do-me/EUR-LEX huggingface dataset:
WRITTEN QUESTION No. 2181/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 - Demonstration of genetic modification (SUPPLEMENTARY ANSWER)
Date: 1997-06-25
Institutions: BREYER, European Parliament
Subjects: crop production, food inspection, genetically modified organism, human nutrition, new product

C 174/8

EN

Official Journal of the European Communities

8. 6. 98

(98/C 174/31)

WRITTEN QUESTION E-2175/97

by Hiltrud Breyer (V) to the Commission

(25 June 1997)

Subject: Novel food regulation No 258/97 › Monitoring of products free of (cid:145)genetic engineering(cid:146)

1. Will  the  research  laboratories  also  be  available  to  manufacturers  not  supplying  products  produced  by
genetic engineering processes and who wish to have this checked?

2. Will such research be free of charge, in order not to place the manufacturers in question at a disadvantage?

On the other hand, will the tests cover not only those foods which manufacturers declare not to have been

3.
produced by genetic engineering?

(98/C 174/32)

WRITTEN QUESTION E-2177/97

by Hiltrud Breyer (V) to the Commission

(25 June 1997)

Subject: Novel food regulation No 258/97 › Demonstration methods

In order to distinguish a genetically engineered product from a product which is not genetically engineered, will
only the proof of the protein created by the new gene be used?

(98/C 174/33)

WRITTEN QUESTION E-2179/97

by Hiltrud Breyer (V) to the Commission

(25 June 1997)

Subject: Novel food regulation 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 174/34)

WRITTEN QUESTION E-2181/97

by Hiltrud Breyer (V) to the Commission

(25 June 1997)

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

How will the criterion of demonstrable genetic modification be applied to seeds if the new protein(s) is/are

1.
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 174/35)

WRITTEN QUESTION E-2183/97

by Hiltrud Breyer (V) to the Commission

(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?
WRITTEN QUESTION No. 2175/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 - Monitoring of products free of 'genetic engineering'
Date: 1997-06-25
Institutions: BREYER, European Parliament
Subjects: consumer information, consumer protection, crop production, environmental protection, food inspection, foodstuffs legislation, genetically modified organism, human nutrition, labelling, new product

25. 2. 98

EN

Official Journal of the European Communities

C 60/109

(98/C 60/185)

WRITTEN QUESTION E-2199/97

by Hiltrud Breyer (V) to the Commission

(25 June 1997)

Subject: Novel food regulation No 258/97 › Recording data on novel food products

What authorities are responsible, pursuant to the novel food regulation, for recording data in databases on all
products which are approved or which have been registered?

(98/C 60/186)

WRITTEN QUESTION E-2201/97

by Hiltrud Breyer (V) to the Commission

(25 June 1997)

Subject: Novel food regulation No 258/97 › Access to data on novel food products

Will there be public access to these data banks, or will some data be subject to confidentiality?

(98/C 60/187)

WRITTEN QUESTION E-2203/97

by Hiltrud Breyer (V) to the Commission

(25 June 1997)

Subject: Novel food regulation No 258/97 › Publication of data on novel food products

Will both the scientific data that have been submitted and the evaluation of such data be published?

(98/C 60/188)

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?

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

(17 September 1997)

The Commission is collecting the information it needs to answer the question. It will communicate its findings as
soon as possible.
WRITTEN QUESTION No. 2165/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 - Demonstrability methods
Date: 1997-06-25
Institutions: BREYER, European Parliament
Subjects: consumer information, consumer protection, crop production, environmental protection, food inspection, foodstuffs legislation, genetically modified organism, human nutrition, labelling, new product

25. 2. 98

EN

Official Journal of the European Communities

C 60/109

(98/C 60/185)

WRITTEN QUESTION E-2199/97

by Hiltrud Breyer (V) to the Commission

(25 June 1997)

Subject: Novel food regulation No 258/97 › Recording data on novel food products

What authorities are responsible, pursuant to the novel food regulation, for recording data in databases on all
products which are approved or which have been registered?

(98/C 60/186)

WRITTEN QUESTION E-2201/97

by Hiltrud Breyer (V) to the Commission

(25 June 1997)

Subject: Novel food regulation No 258/97 › Access to data on novel food products

Will there be public access to these data banks, or will some data be subject to confidentiality?

(98/C 60/187)

WRITTEN QUESTION E-2203/97

by Hiltrud Breyer (V) to the Commission

(25 June 1997)

Subject: Novel food regulation No 258/97 › Publication of data on novel food products

Will both the scientific data that have been submitted and the evaluation of such data be published?

(98/C 60/188)

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?

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

(17 September 1997)

The Commission is collecting the information it needs to answer the question. It will communicate its findings as
soon as possible.
WRITTEN QUESTION No. 2168/97 by Hiltrud BREYER to the Council. Novel food regulation No 97/258 - Carrying out monitoring
Date: 1997-06-25
Institutions: BREYER, European Parliament
Subjects: financing method, food inspection, foodstuff, foodstuffs legislation, human nutrition, new product, producer organisation, research body, vocational training

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.

2.

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

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?
WRITTEN QUESTION No. 2202/97 by Hiltrud BREYER to the Council. Novel food regulation No 258/97 - Publication of data on novel food products
Date: 1997-06-25
Institutions: BREYER, European Parliament
Subjects: access to information, administrative transparency, confidentiality, consumer information, data collection, database, dissemination of information, foodstuff, human nutrition, new product

C 82/44

EN

Official Journal of the European Communities

17. 3. 98

(98/C 82/81)

WRITTEN QUESTION E-2200/97

by Hiltrud Breyer (V) to the Council

(25 June 1997)

Subject: Novel food regulation No 258/97 › Access to data on novel food products

Will there be public access to these data banks, or will some data be subject to confidentiality?

(98/C 82/82)

WRITTEN QUESTION E-2202/97

by Hiltrud Breyer (V) to the Council

(25 June 1997)

Subject: Novel food regulation No 258/97 › Publication of data on novel food products

Will both the scientific data that have been submitted and the evaluation of such data be published?

Joint answer
to Written Questions E-2198/97, E-2200/97 and E-2202/97

(28 October 1997)

The detailed rules governing the protection of data provided by an applicant for a marketing authorization are
adopted in accordance with the procedure laid down in Article 13 of the Regulation referred to by the Honourable
Member.

Regulation No 258/97 (1) makes no provision for the systematic publication of either the scientific data submitted
or  the  evaluation  of  that  data,  nor  does  it  make  provision  for  the  designation  of  authorities  competent  for
recording data concerning the products approved or notidied in accordance with that Regulation.

(1)  OJ L 43, 14.02.1997.

(98/C 82/83)

WRITTEN QUESTION E-2213/97

by Jean-Pierre Bazin (UPE) to the Commission

(30 June 1997)

Subject: Harbour dues in EU ports › unfair competition

According  to  a  comparative  study  of  harbour  dues,  the  dues  charged  by  the  Belgian  port  of  Zeebrugge  are
considerably lower (approximately 50% on average) than the European average.

This difference can only be accounted for by the existence of massive state aid or local practices which are not in
line with the EU rules.

Can the Commission investigate these practices, which are damaging to ports in the Union, and, if necessary,
adopt all requisite measures to re-establish conditions more amenable to fair competition?

Answer given by Mr Kinnock on behalf of the Commission

(12 September 1997)

The Commission does not normally monitor tariff practices nor does it aim to harmonize tariffs in the port sector.
However, in specific cases, such a matter may be examined in the context of individual complaints.

Low port tariffs do not necessarily mean that these particular ports benefit from state aid. Instead low tariff levels
can be due to other factors such as the ports’ commercial policy or efficient port management. Each situation has
to be examined individually in order to establish whether there is aid involved.
WRITTEN QUESTION No. 2191/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 - Submission of genetically modified basic varieties and varieties bred from them
Date: 1997-06-25
Institutions: BREYER, European Parliament
Subjects: consumer information, consumer protection, crop production, environmental protection, food inspection, foodstuffs legislation, genetically modified organism, human nutrition, labelling, new product

25. 2. 98

EN

Official Journal of the European Communities

C 60/109

(98/C 60/185)

WRITTEN QUESTION E-2199/97

by Hiltrud Breyer (V) to the Commission

(25 June 1997)

Subject: Novel food regulation No 258/97 › Recording data on novel food products

What authorities are responsible, pursuant to the novel food regulation, for recording data in databases on all
products which are approved or which have been registered?

(98/C 60/186)

WRITTEN QUESTION E-2201/97

by Hiltrud Breyer (V) to the Commission

(25 June 1997)

Subject: Novel food regulation No 258/97 › Access to data on novel food products

Will there be public access to these data banks, or will some data be subject to confidentiality?

(98/C 60/187)

WRITTEN QUESTION E-2203/97

by Hiltrud Breyer (V) to the Commission

(25 June 1997)

Subject: Novel food regulation No 258/97 › Publication of data on novel food products

Will both the scientific data that have been submitted and the evaluation of such data be published?

(98/C 60/188)

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?

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

(17 September 1997)

The Commission is collecting the information it needs to answer the question. It will communicate its findings as
soon as possible.
WRITTEN QUESTION No. 2201/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 - Access to data on novel food products (SUPPLEMENTARY ANSWER)
Date: 1997-06-25
Institutions: BREYER, European Parliament
Subjects: access to information, consumer information, data collection, database, foodstuffs legislation, genetically modified organism, human nutrition, new product

C 174/10

EN

Official Journal of the European Communities

8. 6. 98

(98/C 174/41)

WRITTEN QUESTION E-2195/97

by Hiltrud Breyer (V) to the Commission

(25 June 1997)

Subject: Novel food regulation No 258/97 › Recording the origins of novel food products

Are manufacturing firms obliged, as part of quality control, to keep a record of the origin of all ingredients used
in food production and, where required, to forward such records to the authorities?

(98/C 174/42)

WRITTEN QUESTION E-2197/97

by Hiltrud Breyer (V) to the Commission

(25 June 1997)

Subject: Novel food regulation No 258/97 › Assessing the effects of the consumption of novel food products

1.
How, and by whom, is the monitoring system called for by the Scientific Committee for Food (opinion on
the assessment of novel foods, III/5915/97) for gathering information on the short- and long-term effects of the
consumption of novel foods to be carried out once it has been introduced?

2. What data are to be recorded and over what period?

3. Will the results of the monitoring programme be made available to the public?

(98/C 174/43)

WRITTEN QUESTION E-2199/97

by Hiltrud Breyer (V) to the Commission

(25 June 1997)

Subject: Novel food regulation No 258/97 › Recording data on novel food products

What authorities are responsible, pursuant to the novel food regulation, for recording data in databases on all
products which are approved or which have been registered?

(98/C 174/44)

WRITTEN QUESTION E-2201/97

by Hiltrud Breyer (V) to the Commission

(25 June 1997)

Subject: Novel food regulation No 258/97 › Access to data on novel food products

Will there be public access to these data banks, or will some data be subject to confidentiality?

(98/C 174/45)

WRITTEN QUESTION E-2203/97

by Hiltrud Breyer (V) to the Commission

(25 June 1997)

Subject: Novel food regulation No 258/97 › Publication of data on novel food products

Will both the scientific data that have been submitted and the evaluation of such data be published?
WRITTEN QUESTION No. 2189/97 by Hiltrud BREYER to the Commission. Novel food regulation No 2587)7 - Submission of proof by applicants
Date: 1997-06-25
Institutions: BREYER, European Parliament
Subjects: consumer information, consumer protection, crop production, environmental protection, food inspection, foodstuffs legislation, genetically modified organism, human nutrition, labelling, new product

25. 2. 98

EN

Official Journal of the European Communities

C 60/109

(98/C 60/185)

WRITTEN QUESTION E-2199/97

by Hiltrud Breyer (V) to the Commission

(25 June 1997)

Subject: Novel food regulation No 258/97 › Recording data on novel food products

What authorities are responsible, pursuant to the novel food regulation, for recording data in databases on all
products which are approved or which have been registered?

(98/C 60/186)

WRITTEN QUESTION E-2201/97

by Hiltrud Breyer (V) to the Commission

(25 June 1997)

Subject: Novel food regulation No 258/97 › Access to data on novel food products

Will there be public access to these data banks, or will some data be subject to confidentiality?

(98/C 60/187)

WRITTEN QUESTION E-2203/97

by Hiltrud Breyer (V) to the Commission

(25 June 1997)

Subject: Novel food regulation No 258/97 › Publication of data on novel food products

Will both the scientific data that have been submitted and the evaluation of such data be published?

(98/C 60/188)

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?

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

(17 September 1997)

The Commission is collecting the information it needs to answer the question. It will communicate its findings as
soon as possible.
WRITTEN QUESTION No. 2158/97 by Hiltrud BREYER to the Council. Novel food regulation No 258/97 - Unintentional inclusion in traditional foods of substances for which labelling is obligatory
Date: 1997-06-25
Institutions: BREYER, European Parliament
Subjects: consumer information, food inspection, foodstuff, genetically modified organism, human nutrition, labelling, marketing, new product, prepared foodstuff, public health

17. 3. 98

EN

Official Journal of the European Communities

C 82/37

3. What form will the labelling take for processed goods which consist only to a limited extent of products for
which labelling is obligatory (e.g. ready meals with many additives)?

Have any proposals already been made for the form of labelling for the products under 1, 2 and 3, and what

4.
information is to be provided in each case?

(98/C 82/58)

WRITTEN QUESTION E-2156/97

by Hiltrud Breyer (V) to the Council

(24 June 1997)

Subject: Novel food regulation No 258/97 › Labelling

Is there any provision for involving national authorities, consumer associations and environmental groups etc. in
making and discussing proposals before the form of labelling is finally agreed?

Joint answer
to Written Questions E-2154/97 and E-2156/97

(20 October 1997)

Article 8 (3) of Regulation No 258/97, adopted by the European Parliament and the Council in accordance with
the procedure laid down in Article 189 b of the Treaty, stipulates how the detailed rules for labelling are to be
drawn up, to be supplemented in accordance with Article 7 (2).

(98/C 82/59)

WRITTEN QUESTION E-2158/97

by Hiltrud Breyer (V) to the Council

(25 June 1997)

Subject: Novel food regulation No 258/97 › Unintentional inclusion in traditional foods of substances for which

labelling is obligatory

1. What  procedure  is  to  be  adopted  towards  products  which,  while  not  consisting  of  genetically  modified
products, may (unintentionally) contain elements of such products?

Is  there  any  provision,  in  these  cases,  for  monitoring  and,  where  appropriate,  labelling  (e.g.  honey  and

2.
honey products with pollen from transgenic plants)?

3.

Are products containing pollen to be tested to ensure that consumption poses no health risk?

Answer

(20 October 1997)

The Regulation referred to by the Honourable Member was adopted by the European Parliament and the Council
in accordance with the procedure laid down in Article 189b of the EC Treaty.

Article 1 of the Regulation defines its scope and, subject to the implementation of paragraph 3 thereof, does not
cover cases where foods or ingredients unintentionally fall within the categories laid down in that Article.

In  any  event,  the  general  provisions  of  Community  legislation  on  the  control  of  foodstuffs  (Directives
89/397/EEC (1) and 93/99/EEC (2)) still apply.

(1)  OJ L 186, 30.06.1989.
(2)  OJ L 290, 24.11.1993.