Factsheet
External Scientific Report
Aspartame
Aspartame is a low-calorie artificial sweetener, which is approximately 200 times sweeter than sugar. It is a white, odourless powder.
In Europe, aspartame is authorised to be used as a food additive A substance deliberately added to foods or beverages for beneficial technological reasons (e.g. to preserve, flavour, colour or ensure a particular texture). Food additives are not normally consumed by themselves nor used as typical ingredients in food. to sweeten a variety of foods and beverages such as drinks, desserts, sweets, dairy products, chewing gum, low-calorie and weight control products, and as a table-top sweetener.
In the EU, as for all food additives, the presence of aspartame must be indicated on the label either by its name or its E number A number used in the European Union to identify permitted food additives. An E number means that an additive has passed safety tests and has been approved for use. (E 951).
The sweetener and its breakdown products have been authorised for human consumption for many years following thorough safety assessments.
In the European Union, all food additives that were already permitted for use prior to 20 January 2009 need to undergo a safety re-evaluation by the European Food Safety Authority (EFSA).
Aspartame (E 951) was one of the first food additives to be fully re-evaluated by EFSA in 2013.
Latest
EFSA’s scientists are currently re-evaluating the safety of two related food additives, the salt of aspartame-acesulfame (E 962) and neotame (E 961), considering all new data that may have become available since they were last evaluated either by EFSA or the European Scientific Committee on Food.
The salt of aspartame-acesulfame (E 962) is a mixture of the two sweeteners aspartame (E 951) and acesulfame K (E 950), while neotame (E 961) is a chemically related substance manufactured from aspartame.
All relevant new studies on aspartame that may have become available after the publication of our scientific opinion Opinions include risk assessments on general scientific issues, evaluations of an application for the authorisation of a product, substance or claim, or an evaluation of a risk assessment. on aspartame in 2013 will be considered and integrated into our assessment of the salt of aspartame-acesulfame (E 962).
We will also update our dietary exposure assessment One of the key steps in risk assessment, this relates to a thorough evaluation of who, or what, has been exposed to a hazard and a quantification of the amounts involved. of aspartame as part of our re-evaluation of the salt of aspartame-acesulfame (E 962).
Milestones
2021
June
EFSA identifies a need for additional data for its re-evaluation of the salt of aspartame-acesulfame (E 962) and neotame (E 961), among other sweeteners.
2020
June
EFSA publishes a call for data on aspartame (E 951) use levels and/or analytical data in food and beverages intended for human consumption in the context of the ongoing re-evaluation of the salt of aspartame-acesulfame (E 962).
2019
May
EFSA seeks additional information from interested parties with respect to the characterisation of the particle size of the substances when used as food additives. Data were also requested for the salt of aspartame-acesulfame (E 962).
2018
January
EFSA publishes a call for food additives usage level and/or concentration data in food and beverages intended for human consumption (Batch 7).
2017
June
EFSA publishes a call for technical and toxicological data on sweeteners authorised as food additives in the EU as part of their re-evaluation. Among the sweeteners to be re-evaluated is the salt of aspartame-acesulfame (E 962).
2013
December
EFSA publishes a full risk assessment of aspartame, concluding that aspartame and its breakdown products are safe for the general population Community of humans, animals or plants from the same species. (including infants, children and pregnant women).
The Acceptable Daily Intake The amount of a substance (e.g. nutrient or chemical) that is ingested by a person or animal via the diet. ( ADI An estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight per day and applies to chemical substances such as food additives, pesticide residues and veterinary drugs.) of 40 milligrams per kilogram of body weight per day (mg/kg bw/day) is considered protective for the general population. Consumer exposure Concentration or amount of a particular substance that is taken in by an individual, population or ecosystem in a specific frequency over a certain amount of time. to aspartame is estimated to be well below this ADI The acceptable daily intake (ADI) is an estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight and applies to chemical substances such as food additives, pesticide residues and veterinary drugs..
For patients suffering from the medical condition phenylketonuria, the ADI An estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight per day and applies to chemical substances such as food additives, pesticide residues and veterinary drugs. is not applicable, as they require strict adherence to a diet low in phenylalanine (an amino acid The constituent block that makes up proteins. Some can be produced by the human body whereas others can be obtained only through the diet. making up proteins found in many foods).
The Appendix A of the scientific opinion reports the selection criteria for how data were considered in the re-evaluation of aspartame.
January and April
EFSA holds a public consultation on its draft scientific opinion on the safety of aspartame, followed by a meeting with interested parties to discuss the feedback received.
2012
July
EFSA launches a call for data on 5-benzyl-3,6-dioxo-2-piperazine acetic acid (DKP) and other degradation products of aspartame.
2011
September
EFSA publishes the list of scientific studies received following a call for data including the 112 original documents on aspartame which were submitted to support the request for authorisation of aspartame in Europe in the early 1980s.
May
The European Commission asks EFSA to bring forward the re-evaluation of aspartame, originally planned for completion by 2020 as part of the systematic re-evaluation of all food additives authorised in the EU prior to 20 January 2009.
2009
EFSA’s experts assess findings on the carcinogenicity of aspartame in rats and conclude that there is no indication that aspartame is genotoxic or carcinogenic and no reason to revise the ADI An estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight per day and applies to chemical substances such as food additives, pesticide residues and veterinary drugs. for aspartame of 40 mg/kg bw/day.
February
EFSA concludes that two publications on artificial sweeteners do not give reason to reconsider previous safety assessments of aspartame or of other sweeteners currently authorised in the EU.
2006
After assessing a long-term carcinogenicity study on aspartame EFSA’s experts conclude that there is no reason to revise the ADI An estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight per day and applies to chemical substances such as food additives, pesticide residues and veterinary drugs. for aspartame of 40 mg/kg bw/day.
EFSA's role
EFSA has three main tasks in relation to food additives such as sweeteners:
- Evaluating the safety of new food additives or proposed new uses of existing food additives before they can be authorised for use in the EU.
- Re-evaluating all food additives already permitted for use in the EU before 20 January 2009.
- Responding to ad-hoc requests from the European Commission to review certain food additives in the light of new scientific information and/or changing conditions of use.
As part of its safety evaluations of food additives EFSA establishes, when possible (i.e. when sufficient scientific information is available), an ADI An estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight per day and applies to chemical substances such as food additives, pesticide residues and veterinary drugs. for each substance.
The ADI An estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight per day and applies to chemical substances such as food additives, pesticide residues and veterinary drugs. is the amount of a substance that people can consume daily during their lifetime without an appreciable risk to health.
ADIs are usually expressed in milligrams per kilogram of body weight per day (mg/kg bw/day). The ADI An estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight per day and applies to chemical substances such as food additives, pesticide residues and veterinary drugs. can apply to a specific additive or a group of additives with similar properties.
When re-evaluating previously authorised additives, EFSA may either confirm, amend, or withdraw an existing ADI An estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight per day and applies to chemical substances such as food additives, pesticide residues and veterinary drugs. following a review of all the available evidence.
The European Commission and national authorities decide on which food additives can be used in foods and at what levels, ensuring consumers stay below the ADI An estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight per day and applies to chemical substances such as food additives, pesticide residues and veterinary drugs. established by EFSA.
EU framework
Under Regulation EC 1333/2008, EFSA is required to re-evaluate all food additives authorised for use in the EU prior to 20 January 2009.
As with other food additives that must be re-evaluated, all data made available for each food additive since the latest evaluation by EFSA or the Scientific Committee on Food, either gathered through the calls for data or the updated literature searches, are checked against the current scientific requirements.