WRITTEN QUESTION E-0374/01

by Cristiana Muscardini (UEN) to the Commission

(15 February 2001)

Subject: Natural products and scientific assessment

Following the submission of an application by a Belgian firm, it appears that the Scientific Committee on Food has banned the use of stevioside, a natural sweetener made of extracts of stevia rebaudiana, which has been used for decades in many countries. This decision dismays consumers, who have serious misgivings about the assessment criteria used by those with the power of decision and fail to see why it is permissible for an artificial sweetener such as aspartame, for example, to be used without restrictions, despite numerous reports of serious side-effects. Consumers have the impression that double standards are applied, when it comes to authorising foodstuffs, depending on whether they are produced by powerful agro-pharmaceutical companies or by small or medium-sized firms.

1. Does the Commission share consumers' misgivings?

2. Does it agree that the current system for approving substances is influenced more by the power of the manufacturers than by the need for consumer protection?

3. Does it not fear that, if the same system is applied to food supplements, it will lead to the disappearance of many of the most effective supplements available at present, as has already happened in the case of sweeteners?

4. Does it not believe that, so long as the directive on food supplements requires strict controls on admissible substances and sources of nutrients, it will always be the power of the large and powerful pharmaceuticals proposing the use of a new substance that determine whether or not it will be accepted?

5. That being so, does it not fear that the traditional food supplements industry, which consists of small and medium-sized undertakings, will be squeezed out of existence by the overwhelming strength of the multinationals operating in the same sector?

Answer given by Mr Byrne on behalf of the Commission

(26 April 2001)

On the basis of applications from two different companies, the Commission requested the Scientific Committee on Food to examine the safety of stevioside as a sweetener and Stevia Rebaudiana Bertoni plants and leaves as novel food. The most recent opinions of the Scientific Committee date from June 1999.

With regard to the plant products, the Committee concluded that the information provided on the specification, standardisation of the product and safety studies was insufficient. This confirmed an initial assessment report carried out by the national authority that received the application. Consequently, the Commission decided not to authorise the placing on the market of Stevia Rebaudiana Bertoni plants and dried leaves as food or a food ingredient(1).

With regard to the sweetener, the Committee expressed concerns regarding the absence of safety data about the genotoxicity potential of a metabolite of stevioside, about the specification of the compound (impurities) and about possible effects on human fertility. Therefore, the Commission did not consider it appropriate to propose the authorisation of this substance as a sweetener for use in foodstuffs.

The Joint Expert Committee on Food Additives and Contaminants of the World Health Organisation (WHO) and Food and Agriculture Organisation (FAO) has expressed similar concerns about stevioside as the Scientific Committee on Food.

Aspartame has also been evaluated by the Scientific Committee on Food and has been found acceptable for use as a sweetener in food. An Acceptable Daily Intake of 40 milligram per kilogram bodyweight has been set by the Committee. Accordingly, this sweetener has been authorised under Community legislation for a restricted range of foods and with maximum usage levels(2).

The Commission would like to reassure the Honourable Member that the size or the area of activity of the manufacturer neither influence evaluations of food additives carried out by the Scientific Committee on Food, nor will they influence future evaluations of substances for use as ingredients in food supplements.

(1) Commission Decision 2000/196/EC of 22 February 2000 refusing the placing on the market of Stevia Rebaudiana Bertoni: plants and dried leaves as a novel food or novel food ingredient under Regulation (EC) No 258/97 of the Parliament and of the Council, OJ L 61, 8.3.2000.

(2) Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in foodstuffs (OJ L 237, 10.9.1994).