but have not yet made any decisions on whether to introduce similar changes.

Respondents to the consultation also asked for some additional flexibility around the point at which the fortificants are added to flour. At the moment flour must be fortified at the mill and the four fortificants are added as a premix at the end of the milling process. Many businesses which manufacture foods both for the home market and for export requested the flexibility to be able to add the fortificants at the bakery stage. They highlighted that the requirement for separate storage and handling for, both fortified and unfortified flour (which is used for exported products) was creating significant manufacturing complexities. That resulted in a more restricted product range and is having an adverse effect on their export potential and their ability to diversify into new global markets. The Government is currently considering this.

Ministers have had a range of discussions or other contact with health ministers in countries that operate a policy of mandatory fortification of flour with folic acid.

In its 2006 report ‘Folate and Disease Prevention’ the Scientific Advisory Committee on Nutrition concluded that overall there was insufficient data in humans to assess the long term effects of exposure to unmetabolised folic acid as a result of the limited capacity of the gut to convert folic acid into methylfolate (or 5-methyl tetrahydrofolic acid).

Ministers have had no discussions with ministers from other countries regarding the United Kingdom policy of mandatory fortification of flour with calcium, iron, niacin and thiamin.

The issue was considered during the 2013 Red Tape Challenge consultation, but an option to exempt flour used at lower levels was not supported by consultees at the time.

The current consultation was prompted by industry concern that new labelling rules introduced at the end of 2014, requiring those added fortificants to be labelled, would place producers at a disadvantage.

Supporting a world-leading UK food industry is a key priority for Government and it is committed to reducing red tape and helping business where it can without compromising public health.

The issue was raised prior to the 2013 decision and an option similar to what is now being proposed was included in the consultation but it was not supported by consultees at the time.

The diagnosis and treatment of pernicious anaemia, the result of a vitamin B12 (cobalamin) deficiency, is well established and reported in the British Committee for Standards in Haematology (BCSH) guidance document, Guidelines for the diagnosis and treatment of Cobalamin and Folate disorders, which was updated in May 2014. A copy of the BCSH guidance document is attached.

The BCSH operates independently of the Department and NHS England and produces evidence based guidelines for both clinical and laboratory haematologists on the diagnosis and treatment of haematological disease, drawing on the advice of expert consultants and clinical scientists practicing in the United Kingdom. It would be for the BCSH, not the Department, to consider whether any adjustments to current best practice, in the diagnosis and treatment of patients with pernicious anaemia were needed, including whether any new or additional tests were appropriate.

The BCSH guidance sets out that cobalamin status is the recommended first line diagnostic test. The Department has no data relating to false positive results in relation to the test. The guidance also states that clinical picture is the most important factor in assessing the significance of the test results.

When anaemia is diagnosed, most patients respond well to treatment through quarterly intramuscular injection of vitamin B12. Whilst some patients with pernicious anaemia might prefer to have more frequent injections, or for other forms of vitamin B12 to be self-administered, these are matters for individual patients to discuss with their general practitioners.

Although the Medicines Healthcare products Regulatory Agency is currently reviewing claims made by some clinics that are administering vitamins and minerals intravenously for nutritional therapy purposes, the agency has not encountered any clinics making claims to treat pernicious anaemia. In addition, the Department does not have any information regarding patients purchasing additional supplies of B12 from unregulated sources.

Regarding the mandatory fortification of flour with folic acid, the Scientific Advisory Committee on Nutrition recommended a number of measures to ensure monitoring and surveillance of the impact of fortification of flour, should it be implemented. This included appropriate systems to monitor any potential adverse effects, including cancer and a review of the evidence on benefits and postulated risks after five years. The National Diet and Nutrition Survey monitors folate intakes and the most recent data, which was published earlier this year, will be carefully considered alongside other information sources before any decision is made on mandatory fortification.

The Department has made no assessment of the social and economic costs of misdiagnosis or late diagnosis of pernicious anaemia and other vitamin B12 deficiencies.

The cost of fortifying flour is borne by the milling industry rather than by central government departments or devolved administrations. It is estimated that, in 2013, UK production of those types of flour which the law requires to be fortified with iron, calcium, thiamine and niacin was approximately 3.5 million tonnes, and the cost to the industry of purchasing the four mandatory fortificants for that tonnage of flour would have been £2.5 million.