59 Amendments of Ulrike MÜLLER related to 2017/2128(INI)
Amendment 3 #
Draft opinion
Paragraph 1
Paragraph 1
1. Welcomes the fact that an implementation report for Regulation (EC) No 1107/2009 is being undertaken with the aim of scrutinising the Regulation's performance in ensuring a high level of protection of both human and animal health as well as the environment, while safeguarding the competitiveness of the EU’s agriculture sector by providing access to a broad range of active substances and Plant Protection Products (PPP) for all farmers and producers, irrespective of the Members States they are operating in;
Amendment 7 #
Motion for a resolution
Recital A
Recital A
A. whereas the evaluation of the implementation of the Regulation revealed that the health and environmental protection objectives are not being achievedshowed its objectives to be relevant while identifying areas for improvement;
Amendment 8 #
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas the EU authorisation system for plant protection products is internationally recognised as one of the strictest systems in the world; whereas its elements, inter alia the thorough peer- review process as well as the strict separation between risk assessment and risk management, already ensure a high level of food safety;
Amendment 9 #
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas the evaluation of the implementation of the Regulation should be considered in conjunction with the EU’s overarching pesticide policy including regulations: Sustainable Use Directive 2009/128/EC, Biocides Regulation EU 528/2012 Maximum Residue Level EC 396/2005, and General Food Law 178/2002;
Amendment 13 #
Motion for a resolution
Recital B
Recital B
B. whereas the implementation of the Regulation is notshould be in line with related EU policies, including in the field of pesticides;
Amendment 14 #
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Takes note of the European Commission's ongoing REFIT Evaluation of Regulation 1107/2009 and of its planned completion by November 2018; trusts that these findings will be an adequate basis for the co-legislators to discuss the future development of Regulation 1107/2009;
Amendment 17 #
Motion for a resolution
Recital C
Recital C
C. whereas the available evidence shows that the practical implementation of the three main instruments of the Regulation – approvals, authorisations and enforcement of regulatory decisions – is unsatisfactory and does not ensure the fulfilment of the purpose of the Regulationcould be improved;
Amendment 18 #
Draft opinion
Paragraph 1 b (new)
Paragraph 1 b (new)
1 b. Recognises that plant protection products have played a significant role in improving the agricultural sector's capability to satisfy global nutritional needs, which has contributed to reducing the global share of undernourished people in the population from 18.6% in 1990- 1992 to around 10.9% in 2014-2016 according to the FAO1a, thus takes the view that the current system should be improved by intensifying efforts to eliminate adverse effects rather than by dismissing it without having alternatives at hand that are equally capable of maintaining and further increasing the supply of food; _________________ 1aSee FAO (2015): The State of Food Security in the World, http://www.fao.org/3/a-i4646e.pdf.
Amendment 22 #
Draft opinion
Paragraph 1 c (new)
Paragraph 1 c (new)
1 c. underlines its belief that the Regulation's set of targets can be achieved most effectively if (complementary to further conditions set in the MRL Regulation and Sustainable Use Directive, in particular the principles of Integrated Pest Management and Good Agricultural Practices) farmers and producers, irrespective of the Member States they are operating in, have access to a broad range of active substances and Plant Protection Products (PPP) that allows them to efficiently tackle pests; stresses that the availability of a broad range of PPPs is the basis for any meaningful reduction strategy, because otherwise farmers would be dependent on less targeted and hence less efficient PPPs, which leads to higher consumption;
Amendment 23 #
Motion for a resolution
Recital D
Recital D
Amendment 27 #
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. Considers that the burden of proof should remain on the applicant, so as to ensure that public money is not spent on studies which can eventually benefit private interests; at the same time, stresses that transparency must be ensured at each step of the authorisation procedure fully in line with intellectual property rights while ensuring that good laboratory principles are consistently upheld throughout the Union;
Amendment 28 #
Motion for a resolution
Recital E
Recital E
E. whereas there are concerns associated with the practical implementation of the established evaluation approach; whereas in particular there are major concerns associated with the incomplete harmonisation of data requirements and methodologies used in some scientific fields that may hinder the evaluation process and thus may lead to direct negative effects on public health and the environment;
Amendment 29 #
Motion for a resolution
Recital E
Recital E
E. whereas there are concerns associated with the practical implementation of the establishedtwo-tier evaluation approach; whereas in particular there are major concerns associated with the incomplete harmonisation of data requirements and methodologies used in some scientific fieldduring evaluations of the products that may hinder the evaluation process and thus may lead to direct negative effects on public health and the environmentelays in the approval process;
Amendment 31 #
Motion for a resolution
Recital F
Recital F
F. whereas the performance of national competent authorities was found to be a major factor influencing the evaluation of active substances; whereas there are substantial differences among Member States as regards available expertise and staff; whereas the Regulation and relevant supporting legal requirements are not uniformly implemented across Member States with relevant health and environment implications;
Amendment 37 #
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2 a. Considers that the Sustainable Use Directive has not been sufficiently implemented by EU Member States; highlights the importance of continuous training and education of farmers in the proper use of plant protection products; urges Member States and competent authorities to make better use of all available measures to increase the safe use of plant protection products and reduce adverse environmental effects;
Amendment 38 #
Motion for a resolution
Recital G
Recital G
G. whereas transparency in all stages of the approval procedure is insufficient and leads to negative effects on health and the environment and provokescould be improved, which would lead to increased public mistrust in the system regulating pesticide substances; whereas the transparency of the authorisation related activities of competent authorities iscould also unsatisfactorybe improved; welcomes the proposed changes to the General Food Law to address this problem;
Amendment 46 #
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2 b. Highlights the potential efficiency gains in plant protection that could be realised through the use of precision farming technologies, which will allow farmers to apply plant protection products more targeted in regard to where and in what quantity exactly they are needed instead of a general application on the entire field, which would lead to a significant reduction of consumption quantity;
Amendment 52 #
Motion for a resolution
Recital I a (new)
Recital I a (new)
Ia. whereas the non-application of plant protection products in crop production can also lead to health consequences for example build-up of mycotoxins; whereas plant protection products play a role in food safety;
Amendment 55 #
Motion for a resolution
Recital I b (new)
Recital I b (new)
Ib. Whereas a wide variety of safe and effective tools are needed to protect plant health;
Amendment 56 #
Motion for a resolution
Recital I c (new)
Recital I c (new)
Ic. Whereas there has been no new active substances put forward for approval since May 31st 2016; whereas innovation and development of new products, particularly low-risk products, is important;
Amendment 57 #
Motion for a resolution
Recital I d (new)
Recital I d (new)
Id. Whereas the availability of counterfeit pesticides on the market is of real concern; whereas counterfeit pesticides can be harmful to the environment and also damage the effectiveness of the Regulation;
Amendment 60 #
Draft opinion
Paragraph 3
Paragraph 3
3. StExpresses the importance of a science-based approachits concern that in recent debates the European Union's current science-based evaluation system for PPPs has been more and more called into question; therefore stresses the importance of maintaining and further strengthening a scientifically robust decision making in authorising any active substance, in line with the EU’s risk analysis principles and the precautionary principle as established in the General Food Law (Regulation (EC) No 178/2002);
Amendment 61 #
Motion for a resolution
Paragraph 1
Paragraph 1
1. Considers that the EU is the appropriate level at which regulatory action in the field of pesticides should continue to take place; notes that the EU plant protection products approval process is one of the most stringent in the world;
Amendment 66 #
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Stresses the importance of a regulatory framework on plant protection products at EU level, that protects the environment and human health, and also stimulates research and innovation in order to develop effective and safe plant protection products;
Amendment 69 #
Motion for a resolution
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Highlights that special attention should be given to the role of small and medium enterprises (SMEs) in the development of new plant protection products, as SMEs often lack the significant resources that are necessary it develop new substance;
Amendment 70 #
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a. Welcomes the Commission's interpretation of the precautionary principle, as expressed in the REFIT evaluation of the general food law1a, that it is not an alternative to a risk management approach but rather a particular form of risk management, recalls that this view is also supported by EU court rulings1b; calls on the Commission to assess whether the cut-off criteria as laid down in 1107/2009 are fit for purpose in this regard; _________________ 1a SWD(2018) 38 final. 1be.g. Judgement of the General Court of 9 September 2011 in France vs. Commission, T-257/07, EU:T:2011:444.
Amendment 71 #
Motion for a resolution
Paragraph 1 c (new)
Paragraph 1 c (new)
1c. Expresses concerns about the low number of new active substances that have been approved, both conventional, low-risk and biological active substances; stresses the importance of a broad range of plant protection products to tackle plant health issues and to secure the EU's food supply;
Amendment 72 #
Motion for a resolution
Paragraph 1 d (new)
Paragraph 1 d (new)
Amendment 73 #
Motion for a resolution
Paragraph 1 e (new)
Paragraph 1 e (new)
1e. Emphasises that special attention and support should be given to plant protection products for minor uses, as there is currently little economic incentive for companies to develop these products;
Amendment 73 #
Draft opinion
Paragraph 3 b (new)
Paragraph 3 b (new)
Amendment 75 #
Draft opinion
Paragraph 3 c (new)
Paragraph 3 c (new)
3 c. Expresses its concern that Regulation 834/2007 provides no equal scientifically robust and thorough regime for the assessment of effects on human health, animal health and the environment for the authorisation of substances for plant protection in organic production; notes that the principle of separating risk assessment and risk management is not applied in that regulation;
Amendment 77 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. Is concerned by the fact that the Regulation has not been effectively implemented and that as a result its objectives are not being achieved in practicehas led to significant delays in the approval process;
Amendment 77 #
Draft opinion
Paragraph 4
Paragraph 4
4. Expresses its concern about systematic delays in the authorisation processes and the increasing use of derogations as laid down in Article 53 of Regulation (EC) No 1107/2009, while underlining the necessity for Member States to comply with the legal deadlines to ensure predictability for applicants and facilitate the market introduction of innovative PPPs that are in line with more stringent requirements;; stresses that these delays seriously hinder the market introduction of efficient and safer innovative products and that they also lead to an increasing use of emergency authorisations, which come with a higher environmental burden; underlines the necessity for Member States to comply with the legal deadlines to ensure predictability for applicants and facilitate the market introduction of innovative PPPs that are in line with more stringent requirements; highlights that a Commission audit carried out in 2016 and 2017 in 7 Member States1a showed that the majority of the audited Member States had no sufficient systems in place to ensure the processing of applications within legal deadlines; _________________ 1ahttp://ec.europa.eu/food/audits- analysis/overview_reports/details.cfm?rep _id=108
Amendment 85 #
Motion for a resolution
Paragraph 3
Paragraph 3
3. Notes that the objectives and instruments of the Regulation and its implementation are not in always sufficiently streamlined with EU policies in the fields of agriculture, food security, water quality, climate change, sustainable use of pesticides and maximum residue levels of pesticides in food and feed;
Amendment 97 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Is concerned by the steadily increasing use and identified cases of misuse of emergency authorisations granted under Article 53; notes that some member states use Article 53 significantly more than others; notes the Commission’s decision to mandate EFSA to investigate Member States' use of emergency authorisations in 2017 in light of the 2013 restrictions on the three neonicotinoids;
Amendment 97 #
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Recalls that the zonal evaluation system should in principle lead to an authorisation of plant protection products that is more time- and cost-efficient for all parties concerned; expresses its concern that in practice those benefits could barely or not be realised due to a lack of cooperation, harmonised methodology and models as well as application conditions (such as quantity per surface area, distance requirements, re-entry safety intervals, periods of application etc.) between Member States, leading to systematic delays in the authorisation process and an increased use of emergency authorisations;
Amendment 99 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Is concerned by the steadily increasing use and identified cases of misuse of emergency authorisations granted under Article 53; Considers that further efforts are needed to ensure that both Union and national agencies have sufficient capacities to process applications for PPP authorisations in order to avoid frequent use of emergency authorisations; Is concerned that Article 53 has been misused for the authorisation of plant protection products;
Amendment 102 #
Draft opinion
Paragraph 6
Paragraph 6
6. StresUrges Member States to fully uses the need to encourage work sharing between Member States by fosteropportunity of work sharing provided by the zonal authorisation system by further developing the availability and use of harmonised methodology and models to conduct evaluations, while reducing the existence of additional national requirements; encourages the Commission and competent authorities to support the Member States in that project;
Amendment 109 #
Motion for a resolution
Paragraph 5
Paragraph 5
5. Is concerned that the incomplete harmonisation of data and testing requirements in some scientific fields may lead to direct negative effects on health, the environment and agricultural producthe evaluation of plant protection products has not been fully achieved, leading to inefficient working methods, lack of trust among national authorities, and unnecessary delays of authorisations;
Amendment 109 #
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Welcomes the idea and targets of the zonal authorisation system, but recognises that those targets potentially could be achieved more efficiently by a single authorisation system on Union level; asks the Commission to evaluate whether the authorisation process could be achieved more time- and cost- efficiently by either improving the current system (e.g. by strengthening the harmonisation of methodology, models and application requirements and/or by introducing a mandatory authorisation for the entire zone following a positive evaluation by the zRMS), or by setting up a single Union approval system;
Amendment 112 #
Motion for a resolution
Paragraph 5
Paragraph 5
5. Is concerned that the incomplete harmonisation of data and testing requirements in some scientific fields may lead to direct negative effects on health, the environment and agricultural productionthe evaluation of products has not yet been fully implemented;
Amendment 114 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Regrets the limited public availability of information on the evaluation and authorisation procedure, as well as the limited access to information; regrets that the level of transparency of the rapporteur Member States is low (acting in the framework of the approval procedure), suggests that accessibility and user friendliness of information at the European Food Safety Authority (EFSA) stage is problematiccould be improved, and that transparency at the risk management stage seems to be lacking and is also considered problematic by stakeholders; welcomes efforts by ECHA to increase transparency and user friendliness through its website and considers this could be a model employed in the future to improve transparency;
Amendment 117 #
Draft opinion
Paragraph 7
Paragraph 7
7. Regards the application of the mutual recognition procedure as an important tool to increase work sharing and ensure compliance with deadlines, as it allows applicants to apply for authorisation in another Member State which makes the same use of the product in question for the same agricultural practices, based on the assessment carried out for the authorisation in the original Member State; expresses its concern that a recent Commission audit1a concludes that some Member States fully or partially re-evaluate applications for mutually recognition, which results in exceeding legal deadlines, although the majority of these evaluations have the same or a very similar outcome; _________________ 1ahttp://ec.europa.eu/food/audits- analysis/overview_reports/details.cfm?rep _id=108
Amendment 120 #
Motion for a resolution
Paragraph 7
Paragraph 7
7. Is concerned that, in some cases, the PPPs available on the market and their application by users do not necessarily comply with the relevant authorisation conditions as regards their composition and usage; underlines the importance of training for professional users; emphasizes that non-professional use should be limited when possible in order to reduce misuse;
Amendment 121 #
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Highlights the importance of continuous training for users to ensure the proper and appropriate use of plant protection products; considers it fitting to distinguish between professional and amateur users; notes that plant protection products are used in private gardens, railways and public parks;
Amendment 125 #
Motion for a resolution
Paragraph 8
Paragraph 8
8. Emphasises that the Regulation should better reflect the need to promote agricultural practices based on integrated pest management as appropriate, including by stimulating the development of low- risk, high-efficacy, substances;
Amendment 129 #
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Stresses the added value of biological products to the market of plant protection products; acknowledges the need for more research into these products as their composition and functioning is radically different from conventional products; underlines this also includes the need for more expertise within EFSA to evaluate these biological active substances; and more expertise in the national competent authorities to evaluate these products;
Amendment 137 #
Motion for a resolution
Paragraph 9
Paragraph 9
9. Highlights that many authorised PPPs have not been evaluated against EU standards for more than 15 years, as a consequence of delays in the authorisation procedures;
Amendment 141 #
Motion for a resolution
Paragraph 10
Paragraph 10
10. Is concerned that the harmonisation of guidelines in fields like ecotoxicology or environmental fate and behaviour isare not yet complensolidated;
Amendment 145 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. 13. Welcomes the concept of the zonal system and its aim to facilitate the efficient authorisation of plant protection products; considers the mutual recognition procedure as vital for sharing the work load and to encourage compliance with deadlines;
Amendment 147 #
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12b. Regrets the lack of trust between Member States in the zonal system leading to significant delays in the approval process; calls on the Commission to improve the functioning of the zonal system.
Amendment 150 #
Draft opinion
Paragraph 8 a (new)
Paragraph 8 a (new)
8 a. Stresses the importance of a regulatory framework that stimulates and facilitates research and innovation in order to develop better and safer plant protection products, while at the same time securing the availability of a broad range of plant protection products.
Amendment 159 #
Motion for a resolution
Paragraph 14
Paragraph 14
14. CThe purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment and at the same time to safeguard the competitiveness of Community agriculture; calls on the Commission and the Member States to acknowledge that plant health and environmental protection objectives should take priority over the objective of improving plant protection; plays an important role in meeting our health and environmental protection objectives;
Amendment 165 #
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Calls on industry to provide all data and scientific studies in a uniform electronic and machine readable format to the Rapporteur Member States and the EU agencies; calls on the Commission to develop a harmonised model for data inputs to facilitate easier data exchange between member states at all stages of the process; acknowledges that this data must be handled within the parameters of EU data protection and intellectual property laws;
Amendment 180 #
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Calls on the Commission, the agencies and competent authorities to review and improve their communication on risk assessment procedures and risk management decisions in order to improve public trust in the authorisation system;
Amendment 191 #
Motion for a resolution
Paragraph 17
Paragraph 17
17. Calls on the Member States to limit the authorisations granted under better implement the national authorisation procedures, in order to limit derogations usingnder Article 53 of the Regulation;
Amendment 200 #
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Is concerned about public perception of plant protection products of biological origin; notes that these substances are not automatically 'low- risk' and should be subject to the same rigorous evaluations as other substances;
Amendment 204 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. Calls on the Commission to limitconsider how to address concerns regarding the use of the confirmatory data procedure and notes that complete dossiers are important for active substance approvals;
Amendment 225 #
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Calls for an awareness campaign on the availability of counterfeit pesticides on the market and the damage they pose to the effective implementation of the Regulation, urges action to combat their use;