do-me/EUR-LEX huggingface dataset:
WRITTEN QUESTION No. 2174/97 by Hiltrud BREYER to the Council. Novel food regulation No 258/97 - Monitoring of products free of 'genetic engineering'
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

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. 2204/97 by Hiltrud BREYER to the Council. Novel food regulation No 258/97 - Transparency of authorizations of novel food products
Date: 1997-06-25
Institutions: BREYER, European Parliament
Subjects: administrative transparency, consumer information, foodstuff, genetically modified organism, human nutrition, labelling, marketing, new product, product safety, public health

17. 3. 98

EN

Official Journal of the European Communities

C 82/43

Joint answer
to Written Questions E-2192/97 and E-2204/97

(28 October 1997)

Without prejudice to the national provisions in this field, it is already stipulated - for example, in Article 5 of the
Regulation quoted by the Honourable Member - that a summary of the notification should be published. The
same applies to the decisions to be taken under Article 7(3) of the same Regulation.

These  provisions  should  make  it  easier  for  a  Member  State  to  implement  Article  12  of  the  Regulation,  if
necessary, in order to restrict or suspend trade in or use in its territory of a food or food ingredient which may
endanger health.

Finally, without prejudice to Article 10 of the Regulation, the national provisions in this field or - if appropriate -
Article  22  of  Directive  90/220/EEC  (1),  Article 14  provides  for  a  report  by  the  Commission  on  the
implementation of the Regulation and for the monitoring (cid:147)of its impact on consumer information.(cid:148)

(1)  OJ L 117, 8.5.1990.

(98/C 82/79)

WRITTEN QUESTION E-2196/97

by Hiltrud Breyer (V) to the Council

(25 June 1997)

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

How, and by whom, is the monitoring system called for by the Scientific Committee for Food (opinion on
1.
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?

Answer

(28 October 1997)

As the Committee referred to by the Honourable Member comes under the Commission, she should apply to the
latter for information on the programme in question.

(98/C 82/80)

WRITTEN QUESTION E-2198/97

by Hiltrud Breyer (V) to the Council

(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?
WRITTEN QUESTION No. 2199/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 - Recording 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. 2201/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 - Access to 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. 2193/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258797 - Recording of, and safety guarantees for, 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. 2192/97 by Hiltrud BREYER to the Council. Novel food regulation No 258797 - Recording of, and safety guarantees for, novel food products
Date: 1997-06-25
Institutions: BREYER, European Parliament
Subjects: administrative transparency, consumer information, foodstuff, genetically modified organism, human nutrition, labelling, marketing, new product, product safety, public health

17. 3. 98

EN

Official Journal of the European Communities

C 82/43

Joint answer
to Written Questions E-2192/97 and E-2204/97

(28 October 1997)

Without prejudice to the national provisions in this field, it is already stipulated - for example, in Article 5 of the
Regulation quoted by the Honourable Member - that a summary of the notification should be published. The
same applies to the decisions to be taken under Article 7(3) of the same Regulation.

These  provisions  should  make  it  easier  for  a  Member  State  to  implement  Article  12  of  the  Regulation,  if
necessary, in order to restrict or suspend trade in or use in its territory of a food or food ingredient which may
endanger health.

Finally, without prejudice to Article 10 of the Regulation, the national provisions in this field or - if appropriate -
Article  22  of  Directive  90/220/EEC  (1),  Article 14  provides  for  a  report  by  the  Commission  on  the
implementation of the Regulation and for the monitoring (cid:147)of its impact on consumer information.(cid:148)

(1)  OJ L 117, 8.5.1990.

(98/C 82/79)

WRITTEN QUESTION E-2196/97

by Hiltrud Breyer (V) to the Council

(25 June 1997)

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

How, and by whom, is the monitoring system called for by the Scientific Committee for Food (opinion on
1.
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?

Answer

(28 October 1997)

As the Committee referred to by the Honourable Member comes under the Commission, she should apply to the
latter for information on the programme in question.

(98/C 82/80)

WRITTEN QUESTION E-2198/97

by Hiltrud Breyer (V) to the Council

(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?
Council Directive 97/40/EC of 25 June 1997 amending Directive 93/113/EC concerning the use and marketing of enzymes, micro-organisms and their preparations in animal nutrition
Date: 1997-06-25
Institutions: Council of the European Union
Subjects: animal nutrition, food additive, marketing, marketing standard, microorganism













EUR-Lex - 31997L0040 - EN






Avis juridique important




|



31997L0040

Council Directive 97/40/EC of 25 June 1997 amending Directive 93/113/EC concerning the use and marketing of enzymes, micro-organisms and their preparations in animal nutrition  


Official Journal L 180 , 09/07/1997 P. 0021 - 0021 





COUNCIL DIRECTIVE 97/40/EC of 25 June 1997 amending Directive 93/113/EC concerning the use and marketing of enzymes, micro-organisms and their preparations in animal nutrition THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof,Having regard to the proposal from the Commission (1),Having regard to the opinion of the European Parliament (2),Having regard to the opinion of the Economic and Social Committee (3),Whereas Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (4) lays down the principles relating to the admission and the use of additives;Whereas Directive 93/113/EC (5) authorizes the Member States to permit provisionally the use and marketing of the products in question provided that, on the basis of available scientific evidence, they do not present any danger to human or animal health;Whereas Directive 93/113/EC requires the Commission to decide before 1 January 1997 on case files submitted by the Member States before 1 January 1996 for the purpose of obtaining Community authorization under Directive 70/524/EEC;Whereas the large number of case files submitted by the Member States has made it impossible to decide, in full knowledge of the facts, on all the authorization applications by 31 December 1996; whereas the date by which the Commission must decide should thus be postponed by 18 months so that the Commission and the Member States have sufficient time to give serious consideration to the files submitted to them,HAS ADOPTED THIS DIRECTIVE:Article 1 The date of 1 January 1997 in Article 5 of Directive 93/113/EC shall be replaced by 1 July 1998.Article 2 This Directive shall enter into force on the seventh day following its publication in the Official Journal of the European Communities.Article 3 This Directive is addressed to the Member States.Done at Luxembourg, 25 June 1997.For the CouncilThe PresidentJ. VAN AARTSEN(1) OJ No C 95, 24. 3. 1997, p. 30.(2) OJ No C 85, 17. 3. 1997, p. 176.(3) OJ No C 133, 28. 4. 1997, p. 26.(4) OJ No L 270, 14. 12. 1970, p. 1. Directive as last amended by Commission Directive 96/66/EC (OJ No L 272, 25. 10. 1996, p. 32).(5) OJ No L 334, 31. 12. 1993, p. 17.
WRITTEN QUESTION No. 2189/97 by Hiltrud BREYER to the Commission. Novel food regulation No 2587)7 - Submission of proof by applicants (SUPPLEMENTARY ANSWER)
Date: 1997-06-25
Institutions: BREYER, European Parliament
Subjects: crop production, food inspection, foodstuffs legislation, genetically modified organism, human nutrition, new product

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. 2182/97 by Hiltrud BREYER to the Council. Novel food regulation No 258/97 -Application of sensitivity limit values
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.