do-me/EUR-LEX huggingface dataset:
WRITTEN QUESTION No. 2163/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 - Demonstrability
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. 2184/97 by Hiltrud BREYER to the Council. Novel food regulation No 258/97 - Further development of demonstration methods
Date: 1997-06-25
Institutions: BREYER, European Parliament
Subjects: food inspection, foodstuff, foodstuffs legislation, human nutrition, new product, research body, research method

17. 3. 98

EN

Official Journal of the European Communities

C 82/41

(98/C 82/72)

WRITTEN QUESTION E-2174/97

by Hiltrud Breyer (V) to the Council

(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?

Joint answer
to Written Questions E-2168/97, E-2172/97 and E-2174/97

(28 October 1997)

The Council has not received any information on Member States(cid:146) arrangements regarding these points.

(98/C 82/73)

WRITTEN QUESTION E-2184/97

by Hiltrud Breyer (V) to the Council

(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?

Answer

(28 october 1997)

The Council has no specific powers in this connection and has not been informed of the intentions of the other
Institutions,  and  in  particular  of  the  European  Parliament,  in  this  area,  leaving  aside  the  Commission(cid:146)s
responsibilities pursuant to Regulation No 258797 (1), and in particular Article 4(4) thereof.

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

(98/C 82/74)

WRITTEN QUESTION E-2188/97

by Hiltrud Breyer (V) to the Council

(25 June 1997)

Subject: Novel food regulkation No 2587)7 › 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.?
WRITTEN QUESTION No. 2171/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 - staff required for monitoring (SUPPLEMENTARY ANSWER)
Date: 1997-06-25
Institutions: BREYER, European Parliament
Subjects: competence of the Member States, crop production, food inspection, foodstuffs legislation, genetically modified organism, human nutrition, new product, staff, vocational training

8. 6. 98

EN

Official Journal of the European Communities

C 174/7

(98/C 174/26)

WRITTEN QUESTION E-2165/97

by Hiltrud Breyer (V) to the Commission

(25 June 1997)

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

1. Who will be responsible for setting up demonstration methods?

2.

3.

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

By what date is this to be done?

(98/C 174/27)

WRITTEN QUESTION E-2167/97

by Hiltrud Breyer (V) to the Commission

(25 June 1997)

Subject: Novel food regulation No 258/97

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

(98/C 174/28)

WRITTEN QUESTION E-2169/97

by Hiltrud Breyer (V) to the Commission

(25 June 1997)

Subject: Novel food regulation No 258/97 › 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 174/29)

WRITTEN QUESTION E-2171/97

by Hiltrud Breyer (V) to the Commission

(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 174/30)

WRITTEN QUESTION E-2173/97

by Hiltrud Breyer (V) to the Commission

(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. 2186/97 by Hiltrud BREYER to the Council. Novel food regulation No 258/97 - Laboratory standards
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

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

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 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  (cid:147)are  different  in
comparison  with  a  conventional  food  or  food  ingredient,  having  regard  to  the  accepted  limits  of  natural
variations for such characteristics(cid:148). 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.
WRITTEN QUESTION No. 2179/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 - Demonstration methods (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. 2195/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 - Recording the origins of novel food products (SUPPLEMENTARY ANSWER)
Date: 1997-06-25
Institutions: BREYER, European Parliament
Subjects: crop production, food inspection, foodstuffs legislation, genetically modified organism, human nutrition, new product, originating product, product quality

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. 2162/97 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?
WRITTEN QUESTION No. 2197/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 - Assessing the effects of the consumption of novel food products (SUPPLEMENTARY ANSWER)
Date: 1997-06-25
Institutions: BREYER, European Parliament
Subjects: EU programme, crop production, data collection, food consumption, food inspection, genetically modified organism, health risk, 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. 2159/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 - Unintentional inclusion in tradcitional foods of substances for which labelling is obligatory
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. 2166/97 by Hiltrud BREYER to the Council. Nivel food regulation No 97/258 - Monitoring requirements
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?