EN Official Journal of the European Union CE 84/68

(2004/C 84 E/0074)

WRITTEN QUESTION P-3594/03

by Wolfgang Kreissl-Dörfler (PSE) to the Commission

(1 December 2003)

Subject: Novel Foods Regulation EC No 258/97, marketing of noni products in the EU

Pursuant to Article l(2)(e) of Regulation EC No 258/97 (1), foods and food ingredients consisting of or isolated from plants and obtained by traditional propagating or breeding practices and having a history of safe food use do not fall within the scope of that Regulation. Pursuant to Article 3(4) of the Regulation, a simplified notification procedure as set out in Article 5 of the Regulation applies to foods or food ingredients that are judged to be substantially equivalent to foods or food ingredients already authorised. The EU has authorised the placing on the market by the company Morinda of noni juice as a novel food. For other products produced from noni fruit, however, the basic possibility of their being regarded as substantially equivalent to the authorised juice has to date always been refused.

The costly authorisation procedure under the Regulation prevents small and medium-sized companies from introducing new natural products into the EU. In effect, this creates a monopoly for large groups, as only big companies have sufficient resources to carry out such procedures.

1. According to what criteria is ‘having a history of safe food use’ defined in this connection, and which institution decides whether a food or food ingredient has a history of safe food use?

2. What legal remedies are available to a distributor seeking to establish that a food or food ingredient has a history of safe food use?

3. What requirements are laid down by the Commission in respect of evidence that a food or food ingredient has a history of safe food use?

4. What legal remedies are available to a distributor where the competent national body referred to in Article 4(3) of the Regulation refuses to deliver on opinion declaring that a food or food ingredient is substantially equivalent to a food already authorised?

5. What is the basis for the EU working party's conclusion that only another juice may be regarded as substantially equivalent to authorised noni juice?

Answer given by Mr Byrne on behalf of the Commission

(15 January 2004)

All Member States and the Commission agree that noni products (Morinda citrifolia) are novel food within the meaning of Regulation (EC) No 258/97 (2), as they have been placed on the market only after the entry into force of the Regulation. Therefore, the marketing of noni products prior to a possible authorisation under the Regulation is considered as illegal in all Member States. In order to ensure that noni products are treated in the same manner throughout the Community, Member States have agreed to take the appropriate steps to end any ongoing marketing of noni products in their territory (see also the Commission's answer to Written Question E-0325/2002 by Mrs Müller (3)).

The scope of the authorisation granted by the Commission Decision 2003/426/EC (4) is limited to the juice of the fruits of Morinda citrifolia as an ingredient to pasteurised fruit juices and it does not cover other uses of the said product. Therefore, other parts of the plant and/or other uses of the juice are not authorised.

In order to protect public health, Regulation (EC) No 258/97 establishes a Community procedure for a single pre-market safety assessment of novel foods and novel food ingredients. The Member States are in charge of enforcement and control. Consequently, it would be the national authorities, probably with the help of the competent food assessment bodies, who would have to determine whether a history of safe human consumption of a particular food is adequately demonstrated. The Regulation does not set out any criteria for defining ‘history of safe consumption’. However, in order to ensure a harmonised approach in the safety assessment of novel foods and novel food ingredients, Member States refer to the criteria and requirements laid down in the Commission Recommendation 618/97/EC (5).

The determination whether the product has or not a history of safe consumption is not applicable in the case of Morinda citrifolia, because Commission Decision 2003/426/EC implies that it is a novel food. For other foods and food ingredients, if appropriate and necessary, a Decision whether a food or food ingredient falls within the scope of Regulation (EC) 258/97 may be taken pursuant to Article 1.3 of the Regulation according to the procedure provided for in Article 13.

Member States and the Commission agree that a request for an opinion about ‘substantial equivalence’ should not be denied. In the unlikely event of such a refusal from a national authority, the recourse to legal remedies would be a question of national administrative law.

However, it should be noted that the simplified procedure is applicable only to products that are substantially equivalent to existing foods and food ingredients, which include foods that were authorised pursuant to the Novel Food Regulation. Obviously, the specified conditions of use have to be taken into account.

Finally, the Commission would like to inform the Honourable Member that a revision of Regulation (EC) 258/97 will be undertaken in the course of 2004 in order to remedy any problems raised in the context of the application of the Regulation and ensure legal certainty and clarity for operators and public authorities.

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

(2) Regulation (EC) No 258/97 of the Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients, OJ L 43, 14.2.1997.

(3) OJ C 160 E, 4.7.2002.

(4) Commission Decision 2003/426/EC of 5 June 2003 authorising the placing on the market of'noni juice' (juice of the fruit of Morinda citrifolia 1.) as a novel food ingredient under Regulation (EC) No 258/97 of the Parliament and of the Council, OJ L 144, 12.6.2003.

(5) Commission Recommendation of 29 July 1997 concerning the scientific aspects and the presentation of information necessary to support applications for the placing on the market of novel foods and novel food ingredients and the preparation of initial assessment reports under Regulation EC No 258/97 of the European Parliament and of the Council, OJ L 253, 16.9.1997.