do-me/EUR-LEX huggingface dataset:
WRITTEN QUESTION No. 2126/97 by Hiltrud BREYER to the Council. Novel food regulation No 258/97 - 'Substantial equivalence' in derived varieties
Date: 1997-06-24
Institutions: BREYER, European Parliament
Subjects: derogation from EU law, foodstuffs legislation, genetically modified organism, human nutrition, marketing

C 82/32

EN

Official Journal of the European Communities

17. 3. 98

(98/C 82/45)

WRITTEN QUESTION E-2128/97

by Hiltrud Breyer (V) to the Council

(24 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?

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 82/46)

WRITTEN QUESTION E-2130/97

by Hiltrud Breyer (V) to the Council

(24 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.

Joint answer
to Written Questions E-2126/97, E-2128/97 and E-2130/97

(20 October 1997)

Article 3 (4) of Regulation No 258/97 on novel foods and novel food ingredients provides for a derogation form
the authorization procedure laid down in that Regulation, where foods or food ingredients, on the basis of the
scientific  evidence  available  and  generally  recognized  or  on  the  basis  of  an  opinion  delivered  by  one  of  the
competent  bodies,  are  substantially  equivalent  to  existing  foods  and  food  ingredients  as  regards  their
composition, nutritional value, etc.

Where  necessary,  it  may  be  determined  in  accordance  with  the  procedure  laid  down  in  Article  13  of  the
Regulation whether a type of food or food ingredient falls under the derogation in question. The arrangements for
notification of these products are laid down in Article 5 of the Regulation.

(98/C 82/47)

WRITTEN QUESTION E-2132/97

by Hiltrud Breyer (V) to the Council

(24 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?
WRITTEN QUESTION No. 2150/97 by Hiltrud BREYER to the Council. Novel food regulation No 258/97 - Labelling information
Date: 1997-06-24
Institutions: BREYER, European Parliament
Subjects: biotechnology, consumer information, crop production, foodstuff, foodstuffs legislation, human nutrition, labelling, marketing, new product, seed

C 82/36

EN

Official Journal of the European Communities

17. 3. 98

(98/C 82/55)

WRITTEN QUESTION E-2148/97

by Hiltrud Breyer (V) to the Council

(24 June 1997)

Subject: Novel food regulation No 258/97 › Varieties directive

1.
In the event of authorization for a plant variety pursuant to the varieties directive which does not require
approval pursuant to the novel food regulation (1), is labelling of this variety › which is required pursuant to the
novel food directive › guaranteed in the case of sale of seeds?

How is this labelling maintained if the seed is passed on or if seedlings are sold (e.g. special packages or

2.
stickers in the case of sale to private or commercial users)?

Is  the  intention  to  revise  the  varieties  directive  so  as  to  guarantee  labelling  pursuant  to  the  novel  food

3.
regulation?

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

(98/C 82/56)

WRITTEN QUESTION E-2150/97

by Hiltrud Breyer (V) to the Council

(24 June 1997)

Subject: Novel food regulation No 258/97 › Labelling information

What sort of information should the labelling provide, and in what form?

Joint answer
to Written Questions E-2148/97 and E-2150/97

(20 October 1997)

The  Honourable  Member  is  requested  to  refer  to  reply  to  question  2112/97  and  to  note  that  Article  8  of
Regulation 258/97 states how the labelling requirements, referred to in Article 7 (2) of the Regulation, will be
established

Since the wording of the question does not allow the (cid:147)Varieties directive(cid:148) to be identified, it is not possible to
indicate whether any amendment to it is envisaged.

(98/C 82/57)

WRITTEN QUESTION E-2154/97

by Hiltrud Breyer (V) to the Council

(24 June 1997)

Subject: Novel food regulation No 258/97 › Form and content of labelling

1. What form will the labelling take for goods sold loose (e.g. fruit and vegetables)?

2. What form will the labelling take for processed goods, which consist largely of products for which labelling
is obligatory (e.g. preserved products and tomato concentrate)?
WRITTEN QUESTION No. 2134/97 by Hiltrud BREYER to the Council. Novel food regulation No 258/97 - Requirements for authorization: checking information supplied by manufacturers
Date: 1997-06-24
Institutions: BREYER, European Parliament
Subjects: competence of the Member States, food inspection, foodstuffs legislation, genetically modified organism, human nutrition, marketing

17. 3. 98

EN

Official Journal of the European Communities

C 82/33

(98/C 82/48)

WRITTEN QUESTION E-2134/97

by Hiltrud Breyer (V) to the Council

(24 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?

Joint answer
to Written Question E-2132/97 and E-2134/97

(20 October 1997)

Article 6 of Regulation No 258/97 and, where applicable, Articles 7 (1) and Article 9 specify the information
required for assessments and the ways in which they are to be carried out.

Under the obligations laid down in Article 6, the procedures followed by the competent assessment bodies are the
responsibility of the Member States.

(98/C 82/49)

WRITTEN QUESTION E-2136/97

by Hiltrud Breyer (V) to the Council

(24 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 covered by either the novel food regulation or the additives regulation?

Answer

(20 October 1997)

Article  2  of  Regulation  No  258/97  concerning  novel  foods  and  novel  food  ingredients  stipulates  that  food
additives, flavourings for use in foodstuffs and extraction solvents used in the production of foodstuffs are not
covered by the Regulation. However, these exclusions will only apply for so long as the safety laid down in the
basic  Directive  correspond  to  the  safety  level  of  the  Regulation  concerning  novel  foods  and  novel  food
ingredients.

The Honourable Member should also note that the Commission has stated that it confirms that should it appear,
in the light of experience, that there are gaps in the system of protection of public health provided for by the
existing legal framework, in particular in respect of processing aids, it will formulate appropriate proposals in
order to fill those gaps (OJ L 43, 14.2.1997, p. 7). The date the Council has received no such proposal.
WRITTEN QUESTION No. 2118/97 by Hiltrud BREYER to the Council. Novel food regulation No 258/97 - Authorization of varieties
Date: 1997-06-24
Institutions: BREYER, European Parliament
Subjects: biotechnology, crop production, foodstuffs legislation, genetically modified organism, human nutrition

3. 4. 98

EN

Official Journal of the European Communities

C 102/15

(98/C 102/22)

WRITTEN QUESTION E-2114/97

by Hiltrud Breyer (V) to the Council

(24 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?

Answer

(31 October 1997)

Regulation No 258/97 is aimed not at plants as such, whether or not transgenic, but at foods and food ingredients
only, as specified in Article 1 thereof.

(98/C 102/23)

WRITTEN QUESTION E-2118/97

by Hiltrud Breyer (V) to the Council

(24 June 1997)

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

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

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

Answer

(31 October 1997)

Regulation No 258/97 does not specifically take into account whether a plant is a follow-on product or not.

(98/C 102/24)

WRITTEN QUESTION E-2208/97

by Hartmut Nassauer (PPE) to the Council

(18 July 1997)

Subject: Protocols to European Union Conventions concerning the Court of Justice

For each Protocol to European Union Conventions under the third pillar concerning preliminary rulings by the
Court of Justice, will the Council set out the date of signature, the date of publication in the Official Journal, the
Member  States  who  have  so  far  made  a  declaration  accepting  the  jurisdiction  of  the  Court,  pursuant  to  the
relevant article in the Protocol, the date on which the declaration was made, and the date of publication of this
declaration in the Official Journal?
WRITTEN QUESTION No. 2136/97 by Hiltrud BREYER to the Council. Novel food regulation No 258/97 - Genetically produced enzymes and additives
Date: 1997-06-24
Institutions: BREYER, European Parliament
Subjects: food additive, foodstuffs legislation, genetic engineering, genetically modified organism, human nutrition, public health

17. 3. 98

EN

Official Journal of the European Communities

C 82/33

(98/C 82/48)

WRITTEN QUESTION E-2134/97

by Hiltrud Breyer (V) to the Council

(24 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?

Joint answer
to Written Question E-2132/97 and E-2134/97

(20 October 1997)

Article 6 of Regulation No 258/97 and, where applicable, Articles 7 (1) and Article 9 specify the information
required for assessments and the ways in which they are to be carried out.

Under the obligations laid down in Article 6, the procedures followed by the competent assessment bodies are the
responsibility of the Member States.

(98/C 82/49)

WRITTEN QUESTION E-2136/97

by Hiltrud Breyer (V) to the Council

(24 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 covered by either the novel food regulation or the additives regulation?

Answer

(20 October 1997)

Article  2  of  Regulation  No  258/97  concerning  novel  foods  and  novel  food  ingredients  stipulates  that  food
additives, flavourings for use in foodstuffs and extraction solvents used in the production of foodstuffs are not
covered by the Regulation. However, these exclusions will only apply for so long as the safety laid down in the
basic  Directive  correspond  to  the  safety  level  of  the  Regulation  concerning  novel  foods  and  novel  food
ingredients.

The Honourable Member should also note that the Commission has stated that it confirms that should it appear,
in the light of experience, that there are gaps in the system of protection of public health provided for by the
existing legal framework, in particular in respect of processing aids, it will formulate appropriate proposals in
order to fill those gaps (OJ L 43, 14.2.1997, p. 7). The date the Council has received no such proposal.
WRITTEN QUESTION No. 2130/97 by Hiltrud BREYER to the Council. Novel food regulation No 258/97 - Requirements for authorization
Date: 1997-06-24
Institutions: BREYER, European Parliament
Subjects: derogation from EU law, foodstuffs legislation, genetically modified organism, human nutrition, marketing

C 82/32

EN

Official Journal of the European Communities

17. 3. 98

(98/C 82/45)

WRITTEN QUESTION E-2128/97

by Hiltrud Breyer (V) to the Council

(24 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?

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 82/46)

WRITTEN QUESTION E-2130/97

by Hiltrud Breyer (V) to the Council

(24 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.

Joint answer
to Written Questions E-2126/97, E-2128/97 and E-2130/97

(20 October 1997)

Article 3 (4) of Regulation No 258/97 on novel foods and novel food ingredients provides for a derogation form
the authorization procedure laid down in that Regulation, where foods or food ingredients, on the basis of the
scientific  evidence  available  and  generally  recognized  or  on  the  basis  of  an  opinion  delivered  by  one  of  the
competent  bodies,  are  substantially  equivalent  to  existing  foods  and  food  ingredients  as  regards  their
composition, nutritional value, etc.

Where  necessary,  it  may  be  determined  in  accordance  with  the  procedure  laid  down  in  Article  13  of  the
Regulation whether a type of food or food ingredient falls under the derogation in question. The arrangements for
notification of these products are laid down in Article 5 of the Regulation.

(98/C 82/47)

WRITTEN QUESTION E-2132/97

by Hiltrud Breyer (V) to the Council

(24 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?
WRITTEN QUESTION No. 2120/97 by Hiltrud BREYER to the Council. Novel food regulation No 258/97 - Authorization requirements
Date: 1997-06-24
Institutions: BREYER, European Parliament
Subjects: biotechnology, crop production, food inspection, foodstuffs legislation, genetically modified organism, human nutrition, marketing

17. 3. 98

EN

Official Journal of the European Communities

C 82/31

(98/C 82/42)

WRITTEN QUESTION E-2120/97

by Hiltrud Breyer (V) to the Council

(24 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)?

Answer

(20 October 1997)

The  Honourable  Member  is  referred  to  Question  No  2118/97  and  should  note  that  the  term  (cid:147)authorization(cid:148)
((cid:147)Zulassung(cid:148)) does not appear in the text of the Regulation.

(98/C 82/43)

WRITTEN QUESTION E-2122/97

by Hiltrud Breyer (V) to the Council

(24 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.

Answer

(20 October 1997)

As far as can be established on the basis of the text of the Question, the cases envisaged by the Honourable
Member would appear to be covered by Article 10 (2) Directive 90/220/EEC (1). This specifies the requirements
for risk assessment.

(1)  OJ L 117, 8.5.1990, p.15.

(98/C 82/44)

WRITTEN QUESTION E-2126/97

by Hiltrud Breyer (V) to the Council

(24 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?