EN Official Journal of the European Union CE 84/137

(2004/C 84 E/0176)

WRITTEN QUESTION E-4036/03

by Hiltrud Breyer (Verts/ALE) to the Commission

(12 January 2004)

Subject: Novel Food Regulation (EC) No 258/97 and Noni products

Two years ago, the German firm Pharmos Naturkosmetik und Heilmittel GmbH was banned from selling capsules filled with pure Noni powder. The competent district authority justified the ban on the grounds that the Novel Food Regulation (NFR) (258/97) (1) applied to Noni products. In the meantime, the application by the American company Morinda to sell Noni products has been granted by the Commission.

1. Why can the authorisation for Morinda's Noni juice not be extended to cover chemically identical Noni products made from the powder of dried Noni fruit?

2. Is the Commission aware of any circumstances in which a dried food product such as dried Noni fruit can damage consumers' health and a chemically identical juice cannot?

3. Following the entry into force of Regulation No 1829/2003 (2) on genetically modified food, the NFR is now unnecessary, having been adopted solely with genetically modified food in mind. What steps is the Commission taking to repeal the regulation?

4. A small or medium-sized business cannot afford the cost of an authorisation under the NFR, like the one obtained by Morinda. What steps is the Commission taking to help small and medium-sized businesses and exporting developing countries obtain authorisation for foods made from plants which are classed as ‘novel food’ under the regulation?

5. Why must environmentally certified plant-based foods, used successfully around the world to prevent illness, be subject to harmful testing on animals in Europe even though millions of people are proof of their safety?

6. When will animal testing be banned for this kind of assessment?

7. Is the Commission aware that its issuing of an authorisation based on its interpretation of the NFR up to now completely contravenes the EU's legislation on monopolies? Has the Commission committed an offence in creating monopolies of this sort?

Answer given by Mr Byrne on behalf of the Commission

(1 March 2004)

An important objective of Regulation (EC) No 258/97 (3) concerning novel foods and novel food ingredients was to enhance food safety by assuring safety assessment before novel foods and novel food ingredients are placed on the market in the EU. This Regulation was not limited to foods or food ingredients that consist of, contain or are derived from genetically modified organisms. In the meantime, Regulation (EC) No 1829/2003 (4) on genetically modified food and feed has introduced a specific Community procedure for the authorization of foods which consist of, contain or are produced from genetically modified organisms. Thus, from 18 April 2004, Regulation (EC) No 258/97 will henceforth apply only to novel foods which are not consisting of, containing or being produced from genetically modified organisms.

As there were no ‘Noni-products’ on the market in the Community when Regulation (EC) No 258/97 entered into force (15 May 1997), they require authorisation under the Regulation.

The authorisation (Commission Decision 2003/426/EC) of the juice of Morinda citrifolia was as a novel food ingredient to be used in pasteurised fruit drinks only. Other uses would require a new assessment.

In accordance with Regulation (EC) No 258/97, safety assessment of novel foods is carried out by Member States' competent bodies and to the appropriate standards. The Commission agrees that, for the purpose of such assessment, the animals testing procedures should be kept to a minimum.

Regulation (EC) No 258/97 provides for a simplified procedure allowing for the placing on the market after a simple notification to the Commission where the product is substantially equivalent to an existent product. This procedure is particularly appropriate for small and medium companies. The Commission has already received and notified to the Member States five such notifications from as many different companies, which are now entitled to place their ‘Noni-juices’ on the market in the EU. Therefore, it cannot be alleged that Regulation (EC) No 258/97 creates monopolies for the benefit of some companies.

The Honourable Member is also invited to refer to the Commission's response to written question P-3594/03 by Mr Kreissl-Dörfler (5).

(1) OJ L 43, 14.2.1997, p. 1.

(2) OJ L 268, 18.10.2003, p. 1.

(3) OJ L 43, 14.2.1997.

(4) OJ L 268, 18.10.2003.

(5) See page 69.