2015/0093(COD) | [ParlTrack]

Proposal for a regulation
Citation 1

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 291(3) thereof,

Amendment 10 #

Proposal for a regulation
Recital 7

(7) The reasons for the amendments made to Directive 2001/18/EC, by Directive (EU) 2015/412 as regards GMOs for cultivation are also relevant for other GMOs and GM food and feed covered by Regulation (EC) No 1829/2003. Indeed, the results of the vote on the implementing decision for the authorisation of products covered by Regulation (EC) No 1829/2003 which are not intended for cultivation in the relevant committee, or in the Council, is always “no opinion” (no qualified majority either in favour of or against the authorisation) and there are also Member States in which the use of these products is prohibited. Taking those matters into account, it is appropriate to amend Regulation (EC) No 1829/2003 in order to provide the possibility for the Member States to restrict or prohibit the use of GMOs and GM food and feed in all or part of their territory, on the basis of compelling grounds compatible with Union law - not related to risks to human and animal health and to the environment, as those are already assessed at Union level, pursuant to Regulation (EC) No 1829/2003. This possibility should not apply to GMOs for cultivation which are already covered by the amendments made to Directive 2001/18/EC, by Directive (EU) 2015/412the national law of the Member State concerned.

Amendment 11 #

Proposal for a regulation
Recital 8

(8) Member States should therefore be allowed to adopt measures restricting or prohibiting the use in all or part of their territory of a GMO or a GM food and feed, or group of GMOs or of GM food and feed, once authorised, provided that such measures are reasoned, based on compelling grounds in accordance with Union law, and are in line with the principles of proportionality and non- discrimination between national and non- national products, and Article 34, Article 36 and Article 216(2) of TFEU.deleted

Amendment 12 #

Proposal for a regulation
Recital 9

~~(9) The restrictions or prohibitions adopted pursuant to this Regulation should refer to the use and not to the free circulation and imports of genetically modified food and feed.~~deleted

Amendment 13 #

Tibor SZANYI

Proposal for a regulation
Recital 9

~~(9) The restrictions or prohibitions adopted pursuant to this Regulation should refer to the use and not to the free circulation and imports of genetically modified food and feed.~~deleted

Amendment 14 #

Proposal for a regulation
Recital 9

~~(9) The restrictions or prohibitions adopted pursuant to this Regulation should refer to the use and not to the free circulation and imports of genetically modified food and feed.~~deleted

Amendment 15 #

Proposal for a regulation
Recital 9

~~(9) The restrictions or prohibitions adopted pursuant to this Regulation should refer to the use and not to the free circulation and imports of genetically modified food and feed.~~deleted

Amendment 16 #

Proposal for a regulation
Recital 10

(10) The level of protection of human and animal health and of the environment achieved through the authorisation procedure provided for by Regulation (EC) No 1829/2003 requires a uniform scientific assessment throughout the Union and this Regulation should not alter that situation. Therefore to avoid any interference with the competences which are granted to the risk assessors and risk managers under Regulation (EC) No 1829/2003, Member States should not be authorised to use grounds which are related to risks to health and to the environment which should be dealt with in accordance with the procedure already established in Regulation (EC) No 1829/2003, and in particular its Articles 10, 22 and 34.deleted

Amendment 17 #

Proposal for a regulation
Recital 10

Amendment 18 #

Proposal for a regulation
Recital 11

(11) Member States’ measures adopted pursuant to this Regulation should be subject to a procedure of scrutiny and information at Union level with a view to the functioning of the internal market. In light of the level of scrutiny and information provided in this Regulation, it is not necessary to provide, in addition, for the application of Directive 98/34/EC of the European Parliament and of the Council15 . The amendments being made to Regulation (EC) No 1829/2003 by this Regulation provide that Member States may restrict or prohibit the use of GMOs or GM food and feed in all or part of their territory for the whole duration of the authorisation, provided that an established standstill period, during which the Commission and the other Member States are given the opportunity to comment on the proposed measures, has elapsed. The Member State concerned should therefore communicate a draft of those measures to the Commission at least 3 months prior to their adoption, in order to give the opportunity to the Commission and the other Member States to comment, and should refrain from adopting and implementing those measures during that period. On the expiry of the established ‘standstill’ period, the Member State should be able to adopt the measures as originally proposed or amended to take into account the Commission’s or the Member States’ comments. Member States should be allowed to notify to the Commission measures pursuant to this Regulation before that the product concerned by the measures is authorised so that the restriction or the prohibition starts its effects as from the date of entry into force of the Union authorisation. __________________ 15Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (OJ L 204, 21.7.1998, p. 37).deleted

Amendment 19 #

Proposal for a regulation
Recital 11

(11) Member States’s measures adopted pursuant to this Regulation should be subject to a procedure of scrutiny and information at Union level with a view to the functioning of the internal market. In light of the level of scrutiny and information provided in this Regulation, it is not necessary to provide, in addition, for the application of Directive 98/34/EC of the European Parliament and of the Council15. The amendments being made to Regulation (EC) No 1829/2003 by this Regulation provide that Member States may restrict or prohibit the use of GMOs or GM food and feed in all or part of their territory for the whole duration of the authorisation, provided that an established standstill period, during which the Commission and the other Member States are given the opportunity to comment on the proposed measures, has elapsed. The Member State concerned should therefore communicate a draft of those measures to the Commission at least 3 months prior to their adoption, in order to give the opportunity to the Commission and the other Member States to comment~~, and should refrain from adopting and implementing those measures during that period~~. On the expiry of the established “standstill” period, the Member State should be able to adopt the measures as originally proposed or amended to take into account the Commission's or the Member States’ comments. Member States should be allowed to notify to the Commission measures pursuant to this Regulation before that the product concerned by the measures is authorised so that the restriction or the prohibition starts its effects as from the date of entry into force of the Union authorisation. __________________ 15 Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (OJ L 204, 21.7.1998, p. 37).

Amendment 2 #

Norbert ERDŐS

Proposal for a regulation
Paragraph 1 a (new)

(1a) Calls on the Commission, within half a year of the adoption of its decision, to submit a legislative proposal restricting or prohibiting the use of GM foods and feed at Union or Member State level which accords with European Union law and the international obligations of the European Union, and which contains rational and practicable provisions;

Amendment 20 #

Proposal for a regulation
Recital 12

(12) In the case where a product was lawfully used before a Member State adopts measures pursuant to this Regulation, sufficient time should be given to operators to allow the phasing out of the product from the market.deleted

Amendment 21 #

Proposal for a regulation
Recital 12

Amendment 22 #

Proposal for a regulation
Recital 13

(13) Measures adopted pursuant to this Regulation, which restrict or prohibit the use of GMOs or GM food and feed should not affect the use in other Member States of these products as well as of products derived from their consumption. In addition, this Regulation and the national measures adopted pursuant to it should be without prejudice to Union law requirements concerning unintended and adventitious presence of GM material in other products and should not affect the placing on the market and use of products complying with these requirements.deleted

Amendment 23 #

Proposal for a regulation
Recital 13

(13) Measures adopted pursuant to this Regulation, which restrict or prohibit the use of GMOs or GM food and feed should not affect the use in other Member States of these products as well as of products derived from their consumption. In addition, tThis Regulation and the national measures adopted pursuant to it should be without prejudice to Union law requirements concerning unintended and adventitious presence of GM material in other products and should not affect the placing on the market and use of products complying with these requirements.

Amendment 24 #

Proposal for a regulation
Recital 14

~~(14) Regulation (EC) No 1829/2003 should be amended accordingly,~~deleted

Amendment 25 #

Proposal for a regulation
Article 1

~~[...]~~deleted

Amendment 26 #

Proposal for a regulation
Article 1 – paragraph 1 – introductory part

~~In Regulation (EC) No 1829/2003 the following Article is inserted:~~ Regulation 182/2011 is hereby amended as follows: (1) The following recital 11a is inserted: (11a) The area of GMO authorisations, whether it is via Directive 2001/18 or via Regulation 1829/2003, is the only field where regularly neither the responsible committee, nor the Council comes to an opinion (no qualified majority either in favour or against the authorisation). As the area is very sensitive for European citizens, the Commission needs a clear indication on how to act in such cases. (2) Recital 14 is changed as follows: (14) When considering the adoption of other draft implementing acts concerning particularly sensitive sectors, notably taxation, consumer health, food safety and protection of the environment, the Commission, in order to find a balanced solution, will, as far as possible, act in such a way as to avoid going against any predominant position which might emerge within the appeal committee against the appropriateness of an implementing act. With regard to the sensitive field of GMO authorisations, no draft implementing act authorising a GMO should be adopted if a simple majority of the component members of the committee opposes it. (3) In Article 6, the following paragraph 3a is inserted: (3a) ‘Where no opinion is delivered in accordance with the second subparagraph of paragraph 3, and where the draft implementing act concerns an application for authorisation of a GMO, in accordance with Directive 2001/18 or Regulation 1829/2003, the Commission shall not adopt the draft implementing act.’ (4) In Article 11, the following second subparagraph is inserted: ‘Where the draft implementing act concerns an application for authorisation of a GMO, in accordance with Directive 2001/18 or Regulation 1829/2003, and where the European Parliament has spoken out against the authorisation, e.g. by means of a resolution, the Commission shall not adopt the draft implementing act.’

Amendment 27 #

Proposal for a regulation
Article 1 – paragraph 1

1. Member States may adopt measures restricting or prohibiting the use of products referred to in Article 3(1) and 15(1) ~~authorised pursuant to this Regulation provided that such measures are:~~.

Amendment 28 #

Proposal for a regulation
Article 1 – paragraph 1

Regulation (EC) 1829/2003
Article 34 a – paragraph 1 – point a

~~(a) reasoned and based on compelling grounds in accordance with Union law which shall, in no case, conflict with the risk assessment carried out pursuant this Regulation;~~deleted

Amendment 29 #

Proposal for a regulation
Article 1 – paragraph 1

Regulation (EC) 1829/2003
Article 34 a – paragraph 1– point b

~~(b) proportional and non-discriminatory.~~deleted

Amendment 3 #

Norbert ERDŐS

Proposal for a regulation
Paragraph 1 b (new)

(1b) Calls on the Commission to draft proposals for increasing European feed production and, as soon as possible, putting an end to the serious lack of self- sufficiency in feed in Europe; considers that the Commission should submit these proposals, at the latest, as part of the mid- term review of the Common Agricultural Policy;

Amendment 30 #

Proposal for a regulation
Article 1 – paragraph 1

Regulation (EC) 1829/2003
Article 34 a –paragraph 2

2. Where a Member State intends to adopt measures as provided for in paragraph 1, it shall first submit to the Commission a draft of those measures, and the corresponding justification. The Commission shall immediately notify to the other Member States the draft measures and the corresponding justification. The Member State may submit the draft measures and such information before the authorisation procedure provided for in Articles 7 and 19 has been completed. During a period of 3 months from the date of submission to the Commission of the draft measures and information in accordance with the first subparagraph: (a) the Member State shall refrain from adopting and implementing those measures; (b) the Commission and the Member States may make any comments they consider appropriate to the Member State which has submitted the draft measures.deleted

Amendment 31 #

Proposal for a regulation
Article 1 – paragraph 1

Regulation (EC) 1829/2003
Article 34 a – paragraph 3

3. Measures adopted in accordance with paragraph 1 of this Article shall provide for a reasonable period of time during which existing stocks of the products referred to in Article 3(1) and 15(1) concerned by such measures, which could legally be used before the date of adoption of the measures, may be used up.deleted

Amendment 4 #

Proposal for a regulation
Recital 2

Amendment 5 #

Proposal for a regulation
Recital 4

(4) The use of genetic engineering in plants and in food and feed is a subject which divides opinion in the Member States and this is reflected in the decision-making process leading to the authorisation of GMOs ~~and GM food and feed. Since the date of application of Regulation (EC) No 1829/2003, t~~for cultivation and of GM food and feed. The results of the voting in the committees or in Council show that there has never been a qualified majority either in favour of or against the authorisation of those products. ~~Therefore~~So far, authorisations have been adopted by the Commission at the end of the procedure, ~~in accordance with applicable legislation,~~ without the support of the Member States’ committee opinion. However, as the area is very sensitive for European citizens, the Commission needs a clear indication on how to act in such cases. Regulation 182/2011 therefore needs to be changed accordingly.

Amendment 6 #

Proposal for a regulation
Recital 5

(5) Once a GMO or a GM food and feed is authorised in accordance with Directive 2001/18/EC or Regulation (EC) No 1829/2003, the Member States may not prohibit, restrict or impede the free circulation of that product within their territory, except in accordance with strict conditions which are laid down by Union law –and require to provide evidence of a severe risk to health or to the environment. Some Member States have had recourse to the safeguard clauses and the emergency measures provided for respectively in Articles 23 of Directive 2001/18/EC and Article 34 of Regulation (EC) No 1829/2003. Other Member States have made use of the notification procedure provided for in Article 114(5) and (6) of TFUE which also is required to be based on new scientific evidence relating to the protection of the environment or the working environment. Other Member States have adopted unilateral prohibitions. Some of these measures have been challenged before national jurisdictions or the Court of Justice.deleted

Amendment 7 #

Proposal for a regulation
Recital 5

(5) Once a GMO or a GM food and feed is authorised in accordance with Directive 2001/18/EC or Regulation (EC) No 1829/2003, the Member States may ~~not~~ prohibit, restrict or impede the free circulation of that product within their territory, except in accordance with strict conditions which are laid down by Union law –and require to provide evidence of a severe risk to health or to the environment. Some Member States have had recourse to the safeguard clauses and the emergency measures provided for respectively in Articles 23 of Directive 2001/18/EC and Article 34 of Regulation (EC) No 1829/2003. Other Member States have made use of the notification procedure provided for in Article 114(5) and (6) of TFUE which also is required to be based on new scientific evidence relating to the protection of the environment or the working environment. Other Member States have adopted unilateral prohibitions. Some of these measures have been challenged before national jurisdictions or the Court of Justice.

Amendment 8 #

Proposal for a regulation
Recital 6

(6) That situation was changed recently as regards GMOs for cultivation due to the adoption, on 13 March 2015, of Directive (EU) 2015/41214 which amended Directive 2001/18/EC to allow Member States to restrict or prohibit the cultivation of GMOs in their territory. The new provisions are primarily aimed at enabling Member States to decide whether or not they wish to permit the cultivation of GMO crops on their territory, without affecting the risk assessment provided in the system of Union authorisations of GMOs. They were intended to provide more predictability to operators and limit the recourse by the Member States to the safeguard clauses provided for in Article 23 of Directive 2001/18/EC and 34 of Regulation (EC) No 1829/2003. It was also expected that those amendments would have a positive impact on the decision-making process for the authorisation of GMOs for cultivation. __________________ 14Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory (OJ L 68, 13.3.2015, p. 1).deleted

Amendment 9 #

Proposal for a regulation
Recital 7

(7) The reasons for the amendments made to Directive 2001/18/EC, by Directive (EU) 2015/412 as regards GMOs for cultivation are also relevant for other GMOs and GM food and feed covered by Regulation (EC) No 1829/2003. Indeed, the results of the vote on the implementing decision for the authorisation of products covered by Regulation (EC) No 1829/2003 which are not intended for cultivation in the relevant committee, or in the Council, is always ‘no opinion’ (no qualified majority either in favour of or against the authorisation) and there are also Member States in which the use of these products is prohibited. Taking those matters into account, it is appropriate to amend Regulation (EC) No 1829/2003 in order to provide the possibility for the Member States to restrict or prohibit the use of GMOs and GM food and feed in all or part of their territory, on the basis of compelling grounds compatible with Union law - not related to risks to human and animal health and to the environment, as those are already assessed at Union level, pursuant to Regulation (EC) No 1829/2003. This possibility should not apply to GMOs for cultivation which are already covered by the amendments made to Directive 2001/18/EC, by Directive (EU) 2015/412.deleted

source: 565.017

2015/09/18 ENVI 55 amendments...

Amendment 1 #

Draft legislative resolution
Citation 4 a (new)

- having regard to the opening statement of Jean-Claude Juncker, at that time candidate for President of the European Commission, in his speech in the European Parliament Plenary Session, Strasbourg, 15 July 20141a; ________________ 1a"I will make sure that the procedural rules governing the various authorisations for GMOs are reviewed. I would not want the Commission to be able to take a decision when a majority of Member States has not encouraged it to do so."

Amendment 10 #

Draft legislative resolution
Paragraph 2 a (new)

2a. Calls on the Commission to ensure that its new proposal provides for the European Parliament's voice being adequately taken into account when it comes to decisions about GMO authorisations;

Amendment 11 #

Draft legislative resolution
Paragraph 2 b (new)

2b. Calls on the Commission not to propose to authorise any new GMO variety and not to renew old ones until the new proposal is agreed upon;

Amendment 12 #

Draft legislative resolution
Paragraph 2 c (new)

2c. Calls on the Commission to take a long-term view in reviewing its policy on proteins, and to introduce adequate measures and instruments that support farmers in improving crop rotation systems and locally-grown fodder so as to substantially reduce the current dependence on feed imports;

Amendment 13 #

Draft legislative resolution
Paragraph 2 d (new)

2d. Calls on the Commission to provide a balanced basis for democratic decision- making, in particular by improving risk assessment, as GMOs still pose many risks and uncertainties, and by ensuring the necessary resources for independent research on the potential risks involved in the deliberate release or the placing on the market of GMOs;

Amendment 14 #

Draft legislative resolution
Paragraph 2 e (new)

2e. Calls on the Commission to increase transparency and choice for consumers by ensuring that products stemming from animals that were fed with GM feed are adequately labelled;

Amendment 15 #

Proposal for a regulation
Citation 1

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 291(3) thereof,

Amendment 16 #

Proposal for a regulation
Citation 1

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Articles 168(7), 169(4) and 193 thereof,

Amendment 17 #

Proposal for a regulation
Recital 2

(2) Both Directive 2001/18/EC and Regulation (EC) No 1829/2003 establish a centralised procedure at Union level whereby the Commission is empowered to adopt implementing decisions granting or refusing application for the authorisation of GMOs and GM food and feed, based on an assessment of the potential risks that they could pose to human or animal health, or the environment. Both Regulation (EC) No 1829/2003 a~~lso provides that other legitimate factors may be taken into account, where appropriate~~nd Regulation (EC) No 178/2002 of the European Parliament and of the Council 1a require the Commission to take other legitimate factors into account, when submitting a draft decision. ______________ 1a Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 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 (OJ L 31, 1.2.2002, p. 1).

Amendment 18 #

Proposal for a regulation
Recital 4

(4) The use of genetic engineering in plants and in food and feed is a subject which divides opinion in the Member States ~~and this is reflected in the decision-making process leading to the authorisation of GMOs and GM food and feed~~. Since the date of application of Regulation (EC) No 1829/2003, the results of the voting in the committees or in Council show that there has never been a qualified majority either in favour of or against the authorisation of those products. ~~Therefore, a~~Authorisations have been adopted by the Commission ~~at the end of the procedure~~, in accordance with applicable legislation, without the support of the Member States' committee opinion.

Amendment 19 #

Proposal for a regulation
Recital 4

(4) The use of genetic engineering in plants and in food and feed is a subject which divides opinion in the Member States and this is reflected in the decision-making process leading to the authorisation of GMOs for cultivation and GM food and feed. ~~Since the date of application of Regulation (EC) No 1829/2003, t~~The results of the voting in the committees or in Council show that there has never been a qualified majority either in favour of or against the authorisation of those products. ~~Therefore~~So far, authorisations have been adopted by the Commission at the end of the procedure, ~~in accordance with applicable legislation,~~ without the support of the Member States' committee opinion. However, as the area is very sensitive for European citizens, the Commission needs a clear indication on how to act in such cases. Regulation (EU) No 182/2011 therefore needs to be changed accordingly.

Amendment 2 #

Guillaume BALAS

Draft legislative resolution
Citation 4 a (new)

- having regard to the speech by the president-elect of the European Commission, Jean-Claude Juncker, in the European Parliament Plenary Session, in Strasbourg, on 15 July 2014;

Amendment 20 #

Proposal for a regulation
Recital 4

(4) The use of genetic engineering in plants and in food and feed is a subject which divides opinion in the Member States and this is reflected in the decision-making process leading to the authorisation of GMOs and GM food and feed. Since the date of application of Regulation (EC) No 1829/2003, the results of the voting in the committees or in Council show that there has never been a qualified majority either in favour of or against the authorisation of those products. Therefore, authorisations have been adopted by the Commission at the end of the procedure, in accordance with applicable legislation, without the support of the Member States' committee opinion. This has led to a democratic deficit which the then-candidate for President, Jean-Claude Juncker, committed himself to solve, pledging to democratise the authorisation procedure.

Amendment 21 #

Proposal for a regulation
Recital 5

Amendment 22 #

Proposal for a regulation
Recital 5

(5) ~~Once a GMO or a GM food and feed is authorised~~The authorisation at EU level, in accordance with Directive 2001/18/EC or Regulation (EC) No 1829/2003, the Member States may not prohibit, restrict or impede the free circulation of that product within their territory, except in accordance with strict conditions which are laid down by Union law –and require to provide evidence of a severe risk to health or to the environment. Some Member States have had recourse to the safeguard clauses and the emergency measures provided for respectively in Articles 23 of Directive 2001/18/EC and Article 34 of Regulation (EC) No 1829/2003. Other Member States have made use of the notification procedure provided for in Article 114(5) and (6) of TFUE which also is required to be based on new scientific evidence relating to the protection of the environment or the working environment. Other Member States have adopted unilateral prohibitions. Some of these measures have been challenged before national jurisdictions or the Court of justice of a GMO or a GM food and feed should be without prejudice to Member States' right to prohibit, restrict or impede the placing on the market of one or more foods or feeds containing GMOs on their territory without impeding their free circulation.

Amendment 23 #

Proposal for a regulation
Recital 5

(5) Once a GMO or a GM food and feed is authorised in accordance with Directive 2001/18/EC or Regulation (EC) No 1829/2003, the Member States may not prohibit, restrict or impede the free circulation of that product within their territory, except for its placing on the market and in accordance with strict conditions which are laid down by Union law –and require to provide evidence of a severe risk to health or to the environment. Some Member States have had recourse to the safeguard clauses and the emergency measures provided for respectively in Articles 23 of Directive 2001/18/EC and Article 34 of Regulation (EC) No 1829/2003. Other Member States have made use of the notification procedure provided for in Article 114(5) and (6) of TFUE which also is required to be based on new scientific evidence relating to the protection of the environment or the working environment. Other Member States have adopted unilateral prohibitions. Some of these measures have been challenged before national jurisdictions or the Court of justice.

Amendment 24 #

Proposal for a regulation
Recital 6

Amendment 25 #

Proposal for a regulation
Recital 6

(6) ~~That situation was changed recently as regards GMOs for cultivation due to the adoption, on 13 March 2015, of~~As regards GMOs for cultivation, Directive (EU) 2015/41214 which amended Directive 2001/18/EC to allow Member States to restrict or prohibit the cultivation of GMOs in their territory was adopted on 13 March 2015. The new provisions are primarily aimed at enabling Member States to decide whether or not they wish to permit the cultivation of GMO crops on their territory, without affecting the risk assessment provided in the system of Union authorisations of GMOs. They were intended to provide more predictability to operators and limit the recourse by the Member States to the safeguard clauses provided for in Article 23 of Directive 2001/18/EC and 34 of Regulation (EC) No 1829/2003. ~~It was also expected that those amendments would have a positive impact on the decision-making process for the authorisation of GMOs for cultivation.~~ __________________ 14 Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 amending Directive 2001/18/EC as regards the possibility for ~~the~~ Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory (OJ L 68, 13.3.2015, p. 1).

Amendment 26 #

Proposal for a regulation
Recital 6

(6) That situation was changed recently as regards GMOs for cultivation due to the adoption, on 13 March 2015, of Directive (EU) 2015/41214 which amended Directive 2001/18/EC to allow Member States to restrict or prohibit the cultivation of GMOs in their territory. The new provisions are primarily aimed at enabling Member States to decide whether or not they wish to permit the cultivation of GMO crops on their territory~~, without affecting the risk assessment provided in the system of Union authorisations of GMOs~~. They were intended to provide more predictability to operators and limit the recourse by the Member States to the safeguard clauses provided for in Article 23 of Directive 2001/18/EC and 34 of Regulation (EC) No 1829/2003. It was also expected that those amendments would have a positive impact on the decision- making process for the authorisation of GMOs for cultivation. __________________ 14 Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory (OJ L 68, 13.3.2015, p. 1).

Amendment 27 #

Proposal for a regulation
Recital 7

Amendment 28 #

Proposal for a regulation
Recital 7

(7) The reasons for the amendments made to Directive 2001/18/EC, by Directive (EU) 2015/412 as regards GMOs for cultivation are also relevant for other GMOs and GM food and feed covered by Regulation (EC) No 1829/2003. Indeed, the results of the vote on the implementing decision for the authorisation of products covered by Regulation (EC) No 1829/2003 which are not intended for cultivation in the relevant committee, or in the Council, is always “no opinion” (no qualified majority either in favour of or against the authorisation) and there are also Member States in which the use of these products is prohibited. Taking those matters into account, it is appropriate to amend Regulation (EC) No 1829/2003 in order to provide the possibility for the Member States to restrict or prohibit the use of GMOs and GM food and feed in all or part of their territory, oin ~~the basis of compelling grounds compatible with Union law - not related to risks to human and animal health and to th~~particular GMOs in respect of which the risk assessment has not provided conclusive envi~~ronment, as those are already assessed at Union level, pursuant to Regulation (EC) No 1829/2003~~dence of there being no environmental and health risks. This possibility should not apply to GMOs for cultivation which are already covered by the amendments made to Directive 2001/18/EC, by Directive (EU) 2015/412.

Amendment 29 #

Proposal for a regulation
Recital 8

Amendment 3 #

Draft legislative resolution
Citation 4 b (new)

- having regard to the Commission work programme, adopted on 16 December 20141a; __________________ 1a SeeAnnex I of the Commission work programme 2015 ("New initiatives"), point 23: Review of the GMO decision- making process: "The review will look at how the rules could be changed to better ensure the majority view of Member States is taken into account".

Amendment 30 #

Proposal for a regulation
Recital 8

(8) Member States should therefore be allowed to adopt measures restricting or prohibiting the use in all or part of their territory of a GMO or a GM food and feed, or group of GMOs or of GM food and feed, once authorised, provided that such measures are reasoned, based on ~~compelling~~ grounds in accordance with Union law, and are in line with the principles of proportionality and non- discrimination between national and non- national products, and Article 34, Article 36 and Article 216(2) of TFEU.

Amendment 31 #

Tibor SZANYI

Proposal for a regulation
Recital 8

Amendment 32 #

Proposal for a regulation
Recital 8

(8) Member States should therefore be allowed to adopt measures restricting or prohibiting the ~~use~~placing on the market in all or part of their territory of a GMO or a GM food and feed, or group of GMOs or of GM food and feed, once authorised, provided that such measures are reasoned, based on compelling grounds in accordance with Union law, and are in line with the principles of proportionality and non- discrimination between national and non- national products, and Article 34, Article 36 and Article 216(2) of TFEU.

Amendment 33 #

Proposal for a regulation
Recital 9

~~(9) The restrictions or prohibitions adopted pursuant to this Regulation should refer to the use and not to the free circulation and imports of genetically modified food and feed.~~deleted

Amendment 34 #

Tibor SZANYI

Proposal for a regulation
Recital 9

~~(9) The restrictions or prohibitions adopted pursuant to this Regulation should refer to the use and not to the free circulation and imports of genetically modified food and feed.~~deleted

Amendment 35 #

Proposal for a regulation
Recital 9

(9) The restrictions or prohibitions adopted pursuant to this Regulation should refer to the ~~use~~placing on the market and not to the free circulation and imports of genetically modified food and feed.

Amendment 36 #

Proposal for a regulation
Recital 10

Amendment 37 #

Proposal for a regulation
Recital 10

(10) The level of protection of human and animal health and of the environment achieved through the authorisation procedure provided for by Regulation (EC) No 1829/2003 requires a uniform scientific assessment throughout the Union and this Regulation should not alter that situation. ~~Therefore to avoid any interference with the competences which are granted to the~~However, in the absence of conclusive scientific evidence that no environmental and health risks assessors and risk managers under Regulation (EC) No 1829/2003, Member States should not be authorised to use grounds which are related to risks to health and to the environment which should be dealt with in accordance with the procedure already established in Regulation (EC) No 1829/2003, and in particular its Articles 10, 22 and 34re associated with the use of GMOs, Member States should be responsible for taking national risk management measures.

Amendment 38 #

Proposal for a regulation
Recital 10

(10) The level of protection of human and animal health and of the environment achieved through the authorisation procedure provided for by Regulation (EC) No 1829/2003 requires a uniform scientific assessment throughout the Union and this Regulation should not alter that situation. Therefore to avoid any interference with the competences which are granted to the risk assessors and risk managers under Regulation (EC) No 1829/2003,which, in line with the Council Conclusions on GMOs adopted by the Environment Council on 4 December 2008 must be reformed to improve the quality of the procedure. Until then Member States should ~~not be authoris~~be permitted to use grounds which are related to risks to health and to the environment ~~which should be dealt with in accordance with the procedure~~, especially when they alre~~ady establish~~ acting based ion ~~Regulation (EC) No 1829/2003, and in particular its Articles 10, 22 and 34~~the concerns of civil society in their country.

Amendment 39 #

Proposal for a regulation
Recital 11

(11) Member States's measures adopted pursuant to this Regulation should be subject to a procedure of scrutiny and information at Union level with a view to the functioning of the internal market. In light of the level of scrutiny and information provided in this Regulation, it is not necessary to provide, in addition, for the application of Directive 98/34/EC of the European Parliament and of the Council15 . The amendments being made to Regulation (EC) No 1829/2003 by this Regulation provide that Member States may restrict or prohibit the use of GMOs or GM food and feed in all or part of their territory for the whole duration of the authorisation, provided that an established standstill period, during which the Commission and the other Member States are given the opportunity to comment on the proposed measures, has elapsed. The Member State concerned should therefore communicate a draft of those measures to the Commission at least 3 months prior to their adoption, in order to give the opportunity to the Commission and the other Member States to comment, and should refrain from adopting and implementing those measures during that period. On the expiry of the established “standstill” period, the Member State should be able to adopt the measures as originally proposed or amended to take into account the Commission's or the Member States' comments. Member States should be allowed to notify to the Commission measures pursuant to this Regulation before that the product concerned by the measures is authorised so that the restriction or the prohibition starts its effects as from the date of entry into force of the Union authorisation. __________________ 15Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (OJ L 204, 21.7.1998, p. 37).deleted

Amendment 4 #

Draft legislative resolution
Citation 4 c (new)

- having regard to the proposal for a Council decision concerning the placing on the market for cultivation, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L., line 1507) genetically modified for resistance to certain lepidopteran pests3 , and the related votes in both regulatory committee (February 2009) and Council (February 2014), where no opinions were delivered;

Amendment 40 #

Proposal for a regulation
Recital 11

(11) Member State~~s’s~~ measures adopted pursuant to this Regulation should be subject to a procedure of scrutiny and information at Union level with a view to the functioning of the internal market. In light of the level of scrutiny and information provided in this Regulation, it is not necessary to provide, in addition, for the application of Directive 98/34/EC of the European Parliament and of the Council15. The amendments being made to Regulation (EC) No 1829/2003 by this Regulation provide that Member States may restrict or prohibit the use of GMOs or GM food and feed in all or part of their territory for the whole duration of the authorisation, provided that an established standstill period, during which the Commission and the other Member States are given the opportunity to submit non- binding comments on the proposed measures, has elapsed. The Member State concerned should therefore communicate a draft of those measures to the Commission at least 3 months prior to their adoption, in order to give the opportunity to the Commission and the other Member States to submit non-binding comments, and should refrain from adopting and implementing those measures during that period. On the expiry of the established “standstill” period, the Member State should be able to adopt the measures as originally proposed or amended to take into account the Commission's or the Member States’ comments. Member States should be allowed to notify to the Commission measures pursuant to this Regulation before that the product concerned by the measures is authorised so that the restriction or the prohibition starts its effects as from the date of entry into force of the Union authorisation. __________________ 15 Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (OJ L 204, 21.7.1998, p. 37).

Amendment 41 #

Proposal for a regulation
Recital 12

Amendment 42 #

Proposal for a regulation
Recital 12

(12) In the case where a product was lawfully ~~used~~placed on the market before a Member State adopts measures pursuant to this Regulation, sufficient time should be given to operators to allow the phasing out of the product from the market.

Amendment 43 #

Proposal for a regulation
Recital 13

Amendment 44 #

Proposal for a regulation
Recital 14

(14) Regulation (ECU) No 1829/200311 should be amended accordingly,

Amendment 45 #

Proposal for a regulation
Article 1

Regulation (EC) No 1829/2003
Article 34a

~~[…]~~deleted

Amendment 46 #

Proposal for a regulation
Article 1 a (new)

Article 1 a Regulation (EU) No 182/2011 is hereby amended as follows: (1) The following recital 11a (new) is inserted: (11a) (new) The area of GMO authorizations, be it via Directive 2001/18/EC or via Regulation (EC) No 1829/2003, is the only field where regularly neither the responsible committee, nor the Council comes to an opinion (no qualified majority either in favour or against the authorisation). As the area is very sensitive for European citizens, the Commission needs a clear indication on how to act in such cases. (2) Recital 14 is changed as follows: (14) When considering the adoption of other draft implementing acts concerning particularly sensitive sectors, notably taxation, consumer health, food safety and protection of the environment, the Commission, in order to find a balanced solution, will, as far as possible, act in such a way as to avoid going against any predominant position which might emerge within the appeal committee against the appropriateness of an implementing act. With regard to the sensitive field of GMO authorisations, no draft implementing act authorising a GMO should be adopted if a simple majority of the component members of the committee opposes it. (3) In Article 6, the following paragraph 3a (new) is inserted: (3a) (new) 'Where no opinion is delivered in accordance with the second subparagraph of paragraph 3, and where the draft implementing act concerns an application for authorisation of a GMO, in accordance with Directive 2001/18/EC or Regulation (EC) No 1829/2003, the Commission shall not adopt the draft implementing act.' (4) In Article 11, the following second subparagraph is inserted: 'Where the draft implementing act concerns an application for authorisation of a GMO, in accordance with Directive 2001/18/EC or Regulation (EC) No 1829/2003, and where the European Parliament has spoken out against the authorisation, e.g. by means of a resolution, the Commission shall not adopt the draft implementing act.'

Amendment 47 #

Proposal for a regulation
Article 1

1. Member States may adopt measures restricting or prohibiting the use of products referred to in Article 3(1) and 15(1) authorised pursuant to this Regulation provided that such measures are: a) reasoned and based on compelling grounds in accordance with Union law which shall, in no case, conflict with the risk assessment carried out pursuant this Regulation; b) proportional and non-discriminatory.deleted

Amendment 48 #

Proposal for a regulation
Article 1

Regulation (EC) No 1829/2003
Article 34a – paragraph 1 – introductory part

1. Member States may, in their capacity as risk managers, adopt measures restricting or prohibiting the use of products referred to in Article 3(1) and 15(1) authorised pursuant to this Regulation ~~provided that such measures are:~~where the findings of the risk assessment have not conclusively ruled out the possibility of any environmental and health risks being associated with those products. Those measures shall be based on grounds compatible with Union law and shall be proportionate and non-discriminatory.

Amendment 49 #

Proposal for a regulation
Article 1

Regulation (EC) No 1829/2002
Article 34a – paragraph 1 – introductory part

1. Member States may adopt measures restricting or prohibiting the ~~use~~placing on the market of products referred to in Article 3(1) and 15(1) authorised pursuant to this Regulation provided that such measures are:

Amendment 5 #

Draft legislative resolution
Citation 4 d (new)

- having regard to the January 2014 European Parliament's resolution on the proposal for a Council decision concerning the placing on the market for cultivation, in accordance with Directive 2001/18/EC, of a maize product (Zea mays L., line 1507) genetically modified for resistance to certain lepidopteran pests, by which the European Parliament opposes the adoption of the proposal;

Amendment 50 #

Proposal for a regulation
Article 1

Regulation (EC) No 1829/2003
Article 34a – paragraph 1 – point a

~~a) reasoned and based on compelling grounds in accordance with Union law which shall, in no case, conflict with the risk assessment carried out pursuant this Regulation;~~deleted

Amendment 51 #

Jørn DOHRMANN

Proposal for a regulation
Article 1

Regulation (EC) No 1829/2003
Article 34a – paragraph 1 – point a

a) reasoned and based on ~~compelling grounds in accordance with Union law which shall, in no case, conflict with the risk assessment carried out pursuant this Regulation~~requirements for product integrity, nutrition, health- protection and safety sovereignly evaluated by the Member State according to the risk assessment set up by its competent authorities;

Amendment 52 #

Proposal for a regulation
Article 1

Regulation (EC) No 1829/2003
Article 34a – paragraph 1 – point a

a) reasoned and based on compelling grounds in accordance with Union law which shall, in no case, conflict with the risk assessment carried out pursuant this Regulation, so as to avoid any interference with the competences assigned to risk managers;

Amendment 53 #

Eleonora EVI

Proposal for a regulation
Article 1

Regulation (EC) No 1829/2003
Article 34a – paragraph 1 – point b

~~b) proportional and non-discriminatory.~~deleted

Amendment 54 #

Proposal for a regulation
Article 1 – paragraph 1

Regulation (EC) No 1829/2003
Article 34a – paragraph 1 – point b a new

(ba) not at odds with the principle of free movement of goods established in the Treaty on the Functioning of the European Union, provided that compliance with the specific labelling rules for GMO food and feed laid down in Regulation (EC) No 1829/2003 and Regulation (EC) No 1830/2003 is ensured.

Amendment 55 #

Jørn DOHRMANN

Proposal for a regulation
Article 1

Regulation (EC) No 1829/2003
Article 34a – paragraph 5 a new

5a. This regulation does not prevent the Member States from sovereignly deciding to retain or introduce, on their territory, restrictions and prohibitions of private and public GMO testing if necessary to ensure compliance with requirements for public health and safety, biodiversity and existing organic farming productions.

Amendment 6 #

Sirpa PIETIKÄINEN

Draft legislative resolution
Paragraph 2

2. Calls on the Commission to withdraw its proposal and submit a new proposal implementing the political guidelines presented to the European Parliament;

Amendment 7 #