2021/2128(DEC) | [ParlTrack]

Draft opinion
Paragraph 1

1. Welcomes the contribution of the European Food Safety Authority (the 'Authority') to the safety of the Union food and feed chain, and ~~its considerable~~to improving animal welfare, urges the Authority to step up its efforts in providing risk managers with timely, comprehensive, independent and up-to- date scientific advice on questions linked to the food ~~chain,~~and feed chain, and to communicating more clearly to the public on its outputs and the information ~~on which they are based, and cooperating with interested parties and institutional partners~~and sometimes lack thereof on which they are based, to promote coherence and trust in the food safety system;

Amendment 10 #

Draft opinion
Paragraph 5

5. Recalls that, in 2020, Parliament adopted nine objections to the import of genetically modified crops for food and feed; highlights that one reason for these objections are gaps in the risk assessment undertaken by the Authority's Panel on Genetically Modified Organisms; urges the Authority to address and close these gaps as a matter of urgency the EU’s risk assessment for genetically modified crops for food and feed is one of the strictest in the world, providing Member States and the public with many opportunities for input, and that products passing the Authority's independent safety assessment should have fair market access;

Amendment 11 #

Draft opinion
Paragraph 5 a (new)

5a. Recalls that, in 2020, Parliament adopted two objections to extensions of approval periods of active ingredients used in pesticides which meet the cut-off criteria and should therefore not be authorised for use in the EU1a; urges the Authority to speed up its assessment of all draft review reports of active ingredients and to do all it can to speed up the reassessment process by the Reporting Member States in order to avoid any new extensions of hazardous pesticides, stresses that the backlog in reassessing biocides is of particular concern as well and increased efforts are needed to resolve this; _________________ 1aEuropean Parliament resolution of 26 November 2020 on Commission Implementing Regulation (EU) 2020/1511 of 16 October 2020 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances amidosulfuron, bifenox, chlorotoluron, clofentezine, clomazone, cypermethrin, daminozide, deltamethrin, dicamba, difenoconazole, diflufenican, fenoxaprop- P, fenpropidin, fludioxonil, flufenacet, fosthiazate, indoxacarb, lenacil, MCPA, MCPB, nicosulfuron, paraffin oils, picloram, prosulfocarb, sulphur, triflusulfuron and tritosulfuron (OJ C 425, 20.10.2021, p. 87) and European Parliament resolution of 10 June 2021 on Commission Implementing Regulation (EU) 2021/745 of 6 May 2021 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances aluminium ammonium sulphate, aluminium silicate, beflubutamid, benthiavalicarb, bifenazate, boscalid, calcium carbonate, captan, carbon dioxide, cymoxanil, dimethomorph, ethephon, extract from tea tree, famoxadone, fat distillation residues, fatty acids C7 to C20, flumioxazine, fluoxastrobin, flurochloridone, folpet, formetanate, gibberellic acid, gibberellins, heptamaloxyloglucan, hydrolysed proteins, iron sulphate, metazachlor, metribuzin, milbemectin, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, plant oils/rape seed oil, potassium hydrogen carbonate, propamocarb, prothioconazole, quartz sand, fish oil, repellents by smell of animal or plant origin/sheep fat, S- metolachlor, Straight Chain Lepidopteran Pheromones, tebuconazole and urea (not yet published in the Official Journal) .

Amendment 12 #

Draft opinion
Paragraph 5 a (new)

5a. Recalls the judgment of the Court of Justice of 1 October 2019 in Case C- 616/171a stating that “it is the duty of the competent authorities, in particular, to take account of the most reliable scientific data available and the most recent results of international research and not to give in all cases preponderant weight to the studies provided by the applicant.” _________________ 1aJudgment of the Court of Justice of 1 October 2019, Criminal proceedings against Mathieu Blaise and Others, C- 616/1, ECLI:EU:C:2019:800, paragraph 94

Amendment 13 #

Draft opinion
Paragraph 5 b (new)

5b. Deplores that, despite Regulation (EC) No 396/2005 of the European Parliament and of the Council1a and Regulation (EC) No 1107/2009 of the European Parliament and of the Council1b providing that known cumulative and synergistic effects need to be taken into account, the Authority still does not have an operational and science- based methodology to assess and prevent such effects; insists that the assessment of cumulative and synergistic effects must be a precondition for any pesticide approval; underlines that the protection of European citizens and the environment from cocktail effects is a core commitment of the with the Chemical Strategy for Sustainability; further stresses that the strategy proposes the establishment of a Mix Assessment Factor (MAF) as the appropriate tool to assess these effects; calls for the immediate implementation of an MAF to pesticides; _________________ 1aRegulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1). 1bRegulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1)

Amendment 14 #

Draft opinion
Paragraph 5 b (new)

5b. Stresses that under no circumstances should the approval period of Glyphosate be extended after its expiration date of 16 December 2022;

Amendment 15 #

Draft opinion
Paragraph 5 c (new)

5c. Demands a full, independent and completely transparent risk assessment of glyphosate, taking into account all available scientific evidence from international organisations such as the IARC and from peer-reviews independent scientific literature, as well as the sustainability goals of the Green Deal and the Farm to Fork Strategy;

Amendment 16 #

Draft opinion
Paragraph 5 c (new)

5c. Considers that it is the role of the Authority to actively look for high-level experts and convince them to take part in its work, by acknowledging the relevance and reliability of their peer-reviewed research when conducting its own scientific analysis;

Amendment 17 #

Draft opinion
Paragraph 6

6. Invites the Commission to grant the Authority, in duly justified cases, the option of hiring contract agents in excess of the establishment plans, for a limited period of time and without exceeding the Authority’s agreed annual budget envelope; considers that such flexibility would speed up the reduction of the cumulated backlog of work that has arisen owing to a lack of human resources; insists that those contract agents obviously need to comply with the Authority’s independence rules;

Amendment 18 #

Draft opinion
Paragraph 6

6. Invites the Commission to grant the Authority, in duly justified cases, the option of hiring contract agents in excess of the establishment plans, for a limited period of time and without exceeding the Authority’s agreed annual budget envelope; considers that such flexibility would speed up the reduction of the cumulated backlog of work ~~that has arisen~~and the belated completion of ongoing dossiers owing to a lack of human resources;

Amendment 19 #

Mick WALLACE

Draft opinion
Paragraph 6 a (new)

6a. Reiterates its regrets that the research funding from companies falling under Authority's remit is not considered relevant to the cooling-off period, as long as amounts at stake do not rise above 25% of the total research budget managed by the expert and/or their research team, and that the threshold is applied to individual sources as opposed to all private sources combined; calls again for this policy to be updated without delay in order to remove the funding threshold from Authority's independence policy and ensure experts' interests are considered within the context of Authority's overall remit, in line with the Parliament's repeated requests on the matter;

Amendment 2 #

Draft opinion
Paragraph 1

1. Welcomes the contribution of the European Food Safety Authority (the 'Authority') to the safety of the Union food and feed chain, ~~and its considerable~~believes that the Authority should increase its efforts in providing risk managers with comprehensive, independent and up-to- date scientific advice on questions linked to the food chain, communicating clearly to the public on its outputs and the information on which they are based, and cooperating with interested parties and institutional partners to promote coherence and trust in the food safety system;

Amendment 20 #

Draft opinion
Paragraph 6 a (new)

6a. Regrets that the new independence policy has not led to any tangible change in the Authority’s policy to select experts and in the working groups composition; exposes for instance that in the context of the working group on the bee guidance revision, only 25% of the experts were scientists publishing on bees and pesticides and that among the experts heard by this working group, 50% of them presented an evident conflict of interest due to their affiliation to "contract research organisations”;

Amendment 21 #

Draft opinion
Paragraph 6 b (new)

6b. Considers that, four years after the updating of the Authority’s independence policy, its limits in addressing properly the main independence loopholes have become evident; stresses that the Authority's scientific conclusions are sometimes openly contradicted by high- level scientists; notes with concern that these continuous controversies around conflicts of interest severely undermine the scientific reliability and credibility of the Authority; recalls that the Authority has under its mandate matters of crucial interest for the health of European citizens as well as the protection of the environment;

Amendment 22 #

Draft opinion
Paragraph 6 b (new)

6b. Deplores the Authority's general lack of transparency towards stakeholders; calls for the creation of a public database to monitor the risk assessment of all substances, such as suspected endocrine disruptors;

Amendment 23 #

Draft opinion
Paragraph 6 c (new)

6c. Calls for a post 5-year independent review of the Authority's independence policy and for appropriate action to be taken on the basis of the conclusions drawn, including a comprehensive reform in 2022; recommends in this context the evaluation of all the industrial interests (in the remit of the Authority and beyond) of board members and experts, the extension of the cooling-off period to 10 years, the implementation of the 25 % threshold of tolerated research funding to expert’s all cumulated funding and for the extension of the scope of private funding to the public-private partnerships; considers the Authority’s independence policy should also apply to all hearing experts and speakers in open conferences;

Amendment 24 #

Draft opinion
Paragraph 6 d (new)

6d. Asks the Authority to publicly commit to carry out an independent and transparent risk assessment of glyphosate, taking into account all available scientific evidence from peer-reviewed independent literature reporting adverse effects of the substance on human health and the environment; calls on the Authority to timely publish its risk assessment opinion over the course of 2022 to avoid any extension of the approval of the substance after its expiration mid-December 2022;

Amendment 25 #

Draft opinion
Paragraph 6 e (new)

6e. Deplores the Authority's general lack of transparency towards stakeholders; calls for the creation of a public database to monitor the risk assessment of all substances, such as suspected endocrine disruptors;

Amendment 26 #

Draft opinion
Paragraph 7

7. Notes with satisfaction that the Authority is moving towards cutting-edge technologies, incorporating new a~~pproach~~lternative methodologies and artificial intelligence to ~~avoid animal testing methods~~supplement animal testing methods; recognizes that the Authority along with ECHA and ECDC and five other agencies performed stress tests of their information and communications technology (ICT) systems before launching full teleworking arrangements which gave further assurance on the functioning of the ICT systems before the move to comprehensive teleworking;

Amendment 27 #

Draft opinion
Paragraph 7

7. Notes with satisfaction that the Authority is moving towards cutting-edge technologies, incorporating new approach methodologies and artificial intelligence to avoid animal testing methods, encourages the Authority to increase its efforts to protect animal welfare even further and to promote the use of non-animal testing methods, also in its cooperation with other institutions;

Amendment 28 #

Draft opinion
Paragraph 7

7. Notes with satisfaction that the Authority is moving towards cutting-edge technologies, incorporating new approach methodologies in the risk management process and artificial intelligence to avoid animal testing methods;

Amendment 29 #

Draft opinion
Paragraph 7 a (new)

7a. Regrets that the new 2017 independence policy of the Authority has not led to any tangible change in its selection policy of external experts and in its working groups composition; notes for example that in the working group on the bee guidance revision, only 25% of the selected experts were publishing scientists on bees and pesticides; notes that among the experts heard by this working group, 50% of them presented an evident conflict of interest due to their affiliation to "contract research organisations”.

Amendment 3 #

Draft opinion
Paragraph 1 a (new)

1a. Believes that the Authority should continue to pay special attention to public opinion, and commit itself to increased openness, transparency and scrutiny to and by the public and independent scientists;

Amendment 30 #

Draft opinion
Paragraph 8 a (new)

8a. Considers that it is the role of the Authority to look actively for high-level experts and convince them to take part in its work, by acknowledging the relevance and reliability of their peer-reviewed research when conducting its own scientific analysis in line with article 8 (5) of Regulation (EC) No 1107/20091a. _________________ 1aRegulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).

Amendment 31 #

Draft opinion
Paragraph 9

9. SEncourages higher transparency towards stakeholders especially from the NGO community; supports the Authority’s strategic objective to further foster partnerships with other agencies, as well as with international organisations and third countries, towards an One Health Union ecosystem, while continuing its engagement with its stakeholders and the public through appropriate platforms and fora, which should result in further economies of scale;

Amendment 32 #

Draft opinion
Paragraph 9 a (new)

9a. Points out that 2020 was an exceptionally challenging year for the European Food Safety Authority in the light of the ongoing pandemic, as it was for a number of other institutions; welcomes in this context the volume of work that the Agency turned out in these difficult conditions;

Amendment 33 #

9a. Recognises the efforts of the Agency to alleviate concerns in relations to the conflict of interests of its employees; notes that conflict of interests standards can be further strengthened;

Amendment 34 #

Draft opinion
Paragraph 9 b (new)

9b. Welcomes the progress made in implementing Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain; highlights in this regard the importance of the close involvement of stakeholders and the public from the very early stages of the risk assessment process;

Amendment 35 #

Draft opinion
Paragraph 9 c (new)

9c. Welcomes the completion of the EU summary report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food, on which the Authority collaborated with the European Centre for Disease Prevention and Control; highlights in this regard the problem of the increasing resistance of these bacteria to commonly used antibiotics;

Amendment 36 #

Draft opinion
Paragraph 9 d (new)

9d. Welcomes the information that the Authority continues to monitor residual veterinary medicinal products and other substances in livestock and animal products; considers that the limits on the content of these substances should be progressively revised on the basis of scientific knowledge and the precautionary principle, taking account of human health and the impact of these substances on the environment;

Amendment 37 #

Draft opinion
Paragraph 9 e (new)

9e. Highlights the importance of a responsible, ethical and up-to-date, science-based approach to improving animal welfare; welcomes in this regard the Authority’s work on the preparation of the Farm to Fork strategy;

Amendment 38 #

Draft opinion
Paragraph 9 f (new)

9f. Welcomes the growing number of quotations of the Authority’s scientific outputs, which exceeded 50 000, a more than twofold increase on 2019;

Amendment 39 #

Draft opinion
Paragraph 9 g (new)

9g. Welcomes the specific steps taken by the Authority on the path to environmental sustainability; takes particular note of the inclusion of the principle of environmental sustainability in the draft EFSA Strategy 2027;

Amendment 4 #

Anja HAZEKAMP

Draft opinion
Paragraph 1 b (new)

1b. Reiterates its regrets that the Authority, in relation to the two-year cooling-off period, still includes in its independence policy the obligation to screen experts' interests only in relation to the mandate of the scientific group to which the expert is applying, and reiterates its regrets that the research funding from companies in the Authority's remit is not considered relevant to the cooling-off period as long as amounts at stake do not rise above 25 % of the total research budget managed by the expert and/or their research team, and that the threshold is applied to individual sources as opposed to all private sources combined1a; highlights that the Authority's refusal to address these two very serious issues in relation to the Authority's prevention and management of conflicts of interests is unacceptable and needs to be resolved immediately; _________________ 1a Decision (EU, Euratom) 2021/1598 of the European Parliament of 28 April 2021 on discharge in respect of the implementation of the budget of the European Food Safety Authority for the financial year 2019 (OJ L 340, 24.9.2021, p. 284).

Amendment 40 #

Draft opinion
Paragraph 9 h (new)

9h. Welcomes the completion of the first assessment of a novel food, dried yellow meal worm, which has thus officially become a food; highlights in this regard the undeniable importance of novel foods on the path to food sustainability;

Amendment 41 #

Draft opinion
Paragraph 11

11. ~~Recommend~~Conditions, based on the facts available, th~~at discharge be granted~~e grant of discharge to the Executive Director of the European Food Safety Authority in respect of the implementation of the Authority's budget for the financial year 2020, to new commitments in terms of independence policy and management of conflict of interests.

Amendment 42 #

Draft opinion
Paragraph 11

11. Recommends, based on the facts available, that discharge should not be granted to the Executive Director of the European Food Safety Authority in respect of the implementation of the Authority's budget for the financial year 2020.

Amendment 5 #

Draft opinion
Paragraph 2

2. Notes that the Authority's final budget for 2020 was EUR 103 023 255,80, and underlines that the entire sum derives from the Union budget and this contributes to Authority's independence; notes that the budget monitoring efforts during 2020 resulted in an implementation rate of 100 % for commitment appropriations and 88 % for payment appropriations; insists that the Authority be granted sufficient resources to carry out its tasks;

Amendment 6 #

Draft opinion
Paragraph 4

4. Highlights that, in 2020, the Authority finalised 697 questions through scientific opinions, technical reports and supporting publications; welcomes the Authority's timely support to policy makers in providing scientific outputs following on mandates given by the European Parliament, mainly in the areas of animal health and welfare, bee health, welfare of rabbits, animal transport and antimicrobial resistance;

Amendment 7 #

Draft opinion
Paragraph 4

4. Highlights that, in 2020, the Authority finalised 697 questions through scientific opinions, technical reports and supporting publications; notes that, although there were 83 fewer questions than planned, in the context of the difficult conditions and the plan updated in October to complete 710 questions, the Authority worked efficiently;

Amendment 8 #

Draft opinion
Paragraph 4

4. Highlights that, in 2020, the Authority finalised 697 questions through scientific o~~pinion~~utputs, technical reports and supporting publications, including external scientific and event reports;

Amendment 9 #