WRITTEN QUESTION No. 2205/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 - Transparency of authorizations of novel food products (SUPPLEMENTARY ANSWER)
Date: 1997-06-25
Institutions: BREYER, European Parliament
Subjects: consumer information, crop production, foodstuffs legislation, genetically modified organism, human nutrition, new product

8. 6. 98

EN

Official Journal of the European Communities

C 174/11

(98/C 174/46)

WRITTEN QUESTION E-2205/97

by Hiltrud Breyer (V) to the Commission

(25 June 1997)

Subject: Novel food regulation No 258/97 › Transparency of authorizations of novel food products

1.

2.

How will the requisite level of long-term public transparency and information be guaranteed?

Are the consumer organizations to be informed of all the products that have been authorized?

3. What guarantees are there that this information will be complete and up-to-date?

Supplementary joint answer
to Written Questions E-2113/97, E-2115/97, E-2117/97, E-2119/97,
E-2121/97, E-2123/97, E-2127/97, E-2129/97, E-2131/97, E-2133/97, E-2135/97, E-2137/97,
E-2139/97, E-2141/97, E-2143/97, E-2145/97, E-2147/97, E-2149/97, E-2151/97, E-2153/97,
E-2155/97, E-2157/97, E-2159/97, E-2161/97, E-2163/97, E-2165/97, E-2167/97, E-2169/97,
E-2171/97, E-2173/97, E-2175/97, E-2177/97, E-2179/97, E-2181/97, E-2183/97, E-2185/97,
E-2187/97, E-2189/97, E-2191/97, E-2193/97, E-2195/97, E-2197/97, E-2199/97, E-2201/97,
E-2203/97 and E-2205/97
given by Mr Bangemann on behalf of the Commission

(11 November 1997)

Further to its answer of 17 September 1997 (1), the Commission can now provide the following information.

E-2113/97, E-2115/97, E-2117/97, E-2119/97, E-2123/97, E-2149/97

At  the  present  time,  seeds  covered  by  Directives  70/457/EEC  and  70/458/EEC,  be  they  genetically  modified
organisms (GMOs) or not, must be registered in the common catalogue of varieties before being placed on the
market within the Community. Before being registered, it must be established that they are distinct, stable and
sufficiently uniform. Where seeds are GMOs, they must, in addition, undergo a human safety and environmental
risk assessment under Council Directive No 90/220/EC of 23 April 1990 concerning the deliberate release of
genetically modified organisms into the environment. The labelling of such products, ie transgenic seeds, must
be carried out in accordance with Annex III to that directive.

Furthermore,  since  15  May  1997,  all  foods  and  food  ingredients  containing,  consisting  of,  or  derived  from
GMOs, which have not hitherto been consumed to a significant degree within the Community, must follow the
procedures laid down in Regulation (EC) 258/97 concerning novel foods and novel food ingredients. Article 8 of
that Regulation also lays down the labelling rules that apply to such products.

As  the  Honourable  Member  is  aware,  Regulation  (EC)  258/97  initiates  the  so-called  (cid:145)one-stop(cid:146)  policy.  This
means that it is possible to carry out the risk assessment relating to Directive 90/220/EC in the framework of the
Regulation.

Moreover,  the  Commission  has  submitted  a  proposal  to  amend  the  directives  relating  to  the  marketing  of
seeds (2). This proposal, on which Parliament has given its opinion, stipulates that an applicant must have the
environmental risks pursuant to Directive 90/220/EC assessed within the framework of the seeds directive, and
also stipulates the possibility of having novel food characteristics analysed, in order to simplify administrative
procedures,  again  in  accordance  with  the  (cid:145)one-stop(cid:146)  principle.  This  possibility,  envisaged  in  Article  3(2)  of
Regulation (EC) 258/97, has not yet been implemented, pending the adoption of the new rules on seeds.

E-2121/97

Normally, the safety evaluation of a novel food will cover all uses of the foodstuff concerned. Thus the safety
evaluation of a genetically modified tomato would cover tomato concentrate, and processed foods containing
that concentrate. However, in certain cases, a separate evaluation of secondary products may be required.