Sweeteners are food additives which are used:
• To impart a sweet taste in foodstuffs
• As table-top sweeteners
As for all food additives, sweeteners are regulated substances which are subject to safety evaluation prior to market authorisation. In the European Union (EU), the European Commission, Parliament and Council regulate the use of food additives; in particular, the Commission and Member States decide which additives can be used in foods and at what levels. All food additives are included in the ingredient lists on product labels which must identify both the function of the food additive in the finished food (i.e. sweetener) and the specific substance used either by referring to the appropriate E number or its name (e.g. E 954 for ‘Saccharin’).
EFSA is holding an open consultation on a draft protocol for the hazard assessment of sweeteners, from 5 July to 6 September 2019. Interested parties and the scientific community are invited to provide feedback on this first part of EFSA’s approach to the re-evaluation of the safety of sweeteners. A second consultation on the assessment of consumer exposure to sweeteners will follow later in 2019.
- Public consultation: Public consultation on the draft protocol for the assessment of hazard identification and characterisation of the sweeteners
This follows two calls for scientific data on sweeteners in 2017 and 2019 when EFSA asked interested parties and stakeholders to submit published, unpublished or newly generated information relevant to the re-evaluation of currently authorised sweeteners.
2013 – EFSA publishes its first full risk assessment of aspartame, with experts concluding that aspartame and its breakdown products are safe for the general population (including infants, children and pregnant women).
2013 - EFSA’s experts conclude that advantame and its metabolites pose no safety concern for consumers at the proposed uses and use levels as a sweetener. They set an Acceptable Daily Intake (ADI) of 5 mg/kg bw/day.
2011 - EFSA is asked by the European Commission to bring forward the full re-evaluation of the safety of aspartame from 2020.
2011 - EFSA reviews its 2010 assessment of steviol glycosides and concludes that, adults and children who are high consumers of foods containing steviol glycosides, could still exceed the ADI established in 2010 if the sweetener is used at the maximum levels proposed. The applicants revise the proposed use levels and the food additive is included in the official EU list of authorised food additives with ‘E 960’ number.
2010 – EFSA concludes that steviol glycosides are neither genotoxic nor carcinogenic and established an ADI of 4 mg/kg bw/day, in line with the recommendation of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 2008.
1. Was aspartame re-evaluated by EFSA?
Aspartame (E 951) is a low-calorie, intense artificial sweetener. In Europe it is authorised for use as a food additive in various foodstuffs and as a table-top sweetener. In May 2011, the European Commission asked EFSA to bring forward the full re-evaluation of the safety of aspartame from 2020. EFSA published its first full risk assessment of aspartame in December 2013. The opinion concluded that aspartame and its breakdown products are safe for general population (including infants, children and pregnant women). For more information see the topic on aspartame:
2. What is EFSA’s assessment on advantame?
Advantame is an intense artificial sweetener derived from isovanillin and aspartame. The chemical properties of the advantame molecule are different to those of aspartame. Depending on how it is used, the sweetness of advantame can be hundreds or even thousands of times greater than that of sugar or other intense sweeteners. For example, 50 times less advantame than aspartame would be needed for use in flavoured drinks.
In July 2013, EFSA’s experts concluded that advantame and its metabolites are neither genotoxic nor carcinogenic and pose no safety concern for consumers at the proposed uses and use levels as a sweetener. The ANS Panel set an Acceptable Daily Intake (ADI) of 5 mg/kg bw/day, in line with the ADI established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 2013. The Panel’s conservative estimates of exposure to advantame considering, for the proposed use levels in foods, high levels of consumption in adults and children are significantly below the ADI.
3. Has EFSA assessed the safety of steviol glycosides?
Steviol glycosides (E 960) are used as sweeteners. They are extracted from the leaves of the stevia plant. This sweetener has up to 300 times the sweetness of sugar but an almost negligible effect on blood glucose levels; hence it is considered by some as an attractive substitute for sugar.
In 2010, EFSA concluded that steviol glycosides are neither genotoxic nor carcinogenic and establishes an ADI of 4 mg/kg bw/day, in line with the recommendation of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 2008. The ANS Panel noted that this ADI could be exceeded by both adults and children if this sweetener is used at the maximum levels proposed by the applicants. The applicants subsequently revised the levels of use.
Regulation EU 1131/2011 authorised the use of steviol glycosides as a sweetener in food with the number ‘E 960’. Since then EFSA has been asked to assess the safety of proposed amendments to the specifications on the food additive.
4. Has EFSA assessed health claims related to intense sweeteners?
In 2011, EFSA’s NDA Panel evaluated the substantiation of claims related to intense sweeteners and certain proposed beneficial health effects. The Panel concluded that there is sufficient scientific information to support the claims that intense sweeteners as all sugar replacers lead to a lower rise in blood sugar levels after meals if consumed instead of sugars, and maintain tooth mineralisation by decreasing tooth demineralisation again if consumed instead of sugars. However, EFSA’s experts could find no clear cause and effect relationship to substantiate the claims that intense sweeteners when replacing sugars maintain normal blood sugar levels, or maintain/achieve a normal body weight.
EFSA’s Panel on Food Additives and Flavourings (FAF Panel) carries out risk assessments and provides scientific advice on food additives used as sweeteners. EFSA’s Panel on Nutrition, Novel Foods and Food Allergens (NDA Panel) is responsible for verifying the scientific substantiation of health claims related to intense sweeteners and suggested beneficial effects for consumers.
EFSA has three main activities in relation to the risk assessment of sweeteners:
- Evaluating the safety of new sweeteners before they can be authorised for use in the EU
- Re-evaluating all sweeteners already permitted for use in the EU before 20 January 2009
- Responding to ad-hoc requests from the European Commission to review certain sweeteners 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 information is available), an Acceptable Daily Intake (ADI) for each food additive or group of additives with similar properties. The ADI is the amount of a substance that people can consume on a daily basis during their whole life without any appreciable risk to health. ADIs are usually expressed in milligrams or micrograms per kg of body weight per day (mg/kg or μg/kg bw/day). When re-evaluating previously authorised food additives, EFSA may confirm, amend or even withdraw an existing ADI following a review of all available scientific information.
In the area of health claims, EFSA has also evaluated some claims of beneficial health effects for consumers related to intense sweeteners.
All food additives must undergo a safety evaluation by EFSA prior to their market authorisation by EU risk managers (European Commission, Member States and European Parliament). Regulation EC 1331/2008 introduced a common authorisation procedure for food additives, food enzymes and flavourings. Regulation EC 1333/2008 on food additives, which entered into force in January 2010, established a Union list of authorised food additives. The Union list, including the name of the food additives and their E numbers, the foods in which the food additives can be used and the conditions of use, is published in Regulation EU 1129/2011 and took effect on 1 June 2013.
- EU legislation on food additives – European Commission
Regulation EC 1333/2008 states that all food additives authorised for use in the EU prior to 20 January 2009 should be subject to a new risk assessment by EFSA. Regulation EU 257/2010 establishes a programme for the re-evaluation of approved food additives, the details of which are in Annex II. The deadlines for the re-evaluations vary by group. As sweeteners were evaluated most recently prior to 2009, they are scheduled to be the last group of food additives to be re-evaluated by 2020. The timetable may be adjusted should a safety concern arise for an individual food additive and/or should new scientific data be made available requiring further review ahead of the agreed deadline. All sweeteners authorised under previous legislation (Directive 94/35/EC on sweeteners) are allowed until their review is complete.
The timeframe for the re-evaluation of food additives is detailed in the topic on food additives.
- Topic: Food additives (under ‘EU framework’)
Regulation EC 1924/2006 lays down harmonised EU-wide rules for the use of health or nutritional claims on foodstuffs based on nutrient profiles. Under this legislation, EFSA is responsible for verifying the scientific substantiation of the submitted claims. EFSA’s scientific advice serves as a basis for the European Commission and Member States, who then decide whether to authorise the claims.