Amendments on EP Report A5-0202/2003 (Recommendation for second reading on the common position for a regulation on genetically modified food and feed)

July 1, 2003

Brussels, 30 Jun 2003

Full text of Amendments 001 - 043 PIN archive of Amendments 001 - 043

26 June 2003 A5-0202/ 1-43

AMENDMENTS 1-43
tabled by the Committee on the Environment, Public Health and Consumer Policy

RECOMMENDATION FOR 2nd READING by Karin Scheele A5-0202/2003
Genetically modified food and feed

Council common position
(5204/3/2003 &emdash; C5-0133/2003 &emdash; 2001/0173(COD))

Council common position

Amendments by Parliament

Amendment 1
Recital 10
(10) The making available of genetically modified micro-organisms for activities regulated under Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms1, including culture collections, the making available of GMOs to be used exclusively for activities where appropriate stringent containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment, and the making available of GMOs to be used exclusively for deliberate releases complying with the requirements referred to in part B of Directive 2001/18/EC , are not considered as forms of marketing under the latter Directive. Those operations are therefore exempted from the need to obtain a Community authorisation under Part C of Directive   2001/18/EC . It is appropriate to apply the same exceptions in this Regulation. It is, however, appropriate to maintain the need for an authorisation for genetically modified food and feed, including food and feed produced from GMOs or genetically modified micro-organisms in contained use.
____________

1 OJ L 117, 8.5.1990, p. 1. Directive as last amended by Decision 2001/204/EC (OJ L 73, 15.3.2001, p. 32).
Deleted

Justification

The exceptions listed are not relevant to the field of food and feed. Moreover, the definition of -"placing on the market" should be derived from food law. The definition proposed to Article 2, paragraph 13, accords with that in Regulation No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety, and also accords with the original Commission proposal (COM 2001 (425)).

Amendment 2
Recital 26
(26) It is appropriate to provide that, when the combined level of adventitious or technically unavoidable presence of genetically modified materials in a food or feed or in one of its components is higher than the set threshold, such presence should be indicated in accordance with this Regulation and that detailed provisions should be adopted for its implementation. The possibility of establishing lower thresholds, in particular for foods and feed containing or consisting of GMOs or in order to take into account advances in science and technology, should be provided for.
(26) It is appropriate to provide that, when the combined level of adventitious or technically unavoidable presence of genetically modified material in a food or feed or in one of its components is higher than the set threshold, such presence should be indicated in accordance with this Regulation and that detailed provisions should be adopted for its implementation. Lower thresholds should be established as and when advances in science and technology allow.

Justification

Amends new text and reflects amendments 163 and 164. Lower thresholds should be established as and when advances in science and technology allow.

Amendment 3
Recital
() It is indispensable that operators strive to avoid any accidental presence of genetically modified material not authorised under Community legislation in food or feed. However, in order to ensure the practicability and feasibility of this Regulation, a specific threshold, with the possibility of establishing lower levels in particular for GMOs sold directly to the final consumer, should be established as a transitional measure for minute traces in food or feed of this genetically modified material, where the presence of such material is adventitious or technically unavoidable and provided that all specific conditions set in this Regulation are met. Directive 2001/18/EC should be amended accordingly. The application of this measure should be reviewed in the context of the general review of the implementation of this Regulation.
() It is indispensable that operators take all measures to avoid any accidental presence of genetically modified material not authorised under Community legislation in food or feed.

Justification

This reintroduces the notion behind first-reading Amendment 162, i.e. Parliament did not want a threshold for unauthorised GMOs. Consumers and operators should be given a guarantee that only GMOs authorised in the European Union may be placed on the Community food and feed market.

Amendment 4
Recital 33
(33) Where the application concerns products containing or consisting of a genetically modified organism, the applicant should have the choice of either supplying an authorisation for the deliberate release into the environment already obtained under Part C of Directive   2001/18/EC , without prejudice to the conditions set by that authorisation, or of applying for the environmental risk assessment to be carried out at the same time as the safety assessment under this Regulation. In the latter case, it is necessary for the evaluation of the environmental risk to comply with the requirements referred to in Directive   2001/18/EC and for the national competent authorities designated by Member States for this purpose to be consulted by the Authority. In addition, it is appropriate to give the Authority the possibility of asking one of these competent authorities to carry out the environmental risk assessment. It is also appropriate, in accordance with Article 12(4) of Directive   2001/18/EC , for the national competent authorities designated under the said Directive in all cases concerning GMOs and food and/or feed containing or consisting of a GMO to be consulted by the Authority before it finalises the environmental risk assessment.
(33) Where the application concerns products containing or consisting of a genetically modified organism, the applicant should have the choice of either supplying an authorisation for the deliberate release into the environment already obtained under Part C of Directive 2001/18/EC , without prejudice to the conditions set by that authorisation, or of applying for the environmental risk assessment to be carried out at the same time as the safety assessment under this Regulation. In the latter case, it is necessary for the evaluation of the environmental risk to comply with the requirements referred to in Directive 2001/18/EC and for the national competent authorities designated by Member States for this purpose to be consulted by the Authority. In addition, it is appropriate to give the Authority the possibility of asking one of these competent authorities to carry out the environmental risk assessment. It is also appropriate, in accordance with Article 12(4) of Directive 2001/18/EC , for the national competent authorities designated under the said Directive in all cases concerning GMOs and food and/or feed containing or consisting of a GMO to be consulted by the Authority before it finalises the environmental risk assessment. However, as this Regulation does not apply to the use of GMOs as seeds or other plant-propagating material, an authorisation in accordance with Part C of Directive 2001/18/EC is required where GMOs shall be used as seeds or other plant- propagating material.

Justification

Reflects amendments 33, 39, 49, 73, 79, 83, 84, 87, 95 and 120 at first reading, adopted on 3 July 2003 and offers a possible compromise regarding the status of the regulation as 'sectoral legislation'. Directive 2001/18/EC should continue to apply to the cultivation of GMOs, whereas the new Regulation on GM food and feed should primarily address food and feed safety aspects and ensure consumer protection.

Amendment 5
Recital 34
(34) In the case of GMOs to be used as seeds or other plant-propagating materials falling within the scope of this Regulation, the Authority should be under an obligation to delegate the environmental risk assessment to a national competent authority. Nonetheless, authorisations under this Regulation should be without prejudice to the provisions of Directives   68/193/EEC , 2002/53/EC and 2002/55/EC , which provide in particular for the rules and the criteria for the acceptance of varieties and their official acceptance for inclusion in common catalogues; nor should they affect the provisions of Directives   66/401/EEC , 66/402/EEC , 68/193/EEC , 92/33/EEC , 92/34/EEC , 2002/54/EC , 2002/55/EC , 2002/56/EC or 2002/57/EC which regulate in particular the certification and the marketing of seeds and other plant-propagating materials.
(34) Authorisations under this Regulation should be without prejudice to the provisions of Directives 68/193/EEC , 2002/53/EC and 2002/55/EC , which provide in particular for the rules and the criteria for the acceptance of varieties and their official acceptance for inclusion in common catalogues; nor should they affect the provisions of Directives 66/401/EEC , 66/402/EEC , 68/193/EEC , 92/33/EEC , 92/34/EEC , 2002/54/EC , 2002/55/EC , 2002/56/EC or 2002/57/EC which regulate in particular the certification and the marketing of seeds and other plant-propagating materials.

Justification

Proposes deletion of new text. In line with amendments 33, 39, 49, 73, 79, 83, 84, 87, 95 and 120 the cultivation of GMOs should be covered exclusively by Directive 2001/18/EC .

Amendment 6
Article 1, point (ca) (new)

(ca) prevent the unintended presence of material containing, consisting of or produced from GMOs in food and feed.

(Reinstates Am. 14 at first reading, adopted on 3 July 2002)

Justification

The need to respect consumers' and producers' freedom of choice means that measures must be taken to ensure the coexistence of GM production and non-GM production.

Amendment 7
Article 2, point (1)
(1) the definitions of "food", "feed", "risk", "final consumer", "food business" and "feed business" given in Regulation (EC) No 178/2002 shall apply;
(1) the definitions of "food", "feed", "final consumer", "food business" and "feed business" given in Regulation (EC) No 178/2002 shall apply;

Justification

A definition of "risk" was not included in the proposal submitted in first reading. If "risk" is defined, the definition should be in line with the scope and objectives of the Regulation.
The definition of "risk" offered by Regulation 178/2002 is limited to "adverse health effects" (see Art. 3, point 9 of Reg. 178/2002). If, however, the new GM food/ feed regulation shall also aim at the prevention of adverse effects on the environment (see Art. 1 (a)), this definition of "risk" is obviously too narrow.
Amendment 8
Article 2, point (1a) (new)

(1a) the definition of `traceability', laid down in Regulation (EC) No ?/2003 of the European Parliament and of the Council of ?/?/? concerning the traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC , shall apply.

Justification

The original Commission proposal, COM(2001)425, defined the term `traceability', and there is no justification for the fact that this common position no longer does so.
As Regulation (EC) No ?/2003 of the European Parliament and of the Council of ?/?/? concerning the traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC and this Regulation are complementary, it is logical to refer to the aforementioned Regulation as regards the definition.

Amendment 9
Article 2, point 13
(13) `placing on the market' means the holding of food or feed for the purpose of sale, including offering for sale, or any other form of transfer, whether free of charge or not, and the sale, distribution and other forms of transfer themselves. The following operations shall not be regarded as placing on the market:
(13) `placing on the market' means the holding of food or feed for the purpose of sale, including offering for sale, or any other form of transfer, whether free of charge or not, and the sale, distribution and other forms of transfer themselves.
&emdash; making available genetically modified micro-organisms for activities regulated under Directive 90/219/EEC , including culture collections,

&emdash; making available GMOs, other than micro-organisms referred to in the first indent, to be used exclusively for activities where appropriate stringent containment measures are used to limit their contact with, and to provide a high level of safety for, the general population and the environment; the measures should be based on the same principles of containment as those referred to in Directive 90/219/EEC ,

&emdash; making available GMOs to be used exclusively for deliberate releases complying with the requirements referred to in Part B of Directive 2001/18/EC ;

Justification

The exceptions listed are not relevant to the field of food and feed. Moreover, the definition of `placing on the market' should be derived from food law. The definition proposed above accords with that in Regulation No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety, and also accords with the original Commission proposal (COM 2001 (425)).

Amendment 10
Article 3, paragraph 1a (new)

1a. This Section shall not apply to the use of GMOs as seeds or other plant-propagating material. Such use requires an authorisation in accordance with Part C of Directive 2001/18/EC .

Justification

Reflects amendments 33, 39, 49, 73, 79, 83, 84, 87, 95 and 120 at first reading, adopted on 3 July 2003 and offers a possible compromise regarding the status of the regulation as 'sectoral legislation'.
Amendments 33, 39, 49, 73, 79, 83, 84, 87, 95 and 120 deny the future Regulation the status of sectoral legislation, implying that no GMO should be approved under the new Regulation without previous authorisation under Part C of Directive 2001/18/EC . Thus, Parliament proposed in first reading that food and feed safety aspects of GMOs should be examined under the new Regulation, whereas environmental effects of GMOs should continue to be examined in the context of the deliberate release Directive.
According to the common position, however, the new GM food / feed Regulation would replace Part C of Directive 2001/18/EC with the consequence that the Standing Committee on the Food Chain and Animal Health would be responsible for both food/feed safety and environmental aspects of GMOs. This is not appropriate, as the Commission statement regarding Art. 35 demonstrates.
As a compromise it is suggested to distinguish between the use of GMOs as food and their use as seeds or propagating material. At least in the latter case, the national authorities competent for Directive 2001/18/EC should have the main responsibility and an authorisation in accordance with part C of Directive 2001/18/EC be required.

Amendment 11
Article 4, paragraph 1, point (a)
(a) present an unacceptable risk for human health or the environment;
(a) present a risk for human health or the environment;

Justification

GMOs must present no risk at all, however small.

Amendment 12
Article 5, paragraph 5
5. In the case of GMOs or food containing or consisting of GMOs, the application shall also be accompanied by:
5. The application shall also be accompanied by:
(a) the complete technical dossier supplying the information required by Annexes III and  IV to Directive 2001/18/EC and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive   2001/18/EC or, where the placing on the market of the GMO has been authorised under Part C of Directive 2001/18/EC , a copy of the authorisation decision;
(a) the complete technical dossier supplying the information required by Annexes III and IV to Directive 2001/18/EC and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC or, where the placing on the market of the GMO has been authorised under Part C of Directive 2001/18/EC or where the GMO shall be used as seeds or other plant-propagating material, a copy of the decision authorising the placing on the market under Part C of Directive 2001/18/EC ;
(b) a monitoring plan for environmental effects conforming with Annex VII to Directive   2001/18/EC , including a proposal for the duration of the monitoring plan; this duration may be different from the proposed period for the consent.
(b) a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC , including a proposal for the duration of the monitoring plan; this duration may be different from the proposed period for the consent.
In such case, Articles 13 to 24 of Directive 2001/18/EC shall not apply.

Justification

Reflects amendment 33 at first reading, adopted on 3 July 2002 and partially reflects the amendments adopted on 3 July 2002 with regard to 'sectoral legislation', see amendments 33, 39, 49, 73, 83, 84, 87, 95 and 120. In the case of products simply produced from GMOs but not containing GMOs, too, the documents for the GMO authorization procedure under Directive 2001/18/EC should be available to the competent authorities. Furthermore, the regulation should not - at least as far as GMOs are destined to be used as seeds or propagating material - replace part C of Directive 2001/18/EC , but, rather, complement it.

Amendment 13
Article 6, paragraph 3, point (c)
(c) may ask a competent authority designated in accordance with Article 4 of Directive   2001/18/EC to carry out an environmental risk assessment; however, if the application concerns GMOs to be used as seeds or other plant-propagating material, the Authority shall ask a national competent authority to carry out the environmental risk assessment;
(c) may ask a competent authority designated in accordance with Article 4 of Directive   2001/18/EC to carry out an environmental risk assessment; however, if the application concerns GMOs which can be used as seeds or other plant-propagating material, the Authority shall ask a national competent authority to carry out the environmental risk assessment;

Justification

The rule should be that all GMOs which can be used as seeds must undergo an environmental risk assessment.

Amendment 14
Article 6, paragraph 5, point (ea) (new)

(ea) effective measures to prevent the unintended presence of the food or foods produced from it in other products.

(Reinstates Am. 43 at first reading, adopted on 3 July 2002.)

Justification

The need to respect consumers' and producers' freedom of choice means that measures must be taken to ensure the coexistence of GM production and non-GM production.

Amendment 15
Article 6, paragraph 7a (new)

7a. Detailed provisions relating to the measures and conditions referred to in Article 6(5) for the protection of particular ecosystems or geographical areas or to ensure the long-term co-existence of conventional and genetically modified products shall be adopted, at the latest six months after the date of publication of this Regulation, in accordance with the procedure referred to in Article 35(2).

Justification

The fundamental aim of the Commission proposal ( COM(2001) 425 ) is to ensure that consumers have freedom of choice. In keeping with Amendments 14, 43 and 88 adopted by the European Parliament at first reading and in the light of the Council's statement concerning Amendments 36 and 164, it is proposed that the technical details of coexistence be decided by means of the commitology procedure.

Amendment 16
Article 9, paragraph 1
1. After an authorisation has been issued in accordance with this Regulation, the authorisation-holder and parties concerned shall comply with any conditions or restrictions which have been imposed in the authorisation and shall in particular make sure that products not covered by the authorisation are not placed on the market as food or feed. Where post-market monitoring as referred to in Article  5(3)(k) and/or monitoring as referred to in Article 5(5)(b) has been imposed on the authorisation-holder, the authorisation-holder shall ensure that it is carried out and shall submit reports to the Commission in accordance with the terms of the authorisation. The monitoring reports referred to shall be made accessible to the public after deletion of any information identified as confidential in accordance with Article  30.
1. After an authorisation has been issued in accordance with this Regulation, the authorisation-holder and parties concerned shall comply with any conditions or restrictions which have been imposed in the authorisation and shall in particular make sure that products not covered by the authorisation are not placed on the market as food or feed. Where post-market monitoring as referred to in Article  5(3)(k) and/or monitoring as referred to in Article 5(5)(b) has been imposed on the authorisation-holder, the authorisation-holder shall ensure that it is carried out and shall submit reports to the competent authority of the Member State in which he applied for the initial authorisation, in accordance with the terms of the authorisation. Article 5(2) shall apply mutatis mutandis. The monitoring reports referred to shall be made accessible to the public after deletion of any information identified as confidential in accordance with Article  30.

Justification

Under the common position, applications for authorisation would have to be addressed to the competent authorities of the Member States, while applications for renewals and interim reports would have to be addressed direct to the Commission. Such a division of responsibilities is contrary to the principles of proper administration.

Amendment 17
Article 9, paragraph 3
3. The authorisation-holder shall forthwith inform the Commission of any new scientific or technical information which might influence the evaluation of the safety in use of the food. In particular, the authorisation-holder shall forthwith inform the Commission of any prohibition or restriction imposed by the competent authority of any third country in which the food is placed on the market
3. The authorisation-holder shall forthwith inform the competent authority of the Member State in which he applied for the initial authorisation of any new scientific or technical information which might influence the evaluation of the safety in use of the food. In particular, the authorisation-holder shall forthwith inform the competent authority of the Member State in which he applied for the initial authorisation of any prohibition or restriction imposed by the competent authority of any third country in which the food is placed on the market. Article 5(2) shall apply mutatis mutandis.

Justification

Under the common position, applications for authorisation would have to be addressed to the competent authorities of the Member States, while applications for renewals and interim reports would have to be addressed direct to the Commission. Such a division of responsibilities is contrary to the principles of proper administration.

Amendment 18
Article 11, paragraph 1
1. Authorisations under this Regulation shall be renewable for ten-year periods, on application to the Commission by the authorisation-holder at the latest one year before the expiry date of the authorisation.
1. Authorisations under this Regulation shall be renewable for ten-year periods, on application by the authorisation-holder, at the latest one year before the expiry date of the authorisation, to the competent authority of the Member State in which he applied for the initial authorisation.

Justification

Under the common position, applications for authorisation would have to be addressed to the competent authorities of the Member States, while applications for renewals would continue to have to be addressed direct to the Commission. Such a division of responsibilities is contrary to the principles of proper administration. It is therefore proposed that applications for both the initial authorisation and renewals should be submitted to the competent authorities of the Member States. This also seems to be in accordance with the Council's wishes, as Article 11(3) provides for the application, mutatis mutandis, of Article 5(2) to the renewal procedure. Pursuant to Article 5(2), applications are to be submitted to the competent authority of a Member State, which is then to forward the application to the Authority.

Amendment 19
Article 12, paragraph 2
2. This Section shall not apply to foods containing material which contains, consists of or is produced from GMOs in a proportion no higher than 0,9  per cent of the food ingredients considered individually or food consisting of a single ingredient, provided that this presence is adventitious or technically unavoidable.
2. This Section shall not apply to foods containing material produced from GMOs in a proportion no higher than 0,5 per cent (or a lower threshold established in accordance with the procedure referred to in Article 35(2)) of the food ingredients considered individually or food consisting of a single ingredient, provided that this presence is adventitious or technically unavoidable. As and when advances in science and technology allow, appropriate lower thresholds shall be established.

Justification

Reflects amendment 164 adopted at first reading.

Amendment 20
Article 12, paragraph 3
3. In order to establish that the presence of this material is adventitious or technically unavoidable, operators must be in a position to supply evidence to satisfy the competent authorities that they have taken appropriate steps to avoid the presence of such material.
3. In order to establish that the presence of this material is adventitious or technically unavoidable, operators must be in a position to supply evidence to satisfy the competent authorities that they have taken appropriate steps to avoid the presence of such material. The Commission shall draw up a list of criteria for determining these "appropriate steps". In cooperation with the Authority, the Member States and the local authorities, the Commission shall also lay down appropriate measures to ensure that the utmost care is taken to avoid contamination.

Justification

Amendment 164 adopted at first reading by Parliament has been taken up in part (second paragraph).

Amendment 21
Article 12, paragraph 4
4. Appropriate lower thresholds may be established in accordance with the procedure referred to in Article  35(2) in particular in respect of foods containing or consisting of GMOs or in order to take into account advances in science and technology.
4. Appropriate lower thresholds shall be established in accordance with the procedure referred to in Article 35(2) as and when advances in science and technology allow.

Justification

Partially reinstates amendment 164 at first reading adopted on 3 July 2002. Lower threshold should be established as soon as science and technology allow.

Amendment 22
Article 14, paragraph 2
2. Specific rules concerning the information to be given by mass caterers providing food to the final consumer may be adopted in accordance with the procedure referred to in Article  35(2).
2. Specific rules concerning implementation of this Section with regard to the information to be given by mass caterers providing food to the final consumer may be adopted in accordance with the procedure referred to in Article 35(2).
In order to take into account the specific situation of mass caterers, such rules may provide for adaptation of the requirements of Article  13(1)(e).

Justification

Proposes amendment to text which was not included in the Commission's proposal. The proposed text would allow to fundamentally change (or 'adapt') the labelling scheme for mass caterers. Such changes - whether they are required or not - should certainly not be made by using the comitology procedure.

Amendment 23
Article 15, paragraph 1a (new)

1a. This Section shall not apply to the use of GMOs as seeds or other plant-propagating material. Such use requires an authorisation in accordance with Part C of Directive 2001/18/EC .

Justification

Partially reflects amendments 33, 39, 49, 73, 79, 83, 84, 87, 95 and 120 at first reading, adopted on 3 July 2003 and proposes a possible compromise regarding the status of the regulation as 'sectoral legislation'. Amendments 33, 39, 49, 73, 79, 83, 84, 87, 95 and 120 deny the future Regulation the status of sectoral legislation, implying that no GMO should be approved under the new Regulation without previous authorisation under Part C of Directive 2001/18/EC . Thus, Parliament proposed in first reading that food and feed safety aspects should be examined under the new Regulation, whereas environmental effects of GMOs should be looked at in the context of the deliberate release Directive.
According to the common position, however, the new GM food / feed Regulation would replace Part C of Directive 2001/18/EC with the consequence that the Standing Committee on the Food Chain and Animal Health would be responsible for both food/feed safety and environmental aspects of GMOs. This is not appropriate, as the Commission statement regarding Art. 35 shows.
The proposed compromise would distinguish between the use of GMOs as feed and their use as seeds or propagating material. At least in the latter case, the national authorities competent for Directive 2001/18/EC should have the main responsibility and an authorisation in accordance with part C of Directive 2001/18/EC be required.

Amendment 24
Article 16, paragraph 1, point (a)
(a) present an unacceptable risk for animal health, human health or the environment;
(a) present a risk for animal health, human health or the environment;

Justification

This amendment reintroduces the notion contained in the Commission's original proposal.

Amendment 25
Article 16, paragraph 4, point (a)
(a) a GMO and feed containing or consisting of that GMO as well as feed produced from that GMO, or
(a) feed containing or consisting of GMOs as well as feed produced from such GMOs, or
(This amendment takes up Amendment 73 adopted by Parliament at first reading))

Justification

The amendment makes it clear that marketing approvals granted under this Regulation address the food and feed safety aspect of genetically modified food and feed whereas the release of GMOs into the environment is covered by Directive 90/220/EEC , which came into force on 17 October 2002.

Amendment 26
Article 17, paragraph 5
5. In the case of GMOs or feed containing or consisting of GMOs, the application shall also be accompanied by:
5. The application shall also be accompanied by:
(a) the complete technical dossier supplying the information required by Annexes III and IV to Directive 2001/18/EC and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC or, where the placing on the market of the GMOs has been authorised under Part C of Directive   2001/18/EC , a copy of the authorisation decision;
(a) the complete technical dossier supplying the information required by Annexes III and IV to Directive 2001/18/EC and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC or, where the placing on the market of the GMO has been authorised under Part C of Directive 2001/18/EC or where the GMO shall be used as seeds or other plant-propagating material, a copy of the decision authorising the placing on the market under Part C of Directive 2001/18/EC ;
(b) a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC , including a proposal for the duration of the monitoring plan; this duration may be different from the proposed period for the consent.
(b) a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC , including a proposal for the duration of the monitoring plan; this duration may be different from the proposed period for the consent.
In such case, Articles 13 to 24 of Directive 2001/18/EC shall not apply.
Deleted

Justification

Reflects amendment 79 at first reading, adopted on 3 July 2002 and partially reflects the amendments adopted on 3 July 2002 with regard to 'sectoral legislation', see amendments 33, 39, 49, 73, 83, 84, 87, 95 and 120. In the case of products simply produced from GMOs but not containing GMOs, too, the documents for the GMO authorization procedure under Directive 2001/18/EC should be available to the competent authorities. Furthermore, the regulation should not - at least as far as GMOs are destined to be used as seeds or propagating material - replace part C of Directive 2001/18/EC , but, rather, complement it.

Amendment
Article 18, paragraph 3, point (c)
(c) may ask a competent authority designated in accordance with Article 4 of Directive   2001/18/EC to carry out an environmental risk assessment; however, if the application concerns GMOs to be used as seeds or other plant-propagating material, the Authority shall ask a national competent authority to carry out the environmental risk assessment;
(c) may ask a competent authority designated in accordance with Article 4 of Directive   2001/18/EC to carry out an environmental risk assessment; however, if the application concerns GMOs which can be used as seeds or other plant-propagating material, the Authority shall ask a national competent authority to carry out the environmental risk assessment;

Justification

The rule should be that all GMOs which can be used as seeds must undergo an environmental risk assessment.

Amendment 28
Article 18, paragraph 5, point (ea) (new)

(ea) effective measures to prevent the unintended presence of the feed or feed produced from it in other feed products.

(Reinstates Am. 88 at first reading, adopted on 3 July 2002)

Justification

The need to respect consumers' and producers' freedom of choice means that measures must be taken to ensure the coexistence of GM production and non-GM production.

Amendment 29
Article 18, paragraph 7a (new)

7a. Detailed provisions relating to the measures and conditions referred to in paragraph 5 for the protection of particular ecosystems or geographical areas or to ensure the long-term co-existence of conventional and genetically modified products shall be adopted, at the latest six months after the date of publication of this Regulation, in accordance with the procedure referred to in Article 35(2).

Justification

The fundamental aim of the Commission proposal ( COM(2001) 425 ) is to ensure that consumers have freedom of choice. In keeping with Amendments 14, 43 and 88 adopted by the European Parliament at first reading and in the light of the Council's statement concerning Amendments 36 and 164, it is proposed that the technical details of coexistence be decided by means of the commitology procedure.

Amendment 30
Article 21, paragraph 1
1. After an authorisation has been issued in accordance with this Regulation, the authorisation-holder and the parties concerned shall comply with any conditions or restrictions which have been  imposed in the authorisation and shall in particular make sure that products not covered by the authorisation are not placed on the market as food or feed. Where post-market monitoring as referred to in Article 17(3)(k) and/or monitoring as referred to in Article  17(5)(b) has been imposed on the authorisation-holder, the authorisation-holder shall ensure that it is carried out and shall submit reports to the Commission in accordance with the terms of the authorisation. The  monitoring reports referred to shall be made accessible to the public after deletion of any information identified as confidential in accordance with Article  30.
1. After an authorisation has been issued in accordance with this Regulation, the authorisation-holder and the parties concerned shall comply with any conditions or restrictions which have been  imposed in the authorisation and shall in particular make sure that products not covered by the authorisation are not placed on the market as food or feed. Where post-market monitoring as referred to in Article 17(3)(k) and/or monitoring as referred to in Article  17(5)(b) has been imposed on the authorisation-holder, the authorisation-holder shall ensure that it is carried out and shall submit reports to the competent authority of the Member State in which he applied for the initial authorisation, in accordance with the terms of the authorisation. Article 17(2) shall apply mutatis mutandis. The  monitoring reports referred to shall be made accessible to the public after deletion of any information identified as confidential in accordance with Article  30.

Justification

Under the common position, applications for authorisation would have to be addressed to the competent authorities of the Member States, while applications for renewals and interim reports would have to be addressed direct to the Commission. Such a division of responsibilities is contrary to the principles of proper administration.

Amendment 31
Article 21, paragraph 3
3. The authorisation-holder shall forthwith inform the Commission of any new scientific or technical information which might influence the evaluation of the safety in use of the feed. In particular, the authorisation-holder shall forthwith inform the Commission of any prohibition or restriction imposed by the competent Authority of any third country in which the feed is placed on the market.
3. The authorisation-holder shall forthwith inform the competent authority of the Member State in which he applied for the initial authorisation of any new scientific or technical information which might influence the evaluation of the safety in use of the feed. In particular, the authorisation-holder shall forthwith inform the competent authority of the Member State in which he applied for the initial authorisation of any prohibition or restriction imposed by the competent Authority of any third country in which the feed is placed on the market. Article 17(2) shall apply mutatis mutandis.

Justification

Under the common position, applications for authorisation would have to be addressed to the competent authorities of the Member States, while applications for renewals and interim reports would have to be addressed direct to the Commission. Such a division of responsibilities is contrary to the principles of proper administration.

Amendment 32
Article 23, paragraph 1
1. Authorisations under this Regulation shall be renewable for ten-year periods, on application to the Commission by the authorisation-holder at the latest one year before the expiry date of the authorisation.
1. Authorisations under this Regulation shall be renewable for ten-year periods, on application by the authorisation-holder to the competent authority of the Member State in which he applied for the initial authorisation at the latest one year before the expiry date of the authorisation.

Justification

Under the common position, applications for authorisation would have to be addressed to the competent authorities of the Member States, while applications for renewals would have to be addressed direct to the Commission. Such a division of responsibilities is contrary to the principles of proper administration. It is therefore proposed that applications for both the initial authorisation and renewals should be submitted to the competent authorities of the Member States. This also seems to be in accordance with the Council's wishes, as Article 23(3) provides for the application, mutatis mutandis, of Article 17(2) to the renewal procedure. Pursuant to Article 17(2), applications are to be submitted to the competent authority of a Member State, which is then to forward the application to the Authority.

Amendment 33
Article 24, paragraph 2
2. This Section shall not apply to feed containing material which contains, consists of or is produced from GMOs in a proportion no higher than 0,9  per cent of the feed and of each feed of which it is composed, provided that this presence is adventitious or technically unavoidable.
2. This Section shall not apply to feed containing material produced from GMOs in a proportion no higher than 0,5 per cent (or a lower threshold established in accordance with the procedure laid down in Article 35(2)) of the feed and of each feed of which it is composed, provided that this presence is adventitious or technically unavoidable. As and when advances in science and technology allow, appropriate lower thresholds shall be established.

Justification

Reflects amendment 163 adopted at first reading.

Amendment 34
Article 24, paragraph 3
3. In order to establish that the presence of this material is adventitious or technically unavoidable, operators must be in a position to supply evidence to satisfy the competent authorities that they have taken appropriate steps to avoid the presence of such materials.
3. In order to establish that the presence of this material is adventitious or technically unavoidable, operators must be in a position to supply evidence to satisfy the competent authorities that they have taken appropriate steps to avoid the presence of such materials. The Commission shall draw up a list of criteria for determining these "appropriate steps". In cooperation with the Authority, the Member States and the local authorities, the Commission shall also lay down appropriate measures to ensure that the utmost care is taken to avoid contamination.

Justification

Amendment 163 adopted at first reading by Parliament has been taken up in part.

Amendment 35
Article 24, paragraph 4
4. Appropriate lower thresholds may be established in accordance with the procedure referred to in Article  35(2) in particular in respect of feed containing or consisting of GMOs or in order to take into account advances in science and technology.
4. Appropriate lower thresholds shall be established in accordance with the procedure referred to in Article 35(2) as and when advances in science and technology allow.

Justification

Partially reinstates amendment 163 at first reading adopted on 3 July 2002. The threshold should be lowered as and when advances in science and technology allow.
Amendment 36
Article , paragraph 1
1. Where a product is likely to be used as both food and feed, a single application under Articles  5 and 17 shall be submitted and shall give rise to a single opinion from the Authority and a single Community decision.
1. Where a product is likely to be used as food, feed and/or seeds or other plant-propagating material, a single application under Articles  5 and 17 shall be submitted and shall give rise to a single opinion from the Authority and a single Community decision.

Justification

As it is intended, as a general rule, that the marketing of GMOs, including seeds, should be authorised under the terms of the common position, it is necessary to extend the proposed `dual use' clause to cover use as seed. In cases where products can be used for more than one purpose, authorisation should also be required for the other purposes.

Amendment 37
Article , paragraph 2
2. The Authority shall consider whether the application for authorisation should be submitted both as food and feed.
2. The Authority shall consider whether the application for authorisation should be submitted both as food and feed and/or seeds or other plant-propagating material.

Justification

As it is intended, as a general rule, that the marketing of GMOs, including seeds, should be authorised under the terms of the common position, it is necessary to extend the proposed `dual use' clause to cover use as seed. In cases where products can be used for more than one purpose, authorisation should also be required for the other purposes.

Amendment 38
Article 29, paragraph 1
1. The application for authorisation, supplementary information from the applicant, opinions from the competent authorities designated in accordance with Article 4 of Directive 2001/18/EC , monitoring reports and information from the authorisation holder, excluding confidential information, shall be made accessible to the public.
1. The application for authorisation, supplementary information from the applicant, opinions from the competent authorities designated in accordance with Article 4 of Directive 2001/18/EC , the Commission's draft decision referred to in Article 7(1), monitoring reports and information from the authorisation holder, excluding confidential information, shall be made accessible to the public.

Justification

Reflects amendment 48 at first reading, adopted on 3 July 2003. The Commission's draft decision should also be made public.
Amendment 39
Article 32, paragraph 3
Applicants for authorisation of genetically modified food and feed shall contribute to supporting the costs of the tasks of the Community reference laboratory and the European Network of GMO laboratories mentioned in the Annex.
Applicants for authorisation of genetically modified food and feed shall contribute to supporting the costs of the tasks of the Community reference laboratory and the European Network of GMO laboratories mentioned in the Annex. However, the contributions paid by the various applicants for authorisation may not exceed the annual Community funding paid over for running the laboratory.

Justification

The independence of the Community laboratory and the European network must be guaranteed.

Amendment 40
Article 34
Where it is evident that products authorised by or in accordance with this Regulation are likely to constitute a serious risk to human health, animal health or the environment, or where, in the light of an opinion of the Authority issued under Article 10 or Article 22, the need to suspend or modify urgently an authorisation arises, measures shall be taken under the procedures provided for in Articles  53 and 54 of Regulation  (EC) No 178/2002.
1. Where a Member State, as a result of new information or a reassessment of existing information, has grounds for considering that the use of a food, feed, seed or other plant-propagating material authorised in accordance with this Regulation endangers human health, animal health or the environment, it may provisionally restrict or prohibit the use and/or sale of the food, feed, seed or other plant-propagating material on its territory, as well as suspending or otherwise restricting imports thereto or exports therefrom until a final decision is taken in accordance with Article 10 or Article 22, as appropriate.

2. Member States shall ensure that, in the event of a severe risk, emergency measures, such as suspension or termination of the placing on the market, shall be applied, including information to the public. The Member State shall immediately inform the Commission, the Authority and the other Member States of action taken under this Article and give reasons for its decision, including the new information or new assessment on which its decision is based, indicating whether and how the conditions of the authorisation should be amended or the authorisation should be withdrawn. A decision on this shall be taken within three months in accordance with the procedure referred to in Article 35 (2).

(Reinstates Am. 117 and 118 at first reading, adopted on 3 July 2002)

Justification

This Regulation is regarded as `sectoral legislation' as referred to in Article 12(3) of Directive 2001/18 . Article 12(3) lays down, inter alia, that safeguard clauses must be equivalent to the requirements laid down in Directive 2001/18 . The formulation proposed here is equivalent to the safeguard clause laid down in Article 23 of Directive 2001/18 .

Amendment 41
ARTICLE 43
Article 12 a (Directive 2001/18/EC )
Article 43
Deleted
Amendment to Directive 2001/18/EC

The following Article shall be inserted in Directive 2001/18/EC with effect from the date of entry into force of this Regulation:

"Article 12a

Transitional measures for adventitious or technically unavoidable presence of genetically modified organisms having benefited from a favourable risk evaluation

1. Placing on the market of traces of a GMO or combination of GMOs in products intended for direct use as food or feed or for processing shall be exempted from Articles 13 to 21 provided that they meet the conditions referred to in Article 47 of Regulation (EC) No ?/2003 of the European Parliament and of the Council of ?.. on genetically modified food and feed .

2. This Article shall be applicable for a period of three years after the date of application of Regulation (EC) No ?/2003."

Justification

Reflects amendment 122 adopted in 1st reading on 3 July 2001. The threshold provided for in Article 12 (a) applies to non-authorised GMOs. The fact that they have "benefited from a favourable risk evaluation" does not necessarily mean that they will finally be approved, as the decisions referred to in Art. 7(1) and 19(1) may also be based on "other legitimate factors". The proposed threshold would undermine the EU biosafety framework. Thresholds for unauthorised GMOs and GM ingredients do not even exist in US law.

Amendment 42
ARTICLE 43a (new)
Article 26a (new) (Directive 2001/18/EC )

Article 43 a

Amendment to Directive 2001/18/EC

The following Article shall be inserted in Directive 2001/18/EC with effect from the date of entry into force of this Regulation:

"Article 26 a
Measures to prevent the unintended presence of GMOs

1. Member States shall take all measures necessary to ensure that at all stages of the placing on the market of the GMO placed on the market as or in products the notifier, any person selling the product or any user of it, take appropriate measures to prevent the unintended presence of the GMO or parts thereof in other products.

2. The Commission shall gather and coordinate information based on studies at Community and national level, observe the developments regarding co-existence in the Member States and, on the basis of the information and observations, develop guidelines on the co-existence of genetically modified, conventional and organic crops.

Justification

The amendment reflects amendments 14, 43 and 88 at first reading adopted on 3 July 2003 and takes account of a new fact that has arisen since the first reading. Given the Commission's decision of 5 March 2003, that "an approach based on subsidiarity could provide a fast and efficient solution" to the problem of co-existence (see Commissioner Fischler's SPEECH/03/205 ), the proposed amendment adjusts amendments 43 and 88 adopted in first reading to this new situation. As decided by the Commission, Member States shall have the repsonsibility to ensure co-existence. The subsidiarity-based approach implies, however, that the amendment should be included in a Directive rather than in a Regulation.
In line with option 1 of Commissioner Fischler's Communication to the Commission on "Co-existence of Genetically Modified, Conventional and Organic Crops" (SEC(2003)258/4), paragraph 2 defines the role of the Commission as regards co-existence.
Amendment 43
Article 47
Article 47
Deleted
Transitional measures for adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation

1. The presence in food or feed of material which contains, consists of or is produced from GMOs in a proportion no higher than 0,5 per cent shall not be considered to be in breach of Article  4(2) or Article 16(2), provided that:

(a) this presence is adventitious or technically unavoidable;

(b) the genetically modified material has benefited from a favourable opinion from the Community Scientific Committee(s) or the Authority before the date of application of this Regulation;

(c) the application for its authorisation has not been rejected in accordance with the relevant Community legislation, and

(d) detection methods are publicly available.

2. In order to establish that the presence of this material is adventitious or technically unavoidable, operators must be in a position to demonstrate to the competent authorities that they have taken appropriate steps to avoid the presence of such materials.

3. The thresholds referred to in paragraph  1 may be lowered in accordance with the procedure referred to in Article 35(2), in particular for GMOs sold directly to the final consumer.

4. Detailed rules for implementing this Article shall be adopted in accordance with the procedure referred to in Article  35(2).

5. This Article shall remain applicable for a period of three years after the date of application of this Regulation.

Justification

Reflects amendments 25 and 74 at 1st reading, adopted on 3 July 2001. The proposed threshold would undermine the EU biosafety framework. Thresholds for unauthorised GMOs and GM ingredients do not even exist under US law.

PE 333.030/ 2
EN

PE 333.030/ 25
EN Full text of Amendments 044 - 048 PIN archive of Amendments 044 - 048

26 June 2003 A5-0202/ 44

AMENDMENT 44
tabled by Karin Scheele, on behalf of the PSE Group,
Renate Sommer, on behalf of the PPE-DE Group,
Chris Davies, on behalf of the ELDR Group,
Jillian Evans, on behalf of the Verts/ALE Group,
Mauro Nobilia, on behalf of the UEN Group

RECOMMENDATION FOR SECOND READING
by Karin Scheele A5-0202/2003
Genetically modified food and feed

Council common position
(5204/3/2003 &emdash; C5-0133/2003 &emdash; 2001/0173(COD))

Council common position

Amendments by Parliament

Amendment 44
ARTICLE 43a (new)
Article 26a (new) (Directive 2001/18/EC )

Article 43a

Amendment of Directive 2001/18/EC
The following Article shall be inserted in Directive 2001/18/EC with effect from the date of entry into force of this Regulation:

"Article 26a

Measures to avoid the unintended presence of GMOs

1. Member States may take appropriate measures to avoid the unintended presence of GMOs in other products.

2. The Commission shall gather and coordinate information based on studies at Community and national level, observe the developments regarding co-existence in the Member States and, on the basis of the information and observations, develop guidelines on the co-existence of genetically modified, conventional and organic crops."

Or. en AMENDMENT 45
tabled by Karin Scheele, on behalf of the PSE Group,
Renate Sommer, on behalf of the PPE-DE Group,
Chris Davies, on behalf of the ELDR Group,
Jillian Evans, on behalf of the Verts/ALE Group,
Mauro Nobilia, on behalf of the UEN Group

RECOMMENDATION FOR SECOND READING
by Karin Scheele A5-0202/2003
Genetically modified food and feed

Council common position
(5204/3/2003 &emdash; C5-0133/2003 &emdash; 2001/0173(COD))

Council common position

Amendments by Parliament

Amendment 45
RECITAL 28a (new)

(28a) Operators should avoid the unintended presence of GMOs in other products. The Commission should gather information and develop on this basis guidelines on the co-existence of genetically modified, conventional and organic crops. Moreover, the Commission is invited to bring forward, as soon as possible, any further necessary proposal.

Or. en AMENDMENT 46
tabled by Karin Scheele, on behalf of the PSE Group,
Renate Sommer, on behalf of the PPE-DE Group,
Chris Davies, on behalf of the ELDR Group,
Jillian Evans, on behalf of the Verts/ALE Group,
Mauro Nobilia, on behalf of the UEN Group

RECOMMENDATION FOR SECOND READING
by Karin Scheele A5-0202/2003
Genetically modified food and feed

Council common position
(5204/3/2003 &emdash; C5-0133/2003 &emdash; 2001/0173(COD))

Council common position

Amendments by Parliament

Amendment 46
Article 4, paragraph 1, point (a)

(a) present an unacceptable risk for human health or the environment;
(a) have adverse effects on human health, animal health or the environment;

Or. en AMENDMENT 47
tabled by Karin Scheele, on behalf of the PSE Group,
Renate Sommer, on behalf of the PPE-DE Group,
Chris Davies, on behalf of the ELDR Group,
Jillian Evans, on behalf of the Verts/ALE Group,
Mauro Nobilia, on behalf of the UEN Group

RECOMMENDATION FOR SECOND READING
by Karin Scheele A5-0202/2003
Genetically modified food and feed

Council common position
(5204/3/2003 &emdash; C5-0133/2003 &emdash; 2001/0173(COD))

Council common position

Amendments by Parliament

Amendment 47
Article 16, paragraph 1, point (a)

(a) present an unacceptable risk for animal health, human health or the environment;
(a) have adverse effects on human health, animal health or the environment;

Or. en AMENDMENT 48
tabled by Karin Scheele, on behalf of the PSE Group,
Renate Sommer, on behalf of the PPE-DE Group,
Chris Davies, on behalf of the ELDR Group,
Jillian Evans, on behalf of the Verts/ALE Group,
Mauro Nobilia, on behalf of the UEN Group

RECOMMENDATION FOR SECOND READING
by Karin Scheele A5-0202/2003
Genetically modified food and feed

Council common position
(5204/3/2003 &emdash; C5-0133/2003 &emdash; 2001/0173(COD))

Council common position

Amendments by Parliament

Amendment 48
Article 32, paragraph 3a (new)

The contributions from applicants shall not exceed the costs incurred in carrying out the validation of detection methods.

Or. en

Report A5-0202/2003

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