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17. 3.

98 EN Official Journal of the European Communities C 82/39

(98/C 82/65) WRITTEN QUESTION E-2178/97


by Hiltrud Breyer (V) to the Council
(25 June 1997)

Subject: Novel food regulastion No 258/97 − Demonstration methods

1. Is the intention also to use indirect detection methods in order to be able to determine the changes
characteristic of genetically modified varieties (e.g. modified fatty acid samples in oil from genetically modified
soya beans)?

2. Will such significant changes be recorded and collected as alternative detection possiblities for monitoring
bodies?

(98/C 82/66) WRITTEN QUESTION E-2180/97


by Hiltrud Breyer (V) to the Council
(25 June 1997)

Subject: Novel food regulation No 258/97 − Demonstration of genetic modification

1. How will the criterion of demonstrable genetic modification be applied to seeds if the new protein(s) is/are
only formed, and can be demonstrated to exist, in plants?

2. What assessment methods are to be used in future to distinguish between different batches of seeds?

(98/C 82/67) WRITTEN QUESTION E-2182/97


by Hiltrud Breyer (V) to the Council
(25 June 1997)

Subject: Novel food regulation No 258/97 -Application of sensitivity limit values

Are the sensitivity limits used to demonstrate genetic modification to be continuously updated in line with the
state of the art?

(98/C 82/68) WRITTEN QUESTION E-2186/97


by Hiltrud Breyer (V) to the Council
(25 June 1997)

Subject: Novel food regulation No 258/97 − Laboratory standards

Are there generally binding procedures and prescribed reporting methods for the work to be carried out in
laboratories?

Joint answer
to Written Questions E-2160/97, E-2162/97, E-2164/97, E-2166/97,
E-2176/97, E-2178/97, E-2180/97, E-2182/97 and E-2186/97
(28 October 1997)

As specified in Article 8(1)(a) of Regulation (EC) No 258/97 (1), an appropriate analysis should be able, if
necessary, to demonstrate that certain characteristics of a novel food or food ingredient “are different in
comparison with a conventional food or food ingredient, having regard to the accepted limits of natural
variations for such characteristics”. It should also be noted that any arrangements for applying Article 8 will be
adopted in accordance with the (Committee) procedure provided for in Article 13.
C 82/40 EN Official Journal of the European Communities 17. 3. 98

The questions are worded in such a way that it is difficult to identify the checks or monitoring to which the
Honourable Member refers. The general provisions of Community legislation on the monitoring of foodstuffs
are in any event applicable.

Regarding the assessments to be carried out under Articles 4 and 6 of Regulation No 258/97, the detailed
arrangements, and notable the role of the Member States as regards the assessment bodies, are laid down in
Article 4(3) and Article 6(2) to (4), supplemented, where Commission will publish recommendations concerning
the scientifc aspects of the preparation of the initial assessment reports. These provisions are supplemented,
where appropriate, by the relevant provisions of Directive 90/220/EEC (2).

Regarding methods of analysis, it will be recalled that Article 4 of Directive 93/99/EEC (3) provides that Member
States shall ensure that the validation of methods of analysis used within the context of official control of
foodstuffs complies whenever possible with certain criteria laid down in Directive 85/591/EEC (4) concerning the
introduction of Community methods of sampling and analysis for monitoring of foodstuffs intended for human
consumption.

(1) OJ L 43, 14.2.1997.


(2) OJ L 117, 8.5.1990.
(3) OJ L 290, 24.11.1993.
(4) OJ L 372, 31.12.1985.

(98/C 82/69) WRITTEN QUESTION E-2168/97


by Hiltrud Breyer (V) to the Council
(25 June 1997)

Subject: Novel food regulation No 97/258 − Carrying out monitoring

Are there any initiatives aimed at setting up special laboratories to carry out the monitoring duties in food
monitoring bodies?

(98/C 82/70) WRITTEN QUESTION E-2170/97


by Hiltrud Breyer (V) to the Council
(25 June 1997)

Subject: Novel food regulation No 258/97 − Staff required for monitoring

1. Are the staffing requirements for the various monitoring methods available, or will they be created?

2. Are there to be any special training measures for staff?

(98/C 82/71) WRITTEN QUESTION E-2172/97


by Hiltrud Breyer (V) to the Council
(25 June 1997)

Subject: Novel food regulation No 258/97 − Financial requirements for monitoring

Have additional appropriations been included in the budgets in the light of the likely duties?