To: Griffith-Sackey, Donna
Subject: Aspartame and other additives
I am very interested in obtaining more information on the use of additives in food and drink products, particularly the use of Aspartame. I am interested to know exactly what research has been conducted to determine the safety of this product and others currently being added to food in vast amounts, I would also like to know who ultimately has the authority to decide if an additive is 'safe' or 'unsafe' and what exactly determines 'safe' and 'unsafe'?
Any information you can provide will be much appreciated,
From: Gloria Obasogie
Subject: Aspartame and other additives
Thank you for your e-mail enquiry of 28 March 2010 to my colleague Donna Griffith-Sackey, requesting information on the use of additives in food and drink products in the European Union (EU). Your enquiry has been forwarded to me for reply.
You may wish to know that in the EU, food additives are controlled by way of a positive list in the legislation, i.e. food additives that do not appear in the list are not permitted in foods if used primarily for an additive function.
The use of additives including sweeteners such as aspartame, colours and miscellaneous additives in the European Union are now controlled by the new European Parliament and Council Regulation on Food Additives (Regulation EC No. 1333/2008). Its enforcement in the UK is provided by the Food Additives (England) Regulations 2009, which replaces and revokes the former Sweeteners in Food Regulations 1995 (as amended), the Colours in Food Regulations 1995 (as amended) and the Miscellaneous Food Additives Regulations 1995 (as amended).
Regulation EC No. 1338/2008 replaces the former Additives Framework Directive (89/107/EEC); as well as the Directives on sweeteners (94/35/EC), colours (94/36/EC) and miscellaneous additives, (95/2/EC). However, the Annexes in Directives 94/35, 94/36 and 95/2 in which permitted additives, sweeteners and colours, and their conditions of use are set out will be maintained on a temporary basis until June 2011.
I have provided links to the following for your viewing:
Regulation EC 1333/2008
The Additives in Food (England) Regulations 2009
The consolidated version of Directive 94/35/EC on sweeteners including amendment 96/83/EC; 2003/115/EC and 2006/52/EC
Directive 94/36/EC on colours
The consolidated version of Directive 95/2/EC on miscellaneous additives including seven amendments
You will also find further information about additives on the Food Standards Agency website. The website address is: www.food.gov.uk In particular you may be interested in the following pages on additives: http://www.food.gov.uk/safereating/chemsafe/additivesbranch/
Additives including sweeteners (such as aspartame), colours and miscellaneous additives are only permitted for use in the EU after very careful evaluation. This includes assessment of safety by committees of independent experts such as the World Health Organisation's Joint Expert Committee on Food Additives (JECFA), the European Commission's Scientific Committee on Food (SCF) whose role has now been taken over by the European Food Safety Authority (EFSA), and the UK's Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT). Furthermore, all approvals of food additives are kept under review as and when new scientific information becomes available. Should this information cast doubt on the safety of an additive, it will be reviewed thoroughly and the approval for the additive may be withdrawn.
The assessments undertaken by independent experts include acute toxicity studies, long term and carcinogenicity studies, reproductive toxicity studies and tests to establish whether the substances are genotoxic (can damage DNA). If a substance is found to cause any adverse effect at the levels that would be used in foods then it would not be approved, and therefore would not be permitted to be used as an additive within the EU. When an additive is approved it is given an "E-number", and an acceptable daily intake level (ADI) is set. This is a level of an additive that can be consumed over a lifetime without any adverse effect on health. The ADI has been set to cover all sectors of the population, including diabetics, children and infants from the age of 12 weeks. Also, it is used to set permitted levels for certain foods by taking into account the consumption patterns of these foods to ensure that even high level consumers are unlikely to exceed the ADI.
The sweetener aspartame is one of the most widely tested additives approved for use in foods and has been reviewed on several occasions by the Joint Expert Committee on Food Additives administered jointly by the United Nations’ Food and Agriculture Organization and the World Health Organization (JECFA); the UK’s Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT); the European Commission’s former Scientific Committee on Food (SCF) and by the European Food Safety Authority (EFSA) who have now assumed the role of the SCF. Studies performed on aspartame (before and after approval) included long term and multiple-generation toxicological studies in animals, and studies on the fate of aspartame and its breakdown products in human volunteers. The independent experts assessed the results of these studies and concluded that aspartame is acceptable for use in food.
The FSA is aware of reports of adverse effects which cast doubt on the safety of aspartame. These reports are taken very seriously by the FSA, and to address the continuing consumer concern and reports of alleged ill-health arising from aspartame consumption, we recently proposed to the European Union that there should be further consideration of the sweetener aspartame. I am pleased to confirm that EFSA has announced an initiative in cooperation with its Advisory Forum to address this public concern, and is currently undertaking a review of all the available information on aspartame, with a view to identifying data gaps in this area.
Included in the EFSA review are case reports detailing the symptoms of those self diagnosed who report they are sensitive to adverse health effects caused by consumption of aspartame. One outcome of the EFSA review is the possibility of an EU-wide study investigating the effects of aspartame in this subgroup of the population. The FSA has recently undertaken a pilot study which would inform experts on the feasibility of conducting such a study on a larger scale. To learn more about the study, please visit our website below:
Additionally, Dr Andrew Wadge, our Chief Scientist, has provided some information on his blog; and a link is provided below for your perusal:
Whilst currently satisfied as to the safety of aspartame, the FSA recognises that some consumers may wish to avoid those foods containing this sweetener, and that all consumers should be able to make an informed choice. Labelling regulations require that aspartame and other food additives appear clearly in the ingredients list on food labels. Aspartame must be identified either by its name (aspartame) or its E number (E951) and this enables consumers to identify the presence of aspartame in foods and to avoid it if they choose to do so. Furthermore, products containing sweeteners such as aspartame must show the statement “with sweetener(s)” on the label close to the main product name. Foods that contain both sugar and sweetener must carry the statement “with sugar and sweetener(s)”. In addition, foods that contain aspartame must be labelled with a warning "contains a source of phenylalanine". This warning is specifically to aid individuals who suffer from phenylketonuria (PKU), so that they can avoid such foods.
I have attached the Agency's note on aspartame. The note summarises our opinion on the safety of aspartame and contains information on safety evaluations, intake levels as well as labelling information for those who wish to avoid aspartame. The note also refers to the opinion on aspartame published by the SCF and the EFSA in 2002 and 2006 respectively. These opinions concluded that on the basis of all the evidence currently available, there was no need to further review the safety of aspartame or to revise the ADI previously established for aspartame of 40 milligrams per kilogram body weight per day.
I hope this information is of help.
I would like to stress that this is our interpretation of the legislation. It would ultimately be a matter for a court of law to provide a definitive legal interpretation.