PEST - DRAFT COMPROMISE AMENDMENTS CA 1 - Purpose of the Regulation and precautionary principle

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1 PEST - DRAFT COMPROMISE AMENDMENTS CA 1 - Purpose of the Regulation and precautionary principle EPP, Greens/EFA, (S&D?), (ECR?), ALDE, (EFDD?), (ENF?) Recitals - Aa(new), A, Aa(new), Ab(new), Ac(new), Ad(new) and Paragraphs 1, 4 and 4a(new) Replaces amendments 41, 42, 43, 44, 45, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 68, 69, 70, 72, 73, 79, 87, 91, 92, 93, 94, 95, 96, 203, 213, 327, 328, 357, 361, 370, 371, 381, 388, 463, 465, 466, 467, 468, 469, 470, 471, 472, 473, 474, 475, 476, 478, 479, 480, 481, 483, 484, 485, 486, 487, 488, 490, 496, 505, 506, 517, 520, 533, 534, 535, 536, 537, 538, 539, 540, 541, 542, 543, 545, 546, 547. Paragraph 1 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; Paragraph 4 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 for it to achieve its purpose; 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 to duly apply the precautionary principle, when following an assessment of the available information the possibility of harmful effects on health is identified but scientific uncertainty persists, by adopting provisional risk management measures necessary to ensure a high level of protection of human health; 1

2 Paragraph 4a (new) 4a. Urges the Commission to communicate systematically on how this principle has been taken into account and how the risk management decision has been made; Recital - Aa (new) -Aa. whereas the purpose of the Regulation is to ensure a high level of protection of both human and animal health and the environment and to improve the functioning of the internal market through the harmonisation of the rules on the placing on the market of plant protection products, while improving agricultural production; Recital A 2

3 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 one of the most stringent in the world; whereas in the light of the concerns raised by several stakeholders 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; Recital Aa (new) Aa. whereas the precautionary principle is an overarching principle for Union policy, as laid down in Article 191 of the Treaty on the Functioning of the European Union; whereas the Regulation, according to its Article 1(4), is underpinned by the precautionary principle; whereas the risk management decision, according to its Article 13(2), must follow the conditions of the precautionary principle as laid down in Article 7(1) of Regulation 178/2002; whereas Article 7(2) of Regulation 178/2002 provides that measures adopted on the basis of the precautionary principle shall be proportionate; Recital Ab (new) 3

4 Ab. whereas according to Article 4(3) of the Regulation, a plant protection product, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use shall, inter alia, have no immediate or delayed harmful effects on human health, including that of vulnerable groups and it shall have no unacceptable effects on the environment; Recital Ac (new) Ac. whereas the evaluation of the implementation of the Regulation has revealed that the objectives of protecting human and animal health and the environment are not fully being achieved and that improvements could be made in order to achieve all the objectives of the Regulation; Recital Ad (new) Ad. whereas independence of the risk assessment is the basis for trust in the Regulation and in EU food law; CA 2 - REFIT EPP, Greens/EFA, S&D, (ECR?), ALDE, (GUE?), (EFDD?), (ENF?) Citation 18a(new) and Paragraph 1a(new) Replaces amendments 467, 519, 462, 467, 483. Paragraph 1 a (new) 4

5 1a. Takes note of the Commission s ongoing REFIT evaluation of the Regulation; Citation 18a(new) - having regard to the ongoing REFIT evaluation by the Commission of the Regulation; CA 3 - Basic principles of risk assessment EPP, Greens/EFA, S&D, (ECR?), ALDE, (GUE?), (EFDD?), (ENF?) Paragraph 1b(new) Replaces amendments 69, 413, 493, 497, 504, 484, 657, 891, 893. Paragraph 1b (new) 1b. Stresses the importance of ensuring independent, objective and transparent scientific assessment of active substances and plant protection products; CA 4 - EU vision for food production EPP, Greens/EFA, S&D, (ECR?), ALDE, (GUE?), (EFDD?), (ENF?) Paragraph 2 (to become Paragraph 9a) Replaces amendments 380, 445, 509, 510, 511, 512, 513, 514, 515, 516, 572, 652, 932. Paragraph 2 (to become Paragraph 9a(new)) 5

6 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; 9a. 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 sustainable food production, including the role of plant protection products therein; whereas such considerations should take into account, among other factors, quality, safety, availability and affordability of food for consumers, the fair income and long-term sustainability of agricultural production, climate change, as well as the short-term and long-term risks and benefits to human and animal health and the environment associated with different scenarios for the use of plant protection products, including integrated pest management and a non-use scenario; CA 5 - Lack of resources EPP, Greens/EFA, S&D, (ECR?), ALDE, (GUE?), (EFDD?), (ENF?) Recital H and Paragraphs 3 and 3a(new) Replaces amendments 184, 185, 186, 187, 188, 191, 197, 204, 275, 364, 414, 415, 427, 502, 518, 521, 522, 523, 524, 525, 526, 527, 528, 532, 548, 977, 988. Paragraph 3 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 Commission and on Member States to allocate sufficient resources and appropriate expertise to the assessment of active substances and plant protection products and to ensure independent, objective and transparent assessment in light of current scientific and technical knowledge; 6

7 Paragraph 3 a (new) Recital H 3a. Calls on the Commission and the Member States to ensure full and uniform application of the hazard-based cut-off criteria for active substances that are mutagenic, carcinogenic, toxic for reproduction or that have endocrine disrupting properties; 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 national competent authorities involved in the approval and authorisation process are in some cases understaffed and underfunded; whereas this risks impacting the quality of the assessments, both for active substances and plant protection products, and the time in which they can be delivered; CA 6 - Inappropriate use of PPPs EPP, Greens/EFA, S&D, ECR, ALDE, (EFDD?), (ENF?) Recital E and Paragraph 5 Replaces amendments 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 147, 149, 459, 550, 551, 552, 553, 554, 555, 556, 557, 558, 559, 560, 561, 562, 563, 564, 565, 568, 576, 581. Paragraph 5 7

8 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, within the EU system, greater attention should be paid to the widespread use, and prophylactic use when inappropriate, of plant protection products and the effects thereof on human health, animal health and the environment as well as on the build-up of resistance in the target organism; Recital E E. whereas the widespread and prophylactic use of plant protection products is of concern; E. whereas the widespread use, and prophylactic use when inappropriate, of plant protection products is of concern; CA 7 - Implementation of Directive 2009/128/EC (including Integrated Pest Management, low-risk pesticides and research) EPP, Greens/EFA, (S&D?), (ECR?), ALDE, (GUE?), (EFDD?), (ENF?)Citation, Recitals AN,ANa(new) and ANb(new), Paragraphs 5a(new), 5b(new), 5c(new), 8, 8a(new), 53, 69 and 71 Replaces amendments 52, 76, 116, 133, 134, 143, 144, 148, 150,152, 154, 207, 211, 322, 261, 402, 406, 407, 408, 409, 410, 411, 412, 419, 423, 424, 457, 458, 461, 464, 485, 501, 521, 550, 553, 561, 564, 565, 566, 567, 570, 572, 573, 574, 577, 578, 579, 582, 583, 584, 607, 611, 612, 613, 614, 615, 616, 617, 618, 619, 620, 621, 622, 623, 624, 625, 626, 627, 628, 629, 630, 631, 632, 638, 639, 641, 646, 647, 648, 649, 651, 653, 654, 655, 661, 662, 668, 670, 673, 684, 918, 920, 975, 978, 979, 980, 981, 982, 984, 990, 991, 995, 1014, 1016, 1020, 1035, 1042, 1087, 1099, 1100, 1102, 1103, 1106, 1109, 1110, 1111, 1113, 1114, 1115, 1116, 1117, 1118, 1119, 1120, 1121, 1122, 1128, 1130, 1133, 1138, 1089, 1090, 1091, 1092, 1093, 1094, 1095, 1096, 1097, 1098, Paragraph 5a (new) 8

9 5a. Stresses the importance of full implementation of the Directive 2009/128/ EC on Sustainable Use of Pesticides given the link of the authorisation system to it, in particular the provisions with regard to Integrated Pest Management and adequate training for farmers therein; refers to the ongoing work in the Parliament on this matter for further details; Paragraph 5b (new) Paragraph 5c (new) 5b. Calls on the Commission and Member States to ensure consistency of purpose between the approval of active substances and authorisation of plant protection products under this Regulation with the purpose of Directive 2009/128/EC; 5c. Calls on the Commission and Member States to no longer allow the use of active substances/plant protection products for desiccation nor in areas used by the general public or by vulnerable groups, as defined in Article 12a of Directive 2009/128/EC; Paragraph 8 9

10 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. Considers it essential that research and innovation continue to be developed in the Union, thus calls for Horizon Europe and other Union financial instruments and Member States to provide sufficient funding to promote: a. independent research on the effects of plant protection products on human and animal health, the environment and agricultural production; b. research into alternatives to plant protection products including nonchemical methods, including low-risk pesticides, to present farmers with new solutions for sustainable agriculture, as well as research in agro-ecological and precision farming techniques to minimise the external input and to optimise pest control to a targeted and sustainable manner; 10

11 AN. whereas there is a lack of availability of low-risk plant protection products; whereas only ten substances are approved as low-risk active substances out of a total of almost 500 available on the EU market; whereas the lack of availability of low-risk plant protection products makes Integrated Pest Management implementation and development more difficult; whereas the lack of availability of low-risk plant protection products is caused by the lengthy evaluation, authorisation and registration process; Recital AN a (new) AN a. whereas the use of plant protection products for desiccation (ie the treatment of the actual crop plant prior to harvest in order to accelerate its ripening and facilitate its harvesting) is inappropriate; Recital AN b (new) AN b. whereas the use of plant protection products in areas used by the general public or by vulnerable groups is inappropriate; Citation 11

12 - having regard to the pending resolution of XXX on the implementation of Directive 2009/128/EC on the sustainable use of pesticides 1, OJ L 309, , p. 71 CA 8 - Post-market monitoring Recitals F and G and Paragraphs 6, 6 a(new), 28 and 29 EPP, Greens/EFA, S&D, (ECR?), ALDE, (GUE?), (EFDD?), (ENF?) Replaces amendments 117, 145, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 167, 168, 169, 170, 171, 174, 176, 177, 178, 179, 180, 182, 589, 590, 591, 592, 593, 594, 595, 596, 597, 598, 599, 607, 609 (partly), 650, 767, 827, 828, 829, 830, 831, 832, 833, 834, 835, 836, 837, 838, 839, 840, 841, 842, 843, 850, 853, 854, 998, 1017, 1018, 1019, 1104, Paragraph 6 6. Calls for the creation of an effective post-market vigilance system to monitor the impacts of the use of plant protection products on human and animal health and on the environment as a whole; 6. Calls for the creation of an effective postmarket vigilance system to systematically monitor the real-life impacts of the use of plant protection products on human and animal health and on the environment as a whole, including on the long-term; stresses that post-market vigilance for plant protection products should ensure effective data collection and communication among all stakeholders, be transparent and publicly accessible; calls on EFSA and ECHA to develop harmonized guidelines for effective post-market vigilance in this field; Paragraph 6 a (new) 12

13 6a. Calls on the Commission to conduct an epidemiological study on the real-life impacts of plant protection products on human health of professional users; Paragraph 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; Deleted Motion for a Resolution Paragraph Calls on the Commission to develop a standardised EU-wide IT platform or database to support the sharing of postmarket monitoring data; 29. Calls on the Commission to develop a standardised EU-wide IT platform or database to support the sharing of postmarket monitoring data and considers that post-market monitoring data and other available monitoring data should be used in the authorisation process; Recital F 13

14 F. whereas there is a lack of monitoring post-authorisation; Recital G G. whereas the lack of data concerns active substances, safeners, synergists and coformulants, 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; F. whereas authorisation decisions on newly developed active substances and plant protection products are invariably made under uncertainty on real-life impacts; whereas there is a lack of monitoring post-authorisation; whereas data are missing on exact quantities of each plant protection product applied, on implementation and effectiveness of mitigation measures, and the potential harmful effects on human and animal health and the environment; G. whereas the lack of data concerns real-life impacts of 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; CA 9 - DNT effects EPP, Greens/EFA, S&D, (ECR?), ALDE, (GUE?), (EFDD?), (ENF?) Recital K and Paragraph 7 Replaces amendments 200, 201, 202, 600, 601, 602, 603, 604, 605, 606. Paragraph 7 14

15 7. Welcomes EFSA s ongoing project to model DNT effects, but considers this to be insufficient until there is a legal requirement for active substances and other pesticide components to be assessed for DNT effects as part of the authorisation process; calls on the Commission to propose amending the Regulation to ensure that active substances and other components in plant protection products be assessed for DNT effects; 7. Welcomes EFSA s ongoing project to model DNT effects, but considers this to be insufficient until there is a legal requirement for active substances and other pesticide components to be assessed for DNT effects as part of the authorisation process; thus calls on the Commission to assess options of ensuring that active substances and other components in plant protection products be assessed for DNT effects, fully taking into account reliable animal-free human focused mechanistic methods for DNT hazard assessment; Recital K K. whereas there is currently no legal obligation to test active substances for their developmental neurotoxicity (DNT), examples of which include causing autism, attention deficit hyperactivity disorder (ADHD) and dyslexia; whereas, in this context, EFSA is working on an ongoing project to develop non-animal alternatives for screening DNT effects; K. whereas there is currently no legal obligation to test active substances for their developmental neurotoxicity (DNT), examples of which include causing autism, attention deficit hyperactivity disorder(adhd) and dyslexia; whereas developmental toxicity and neurotoxicity studies are required and may trigger studies with ad-hoc study design to address specific concerns; whereas in this context, EFSA is working on an ongoing project to develop non-animal alternatives for screening DNT effects; CA 10 - Risk communication Recitals B(a)new and B(b)new and Paragraph 9 EPP, Greens/EFA, S&D, (ECR?), ALDE, (GUE?), (EFDD?), (ENF?) Replaces amendments 66, 90, 183, 301, 497, 633, 634, 635, 636, 644, 730, 884, Paragraph 9 15

16 9. Calls on EFSA and the Commission to improve their risk communication in order to inform the public in an appropriate and easily understandable way; 9. Calls on EFSA and the Commission to improve their risk communication in order to inform the public in an appropriate, understandable and easily accessible way; considers that it is important to improve public knowledge about hazard and risk, acceptable and unacceptable hazards and risks, awareness of the level of compliance with MRL values across Europe and inform users of possible risk mitigation measures; Recital B a (new) Ba. whereas there is a lack of public knowledge about hazard and risk, acceptable and unacceptable hazards and risks and about the level of compliance with maximum residue level (MRL) values across Europe; Recital B b (new) Bb. whereas the right of access to documents held by EU institutions, including EU agencies, is an important right, exceptions to which are to be interpreted narrowly; points to the case law of the Court of Justice of the European Union, according to which transparency and access to documents contribute to greater legitimacy of EU agencies in the eyes of citizens and to ensuring EU agencies are more accountable to citizens in a democratic system 1a ; Ba. whereas there is a lack of public knowledge about hazard and risk, acceptable and unacceptable risks and established safe uses as well as about the level of compliance with maximum residue level (MRL) values across Europe; 1a See Case T-235/15, Pari Pharma v EMA; see also Case T-729/15, MSD Animal Health Innovation and Intervet International, and Case T-718/15, PTC Therapeutics International v EMA. 1b See Case C-442/14 Bayer CropScience. 16

17 CA 11 - Appointment of RMS (upon first application for approval) EPP, Greens/EFA, S&D, (ECR?), ALDE, (GUE?), (EFDD?), (ENF?) Recitals L and U and Paragraph 10 Replaces amendments 217, 218, 219, 220, 221, 277, 280, 281, 674, 675, 676, 677, 678, 679, 680, 681, 682, 683, 687, 696, 700. Paragraph Calls on the Commission to propose amending the Regulation so as to empower it to adopt a work programme with regard to the designation of the RMS for applications for approvals, on the basis of expertise, resources, relevance for the product, technical capacity and ability to achieve scientifically robust and reliable outcomes, together with a comprehensive peer review process and a stakeholder consultation, on lines similar to the system for reapproval of active substances; 10. Calls on the Commission to propose amending the Regulation so as to empower it to adopt a work programme with regard to the designation of the RMS for applications for approvals, on the basis of criteria for an independent, objective and transparent assessment: expertise, resources, absence of conflict of interest, relevance for the product, technical capacity and ability to achieve scientifically robust and reliable outcomes within the given timeframe, together with a comprehensive peer review process and a stakeholder consultation, on lines similar to the system for re-approval of active substances; Recital L L. whereas concern has been raised about the right of applicants to choose the Rapporteur Member State (RMS) upon first application for approval of an active substance; L. whereas concern in terms of transparency and conflict of interests has been raised by several stakeholders about the right of applicants to choose the Rapporteur Member State (RMS) upon first application for approval of an active substance; Recital U 17

18 U. whereas pursuant to Article 11(2) of the Regulation the rapporteur Member State shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge ; U. whereas pursuant to Article 11(2) of the Regulation the rapporteur Member State shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge ; CA 12 - Appointment of RMS for renewal EPP, Greens/EFA, S&D, (ECR?), ALDE, (GUE?), (EFDD?), (ENF?) Recital M and Paragraph 11 Replaces amendments 222, 223, 224, 225, 689, 690, 691, 692. Paragraph Calls on the Commission to allocate the evaluation of applications for renewal to a Member State other than that which was in charge of the previous evaluation(s), provided the necessary level of expertise and resources can be ensured; 11. Calls on the Commission to allocate the evaluation of applications for renewal to a Member State other than that which was in charge of the previous evaluation(s), provided the necessary level of expertise and resources can be ensured; Recital M M. whereas concern has furthermore been raised over the fact that the RMS given responsibility by the Commission for the renewal of an assessment report may be the same one which did the initial draft assessment report; M. whereas concern in terms of transparency and conflict of interests has furthermore been raised by several stakeholders over the fact that the RMS given responsibility by the Commission for the renewal of an assessment report may be the same one which did the initial draft assessment report; 18

19 CA 13 - Assessment by RMS EPP, Greens/EFA, S&D, (ECR?), ALDE, GUE, (EFDD?), (ENF?) Recital N, Na(new) and Paragraph 12 Replaces amendments 87, 89, 185, 226, 227, 228, 229, 230, 231, 232, 233, 272, 279, 280, 282, 283, 427, 529, 656, 693, 694, 695, 696, 697, 698, 699, 700, 701, 702, 703. Paragraph 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 and that have effective procedures for assessing conflicts of interests become RMS; Recital N N. whereas for new active substances, only 11 out of 28 Member States have been chosen as Rapporteur Member States by applicants since the entry into force of the Regulation, which illustrates that there are significant differences concerning expertise and staffing; N. whereas for new active substances, only 11 out of 28 Member States have been chosen as Rapporteur Member States by applicants since the entry into force of the Regulation, which illustrates that there are significant differences concerning expertise and staffing; Recital Na (new) Na. whereas France, the Netherlands, Germany and the UK performed about 80% of all dossiers; whereas Brexit will have a significant impact on the workload of other Member States; 19

20 CA 14 - National reference laboratories EPP, Greens/EFA, S&D, (ECR?), ALDE, (GUE?), (EFDD?), (ENF?) Paragraph 13 Replaces amendments 701, 707, 708, 709, 710. Paragraph Calls on EFSA to carry out an assessment of the national reference laboratories attached to the competent authorities of the RMS concerned in order to ensure the same level of expertise for the RMS draft assessment report (DAR); 13. Calls on the Commission, with the support of EFSA, to carry out an assessment of the national reference laboratories attached to the competent authorities of the RMS concerned in order to ensure the same level of expertise for the RMS draft assessment report (DAR); CA 15 - GLP laboratories EPP, Greens/EFA, S&D, (ECR?), ALDE, (GUE?), (EFDD?), (ENF?) Paragraph 14 and Recital Ta(new) Replaces amendments 711, 712, 713, 714, 715, 716, 717, 718. Paragraph Further calls on the Member States to responsibly carry out their auditing of GLPcertified laboratories, and calls on the Commission to create a verification system for Member State audits led by itself; 14. Further calls on the Member States to responsibly carry out their auditing of GLPcertified laboratories, and calls on the Commission to create a Union verification system for Member State audits led by itself; Recital Ta (new) 20

21 Ta. whereas, as reported by the Commission in 2015, all Member States have transposed the GLP Directives and have established functioning national GLP compliance monitoring programmes; CA 16 - GFL proposal EPP, Greens/EFA, S&D, (ECR?), ALDE, (GUE?), (EFDD?), (ENF?) Paragraph 15 Replaces amendments 88, 106, 218, 277, 376, 383, 397, 410, 466, 494, 503, 517, 547, 549, 720, 721, 722, 723, 724, 725, 726, 737, 747, 764, 770, 778, 791, 798, 811, 835, 842, 1002, 1006, 1009, Paragraph 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 thus welcomes the opportunity to improve the current situation in this respect; CA 17 - Public register of studies EPP, Greens/EFA, S&D, (ECR?), ALDE, (GUE?), (EFDD?), (ENF?) Recital O and Paragraph 16 Replaces amendments 234, 235, 731, 732, 733, 734, 735, 736. Paragraph 16 21

22 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 that will be performed, in a public register and allow a comment period during which stakeholders are able to provide existing data to 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; including the methodology of tests that will be performed while respecting the protection of personal data; considers that only regulatory studies that have been registered may be submitted with an application; Recital O O. whereas Article 8(1) of the Regulation requires the applicant to provide a summary dossier, which should include inter alia the summaries and results of tests and studies for each point of the data requirements, including an assessment of all information submitted; O. whereas Article 8(1) of the Regulation requires the applicant to provide a summary dossier, which should include inter alia the summaries and results of tests and studies for each point of the data requirements, including an assessment of all information submitted; CA 18 - Provision of studies on active substances in machine-readable format and public access to studies on active substances EPP, Greens/EFA, ALDE, (GUE?), (EFDD?), (ENF?) Recital B and Paragraphs 17 and 18 Replaces amendments 81, 82, 83, 84, 85, 98, 110, 189, 196, 209, 245, 247, 248, 278, 284, 285, 580, 686, 737, 738, 739, 740, 742, 743, 744, 745, 746, 747, 748, 749, 750, 751, 753, 754, 755, 756, 769, 784, 786, 787,

23 Paragraph Stresses the need to require applicants to provide all studies to the RMS, including the raw data, in a machinereadable format; 17. Stresses the need to require applicants to provide all studies to the RMS, including the raw data, in a machinereadable format; Paragraph 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 above studies, including all supporting data and information relating to applications for authorisation, in a machine-readable format and in their entirety,, in order to ensure transparency which allows for timely independent scrutiny while protecting personal data and ensuring that those who requested the studies can only use them for non-commercial purpose, so as to safeguard the relevant intellectual property rights; Recital B B. whereas the decision-making process has been found to be lacking in transparency throughout the procedure, from lack of public access to the full studies and raw data through to the risk management stage; B. whereas the decision-making process has been found to be lacking in transparency throughout the procedure, from lack of public access to the full studies and raw data through to the risk management stage; 23

24 CA 19 - Burden of proof (including regulatory studies, peer-reviewed open literature and assessment thereof) EPP, Greens/EFA, S&D, (ECR?), ALDE, (GUE?), (EFDD?), (ENF?) Recital P, Paragraphs 19 and 20a(new) Replaces amendments 86, 98, 110, 189, 196, 209, 237, 238, 239, 240, 241, 242, 243, 245, 247, 248, 249, 250, 253, 263, 274, 544, 661, 662, 663, 685, 686, 688, 695, 706, 752, 757, 758, 759, 760, 761, 762, 763, 764, 765, 766, 768, 769, 784, 785, 786, 787, 795. Paragraph 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 assigning this task to the RMS, to be assisted by EFSA; Motion for a Resolution Paragraph 20a (new) Motion for a Resolution 20a. Calls on the Commission to assess whether it would be appropriate to no longer require the applicant to assess the data to be provided as part of the application, instead assigning this task to the Rapporteur Member States; Recital P 24

25 P. whereas concern has been raised by stakeholders concerning the evaluation approach as established by law, and in particular over who should produce the scientific studies and evidence for the evaluation of active substances; P. whereas concern has been raised by several stakeholders concerning the evaluation approach as established by law, and in particular over who should produce the scientific studies and evidence for the evaluation of active substances, who should provide scientific peer-reviewed literature and who should assess the studies; CA 20 - Weight of evidence (GLP studies vs peer-reviewed open literature) EPP, Greens/EFA, S&D (?),, ALDE, GUE, (EFDD?), (ENF?) Recitals Q, R, S, T, Ta(new), Paragraphs 20 and 21 Replaces amendments 246, 254, 255, 256, 257, 258, 259, 260, 261, 262, 263, 264, 265, 266, 267, 268, 269, 300, 367, 770, 771, 772, 773, 774, 775, 776, 777, 778, 779, 780. Paragraph Stresses that scientific peer-reviewed open literature, where available, should be given the same weight in the assessment as GLP-based studies; 20. Stresses that scientific peer-reviewed open literature, where available, should be given the equivalent weight in the assessment as GLP-based studies; considers that they are both valid as contributions to the assessment and should be weighted according to the relative quality of the studies and their relevance to the application under consideration; Motion for a Resolution Paragraph Recommends a reassessment of the current rules for the literature review so as to ensure a balance between peer-reviewed and GLP-based studies; 21. Calls for an independent reassessment of the current rules for the literature review so as to ensure that all relevant studies are considered; 25

26 Recital Q Q. whereas Article 8(5) of the Regulation requires the applicant to add scientific peerreviewed open literature on the active substance and its relevant metabolites to the dossier; Q. whereas Article 8(5) of the Regulation requires the applicant to add scientific peerreviewed open literature on the active substance and its relevant metabolites to the dossier; 26

27 27

28 Motion for a Resolution Recital R Motion for a Resolution R. whereas for new active substances, normally only data from regulatory studies generated by the applicant are available; R. whereas for new active substances, normally only data from regulatory studies generated by the applicant are available; Motion for a Resolution Recital S Motion for a Resolution S. whereas scientific peer-reviewed open literature provides important complementary information to the studies based on Good Laboratory Practices (GLP) provided by applicants, and can include findings that alert evaluators to adverse effects that are not seen by standard testing; S. whereas risk assessment shall be based on all relevant available scientific evidence; whereas scientific peer-reviewed open literature provides important complementary information to the studies based on Good Laboratory Practices (GLP) provided by applicants, and can include findings that alert evaluators to adverse effects that are not seen by standard testing; Motion for a Resolution Recital T Motion for a Resolution 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 28 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;

29 Motion for a Resolution Recital Ta (new) Motion for a Resolution Ta. whereas OECD test guidelines ensure that research is reproducible, consistent and uniform and enables regulators to assess the quality and relevance of a study, to ensure the methodological validity of a study and to facilitate mutual acceptance of data among Member States; CA 21 - Completeness of applications EPP, Greens/EFA, S&D, ECR, ALDE, (GUE?), (EFDD?), (ENF?) Paragraph 22 Replaces amendments 695, 706, 788, 789, 790, 791, 792, 793. Motion for a Resolution Paragraph 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 should strictly apply Article 9 of the Regulation, so as to ensure that applications are complete before they are deemed admissible; 29

30 CA 22 - Evidence assessed by RMS EPP, Greens/EFA, S&D (?), ECR, ALDE, (GUE?), (EFDD?), (ENF?) Paragraph 23 Replaces amendments 114, 741, 796, 797, 798, 799, 800, 801, 802, 803, 810. Motion for a Resolution Paragraph 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 as available at that stage of the evaluation; 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 for example the proper application of relevant OECD guidance documents; CA 23 - Assessment of active substances (most frequent uses, most frequently used formulations etc.) EPP, Greens/EFA, S&D, ECR, ALDE, (GUE?), (EFDD?), (ENF?) Paragraph 24 Replaces amendments 804, 805, 806, 807, 808, 809, 824, 957. Motion for a Resolution Paragraph 24 30

31 24. Calls on the Commission to propose amending the Regulation to ensure that an active substance is assessed on the basis of the most frequent uses and the most frequently used formulations; 24. Calls on the Commission to assess how best to ensure that active substances are assessed on the basis of the most frequent uses, the most frequently used formulations, their dosage and relevant exposure scenarios; CA 24 - Reproducing paragraphs in DAR EPP, Greens/EFA, S&D (?), (ECR?), ALDE, (GUE?), (EFDD?), (ENF?) Recitals V, W and Paragraph 26 Replaces amendments 287, 288, 290, 291, 292, 293, 294, 295, 296, 297, 298, 812, 813, 814, 815 Motion for a Resolution Paragraph Recommends that the RMS should limit reproducing paragraphs to a minimum and only to justified cases; insists that, as long as the assessment is made by the applicant, should passages be taken from the application dossier a clear distinction should be made between the assessment of the authority and the assessment of the applicant; 26. Recommends that the RMS should limit reproducing paragraphs to a minimum and only to justified and duly reported cases; insists that, as long as the assessment is made by the applicant, should passages be taken from the application dossier a clear distinction should be made between the assessment of the authority and the assessment of the applicant; 31

32 Motion for a Resolution Recital V V. whereas it has been found that different Member States, when acting as RMS, use different practices when it comes to referencing the applicant s summaries of peer-reviewed literature; whereas it is a fundamental rule that any scientific work should clearly indicate statements made by others by using quotation marks; V. whereas it has been found that different Member States, when acting as RMS, use different practices when it comes to referencing the applicant s summaries of peer-reviewed literature; whereas it is a fundamental rule that any scientific work should clearly indicate statements made by others by using quotation marks; Motion for a Resolution Recital W W. whereas Parliament acknowledges the debate over the literature review in the risk assessment report on glyphosate by the German Federal Institute for Risk Assessment (BfR); whereas there are concerns that important assessment elements in the draft risk assessment report on glyphosate were taken from the application, without being clearly indicated as references; W. whereas Parliament acknowledges the debate over the literature review in the risk assessment report on glyphosate by the German Federal Institute for Risk Assessment (BfR); whereas there are concerns several stakeholders that important assessment elements in the draft risk assessment report on glyphosate were taken from the application, without being clearly indicated as references; CA 25 - Inclusion of key tests and up-to-date methods in risk assessment EPP, Greens/EFA, S&D (?), (ECR?), ALDE, (GUE?), (EFDD?), (ENF?) Recital C and Paragraphs 27, 27a(new) and 27b(new) Replaces amendments 7, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 111, 121, 124, 816, 817, 818, 819, 820, 821, 822, 823, 824, 825, 826, 985. Motion for a Resolution Paragraph 27 32

33 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 key tests (e.g. up-to-date ecotoxicological tests for soil organisms, assessment of environmental concentration and residues in dust, wind, air and water and tests addressing long-term toxic effects, in particular for vulnerable groups), and up-to-date scientific and technological developments in methods are included in the risk assessment; Motion for a Resolution Paragraph 27a (new) 27 a. Calls on the Commission to duly update its overview on up-to-date guidance documents and test guidelines; Motion for a Resolution Paragraph 27b (new) Recital C 27 b. Calls on the Commission to facilitate and enhance the completion of the harmonisation process regarding the data requirements and methodologies, in particular in the field of guidance documents on ecotoxicology and environmental fate and behaviour; 33

34 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 Commission Regulation 283/2013 setting out minimum data requirements for the approval of active substances 1a should be regularly updated to take into account current scientific and technical knowledge; whereas Commission Communication 2013/ C95/01 1b remains the most comprehensive source of guidance documents and test guidelines, while several of the documents listed may have been superseded and should be updated; 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); 1a OJL 93, , p.1. 1b OJC 95, , p.1. CA 26 - Maximum residue levels EPP, Greens/EFA, S&D, (ECR?), ALDE, (GUE?), (EFDD?), (ENF?) Paragraphs 30 and 30a(new) Replaces amendments 193, 844, 845, 846, 847, 848, Motion for a Resolution Paragraph Calls on the Commission to set maximum residue levels for soils, using, inter alia, the data collected through postmarket environmental monitoring; 30. Calls on the Commission to set maximum residue levels for soils and surface waters using, inter alia, the data collected through post-market environmental monitoring; 34

35 Motion for a Resolution Paragraph 30a (new) 30a. Calls for MRLs for food and feed to be set sooner and with more efficiency, as well as greater coherence brought about by standardising the assessment periods between the MRLs and approval or renewal; CA 27 - Long-term toxicity of plant protection products EPP, Greens/EFA, S&D, (ECR?), ALDE, (GUE?), (EFDD?), (ENF?) Recital AW and Paragraph 32 Replaces amendments 182, 431, 432, 433, 434, 435, 436, 855, 856, 857, 858, 859, 860, 861, 985,

36 Motion for a Resolution Paragraph Calls on the Commission to propose amending Commission Regulation (EU) No 284/2013 to include data requirements regarding the long-term toxicity of the pesticide product and further routes of exposure, notably via wind and water erosion of soil, using up-to-date modelling; 32. Calls on the Commission to propose amending Commission Regulation (EU) No 284/2013 to include data requirements regarding the long-term toxicity of the plant protection product and further routes of exposure, notably via wind and water erosion of soil, using up-to-date modelling; Motion for a Resolution Recital AW 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 283/2013 requires studies on the longterm toxicity; whereas Commission Regulation (EU) No 284/2013 currently requires toxicological studies on operator, bystander and resident as well as worker exposure, several long-term and chronical toxicology studies for animals, and on fate and behaviour in soil, water and air including route and degradation in air and transport via air, but not on the long-term toxicity of plant protection products; CA 28 - Effects of residue mixtures and formulations in soil EPP, Greens/EFA, S&D, ECR, ALDE, (GUE?), (EFDD?), (ENF?) Paragraphs 33 and 33a (new) Replaces amendments 125, 182, 378, 669, 690, 767, 783, 864, 865, 866, 867, 868, 869, 871, 872. Paragraph 33 36

37 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 longterm 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 longterm effects of residue levels of active substances, formulations and mixtures in surface waters, soil, wind and dust; Paragraph 33 a (new) 33a. considers that the guidance documents should provide sufficiently clear orientations for risk assessors managers to guarantee a high quality assessment and ensure predictability and consistency for applicants; CA 29 - Cumulative effects EPP, Greens/EFA, S&D, (ECR?), ALDE, (GUE?), (EFDD?), (ENF?) Recitals I and J and Paragraphs 35 and 35a(new) Replaces amendments 107, 192, 193, 194, 195, 198, 199, 244, 585, 719, 783, 850, 862, 875, 876, 877, 878, 879, 880, 957, 985, 994, Paragraph 35 37

38 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, 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; Paragraph 35a (new) 35 a. Calls on EFSA, the Commission and the Member States to apply an extra safety factor when calculating the "safe" doses of exposure to address potential mixture toxicity in cases of high remaining uncertainty which could not be decreased by additional tests of mixtures; Recital I 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 the Regulation 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 ; 38