WRITTEN QUESTION E-2639/02

by Kathleen Van Brempt (PSE) to the Commission

(18 September 2002)

Subject: Ban on fluoride supplements

Belgium will shortly become the first EU Member State to ban fluoride supplements. This will also make Belgium the first country in the world to introduce such a ban. The Federal Minister of Public Health says that he has asked the Commission to ban fluoride supplements throughout the EU. According to the minister, the Commission has so far refused to do so. The minister also wishes to see a general ban on fluoride at a later stage.

1. Does the Commission agree with the reasoning of the Belgian minister that fluoride and fluoride supplements present a risk to physical and mental health?

2. What is the Commission's precise reason for refusing to follow Belgium's example?

3. The minister claims that the number of cases of fluoride poisoning is rising. Is the Commission aware of any cases of fluoride poisoning in the EU? If so, how many cases have there been, exactly? What were the consequences for the victims?

4. Will the Commission in future take measures to ban fluoride supplements and later fluoride in general? If so, when?

Joint answerto Written Questions E-2560/02 and E-2639/02given by Mr Byrne on behalf of the Commission

(30 October 2002)

The Commission received on 2 August 2000, in the framework of Directive 98/34/EC establishing a procedure for the provision of information in the fields of technical standards and regulations(1), the Belgian draft Royal decree amending the Royal Decree of 3 March 1992 concerning trade in nutrients and in foodstuffs to which nutrients have been added. In particular, the draft intended to remove chromium and fluorine from the approved list of nutrients. The Commission reacted to the notification noting that with regard to the use of chromium and fluorine in the form of food supplements, the draft concerned a subject covered by the proposal for a Directive on food supplements(2) which was submitted to the Parliament and the Council on 8 May 2000. The Belgian authorities were required, in conformity with the provisions of Article 9, paragraphs 3 and 4 of Directive 98/34/EC, to defer the adoption of the draft in question for twelve months from the date the Commission received the notification. The Belgian authorities respected their obligation of postponing at that time the adoption of the draft which they adopted in July this year.

The Commission does not intend to propose a ban on fluoride in food supplements. It is important to note that the Union legislation on food supplements, Directive 2002/46/EC of the Parliament and the Council on food supplements(3), was adopted on 10 June 2002. The adopted text was based on the Common Position (EC) No 18/2002(4) that had been finalised and adopted under the Belgian Presidency in December 2001. The Directive entered into force on 12 July 2002 and Member States are required to bring into force the laws, regulations and administrative provisions necessary to comply with the Directive by 31 July 2003. It should also be noted that fluoride is one of the vitamins and minerals, listed in annex I of the Directive, which may be used in the manufacture of food supplements under specific conditions.

The Commission is aware of certain concerns regarding high intakes of fluoride. The Scientific Committee for Food in its 1992 opinion on nutrient and energy intakes for the European Community(5) noted that fluoride is beneficial to dental health, although chronic exposure to intakes of 10-25 mg per day can have effects on the muscles and skeleton that can manifest as debilitating musculo-skeletal deformities. The Scientific Committee on Food is currently undertaking risk assessments on the tolerable upper levels of intake for all the nutrients listed in the Directive on food supplements, including fluoride. Maximum levels for vitamins and minerals in food supplements will therefore be established at the Union level on the basis of the scientific risk assessments and calculations of intakes from other food sources, with due account taken of reference intakes of vitamins and minerals for the population.

Regarding drinking water, its quality is regulated in the Community by Council Directive 80/778/EEC of 15 July 1980 relating to the quality of water intended for human consumption(6), which will be replaced by 25 December 2003 by the drinking water Directive 98/83/EC of the Council of 3 November 1998(7). In both Directives there is a limit concerning the maximum admissible concentration of fluoride in drinking water, regardless of its origin, i.e. naturally present or artificially added. The limit set out in the drinking water Directive is 1,5 milligram per litre, which according to the view of the World Health Organisation (WHO) as expressed in its drinking water quality guidelines(8) represents a good balance between the positive and negative effects of fluoride. At present the Commission is not considering revision of the legislation.

The Commission is not able to provide the requested data on the impact of fluoride on dental health or other effects on health in the population of the Union as it does not have the responsibility for collecting such data. However, it is expected that the new health programme 2003-2008 will lead to the development of a system for the collection by Member States of comparable data on the impact on health of individual substances in the diet.

(1) OJ L 204, 21.7.1998.

(2) OJ C 311 E, 31.10.2000.

(3) OJ L 183, 12.7.2002.

(4) OJ C 90 E, 16.4.2002.

(5) Reports of the Scientific Committee for Food 31st series. Nutrient and energy intakes for the European Community (Opinion expressed on 11 December 1992). Office for Official Publications of the European Communities, Luxembourg 1993.

(6) OJ L 229, 30.8.1980.

(7) OJ L 330, 5.12.1998.

(8) World Health Organisation. Guidelines for drinking water quality. Second edition, volume 2. Geneva, 1996.