WRITTEN QUESTION P-3594/03 by Wolfgang Kreissl-Dörfler (PSE) to the Commission. Novel Foods Regulation EC No 258/97, marketing of noni products in the EU.
Date: 2003-12-01
Institutions: European Parliament, Provisional data
Subjects: food inspection, food safety, foodstuffs legislation, fruit product, human nutrition, marketing, tropical fruit

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congestion and environmental problems. Cross-border sections and crossing of natural barriers were
identified as two key areas. Therefore, the proposal puts an important focus on railway investments
crossing the Alps.

A new proposal to amend the so-called Eurovignette directive proposes a harmonised method for charging
full infrastructure costs to heavy goods vehicles. According to this proposal, a mark-up can be levied in
environmentally sensitive zones such as the Alps to cross-finance investments in alternative modes.

In the case of the Alps, where transport capacity is scarce,
improved railway services, based on the
respective infrastructure improvements, will reduce demand on road according to recent studies. On the
other hand, charging for road use will also induce higher demand for railways.

The Commission proposal of 1 October 2003 identifies the European priority projects,
including the
Brenner base tunnel and the Turin-Lyon base tunnel. This Commission proposal is currently discussed in
the Council and the Parliament.

The Commission cannot intervene in a decision taken at a national level like the decision to ratify the
Transport Protocol of the Alpine Convention. However, when assessing Member States’ proposals for
project funding, an assessment will be made as to the financial feasibility as well as to the strategic
environmental impacts. Consideration will therefore be given to parallel projects developed on a national
basis and influencing the profitability of the rail tunnels.

(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 1(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.

According to what criteria is ‘having a history of safe food use’ defined in this connection, and which

1.
institution decides whether a food or food ingredient has a history of safe food use?

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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?

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

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 (1), 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 (2)).

The scope of the authorisation granted by the Commission Decision 2003/426/EC (3) 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 (4).

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.

it should be noted that

However,
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.

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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) 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.

(2) OJ C 160 E, 4.7.2002.
(3) 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 l.) as a novel food ingredient under Regulation (EC) No 258/97 of the Parliament and
of the Council, OJ L 144, 12.6.2003.

(4) 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.

(2004/C 84 E/0075)

WRITTEN QUESTION E-3597/03

by Glyn Ford (PSE) to the Commission

(5 December 2003)

Subject: Tendering processes for development and humanitarian assistance

Would the Commission comment on how many Member States have less rigorous controls on tendering
than those operated by the EU?

Answer given by Mr Bolkestein on behalf of the Commission

(16 February 2004)

All public contracts undertaken by a Member State for pecuniary interest are subject to the EU Public
Procurement Directives (1) provided their value exceeds the threshold set in the relevant directive. This
includes contracts financed through bilateral development aid granted by the Member States to which the
contracting authorities belong and under whose financial responsibility the tender is organized.

Following a complaint, the European Commission carried out an extensive enquiry into the procurement
practices of all 15 Member States concerning purchases financed by development aid, which led to the
opening of a number of infringement procedures. Indeed, it appeared that some Member States used to
make the grant of aid to developing countries conditional on the purchase of goods, services or works
originating from the donor country (‘tied aid’). Pursuant to the Commission’s enquiry only four Member
States are still in the course of taking steps to remedy infringements to public procurement law.

As regards development aid granted by the Commission itself, specific provisions apply in accordance with
the Financial Regulation (2), the Implementing Rules for the Financial Regulation (3), the General Regulation
for service, supply and works contracts financed by the European Development Fund (EDF) (4) and the
Financial Regulation applicable to the 9th EDF (5). Detailed provisions on controls on public procurement
are applied in this framework.

As regards humanitarian aid granted by the Member States, the Commission is not at this stage aware of
problems linked to the way Member States organize tender procedures. As far as Community humanitarian
aid is concerned, the Commission has adopted, as stipulated by Article 238(3) of the Financial Regulation’s
Implementing Rules, specific procurement procedures, which are contained in Annex V of the Framework
Partnership Agreement applicable to humanitarian operations. These procedures share the objectives of