Aspartame: EFSA consults on its first full risk assessment

Press Release
8 January 2013

The European Food Safety Authority (EFSA) has today launched a public consultation on its draft scientific opinion on the safety of the artificial sweetener aspartame. To carry out this full risk assessment, EFSA has undertaken an in-depth review of peer-reviewed scientific and other literature on aspartame and its breakdown products, including new human studies. All stakeholders and interested parties are invited to comment on the draft opinion through the online public consultation by 15 February 2013. As part of this important process and the Authority’s commitment to actively engaging with stakeholders, EFSA will also hold a meeting with interested parties to discuss its draft opinion and the feedback received from the online public consultation.

Regulatory bodies around the world have evaluated the safety of aspartame since the 1980s; however, this is the first full evaluation of aspartame that has been requested of EFSA and has been carried out by the Authority’s Scientific Panel on Food Additive and Nutrient Sources Added to Food (ANS Panel). In this re-evaluation of the safety of aspartame, EFSA’s scientific experts have drawn upon all available information on aspartame and its breakdown products and, following a detailed and methodical analysis, have concluded in this draft opinion that they pose no toxicity concern for consumers at current levels of exposure. The current Acceptable Daily Intake (ADI) is considered to be safe for the general population and consumer exposure to aspartame is below this ADI.

In setting the ADI, the ANS Panel considered findings from long-term studies conducted in experimental animals related to toxicity and carcinogenicity and possible adverse health effects of phenylalanine, one of aspartame’s breakdown products, on the developing fetus. Phenylalanine is an amino acid making up protein found in many foods. It is known to be toxic at high intake levels, in particular to the developing fetus in women suffering from the medical condition phenylketonuria (PKU). This inherited disorder increases blood phenylalanine concentrations to levels toxic to the developing brain. The Panel confirmed that the ADI, while protective of the general population, is not applicable to people who suffer from PKU, as they require strict adherence to a low phenylalanine diet.

The ANS Panel’s draft opinion has benefitted from the latest scientific thinking and methodological approaches. This comprehensive review was made possible following two public calls for data which made available a large body of scientific information, comprising both published and previously unpublished data and studies. This included the 112 original documents on aspartame that were submitted to support the request for authorisation of aspartame in Europe in the early 1980s. In the interest of transparency and openness EFSA published the full list of these scientific studies and also made publicly available previously unpublished scientific data. This information has been critically evaluated and interpreted by EFSA’s experts to underpin the key discussion points addressed in the draft opinion.

Also published today, EFSA has prepared a set of Frequently Asked Questions to help explain some of the key scientific concepts and initial conclusions of the draft opinion. Feedback from the consultation will be compiled in a report and, where appropriate, incorporated into the final scientific opinion, which the ANS Panel aims to adopt by May 2013.


Notes to editors:

  • Aspartame is a low-calorie, intense sweetener that is approximately 200 times sweeter than sucrose (table sugar). Aspartame is authorised in the EU for use as a food additive to sweeten a variety of foods and beverages such as drinks, desserts, sweets, chewing gum, yogurt, energy-reduced and weight control products and as a table-top sweetener. It has been authorised for use in foods and as a table-top sweetener for over 20 years in many countries throughout the world following thorough safety evaluations. The first safety assessment of aspartame carried out in Europe was published by the European Commission’s former Scientific Committee on Food (SCF) in 1984. Subsequent complementary assessments were made by the SCF in 1988, 1997 and 2002. Since EFSA’s establishment in 2002, the Authority issued advice on new scientific studies related to this sweetener in 2006, 2009 and 2011 but to date has not carried out a full risk assessment of this sweetener). For more background information on aspartame see the more general FAQ on aspartame .
  • The re-evaluation of aspartame is part of the systematic re-evaluation of all food additives authorised in the EU prior to 20 January 2009. In May 2011, EFSA was asked by the European Commission to bring forward the full re-evaluation of the safety of aspartame (E 951), which was previously planned for completion by 2020. For the EU regulatory framework on food additives such as sweeteners and EFSA’s role in relation to aspartame see Topic on aspartame .
  • Phenylalanine (Phe) is an amino acid used as a building block for proteins. It can also be converted by the body into tyrosine, which is another amino acid used in proteins or further changed into other chemicals in the body, including chemical messengers such as hormones or neurotransmitters. Phenylalanine is a so-called essential amino acid as it cannot be produced by the body and must be supplied in the diet.
  • Phenylketonuria (PKU) is an inherited disorder that causes high levels of phenylalanine and low levels of tyrosine in the blood. High blood phenylalanine levels are toxic to the brain and can, if left untreated, affect brain development and cause mental retardation, mood disorders and behavioural problems. Most treatment of PKU aims to keep blood phenylalanine at acceptable levels by restriction of foods rich in protein (meat, fish, eggs, dairy products, nuts and seeds), many starchy foods, including those containing flour (bread, pasta), as well as foods and drinks containing aspartame.
  • In the European Union, because they are a source of phenylalanine, all products containing aspartame must be labelled “Contains a source of phenylalanine” in order to protect consumers who need to avoid exposure to this substance.

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