Low calorie sweeteners regulation & safety


Posted: 10 October 2016

Low calorie sweeteners are amongst the most thoroughly researched ingredients worldwide. European and international authorities that have approved the safety of these ingredients include the European Food Safety Authority (EFSA) and the Joint Food and Agriculture Organisation/ World Health Organisation Expert Committee on Food Additives (JECFA).

In the European Union (EU), the following 11 low calorie sweeteners are approved for use in foods and drinks.

  • acesulfame-K (E950)
  • aspartame (E951)
  • cyclamate (E952)
  • saccharin (E954)
  • sucralose (E955)
  • thaumatin (E957)
  • neohesperidine DC (E959)
  • steviol glycosides (E960)
  • neotame (E961)
  • aspartame-acesulfame salt (E962)
  • advantame (E969)

The Regulation of Low Calorie Sweeteners

Sweeteners were first regulated at European level in the 1990’s with the entry into force of Directive 94/35/EC of the European Parliament and the Council on sweeteners in foodstuffs, also known as the "Sweeteners Directive". More recently, the European Parliament and the Council adopted a framework regulation, Regulation 1333/2008, to consolidate all current authorisations for sweeteners and food additives into one legal text. Annex II of this legislation, established by Commission Regulation 1129/2011, provides a Community list of sweeteners approved for use in foods, beverages and table-top sweeteners and their conditions of use.

Sweeteners were first regulated at European level in the 1990’s with the entry into force of Directive 94/35/EC of the European Parliament and the Council on sweeteners in foodstuffs, also known as the "Sweeteners Directive". As with any other food ingredient, the presence of a low calorie sweetener in a food or beverage is indicated on the food label (‘with sweetener’) and also in the list of ingredients (full name /’E’ number). The ‘E’ reference for each additive refers to Europe and indicates that the food additive is safe and approved in foods and beverages in Europe.

How is a Low Calorie Sweetener Approved for Use in the EU?

The authorisation and conditions of use of a low calorie sweetener, like any other food additive, is harmonised at EU level. The European Food Safety Authority is responsible for the provision of scientific advice to support European Union legislation and policies in all fields that have a direct or indirect impact on food and food safety. Applicants (ingredient manufacturers) can only apply for approval of a low calorie sweetener after extensive safety tests have been completed and scientific evidence provided in support of the ingredient’s safety and benefit for the consumer. The application consists of comprehensive data obtained from safety studies and also includes details about how the ingredient will be used in foods and beverages. Following the publication of a positive scientific opinion from EFSA, the European Commission drafts a proposal for the authorisation of use of the sweetener in foods and drinks on the European market, which is then discussed with EU Member State experts before being adopted.

Low calorie sweeteners safety

An extensive number of scientific studies have examined and confirmed that low calorie sweeteners are safe. This data has been evaluated by globally recognised authorities, including the Joint Food and Agriculture Organisation (FAO)/ World Health Organisation (WHO) Expert Committee on Food Additives (JECFA) and the European Food Safety Authority (EFSA). All of the low calorie sweeteners used in foods and drinks in Europe today have been subjected to rigorous safety testing by EFSA.

In the approval process, an Acceptable Daily Intake (ADI) is set for each low calorie sweetener by EFSA. The ADI is a guideline quantity that represents the amount of low calorie sweetener that can be safely consumed on a daily basis throughout a person’s lifetime without any health problems.

At the request of the European Commission, the European Food Safety Authority is currently carrying out an ambitious re-evaluation of the safety of all food additives, which were approved on the EU market before 20th January 2009. Aspartame was the first sweetener to go through the process of re-evaluation. In 2013, following one of the most comprehensive scientific risk assessments undertaken on a food additive, EFSA published the results of this assessment re-confirmed that aspartame is safe for consumers.

For more information on the regulation and safety of low calorie sweeteners you may download the ISA booklet “Low calorie sweeteners: Role and benefits”.