2017/2128(INI) | [ParlTrack]

Draft opinion
Paragraph 1

Amendment 100 #

Draft opinion
Paragraph 5 a (new)

5 a. Highlights the imbalance in the number of applications between some MS of the same zone and of similar size and agricultural conditions;

Amendment 101 #

Draft opinion
Paragraph 6

6. Stresses the need to encourage work sharing and information exchange between Member States by fostering the availability and use of harmonised methodology and models to conduct evaluations, while reducing the existence of additional national requirements, in order to ensure the optimal operation of the internal market;

Amendment 102 #

Draft opinion
Paragraph 6

6. ~~Stres~~Urges Member States to fully uses the ~~need to encourage work sharing between Member States by foster~~opportunity 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 103 #

Draft opinion
Paragraph 6

6. Stresses the need to encourage work sharing between Member States by fostering the availability and use of harmonised methodology and models to conduct evaluations, ~~while reducing the existence of additional national require~~provided that such methodology is aimed at harmonisation based on better standards to protect public health, safety, and the environments;

Amendment 104 #

Draft opinion
Paragraph 6

6. Stresses the need to encourage ~~work~~data sharing between Member States by fostering the availability and use of harmonised methodology ~~and models to conduct evaluations, while reducing the existence of additional national requirements~~where feasible;

Amendment 105 #

Georgios EPITIDEIOS

Draft opinion
Paragraph 6

6. Stresses the need to encourage ~~work sharing~~such cooperation between Member States by fostering the availability and use of harmonised methodology and models to conduct evaluations, while ~~reducing the existence of additional national~~updating national measures in line with present- day requirements;

Amendment 106 #

Hannu TAKKULA, Ivan JAKOVČIĆ

Draft opinion
Paragraph 6

6. Stresses the need to encourage work sharing between Member States by ~~fostering the availability and use of~~making available a harmonised methodology and models to conduct evaluations, while reducing the existence of additional national requirements, which often give rise to distortions of competition;

Amendment 107 #

Draft opinion
Paragraph 6

6. Stresses the need to encourage work sharing between Member States by fostering the availability and use of harmonised methodology and models to conduct evaluations, while reducing the existence of unnecessary additional national requirements;

Amendment 108 #

Draft opinion
Paragraph 6

6. Stresses the need to encourage ~~work~~information sharing ~~between~~among Member States by fostering the availability and use of harmonised methodologyies and models to conduct evaluations, ~~while reducing the existence of addi~~in order to reduce unnecessary duplicational by national ~~requirement~~authorities;

Amendment 109 #

Draft opinion
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 11 #

Draft opinion
Paragraph 1

1. ~~Welcomes the fact~~Notes that an implementation report for Regulation (EC) No 1107/2009 is being undertaken with the aim of ensuring a high level of protection of both human and animal health as well as the environment~~, while safeguarding~~; calls for the competitiveness of the EU’s agriculture sector to be safeguarded 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 110 #

Draft opinion
Paragraph 6 a (new)

6a. Reminds the Commission and the Member States of the importance of financing research and innovation aimed at finding viable alternative solutions to PPPs in environmental, health and economic terms and stresses the need to guide farmers in the implementation of these alternative solutions to enable them to reduce their use of PPPs;

Amendment 111 #

Draft opinion
Paragraph 6 a (new)

6 a. Calls on the European Commission to improve the functioning of the Mutual Recognition system and for Mutual Recognition to be obligatory unless there are unacceptable environmental effects or different Generally Accepted Practices;

Amendment 112 #

Draft opinion
Paragraph 6 a (new)

6 a. Notes the excellent quality and sufficient provisioning of organic products, the vast majority of which are produced with out resorting to any chemical pesticides, but use a wide range of effective agronomic and physical methods and biological controls;

Amendment 113 #

Draft opinion
Paragraph 6 a (new)

6 a. Stresses that PPPs are not only used in agriculture but also for weed and pest control in urban areas including public parks and railways; emphasises that professional and non-professional users of PPPs should receive adequate training;

Amendment 114 #

Draft opinion
Paragraph 6 b (new)

6 b. Notes the unintentional effects of pesticides on soil and non-target species and also organic farmers who suffer economic losses from their neighbours' pesticide use, whereby drift from pesticide spraying and movement of persistent active substances in the environment contaminate organic produce and soils; notes that organic farmers are often forced to sell that produce as conventional, losing out on their price premium, or worse become decertified, due to actions that are not their own;

Amendment 115 #

Draft opinion
Paragraph 7

Amendment 116 #

Draft opinion
Paragraph 7

7. ~~Regards the applica~~Calls attention tof the ~~mutual recognition procedure as an important tool to increase work sharing and ensure compliance with deadlines, as it allows applicants to apply for~~fact that, if the significant discrepancies between the Member States with regard to authorised PPPs and the mistrust between them persist, the principle of mutual recognition, according to which a PPP which is authorised in one Member State may be authoris~~ation~~ed 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, cannot be applied effectively; therefore calls on the Commission to proceed in two stages;

Amendment 117 #

Draft opinion
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 118 #

Draft opinion
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 Statconflicting with the subsidiarity principle;

Amendment 119 #

Draft opinion
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, which, for its part, shall be responsible at all times for the assessment issued to Member States applying mutual recognition, as laid down in Regulation (EU) No 528/2012 on biocidal products;

Amendment 12 #

Draft opinion
Paragraph 1 a (new)

1 a. Notes the outcome of the European Parliament Hearing on Sustainable Plant Protection held on 20th March 2017 which concluded that the EU approval process for Plant Protection Products is one of the most stringent in the world. It currently takes over 11 years, requires an average of over 200 scientific studies and costs in excess of 220 million euros to bring a product to the EU market. This rigorous testing, combined with farmers' commitment to responsible use and stewardship, ensures that products are safe for human health and the environment. It does, however, result in a challenging shortage of active ingredients for use on speciality crops which include most fruit and vegetables;

Amendment 120 #

Draft opinion
Paragraph 7

7. Regards the application of the mutual recognition procedure as an important tool to increase work sharing and ensure compliance with deadlines whilst guaranteeing optimum protection for users, 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;

Amendment 121 #

Draft opinion
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~~ allowsing 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;

Amendment 122 #

Draft opinion
Paragraph 7 – point a (new)

(a) review the mutual recognition procedure with the aim of increasing its effectiveness and improving implementation, meeting deadlines and mutual trust between the Member States;

Amendment 123 #

Draft opinion
Paragraph 7 – point b (new)

(b) carry out an impact assessment in order to gauge the feasibility of setting up an authorisation procedure for PPPs (at European level and directly spearheaded by the Commission), taking into account specific geographical characteristics, with the aim of harmonising the rules among the Member States, dramatically reducing costs and time limits and resolving problems of unfair competition by strengthening the internal market for PPPs, and bearing in mind the fact that this kind of procedure will not be possible without sufficient budget resources and expertise from the Member States;

Amendment 124 #

Draft opinion
Paragraph 7 a (new)

7a. Believes that establishing a single authority at EU level, responsible for all aspects of the evaluation and authorisation of active substances, would avoid duplication of work, significantly reducing costs and the administrative burden, and would ensure a uniformly high level of protection of the environment and human health as well as providing a 'one-stop shop' for the evaluation and registration of active substances;

Amendment 125 #

Draft opinion
Paragraph 7 a (new)

7a. Takes the view that an authorisation procedure for PPPs which is harmonised at European level might provide common solutions for small farms which are currently in technical dead- ends because of the cost of obtaining authorisation and the lack of investment and research on the part of private and public stakeholders;

Amendment 126 #

Karin KADENBACH, Maria NOICHL, Daciana Octavia SÂRBU

Draft opinion
Paragraph 7 a (new)

7 a. Expresses its concern that the Member States are not sufficiently equipped to deal with illegal and counterfeit plant protection products;

Amendment 127 #

Draft opinion
Paragraph 7 a (new)

7 a. States that the Member States' right to refuse authorized Plant Protection Products remain unaffected;

Amendment 128 #

Draft opinion
Paragraph 7 b (new)

7 b. Notes that the lack of coordination between the Member States is leading to duplication of work, resulting in inefficient expenditure and administrative burden;

Amendment 129 #

Miguel VIEGAS

Draft opinion
Paragraph 8

8. Stresses the contribution that the authorisation of low-risk PPPs makes to a sustainable EU farming sector, and draws attention to the importance of contributing to a better functioning agricultural ecosystem and a sustainable farming sector, while pointing out that the lack of availability of PPPs could jeopardise the diversification of agriculture and cause harmful organisms to become resistant to PPPs; points out that the growing need for PPPs stems from deregulation and liberalisation of the common agricultural policy, a process that is making farmers adopt increasingly more intensive practices requiring additional substances which in many cases are at odds with sustainable practices, thus endangering public health and biodiversity.

Amendment 13 #

Draft opinion
Paragraph 1 a (new)

1 a. Notes the failure of the regulatory framework to consider inevitable non- target impacts, notably on bees and other pollinators and other insects beneficial to farming like predators of pests; Notes the recent scientific study illustrating the "insect Armageddon"1a , whereby 75% winged insects have become regionally extinct across Germany, even in nature reserves where no pesticides were used for agriculture. _________________ 1aMore than 75 percent decline over 27 years in total flying insect biomass in protected areas, Hallmann et al, 2017. http://journals.plos.org/plosone/article?id =10.1371/journal.pone.0185809

Amendment 130 #

Draft opinion
Paragraph 8

8. Stresses the contribution that the authorisation of ~~low-risk PPPs~~PPPs which pose little risk to human health and the environment makes to a sustainable EU farming sector, and draws attention to the ~~importance of contributing~~fact that this category currently contains only ten substances, while some substances which were granted authorisation before 2011 might satisfy the conditions, and that it is therefore necessary to reassess these in order to increase this number and contribute to a better functioning agricultural ecosystem and a sustainable farming sector, while pointing out that the lack of availability of PPPs could jeopardise the diversification of agriculture and cause harmful organisms to become resistant to PPPs.

Amendment 131 #

Draft opinion
Paragraph 8

8. Stresses the contribution that the authorisation of low-risk ~~PPPs~~natural PPPs based on natural products can makes to a sustainable EU farming sector, and draws attention to the importance of contributing to a better functioning agricultural ecosystem and a sustainable farming sector, while pointing outhat th~~at the lack of availability~~is category should not be used as a loophole for GMOs and mainstream chemical pesticides to avoid the authorization process, also points out that the overuse of PPPs could jeopardise the diversification of agriculture and cause harmful organisms to become resistant to PPPs.

Amendment 132 #

Georgios EPITIDEIOS

Draft opinion
Paragraph 8

Amendment 133 #

Draft opinion
Paragraph 8

8. Stresses the contribution that the authorisation of low-risk ~~PPPs~~natural PPPs based on natural products can makes to a sustainable EU farming sector, ~~and d~~especially efficient when introduced/used in combination with good agronomic practices; Draws attention to the importance of contributing to a better functioning agricultural ecosystem and a sustainable farming sector~~, while p~~; Point~~ing~~s out that the ~~lack of availability~~overuse of PPPs could jeopardise the diversification of agriculture and cause ~~harmful organism~~pests and diseases to become resistant to PPPs.

Amendment 134 #

Momchil NEKOV, Karin KADENBACH

Draft opinion
Paragraph 8

8. Stresses the contribution that the authorisation of low-risk PPPs might makes to a sustainable EU farming sector in the short term, and draws attention to the importance of contributing to a better functioning agricultural ecosystem ~~and a sustainable farming sector, while pointing out that the lack of availability of PPPs could jeopardise the diversification of agriculture and cause harmful organisms to become resistant to PPPs.~~by employing sustainable, innovative soil management techniques;

Amendment 135 #

Draft opinion
Paragraph 8

Amendment 136 #

Draft opinion
Paragraph 8

Amendment 137 #

Draft opinion
Paragraph 8

Amendment 138 #

Jan HUITEMA, Hannu TAKKULA, Hilde VAUTMANS

Draft opinion
Paragraph 8

8. Stresses the contribution that the authorisation of low-risk PPPs makes to a sustainable EU farming sector, and the importance of ensuring their availability; draws attention to the importance of contributing to a better functioning agricultural ecosystem and a sustainable farming sector, while pointing out that the lack of availability of PPPs could jeopardise the diversification of agriculture and cause harmful organisms to become resistant to PPPs.;

Amendment 139 #

Draft opinion
Paragraph 8 – subparagraph 1 (new)

Expresses concerns about the small amount of new substances that have been approved, while at the same time other substances have been taken of the market; stresses the importance of a suitable tool box of plant protection products for farmers to secure the EU's food supply;

Amendment 14 #

Draft opinion
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 140 #

Draft opinion
Paragraph 8 a (new)

8 a. believes as a complement to low risk PPPs Integrated pest management should be mainstreamed into EU agriculture, this means careful consideration of all available plant protection methods and subsequent integration of appropriate measures that discourage the development of populations of harmful organisms and keep the use of plant protection products and other forms of intervention to levels that are economically and ecologically justified and reduce or minimise risks to human health and the environment.'Integrated pest management' emphasises the growth of a healthy crop with the least possible disruption to agro-ecosystems and encourages natural pest control mechanisms. The prevention and/or suppression of harmful organisms should be achieved or supported among other options especially by: crop rotation, use of adequate cultivation techniques (e.g. stale seedbed technique, sowing dates and densities, under-sowing, conservation tillage, pruning and direct sowing), use, where appropriate, of resistant/tolerant cultivars and standard/certified seed and planting material, use of balanced fertilisation, liming and irrigation/drainage practices, preventing the spreading of harmful organisms by hygiene measures (e.g. by regular cleansing of machinery and equipment), protection and enhancement of important beneficial organisms, e.g. by adequate plant protection measures or the utilisation of ecological infrastructures inside and outside production sites.

Amendment 141 #

Draft opinion
Paragraph 8 a (new)

8a. Stresses that PPPs can contribute to reducing biodiversity and to the poor state of bodies of water and soil in the Member States, and that there is a need to encourage investment in research to develop new low-risk PPPs and meet the growing demand so that agricultural production can be brought more into line with the protection of health and the environment; underlines, however, the importance of not depriving farmers of PPPs and of replacing these with other substances or production methods which would be more harmful to the environment and human health;

Amendment 142 #

Esther HERRANZ GARCÍA, Gabriel MATO, Ramón Luis VALCÁRCEL SISO

Draft opinion
Paragraph 8 a (new)

8a. Reiterates and underlines that on 15 February 20171 a Parliament asked the Commission, by the end of 2018, to submit a specific legislative proposal to amend Regulation (EC) No 1107/2009, over and above the general revision under the REFIT initiatve, in order to introduce an accelerated procedure for the evaluation, authorisation and registration of biological low-risk plant protection products; _________________ 1a European Parliament resolution of 15 February 2017 on low-risk pesticides of biological origin (2016/2903(RSP))

Amendment 143 #

Draft opinion
Paragraph 8 a (new)

8a. Welcomes the effort made by the European Commission in creating the coordination tool for the approval of plant protection products for minor uses but stresses the need to make active substances for these purposes more widely available, and recalls that in many Member States, minor uses represent a large majority of crops;

Amendment 144 #

Paolo DE CASTRO, Ricardo SERRÃO SANTOS, Tibor SZANYI, Nikos ANDROULAKIS, Michela GIUFFRIDA, Karin KADENBACH

Draft opinion
Paragraph 8 a (new)

8 a. Underlines the important role low- risk PPPs can play in a comprehensive strategy of integrated pest management; calls for a better implementation of the existing regulation in regards to the market authorization for low-risk PPPs; stresses the importance of the effectiveness of low-risk PPPs in order to increase acceptance and facilitate a broad uptake in farmers’ crop protection strategies.

Amendment 145 #

Draft opinion
Paragraph 8 a (new)

8a. Takes the view that Regulation 1107/2009 should also be amended to take more account of substances not regarded as PPPs and which, when used for plant protection, are governed by the Regulation; such substances offer interesting alternatives in terms of integrated production methods and some bio-control products.

Amendment 146 #

Draft opinion
Paragraph 8 a (new)

8 a. Notes with concern that farmers have fewer tools available to them due to the low number of new active substances approved since the implementation of Regulation (EC) 1107/2009; notes that research and technology have an important role to play in increasing available tools to meet current and future challenges to agriculture such as counteracting resistance.

Amendment 147 #

Draft opinion
Paragraph 8 a (new)

8a. Supports the dissemination of organic crop-growing techniques in order to provide an alternative to the use of PPPs, and maintains that an approach based on prevention, protective measures, and early detection of pathogens harmful to plants is the best safe way to improve crops.

Amendment 148 #

Draft opinion
Paragraph 8 a (new)

8a. Calls for the development of low- risk PPPs to be encouraged, with the proviso that an assessment of their effectiveness and risks, and of their capacity to meet the environmental, health and economic needs of agriculture, must be guaranteed;

Amendment 149 #

Draft opinion
Paragraph 8 a (new)

8 a. Welcomes the setting up of the Minor Uses Coordination Facility as a forum for improving the co-ordination between Member States, grower organisations and industry in developing solutions for minor uses; stresses the need for long lasting and sustained financing of this facility;

Amendment 15 #

Jan HUITEMA, Ulrike MÜLLER, Hilde VAUTMANS

Draft opinion
Paragraph 1 a (new)

1 a. Underlines that the provisions of the Regulations are underpinned by the precautionary principle in order to ensure that active substances or products placed on the market do not adversely affect human or animal health or the environment;

Amendment 150 #

Draft opinion
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 151 #

Draft opinion
Paragraph 8 a (new)

8 a. Points out that this low risk PPP category is useful for natural products that carry less risk and therefore should not have to jump through the same legislative hoops to ensure public and environmental safety;

Amendment 152 #

Ivari PADAR

Draft opinion
Paragraph 8 a (new)

8a. Stresses that glyphosates do not end up in the environment only due to farmers’ activities, as they are also widely used in forestry, to treat roadside verges and on railways and greenery;

Amendment 153 #

Draft opinion
Paragraph 8 b (new)

8 b. Stresses the importance of research and innovation in developing low-risk PPPs; highlights that public- private partnerships may help funding of research and ensure sustainable agriculture meets the demands of a growing global population, as well as addressing environmental and health concerns; notes that existing EU agricultural policies and research programmes can play a role in encouraging investment in precision agriculture;

Amendment 154 #

Draft opinion
Paragraph 8 b (new)

8b. Calls for greater funding for inspections and 'hazard-based surveys' in order to contain and prevent the spread of pathogens that damage crops; believes that when such inspections are conducted, higher priority should be assigned to tree species significant to the EU's historical and cultural heritage.

Amendment 155 #

Paolo DE CASTRO, Ricardo SERRÃO SANTOS, Tibor SZANYI, Nikos ANDROULAKIS, Michela GIUFFRIDA, Karin KADENBACH

Draft opinion
Paragraph 8 b (new)

8b. Calls on the Member States to undertake an exchange of information and good practice resulting from research into combating organisms which are harmful to crops, thereby paving the way for alternative solutions which are practicable in environmental, health and economic terms;

Amendment 156 #

Draft opinion
Paragraph 8 b (new)

8 b. Underlines the transformative role precision agriculture and digital farming can play regarding the use and application of PPPs; calls on the Commission to fully embrace this scientific and technological progress and ensure that farmers, consumers and the environment benefit from it;

Amendment 157 #

Jan HUITEMA, Hannu TAKKULA, Hilde VAUTMANS

Draft opinion
Paragraph 8 b (new)

8 b. Highlights that special attention should be given to the role of small and medium entreprises (SMEs) in the development of new products, as SMEs often lack the extraordinary resources that are nessesary in the process of development and approval of new substances.

Amendment 158 #

Draft opinion
Paragraph 8 b (new)

8 b. Underlines that the low risk PPP category should not be used as a loophole for avoiding other justifiably more complex authorisation processes for GMOs and mainstream chemical pesticides.

Amendment 159 #

Esther HERRANZ GARCÍA, Gabriel MATO, Ramón Luis VALCÁRCEL SISO

Draft opinion
Paragraph 8 b (new)

8 b. Calls on the Commission to strengthen the co-ordination of data generation, particularly residues data, across the Member States;

Amendment 16 #

Draft opinion
Paragraph 1 a (new)

1a. Stresses the fact that between 1993 and 2009 the number of authorised active pesticidal substances fell by 70% while the number of pest outbreaks in the EU increased;

Amendment 160 #

Esther HERRANZ GARCÍA, Gabriel MATO, Ramón Luis VALCÁRCEL SISO

Draft opinion
Paragraph 8 b (new)

8b. Deplores the fact that the credibility of the European Union's scientific agencies is being unjustifiably undermined.

Amendment 161 #

Paolo DE CASTRO, Ricardo SERRÃO SANTOS, Tibor SZANYI, Nikos ANDROULAKIS, Michela GIUFFRIDA, Karin KADENBACH

Draft opinion
Paragraph 8 c (new)

8 c. Notes that some member states have a tax on pesticide production and usage to cover costs currently eternalised to public health and environmental budgets and so carried by the ordinary citizens and the public purse ; Invites therefore MS and the Commission to look seriously to mainstreaming this tax approach to enforce the Polluter Pays Principle.

Amendment 162 #

Draft opinion
Paragraph 8 c (new)

8 c. Highlights the importance and the need for the Common Agricultural Policy, Horizon 2020 and other supportive funding schemes, to encourage farmers to invest in new technologies adapted to their farm size, such as precision and digital farming tools that optimize the use of PPPs, reduce environmental emissions and exposure to operators;

Amendment 163 #

Draft opinion
Paragraph 8 c (new)

8c. Takes the view that, for each request for a PPP to be placed on the market, Regulation 1107/2009 should provide for a comparative assessment with non-chemical methods of preventing or combating pests in order to give priority to methods which best protect health and the environment.

Amendment 164 #

Draft opinion
Paragraph 8 c (new)

8 c. Considers that products imported from outside the EU grown using PPPs should be subject to the same strict criteria as products produced inside the EU; is concerned that PPPs not registered in the EU may be used in the production of imported produce;

Amendment 165 #

Jan HUITEMA, Hilde VAUTMANS

Draft opinion
Paragraph 8 c (new)

8 c. Calls on the Commission to propose a pan-European system of authorisation for Minor Uses and Speciality Crops and a common list of major/minor crops to be applied at EU level;

Amendment 166 #

Draft opinion
Paragraph 8 c (new)

8 c. Stresses that more priority should be given to the authorisation process of low-risk substances

Amendment 167 #

Draft opinion
Paragraph 8 d (new)

8 d. Notes that although Precision agriculture can be used to better target pesticide use where it is genuinely needed and cut overall usage, it can in some cases simply shift the type of input dependencies, while many farmers want to become more autonomous and cut input costs.

Amendment 168 #

Draft opinion
Paragraph 8 d (new)

8 d. Takes the view that low-risk pesticides can play an important role in integrated pest management and calls for an accelerated authorisation process for these substances in order to facilitate their inclusion in crop protection strategies;

Amendment 169 #

Karin KADENBACH, Maria NOICHL, Daciana Octavia SÂRBU

Draft opinion
Paragraph 8 e (new)

8 e. Calls for the same approach we currently have for antimicrobial resistance to be applied also to pesticide resistance.

Amendment 17 #

Draft opinion
Paragraph 1 a (new)

1 a. Points out that environmental measures aimed to prevent, limit and contain the spread of pathogens and pests has to remain the focus of all current and further actions;

Amendment 18 #

Ulrike MÜLLER, Hilde VAUTMANS, Hannu TAKKULA

Draft opinion
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 19 #

Draft opinion
Paragraph 1 b (new)

1 b. Stresses the importance of creating an innovation friendly regulatory framework, which allows for the replacement of older chemistry by new and better crop protection products; underlines the importance of the availability of a broad spectrum of Plant Protection Products with different modes of action to avoid the development of resistances and maintain the effectiveness of crop protection product application;

Amendment 2 #

Esther HERRANZ GARCÍA, Gabriel MATO, Ramón Luis VALCÁRCEL SISO

Draft opinion
Paragraph 1

1. Welcomes the fact that an implementation report for Regulation (EC) No 1107/2009 is being undertaken with the aim of ensuring a high level of protection of ~~both~~ human, plant and animal health as well as the environment and improving the sustainability of agricultural development, while safeguarding the competitiveness of the EU’s agriculture sector by continuing to provid~~ing~~e 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 and in tandem with increased research and the use of alternatives to PPPs;

Amendment 20 #

Draft opinion
Paragraph 1 b (new)

1b. Underlines that that EU rules for the approval of active substances for agricultural uses are among the most restrictive in the world, thus putting EU farmers – who have to compete in an increasingly globalised market with imports from countries which permit the use of substances and technologies that are prohibited in the EU – at a competitive disadvantage;

Amendment 21 #

Draft opinion
Paragraph 1 b (new)

1 b. Calls for the implementation by the MS of the 2013 EFSA guidelines 1c on assessing risk of PPPs to bees, developed collaboratively between the Commission and the MS, which has regrettably not been implemented so far; _________________ 1c https://www.efsa.europa.eu/en/efsajournal /pub/3295

Amendment 22 #

Esther HERRANZ GARCÍA, Ramón Luis VALCÁRCEL SISO, Gabriel MATO

Draft opinion
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 #

Draft opinion
Paragraph 1 c (new)

1c. Expresses concern at the small number of new active substances that have been authorised since Regulation (EC) No 1107/2009 entered into force; points out that since the current rules were introduced, only eight new active substances have been authorised for use on the EU market;

Amendment 24 #

Draft opinion
Paragraph 1 c (new)

1 c. Notes that the cumulative effects of pesticides on non-target species, and also synergistic effects as pesticides are increasingly applied in cocktails of different products, which can alter the expected impacts on organisms exposed to them;

Amendment 25 #

Draft opinion
Paragraph 1 d (new)

1 d. Notes the duty of care of the Commission, in balancing the public and environmental health with economic interests of chemical producers to ensure only genuinely safe active substances are approved;

Amendment 26 #

Draft opinion
Paragraph 1 e (new)

1 e. Notes that the final approval of the product by the MS is often granted conditionally upon certain mitigation criteria being fulfilled, for example in restricting use under certain conditions; Regrets that these are so poorly controlled, if at all, by the MS authorities;

Amendment 27 #

Draft opinion
Paragraph 1 f (new)

1 f. Notes that because both active substance and product authorisations are often granted conditional upon fulfilment of certain criteria of use which are then not checked, this means that even if mitigation measures intending to limit environmental damage were disregarded, inappropriate and illegal use has been rewarded with CAP payments. This should not continue, and respect of mitigation measures should form part of the baseline of sustainability in the CAP;

Amendment 28 #

Draft opinion
Paragraph 1 g (new)

1 g. Notes the health costs associated with pesticide use, which are often hidden, and the struggle of farmers and agricultural workers as well as those working in storage and transport of grain who are poisoned by pesticides; Notes further that these hidden costs and personal struggles are too often conveniently forgotten by the representatives of farming communities;

Amendment 29 #

Draft opinion
Paragraph 1 h (new)

1 h. Calls for neonicotinoids and other systemic insecticides that are damaging to non-target species especially bees to be comprehensively banned, in order to ensure pollination and other biodiversity- driven ecosystem services useful for farmers, also including predators keeping pest populations in check;

Amendment 3 #

Draft opinion
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 30 #

Draft opinion
Paragraph 1 i (new)

1 i. Notes a weed is defined simply as a plant in the wrong place, and notes they are also wildflowers that feed bees and pollinators and also support natural predators of pests and other beneficial species useful to farming; Notes further only 20% of weed species are actually capable of damaging crops and then, only when in sufficiently high concentrations to affect the yield; 80% of them are so weak in competition with the crops that they do not affect yield substantially 1d. _________________ 1dAndreasen, C. et al., 1996: Decline of the flora in the Danish Arable field. J. Appl. Ecol. 33, p. 619-626. Studies on wild plant species from 1970 to 1990 on approx. 200 wild plant species

Amendment 31 #

Draft opinion
Paragraph 2

2. Points out that this regulation is part of the wider EU Plant Protection Products (PPP) regime, which also includes the Sustainable Use Directive (SUD) and the regulation setting Maximum Residue Levels (MRL), and that all three parts must be considered together in order to identify whether they are fit for purpose, including with a view to reducing the total volume of PPPs used, notably through the MS and the Commission ensuring implementation of Integrated Pest Management (IPM) , which can be as simple as crop rotation, and for IPM to be integrated into the CAP as foreseen already in the SUD and the current CAP regulations since 2013;

Amendment 32 #

Draft opinion
Paragraph 2

Amendment 33 #

Draft opinion
Paragraph 2

2. Points out that this regulation is part of the wider EU Plant Protection Products (PPP) regime, which also includes the Sustainable Use Directive (SUD) ~~and~~, the regulation setting Maximum Residue Levels (MRL), and th~~at all three~~e Regulation on Classification, Labelling and Packaging of Substances and Mixtures, and that all four parts must be considered together in order to identify whether they are fit for purpose, including with a view to reducing the total volume of PPPs used;

Amendment 34 #

Mairead McGUINNESS

Draft opinion
Paragraph 2

Amendment 35 #

Draft opinion
Paragraph 2

Amendment 36 #

Draft opinion
Paragraph 2 a (new)

2 a. Notes that a farmer's "toolbox" is based on methods, agronomic practices as well as chemical substances and alternatives to those, such as biological control.Notes that this broader definition of toolkit is the basis of IPM, which can cut pesticide use by between 50-30%, and can be as simple as crop rotation or avoiding monocultures; Notes the "many little hammers" approach of these alternative tools, as opposed to blanket metaphylaxis by broad spectrum chemical pesticides that can disable other tools in the toolbox;

Amendment 37 #

Draft opinion
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 #

Draft opinion
Paragraph 2 a (new)

2a. Points out that fewer and fewer active substances for plant protection purposes are available on the EU market; stresses that European farmers and horticulturalists need to have at their disposal a range of products for effective plant protection and pest management; stresses that green low-risk plant protection products (and the active substances in them) play a key role here;

Amendment 39 #

Draft opinion
Paragraph 2 a (new)

2 a. Notes that the proper use of plant protection products shall comply with the provisions of Directive 2009/128/EC and in particular, with general principles of integrated pest management (IPM); regrets that those principles are not used to their full potential in the MS and that IPM development is hindered by limited availability of low risk and non-chemical pesticides;

Amendment 4 #

Karin KADENBACH, Maria NOICHL, Daciana Octavia SÂRBU

Draft opinion
Paragraph 1

Amendment 40 #

Draft opinion
Paragraph 2 a (new)

2 a. Recalls that there is a substantial need for an integrative approach and that the Regulation (EC) No 1185/2009 on statistics on pesticides has to be part of the assessment by using its results reducing the quantity and as consequence minimising the risks and their negative impact on health and environment;

Amendment 41 #

Draft opinion
Paragraph 2 a (new)

2a. Stresses that farmers and producers need guidance in good PPP practice, as do actors in these sectors in the transition of agricultural systems towards reducing the use of PPPs;

Amendment 42 #

Draft opinion
Paragraph 2 a (new)

2 a. Urges the Commission to ensure that technological innovation in agriculture is specifically taken into account to match the way that Plant Protection Products are applied in the implementation of Integrated Pest Management practices, in line with the principles of 2009/128/EC;

Amendment 43 #

Esther HERRANZ GARCÍA, Gabriel MATO, Ramón Luis VALCÁRCEL SISO

Draft opinion
Paragraph 2 a (new)

2 a. Considers that all future reviews of the regulatory framework for PPPs should encourage competitiveness and innovation in order to produce PPPs that are compatible with sustainable agriculture systems, environmentally sound, effective and affordable;

Amendment 44 #

Draft opinion
Paragraph 2 a (new)

2a. Highlights the potential that precision farming techniques can have in helping European farmers optimise pest control arrangements in a more sustainable manner;

Amendment 45 #

Jan HUITEMA, Hannu TAKKULA, Hilde VAUTMANS

Draft opinion
Paragraph 2 a (new)

2 a. Highlights the importance of a holistic approach that includes integrated pest management (IPM);

Amendment 46 #

Ulrike MÜLLER, Jan HUITEMA, Hilde VAUTMANS, Hannu TAKKULA

Draft opinion
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 47 #

Draft opinion
Paragraph 2 b (new)

2b. Stresses the need to distinguish between the professional and the private use of PPPs, given that they do not share the same framework obligations, and calls on the Commission and the Member States to clearly distinguish between these two kinds of use and to amend the rules accordingly;

Amendment 48 #

Esther HERRANZ GARCÍA, Gabriel MATO, Ramón Luis VALCÁRCEL SISO

Draft opinion
Paragraph 2 b (new)

2b. Stresses that the application of integrated pest management is mandatory in the Union under Directive 2009/128/EC; considers that Member States and local authorities should place more emphasis on the sustainable use of pesticides, including low-risk plant protection alternatives;

Amendment 49 #

Draft opinion
Paragraph 2 b (new)

2b. Stresses the fact that, if farmers have no access to plant-protection products, they will be powerless to prevent the growth of some natural pathogens present in crops, thus jeopardising our food security;

Amendment 5 #

Draft opinion
Paragraph 1

1. Welcomes the fact that an implementation report for Regulation (EC) No 1107/2009 is being undertaken with the aim of ensuring a high level of protection of both human and animal health ~~as well as the environment~~, food safety and environmental protection, while safeguarding the competitiveness of the EU’s agriculture sector by providing a level playing field through access to a broad range of active substances and Plant Protection Products (PPP) ~~for all~~to farmers and producers, irrespective of ~~the~~which Members States they are operating in;

Amendment 50 #

Draft opinion
Paragraph 2 b (new)

2 b. Notes that for some tools of the "toolkit" like biological controls using natural predators of pests or their parasites or parasitoids to work, it is important that untargeted broad spectrum pesticides should be avoided until being used as a last resort:

Amendment 51 #

Draft opinion
Paragraph 2 b (new)

2 b. Highlights the importance of encouraging farmers to invest in new technologies such as precision and low drift sprayers, deflectors and digital farming tools that optimise the use of Plant Protection Products and reduce environmental impact;

Amendment 52 #

Mairead McGUINNESS

Draft opinion
Paragraph 2 b (new)

2 b. Highlights the important role PPPs play in enabling crops to be grown and harvested with reduced losses arising from diseases and pest infestations, and increasing quality yields and rural incomes;

Amendment 53 #

Draft opinion
Paragraph 2 c (new)

2 c. Notes the need to for careful use of pesticides and only when all other alternative methods have failed, due to growth of resistance of pests to overused pesticides: Notes resistance is a biological inevitability when dealing with fast- reproducing pests and diseases; Emphasises the use of IPM as a way to prevent resistance and the need to avoid blanket or metaphylactic treatment often when no single pests is even detected, which also knocks out other beneficial species, which would otherwise be regulating pest populations, leaving crops susceptible to future attacks;

Amendment 54 #

Draft opinion
Paragraph 2 c (new)

2 c. Notes that PPPs represent a significant expense for farmers as part of their crop production systems;

Amendment 55 #

Draft opinion
Paragraph 2 d (new)

2 d. Underlines the need for knowledge sharing and skill acquisition for alternatives to chemical pesticides and IPM, including finding the optimum crop rotation for farmers' market and climatic situations; Notes further that this is already foreseen in the horizontal regulation of the CAP, notably also Farm Advisory Services financed within Rural Development;

Amendment 56 #

Draft opinion
Paragraph 2 e (new)

2 e. Notes the increasing use of broad spectrum pesticides as desiccants and crop ripeners and underlines the principle of not applying pesticide on the final products as this will inevitably raise residue levels in food and feed sometimes to unacceptable levels, given the proximity of this usage to human food chain; Calls therefore for severely limiting this use, with a view to re-writing the authorisations and phasing out this use of pesticides;

Amendment 57 #

Draft opinion
Paragraph 2 f (new)

2 f. Stresses the importance of using IPM as the basis for approving less damaging active substances, when candidates for substitution of the most dangerous pesticides are being considered; this means when MS are considering to authorise an alternative chemical (to substitute a more dangerous one), if the same effect to protect against past damage can be ensured by agronomic practices or alternatives, neither pesticide should be approved;

Amendment 58 #

Draft opinion
Paragraph 3

3. Stresses the importance of a science-based approach 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); sees a need to review the procedure currently used to evaluate substances before their approval for distribution in order to improve evaluations, increase the independence of the authorities tasked with carrying out studies, avoid conflicts of interest and make the procedure more transparent;

Amendment 59 #

Ulrike MÜLLER, Hilde VAUTMANS, Hannu TAKKULA

Draft opinion
Paragraph 3

3. Stresses the importance of ~~a science-based~~objective, peer-reviewed evidence, derived from an open independent, and multidisciplinary scientific approach 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), further believes that the commercial formulations in PPPs must be assessed and analyzed as research has shown that exposure to the "cocktail effect" can be much more hazardous than exposure to the single active ingredient;

Amendment 6 #

Miguel VIEGAS

Draft opinion
Paragraph 1

Amendment 60 #

Draft opinion
Paragraph 3

3. StExpresses ~~the importance of a science-based approach~~its 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 #

Peter JAHR, Albert DESS, Mairead McGUINNESS, Angélique DELAHAYE, Norbert LINS

Draft opinion
Paragraph 3

3. Stresses the importance of a science-based approach 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); calls therefore for an adequate and sufficient funding as well as for the appropriate amount of staff of the relevant agencies such as for example EFSA, ECHA, etc. in order to ensure an independent, transparent and timely authorization process;

Amendment 62 #

Daniel BUDA, Viorica DĂNCILĂ

Draft opinion
Paragraph 3

3. Stresses the importance of a science-based approach 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); insists that the procedure for approval of active substances must take into account the actual use of plant protection products, as well as scientific and technological progress in this area;

Amendment 63 #

Mairead McGUINNESS

Draft opinion
Paragraph 3

3. Stresses the importance of a science-based approach 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); expresses concern about the impact of recent political debates on EFSA and ECHA and their role in the authorisation of active substances;

Amendment 64 #

Draft opinion
Paragraph 3

3. Stresses the importance of ~~a science-based~~objective, peer-reviewed evidence derived from an open and independent, holistic and multidisciplinary scientific approach in authorising any active substance, in line with the EU’s ~~risk~~ analysis ~~principle~~of hazards and the precautionary principle as established in the General Food Law (Regulation (EC) No 178/2002);

Amendment 65 #

Draft opinion
Paragraph 3

3. Stresses the importance of a ~~science-based approach~~n approach based on sound, objective and non-discriminatory scientific principles 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 66 #

Draft opinion
Paragraph 3

3. Stresses the importance of a science-based approach in authorising any active substance, in line with the Member States' and the EU’s risk analysis principles and the precautionary principle as established in the General Food Law (Regulation (EC) No 178/2002);

Amendment 67 #

Draft opinion
Paragraph 3

3. Stresses the importance of a sciencetifically robust risk-based approach 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 68 #

Norbert ERDŐS

Draft opinion
Paragraph 3 a (new)

3 a. In the event of a pesticide active substance not being granted EU authorisation or having authorisation withdrawn in the course of the appropriate procedure and on the basis of scientific evidence, calls on the Commission, the Member States and pesticide manufacturers urgently to consider introducing replacement substances for the relevant active substances and encourage farming practices such as plant protection using few pesticides, biological monitoring or integrated plant protection;

Amendment 69 #

Draft opinion
Paragraph 3 a (new)

3 a. Notes that Ecology is also a scientific discipline that deals with the interaction between all living organisms including the impacts of chemicals on non-target species. Notes that Toxicology is also a scientific discipline, with the sub- discipline of Ecotoxicology. Welcomes therefore a holistic, science-based approach based on publically funded and published, peer-reviewed science, and especially welcomes moving on from outdated 1950's arguments that undermine scientific approaches that are not chemistry;

Amendment 7 #

Draft opinion
Paragraph 1

Amendment 70 #

Draft opinion
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 #

Draft opinion
Paragraph 3 a (new)

3 a. Notes that the rapporteur Member State shall prepare and submit to the Commission, with a copy to the Authority , a report referred to as " draft assessment report", assessing whether the active substance can be expected to meet the approval criteria provided for in article 4; highlights that the rapporteur Member State shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge;

Amendment 72 #

Ulrike MÜLLER, Hilde VAUTMANS, Hannu TAKKULA

Draft opinion
Paragraph 3 a (new)

3a. Considers it vital to improve harmonisation in the legislation on placing PPPs on the market in the EU in order to prevent distortions of competition in production and cross-border product- trafficking and enabling a product which is authorised in one country but not in another to enter and be used in the latter;

Amendment 73 #

Draft opinion
Paragraph 3 b (new)

3 b. Highlights that the credibility of the PPP authorisation system strongly depends on public trust in EFSA, which provides the scientific opinions that are the basis for approvals and risk management; underlines that transparency of the scientific assessment is important to maintain public trust; welcomes in this regard that the Commission in its REFIT evaluation of the General Food Law1a comes to the conclusion that EFSA has been highly transparent and has shared data within the boundaries of strict confidentiality rules given be the Co-Legislators; further welcomes the EFSA's continuous efforts to improve its system to ensure independence and the management of potential conflicts of interests which was praised by the Court of Auditors as the most advanced system of the audited agencies in 2012 1b and has recently been updated in June 20171c; calls on the Commission to propose improvements to further enhance the transparency of the regulatory process, including the access to the data of safety studies submitted by producers as part of their applications for market authorization of PPPs in the EU; _________________ 1a SWD(2018) 38 final. 1b https://www.eca.europa.eu/Lists/News/NE WS1210_11/NEWS1210_11_EN.PDF 1c https://www.efsa.europa.eu/sites/default/fi les/corporate_publications/files/policy_ind ependence.pdf

Amendment 74 #

Draft opinion
Paragraph 3 b (new)

3 b. Notes that in science it is harder to find a causal relationship than for this relationship to remain hidden, and that determining those causal relationships and impacts requires objective investigation in the right places, in replicable datasets and for long enough time periods - this is rarely the case, which limits the useful of the weight of evidence approach, especially when those conducting experiments and field trials, e.g. via private science, have a vested interest not to find anything;

Amendment 75 #

Draft opinion
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 76 #

Draft opinion
Paragraph 3 c (new)

3 c. Notes that the weight of evidence approach is not used in the same way for the approval of pharmaceuticals, where risk managers avoid using any studies that are repeated, are not peer reviewed, are not published, are duplicated, have conflicts of interest or are otherwise compromised;

Amendment 77 #

Nicola CAPUTO, Karin KADENBACH, Molly SCOTT CATO

Draft opinion
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 78 #

Draft opinion
Paragraph 4

Amendment 79 #

Esther HERRANZ GARCÍA, Gabriel MATO, Ramón Luis VALCÁRCEL SISO

Draft opinion
Paragraph 4

4. Expresses its concern about systematic delays in the authorisation processes ~~and the increasing~~for new active substances and products and in the re-evaluation processes for substances and products already available on the market, and stresses that these delays lead to the increased 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;

Amendment 8 #

Draft opinion
Paragraph 1

Amendment 80 #

Draft opinion
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; considers that any derogation should be duly justified and reassessed at regular intervals, while underlining the necessity for Member States to comply with the legal deadlines to ensure predictability and legal security for applicants and facilitate the market introduction of innovative PPPs that are in line with more stringent requirements;

Amendment 81 #

Draft opinion
Paragraph 4

4. Expresses its concern about systematic delays in the authorisation processes and the increasing use of unjustified and inappropriate derogations as laid down in Article 53 of Regulation (EC) No 1107/2009, and the associated working document 1b , 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; _________________ 1bsee annex 1 of the Working Document on Emergency Situations According to Art.53 of Reg.1107/2009 of DG SANTE of the Commission

Amendment 82 #

Draft opinion
Paragraph 4

4. Expresses its concern about systematic delays in the authorisation processes and condemns 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;

Amendment 83 #

Draft opinion
Paragraph 4

4. ~~Expresses its concern about~~Highlights the existence of systematic delays in the authorisation processes and ~~the~~an 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;

Amendment 84 #

Draft opinion
Paragraph 4 a (new)

4 a. Expresses dissatisfaction regarding derogations to prohibitions of use, and notes the rules are being abused; notes the current regulation and comitology arrangement allows a member state to simply announce its will to derogate and it is deemed to pass; Notes that often there is no justification for derogations, e.g. those that have been systematically granted to the partial neonicotinoid bans. Underlines that the Commission has a duty as Guardian of the Treaties to check the derogations are really justified and there are no alternatives, such as crop rotation or combinations of alternatives, that negate the need to use those substances or limit the extent of an expected pest outbreak. If no alternative preventive measures are taken, the derogations should not be granted;

Amendment 85 #

Draft opinion
Paragraph 4 a (new)

4 a. Notes that by the way of derogation from article 28, in special circumstances a Member State may authorise, for a period not exceeding 120 days, the placing on the market of plant protection products, for limited and controlled use, where such a measure appears necessary because of a danger which cannot be contained by any other reasonable means; raises concerns that Article 53 is being used as a loophole for placing products on the market and that sometimes the derogations are granted without proper justification;

Amendment 86 #

Karin KADENBACH, Maria NOICHL, Daciana Octavia SÂRBU

Draft opinion
Paragraph 4 a (new)

4a. Deplores unilateral decisions by Member States which can lead to the abolition or a restriction in the use of products approved by other Member States, and the lack of harmonisation in the time taken to process requests for authorisation, which gives rise to distortions of competition in the internal market and forces farmers into technical dead-ends which are both harmful to the environment and counter-productive for the competitiveness of farms;

Amendment 87 #

Draft opinion
Paragraph 4 a (new)

4 a. Recalls that in case of emergency Plant Protection Products authorisations the standard of the technical audit has to remain at a constant high level to ensure protection of human health and/or environment in particular with regard to ecologically or environmentally sensitive areas and that these derogations and their justifications are constantly subject to a critical review;

Amendment 88 #

Draft opinion
Paragraph 4 a (new)

4a. Points to the existence of specific requirements in each Member State and the lack of harmonisation in the methodologies used for the evaluations as the main causes of the lack of trust between states and the reason why they carry out re-assessments based on their own national models;

Amendment 89 #

Draft opinion
Paragraph 4 a (new)

4 a. Underlines the role of Member States in the effective implementation of Regulation (EC) 1107/2009; highlights the benefits of efficient authorisation, including more timely access to PPPs including low risk alternatives;

Amendment 9 #

Karin KADENBACH, Maria NOICHL, Daciana Octavia SÂRBU

Draft opinion
Paragraph 1

Amendment 90 #

Draft opinion
Paragraph 4 b (new)

4 b. Observes in this context that there is still a lack in the availability of detailed data associated with market authorisations and the criteria for the application of active substances in Plant Protection Products whereby their risk assessment for health and environment cannot be carried out in an appropriate manner by sciences, research or other user groups; therefore the confidentiality restrictions have to be abolished;

Amendment 91 #

Nicola CAPUTO, Karin KADENBACH, Molly SCOTT CATO

Draft opinion
Paragraph 4 b (new)

4b. Stresses that the aim, in terms of the single market, of the procedure of mutual recognition by Member States in a particular geographical region was to simplify procedures and increase trust among the Member States; is of the opinion that, given the discrepancies in practice among the Member States and the list of products which are effectively authorised, these objectives have not been achieved;

Amendment 92 #

Draft opinion
Paragraph 5

5. Points out that the zonal evaluation of PPP applications, which allows applicants to propose one zonal Rapporteur Member State (zRMS) to carry out the assessment, should lead to the concerned Member States (cMS) taking a decision within the maximum time limit of 120 days after the zRMS has issued the registration report; recalls recital (16) of Regulation (EC) No 1107/2009 which clearly highlights the possibility of amending or withdrawing the approval of an active substance in cases where the criteria for approval are no longer satisfied, or where compliance with Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy is compromised, should be provided for under certain conditions;

Amendment 93 #

Georgios EPITIDEIOS

Draft opinion
Paragraph 5

Amendment 94 #

Draft opinion
Paragraph 5

5. Points out that the zonal evaluation of PPP applications, which allows applicants to propose one zonal Rapporteur Member State (zRMS) to carry out the assessment, ~~should lead to the concerned Member States (cMS) taking a decision with~~violates the subsidiarity principle and increases the lack of transparency surrounding the ~~maximum time limit of 120 days after the zRMS has issued the registration report~~decisions taken by Member States' health agencies;

Amendment 95 #

Draft opinion
Paragraph 5

5. Points out that the aim of the zonal evaluation of PPP applications, which allows applicants to propose one zonal Rapporteur Member State (zRMS) to carry out the assessment, ~~should~~was to lead to the concerned Member States (cMS) taking a decision within the maximum time limit of 120 days after the zRMS has issued the registration report;

Amendment 96 #

Draft opinion
Paragraph 5 a (new)

5 a. Notes that Reg.1107/2009 gives the possibility of amending or withdrawing the approval of an active substance in cases where the criteria for approval are no longer satisfied, or where its use breaches or compromises compliance with the Water Framework Directive 2000/60/EC 1e ; Notes in this regard that the first systematic testing of rivers was mandated the WFD - as an example in the UK these were conducted in 2016, and results showed that half of the 16 rivers tested in England had either chronic or acute levels of neonicotinoid contamination, and they were found in 17 of the 23 rivers tested across Britain; _________________ 1eDirective 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy

Amendment 97 #

Draft opinion
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 98 #

Esther HERRANZ GARCÍA, Gabriel MATO, Ramón Luis VALCÁRCEL SISO

Draft opinion
Paragraph 5 a (new)

5 a. Regrets the lack of trust between EU Member States regarding scientific assessments of substance authorisations as well as the zonal authorisation system; calls on the Commission to properly implement the existing regulatory framework to harmonise the approval system and ensure mutual recognition of products across the EU Member States in the zones identified in Regulation EC 1107/2009;underlines that the full implementation of the existing legislation should have the aim of avoiding duplication of work and making new substances available to farmers without unnecessary delays;

Amendment 99 #

Draft opinion
Paragraph 5 a (new)

5a. Points out that the complexities of the current evaluation and authorisation system lead to deadlines being missed and mean that the entire system cannot work properly; stresses, therefore, the need to review and simplify this system;

source: 616.638

2018/06/13 ENVI 226 amendments...

Amendment 1 #

Motion for a resolution
Citation 5

– having regard to its resolution of 24 October 2017 on the draft Commission implementing regulation renewing the approval of the active substance glyphosate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/201112, _________________ 12 Texts adopted, P8_TA(2017)0395.deleted

Amendment 10 #

Motion for a resolution
Recital A a (new)

Aa. whereas the evaluation of the implementation of the Regulation revealed that research and innovation in the field of plant protection products needs to be stepped up;

Amendment 100 #

Herbert DORFMANN

Motion for a resolution
Paragraph 4

4. Is concerned by the steadily increasing use ~~and identified cases of misuse~~ of emergency authorisations granted under Article 53;

Amendment 101 #

Motion for a resolution
Paragraph 4 a (new)

4a. Recalls that in case of emergency Plant Protection Products authorisations the standard of the technical audit has to remain at a constant high level to ensure protection of human health and/or environment in particular with regard to ecologically or environmentally sensitive areas and that these derogations and their justifications are constantly subject to a critical review;

Amendment 102 #

Motion for a resolution
Paragraph 4 a (new)

4a. Reiterates that the number of derogations granted is linked to the fact that very few new products have been approved for minor crops; asks the Commission therefore to introduce an EU marketing authorisation for minor crops, or crops accounting for less than 0.2% of utilised agricultural area (UAA), grown in several EU regions;

Amendment 103 #

Motion for a resolution
Paragraph 4 a (new)

4a. Condemns the Commission for its unlawful actions with regard to the adoption of scientific criteria for the determination of endocrine disrupting properties (failure to act due to the commissioning of an irrelevant impact assessment; unlawful attempt to change an essential element of the basic act via an implementing act);

Amendment 104 #

Motion for a resolution
Paragraph 4 a (new)

4a. Welcomes the choice of a hazard- based evaluation approach as opposed to a purely risk-based approach; nonetheless notes that it needs improvement in relation to the harmonisation of criteria and procedures, as well as the practical work of national and EU authorities;

Amendment 105 #

Motion for a resolution
Paragraph 4 a (new)

4a. Stresses the importance of policy making that is informed by regulatory science, producing verifiable and repeatable evidence using internationally agreed scientific principles including guidelines, good laboratory practices and peer-reviewed research;

Amendment 106 #

Motion for a resolution
Paragraph 4 b (new)

4b. Observes in this context that there is still a lack in the availability of detailed data associated with market authorisations and the criteria for the application of active substances in Plant Protection Products whereby their risk assessment for health and environment cannot be carried out in an appropriate manner by sciences, research or other user groups; therefore the confidentiality restrictions have to be abolished;

Amendment 107 #

Motion for a resolution
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 production; believes that any harmonised requirements should be the subject of specific evaluation, to ensure that it meets the objectives of the Regulation and provides for a predictable and reliable process;

Amendment 108 #

Jan HUITEMA, Pavel TELIČKA, Gerben-Jan GERBRANDY, Ulrike MÜLLER

Motion for a resolution
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 production; as well as delays in the authorisation process, which negatively affects the accessibility of new and improved crop protection products, to the detriment of farmers the environment;

Amendment 109 #

Motion for a resolution
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 produc~~the 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 11 #

Motion for a resolution
Recital B

~~B. whereas the implementation of the Regulation is not in line with related EU policies, including in the field of pesticides;~~deleted

Amendment 110 #

Motion for a resolution
Paragraph 5

5. Is concerned that the incomplete harmonisation of data and testing requirements in some scientific fields, together with the sometimes insufficient level of said requirements, may lead to direct negative effects on health, the environment and agricultural production;

Amendment 111 #

Motion for a resolution
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 human health, animal health and the environment and ~~agricultural production~~for the production of safe and sustainable food;

Amendment 112 #

Mairead McGUINNESS, Annie SCHREIJER-PIERIK, Julie GIRLING, Norbert LINS, Angélique DELAHAYE, Pilar AYUSO, Jan HUITEMA, Peter JAHR, Ulrike MÜLLER, Michel DANTIN, Herbert DORFMANN

Motion for a resolution
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 production~~the evaluation of products has not yet been fully implemented;

Amendment 113 #

5a. Calls on the Commission to set up a European minor uses fund to meet the cost of the effectiveness and residue tests needed to obtain marketing authorisation;

Amendment 114 #

Mairead McGUINNESS, Annie SCHREIJER-PIERIK, Julie GIRLING, Norbert LINS, Angélique DELAHAYE, Pilar AYUSO, Jan HUITEMA, Peter JAHR, Ulrike MÜLLER, Michel DANTIN, Herbert DORFMANN

Motion for a resolution
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 problematic~~could 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 115 #

Motion for a resolution
Paragraph 6

6. Regrets the blatantly 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), that accessibility and user friendliness of information at the European Food Safety Authority (EFSA) stage is problematic, and that transparency at the risk management stage seems to be lacking and is also considered problematic by stakeholders; points out, in that connection, that the constant public calls for transparency are justified;

Amendment 116 #

Motion for a resolution
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) and that they take little account of the opinions of the other Member States and of independent scientists, that accessibility and user friendliness of information at the European Food Safety Authority (EFSA) stage is problematic, and that transparency at the risk management stage is~~eems to be~~ lacking and is also considered problematic by stakeholders;

Amendment 117 #

Motion for a resolution
Paragraph 6 a (new)

6a. Calls on the Commission to create a single area for European marketing authorisations; calls on the Commission to guarantee the mutual recognition of authorisations by automatically issuing a single marketing authorisation for all Member States in a single area;

Amendment 118 #

Motion for a resolution
Paragraph 6 b (new)

6b. Calls on the Commission to establish a European usage catalogue in order to better harmonise the regulation;

Amendment 119 #

Amendment 12 #

Jan HUITEMA, Pavel TELIČKA, Gerben-Jan GERBRANDY, Ulrike MÜLLER, Carolina PUNSET

Motion for a resolution
Recital B

B. whereas the implementation of the Regulation is not in line with related EU policies, ~~including in the field of pes~~for example the EU's agricultural policy is at odds with the targets for reducing use of pesticides, and even more so with its key priority of protecting pollinators, the first victims of neonicotinoid insecticides;

Amendment 120 #

Motion for a resolution
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 #

Mairead McGUINNESS, Annie SCHREIJER-PIERIK, Julie GIRLING, Norbert LINS, Angélique DELAHAYE, Pilar AYUSO, Jan HUITEMA, Peter JAHR, Ulrike MÜLLER, Michel DANTIN, Herbert DORFMANN

Motion for a resolution
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 122 #

Motion for a resolution
Paragraph 7 a (new)

7a. States that the Member States' right to refuse authorised Plant Protection Products remain unaffected;

Amendment 123 #

Motion for a resolution
Paragraph 8

8. Emphasises that the Regulation should better reflect the need to promote agricultural practices based on integrated pest management, ~~including by stimulating the development of low-risk substances;~~and support the transition to biopesticides, pesticides based on micro-organisms or natural products, and strengthening of the natural plant defence mechanisms

Amendment 124 #

Motion for a resolution
Paragraph 8

8. Emphasises that the Regulation should better reflect the need to promote agricultural practices based on integrated pest management, including by stimulating the development of low-risk substances and, wherever possible, to consider non- chemical and natural methods of plant protection;

Amendment 125 #

Mairead McGUINNESS, Julie GIRLING, Norbert LINS, Angélique DELAHAYE, Pilar AYUSO, Jan HUITEMA, Peter JAHR, Ulrike MÜLLER, Michel DANTIN, Herbert DORFMANN

Motion for a resolution
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 126 #

Motion for a resolution
Paragraph 8

8. Emphasises that the Regulation should better reflect the need to promote organic agricultural practices based on integrated pest management~~, including~~ by stimulating the development of ~~low~~zero-risk substances and products;

Amendment 127 #

Motion for a resolution
Paragraph 8

8. Emphasises that the Regulation should better reflect elements such as the need to promote agricultural practices based on integrated pest management, including by stimulating the development of low-risk substances;

Amendment 128 #

Jan HUITEMA, Pavel TELIČKA, Gerben-Jan GERBRANDY, Ulrike MÜLLER, Carolina PUNSET, Mairead McGUINNESS

Motion for a resolution
Paragraph 8

8. Emphasises that the ~~Regulation~~application of the Regulation and related policy areas should better reflect the need to promote agricultural practices based on integrated pest management~~, including by stimulating the development of low-risk substances~~;

Amendment 129 #

Motion for a resolution
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 13 #

Jan HUITEMA, Pavel TELIČKA, Ulrike MÜLLER, Mairead McGUINNESS

Motion for a resolution
Recital B

B. whereas the implementation of the Regulation ~~is not~~should be in line with related EU policies, including in the field of pesticides;

Amendment 130 #

Motion for a resolution
Paragraph 8 a (new)

8a. Stresses that the application of integrated pest management is mandatory in the Union under Directive 2009/128/EC; considers that Member States and local authorities should place more emphasis on the sustainable use of pesticides, including alternative low-risk plant protection products;

Amendment 131 #

Pavel POC, Nicola CAPUTO, Simona BONAFÈ, Jytte GUTELAND, Susanne MELIOR, Guillaume BALAS, Nessa CHILDERS, Daciana Octavia SÂRBU, Eric ANDRIEU, Karin KADENBACH

Motion for a resolution
Paragraph 8 a (new)

8a. Highlights that the lack of availability of low-risk plant protection products hinders Integrated Pest Management developments, stresses that only 10 substances are approved as low- risk plant protection products out of a total of almost 500 available on the EU market;

Amendment 132 #

Motion for a resolution
Paragraph 8 a (new)

8a. Highlights the importance of encouraging farmers to invest in new technologies such as precision and low drift sprayers, deflectors and digital farming tools that optimise the use of Plant Protection Products and reduce environmental impact;

Amendment 133 #

Motion for a resolution
Paragraph 8 b (new)

8b. Reiterates that on 15 February 1 a 2017 Parliament demanded that the Commission should , by the end of 2018, submit a specific legislative proposal to amend Regulation (EC) No 1107/2009, separately from the general revision under the REFIT initiative, in order to introduce an accelerated (fast- track) procedure for the evaluation, authorisation and registration of low-risk green plant protection products; _________________ 1a European Parliament resolution of 15 February 2017 on low-risk pesticides of biological origin (2016/2903 (RSP)).

Amendment 134 #

Pavel POC, Nicola CAPUTO, Simona BONAFÈ, Jytte GUTELAND, Susanne MELIOR, Guillaume BALAS, Nessa CHILDERS, Daciana Octavia SÂRBU, Eric ANDRIEU, Karin KADENBACH

Motion for a resolution
Paragraph 8 b (new)

8b. Emphasises that the authorisation and promotion of low-risk and non- chemical pesticides is an important measure to support low pesticide-input pest management;

Amendment 135 #

Motion for a resolution
Paragraph 8 c (new)

8c. Welcomes the adoption of Commission Regulation (EU) 2017/1432 of 7 August 2017 amending Regulation (EC) No 1107/2009 of the European Parliament and the Council concerning the placing of plant protection products on the market as regards the criteria for the approval of low-risk active substances; deplores, however, the fact that the Commission has still not submitted a specific legislative proposal amending Regulation (EC) No 1107/2009 in order, separately from the general revision in connection with the REFIT initiative, to establish a fast-track evaluation, authorisation and registration process for low-risk plant protection products of biological origin;

Amendment 136 #

Jan HUITEMA, Pavel TELIČKA, Ulrike MÜLLER, Mairead McGUINNESS

Motion for a resolution
Paragraph 9

9. Highlights that ~~many~~there remain some authorised PPPs have not been evaluated against EU standards for more than 15 years, due to difficulties relating to the proper implementation of the re-approval process; considers that the implementation of the new principles of the Regulation relating to re-approval will address this over time;

Amendment 137 #

Motion for a resolution
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 138 #

Motion for a resolution
Paragraph 9 a (new)

9a. Stresses the importance of creating an innovation friendly regulatory framework, which allows for the replacement of older chemistry by new and better crop protection products; underlines the importance of the availability of a broad spectrum of Plant Protection Products with different modes of action to avoid the development of resistances and maintain the effectiveness of crop protection product application;

Amendment 139 #

Motion for a resolution
Paragraph 10

10. Is concerned that the harmonisation of guidelines in fields like ecotoxicology or environmental fate and behaviour is not yet complete; and that the requirements of Directive 2010/63/EU on the protection of animals used for scientific purposes are not given sufficient consideration;

Amendment 14 #

Mairead McGUINNESS, Julie GIRLING, Norbert LINS, Angélique DELAHAYE, Pilar AYUSO, Jan HUITEMA, Peter JAHR, Michel DANTIN, Herbert DORFMANN

Motion for a resolution
Recital B

B. whereas the implementation of the Regulation ~~is not~~should be in line with related EU policies, including in the field of pesticides;

Amendment 140 #

Motion for a resolution
Paragraph 10

10. Is concerned that ~~the harmonisation of guidelines in fields like~~fields such as the effect on endocrine disruptors, ecotoxicology or environmental fate and behaviour is not yet ~~complete~~being systematically taken into account in assessments;

Amendment 141 #

Mairead McGUINNESS, Julie GIRLING, Norbert LINS, Angélique DELAHAYE, Pilar AYUSO, Jan HUITEMA, Peter JAHR, Ulrike MÜLLER, Michel DANTIN, Herbert DORFMANN

Motion for a resolution
Paragraph 10

10. Is concerned that the harmonisation of guidelines ~~in fields like ecotoxicology or environmental fate and behaviour is~~are not yet co~~mple~~nsolidated;

Amendment 142 #

Motion for a resolution
Paragraph 11 a (new)

11a. Further stresses that the process of development of methodologies should be scrutinised with a view to avoiding influence from the industry;

Amendment 143 #

Motion for a resolution
Paragraph 12

12. Highlights that available guidance documents are not always legally binding, which creates regulatory uncertainty for the applicants and brings into question the results of the evaluations carried out in the framework of the approval procedures;deleted

Amendment 144 #

Motion for a resolution
Paragraph 12

12. Highlights that available guidance documents are not always legally binding and, therefore, not applied by all national competent authorities, which creates regulatory uncertainty for the applicants and brings into question the results of the evaluations carried out in the framework of the approval procedures;

Amendment 145 #

Mairead McGUINNESS, Annie SCHREIJER-PIERIK, Julie GIRLING, Norbert LINS, Angélique DELAHAYE, Pilar AYUSO, Jan HUITEMA, Peter JAHR, Ulrike MÜLLER, Michel DANTIN, Herbert DORFMANN

Motion for a resolution
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 146 #

Motion for a resolution
Paragraph 12 a (new)

12a. 1. Regrets that the Commission leaves measures to mitigate risks identified at EU level to the Member States;

Amendment 147 #

Mairead McGUINNESS, Annie SCHREIJER-PIERIK, Julie GIRLING, Norbert LINS, Angélique DELAHAYE, Pilar AYUSO, Jan HUITEMA, Peter JAHR, Ulrike MÜLLER, Michel DANTIN, Herbert DORFMANN

Motion for a resolution
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 148 #

Motion for a resolution
Subheading 2 a (new)

Calls on the Commission and the Member States to prohibit animal testing in all PPP related research and assessment procedures;

Amendment 149 #

Motion for a resolution
Paragraph 13

13. Calls on the Commission ~~and the Member States to ensure effective implementation of the Regulation as regards their specific roles in the approval and authorisation procedures~~to submit to the Council and Parliament an extensive revision and modification of the approval and authorisation procedures and governance system, giving the Member States back their authority and their freedom to cooperate within the system;

Amendment 15 #

Motion for a resolution
Recital B a (new)

Ba. whereas Regulation (EC) No 1107/2009 established a complicated dual system for authorisations (active substances are approved at EU level while approval of plant protection products containing these active substances comes under the authority of the Member States) which is not proving satisfactory;

Amendment 150 #

Motion for a resolution
Paragraph 13 a (new)

13a. Draws attention to the fact that, if the significant discrepancies and mistrust between the Member States with regard to authorised PPPs persist, the principle of mutual recognition - according to which a PPP authorised in one Member State may be authorised in another Member State for the same agricultural practices, on the basis of the authorisation assessment carried out in the first Member State - cannot be applied effectively;

Amendment 151 #

Motion for a resolution
Paragraph 13 a (new)

13a. Further calls on the Commission to make a proposal for the centralisation of the allocation procedures of first approval dossiers to national competent authorities, as a way to provide a better distribution of the workload among Member States, as well as to allow all of them to build experience with approvals;

Amendment 152 #

Motion for a resolution
Paragraph 13 a (new)

13a. Calls on the Commission and Member States to properly implement the existing regulatory framework to harmonise the approval system of products, and ensure effective mutual recognition procedures between EU Member States in the zones identified in Regulation EC 1107/2009, avoiding duplication and delays.

Amendment 153 #

Motion for a resolution
Paragraph 13 a (new)

13a. Calls on the Commission to do all it can to guarantee the competitiveness of European agriculture and to take action to ensure that the excessive application of the precautionary principle does not jeopardise opportunities for farmers.

Amendment 154 #

Pavel POC, Nicola CAPUTO, Simona BONAFÈ, Susanne MELIOR, Guillaume BALAS, Nessa CHILDERS, Daciana Octavia SÂRBU, Eric ANDRIEU, Karin KADENBACH

Motion for a resolution
Paragraph 13 a (new)

13a. Calls on the Member States to improve the serious and chronic understaffing of the national competent authorities which leads to delays at the stage of hazard identification and initial risk assessment performed by Member States;

Amendment 155 #

Motion for a resolution
Paragraph 13 b (new)

13b. Calls, therefore, on the Commission to proceed in two stages: a. review the mutual recognition procedure with the aim of increasing its effectiveness and improving implementation, the meeting of deadlines and mutual trust between the Member States; b. carry out an impact assessment in order to gauge the feasibility of setting up an authorisation procedure for PPPs at European level, taking into account specific geographical characteristics, with the aim of harmonising the rules among the Member States, dramatically reducing costs and time limits and resolving issues of unfair competition by strengthening the internal market for PPPs, keeping in mind the fact that this kind of procedure will not be possible without sufficient budget resources and expertise from the Member States;

Amendment 156 #

Pavel POC, Nicola CAPUTO, Jytte GUTELAND, Susanne MELIOR, Nessa CHILDERS, Daciana Octavia SÂRBU, Eric ANDRIEU, Karin KADENBACH

Motion for a resolution
Paragraph 13 b (new)

13b. Calls on the holders of authorisations for plant protection products in one Member State to fully implement the mutual recognition principle and apply for authorisation for the same product and the same uses in another Member State, calls on the Member States to improve the current lack of confidence which leads to the repetition of evaluations of the same products and to fully apply this principle in the authorisation of plant protection products;

Amendment 157 #

Motion for a resolution
Paragraph 13 b (new)

13b. Calls on the Commission to consider changing the unjustifiably rigorous system with regard to illegal substance use and the phasing-out of active substances. Further tightening of the system might result in an increase in the illegal use of preparations, which are authorised in non-EU countries but have been withdrawn in the EU.

Amendment 158 #

Motion for a resolution
Paragraph 13 c (new)

13c. Takes the view that an authorisation procedure for PPPs which is harmonised at European level might provide common solutions for small farms which are currently in technical dead- ends as a result of the cost of obtaining authorisation and the lack of investment and research on the part of private and public stakeholders;

Amendment 159 #

Mairead McGUINNESS, Annie SCHREIJER-PIERIK, Julie GIRLING, Norbert LINS, Angélique DELAHAYE, Pilar AYUSO, Jan HUITEMA, Peter JAHR, Ulrike MÜLLER, Michel DANTIN, Herbert DORFMANN

Motion for a resolution
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 16 #

Julie GIRLING

Motion for a resolution
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 Regulation;deleted

Amendment 160 #

Motion for a resolution
Paragraph 14

14. Calls on the Commission and the Member States to acknowledge that health and environmental protection ~~objectives should take priority over the~~are the primary objectives of the legislation; considers that innovation, production and competitiveness of the agricultural sector are also important objectives of ~~improving plant protection~~the legislation, as well as safe and affordable food, which is more resource efficient;

Amendment 161 #

Motion for a resolution
Paragraph 14

14. Calls on the Commission and the Member States to acknowledge that the objectives to protect human health, animal health and the environment~~al protection objectives~~ should take priority over the objective of improving plant protection, and therefore that they guarantee that the precautionary principle will constitute as the underlying and guiding principle of the Regulation;

Amendment 162 #

Motion for a resolution
Paragraph 14

14. Calls on the Commission and the Member States to acknowledge that health and environmental protection objectives ~~should~~clearly must, in line with the basic principles of public health and environmental protection, take priority over the objective of improving plant protection;

Amendment 163 #

Motion for a resolution
Paragraph 14

14. Calls on the Commission and the Member States to ~~acknowledge that health and environmental protection objectives should take priority over~~better implement and enforce the Regulation, to ensure the continuing attainment of the objectives and the better achievement of the objective tof improv~~ing plant~~e agricultural proteduction; ;

Amendment 164 #

14. Calls on the Commission and the Member States to acknowledge that health ~~and~~, environmental and biodiversity protection objectives should take priority over the objective of improving plant protection;

Amendment 165 #

Mairead McGUINNESS, Annie SCHREIJER-PIERIK, Angélique DELAHAYE, Pilar AYUSO, Peter JAHR, Julie GIRLING, Ulrike MÜLLER, Michel DANTIN, Herbert DORFMANN

Motion for a resolution
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 166 #

Motion for a resolution
Paragraph 14 a (new)

14a. Calls on the Commission and the Member States to ensure that PPPs can and will be taken of the market immediately if scientific uncertainty or concern is raised regarding the potential negative effects, both direct and indirect, on human health, animal health or the environment;

Amendment 167 #

Motion for a resolution
Paragraph 14 a (new)

14a. Calls on the Member States to strictly apply Article 9 of the Regulation on the admissibility of the application and to only accept complete applications for the assessment of the active substance;

Amendment 168 #

Jan HUITEMA, Pavel TELIČKA, Ulrike MÜLLER, Mairead McGUINNESS

Motion for a resolution
Paragraph 14 b (new)

14b. Calls on the Commission and the Member States to implement a systematic post-market vigilance, for instance, by collecting, sharing and analysing data on real-life behaviour and practices of operators, on environmental impact and on PPP-related illnesses (including those suspected of being caused by EDCs);

Amendment 169 #

Merja KYLLÖNEN

Motion for a resolution
Paragraph 15

15. Calls on the Commission and the Member States to ensure full and uniform application of the hazard cut-off criteria, following existing harmonised guidance, and to make sure that substances are assessed for their risk only if there is evidence that they do not present hazardous (cut-off) properties, as required by the Regulation; reminds that any change to the derogation from the cut-off rule will change the scope of the Regulation; Justification: The Commission is not entitled change the derogations of these kinds. This is a matter of policy which falls within the European Union legislation.

Amendment 17 #

Motion for a resolution
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 Regulation~~could be improved;

Amendment 170 #

Motion for a resolution
Paragraph 15

15. Calls on the Commission and the Member States to ensure full and uniform application of the hazard cut-off criteria, following existing harmonised guidance, and to make sure that substances are assessed for their risk only if there is evidence that they do not present hazardous (cut-off) properties, as required by the Regulationcritically assess the hazard cut-off criteria, taking into consideration potential unintended consequences on public health, environmental safety and agronomic practices; calls on the Commission to assess, as part of its REFIT analysis, the performance of the legislation regarding access to the market for new, innovative products, meeting the needs of the agricultural sector;

Amendment 171 #

Motion for a resolution
Paragraph 15 a (new)

15a. 1. Calls on the Commission to finally implement provisions on co- formulants, safeners and synergists, calls on the Commission to establish a list of unacceptable co-formulants and rules so that safeners and synergists are tested at EU level, and only those chemicals that comply with the EU approval criteria can be marketed;

Amendment 172 #

Motion for a resolution
Paragraph 15 a (new)

15a. Calls on the Commission and the Member States to commit to assessing PPPs as rigorously as active substances, to take into account and assess (the effect of) formulations and residues in the risk assessment procedure, and to incorporate epidemiological studies as well as environmental impact studies into the legislation;

Amendment 173 #

Motion for a resolution
Paragraph 15 b (new)

15b. Calls on the Commission to get agreement from the Member States on how to decide whether exposure of humans and other non-target organisms is “negligible”;

Amendment 174 #

Motion for a resolution
Paragraph 16

16. Calls on the Commission and the Member States when acting as risk managers in the approval and authorisation procedures, to duly apply the precautionary principle ~~and to pay particular attention to the protection of vulnerable groups of the population, including pregnant women, infants and children~~, to guarantee that the substances or products placed on the market do not pose a risk or have any harmful effect on human health, animal health or the environment; to pay particular attention to the protection of vulnerable groups of the population, including pregnant women, infants and children, as well as to adequately protect citizens living in the vicinity of areas with an increased risk of exposure to pesticides, such as horticultural and agricultural areas;

Amendment 175 #

Motion for a resolution
Paragraph 16

16. Calls on the Commission and the Member States when acting as risk managers in the approval and authorisation procedures, to ~~duly apply the precautionary principle~~focus on evidence based risk assessment, rather than a hazard based approach and to pay particular attention to the protection of vulnerable groups of the population, including pregnant women, infants and children; calls on the Commission to minimise the risk of unintended consequences of non- authorization of plant protection products, such as lack of alternatives for crop protection of the agricultural sector;

Amendment 176 #

Motion for a resolution
Paragraph 16

16. Calls on the Commission and the Member States when acting as risk managers in the approval and authorisation procedures, to duly apply the precautionary principle a~~nd to pay particular attention to the protection of vulnerable groups of the population, including pregnant women, infants and children~~s is presently the case;

Amendment 177 #

Motion for a resolution
Paragraph 16

16. Calls on the Commission and the Member States when acting as risk managers in the approval and authorisation procedures, to duly apply the precautionary principle at zonal and inter-zonal level, and to pay particular attention to the protection of vulnerable groups of the population, including pregnant women, infants and children;

Amendment 178 #

Motion for a resolution
Paragraph 16

16. Calls on the Commission and the Member States when acting as risk managers in the approval and authorisation procedures, to duly apply the precautionary principle and to pay particular attention to the protection of vulnerable groups of the population, in~~cluding~~ particular pregnant women, infants and children;

Amendment 179 #

Ulrike MÜLLER, Jan HUITEMA, Mairead McGUINNESS

Motion for a resolution
Paragraph 16 a (new)

16a. Calls on the Commission and Member States to also address the problem of inconsistency in the interpretation and/or application of the other principles underpinning the Regulation, namely mutual recognition, sustainability and substitution;

Amendment 18 #

Mairead McGUINNESS, Norbert LINS, Angélique DELAHAYE, Pilar AYUSO, Jan HUITEMA, Peter JAHR, Michel DANTIN, Herbert DORFMANN

Motion for a resolution
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~~leaves room for improvement and does not ensure the complete fulfilment of the ~~purpose~~objectives of the Regulation;

Amendment 180 #

Motion for a resolution
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 181 #

Motion for a resolution
Paragraph 16 a (new)

16a. Calls on the Commission and the Member States invest in the research and development of alternative pesticides, especially biopesticides, and aim to mainstream the usage of biocides in the future

Amendment 182 #

Motion for a resolution
Paragraph 16 a (new)

16a. Calls on the Commission to ensure full application of Article 25 of the Regulation so that that safeners and synergists may only be used following their approval;

Amendment 183 #

Motion for a resolution
Paragraph 16 b (new)

16b. Calls on the Commission to swiftly adopt the negative list of co-formulants pursuant to Article 27 of the Regulation;

Amendment 184 #

Motion for a resolution
Paragraph 16 c (new)

16c. Calls on the Commission to include legally binding risk mitigation measures into the approval of active substances rather than leaving it to the discretion of Member States to deal with known risks posed by pesticides;

Amendment 185 #

Herbert DORFMANN

Motion for a resolution
Paragraph 17

~~17. Calls on the Member States to limit the authorisations granted under derogations using Article 53 of the Regulation;~~deleted

Amendment 186 #

Motion for a resolution
Paragraph 17

~~17. Calls on the Member States to limit the authorisations granted under derogations using Article 53 of the Regulation;~~deleted

Amendment 187 #

Motion for a resolution
Paragraph 17

17. Calls on the Member States to ~~limit the~~use Article 53 of the Regulation according to its original purpose or, more specifically, in "emergency situations" where such authoriszation~~s granted under derogations using Article 53 of the Regulation~~ is necessitated by a danger or threat that cannot be contained by any other reasonable means; further calls on the Member States to fully comply with the obligation of information to other Member States and the Commission set out in Article 53(1), in particular regarding any measures taken to ensure consumer safety;

Amendment 188 #

Motion for a resolution
Paragraph 17

17. Calls on the Member States to ~~limit the~~cease the granting of authorisations ~~granted~~ under derogations using Article 53 of the Regulation and to withdraw those already granted in case the substances or products in question could pose a risk to human health, animal health or the environment, and for as long as the potential risk for and/or the effect on human health, animal health and the environment have not been established;

Amendment 189 #

Motion for a resolution
Paragraph 17

17. Calls on the Member States to ~~limit the authorisations granted under~~only grant derogations using Article 53 of the Regulation in actual emergency situations, and calls on the Commission to fully use its control rights under Article 53(2) and (3);

Amendment 19 #

Motion for a resolution
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 Regulation~~remains a “mixed picture” and could be improved;

Amendment 190 #

Jan HUITEMA, Pavel TELIČKA, Gerben-Jan GERBRANDY, Ulrike MÜLLER, Mairead McGUINNESS

Motion for a resolution
Paragraph 17

17. Calls on the Member States to limit the authorisations granted under derogations using Article 53 of the Regulation; points out that the majority of such authorisations are given for “minor uses”;

Amendment 191 #

Motion for a resolution
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 u~~sing~~nder Article 53 of the Regulation;

Amendment 192 #

Motion for a resolution
Paragraph 17 a (new)

17a. Calls on the Commission to propose a pan-European system of authorisation for Minor Uses and Speciality Crops and a common list of major/minor crops to be applied at EU level;

Amendment 193 #

Motion for a resolution
Paragraph 17 a (new)

17a. Calls on the Commission to refrain from proposing any modification of the term ‘negligible exposure’ via an implementing act, as doing so would exceed its competences;

Amendment 194 #

Motion for a resolution
Paragraph 17 a (new)

17a. Calls on the Commission to make all the derogations granted by Member States under Article 53 available to the public;

Amendment 195 #

Motion for a resolution
Paragraph 17 b (new)

17b. Calls on the Commission to update the working document on Article 53 emergency situations by taking full account of their increased use for soil disinfection purposes and for minor uses authorisations; further calls on the Commission to analyse why Article 53 derogations are also used to provide access to biopesticides and mineral or plant-based substances for integrated pest management and organic agriculture;

Amendment 196 #

Motion for a resolution
Paragraph 18

18. Calls on the Commission to finalise methods to determine whe~~ther~~n certain derogations should be applied, in particular as regards ‘negligible exposure’ or ‘serious danger to plant health’, without changing the letter or the spirit of the law; warns the Commission that any reinterpretation of the term 'negligible exposure' to 'negligible risk' would be against the letter and the spirit of the law;

Amendment 197 #

Motion for a resolution
Paragraph 18

18. Calls on the Commission to finalise methods to determine whether certain derogations should be applied, in particular as regards ‘negligible exposure’ or ‘serious danger to plant health’; further calls on the Commission to work together with EFSA to define the role of epidemiology findings in regulatory risk assessment;

Amendment 198 #

Pavel POC, Nicola CAPUTO, Simona BONAFÈ, Jytte GUTELAND, Susanne MELIOR, Nessa CHILDERS, Daciana Octavia SÂRBU, Eric ANDRIEU, Karin KADENBACH

Motion for a resolution
Paragraph 18 a (new)

18a. Calls on the Commission and the Member States to incentivise research initiatives on active substances and plant protection products within Horizon Europe and the Multiannual Financial Framework 2021-2027 in general and to support exchanges among national authorities and extending this also to international authorities and relevant scientific bodies so as to develop a stronger and more cohesive scientific base;

Amendment 199 #

Motion for a resolution
Paragraph 18 a (new)

18a. Calls on the Commission and the Member States to concentrate on the risk assessment of added co-formulants in commercial plant protection products in order to establish a precise list of co- formulants whose use is banned, in line with Annex III of the Regulation;

Amendment 2 #

Motion for a resolution
Citation 12 a (new)

– having regard to the mandate and the work of the European Parliament's Special Committee on the Union's authorisation procedure for pesticides (PEST);

Amendment 20 #

Motion for a resolution
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~~can be improved in order to truly fulfil the purposes of the Regulation;

Amendment 200 #

Mairead McGUINNESS, Julie GIRLING, Angélique DELAHAYE, Pilar AYUSO, Jan HUITEMA, Ulrike MÜLLER, Michel DANTIN, Herbert DORFMANN

Motion for a resolution
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 201 #

Motion for a resolution
Paragraph 18 a (new)

18a. Calls on the Member States to establish national action plans to reduce 'orphan' uses, which create derogations and distortions between Member States;

Amendment 202 #

Motion for a resolution
Paragraph 19

~~19. Calls on the Commission to limit the use of the confirmatory data procedure;~~deleted

Amendment 203 #

Motion for a resolution
Paragraph 19

19. Calls on the Commission to strictly limit the use of the confirmatory data procedure; to its purpose as laid down in Article 6(f) of the Regulation, namely where new requirements are established during the evaluation process or as a result of new scientific and technical knowledge, but not to use it to deal with data gaps;

Amendment 204 #

Mairead McGUINNESS, Annie SCHREIJER-PIERIK, Jan HUITEMA, Peter JAHR, Pilar AYUSO, Angélique DELAHAYE, Julie GIRLING, Ulrike MÜLLER, Michel DANTIN, Herbert DORFMANN

Motion for a resolution
Paragraph 19

19. Calls on the Commission to ~~limit~~consider how to address concerns regarding the use of the confirmatory data procedure and notes that complete dossiers are important for active substance approvals;

Amendment 205 #

Motion for a resolution
Paragraph 19

19. Calls on the Commission to ~~limit~~cease the use of the confirmatory data procedure;

Amendment 206 #

Motion for a resolution
Paragraph 20

20. Calls on the Commission and the Member States to increase the overall transparency of the procedures; including a thorough reform of EFSA so as to guarantee the agency's (scientific) independence from politics and industry, full transparency regarding the agency's procedures, the most stringent requirements for its scientific advisors and panels, and complete disclosure of data and studies submitted or used in the application and (re-)authorisations procedures including data from studies sponsored by the industry which were or are deemed confidential;

Amendment 207 #

Motion for a resolution
Paragraph 20

20. Calls on the Commission and the Member States to increase the overall transparency of the procedures, while simultaneously ensuring protection of intellectual property and confidential business information, in order to maintain innovation incentives;

Amendment 208 #

Motion for a resolution
Paragraph 20

20. Calls on the Commission and the Member States to increase the overall transparency of the procedures, including by providing for detailed minutes on the comitology discussions among decision- makers and the arguments behind the final decisions;

Amendment 209 #

Motion for a resolution
Paragraph 20

20. Calls on the Commission and the Member States to increase the overall transparency of the procedures to the maximum by means of full disclosure of the studies leading to the authorisation of pesticides;

Amendment 21 #

Motion for a resolution
Recital C a (new)

Ca. whereas certain provisions of the Regulation have not been applied at all by the Commission, in particular Article 25 on the approval of safeners and synergists and Article 27 on a negative list of unacceptable co-formulants;

Amendment 210 #

Motion for a resolution
Paragraph 20

20. Calls on the Commission and the Member States to increase the overall transparency of the procedures; but at the same time to allow professional organisations the freedom of the authorising authority.

Amendment 211 #

Motion for a resolution
Paragraph 20 a (new)

20a. Takes note of the Commission’s initiative on transparency and sustainability of the EU risk assessment model in the food chain to propose improvements for the transparency of the regulatory process for plant protection products; stresses the importance of transparency to regain trust in the authorization system; underlines the importance of an effective protection of intellectual property and confidential business information to maintain incentives for innovation

Amendment 212 #

Pavel POC, Nicola CAPUTO, Simona BONAFÈ, Jytte GUTELAND, Susanne MELIOR, Guillaume BALAS, Nessa CHILDERS, Daciana Octavia SÂRBU, Eric ANDRIEU, Karin KADENBACH

Motion for a resolution
Paragraph 20 a (new)

20a. Calls in particular to improve transparency in the process and the overall accountability of the system by explaining and justifying the PAFF Committee decisions over precautionary risk mitigation measures, precautionary bans, and approvals;

Amendment 213 #

Motion for a resolution
Paragraph 21

21. Calls on the Commission and the Member States to ensure better coherence of the Regulation and its implementation with related EU legislation and policies, in particular with the Sustainable Use of Pesticides Directive; notes the failure of the regulatory framework to consider inevitable non-target impacts, notably on bees and other pollinators and other insects beneficial to farming like predators of pests; Notes the recent scientific study illustrating the "insect Armageddon"1a , whereby 75% winged insects have become regionally extinct across Germany, even in nature reserves where no pesticides were used for agriculture;

Amendment 214 #

Motion for a resolution
Paragraph 21

21. Calls on the Commission and the Member States to ensure better coherence of the Regulation and its implementation with related EU legislation and policies, in particular with the Sustainable Use of Pesticides Directive; and to ensure coherence of the Common Agricultural Policy with the plant protection products legislation namely by maintaining the obligations under Regulation (EC) 1107/2009 and Directive 2009/128/EC on the list of statutory management requirements (SMR 12 and SMR 13) as proposed by the Commission in the Regulation [CAP Strategic Plans Regulation]3a _________________ 3aproposal for the CAP Strategic Plans Regulation COM(2018) 392

Amendment 215 #

Motion for a resolution
Paragraph 21

21. Calls on the Commission and the Member States to ensure better coherence of the Regulation and its implementation with related EU legislation and policies, in particular with the Sustainable Use of Pesticides Directive, and to provide for incentives, including making available sufficient resources, that promote and stimulate in the short term the development and use of safe and non- toxic alternatives to PPP's;

Amendment 216 #

Motion for a resolution
Paragraph 21

Amendment 217 #

Pavel POC, Nicola CAPUTO, Jytte GUTELAND, Susanne MELIOR, Guillaume BALAS, Nessa CHILDERS, Daciana Octavia SÂRBU, Eric ANDRIEU, Karin KADENBACH

Motion for a resolution
Paragraph 21 a (new)

21a. Calls on the Commission to submit, before the end of 2018, a specific legislative proposal amending Regulation (EC) No1107/2009, outside of the general revision in connection with the REFIT initiative, with a view to establishing a fast-track evaluation, authorisation and registration process for low-risk pesticides of biological origin;

Amendment 218 #

Motion for a resolution
Paragraph 21 a (new)

21a. Calls on the Commission and the Member States to prioritise the assessment of active substances that are considered low-risk, and to apply Article 47 of Regulation (EC) No 1107/2009 broadly;

Amendment 219 #

Motion for a resolution
Paragraph 21 a (new)

21 a. calls on the Commission to set up EU-wide mitigation measures;

Amendment 22 #

Motion for a resolution
Recital C b (new)

Cb. whereas other key provisions such as application of the cut-off criteria for active substances that are endocrine disrupters have been significantly delayed due to unlawful behaviour by the Commission;

Amendment 220 #

Motion for a resolution
Paragraph 21 b (new)

21b. Takes the view that the current regulatory framework should be adapted to include a presumption of low-risk status for the micro-organisms as active substances;

Amendment 221 #

Motion for a resolution
Paragraph 22

22. Call on the Member States to ensure effective enforcement of the Regulation especially as regards controls of the plant protection products marketed in the EU, regardless of whether they have been produced in the EU or imported from third countries; regrets the lack of trust between EU Member States regarding scientific assessments of substance authorisations as well as the zonal authorisation system; calls on the Commission to properly implement the existing regulatory framework to harmonise the approval system and ensure mutual recognition of products across the EU Member States in the zones identified in Regulation EC 1107/2009; underlines that the full implementation of the existing legislation should have the aim of avoiding duplication of work and making new substances available to farmers without unnecessary delays;

Amendment 222 #

Motion for a resolution
Paragraph 22

Amendment 223 #

Pavel POC, Nicola CAPUTO, Jytte GUTELAND, Susanne MELIOR, Nessa CHILDERS, Daciana Octavia SÂRBU, Eric ANDRIEU, Karin KADENBACH

Motion for a resolution
Paragraph 22

22. Calls on the Member States to ensure effective enforcement of the Regulation especially as regards controls of the plant protection products marketed in the EU, regardless of whether they have been produced in the EU or imported from third countries;

Amendment 224 #

Motion for a resolution
Paragraph 22 a (new)

22a. Urges the Commission and the Member States to recognise bans imposed by a Member State, even if the product or substance remains authorised in the EU, thus making it possible for that Member State to prohibit imports onto its territory of foodstuffs that have been in contact with the product or substance in question (for example, dimethoate, which is banned by France, Spain, Italy, Greece, and Slovenia but still authorised by the European Union, which means that Turkish imports treated with dimethoate are free to enter the single market);

Amendment 225 #

Mairead McGUINNESS, Annie SCHREIJER-PIERIK, Julie GIRLING, Angélique DELAHAYE, Pilar AYUSO, Jan HUITEMA, Peter JAHR, Ulrike MÜLLER, Michel DANTIN, Herbert DORFMANN

Motion for a resolution
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;

Amendment 226 #

Jan HUITEMA, Pavel TELIČKA, Ulrike MÜLLER

Motion for a resolution
Paragraph 23 a (new)

23a. Considers that, when pesticides have not been evaluated on the basis of EU standards for more than 15 years, the precautionary principle should be applied;

Amendment 23 #

Motion for a resolution
Recital D

~~D. whereas there are concerns associated with the evaluation approach, as established by law, in particular as regards who should produce the evidence for evaluations and the hazard-based approach;~~deleted

Amendment 24 #

Motion for a resolution
Recital D

D. whereas ~~there are~~certain stakeholders raised concerns associated with the evaluation approach, as established by law, in particular as regards who should produce the evidence for evaluations and the hazard-based approach; whereas there are also many views expressed in the context of the evaluation which support the current evaluation approach.

Amendment 25 #

Mairead McGUINNESS, Julie GIRLING, Norbert LINS, Angélique DELAHAYE, Pilar AYUSO, Peter JAHR, Michel DANTIN, Herbert DORFMANN

Motion for a resolution
Recital D

D. whereas there are concerns associated with the evaluation approach, as established by law, in particular as regards who should produce the ~~evidence for~~scientific studies and evidence for the active substance evaluations and the use of the hazard- based approach during these evaluations;

Amendment 26 #

Jan HUITEMA, Pavel TELIČKA, Ulrike MÜLLER

Motion for a resolution
Recital D

D. whereas ~~there are concerns associated with~~ the evaluation approach, has ~~established by law~~revealed very serious problems, and there are concerns associated with it, in particular as regards who should produce the evidence for evaluations and the hazard-based approach;

Amendment 27 #

Motion for a resolution
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 #

Jan HUITEMA, Pavel TELIČKA, Ulrike MÜLLER, Mairead McGUINNESS

Motion for a resolution
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 #

Mairead McGUINNESS, Annie SCHREIJER-PIERIK, Julie GIRLING, Norbert LINS, Angélique DELAHAYE, Pilar AYUSO, Jan HUITEMA, Peter JAHR, Ulrike MÜLLER, Michel DANTIN, Herbert DORFMANN

Motion for a resolution
Recital E

E. whereas there are concerns associated with the practical implementation of the ~~established~~two-tier evaluation approach; whereas in particular there are major concerns associated with the incomplete harmonisation of data requirements and methodologies used ~~in some scientific field~~during evaluations of the products that may hinder the ~~evaluation~~ process and thus may lead to d~~irect negative effects on public health and the environment~~elays in the approval process;

Amendment 3 #

Jan HUITEMA, Pavel TELIČKA, Ulrike MÜLLER, Mairead McGUINNESS

Motion for a resolution
Recital A

A. whereas the evaluation of the implementation of the Regulation revealed that the health and environmental protection objectives are not being achieved, even though the EU is required by virtue of Article 168 of the Treaty on the Functioning of the European Union to ensure a high level of human health protection in the definition and implementation of all its policies and actions;

Amendment 30 #

Mairead McGUINNESS, Annie SCHREIJER-PIERIK, Julie GIRLING, Norbert LINS, Angélique DELAHAYE, Pilar AYUSO, Jan HUITEMA, Peter JAHR, Michel DANTIN, Herbert DORFMANN

Motion for a resolution
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 31 #

Motion for a resolution
Recital F

Amendment 32 #

Motion for a resolution
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~~, staff and technologies; whereas the Regulation and relevant supporting legal requirements are not uniformly implemented across Member States with relevant health and environment implications;

Amendment 33 #

Pavel POC, Nicola CAPUTO, Simona BONAFÈ, Jytte GUTELAND, Susanne MELIOR, Nessa CHILDERS, Daciana Octavia SÂRBU, Eric ANDRIEU, Karin KADENBACH

Motion for a resolution
Recital F a (new)

Fa. Underlines that the capacities of competent authorities in terms of expertise and staff and thus the quality of the results from the evaluations of hazard identification and initial risk assessment performed at national level, differ across Member States;

Amendment 34 #

Mairead McGUINNESS, Julie GIRLING, Norbert LINS, Angélique DELAHAYE, Pilar AYUSO, Peter JAHR, Michel DANTIN, Herbert DORFMANN

Motion for a resolution
Recital G

G. whereas transparency inat all stages of the approval procedure ~~is insufficient and leads to negative effects on health and the environment and provokes public mistrust~~could be improved; increased transparency may help to encourage public confidence in the system regulating p~~esticide substance~~lant protection products; whereas the transparency of the authorisation related to the activities of competent authorities ~~is also unsatisfactor~~can be further developed; whereas the European Commission has proposed changes to the General Food Law with an aim to address concerns relating to the data and evidence supplied during the evaluation process and to increase transparency;

Amendment 35 #

Motion for a resolution
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 provokes public mistrust in the system regulating pesticide substances; whereas the transparency of the authorisation related activities of competent authorities is ~~also unsatisfactory~~deeply unsatisfactory, with stakeholders generally not included in the consultation procedures related to the risk assessment and the public not provided with explanations on the final risk management decisions;

Amendment 36 #

Motion for a resolution
Recital G

G. wWhereas transparency ~~in all stages~~ of the approval procedure is i~~nsufficient and leads to negative effects on health and the environment and provokes public mistrust in the system regulating pesticide substances; whe~~mportant to foster a better understanding of the robust system and increas the tr~~ansparency of the authorisation related activities of competent authorities is also unsatisfactory;~~ust in the scientific method.

Amendment 37 #

Jan HUITEMA, Pavel TELIČKA, Ulrike MÜLLER, Mairead McGUINNESS

Motion for a resolution
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 provokes~~can be improved, which could increase public ~~mis~~trust in the ~~system regulating pesticide substances~~approval system; whereas the transparency of the authorisation related activities of competent authorities is also unsatisfactory;

Amendment 38 #

Motion for a resolution
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 provokes~~could be improved, which would lead to increased public ~~mis~~trust in the system regulating pesticide substances; whereas the transparency of the authorisation related activities of competent authorities iscould also ~~unsatisfactory~~be improved; welcomes the proposed changes to the General Food Law to address this problem;

Amendment 39 #

Motion for a resolution
Recital G

G. whereas transparency in all stages of the approval procedure is insufficient and leads to negative effects on human health, animal health and the environment and provokes public mistrust in the system regulating pesticide substances; whereas the transparency of the authorisation related activities of competent authorities is also unsatisfactory;

Amendment 4 #

Motion for a resolution
Recital A

A. whereas the evaluation of the implementation of the Regulation ~~revealed that the health and~~; considered that improvements could be made to achieve all objectives of the Regulation; whereas the majority of respondents considered the environmental ~~protection~~and health objectives ~~are not being achiev~~to be met, the majority of respondents did not consider that the objective to improve agricultural production had been attained;

Amendment 40 #

Motion for a resolution
Recital G

G. whereas transparency in all stages of the approval procedure is i~~nsufficient and leads to negative effects on health and the environment and provokes~~dentified as an area for improvement; whereas it is noted that public ~~mis~~trust in the system regulating pesticide substances would benefit from increased transparency; whereas the transparency of the authorisation related activities of competent authorities is also ~~unsatisfactory~~can be improved;

Amendment 41 #

G. whereas transparency in all stages of the approval procedure is seriously insufficient and leads to negative effects on health and the environment and provokes public mistrust in the system regulating pesticide substances; whereas the transparency of the authorisation related activities of competent authorities is also unsatisfactory;

Amendment 42 #

Motion for a resolution
Recital G a (new)

Ga. whereas the European Ombudsman, in her decision in case 12/2013/MDC of 18 February 2016 on the practices of the European Commission regarding the authorisation and placing on the market of plant protection products (pesticides), called on the Commission to review its approach to the definition and implementation of mitigation measures (conditions and restrictions), so as to include further requirements aimed at ensuring that the Commission does not evade its responsibility to ensure the effective protection of human health, animal health and the environment by allowing Member States almost absolute discretion as regards the definition of mitigation measures for potentially unsafe substances, given that standard formulations are very open-ended and it can be doubted whether they can be legally described as requiring mitigation measures at all;

Amendment 43 #

Motion for a resolution
Recital G a (new)

Ga. whereas following the 'Monsanto Papers' scandal and concerns over the risk assessment of the herbicide glyphosate, the European Parliament decided to set up a Special Committee on the Union's authorisation procedure for pesticides to examine the role of the EU agencies, possible conflicts of interest and failings in how these substances are scientifically assessed and authorised;

Amendment 44 #

Herbert DORFMANN

Motion for a resolution
Recital H

H. whereas authorisations of plant protection products, which take place exclusively at national level, often face delays in risk management decisions; whereas in consequence this leads in some cases to an increase of authorisations granted by Member States under derogation, making use of Article 53 of the Regulation; whereas there are cases where such derogations are used against the initial intention of the legislator;

Amendment 45 #

Motion for a resolution
Recital H

H. whereas authorisations of plant protection products, which take place exclusively at national level, often face delays in risk management decisions; whereas in consequence this leads in some cases to an increase of authorisations granted by Member States under derogation, making use of Article 53 of the Regulation; ~~whereas there are cases where such derogations are used against the initial intention of the legislator;~~

Amendment 46 #

Motion for a resolution
Recital H

Amendment 47 #

Pavel POC, Nicola CAPUTO, Simona BONAFÈ, Jytte GUTELAND, Susanne MELIOR, Nessa CHILDERS, Daciana Octavia SÂRBU, Eric ANDRIEU, Karin KADENBACH

Motion for a resolution
Recital H a (new)

Ha. Whereas the implementation of the Regulation is not fully coherent with the principle of mutual recognition, whereas the mutual recognition principle was assessed by stakeholders as one of the most problematic instruments to implement, whereas national evaluators tend to re-evaluate dossiers which were already evaluated by the zonal Rapporteur Member State;

Amendment 48 #

Motion for a resolution
Recital H a (new)

Ha. whereas Regulation (EC) No1107/2009 introduces that integrated pest management should have become part of the statutory management requirements under rules of cross- compliance of the Common Agricultural Policy, whereas this is yet to happen

Amendment 49 #

Motion for a resolution
Recital H a (new)

Ha. whereas during the preceding two years no applications have been submitted for the approval of a new active substance;

Amendment 5 #

A. whereas the evaluation of the implementation of the Regulation revealed that the objectives to protect human health, animal health and the environment~~al protection objectives~~ are not being achieved;

Amendment 50 #

Motion for a resolution
Recital I

I. whereas the ~~available evidence~~results and problems noted shows that this piece of EU-level regulation ~~enhances~~has failed in its aims of clarity, transparency and addsing value to national efforts and actions;

Amendment 51 #

Motion for a resolution
Recital I a (new)

Ia. whereas serious considerations of alternatives often emerge only after change in legal requirements, whereas e.g. in case of extended ban on neonicotinoids it was assessed to date (30/5/2018)1a that readily available non- chemical alternatives exist for 78% of uses of neonicotinoids _________________ 1a ANSES- Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail- conclusions, 2018

Amendment 52 #

Mairead McGUINNESS, Annie SCHREIJER-PIERIK, Julie GIRLING, Norbert LINS, Angélique DELAHAYE, Pilar AYUSO, Jan HUITEMA, Peter JAHR, Ulrike MÜLLER, Michel DANTIN, Herbert DORFMANN

Motion for a resolution
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 53 #

Motion for a resolution
Recital I a (new)

Ia. whereas the plant protection products often harm the biodiversity and human health; whereas over time their effectiveness deteriorates

Amendment 54 #

Motion for a resolution
Recital I b (new)

Ib. whereas despite suggestions that ban on neonicotinoids would cost millions in losses in revenues, evidence shows that on the contrary yields went up 2a, which could have been the result of improved pollination and possibly more insect predators in the crop _________________ 2aoilseed rape in the UK yielding on average 3.6 tonnes per hectare in the three years since the ban, against 3.4 in the five years prior to the ban (2009-13)

Amendment 55 #

Mairead McGUINNESS, Annie SCHREIJER-PIERIK, Julie GIRLING, Norbert LINS, Angélique DELAHAYE, Pilar AYUSO, Jan HUITEMA, Peter JAHR, Ulrike MÜLLER, Michel DANTIN, Herbert DORFMANN

Motion for a resolution
Recital I b (new)

Ib. Whereas a wide variety of safe and effective tools are needed to protect plant health;

Amendment 56 #

Mairead McGUINNESS, Annie SCHREIJER-PIERIK, Julie GIRLING, Norbert LINS, Angélique DELAHAYE, Pilar AYUSO, Jan HUITEMA, Peter JAHR, Ulrike MÜLLER, Michel DANTIN, Herbert DORFMANN

Motion for a resolution
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 #

Mairead McGUINNESS, Annie SCHREIJER-PIERIK, Julie GIRLING, Angélique DELAHAYE, Pilar AYUSO, Jan HUITEMA, Peter JAHR, Ulrike MÜLLER, Michel DANTIN, Herbert DORFMANN

Motion for a resolution
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 58 #

Motion for a resolution
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;~~deleted

Amendment 59 #

Motion for a resolution
Paragraph 1

1. Considers that the EU is not the appropriate level at which regulatory action in the field of pesticides should continue to take place insofar as decision-making is not always sufficiently independent since these institutions may be too open to attempts by certain pressure groups to influence outcomes;

Amendment 6 #

Motion for a resolution
Recital A

A. whereas the evaluation of the implementation of the Regulation revealed that the ~~health and environmental protection objectives~~objectives relating to protection of health, animals and the environment are not being achieved;

Amendment 60 #

Motion for a resolution
Paragraph 1

1. Considers that to avoid any distortion of competition, the EU is the appropriate level at which regulatory action in the field of pesticides should continue to take place, notably as regards approval of active substances and marketing authorisation for plant protection products;

Amendment 61 #

Mairead McGUINNESS, Annie SCHREIJER-PIERIK, Julie GIRLING, Norbert LINS, Angélique DELAHAYE, Pilar AYUSO, Jan HUITEMA, Peter JAHR, Ulrike MÜLLER, Michel DANTIN, Herbert DORFMANN

Motion for a resolution
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 62 #

Motion for a resolution
Paragraph 1

1. Considers that the EUjoint approach involving EU and national-level action is the appropriate level at which regulatory action in the field of pesticides should continue to take place;

Amendment 63 #

Motion for a resolution
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 is that of the EU and cooperation among Member States;

Amendment 64 #

Motion for a resolution
Paragraph 1 a (new)

1a. Deplores therefore unilateral decisions by Member States which can lead to the abolition or a restriction in the use of products approved by other Member States, and the lack of harmonisation in the time taken to process requests for authorisation, which gives rise to distortions of competition in the internal market and forces farmers into technical dead-ends which are both harmful to the environment and counter- productive for the competitiveness of farms;

Amendment 65 #

Jan HUITEMA, Pavel TELIČKA, Gerben-Jan GERBRANDY, Ulrike MÜLLER, Carolina PUNSET, Mairead McGUINNESS

Motion for a resolution
Paragraph 1 a (new)

1a. Is concerned that there are significant differences in the area of expertise and staffing between the Member States, which must urgently be resolved. The existing lack of capacity in the Member States must be addressed by the provision of appropriate staff numbers.

Amendment 66 #

Motion for a resolution
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 67 #

Motion for a resolution
Paragraph 1 a (new)

1a. Notes the outcome of the European Parliament Hearing on Sustainable Plant Protection held on 20th March 2017, which concluded that the EU approval process for Plant Protection Products is one of the most stringent in the world.

Amendment 68 #

Jan HUITEMA, Pavel TELIČKA, Gerben-Jan GERBRANDY, Ulrike MÜLLER, Mairead McGUINNESS

Motion for a resolution
Paragraph 1 a (new)

1a. Points out that environmental measures aimed to prevent, limit and contain the spread of pathogens and pests has to remain the focus of all current and further actions;

Amendment 69 #

Motion for a resolution
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 7 #

Mairead McGUINNESS, Peter JAHR, Annie SCHREIJER-PIERIK, Julie GIRLING, Norbert LINS, Angélique DELAHAYE, Pilar AYUSO, Jan HUITEMA, Ulrike MÜLLER, Michel DANTIN, Herbert DORFMANN

Motion for a resolution
Recital A

A. whereas the evaluation of the implementation of the Regulation ~~revealed that the health and environmental protection objectives are not being achieved~~showed its objectives to be relevant while identifying areas for improvement;

Amendment 70 #

Jan HUITEMA, Ulrike MÜLLER, Mairead McGUINNESS

Motion for a resolution
Paragraph 1 b (new)

1b. Considers that the adoption and implementation of the Regulation represents a significant step forward regarding the treatment of PPPs in the European Union compared to the past;

Amendment 71 #

Motion for a resolution
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 #

Jan HUITEMA, Pavel TELIČKA, Ulrike MÜLLER, Mairead McGUINNESS

Motion for a resolution
Paragraph 1 d (new)

1d. Underlines that there is always a certain amount of risk involved when one interferes in nature, whether it is with chemical, biological or low-risk plant protection products. Risks can never be excluded, however, they can be managed. Therefore, legislation on plant protection products should set criteria and levels for acceptable risk;

Amendment 73 #

Jan HUITEMA, Pavel TELIČKA, Gerben-Jan GERBRANDY, Ulrike MÜLLER

Motion for a resolution
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 74 #

Motion for a resolution
Paragraph 2

2. Is concerned by the fact that the Regulation has not been effectively implemented, and that as a ~~result~~consequence the extensive and ever increasing use of PPP's its ~~objectives are not being achieved in practice~~causing irreversible damage to biodiversity, is threatening our drinking water and is posing serious risks to human and animal health, and that, as such, the objectives of protecting human health, animal health and the environment are not being achieved;

Amendment 75 #

Motion for a resolution
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 practice, notably the procedure for mutual recognition by Member States in a particular geographical region, the aim of which was to simplify procedures within the single market and increase trust among Member States;

Amendment 76 #

Motion for a resolution
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 practice~~, as regards to agricultural production, and innovation are not being achieved in practice; highlights the fact that, partly due to low degree of innovation, the number of pesticide active substances are decreasing;

Amendment 77 #

Mairead McGUINNESS, Annie SCHREIJER-PIERIK, Julie GIRLING, Norbert LINS, Angélique DELAHAYE, Pilar AYUSO, Jan HUITEMA, Peter JAHR, Ulrike MÜLLER, Michel DANTIN, Herbert DORFMANN

Motion for a resolution
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 practice~~has led to significant delays in the approval process;

Amendment 78 #

Motion for a resolution
Paragraph 2

2. ~~Is concerned by~~Notes the fact that the Regulation has not been effectively implemented and that as a result its objectives are not being achieved in practice;

Amendment 79 #

Ulrike MÜLLER, Jan HUITEMA, Mairead McGUINNESS

Motion for a resolution
Paragraph 2

2. ~~Is concerned by the fact~~Believes that the Regulation ~~has not been~~can be more effectively implemented and that a~~s a result its objectives are not being achieved in practice~~chievement of all of its objectives can be attained;

Amendment 8 #

Motion for a resolution
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 80 #

Motion for a resolution
Paragraph 2 a (new)

2a. Considers that a proper implementation and enforcement of Regulation EC 1107/2009 would lead to an acceleration of the approval process of innovative solutions while guaranteeing the highest levels of human and environmental safety; underlines that the prospect of a more time efficient authorization process could create incentives into the development of new synthetic, biological and low-risk plant protection products.

Amendment 81 #

Motion for a resolution
Paragraph 2 a (new)

2a. Deplores the fact that fewer and fewer active substances for plant protection purposes are available on the EU market; stresses that European farmers and horticulturalists need to have at their disposal a range of products for effective plant protection and pest management; stresses that low-risk green plant protection products (and the active substances in them) play a key role here;

Amendment 82 #

Motion for a resolution
Paragraph 2 a (new)

2a. Recalls that there is a substantial need for an integrative approach and that the Regulation (EC) No 1185/2009 on statistics on pesticides has to be part of the assessment by using its results reducing the quantity and as consequence minimising the risks and their negative impact on health and environment;

Amendment 83 #

Motion for a resolution
Paragraph 2 a (new)

2a. Regrets that the Commission failed to complete the provisions of the Regulation and ensure full application of the Regulation;

Amendment 84 #

Jan HUITEMA, Pavel TELIČKA, Gerben-Jan GERBRANDY, Ulrike MÜLLER, Mairead McGUINNESS

3. Notes that the objectives and instruments of the Regulation and its implementation are not in line with EU policies in the fields of agriculture, food security, climate change, sustainable use of pesticides and maximum residue levels of pesticides in food and feed;deleted

Amendment 85 #

Motion for a resolution
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 86 #

Motion for a resolution
Paragraph 3

3. Notes that the objectives and instruments of the Regulation and its implementation are not in line with EU policies in the fields of agriculture, health, animal welfare, food security, climate change, sustainable use of pesticides and maximum residue levels of pesticides in food and feed;

Amendment 87 #

Motion for a resolution
Paragraph 3

3. Notes that the objectives and instruments of the Regulation and its implementation are not in line with EU policies in the fields of agriculture, food security, climate change, ~~sustainabl~~reducing the use of pesticides and maximum residue levels of pesticides in food and feed;

Amendment 88 #

Mairead McGUINNESS, Annie SCHREIJER-PIERIK, Julie GIRLING, Norbert LINS, Angélique DELAHAYE, Pilar AYUSO, Peter JAHR, Michel DANTIN, Herbert DORFMANN

Motion for a resolution
Paragraph 3

3. Notes that the objectives and instruments of the Regulation and its implementation ~~are not in~~should be line with EU policies in the fields of agriculture, food security, climate change, sustainable use of pesticides and maximum residue levels of pesticides in food and feed;

Amendment 89 #

Motion for a resolution
Paragraph 3 a (new)

3a. Recognises the importance of plant protection products to ensure food safety in the EU, in particular given the increasing risks derived from invasive pest and diseases as well as natural and microbial food contaminants, such as mycotoxins and other fungal toxins, one of the top three causes of food safety alerts in the European Commission’s Rapid Alert System for Food and Feed (RASFF).

Amendment 9 #

Mairead McGUINNESS, Julie GIRLING, Norbert LINS, Angélique DELAHAYE, Pilar AYUSO, Jan HUITEMA, Peter JAHR, Ulrike MÜLLER, Michel DANTIN, Herbert DORFMANN

Motion for a resolution
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 90 #

Motion for a resolution
Paragraph 3 a (new)

3a. Recalls that the precautionary principle is a general EU principle laid down in Article 191 of the Treaty on the Functioning of the European Union, that this principle aims to ensure a high level of protection for the environment through preventive decision-making in the event of any risk, and reiterates that it is clearly not being applied in the general context of risk analysis of pesticides;

Amendment 91 #

Motion for a resolution
Paragraph 3 a (new)

3a. Is concerned that rapporteur Member States do not strictly apply Article 9 of the Regulation on the admissibility of the application and accept applications despite missing elements;

Amendment 92 #

Motion for a resolution
Paragraph 3 b (new)

3b. Expresses concern that the tool box of available plant protection products is continuously decreasing; warns against the impact this has on the viability and resilience of agriculture in the EU, the production of specialty crops such as fruit and vegetables as well as a sufficient and continuous supply of safe food.

Amendment 93 #

Motion for a resolution
Paragraph 3 b (new)

3b. Finds it unacceptable that the approval requirements for safeners and synergists have not yet been applied, contrary to Article 25 of the Regulation;

Amendment 94 #

Motion for a resolution
Paragraph 3 c (new)

3c. Finds it unacceptable that the negative list of co-formulants has still not been adopted, especially after the ban of the POE-tallowamines in combination with glyphosate, which has highlighted the adverse effect that certain co- formulants can have;

Amendment 95 #

Motion for a resolution
Paragraph 4

4. Is concerned by the steadily increasing use and identified cases of misuse of emergency authorisations granted under Article 53; notes that amongst these cases, the derogation-by- confirmatory-data procedure has enabled regulators to put or keep dozens of pesticides on the market that would have been banned otherwise, that is, if Regulation 1107/2009 had been accurately and properly implemented; notes also that as a consequence, there has been unnecessary exposure to dangerous pesticides for the public, for the animals and for the environment which is a violation of Art. 4 of Regulation 1107/2009 and the precautionary principle;

Amendment 96 #

Motion for a resolution
Paragraph 4

4. ~~Is concerned by the steadily increasing use and identified cases of misuse of emergency authorisations granted under Article 53~~Considers that emergency authorisations granted under Article 53 are rightly controlled under a series of limiting conditions, such as approval for a restricted period or under controls on application; believes that the option of emergency authorisation must be retained in order that European agriculture has the tools necessary to address problems where no other reasonable means are available; considers this to be of particular importance to minor crops;

Amendment 97 #

Mairead McGUINNESS, Annie SCHREIJER-PIERIK, Julie GIRLING, Norbert LINS, Angélique DELAHAYE, Jan HUITEMA, Peter JAHR, Ulrike MÜLLER, Michel DANTIN, Herbert DORFMANN

Motion for a resolution
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 98 #