do-me/EUR-LEX huggingface dataset:
WRITTEN QUESTION No. 2173/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 - Financial requirements for monitoring
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. 2194/97 by Hiltrud BREYER to the Council. Novel food regulation No 258/97 - Recording the origins of novel food products
Date: 1997-06-25
Institutions: BREYER, European Parliament
Subjects: exchange of information, food inspection, foodstuff, genetically modified organism, human nutrition, marketing, new product, originating product, product quality

C 82/42

EN

Official Journal of the European Communities

17. 3. 98

(98/C 82/75)

WRITTEN QUESTION E-2190/97

by Hiltrud Breyer (V) to the Council

(25 June 1997)

Subject: Novel food regulation No 258/97 › Submission of genetically modified basic varieties and varieties

bred from them

Is it intended for the manufacturer to submit, in parallels with the tests, both genetically modified basic vartieties
and  varieties  bred  from  them  (given  that  in  some  cases  significant  changes  are  apparent  only  from  a  direct
comparison)?

(98/C 82/76)

WRITTEN QUESTION E-2194/97

by Hiltrud Breyer (V) to the Council

(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?

Joint answer
to Written Questions E-2188/97, E-2190/97 and E-2194/97

(28 October 1997)

Article 4(4) of the Regulation cited by the Honourable Member, with any supplements adopted in accordance
with paragraph 5 or, where applicable, Article 3(4) or Article 9(1) of the Regulation, covers the information to be
supplied in support of a request for the placing of products on the market.

This  information  does  not  prejudge  implementation  of  the  assessment  procedures  by  the  assessment  bodies
referred to in Article 4(3) of that Regulation.

(98/C 82/77)

WRITTEN QUESTION E-2192/97

by Hiltrud Breyer (V) to the Council

(25 June 1997)

Subject: Novel food regulation No 258797 › Recording of, and safety guarantees for, novel food products

Is it intended that authorities should keep a record of the foods in which various manufacturers use genetically
modified products so that if, following consumption of such foods, there is an occurrence of a health problem
which cannot be foreseen at present, all the products in question can be recalled?

(98/C 82/78)

WRITTEN QUESTION E-2204/97

by Hiltrud Breyer (V) to the Council

(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?
WRITTEN QUESTION No. 2187/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 - Laboratory standards
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. 2183/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 -Application of sensitivity limit values (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. 2203/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 - Publication of data on novel food products
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. 2175/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 - Monitoring of products free of 'genetic engineering' (SUPPLEMENTARY ANSWER)
Date: 1997-06-25
Institutions: BREYER, European Parliament
Subjects: food inspection, human nutrition, labelling, marketing, research body

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. 2185/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 - Further development of demonstration methods (SUPPLEMENTARY ANSWER)
Date: 1997-06-25
Institutions: BREYER, European Parliament
Subjects: EU programme, European standard, competence of the Member States, crop production, food inspection, genetically modified organism, human nutrition, new product, research programme

8. 6. 98

EN

Official Journal of the European Communities

C 174/9

(98/C 174/36)

WRITTEN QUESTION E-2185/97

by Hiltrud Breyer (V) to the Commission

(25 June 1997)

Subject: Novel food regulation No 258/97 › Further development of demonstration methods

What efforts are the Institutions of the EU making to facilitate further development of demonstration methods?

(98/C 174/37)

WRITTEN QUESTION E-2187/97

by Hiltrud Breyer (V) to the Commission

(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?

(98/C 174/38)

WRITTEN QUESTION E-2189/97

by Hiltrud Breyer (V) to the Commission

(25 June 1997)

Subject: Novel food regulation No 258/97 › Submission of proof by applicants

Will it continue to be a requirement that manufacturers are obliged to forward to the monitoring authorities their
demonstration  systems,  including  samples,  antibodies  required  for  demonstration  purposes,  gene  probes  and
extraction records etc.?

(98/C 174/39)

WRITTEN QUESTION E-2191/97

by Hiltrud Breyer (V) to the Commission

(25 June 1997)

Subject: Novel food regulation No 258/97 › Submission of genetically modified basic varieties and varieties

bred from them

Is it intended for the manufacturer to submit, in parallels with the tests, both genetically modified basic vartieties
and  varieties  bred  from  them  (given  that  in  some  cases  significant  changes  are  apparent  only  from  a  direct
comparison)?

(98/C 174/40)

WRITTEN QUESTION E-2193/97

by Hiltrud Breyer (V) to the Commission

(25 June 1997)

Subject: Novel food regulation No 258/97 › Recording of, and safety guarantees for, novel food products

Is it intended that authorities should keep a record of the foods in which various manufacturers use genetically
modified products so that if, following consumption of such foods, there is an occurrence of a health problem
which cannot be foreseen at present, all the products in question can be recalled?
WRITTEN QUESTION No. 2200/97 by Hiltrud BREYER to the Council. Novel food regulation No 258/97 - Access to 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. 2164/97 by Hiltrud BREYER to the Council. Novel food regulation No 258/97- Demonstrability
Date: 1997-06-25
Institutions: BREYER, European Parliament
Subjects: crop production, food inspection, foodstuff, foodstuffs legislation, genetically modified organism, human nutrition, new product, seed, vegetable protein

C 82/38

EN

Official Journal of the European Communities

17. 3. 98

(98/C 82/60)

WRITTEN QUESTION E-2160/97

by Hiltrud Breyer (V)

to the Council (25 June 1997)

Subject: Novel food regulation No 258/97 › (cid:145)appropriate analysis(cid:146)

1. What is understood by (cid:145)appropriate analysis(cid:146) (novel food regulation No 258/97/EEC (1))?

2.

How is monitoring to be carried out?

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

(98/C 82/61)

WRITTEN QUESTION E-2162/97

by Hiltrud Breyer (V) to the Council

(25 June 1997)

Subject: Novel food regulation No 258/97 › Demonstrability

1. What systems are to be set up for the (cid:145)appropriate analysis(cid:146)?

2. What methods will probably be used?

(98/C 82/62)

WRITTEN QUESTION E-2164/97

by Hiltrud Breyer (V) to the Council

(25 June 1997)

Subject: Novel food regulation No 258/97- Demonstrability

1. Who will be responsible for establishing demonstration methods?

2.

3.

By which authorities and/or private institutions will the checks be carried out?

By what date is this to be done?

(98/C 82/63)

WRITTEN QUESTION E-2166/97

by Hiltrud Breyer (V) to the Council

(25 June 1997)

Subject: Nivel food regulation No 97/258 › Monitoring requirements

What method will be used to finance the setting up and maintenance of the authorities responsible for monitoring
and assessment?

(98/C 82/64)

WRITTEN QUESTION E-2176/97

by Hiltrud Breyer (V) to the Council

(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?