WRITTEN QUESTION E-4036/03 by Hiltrud Breyer (Verts/ALE) to the Commission. Novel Food Regulation (EC) No 258/97 and Noni products.
Date: 2004-01-12
Institutions: European Parliament, Provisional data
Subjects: animal experimentation, food inspection, food safety, foodstuff, foodstuffs legislation, fruit product, market approval, marketing, tropical fruit

3.4.2004

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Official Journal of the European Union

C 84 E/137

How can the number of hunting licences be increased so as to render it commensurate with an area’s

2.
wild animal population?

Answer given by Mrs Wallström on behalf of the Commission

(5 February 2004)

Several large carnivores, such as the wolf, brown bear and lynx, are protected by Council Directive 92/43/
EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (1), Annex IV(a).
These species are therefore subject to the strict protection scheme that requires, among others, that their
deliberate killing is prohibited. The Directive does, however, recognize that in certain situations there may
exist the need for a derogation to this general rule of strict protection. These justifications, which include
‘inter alia’ public safety and preventing serious damage to livestock, are listed in Article 16 of the Directive.
Member States may apply these derogations provided that there is no satisfactory alternative and the
derogation is not detrimental to the maintenance of the populations of the species concerned at a
favourable conservation status in their natural range.

The number of bears in Finland (830 in 2002)
is, according to the authorities, stable rather than
expanding. The 2003 hunting quota for bears in Finland was 90 individuals which cannot be considered a
small number. The number of wolves is 130 which would still mean that its conservation status is not
favourable. When defining the national conservation status of these species, Russian influence has been
taken into account and the degree downgraded accordingly: bears from actual ‘Vulnerable’ (vaarantunut) to
‘Near
(äärimmäisen
uhanalainen) to ‘Endangered’ (erittäin uhanalainen).

(silmälläpidettävä) and wolves similarly from ‘Critically endangered’

threatened’

The Commission is aware that the Finnish authorities, in granting permits to hunt bear, are adjusting the
regional quotas according to the population in the areas concerned. With respect to wolves, specific
permits are granted for the destruction of individuals that have become problematic for the justifications
foreseen in the Directive.

The Commission is, therefore, of the view that the Directive allows for appropriate management of the
species to avoid problems of public safety and damage to agricultural interests. In discussions with the
Finnish authorities, the Commission has requested that these measures should be structured in the form of
a management plan which addresses the conservation management objectives for the species alongside the
issue of population control and the approaches that should be taken to promote co-existence between
large carnivores and human populations. It is clear that there is much experience of this in Member States.
A recent conference on the specific issue of the wolf, ‘Living with the Wolf’ organized by the Commission
in collaboration with the Spanish authorities and with participants from all Member States with wolf
populations, was the first in a series of actions the Commission is proposing to promote such positive
co-operation between Member States.

(1) OJ L 206, 22.7.1992.

(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
In the meantime, the
that the Novel Food Regulation (NFR)
application by the American company Morinda to sell Noni products has been granted by the
Commission.

(258/97) (1) applied to Noni products.

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?

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3.4.2004

Is the Commission aware of any circumstances in which a dried food product such as dried Noni

2.
fruit can damage consumers’ health and a chemically identical juice cannot?

Following the entry into force of Regulation No 1829/2003 (2) on genetically modified food, the NFR
3.
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?

(1) OJ L 43, 14.2.1997, p. 1.
(2) OJ L 268, 18.10.2003, p. 1.

Answer given by Mr Byrne on behalf of the Commission

(1 March 2004)

An important objective of Regulation (EC) No 258/97 (1) concerning 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 (2) 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.

foods and novel

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.

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The Honourable Member is also invited to refer to the Commission’s response to written question
P-3594/03 by Mr Kreissl-Dörfler (3).

(1) OJ L 43, 14.2.1997.
(2) OJ L 268, 18.10.2003.
(3) See page 69.

(2004/C 84 E/0177)

WRITTEN QUESTION E-4037/03

by Hiltrud Breyer (Verts/ALE) to the Commission

Subject: Health reform and natural remedies in Germany

(12 January 2004)

the German Government’s

As part of its health reforms, Germany has changed the law and made competition between conventional
pharmaceutical medicines and natural remedies virtually impossible. Although experts have been working
on a positive list of medicinal products including herbal, homeopathic and anthroposophic remedies for
years,
so-called health reform has now removed the possibility of
reimbursement for natural medicines through health insurance schemes. Thanks to the health reform,
a distortion in competition has emerged that benefits pharmaceutical products. Many patients use natural
treatments and remedies, which produce better results in many cases than conventional treatment. These
successes should not be brought to an end by market competition between pharmaceutical and natural
products favouring the former. As well as the prospect of worse treatment for patients opting for natural
medicine, small manufacturers of natural remedies in particular are threatened with bankruptcy.

How does the Commission view this situation from the point of view of competition law?

Answer given by Mr Monti on behalf of the Commission

(10 February 2004)

It is established case law of the European Courts that Community law does not detract from the powers of
Member States to organise their social security systems and to adopt, in particular, provisions intended to
govern the consumption of pharmaceutical preparations in order to promote the financial stability of their
health-care insurance schemes (1). Based on the description given by the Honourable Member,
the
Commission does not have reason to believe that the legal provisions adopted by the German legislator
with the object of refusing insured persons the right to be supplied with prescription-free medicinal
preparations at the expense of the statutory sickness funds would infringe European competition law.

(1) See for example Judgment of the Court of 7 February 1984 in Case 238/82 Duphar BV and others v. The

Netherlands State [1984] European Court Reports 1984 page 523.

(2004/C 84 E/0178)

WRITTEN QUESTION E-4057/03

by Elspeth Attwooll (ELDR) to the Commission

(13 January 2004)

Subject: Trans-European telecommunications networks

What proportion of rural residents in the EU have broadband internet access, and how does this compare
to that in urban areas? What is the projected impact in terms of economic growth of expanding
broadband access in rural areas?