11 Amendments of Piernicola PEDICINI related to 2015/0093(COD)
Amendment 16 #
Proposal for a regulation
Citation 1
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 18 #
Proposal for a regulation
Recital 4
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, aAuthorisations 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 22 #
Proposal for a regulation
Recital 5
Recital 5
(5) Once a GMO or a GM food and feed is authorisedThe 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 25 #
Proposal for a regulation
Recital 6
Recital 6
(6) That situation was changed recently as regards GMOs for cultivation due to the adoption, on 13 March 2015, ofAs 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 28 #
Proposal for a regulation
Recital 7
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 thparticular GMOs in respect of which the risk assessment has not provided conclusive environment, as those are already assessed at Union level, pursuant to Regulation (EC) No 1829/2003dence 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 30 #
Proposal for a regulation
Recital 8
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 37 #
Proposal for a regulation
Recital 10
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 theHowever, 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 40 #
Proposal for a regulation
Recital 11
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 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 47 #
Proposal for a regulation
Article 1
Article 1
Amendment 48 #
Proposal for a regulation
Article 1
Article 1
Regulation (EC) No 1829/2003
Article 34a – paragraph 1 – introductory part
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 50 #
Proposal for a regulation
Article 1
Article 1
Regulation (EC) No 1829/2003
Article 34a – paragraph 1 – point a
Article 34a – paragraph 1 – point a