Lord Rooker

The UK Government and devolved administrations ran a public consultation on proposals to amend the Bread and Flour Regulations 1998 and the Bread and Flour Regulations (Northern Ireland) 1998 from the 1^st September – 23^rd November 2022. Early analysis suggests Defra received around 369 responses although this is subject to verification checks. Respondents were asked which category of field or role best described the sector they belong to. The initial analysis of this is as follows: approximately 18% identified as belonging to one of the food industry categories (flour miller, premix supplier, retailer, food manufacturer), 1% enforcement authorities, 11% health care professionals, 56% consumers, 11% answered other, and 2% did not answer this question. It should be noted that several of these responses were received from representative trade associations. Detailed analysis and verification of responses is currently underway which may change the numbers above. A summary of responses received, including final figures on respondents and their field/role will be published alongside the government response in due course.

No specific assessment has been made. However, the Government promotes the recommendation to take folic acid supplements to those who could become or are pregnant and other measures to promote good health in the first 1,000 days of life, through the Better Health Start for Life programme and via online National Health Service information.

The Department has engaged with New Zealand and Australia during the development of folic acid fortification policy. The proposed changes to the Bread and Flour Regulations 1998, including the introduction of mandatory fortification of non-wholemeal wheat flour with folic acid, will require notification to the World Trade Organization in respect of Technical Barriers to Trade in advance of any new requirements. When the notification is made, there will be an opportunity for WTO members, including the European Union, to comment on the proposals.

The Department has engaged with New Zealand and Australia during the development of folic acid fortification policy. The proposed changes to the Bread and Flour Regulations 1998, including the introduction of mandatory fortification of non-wholemeal wheat flour with folic acid, will require notification to the World Trade Organization in respect of Technical Barriers to Trade in advance of any new requirements. When the notification is made, there will be an opportunity for WTO members, including the European Union, to comment on the proposals.

Fortification of food with folic acid is voluntary and there is no requirement to notify the Government when it is added or removed from a product. As such, the Government is not aware of any such industry considerations. The rules on fortification under existing legislation requires that where vitamins and minerals are added to food, it must be at a minimum level of 15% of the Nutrient Reference value in Retained Regulation (EU) No. 1169/2011 or 200 micrograms per 100 grams for folic acid.

No specific assessment has been made. The consultation on amending the Bread and Flour Regulations 1998 and the Bread and Flour Regulations (Northern Ireland) 1998 cited research from Germany, as a relevant academic study in the United Kingdom was not available.

The National Diet and Nutrition Survey (NDNS) provides information on dietary intakes and nutritional status for males and females by age group. The latest data from the NDNS 2016 to 2019 shows that dietary intakes of most vitamins are adequate, however there is evidence of low dietary intakes of vitamin D and of some minerals including magnesium, potassium, iodine and selenium. Assessment of nutritional status in the NDNS shows low blood levels for vitamin D and folate across age and sex groups. Low dietary intakes and blood levels of iron are also seen in women and girls.

The NHS Fetal Anomaly Screening Programme aims to detect neural tube defects through the 20-week screening scan rather than a blood sample.

The National Congenital Anomaly and Rare Disease Service collects data for all regions in England and the Crown Dependencies for births from 1 January 2018.

The information is not collected centrally.

This information is not held in the format requested.

There is no specific measure on the effectiveness of advice given to women of child-bearing age planning a pregnancy.

This information is not collected in the format requested. Information on neural tube defects is collected by the number of mentions, rather than number of pregnancies terminated. It is possible for a pregnancy to have multiple neural tube defects. From 2017 to 2021, there were 4,697 mentions of congenital malformations of the nervous system in Ground E abortions for residents of England and Wales. This has remained stable over the last five years, other than a small decline in 2019. Data for 2022 is due to be published in June 2023.

Two neural tube defects, anencephaly and spina bifida, are screened for by the NHS Fetal Anomaly Screening Programme at the 20 week scan. In England and the crown dependencies, there were 752 births with neural tube defects in 2019 and a prevalence of 12.2 births per 10,000 total births.

The National Congenital Anomaly and Rare Disease Registration Service submits data to EUROCAT, the European network of population-based registries for the epidemiological surveillance of congenital anomalies. In 2019, the overall prevalence of neural tube defects for participating full registries across Europe, including full participating regions of England, was 11.36 per 10,000 births.

The information is not collected in the format requested.

Through the National Institute for Health Research (NIHR), the Department funds research into the safety of maternity and neonatal services and the national maternity ambition to halve maternal deaths, stillbirths and neonatal deaths and brain injury by 2025. The NIHR’s Oxford Biomedical Research Centre has supported 19 studies on neural tube defects. The NIHR has also funded a £2.2 million multicentre randomised controlled trial, which included children with neural tube defects, to determine the optimal type of shunt to treat hydrocephalus and reduce infection rates. The NIHR welcomes funding applications for research into any aspect of human health, including research on neural tube birth defects.

The following table shows the number of births and birth prevalence for spina bifida, hydrocephalus and anencephaly caused by neural tube defects in 2018 and 2019. Data prior to 2018 is not available in the format requested. Data for 2020 will be published in December.

Source: The National Congenital Anomaly and Rare Disease Registration Service

Note:

The denominator used to calculate prevalence is obtained from the Office for National Statistics and reflects all live and still births in 2018 and 2019. These figures are for England and the crown dependencies.

The scientific contestation referred to is summarised in the paper Folic acid and neural tube defects: Discovery, debate and the need for policy change by Professor Nicholas Wald. Professor Wald asserts that the United Kingdom should pursue a higher level of fortification than would be permitted by the UK’s Tolerable Upper Level (TUL). A copy of the paper is attached.

The Government and its independent scientific advisory bodies have agreed that fortification of non-wholemeal wheat flour with folic acid, at a level informed by the guidance for supplemental intake of folic acid intake advised by the UK Expert Group on Vitamins and Minerals, is a safe and effective measure to reduce the number of neural tube defects (NTDs).

This view is supported by the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) and by the Scientific Advisory Committee on Nutrition (SACN). In 2018 COT published Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment: COT position paper on the current upper level for folic acid intake in response to a previous paper by Professor Wald, addressing the technical points raised in objection to the TUL and continuing to recommend its use. A copy of this paper is attached.

Deaths associated with high levels of folic acid refers to potential unintended harms which may arise following the fortification of flour with folic acid, such as an increase in the potential masking of vitamin B12 deficiency or pernicious anaemia where the deficiency can cause permanent neurological damage which can lead to death if untreated.

No recent discussions have taken place with countries which have implemented folic acid fortification on unintended consequences of the policy. However, evidence from a number of countries, including those which have implemented folic acid fortification policies, was considered by the SACN and COT to establish the safety and efficacy of fortifying food with folic acid. Analysis by COT and the SACN found that there was insufficient evidence to discount a number of potential risks at very levels of fortification.

While there is no specific scientific briefing relating to the debate between heliocentrism versus geocentrism, as I stated in the debate, we will routinely review the policy post-implementation to ensure it meets the objective of reducing NTDs while avoiding any unintended consequences. The forthcoming consultation will outline the proposed fortification levels with the supporting scientific rationale.

The scientific contestation referred to is summarised in the paper Folic acid and neural tube defects: Discovery, debate and the need for policy change by Professor Nicholas Wald. Professor Wald asserts that the United Kingdom should pursue a higher level of fortification than would be permitted by the UK’s Tolerable Upper Level (TUL). A copy of the paper is attached.

The Government and its independent scientific advisory bodies have agreed that fortification of non-wholemeal wheat flour with folic acid, at a level informed by the guidance for supplemental intake of folic acid intake advised by the UK Expert Group on Vitamins and Minerals, is a safe and effective measure to reduce the number of neural tube defects (NTDs).

This view is supported by the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) and by the Scientific Advisory Committee on Nutrition (SACN). In 2018 COT published Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment: COT position paper on the current upper level for folic acid intake in response to a previous paper by Professor Wald, addressing the technical points raised in objection to the TUL and continuing to recommend its use. A copy of this paper is attached.

Deaths associated with high levels of folic acid refers to potential unintended harms which may arise following the fortification of flour with folic acid, such as an increase in the potential masking of vitamin B12 deficiency or pernicious anaemia where the deficiency can cause permanent neurological damage which can lead to death if untreated.

No recent discussions have taken place with countries which have implemented folic acid fortification on unintended consequences of the policy. However, evidence from a number of countries, including those which have implemented folic acid fortification policies, was considered by the SACN and COT to establish the safety and efficacy of fortifying food with folic acid. Analysis by COT and the SACN found that there was insufficient evidence to discount a number of potential risks at very levels of fortification.

While there is no specific scientific briefing relating to the debate between heliocentrism versus geocentrism, as I stated in the debate, we will routinely review the policy post-implementation to ensure it meets the objective of reducing NTDs while avoiding any unintended consequences. The forthcoming consultation will outline the proposed fortification levels with the supporting scientific rationale.

The scientific contestation referred to is summarised in the paper Folic acid and neural tube defects: Discovery, debate and the need for policy change by Professor Nicholas Wald. Professor Wald asserts that the United Kingdom should pursue a higher level of fortification than would be permitted by the UK’s Tolerable Upper Level (TUL). A copy of the paper is attached.

The Government and its independent scientific advisory bodies have agreed that fortification of non-wholemeal wheat flour with folic acid, at a level informed by the guidance for supplemental intake of folic acid intake advised by the UK Expert Group on Vitamins and Minerals, is a safe and effective measure to reduce the number of neural tube defects (NTDs).

This view is supported by the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) and by the Scientific Advisory Committee on Nutrition (SACN). In 2018 COT published Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment: COT position paper on the current upper level for folic acid intake in response to a previous paper by Professor Wald, addressing the technical points raised in objection to the TUL and continuing to recommend its use. A copy of this paper is attached.

Deaths associated with high levels of folic acid refers to potential unintended harms which may arise following the fortification of flour with folic acid, such as an increase in the potential masking of vitamin B12 deficiency or pernicious anaemia where the deficiency can cause permanent neurological damage which can lead to death if untreated.

No recent discussions have taken place with countries which have implemented folic acid fortification on unintended consequences of the policy. However, evidence from a number of countries, including those which have implemented folic acid fortification policies, was considered by the SACN and COT to establish the safety and efficacy of fortifying food with folic acid. Analysis by COT and the SACN found that there was insufficient evidence to discount a number of potential risks at very levels of fortification.

While there is no specific scientific briefing relating to the debate between heliocentrism versus geocentrism, as I stated in the debate, we will routinely review the policy post-implementation to ensure it meets the objective of reducing NTDs while avoiding any unintended consequences. The forthcoming consultation will outline the proposed fortification levels with the supporting scientific rationale.

The scientific contestation referred to is summarised in the paper Folic acid and neural tube defects: Discovery, debate and the need for policy change by Professor Nicholas Wald. Professor Wald asserts that the United Kingdom should pursue a higher level of fortification than would be permitted by the UK’s Tolerable Upper Level (TUL). A copy of the paper is attached.

The Government and its independent scientific advisory bodies have agreed that fortification of non-wholemeal wheat flour with folic acid, at a level informed by the guidance for supplemental intake of folic acid intake advised by the UK Expert Group on Vitamins and Minerals, is a safe and effective measure to reduce the number of neural tube defects (NTDs).

This view is supported by the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) and by the Scientific Advisory Committee on Nutrition (SACN). In 2018 COT published Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment: COT position paper on the current upper level for folic acid intake in response to a previous paper by Professor Wald, addressing the technical points raised in objection to the TUL and continuing to recommend its use. A copy of this paper is attached.

Deaths associated with high levels of folic acid refers to potential unintended harms which may arise following the fortification of flour with folic acid, such as an increase in the potential masking of vitamin B12 deficiency or pernicious anaemia where the deficiency can cause permanent neurological damage which can lead to death if untreated.

No recent discussions have taken place with countries which have implemented folic acid fortification on unintended consequences of the policy. However, evidence from a number of countries, including those which have implemented folic acid fortification policies, was considered by the SACN and COT to establish the safety and efficacy of fortifying food with folic acid. Analysis by COT and the SACN found that there was insufficient evidence to discount a number of potential risks at very levels of fortification.

While there is no specific scientific briefing relating to the debate between heliocentrism versus geocentrism, as I stated in the debate, we will routinely review the policy post-implementation to ensure it meets the objective of reducing NTDs while avoiding any unintended consequences. The forthcoming consultation will outline the proposed fortification levels with the supporting scientific rationale.

Officials from the Department of Health and Social Care, the Department for the Environment, Food and Rural Affairs, the Food Standards Agency and Food Standards Scotland are working to implement folic acid fortification, as part of the review on the Bread and Flour Regulations 1998 and the Bread and Flour (Northern Ireland) Regulations 1998.

The UK Government and the devolved administrations have engaged industry on the decision to fortify non-wholemeal wheat flour with folic acid and are now developing draft legislation and an impact assessment for future consultation.

Personal protective equipment (PPE) made in the UK as at 1 December 2020 reported on the delivery of a specific commitment to ensure that UK Make supply would be sufficient to meet 70% of demand for the coming winter, for all items except gloves, by 1 December 2020. The table referred to reports on that commitment and confirms that it was met therefore there are no plans to update or modify it. In practice, we found that UK Make supply met 82% of the demand for that period.

The Department has investigated biodegradable personal protective equipment (PPE) from United Kingdom and overseas suppliers. However, waste stream channels from health and social care settings do not facilitate the separation of these products, unless they have been used for non-healthcare functions, such as catering. Most biodegradable products are single use and contribute to the environmental impacts from excessive manufacture, transportation and storage. Therefore, biodegradable products are not the most effective solution for single use health care infected PPE. The Department is exploring reusable products for Type IIR masks, eye protection and transparent masks.

NHS Supply Chain is working with 30 United Kingdom manufacturers to build resilience within the manufacture of personal protective equipment. This also includes addressing innovation, sustainability and fit testing of masks for the National Health Service and social care.

There are no current plans to further consult scientists on flour fortification. We are finalising agreement of a four-nation response to the United Kingdom-wide consultation on the proposed mandatory fortification of flour with folic acid which ran from 13 June to 9 September 2019. The next steps will be laid out in the Government’s response.

Under the terms of the Protocol on Ireland/Northern Ireland, European Union legislation will apply in the United Kingdom in respect of Northern Ireland. Regulation 1925/2006 on the Addition of Vitamins and Minerals to Foods is included the Northern Ireland Protocol. Consideration is therefore necessary in discussion with the devolved administrations to ensure the consultation response and any proposed fortification policy takes into account the Northern Ireland Protocol.

The Food Standards Agency (FSA) has advised that it is aware of this research. The FSA’s view is that whilst it is plausible that viable but nonculturable cells could potentially cause foodborne disease, to date there is no documented evidence that demonstrates this occurs in the food chain. There remains a high level of uncertainty over the likelihood of occurrence and conditions that would be needed for this to happen but the FSA will continue to review the literature and monitor the latest developments on the topic.

Data for 2019/20, the most recent reporting period, is not yet available. Data for 2010/11 to 2018/19 in provided in the following table. Interventions include hygiene inspections and audits, verification and surveillance, sampling visits, advice and education and intelligence gathering.

The total number of interventions for the period 2015/16 to 2018/19 and for the period 2010/11 to 2018/19 are also shown.

Note:

* Based on 9 months data for Northern Ireland.