No assessment has been made in relation to the use of aspartame in drinks in scope of the Soft Drinks Industry Levy. The safety of sweeteners, including aspartame, is the responsibility of the Food Standards Agency (FSA). The FSA considers that the safety of aspartame has been evaluated by various Scientific Committees and it is considered safe at current permitted levels of use.

The International Agency for Research on Cancer (IARC) report on the evaluation of the potential carcinogenic effects of aspartame has not yet been published. Once IARC’s report is published, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) will undertake their risk assessment on the use of aspartame as an additive. Following JECFA’s assessment, the FSA will review the evidence and decide whether any further actions are needed.

As an independent Government department, the Food Standards Agency (FSA) keeps under review the evolving body of credible scientific evidence on the safety of all food additives including aspartame and advises the Government if any action is needed.

The FSA is aware of both the paper written by Professor Millstone and Dr Dawson criticising the European Food Safety Authority’s (EFSA) assessment of the safety of aspartame, and the response issued by EFSA. The FSA does not consider that any action in relation to the safety of aspartame is needed at the present time.

In 2013, the European Food Safety Agency (EFSA) completed a comprehensive risk assessment of the safety of aspartame as a food additive and concluded that aspartame and its breakdown products are safe for human consumption, including pregnant women and children, at the current level of exposure. The EFSA panel agreed with previous opinion that the available data did not provide evidence for a relationship between aspartame consumption and enhanced susceptibility to seizures.

In April 2016, taking the EFSA review into account, the European Medicines Agency (EMA) published a draft of updated labelling guidance for products containing aspartame, which can be found at the EMA website below:

www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/05/WC500205999.pdf

There were no significant changes proposed to the current guidance on ‘Excipients in the label and package leaflet of medicines for human use’ (CPMP/463/00 Rev 1), which can be found at the EMA website below:

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003412.pdf

Vimpat (lacosamide), an antiepileptic drug, has been authorised in the European Union since 29 August 2008 and is currently approved as an add-on therapy to other antiepileptic medicines in the treatment of partial onset seizures with or without secondary generalisation in adult and adolescent (16-18 years) patients with epilepsy. Vimpat syrup contains aspartame and this is declared in the product literature.

As with all medicines, after approval, the safety of the medicine is continuously monitored throughout their use in healthcare practice by pharmacovigilance activities. New safety signals reported by patients/healthcare professionals will be monitored/reviewed continuously.

We are advised by the Food Standards Agency (FSA) that aspartame is permitted in all European Union Member States. It is also permitted in those countries aligned to EU legislation participating in the European Economic Area and European Free Trade Association.

Aspartame has also been evaluated for safety by The Joint FAO/WHO Expert Committee on Food Additives and provisions for its use are included in the international Codex Alimentarius General Standard on Food Additives.

Whilst the FSA is not aware of any countries where aspartame is banned, it is possible there are countries which do not have legislation regulating the use of aspartame or other food additives.

We are advised by the Food Standards Agency (FSA) that all food additives, including sweeteners, are only permitted after a robust evaluation of their safety. The foods in which the sweeteners can be used and their conditions of use are regulated under harmonised European Union legislation on food additives.

The results of an FSA funded study on aspartame were published in March 2015. The study was designed to examine whether self-diagnosed individuals exhibit any reactions which can be observed in a clinical setting, after consuming bars that do or do not contain aspartame. Participants showed no difference in their response whether they contained aspartame or not.

As part of its systematic re-evaluation of all food additives, the European Food Safety Authority (EFSA) re-evaluated the safety of aspartame and concluded in December 2013 that 'aspartame and its breakdown products are safe for human consumption at current levels of exposure'. In undertaking their re-evaluation EFSA had access to all available, relevant scientific studies and data on aspartame.

Officials in the FSA have regular discussions with industry, and other interested parties, on a range of issues. Since EFSA reaffirmed the safety on the current use of aspartame, these have not routinely included discussions on aspartame or other sweeteners.

We are advised by the Food Standards Agency (FSA) that all food additives, including sweeteners, are only permitted after a robust evaluation of their safety. The foods in which the sweeteners can be used and their conditions of use are regulated under harmonised European Union legislation on food additives.

The results of an FSA funded study on aspartame were published in March 2015. The study was designed to examine whether self-diagnosed individuals exhibit any reactions which can be observed in a clinical setting, after consuming bars that do or do not contain aspartame. Participants showed no difference in their response whether they contained aspartame or not.

As part of its systematic re-evaluation of all food additives, the European Food Safety Authority (EFSA) re-evaluated the safety of aspartame and concluded in December 2013 that 'aspartame and its breakdown products are safe for human consumption at current levels of exposure'. In undertaking their re-evaluation EFSA had access to all available, relevant scientific studies and data on aspartame.

Officials in the FSA have regular discussions with industry, and other interested parties, on a range of issues. Since EFSA reaffirmed the safety on the current use of aspartame, these have not routinely included discussions on aspartame or other sweeteners.

The Food Standards Agency (FSA) advise that the paper is still in the peer-review process. Publication in a scientific journal is expected and is the preferable route as it makes the data more readily available to the scientific community. Once this happens the FSA will publish the final report on foodbase, the FSA’s open access repository.

The study work has been completed. However, the contractor has experienced delays in preparing and submitting the final report. The Food Standards Agency continues to press the contractor to submit the study for peer reviewed publication as soon as possible.

There has been no increase to the costs of this study since the information previously provided. The cost for the initial plan was £150,728; metabolomic profiling, to determine any effects on plasma and urinary metabolite profile, was added at an additional cost of £136,995.

To make the study more robust the number of self-diagnosed aspartame-sensitive participants was increased from 50 to 75, with the same increase in matched controls; the increase in participants and additional metabolomic analysis increased the cost by a further £173,664; and the cost for the additional clinical chemistry analysis of the samples in order to put any findings from the metabolomic profiling in context was £70,000.

We are advised by the Food Standards Agency (FSA), the non-ministerial Government Department with responsibility for food safety, that aspartame has been extensively tested and reviewed for safety by independent experts at national, European and international level and found to be safe at current levels of use.

The European Food Safety Authority (EFSA's) latest draft opinion, published for consultation in January, has confirmed this. Despite this, some people consider they react badly to consuming aspartame. Although not a safety study, the FSA commissioned a research study which looked at self-diagnosed individuals who consider they experience adverse effects after consuming aspartame. The results of the study will be subjected to peer review prior to publication later this year, as well as being shared with the EFSA for consideration as part of their current re-evaluation of aspartame.

The Food Standards Agency (FSA) will review the relevant papers of the Food Advisory Committee and the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment with a view to placing the requested information in the Library. FSA officials are currently collating the information and I will write to the noble Countess, in due course, to inform her of the outcome of that process and place a copy of the letter in the Library.

Aspartame has been extensively tested to ensure it can be safely used but there are a small number of people who allege ill-health effects following consumption. The Food Standards Agency (FSA) therefore commissioned Hull University to carry out a study on alleged adverse reactions to aspartame.

The study commenced in July 2009, was scheduled for completion in October 2010 and aimed to recruit 50 self-diagnosed aspartame-sensitive participants along with 50 matched controls. The cost for this initial plan was £150,728. Metabolomic profiling, to determine any effects on plasma and urinary metabolite profile, was added at an additional cost of £136,995. To make the study more robust the number of self-diagnosed aspartame-sensitive participants was increased from 50 to 75, with the same increase in matched controls. The increase in participants and additional metabolomic analysis increased the cost by a further £173,664.

Metabolomic profiling is a rapidly developing scientific field. In order to put any findings from the profiling in context, additional clinical chemistry analysis of the clinical samples is required. The contractual documents for this additional analysis are not yet complete and we are therefore unable to provide further information on the costs at this time but shall let the noble Countess have this information once the contract is signed.

Difficulties were encountered with recruiting sufficient volunteers to participate in the study which caused delay. However, subsequent changes in the recruitment approach remedied this. The draft study report, including results from the additional analysis under negotiation, is expected to be with the FSA in January 2013. It will then be subjected to peer review before publication.

In 1982, the Committee on the Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) classified aspartame as Group A, “Substances that the available evidence suggests are acceptable for use in food”. In 1992, when the COT moved towards the use of acceptable daily intakes (ADIs) in the assessment of food additives, ADIs were established for both aspartame and its breakdown product diketopiperazine. The COT did not establish an ADI for methanol as they noted that the amounts

of methanol that could be present in aspartame sweetened products were lower than those present in some foods and were not of concern.

Maximum permitted levels for aspartame are established in legislation, which also specifies the various foods in which it is permitted. These levels are set so that consumers, including certain sub-populations such as children, are unlikely to exceed the acceptable daily intake of aspartame.

It is the food businesses' responsibility to comply with food law; however, enforcement of food legislation is the responsibility of local authorities. Data held by the Food Standards Agency (FSA) for 2012 shows that 175 samples were analysed for aspartame. Only one sample was found to be non-compliant as it was not permitted to contain aspartame. This figure only covers those local authorities who are using the UK Food Surveillance System national database.

The FSA is not aware of any prosecutions regarding aspartame.