The European Ombudsman finally acknowledged, after 7 years, the repeated complaints filed by PAN(Pesticide Active Network) Europe. And the European Commission was censured for violating rules essential to protect public health and the environment. (1)
The Brussels executive cannot be allowed to authorize risky pesticides in the absence of proper EFSA(European Food Safety Authority) assessments of safety for their intended uses. Nor can the convenient recourse to ‘further confirmation‘ coming from agrotoxin manufacturers be admitted. Nor, again, the secrecy of data regarding the nebulous procedures.
However, the European Ombudsman concludes its inquiry with some ‘suggestions‘. It is now up to the Von der Leyen Commission to adjust procedures and propose necessary reforms. And it is the responsibility of the other institutions, the European Parliament and the EU Council above all, to oversee their diligent fulfillment.
Pesticides and the precautionary principle, Regulation (EC) No. 1107/2009
The so-called Pesticides Regulation, reg. EC 1107/09, ‘lays down rules concerning the authorization, placing on the market, use and control within the Community of plant protection products, as they are presented in their commercial form‘ (Art. 1.1).
‘The provisions of this Regulation are based on the precautionary principle in order to ensure that active substances or products placed on the market do not have harmful effects on human or animal health or the environment‘ (Reg. EC 1107/09, Art. 1.4).
The precautionary principleunderpinning European environmental policy (TFEU, Article 191.1), also legitimizes the adoption by member states of additional restrictive measures, ‘When there is scientific uncertainty as to the risks to human and animal health or the environment of the plant protection products to be authorized in their territories‘ (EC Reg. 1107/09, Art. 1.4, last paragraph). As reiterated by the European Court of Justice in its ruling 8.10.20 in Case C-514/19. (3)
Active substances and potentially hazardous substances
Active substances are defined as ‘substances, including microorganisms that exert general or specific action against harmful organisms or on plants, plant parts or plant products‘ (EC Reg. 1107/09, Art. 2.2).
‘Potentially dangerous substance’ is instead ‘Any substance that is inherently capable of causing adverse effects on humans, animals, or the environment and that is contained or produced in a plant protection product in concentrations that pose a risk of such effects occurring‘ (EC Reg. 1107/09, Art. 3.4).
Active substances, safety requirements
An active substance Is approved at the European level – sine qua non For its marketing in the EU – ‘whether, in the light of current scientific and technical knowledge, it can be expected that, taking into account the approval criteria (…), plant protection products containing this active substance‘ meet the following criteria (EC Reg. 1107/09, Article 4.1).
‘Residues of plant protection products, under conditions of use consistent with good plant protection practices and taking into account realistic conditions of use, meet the following requirements:
(a) have no harmful effect either on human health, including that of vulnerable groups, or animal health, taking into account known cumulative and synergistic effects, when scientific methods accepted by the Authority to assess them are available, or on groundwater,
(b) have no unacceptable effect on the environment‘ (EC Reg. 1107/09, Article 4.2).
Plant protection products, safety requirements
‘Plant protection products’ (plant protection products in the English text of the regulation, ‘poisons’ in Veneto peasant slang), ‘under conditions of use in accordance with good plant protection practices and taking into account realistic conditions of use,’ must meet the following requirements:
(a) ‘is sufficiently effective;
(b) has no harmful effect, immediate or delayed, on human health, including that of vulnerable groups, or animal health, directly or through: drinking water (taking into account substances resulting from the treatment of drinking water), food, feed, or air; nor does it affect the workplace or through other indirect effects, taking into account known cumulative and synergistic effects, when scientific methods accepted by the Authority to assess them are available, nor on groundwater,
(c) has no unacceptable effect on plants or plant products;
(d) does not cause vertebrates [la necessità di] fight unnecessary suffering and pain,
(e) has no unacceptable effect on the environment, taking into account in particular, when the scientific methods accepted by the Authority to assess such effects are available:
(i) of its fate and distribution in the environment, particularly with regard to contamination of surface water, including estuarine and coastal waters, groundwater, air, and soil, taking into account locations distant from the place of use as a result of long-distance environmental propagation, (4)
(ii) of its impact on non-target species, including on their current behavior;
(iii) its impact on biodiversity and the ecosystem‘ (EC Reg. 1107/09, Article 4.3).
Scripted authorizations, the European Ombudsman’s investigation.
PAN Europe urged the European Ombudsman to open an investigation into the European Commission’s habit of approving the use of active substances in relation to which the European Food Safety Authority (EFSA, European Food Safety Authority), identified critical areas of concern or unsafe uses (e.g., flazasulfuron, isofetamid, picolinafen, benzovindiflupyr, and epoxiconazole). As well as the practice of approving substances for which additional data are needed to confirm their safety.
In fact, the European Commission has the function of risk management and not also that of risk assessment, i.e., scientific risk assessment, which has instead been entrusted to EFSA since the General Food Law (reg. EC 178/02) came into force. It must therefore approve only the active ingredients and in relation to only those uses evaluated as safe by EFSA. Without possibility of considering other factors, such as use hypothetically regarded as safe in one or more member countries-not specifically evaluated by EFSA.
Lack of motivation and inaccessibility of data
The European Ombudsman’s investigation then found that the European Commission does not adequately justify its approval decisions for active substances identified as critical. The lack of rationale is particularly serious in the cases under investigation, where the Brussels executive approved the use of active ingredients whose analyses did not meet the approval criteria of Regulation (EU) No. 1107/09.
The inaccessibility of data on licensing procedures is the subject of further censure to the European Commission by theEuropean Ombudsman. The texts of decisions should always specify the dutiful reasons for them, in clear language that is easily understood by the public. (5) Administrative activities must come under the principles of accountability and transparency. With good memory, it is worth adding, of the 16th but not the last of the SDGs(Sustainable Development Goals) in UN Agenda 2030.
#SDG16. Promote just, peaceful and inclusive societies.Promote peaceful and inclusive societies for sustainable development, provide access to justice for all and build effective, accountable and inclusive institutions at all levels.
Retrospective adjustments
The European executive’s maladministration is also stigmatized in the ‘ex-post adjustments’ of already granted authorizations on potentially dangerous active substances. The ombudsman censured the European Commission’s practice of requesting additional and clarifying documents (so-called ‘confirmation data’) from the manufacturer only after it had approved the substance. A dangerous habit, since in the meantime agrotoxics ‘can cause serious, even irreversible, damage to human or animal health or the environment.’ (1)
The ex-post data confirmation procedure must be used with particular caution and in strict adherence to the precautionary principle, the Ombudsman warns. Especially where applicants are not likely to be able to submit confirmation data in a short period of time. The occasion would also have been worthwhile to denounce Brussels’ inaction with respect to the overt scientific fraud on the basis of which the authorizations of glyphosate, or glyphosate, are still based (6,7,8).
Interim conclusions
The European Ombudsman’s investigation concluded with a number of ‘suggestions,’ unfortunately not legally binding. However, theOmbudsman noted how the European Commission itself, in presenting the Strategy for Biodiversity in the EU to 2030, stated a commitment to take action to reduce the overall use and risk of chemical pesticides by 50 percent by 2030. (9)
It is crucial now to reach the million signatures needed to force the European Commission to adopt a special regulation to protect bees, ecosystems and public health from the serious dangers we are still exposed to from agrotoxin abuse in the European Union. (10) We invite our readers to sign the European citizens’ initiative ‘Save the bees and the farmers!’ By grace, a
SIGN HERE
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Protecting the health of our loved ones and generations to come will always depend on our power as consumers. We choose organic food produced near us to force the supply chain to give up poisons. Keeping in mind that already 77.3 percent of surface water in Italy is contaminated with neurotoxic pesticide cocktails and other substances with endocrine disrupting actions, mutagenic and carcinogenic risks. (4)
Dario Dongo and Silvia Giordanengo
Notes
(1) European Ombudsman. Decision in joint cases 1570/2018/JF-JN and 1973/2018/JF-JN on how the European Commission approves substances used in plant protection products (pesticides). 30.11.20, https://www.ombudsman.europa.eu/es/decision/en/135628
(2) Reg. EC 1107/2009, concerning the placing of plant protection products on the market. Consolidated text as of 12/14/19 at https://eur-lex.europa.eu/legal-content/IT/TXT/?uri=CELEX%3A32009R1107&qid=1611092734251
(3) Dario Dongo, Gioele Lucchese. Pesticides, EU Court of Justice green light for national bans. Saving the bees. GIFT (Great Italian Food Trade). 7.11.20, https://www.greatitalianfoodtrade.it/progresso/pesticidi-via-libera-della-corte-di-giustizia-ue-ai-divieti-nazionali-salviamo-le-api
(4) Dario Dongo. ISPRA, 2020 report on pesticides in water. GIFT(Great Italian Food Trade). 12/24/20 , https://www.greatitalianfoodtrade.it/sicurezza/ispra-rapporto-2020-sui-pesticidi-nelle-acque
(5) The right to full access to EFSA’s risk assessment files was already affirmed by the EU General Court in its 7.3.19 judgment in Cases T-716/14 Anthony C. Tweedale v. European Food Safety Authority (EFSA) and T-329/17 Hautala and Others v. EFSA
(6) Dario Dongo. Glyphosate, European Chemical Agency Echa report overlooks the falsity of data produced by Monsanto. Corporation now on trial in the US. GIFT(Great Italian Food Trade) 17.3.17, https://www.greatitalianfoodtrade.it/consum-attori/glifosato-il-rapporto-dell-echa-agenzia-chimica-europea-trascura-la-falsità-dei-dati-prodotti-da-monsanto-la-corporation-ora-sotto-processo-in-usa
(7) Dario Dongo. Glyphosate and GMO soybeans, the big scam. Scientific study. GIFT (Great Italian Food Trade). 6.1.20, https://www.greatitalianfoodtrade.it/consum-attori/glifosato-e-soia-ogm-la-grande-truffa-studio-scientifico
(8) Dario Dongo. Glyphosate, more fraud in scientific studies produced by ‘Corporations’. GIFT(Great Italian Food Trade). 16.2.20, https://www.greatitalianfoodtrade.it/sicurezza/glifosato-altre-frodi-negli-studi-scientifici-prodotti-dalle-corporation
(9) Dario Dongo. Special – EU 2030 Biodiversity Strategy, the plan announced in Brussels. GIFT(Great Italian Food Trade). 5/31/20 , https://www.greatitalianfoodtrade.it/progresso/speciale-strategia-ue-2030-per-la-biodiversità-il-piano-annunciato-a-bruxelles
(10) Dario Dongo. #Savethebees. Let’s save the bees! European citizens’ initiative. Égalité. 15.1.21 https://www.egalite.org/savethebees-salviamo-le-api-iniziativa-dei-cittadini-europei/