European Parliament resolution of 13 March 2019 on the draft Commission implementing regulation amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances abamectin, Bacillus subtilis (Cohn 1872) Strain QST 713, Bacillus thuringiensis subsp. Aizawai, Bacillus thuringiensis subsp. israeliensis, Bacillus thuringiensis subsp. kurstaki, Beauveria bassiana, benfluralin, clodinafop, clopyralid, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, epoxiconazole, fenpyroximate, fluazinam, flutolanil, fosetyl, Lecanicillium muscarium, mepanipyrim, mepiquat, Metarhizium anisopliae var. Anisopliae, metconazole, metrafenone, Phlebiopsis gigantea, pirimicarb, Pseudomonas chlororaphis strain: MA 342, pyrimethanil, Pythium oligandrum, rimsulfuron, spinosad, Streptomyces K61, thiacloprid, tolclofos-methyl, Trichoderma asperellum, Trichoderma atroviride, Trichoderma gamsii, Trichoderma harzianum, triclopyr, trinexapac, triticonazole, Verticillium albo-atrum and ziram (D060042/02 — 2019/2541(RSP))
Date: 2019-03-13
Institutions: Committee on the Environment, Climate and Food Safety, European Parliament
Subjects: market approval, plant health control, plant health product








C_2021023EN.01005401.xml










21.1.2021   


EN


Official Journal of the European Union


C 23/54






P8_TA(2019)0199
Active substances, including thiacloprid
European Parliament resolution of 13 March 2019 on the draft Commission implementing regulation amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances abamectin, Bacillus subtilis (Cohn 1872) Strain QST 713, Bacillus thuringiensis subsp. Aizawai, Bacillus thuringiensis subsp. israeliensis, Bacillus thuringiensis subsp. kurstaki, Beauveria bassiana, benfluralin, clodinafop, clopyralid, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, epoxiconazole, fenpyroximate, fluazinam, flutolanil, fosetyl, Lecanicillium muscarium, mepanipyrim, mepiquat, Metarhizium anisopliae var. Anisopliae, metconazole, metrafenone, Phlebiopsis gigantea, pirimicarb, Pseudomonas chlororaphis strain: MA 342, pyrimethanil, Pythium oligandrum, rimsulfuron, spinosad, Streptomyces K61, thiacloprid, tolclofos-methyl, Trichoderma asperellum, Trichoderma atroviride, Trichoderma gamsii, Trichoderma harzianum, triclopyr, trinexapac, triticonazole, Verticillium albo-atrum and ziram (D060042/02 — 2019/2541(RSP))
(2021/C 23/09)

The European Parliament,






—


having regard to Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides (1),










—


having regard to the draft Commission implementing regulation amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances abamectin, Bacillus subtilis (Cohn 1872) Strain QST 713, Bacillus thuringiensis subsp. Aizawai, Bacillus thuringiensis subsp. israeliensis, Bacillus thuringiensis subsp. kurstaki, Beauveria bassiana, benfluralin, clodinafop, clopyralid, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, epoxiconazole, fenpyroximate, fluazinam, flutolanil, fosetyl, Lecanicillium muscarium, mepanipyrim, mepiquat, Metarhizium anisopliae var. Anisopliae, metconazole, metrafenone, Phlebiopsis gigantea, pirimicarb, Pseudomonas chlororaphis strain: MA 342, pyrimethanil, Pythium oligandrum, rimsulfuron, spinosad, Streptomyces K61, thiacloprid, tolclofos-methyl, Trichoderma asperellum, Trichoderma atroviride, Trichoderma gamsii, Trichoderma harzianum, triclopyr, trinexapac, triticonazole, Verticillium albo-atrum and ziram (D060042/02,










—


having regard to Regulation (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 (2), and in particular the first paragraph of Article 17 thereof,










—


having regard to the Renewal Assessment Report of October 2017 prepared according to the Commission Regulation (EC) No 1107/2009 on thiacloprid (3),










—


having regard to Articles 11 and 13 of Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (4),










—


having regard to the motion for a resolution of the Committee on the Environment, Public Health and Food Safety,










—


having regard to Rule 106(2) and (3) of its Rules of Procedure,






Introducing the context








A.


whereas thiacloprid has been approved for use as an insecticide since 1 January 2005;










B.


whereas a procedure to renew the approval of thiacloprid under Commission Implementing Regulation (EU) No 844/2012 (5) has been ongoing since 2015 and includes the three years’ notice required; whereas the current approval period expires on 30 April 2019;










C.


whereas the approval period of the active substance thiacloprid has already been extended by Commission Implementing Regulation (EU) 2018/524 (6);










D.


whereas the Commission fails to explain the reasons for a second extension apart from stating: ‘Due to the fact that the assessment of those substances [including thiacloprid] has been delayed for reasons beyond the control of the applicants, the approval of those active substances are likely to expire before a decision on the renewal of the approval has been taken’;










E.


whereas Regulation (EC) No 1107/2009 aims to ensure a high level of protection of both human and animal health and the environment and at the same time to safeguard the competitiveness of Union agriculture; whereas particular attention should be paid to the protection of vulnerable groups of the population, including pregnant women, infants and children;










F.


whereas the precautionary principle should apply, and whereas Regulation (EC) No 1107/2009 specifies that substances should only be included in plant protection products where it has been demonstrated that they present a clear benefit for plant production and they are not expected to have any harmful effect on human or animal health or any unacceptable effects on the environment;










G.


whereas Regulation (EC) No 1107/2009 states that to speed up the approval of active substances, strict deadlines should be established for the different procedural steps, which has clearly not happened;










H.


whereas Regulation (EC) No 1107/2009 indicates that in the interest of safety, the approval period for active substances should be limited in time; whereas the approval period should be proportionate to the possible risks inherent in the use of such substances, but such proportionality is obviously lacking;










I.


whereas the active substance thiacloprid is a cyano-substituted neonicotinoid widely used to replace clothianidin, imidacloprid and thiamethoxam, which are prohibited in the Union except for use in greenhouses;










J.


whereas the formulations based on thiacloprid are sprayed in fields at a much higher rate than the previously used substances clothianidin, imidacloprid and thiamethoxam;










K.


whereas thiacloprid formulations are allowed to be used during flowering because less damage to pollinators is expected;






Endocrine disrupting properties








L.


whereas several recent studies suggest that thiacloprid has endocrine disrupting effects (7), genotoxic and cytotoxic effects (8), (9) and a neurodevelopmental impact, and is neurotoxic (10) and immunotoxic (11);










M.


whereas the active substance thiacloprid is considered to present ‘endocrine disrupting properties’ in the EU Pesticides database (12) and is a candidate for substitution;










N.


whereas the European Chemicals Agency has established the following classification and labelling for the active substance thiacloprid: ‘suspected human carcinogen and presumed human reproductive toxicant’;










O.


whereas the European Food Safety Authority published alarming and irrevocable conclusions regarding the dangerousness of thiacloprid for human health in the Renewal Assessment Report of October 2017 on thiacloprid, which was issued for public consultation (13);










P.


whereas at a meeting of the Committee on the Environment, Public Health and Food Safety of 16 June 2016, Commissioner Andriukaitis explained that the precautionary principle would prevail in case of doubt as regards the criteria for endocrine disruptors;










Q.


whereas the French environmental agency ANSES gave an unfavourable opinion regarding the active substance thiacloprid in its report on neonicotinoids of May 2018 (14), (15), (16);










R.


whereas France has banned the use of thiacloprid since September 2018 on account of its suspected carcinogenicity;






Threat to biodiversity








S.


whereas thiacloprid can be as toxic to honey bees as imidacloprid and thiamethoxam (17);










T.


whereas thiacloprid can affect the learning and memory performance of honey bees and thus the vitality of their colonies (18); whereas recent scientific data (19) shows that chronic exposure of honey bees in fields, at low concentration, to the active substance thiacloprid leads to important sub-lethal effects, such as impaired foraging behaviour, communication and navigation of those animals, which means that the question can be raised whether the use of the active substance thiacloprid is actually in compliance with Regulation (EC) No 396/2005 of the European Parliament and of the Council (20);










U.


whereas, in addition to the already known side-effects of neonicotinoids on pollinators, recent scientific publications (21) have demonstrated that the active substance thiacloprid affects the immunocompetence of honey bees, which is already considerably weakened;










V.


whereas the increase in toxicity to pollinators is the result of a cocktail effect (22) from the use of multiple pesticides and insecticides, including thiacloprid;












1.


Considers that the draft Commission implementing regulation exceeds the implementing powers provided for in Regulation (EC) No 1107/2009;












2.


Considers that the decision to register thiacloprid cannot be justified, as there is insufficient evidence to suggest that unacceptable risks to animals, food safety and pollinators will be prevented;












3.


Considers that the draft Commission implementing regulation is not based on an urgent need for the active substance thiacloprid for the purposes of agriculture in the Union;












4.


Considers that the draft Commission implementing regulation does not respect the precautionary principle;












5.


Considers it appropriate for the Commission to propose instead a special status for honey bees, which takes into account the fact that pollinators are indispensable for sustainable agriculture, for crop production and simultaneously for other wild and food-producing animals, and to propose to modify, harmonise and increase the coherence of relevant regulations in the light of this, with a view to ensuring a high level of protection for honey bees and other pollinators;












6.


Calls on the Commission to withdraw its draft implementing regulation and to submit a new draft to the committee that takes into account the chronic effect of the active substance thiacloprid on honey bees, human and animal health, and the environment;












7.


Calls on the Commission to ban, without delay, active substances in the neonicotinoid class or substances that act in the same way, including thiacloprid;












8.


Instructs its President to forward this resolution to the Council and the Commission, and to the governments and parliaments of the Member States.






(1)  OJ L 309, 24.11.2009, p. 71.

(2)  OJ L 309, 24.11.2009, p. 1.

(3)  Renewal Assessment Report prepared according to the Commission Regulation (EC) No 1107/2009, Thiacloprid, Volume 1, October 2017, https://www.efsa.europa.eu/en/consultations/call/180123

(4)  OJ L 55, 28.2.2011, p. 13.

(5)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).

(6)  Commission Implementing Regulation (EU) 2018/524 of 28 March 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances Bacillus subtilis (Cohn 1872) Strain QST 713, identical with strain AQ 713, clodinafop, clopyralid, cyprodinil, dichlorprop-P, fosetyl, mepanipyrim, metconazole, metrafenone, pirimicarb, Pseudomonas chlororaphis strain: MA 342, pyrimethanil, quinoxyfen, rimsulfuron, spinosad, thiacloprid, thiamethoxam, thiram, tolclofos-methyl, triclopyr, trinexapac, triticonazole and ziram (OJ L 88, 4.4.2018, p. 4).

(7)  Effects of commercial formulations of deltamethrin and/or thiacloprid on thyroid hormone levels in rat serum. Sekeroglu, V., 2014, https://www.ncbi.nlm.nih.gov/pubmed/22677783

(8)  In vitro investigation of the genotoxic and cytotoxic effects of thiacloprid in cultured human peripheral blood lymphocytes. Kocaman, A.Y., 2014, https://www.ncbi.nlm.nih.gov/pubmed/22730181

(9)  Investigation of the genotoxic and cytotoxic effects of widely used neonicotinoid insecticides in HepG2 and SH-SY5Y cells. Şenyildiz, M., 2018, https://www.ncbi.nlm.nih.gov/pubmed/29591886

(10)  A critical review of neonicotinoid insecticides for developmental neurotoxicity. Sheets, L.P., 2015, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4732412/

(11)  Effects of thiacloprid, deltamethrin and their combination on oxidative stress in lymphoid organs, polymorphonuclear leukocytes and plasma of rats. Birsen Aydin, 2011, https://www.sciencedirect.com/science/article/abs/pii/S0048357511000617

(12)  https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/active-substances/?event=as.details&as_id=841

(13)  https://www.efsa.europa.eu/en/consultations/call/180123

(14)  Risques et bénéfices relatifs des alternatives aux produits phytopharmaceutiques comportant des néonicotinoïdes, Tome 1 — Rapport du groupe de travail Identification des alternatives aux usages autorisés des néonicotinoïdes. Rapport d’expertise collective, Mai 2018, https://www.anses.fr/fr/system/files/PHYTO2016SA0057Ra-Tome1.pdf

(15)  Risques et bénéfices relatifs des alternatives aux produits phytopharmaceutiques comportant des néonicotinoïdes, Tome 2 — Rapport sur les indicateurs de risque. Rapport d’expertise collective, Mai 2018, https://www.anses.fr/fr/system/files/PHYTO2016SA0057Ra-Tome2.pdf

(16)  Risques et bénéfices relatifs des alternatives aux produits phytopharmaceutiques comportant des néonicotinoïdes, Tome 3 — Rapport d’appui scientifique et technique sur l’impact agricole. Rapport d’expertise collective, Mai 2018, https://www.anses.fr/fr/system/files/PHYTO2016SA0057Ra-Tome3.pdf

(17)  https://www.farmlandbirds.net/en/content/acetamiprid-and-thiacloprid-can-be-toxic-honey-bees-imidacloprid-and-thiamethoxam?page=1

(18)  https://www.ncbi.nlm.nih.gov/pubmed/28819056

(19)  https://pubs.acs.org/doi/abs/10.1021/acs.est.6b02658?journalCode=esthag

(20)  Regulation (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).

(21)  https://www.sciencedirect.com/science/article/pii/S0022191016300014

(22)  Traynor, K.S., Pettis, J.S., Tarpy, D.R., Mullin, C.A., Frazier, J.L., Frazier, M., van Engeldsorp, D., ‘In-hive Pesticide Exposome: Assessing risks to migratory honey bees from in-hive pesticide contamination in the Eastern United States’, Scientific Reports 6, 15 September 2016, http://www.nature.com/articles/srep33207