do-me/EUR-LEX huggingface dataset:
WRITTEN QUESTION No. 2151/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 - Labelling information
Date: 1997-06-23
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. 2131/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 - Requirements for authorization (SUPPLEMENTARY ANSWER)
Date: 1997-06-23
Institutions: BREYER, European Parliament
Subjects: consumer protection, crop production, environmental protection, food inspection, foodstuffs legislation, genetically modified organism, human nutrition, labelling, marketing, new product

8. 6. 98

EN

Official Journal of the European Communities

C 174/3

2.

If not, how will national and EU authorities be informed of the market launch of such products?

How can these authorities test whether there is an obligation to label such products pursuant to the novel

3.
food regulation?

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

(98/C 174/09)

WRITTEN QUESTION E-2131/97

by Hiltrud Breyer (V) to the Commission

(23 June 1997)

Subject: Novel food regulation No 258/97 › Requirements for authorization

What exactly are the test criteria, in accordance with which applications for authorization for products under the
novel food regulation (1) have to be assessed to see whether permission is required or whether simple registration
will be deemed to be sufficient if the manufacturer has not applied for permission?

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

(98/C 174/10)

WRITTEN QUESTION E-2133/97

by Hiltrud Breyer (V) to the Commission

(23 June 1997)

Subject: Novel food regulation No 258/97 › Requirements for authorization: checking information supplied by

manufacturers

1. What information is supposed to be used as the basis for assessment?

2.

Is there provision for independent testing of the data submitted by manufacturers?

(98/C 174/11)

WRITTEN QUESTION E-2135/97

by Hiltrud Breyer (V) to the Commission

(23 June 1997)

Subject: Novel food regulation No 258/97 › Requirements for authorization: checking information supplied by

manufacturers

1.

Is the information supplied by manufacturers to be checked, at least on a sample basis?

2.
If so, how will the risk of allergies be assessed in products, the novel ingredients of which have hitherto not
normally been consumed or have not usually been contained in foodstuffs (e.g. proteins from bacteria from hot
springs?

(98/C 174/12)

WRITTEN QUESTION E-2137/97

by Hiltrud Breyer (V) to the Commission

(23 June 1997)

Subject: Novel food regulation No 258/97 › Genetically produced enzymes and additives

Are  there  plans  for  activities  for  the  European  Union  aimed  at  plugging  the  existing  legislative  gaps  for  the
authorization of enzymes or additives produced with the aid of genetically modified micro-organisms which are
not converted by either the novel food regulation or the additives regulation?
WRITTEN QUESTION No. 2115/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 - Authorization through entry in the catalogue of species (SUPPLEMENTARY ANSWER)
Date: 1997-06-23
Institutions: BREYER, European Parliament
Subjects: consumer protection, crop production, environmental protection, food inspection, foodstuffs legislation, genetically modified organism, human nutrition, labelling, marketing, new product

8. 6. 98

EN

Official Journal of the European Communities

C 174/1

I

(Information)

EUROPEAN PARLIAMENT

WRITTEN QUESTIONS WITH ANSWER

(98/C 174/01)

WRITTEN QUESTION E-2113/97

by Hiltrud Breyer (V) to the Commission

(23 June 1997)

Subject: Novel food regulation No 258/97 › Authorization for varieties

1.
Is it true that if genetically modified plants are registered in the common list of varieties for agricultural
plant varieties (70/457/EEC) (1) (FN) and for seeds (70/458/EEC) (2) (FN) no further approval is required for
these plants under the novel food regulation (3) (FN)?

2.

If this is the case, will only the labelling of such plants bed covered by the novel food regulation?

(1)  OJ L 225, 12.10.1970, p. 1.
(2)  OJ L 225, 12.10.1970, p. 7.
(3)  OJ L 43, 14.2.1997, p. 1.

(98/C 174/02)

WRITTEN QUESTION E-2115/97

by Hiltrud Breyer (V) to the Commission

(23 June 1997)

Subject: Novel food regulation No 258/97 › Authorization through entry in the catalogue of species

In future will transgenic plants still require any authorization and approval before being entered in the common
catalogue of species?

(98/C 174/03)

WRITTEN QUESTION E-2117/97

by Hiltrud Breyer (V) to the Commission

(23 June 1997)

Subject: Novel food regulation No 258/97 › Authorization of varieties

Is it true that all plant products which are authorized as varieties will Longer require application or the

1.
simplified authorization procedure pursuant to the novel food regulation (1)?

If  so,  will  any  products  processed  from  such  plants  require  authorization  pursuant  to  the  novel  food

2.
regulation?

(1)  OJ L 43, 14.2.1997, p. 1.
WRITTEN QUESTION No. 2157/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 - Form and content of labelling
Date: 1997-06-23
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. 2137/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 - Genetically produced enzymes and additives
Date: 1997-06-23
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. 2121/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 - Authorization requirements (SUPPLEMENTARY ANSWER)
Date: 1997-06-23
Institutions: BREYER, European Parliament
Subjects: consumer protection, crop production, environmental protection, food inspection, foodstuffs legislation, genetically modified organism, human nutrition, labelling, marketing, new product

C 174/2

EN

Official Journal of the European Communities

8. 6. 98

(98/C 174/04)

WRITTEN QUESTION E-2119/97

by Hiltrud Breyer (V) to the Commission

(23 June 1997)

Subject: Novel food regulation No 258/97 › Authorization of varieties

Will secondary products of plants already covered by variety authorization needed to be tested and authorized
individually pursuant to the novel food regulation (1)?

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

(98/C 174/05)

WRITTEN QUESTION E-2121/97

by Hiltrud Breyer (V) to the Commission

(23 June 1997)

Subject: Novel food regulation No 258/97 › Authorization requirements

Will secondary products which contain only a small, percentage of plant products requiring authorization need to
undergo separate authorization (e.g. tomato concentrate in ready made pizzas)?

(98/C 174/06)

WRITTEN QUESTION E-2123/97

by Hiltrud Breyer (V) to the Commission

(23 June 1997)

Subject: Novel food regulation No 258/97 › Testing the health and environmental impact

When new genetically modified varieties are entered in the common list of varieties which require neither an
authorization pursuant to the novel food regulation (1)  nor  an authorization pursuant to the  deliberate release
directive (2), what form does testing of health conformity and the ecological effects tasks?

(1)  OJ L 43, 14.2.1997, p. 1.
(2)  OJ L 117, 8.5.1990, p. 15.

(98/C 174/07)

WRITTEN QUESTION E-2127/97

by Hiltrud Breyer (V) to the Commission

(23 June 1997)

Subject: Novel food regulation No 258/97 › (cid:145)Substantial equivalence(cid:146) in derived varieties

1. What  guarantees  will  there  be  that  the  (cid:145)substantial  equivalence(cid:146)  of  all  plants  of  the  same  tested  and
authorized line remain present, or that they can be tested?

2. What will be the approach towards derived varieties?

(98/C 174/08)

WRITTEN QUESTION E-2129/97

by Hiltrud Breyer (V) to the Commission

(23 June 1997)

Subject: Novel food regulation No 258/97 › Reporting

1. Will  new  or  unmodified  products  which  do  not  have  to  be  authorized,  pursuant  to  the  novel  food
regulation (1), be subject to a reporting obligation?
WRITTEN QUESTION No. 2137/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 - Genetically produced enzymes and additives (SUPPLEMENTARY ANSWER)
Date: 1997-06-23
Institutions: BREYER, European Parliament
Subjects: consumer protection, crop production, environmental protection, food inspection, foodstuffs legislation, genetically modified organism, human nutrition, labelling, marketing, new product

8. 6. 98

EN

Official Journal of the European Communities

C 174/3

2.

If not, how will national and EU authorities be informed of the market launch of such products?

How can these authorities test whether there is an obligation to label such products pursuant to the novel

3.
food regulation?

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

(98/C 174/09)

WRITTEN QUESTION E-2131/97

by Hiltrud Breyer (V) to the Commission

(23 June 1997)

Subject: Novel food regulation No 258/97 › Requirements for authorization

What exactly are the test criteria, in accordance with which applications for authorization for products under the
novel food regulation (1) have to be assessed to see whether permission is required or whether simple registration
will be deemed to be sufficient if the manufacturer has not applied for permission?

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

(98/C 174/10)

WRITTEN QUESTION E-2133/97

by Hiltrud Breyer (V) to the Commission

(23 June 1997)

Subject: Novel food regulation No 258/97 › Requirements for authorization: checking information supplied by

manufacturers

1. What information is supposed to be used as the basis for assessment?

2.

Is there provision for independent testing of the data submitted by manufacturers?

(98/C 174/11)

WRITTEN QUESTION E-2135/97

by Hiltrud Breyer (V) to the Commission

(23 June 1997)

Subject: Novel food regulation No 258/97 › Requirements for authorization: checking information supplied by

manufacturers

1.

Is the information supplied by manufacturers to be checked, at least on a sample basis?

2.
If so, how will the risk of allergies be assessed in products, the novel ingredients of which have hitherto not
normally been consumed or have not usually been contained in foodstuffs (e.g. proteins from bacteria from hot
springs?

(98/C 174/12)

WRITTEN QUESTION E-2137/97

by Hiltrud Breyer (V) to the Commission

(23 June 1997)

Subject: Novel food regulation No 258/97 › Genetically produced enzymes and additives

Are  there  plans  for  activities  for  the  European  Union  aimed  at  plugging  the  existing  legislative  gaps  for  the
authorization of enzymes or additives produced with the aid of genetically modified micro-organisms which are
not converted by either the novel food regulation or the additives regulation?
WRITTEN QUESTION No. 2139/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 - Composition of the Food Committee
Date: 1997-06-23
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. 2123/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 - Testing the health and environmental impact (SUPPLEMENTARY ANSWER)
Date: 1997-06-23
Institutions: BREYER, European Parliament
Subjects: consumer protection, crop production, environmental protection, food inspection, foodstuffs legislation, genetically modified organism, human nutrition, labelling, marketing, new product

C 174/2

EN

Official Journal of the European Communities

8. 6. 98

(98/C 174/04)

WRITTEN QUESTION E-2119/97

by Hiltrud Breyer (V) to the Commission

(23 June 1997)

Subject: Novel food regulation No 258/97 › Authorization of varieties

Will secondary products of plants already covered by variety authorization needed to be tested and authorized
individually pursuant to the novel food regulation (1)?

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

(98/C 174/05)

WRITTEN QUESTION E-2121/97

by Hiltrud Breyer (V) to the Commission

(23 June 1997)

Subject: Novel food regulation No 258/97 › Authorization requirements

Will secondary products which contain only a small, percentage of plant products requiring authorization need to
undergo separate authorization (e.g. tomato concentrate in ready made pizzas)?

(98/C 174/06)

WRITTEN QUESTION E-2123/97

by Hiltrud Breyer (V) to the Commission

(23 June 1997)

Subject: Novel food regulation No 258/97 › Testing the health and environmental impact

When new genetically modified varieties are entered in the common list of varieties which require neither an
authorization pursuant to the novel food regulation (1)  nor  an authorization pursuant to the  deliberate release
directive (2), what form does testing of health conformity and the ecological effects tasks?

(1)  OJ L 43, 14.2.1997, p. 1.
(2)  OJ L 117, 8.5.1990, p. 15.

(98/C 174/07)

WRITTEN QUESTION E-2127/97

by Hiltrud Breyer (V) to the Commission

(23 June 1997)

Subject: Novel food regulation No 258/97 › (cid:145)Substantial equivalence(cid:146) in derived varieties

1. What  guarantees  will  there  be  that  the  (cid:145)substantial  equivalence(cid:146)  of  all  plants  of  the  same  tested  and
authorized line remain present, or that they can be tested?

2. What will be the approach towards derived varieties?

(98/C 174/08)

WRITTEN QUESTION E-2129/97

by Hiltrud Breyer (V) to the Commission

(23 June 1997)

Subject: Novel food regulation No 258/97 › Reporting

1. Will  new  or  unmodified  products  which  do  not  have  to  be  authorized,  pursuant  to  the  novel  food
regulation (1), be subject to a reporting obligation?