Amen­­de­­menten Hazekamp op het ontwer­p­verslag van de pesti­­ci­­den­­com­­missie over de toela­­tings­pro­­cedure van de Europese Unie voor pesti­­ciden

Motion for a resolution

Amendment

- having regard to Regulation (EU) No 1185/2009 of the European Parliament and of the Council of 25 November 2009 concerning statistics on pesticides;

Motion for a resolution

Amendment

- having regard to the Commission's report on the implementation of Regulation (EC) No 1185/2009 concerning statistics on pesticides (COM(2017) 109 final);

Motion for a resolution

Amendment

- having regard to the EPRS study "European Implementation Assessment" of the Regulation 1107/2009 on the placing on the market of Plant Protection Products;

Motion for a resolution

Amendment

- having regard to the European Citizens Initiative 'Ban Glyphosate';

Motion for a resolution

Amendment

- having regard to the Monsanto Papers and the judgement of the United States district Court for the Northern District of California (Case 16-MD-2741-VC), known as the "Roundup case";

Motion for a resolution

Amendment

- having regard to Article 13 TFEU that states that when formulating and implementing the Union's policies, in particular concerning its internal market, full regard should be paid to the welfare requirements of animals, since animals are sentient beings;

Motion for a resolution

Amendment

- having regard tho the Special Barometer 442 survey of March 2016, 89% of EU citizens agree that the EU should do more to promote a greater awareness of the importance of animal welfare internationally and 90% of EU citizens agree that it is important to establish high animal welfare standards;

Motion for a resolution

Amendment

- having regard to the fact that the European Parliament receives numerous petitions from concerned citizens exercising their right under Articles 24 and 227 TFEU and Article 44 of the Charter of Fundamental Rights of the European Union, calling for an end to animal testing in Europe and worldwide and for the establishment of international animal welfare standards;

Motion for a resolution

Amendment

- having regard to Directive 2010/63 EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes;

Motion for a resolution

Amendment

- having regard to the 2017 report of the United Nations Special Rapporteur on the right to food;

Motion for a resolution

Amendment

- having regard to Directive 2003/35/EC of the European Parliament and of the Council of 26 May 2003 providing for public participation in respect of the drawing up of certain plans and programmes relating to the environment and amending with regard to public participation and access to justice Council Directives 85/337/EEC and 96/61/EC;

Motion for a resolution

Amendment

- having regard to the United Nations Economic Commission for Europe (UNECE) Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters (the Aarhus Convention);

Motion for a resolution

Amendment

A. whereas the EU authorisation procedure for plant protection products is one of the most stringent in the world; whereas in the light of the concerns raised about the assessment of glyphosate, the Special Committee on the Union’s authorisation procedure for pesticides (PEST) aims to identify areas that can be further improved with regard to the Union authorisation procedure for plant protection products, by providing recommendations that it considers to be necessary in order to ensure the achievement of a high level of protection of both human and animal health and the environment;

A. whereas the EU authorisation procedure for plant protection products is considered as one of the most stringent in the world; whereas the failures exposed in the assessment procedure and the renewal of the approval of glyphosate have clearly demonstrated that the Union's authorisation procedures are not sufficient and/or not appropriately implemented in order to ensure a high level of protection of both human and animal health and of the environment; whereas the Special Committee on the Union’s authorisation procedure for pesticides (PEST) aims to identify areas that should be redefined and improved with regard to the Union authorisation procedure for plant protection products, by providing recommendations that it considers to be necessary in order to ensure the achievement of a high level of protection of both human and animal health and the environment;

Motion for a resolution

Amendment

A a. whereas according to FAO data, in 2016 only the EU used 368.588,42 tonnes of active substances, making Europe with 11.8% of all pesticides used worldwide, the third biggest consumer of pesticides, with France, Italy and Spain amongst the top ten biggest users of pesticides (http://www.fao.org/faostat/en/#data/RP/visualize);

Motion for a resolution

Amendment

A b. whereas harmonised and comparable Community Statistics on pesticide sales and on pesticide use, both are essential for the development and monitoring of relevant Community legislation and policies;

Motion for a resolution

Amendment

C. whereas the methodologies used for the scientific assessment of active substances, in the form of guidance used by EFSA and Member States, do not always reflect the current state of scientific and technical knowledge as required by Article 4 of the Regulation; whereas some key tests are either not included in the risk assessment or recent scientific methods are missing (as in the cases of up-to-date ecotoxicological tests for soil organisms and assessment of environmental concentration and residues in dust, wind, air and water);

C. whereas the methodologies used for the scientific assessment of active substances, in the form of guidance used by EFSA and Member States, do not always reflect the current state of scientific and technical knowledge as required by Article 4 of the Regulation and many are not designed in a fully independent way; whereas some key tests are either not included in the risk assessment or recent scientific methods are missing (as in the cases of up-to-date ecotoxicological tests for soil organisms and assessment of environmental concentration and residues in dust, wind, air and water);

Motion for a resolution

Amendment

C a. whereas in the current assessment of the active substances and the PPPs, the following parameters are not taken into account properly: multiplicity of pollutants co-existing in nature, chronic exposure, toxicity of mixtures, interaction between active substances and other chemicals (synergistic toxicity, such as food additives, food contaminants and silos), frequency of usage, exposure time, nor parameters related to the landscape and the climate (cfr written response of Noa Simon Delson at the hearing dd. 06/06/2018);

Motion for a resolution

Amendment

C b. whereas scientific evidence for adverse effects in industry sponsored studies is frequently dismissed for unscientific and non-transparent reasons (e.g. historical controls);

Motion for a resolution

Amendment

C c. whereas COM(2017) 587 final on Member State National Action Plans and on progress in the implementation of Directive 2009/128/EC on the sustainable use of pesticides saying: Integrated Pest Management is a cornerstone of the Directive, and it is therefore of particular concern that Member States have not yet set clear targets and ensured their implementation , including for the more widespread use of land management techniques such as crop rotation; therefore calls on the Member States to improve the quality of their plans, primarily by establishing specific and measurable targets and indicators for a long-term strategy for the reduction of risks and impacts from pesticide use, taking into account that these improvements should be included in the revised action plans which would allow Member States to continuously monitor progress with implementation and adjust their strategy accordingly and as necessary;

Motion for a resolution

Amendment

E. whereas the widespread and prophylactic use of plant protection products is of concern;

E. whereas the widespread, prophylactic and ever increasing use of plant protection products (source Eurostat), including those with endocrine disrupting properties, is of great concern for its negative impact on human and animal health and for the environment; whereas this concern also applies to the fact that the toxicity of these plant protection products is increasing as well;

Motion for a resolution

Amendment

E a. whereas the widespread, increasing and prophylactic use of plant protection products is of concern;

Motion for a resolution

Amendment

F. whereas there is a lack of monitoring post-authorisation;

F. whereas there is a lack of monitoring post-authorisation; whereas real-time data are missing particularly on implementation and effectiveness of mitigation measures, quantities and types of pesticides applied, exposure and potential harmful effect on farmers, workers, residents of agricultural areas, the environment and its ecosystems;

Motion for a resolution

Amendment

F. whereas there is a lack of monitoring post-authorisation;

F. whereas there is a lack of monitoring post-authorisation, which does not allow one to verify whether the assumptions and/or criteria were valid, nor to verify whether th risk mitigation measures are sufficiently implemented;

Motion for a resolution

Amendment

F a. whereas COM(2017) 109 final report from the Commission to the European Parliament and the Council on the implementation of Regulation (EC) No 1185/2009 of the European Parliament and of the Council of 25 November 2009 concerning statistics on pesticides highlights the lack of statistics on pesticide use as well as knowledge of specific active substances;

Motion for a resolution

Amendment

G. whereas the lack of data concerns active substances, safeners, synergists and co-formulants, as well as formulations and mixtures of products; whereas, therefore, the full impact of pesticides on human and animal health as well as on the environment is not properly known;

G. whereas the lack of data concerns active substances, safeners, synergists and co-formulants, as well as formulations and mixtures of products; whereas testing for human health effects involves use of animals and does not necessarily accurately predict human reactions, whereas, therefore, the full impact of pesticides on human and animal health as well as on the environment is not properly known;

Motion for a resolution

Amendment

G. whereas the lack of data concerns active substances, safeners, synergists and co-formulants, as well as formulations and mixtures of products; whereas, therefore, the full impact of pesticides on human and animal health as well as on the environment is not properly known;

G. whereas the lack of data concerns active substances, safeners, synergists and co-formulants and their metabolites as well as formulations and mixtures of products; whereas, therefore, the full impact of pesticides on human and animal health as well as on the environment is not properly known;

Motion for a resolution

Amendment

G a. whereas formulations are not adequately assessed because only their acute toxic effects are studied, while long-term health effects of pesticide residues (of commercial formulations) are never tested;

Motion for a resolution

Amendment

H. whereas it has been found that national competent authorities involved in the approval and authorisation process are in some cases understaffed and underfunded; whereas this impacts on the quality of the assessments, both for active substances and plant protection products, and the time in which they can be delivered;

H. whereas it has been found that both EFSA and national competent authorities involved in the approval and authorisation process are in many cases understaffed and underfunded; whereas this impacts on the quality of the assessments, both for active substances and plant protection products, and the time in which they can be delivered;

Motion for a resolution

Amendment

I. whereas EU Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin provides that ‘known cumulative and synergistic effects’ must be considered ‘when the methods to assess such effects are available’;

I. whereas Article 4.3 of EU Regulation (EC) 1107/2009 concerning the placement of plant protection products on the market provides that plant protection products "shall have no immediate or delayed effect on human health... taking into account known cumulative and synergistic effects where the scientific methods accepted by the Authority to assess such effects are available"; whereas EU Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin provides that ‘known cumulative and synergistic effects’ must be considered ‘when the methods to assess such effects are available’;

Motion for a resolution

Amendment

I a. whereas the historical mistake to allow applicants to do the safety testing of their own products themselves should be repaired, while the cost burden remains with the applicant;

Motion for a resolution

Amendment

I b. whereas according to the Regulation, the use of pesticide active substances, products and residues should result in no adverse effects to humans, animals and the environment, but the evidence from scientific literature shows that adverse effects due to pesticide exposure have been observed in humans, animals and environmental ecosystems;

Motion for a resolution

Amendment

K a. whereas the historical mistake to allow applicants to do the safety testing of their own products should be repaired;

Motion for a resolution

Amendment

K b. whereas there is a need to hasten the development and validation of new non-animal methodologies that provide information on the underlying mechanisms of human toxicity, including the pathways that lead to adverse outcomes in people; whereas for ethical reasons the replacement of animal test methods should be prioritised;

Motion for a resolution

Amendment

K c. whereas Directive 2010/63 EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes requires that wherever possible, a scientifically satisfactory method or testing strategy, not entailing the use of live animals, shall be used instead of a procedure, and requires that the Commission and Member States contribute to the development and validation of alternative approaches which could provide the same or higher levels of information as those obtained in procedures using animals;

Motion for a resolution

Amendment

K d. whereas, apart from its conclusion on the carcinogenicity of glyphosate, ECHA concludes that glyphosate causes serious eye damage and is toxic to aquatic life, with long-lasting effects;

Motion for a resolution

Amendment

K e. whereas serious considerations of alternatives often emerge only after a change in the legal requirements; whereas, for example, in the case of the extended ban on neonicotinoids the most recent assessment (30 May 2018) suggests that readily available non-chemical alternatives exist for 78% of uses of neonicotinoids;

Motion for a resolution

Amendment

N a. whereas not all Member States have equal status and large Member States automatically receive more active substances for approval; whereas Germany, United Kingdom, France and the Netherlands performed about 80% of all approval/assessment procedures of active substances;

Motion for a resolution

Amendment

T. whereas the principles of GLP have been developed by the OECD to ensure that a study was carried out as prescribed by a particular test method to prevent fraudulent practices; whereas the EU has adopted these principles through Directive 2004/10/EC, which requires Member States to ensure that laboratories carrying out safety studies on chemical products comply with the OECD Principles of GLP and with Directive 2004/9/EC, which lays down the obligation of Member States to designate the authorities responsible for GLP inspections in their territory; whereas OECD test guidelines have been adopted to ensure the methodological validity of a study;

T. whereas the principles of GLP, which are crucial so as to guarantee that all research is reproducible, consistent and uniform, have been developed by the OECD to ensure that a study was carried out as prescribed by a particular test method to prevent fraudulent practices; whereas the EU has adopted these principles through Directive 2004/10/EC, which requires Member States to ensure that laboratories carrying out safety studies on chemical products comply with the OECD Principles of GLP and with Directive 2004/9/EC, which lays down the obligation of Member States to designate the authorities responsible for GLP inspections in their territory; whereas OECD test guidelines have been adopted to ensure the methodological validity of a study;

Motion for a resolution

Amendment

T a. whereas the EU has promoted international collaboration on alternative methods under the European Partnership for Alternative Approaches to Animal Testing (EPAA) and has been involved in other relevant international processes, such as the International Cooperation on Cosmetics Regulation (ICCR) and the International Cooperation on Alternative Test Methods (ICATM);

Motion for a resolution

Amendment

T b. whereas the European Laboratory for Alternatives to Animal Testing (EURL ECVAM) coordinates and promotes the development and use of alternatives; whereas Member States contribute to this crucial activity by law and a network of national regulators was established to guide the validation of methods with the highest regulatory relevance (PARERE Network);

Motion for a resolution

Amendment

T c. whereas Directive 2010/63/EU mandates the application of scientifically valid alternative approaches and establishes mechanisms to speed up the development, validation and uptake;

Motion for a resolution

Amendment

U a. whereas PPP producers have the possibility to obstruct the disclosure of the studies, data and information which they submit for the risk assessment; whereas this leads to a situation in which it is impossible for third-party scientists to scrutinise these studies, data and information;

Motion for a resolution

Amendment

U b. whereas all scientific assessments, whether carried out by EFSA or by national authorities, must be based on published information;

Motion for a resolution

Amendment

U c. whereas the public interest in the disclosure of information on the health and environmental impacts of pesticides prevails over industry interest to keep information confidential;

Motion for a resolution

Amendment

X. whereas the decreasing trust in EFSA is a concern;

X. whereas the decreasing trust in EFSA, and especially EFSA panels, is a concern;

Motion for a resolution

Amendment

X a. whereas EFSA needs to be independent from the Commission, the Member States and from the industry;

Motion for a resolution

Amendment

AB a. whereas asking ECHA for an assessment of an active substance has limited added-value or is even useless compared to the one performed by EFSA, as ECHA is using the same studies provided for by the industry; whereas this only creates extra work for the agency merely to produce predictable results;

Motion for a resolution

Amendment

AE a. whereas more than 1 million EU citizens have signed the ECI Ban Glyphosate, calling for better protection of citizens' health, animal health and the environment from toxic pesticides, calling for a reform of the pesticide approval procedure, and calling for mandatory and EU-wide reduction targets for pesticide use;

Motion for a resolution

Amendment

AI. whereas it is not clear under what conditions the Commission considers a risk to be unacceptable for the environment;

AI. whereas it is not clear under what conditions the Commission considers a risk to be unacceptable for the environment, whereas since 2005 the Commission considers the environment as a "minor issue";

Motion for a resolution

Amendment

AW. whereas Commission Regulation (EU) No 284/2013 setting out the data requirements for plant protection products requires data on acute toxicity of the plant protection product but not on its long-term toxicity;

AW. whereas Commission Regulation (EU) No 284/2013 setting out the data requirements for plant protection products requires data on acute toxicity of the plant protection product but not on its long-term toxicity; whereas testing on animals produces results that often lack relevance to human health and are frequently difficult to interpret;

Motion for a resolution

Amendment

AW. whereas Commission Regulation (EU) No 284/2013 setting out the data requirements for plant protection products requires data on acute toxicity of the plant protection product but not on its long-term toxicity;

AW. whereas Commission Regulation (EU) No 284/2013 setting out the data requirements for plant protection products requires data on acute toxicity of the plant protection product but not on its long-term toxicity, such as a potential for genotoxicity, endocrine disruption and neurotoxicity;

Motion for a resolution

Amendment

AX. whereas Member States are working on setting up a comparative assessment of plant protection products with substitution candidates; whereas the objective is to replace such products with lower-risk plant protection products;

AX. whereas Member States are working on setting up a comparative assessment of plant protection products with substitution candidates; whereas the objective is to replace such products with lower-risk plant protection products and non-chemical alternatives as defined in the EU Directive on sustainable use of pesticides 2009/12/EC;

Motion for a resolution

Amendment

AY a. Notes that there is a steadily increasing use as well as 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 110/2009 and the precautionary principle;

Motion for a resolution

Amendment

AZ a. Notes that the PPP regulation has not been effectively implemented and that as a consequence the widespread, prophylactic and ever increasing use of PPP's is 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 and animal health and the environment are not being achieved;

Motion for a resolution

Amendment

1. Considers that, although the EU has one of the most stringent systems in the world, both the Regulation as such and its implementation need to be improved;

1. Considers that, although the EU is said to have one of the most stringent systems in the world, both the Regulation as such and its implementation need to be redefined and improved whereby the Commission must cease immediately considering the protection of human and animal health and the environment as a minor issue or one of less priority;

Motion for a resolution

Amendment

1. Considers that, although the EU has one of the most stringent systems in the world, both the Regulation as such and its implementation need to be improved;

1. Considers that, although the EU has one of the most stringent systems in the world, both the Regulation as such and its implementation need to be improved; calls on the Commission to stop considering the protection of the environment as a "minor issue";

Motion for a resolution

Amendment

1 a. Considers that, since the Union's authorisation procedures are failing to ensure a high level of protection, the Regulation as such, its implementation and the bodies and agencies involved, need to be reviewed so as to achieve its objective of protecting both human and animal health and the environment;

Motion for a resolution

Amendment

1 b. Notes that the evaluation of the implementation of the PPP Regulation has revealed that the objectives to protect human and animal health and the environment are not being achieved;

Motion for a resolution

Amendment

1 c. Calls on the Commission and the Member States to acknowledge and reiterate that the objectives to protect human and animal health and the environment take priority over the objective of developing, promoting and authorising non-sustainable/non-ecological plant protection products and over commercial interests, and therefore that it is guaranteed that the precautionary principle will constitute as the underlying and guiding principle in the Union's authorisation procedures;

Motion for a resolution

Amendment

1 d. Considers it unacceptable that the EU is the 3rd largest user of pesticides, while, when taking into account the population, the surface and the climatic and geological conditions, EU legislation does not allow for pesticide use to such an extent;

Motion for a resolution

Amendment

2. Welcomes the recommendation of the Scientific Advice Mechanism that the Commission facilitate a broader discussion throughout society in order to establish an EU-wide shared vision for food production, including the role of plant protection products therein; whereas such considerations should take into account, among other factors, affordability of food for consumers, income and long-term viability of agricultural production, as well as the risks and benefits to human and animal health and the environment associated with different scenarios for the use of plant protection products, including a zero use scenario;

2. Welcomes the recommendation of the Scientific Advice Mechanism; notes however that instead of facilitating a broader discussion on food production which continues along the lines of the currently unsustainable food production system, the Commission should facilitate and promote an EU-wide shared vision for a sustainable food production system which is both pesticide-free and EDC-free and which is to the benefit rather than to the detriment of both human and animal health and to the environment;

Motion for a resolution

Amendment

2 a. Stresses that under the pesticides authorisation Regulation no pesticide is supposed to be approved if it has not been established that there is no immediate nor any delayed harm to both human and animal health and to the environment;

Motion for a resolution

Amendment

3. Calls on the Member States to allocate sufficient resources to the assessment of active substances and plant protection products and to ensure independent, objective and transparent assessment;

3. Calls on the Member States and the Commission to allocate sufficient resources to the assessment of active substances and plant protection products so as to ensure independent, objective and transparent assessment;

Motion for a resolution

Amendment

4. Calls on the Commission and the Member States in their role as risk managers to duly apply the precautionary principle when deciding whether or not to authorise active substances / plant protection products, and under what conditions, and to communicate systematically on how this principle has been taken into account;

4. Calls on the Commission and the Member States in their role as risk managers not to allow for the innovation principle (introduced and promoted by the industry and its lobbyists) to find its way into EU legislation nor into any of the Union's authorisation procedures, but instead to duly apply the precautionary principle when deciding whether or not to authorise active substances and PPPs, and under what conditions, and to communicate systematically on how exactly the application of the precautionary principle will offer the highest level of protection of both human and animal health and the environment;

Motion for a resolution

Amendment

4 a. Calls on the Commission and the Member States to acknowledge that in order to restore public trust and in order to protect human and animal health and the environment, PPPs need to be taken of the market immediately if scientific uncertainty or concern is raised regarding the potential negative effect, both direct and indirect, on human or animal health or on the environment;

Motion for a resolution

Amendment

5. Considers that greater attention should be paid to the widespread and prophylactic use of plant protection products and the effects thereof on the environment in the EU system;

5. Considers that urgent attention should be paid to the widespread, prophylactic and ever increasing use of plant protection products and the effects thereof on both human and animal health and on the environment; calls on the Commission and the Member States to put in all efforts in order move to a sustainable food production system which is pesticide-free and EDC-free and which is to the benefit rather than the detriment of both human and animal health and to the environment; therefore calls on the Commission and the Member States to start this move to a sustainable food production system by including a mandatory target of 50% use reduction for every Member State by 2023, based on the principles of Integrated Pest management;

Motion for a resolution

Amendment

5 a. Stresses that the EU needs to rapidly reduce the use of pesticides and move to ecological farming and to a sustainable food system production, in order to reduce the immense costs resulting from the harmful effects on human and animal health and in order to drastically reduce the burden on the environment;

Motion for a resolution

Amendment

5 b. Considers that Risk Managers should ensure that Member States fully comply with the Sustainable Use of Pesticides Directive 2009/128/EC, under which farmers should use synthetic, chemical pesticides only as a last resort, give preference to non-chemical alternatives or to pesticides of low-risk, implement land-management techniques (e.g. crop rotation), implement strict mitigation measures (e.g. buffer zones), set clear targets to reduce volumes of pesticide use (including a mandatory target of 50% use reduction by 2023), and explicitely adopt and implement a policy of substituting less safe compounds with safe ones;

Motion for a resolution

Amendment

6 a. Calls on the Commission and the Member States to acknowledge and reiterate the need for the implementation of a systematic post-market vigilance system, which includes the collection, sharing and analysis of data on real-life behaviour and practices of operators, on environmental impact and on illnesses related to PPPs, including those suspected of being caused by EDCs;

Motion for a resolution

Amendment

8. Calls for Horizon Europe to provide sufficient funding to promote independent research on the adverse effects of plant protection products on human and animal health and the environment;

8. Calls for Horizon Europe to provide sufficient funding to promote independent research on the adverse effects of plant protection products on human and animal health and the environment, making sure that commercial parties are not involved in developing methods and tools for risk assessment and prioritising methods that provide human-focused mechanistic data to generate information on human health effects;

Motion for a resolution

Amendment

8. Calls for Horizon Europe to provide sufficient funding to promote independent research on the adverse effects of plant protection products on human and animal health and the environment;

8. Calls for Horizon Europe to provide sufficient funding to promote independent research on the adverse effects of plant protection products on human and animal health and the environment, making sure that commercial parties are not involved in developing methods and tools for risk assessment;

Motion for a resolution

Amendment

8 a. Calls on the Member States to allocate in their research policies sufficient funding for public research projects to investigate the possible risks from pesticide products, without any industry involvement in order to develop and maintain public sector capacity and expertise in these fields;

Motion for a resolution

Amendment

10 a. Stresses the importance that risk assessment studies are open to public scrutiny, ensuring that not only EFSA, the Commission and National Authorities, but also the public and the broader scientific community have access to those studies, based on the passive right of access to information from the Aarhus Convention;

Motion for a resolution

Amendment

10 b. Stresses that risk assessments provided for by applicants have often been proven to be inherintly biased as applicants, being pesticide producers, have a commercial interest in providing data favourable for the application;

Motion for a resolution

Amendment

12. Calls on the Commission to ensure that only Member States that can guarantee a high quality of assessment become RMS;

12. Calls on the Commission to ensure that only Member States that can guarantee a high quality of assessment become RMS, and that EFSA shall be made responsible for the completeness check of the dossier and the literature review;

Motion for a resolution

Amendment

12. Calls on the Commission to ensure that only Member States that can guarantee a high quality of assessment become RMS;

12. Calls on the Commission to ensure that only Member States that can guarantee a high quality of assessment with no ties to the pesticide industry become RMS;

Motion for a resolution

Amendment

12 a. Emphasizes that the individual experts responsible for the draft assessment report (DAR) or renewal assessment report (RAR), as well as the authorities they work for, must not have any ties with the pesticide manufacturing industry;

Motion for a resolution

Amendment

12 b. Calls on the Commission to endorse an independence policy and ensure that Members of the Standing Committee on Plants, Animals, Food and Feed have no conflict of interest and no ties to the pesticide industry;

Motion for a resolution

Amendment

12 c. Calls on the Commission to make EFSA responsible for the completeness check of the dossier and the scientific literature review (in order to avoid data gaps);

Motion for a resolution

Amendment

15. Takes note of the Commission’s proposal on the transparency and sustainability of the EU risk assessment in the food chain;

15. Takes note of the Commission’s proposal on the transparency and sustainability of the EU risk assessment in the food chain and considers the proposal lacking the necessary guarantees to ensure transparancy in the Union's authorisation procedures, to ensure the independence and reliability of (scientific) studies and of scientific/experts panels, and to ensure full disclosure of studies, data and information;

Motion for a resolution

Amendment

15 a. Notes that in view of the testing methods used for the assessment/authorisation procedures of PPPs, there is a large public demand for the adoption and implementation of a new legislative framework to eliminate animal testing; notes also that the EU should intensify its international cooperation on alternative testing methods under EPAA, ICCR and ICATM;

Motion for a resolution

Amendment

15 b. Calls on the Commission and the Member States to make non-animal testing methods, such as in vitro and in silico testing, mandatory for all tests used in view of the Union's assessment/authorisation procedures of PPPs;

Motion for a resolution

Amendment

15 c. Calls for a new legislative framework to eliminate animal testing; urges the Commission and the Member States to consider this new framework as an integral part of the Union's assessment/authorisation procedures of PPPs;

Motion for a resolution

Amendment

15 d. Calls on the Commission to acknowledge that there is an urgent need for a full implementation of the transparency provisions of the Aarhus Convention and hence, act upon it, including by providing clarity on how these provisions and those of Regulation (EC) 1367/2006 apply in the context of relevant EU legislation;

Motion for a resolution

Amendment

16. Considers it important that applicants should be required to register all regulatory studies to be performed, in a public register and prior to starting the studies; stresses that the provisions regarding the public register also include registration by the certified laboratory of the dates when the study has started and concluded, and the publication of the control data, to be included in a register of historical controls; considers that only regulatory studies that have been registered may be submitted with an application;

16. Considers it important that applicants should be required to register all regulatory studies to be performed, in a public register and prior to starting the studies and allow a comment period before testing commences, during which stakeholders are able to provide existing data to reduce duplicate animal testing and ensure all relevant information is taken into account; stresses that the provisions regarding the public register also include registration by the certified laboratory of the dates when the study has started and concluded, and the publication of the control data, to be included in a register of historical controls; considers that only regulatory studies that have been registered may be submitted with an application;

Motion for a resolution

Amendment

18. Calls for public access to be granted to the studies in a machine-readable format and in their entirety, directly following adoption of the DAR, in order to allow for independent scrutiny while ensuring that those who requested the studies can only use them for non-commercial purpose, so as to safeguard the relevant intellectual property rights;

18. Calls for public access to be granted to the studies in a machine-readable format and in their entirety, as soon as they are registered by the applicant, in order to allow for independent scrutiny while ensuring that those who requested the studies can only use them for non-commercial purpose, so as to safeguard the relevant intellectual property rights;

Motion for a resolution

Amendment

18 a. Calls on the Commission to explore options so as to ensure that it is public authorities rather than the pesticide manufacturers who are responsible for the commissioning of regulatory studies, whereas the industry continues to pay for the studies as well as the administrative effort involved; insists that the Commission should present its finding to the European Parliament and the Council by the end of 2019;

Motion for a resolution

Amendment

19. Calls on the Commission to assess whether it would be appropriate to no longer require the applicant to provide scientific peer-reviewed open literature on the active substance and related formulations, instead assigning this task to the RMS;

19. Calls on the Commission to assess whether it would be appropriate to no longer require the applicant to provide scientific peer-reviewed open literature on the active substance and related formulations, instead to assign this task to EFSA;

Motion for a resolution

Amendment

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

Motion for a resolution

Amendment

19 b. Calls on the Commission to no longer require the applicant to provide its own safety tests on the active substance and related formulations, but assign instead the commissioning of the safety studies to a public authority such as EFSA, which in turn will contract independent laboratories to carry out these tests, whereby the applicant would still have to cover the costs;

Motion for a resolution

Amendment

22. Insists that the RMS should strictly apply Article 9 of the Regulation, so as to ensure that applications are complete before they are deemed admissible;

22. Insists that the RMS, with assistance of EFSA, should strictly apply Article 9 of the Regulation, so as to ensure that applications are complete before they are deemed admissible, and that in case of data gaps in the data requirements the dossier should be considered non-admissable;

Motion for a resolution

Amendment

22 a. Calls on the Commission to explore opportunities to require submission of relevant human data, for example data generated during clinical trials conducted during testing of medicinal products, to the open-access database envisaged in the ECHA/EFSA call for tender, so that human data can be used to validate non-animal methodologies under development;

Motion for a resolution

Amendment

23. Stresses that the assessment should include a thorough evaluation of the raw data, as well as data related to final product formulations; calls on the RMS to clearly demonstrate in the DAR that all studies have been properly checked for their relevance, scientific quality and validity, and if necessary to include further studies that were considered as not relevant by the applicant;

23. Stresses that the assessment should include a thorough evaluation of the raw data, as well as data related to final product formulations; calls on the RMS to clearly demonstrate in the DAR that all studies have been properly checked for their relevance, scientific quality and validity, and if necessary to include further studies that were considered as not relevant by the applicant; points out that dismissing data reporting adverse effects should be based only on scientific evidence-based justification;

Motion for a resolution

Amendment

23 a. Underlines that the RMS as well as EFSA should perform a truly independent evaluation and cannot rely on the industry's interpretation of the data and information;

Motion for a resolution

Amendment

27. Calls on the Commission and the Member States to ensure that key tests (e.g. up-to-date ecotoxicological tests for soil organisms and assessment of environmental concentration and residues in dust, wind, air and water) and up-to-date scientific methods are included in the risk assessment;

27. Calls on the Commission and the Member States to ensure that the most sensitive key tests (e.g. up-to-date ecotoxicological tests for soil organisms and assessment of environmental concentration and residues in dust, wind, air and water), tests addressing long-term toxic effects of substances following pre-natal exposure, and up-to-date scientific methods are included in the risk assessment;

Motion for a resolution

Amendment

28. Calls on the Commission to propose amending the Regulation in order to include in it a post-marketing monitoring system similar to pharmacovigilance, with a view to enabling proper assessment of the long-term effects on human and animal health and on the environment;

28. Calls on the Commission to propose amending the Regulation in order to include in it a post-marketing monitoring system similar to pharmacovigilance, with a view to enabling proper assessment of both acute and the long-term effects on human and animal health and on the environment, and further calls for all reports of adverse impacts regarding both acute and chronic adverse health effects - especially from high risk exposure groups such as rural residents and communities living in the locality of pesticide spraying crops - be properly assesses, recorded and acted upon;

Motion for a resolution

Amendment

29. Calls on the Commission to develop a standardised EU-wide IT platform or database to support the sharing of post-market monitoring data;

29. Calls on the Commission to develop a standardised EU-wide IT platform or database to support the sharing of post-market monitoring data, post monitoring data and other available monitoring data shall be used in authorisation decisions;

Motion for a resolution

Amendment

31 a. Calls on the Commission to propose a revision of Regulation (EC) No 1185/2009 on pesticide statistics so as to allow the publication of detailed information on the sale and use of individual active substances, safeners, synergists and co-formulants in each EU Member State and in the EU;

Motion for a resolution

Amendment

31 b. Calls for the data collected through post-market biomonitoring to be used to verify the accuracy of predicted exposure levels for farm workers, bystanders and consumers, as well as farm animals;

Motion for a resolution

Amendment

33. Calls on EFSA to regularly update its guidance documents in line with the most recent developments in all relevant fields, with a view to assessing the short- and long-term effects of residue mixtures and formulations in soil and residue levels in wind and dust; stresses that the guidance documents should provide sufficiently clear orientations for risk managers;

33. Calls on EFSA to regularly update its guidance documents in line with the most recent developments in all relevant fields, with a view to assessing the short- and long-term effects of residue mixtures and formulations in air, soil and residue levels in wind and dust; stresses that the guidance documents should provide sufficiently clear orientations for risk managers;

Motion for a resolution

Amendment

35. Welcomes the pilot assessment on cumulative effects, and calls for its completion as planned by the end of 2018 and the rapid implementation thereafter of cumulative risk assessments as part of the authorisation process; calls for research in relation to other routes of exposure in addition to the nervous and thyroid systems to be prioritised and accelerated;

35. Welcomes the pilot assessment on cumulative effects, except for the part on probabilistic modelling, and calls for its completion as planned by the end of 2018 by a deterministic assessment only and the rapid implementation thereafter of cumulative risk assessments as part of the authorisation process; calls for research in relation to other routes of exposure in addition to the nervous and thyroid systems to be prioritised and accelerated;

Motion for a resolution

Amendment

35 a. Calls on EFSA, the Commission and the Member States to apply an extra safety factor of at least 10 when calculating the "safe" doses of exposure to address potential mixture toxicity;

Motion for a resolution

Amendment

37. Calls on the Member States to ensure that they are properly represented in EFSA;

37. Calls on the Member States to ensure that they are properly represented in EFSA by fully independent scientists that are actively publishing in peer-reviewed journals;

Motion for a resolution

Amendment

38. Recommends that scientific knowledge and capacity be secured by supporting, expanding and strengthening the expert network of EU agencies, Member State bodies, institutes and university research groups involved in risk assessments;

38. Recommends that scientific knowledge and capacity be secured by supporting, expanding and strengthening the expert network of EU agencies, Member State bodies, institutes and university research groups involved in risk assessments, and ensure that all experts involved in the assessment procedure follow an independence policy and have no conflict of interest, such as links to commercial parties;

Motion for a resolution

Amendment

41. Calls for EFSA to be allocated sufficient funds to enable it to carry out its tasks in an independent, objective and transparent manner, so as to ensure a high level of protection of human and animal health and the environment;

41. Calls for EFSA to be allocated sufficient funds to enable it to carry out its tasks in an independent, objective and transparent manner, so as to ensure a high level of protection of human and animal health and the environment, on the condition that for each panel member in the EFSA committee there is no (potential) conflict of interest of any kind or type (including funding and intellectual and personal links) to applicants and/or industrial parties in the last 5 years to ensure their full independence;

Motion for a resolution

Amendment

42. Calls for adequate resources to be allocated to enable finalisation of landscape-scale post-market environmental monitoring and analysis, including monitoring of pesticide residues in soils and dust, the results of which should be shared with EFSA;

42. Calls for adequate resources to be allocated to enable finalisation of landscape-scale post-market environmental monitoring and analysis, including monitoring of pesticide residues in air, soils and dust, the results of which should be shared with EFSA;

Motion for a resolution

Amendment

42. Calls for adequate resources to be allocated to enable finalisation of landscape-scale post-market environmental monitoring and analysis, including monitoring of pesticide residues in soils and dust, the results of which should be shared with EFSA;

42. Calls for adequate resources to be allocated to enable finalisation of landscape-scale post-market environmental monitoring and analysis, including monitoring of pesticide residues in air, soils and dust, the results of which should be shared with EFSA;

Motion for a resolution

Amendment

45. Strongly regrets the numerous delays at Commission level following peer review by EFSA, and urges the Commission to meet its deadlines as laid down in the Regulation;

45. Strongly regrets the numerous delays at Commission level following peer review by EFSA, especially those of classified pesticides in accordance to Annex II of 1107/2009 as stated in Article 4.1, and urges the Commission to meet its deadlines as laid down in the Regulation;

Motion for a resolution

Amendment

46. Expresses its concern at the lack of transparency in the PAFF Committee; calls on the Commission and the Member States to increase the overall transparency of the procedures, including by providing detailed minutes on the comitology discussions and the respective positions, in particular by explaining and justifying the PAFF Committee’s decisions;

46. Expresses its concern at the lack of transparency and expert independence in the PAFF Committee; calls on the Commission and the Member States to increase the overall transparency of the procedures, including by providing detailed minutes on the comitology discussions and the respective positions, in particular by explaining and justifying the PAFF Committee’s decisions, as well as to ensure an independence policy to limit conflict of interest in the assessment procedure;

Motion for a resolution

Amendment

46. Expresses its concern at the lack of transparency in the PAFF Committee; calls on the Commission and the Member States to increase the overall transparency of the procedures, including by providing detailed minutes on the comitology discussions and the respective positions, in particular by explaining and justifying the PAFF Committee’s decisions;

46. Expresses its concern at the lack of transparency in the PAFF Committee; calls on the Commission and the Member States to increase the overall transparency of the procedures, including by providing detailed minutes on the comitology discussions and the respective positions, in particular by explaining and justifying the PAFF Committee’s decisions, and by making all the Commission's proposals, and the comments and voting positions of the Member States, public;

Motion for a resolution

Amendment

46 a. Notes that transparency in all stages of the Union's authorisation procedures is insufficient and that this leads to negative effects on human health, animal health and the environment, which provokes public mistrust in the system regulating PPPs; notes also that the transparency of the authorisation related activities of competent authorities is unsatisfactory as well;

Motion for a resolution

Amendment

46 b. Calls on the Commission and the Member States to acknowledge that there is an urgent need to increase the overall transparency of the procedures; therefore, calls on the Commission to prioritise the reform of EFSA in order to secure that the agency's Management Board as well as its Scientific Panels are selected based upon the highest standards of competence, impartiality, independence and absence of any conflict of interest; also calls on the Commission to reform EFSA in such a way that (scientific) independence from politics and industry is secured, that full transparency regarding the agency's procedures is guaranteed, that complete disclosure of all data and studies submitted or used in the application and/or renewal procedures is granted;

Motion for a resolution

Amendment

47. Calls on the Commission to adopt clear criteria for what constitutes unacceptable effects on the environment;

47. Calls on the Commission to adopt clear criteria for what constitutes unacceptable effects on the environment; calls on the Commission to strictly apply Art. 4 of the Regulation and to justify the reasons not applying Art. 4 of the Regulation when it takes approval decisions;

Motion for a resolution

Amendment

48. 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; stresses that complete dossiers are essential for active substance approvals; regrets that the derogation by confirmatory data procedure has led to certain plant protection products that would have otherwise been banned to remain on the market for an extended period of time;

48. Calls on the Commission to acknowledge the need to cease the use of the confirmatory data procedure and demands the Commission to limit the use of this procedure to a bare minimum and according to the strictest possible conditions, being at least 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; stresses that complete, accurate, up-to-date and reliable dossiers are essential for active substance approvals; regrets that the derogation by confirmatory data procedure has led to the approval of harmful plant protection products that would have otherwise been banned and as a result could remain on the market and cause harm to human health, animal health and the environment for an extended period of time;

Motion for a resolution

Amendment

50. Calls on the Commission to include legally binding risk mitigation measures in the approval of active substances in order to deal with known risks posed by plant protection products, rather than leaving the matter to the discretion of Member States alone;

50. Calls on the Commission to include legally binding risk mitigation measures in the approval of active substances in order to deal with known risks posed by plant protection products, rather than leaving the matter to the discretion of Member States alone; also calls on the Commission to ensure that post-market monitoring will assess the effectiveness and efficiency of the implemented mitigation measures, and retract the authorisation of substances in cases of low effectiveness and efficiency;

Motion for a resolution

Amendment

50 a. Calls on the Commission to apply Article 6(g) of the Regulation and restrict the use of pesticide substances in public areas and private gardens;

Motion for a resolution

Amendment

56. Calls on the Member States to ensure that all plant protection products undergo proper assessments, including exposure scenarios, on the basis of data obtained for the plant protection product itself, and considers that extrapolation of data on plant protection products should only be done from data obtained on active substances, where this is scientifically justified and confirmed as reliable by post-market monitoring;

56. Calls on the Member States to ensure that all plant protection products undergo proper assessments, including exposure scenarios, on the basis of data obtained for the plant protection product itself, and considers that extrapolation of data on plant protection products should only be done from data obtained on active substances, only where this is scientifically justified and confirmed as reliable by post-market monitoring; calls on the Commission to report to the European Parliament within 2 years on national practices of risk assessment and risk management of plant protection products in a detailed manner;

Motion for a resolution

Amendment

56 a. Calls on the Member States to strictly apply Article 55 of the Regulation so that the use of all plant protection products complies with the principle of Integrated Pest Management; calls on the Member States to adopt National Action Plans to set up their quantitative objectives, targets, measures and timetables to reduce risks and impacts of pesticide use on human health and the environment and to encourage the development of integrated pest management and of alternative approaches and techniques in order to reduce dependency on the use of pesticides;

Motion for a resolution

Amendment

61. Calls on the Member States to do their utmost to meet the deadlines and provisions relating to mutual recognition;

61. Is concerned by the fact that a rather high number of authorisations granted are based on the procedure of mutual recognition, which proved to be inefficient; therefore calls on the Member States to meet the deadlines and provisions relating to mutual recognition;

Motion for a resolution

Amendment

64. Calls on the Commission to fully use its control rights under Article 53(2) and (3), in order to limit the derogations and extensions granted under Article 53 to actual emergency situations;

64. Calls on the Commission to fully use its control rights under Article 53(2) and (3), in order to limit the number and scale of derogations and extensions granted under Article 53 to actual emergency situations; justifications should also include the use of non-chemical methods and practices;

Motion for a resolution

Amendment

66 a. Calls on the Commission and the Member States to acknowledge and reiterate that there is an urgent need to cease the granting of authorisations 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 potential 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 or the environment has not been proven scientifically;

Motion for a resolution

Amendment

69. Calls on the Commission and the Member States to promote low-risk pesticides, as an important measure for reducing the adverse impacts of pest management; acknowledges the need for more research in and development of these products;

69. Calls on the Commission and the Member States to promote the use of sustainable and ecological alternatives for plant protection instead of continuing along the current lines of protecting plants in an unsustainable way with harmful PPPs and so-called low-risk pesticides, as an important measure for reducing the adverse impacts of pest management; calls on the Commission to promote research into new sustainable and ecological methods so as to broaden the array of available methods;

Motion for a resolution

Amendment

69 a. Calls on the Commission to propose amending the Regulation to ensure even further requirements for the prioritisation of non-chemical methods of pest control in order to move crop protection away from the reliance on chemical pesticides to non-chemical farming methods as recommended in the 2017 report of the United Nations Special Rapporteur on the right to food;

Motion for a resolution

Amendment

69 b. Calls on the Commission to propose amending the Regulation to ensure even further requirements for the prioritisation of non-chemical methods of pest control in order to move crop protection away from the reliance on chemical pesticides to sustainable non-chemical alternatives;

Motion for a resolution

Amendment

71. Calls on the Member States to scale up their efforts to ensure that farmers are adequately trained in the proper use of plant protection products and the application of Integrated Pest Management (IPM);

71. Calls on the Member States to establish a Farm Advisory System, as indicated under the Common Agricultural Policy as a support scheme to ensure that farmers are adequately trained in the proper use of plant protection products and the application of Integrated Pest Management (IPM), prioritising the use of non-chemical methods of plant protection and pest and crop management;

Motion for a resolution

Amendment

71. Calls on the Member States to scale up their efforts to ensure that farmers are adequately trained in the proper use of plant protection products and the application of Integrated Pest Management (IPM);

71. Calls on the Member States to scale up their efforts to ensure that farmers are adequately informed and trained in the use of sustainable and ecological methods for plant protection;

Motion for a resolution

Amendment

71 a. Calls on the Commission to set up a pesticide labelling scheme for food produced in, or imported into, the EU in order to enhance consumer choice. The labelling should inform consumers about any pesticide treatments that have been applied during the production of the food in question, taking into account the dose and frequency of treatment, as well as the toxicity of the chemicals used;

Motion for a resolution

Amendment

71 b. Calls on the Commission and the Member States to pay particular attention to the protection of vulnerable groups as defined in Article 3(14) of the Regulation, especially considering the existing lack of protection of the millions of EU rural residents living in the locality of crops, and to propose amending the Regulation to prohibit the use of pesticides in substantial distances near residents' homes, schools, playgrounds, nurseries and hospitals;

Motion for a resolution

Amendment

71 c. Calls on the Commission and the Member States to ensure that the requirements in the Regulation for the prioritisation of non-chemical methods are properly implemented;

Motion for a resolution

Amendment

71 d. Calls on the Commission to finalise methods to determine when certain derogations should be applied, if at all, 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 as 'negligible risk' would be against the letter and the spirit of the law; and further that any outdoor use of pesticides sprayed on crops in the open air cannot in any circumstances be classified or interpreted as being used in 'closed systems' or in 'other conditions excluding contact with humans';

Motion for a resolution

Amendment

71 e. Calls on the Commission, EFSA and the Member States to ensure that all relevant stakeholders are included in any stakeholder activities on pesticides including the public, as provided for in Directive 2003/35/EC and the UN Economic Commission for Europe (UNECE) Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters (the Aarhus Convention);

Motion for a resolution

Amendment

71 f. Calls on the Commission and the Member States to include legally binding requirements in the approval of active substances and pesticide products for prior notification and direct access to information for rural residents regarding pesticides sprayed on fields in their surrounding areas;

Motion for a resolution

Amendment

71 g. Calls on the Commission and the Member States to acknowledge that there is a need for better coherence of the PPP Regulation and its implementation with related EU legislation and policies, in particular with the Sustainable Use of Pesticides, and the only acceptable way to proceed is to provide for incentives, including making available sufficient resources, that promote and stimulate in the short term the further development and use of safe, sustainable and ecological (non-chemical) plant protection methods;