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Bianca Puleo

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Diederik Pierani

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THE CONTEXT

Organic production does not allow the use of pesticides, fertilizers or any synthetic herbicides. However, their widespread use among most farmers creates an ever-present risk of contamination of the entire food chain. Pesticides travel through air, groundwater and flowing water, and are transferred through handling in the food chain or persist for a long time in the environment. Food production, on the other hand, is an open system. In addition, the enormous progress in analytical studies makes the detection of residue and contaminants even more frequent than in the past. Organic operators are thus faced with a constant threat of contamination and limitations to their freedom of business: they have the responsibility to protect their activities through proportionate and appropriate precautionary measures within their control. However, due to the ever-present pollution resulting from non-biological agricultural activities of the past or the present, the risk of contamination, decertification and product blocking is constantly present. It should also be acknowledged that all parties concerned are aware that residues are sometimes unavoidable and sources and causes cannot always be determined, even with the best efforts by organic farms, certification bodies and regulatory authorities. Organic operators are not to blame for this and the inevitable contamination in organic production should not have any influence on the biological status, because it does not represent an automatic violation of the law.

RESPONSIBILITIES OF OPERATORS

UE Reg 2018/848 requires specific actions concerning suspicion of non-compliance with Article 27 and precautionary measures to avoid the presence of products and substances not authorised under Article 28. Organic operators must do what is under their control, proportionate and appropriate to their activities (Recital 68) to avoid the presence of residues in organic products and are the first who want a solid control system to create a climate of trust between operators and consumers, but this control system must be effective and efficient. It should be avoided that for every presence, even if it is not a well-founded suspicion, an official procedure is initiated, which consumes considerable resources on the part of organic operators, certification bodies, regulatory authorities and competent authorities. This is why each operator must commit , within its Manual of Self-control, to carry out a risk analysis that, as a minimum:

    • Indicates, depending on their sector, the type of verification, the duration of the controls, the number and the object of the testing (mainly on suppliers of raw materials and packaged products, especially if branded).
    • Identifies the critical period for an inspection and analysis programme based on the geographical site and the crop in being grown. Makes specific check lists for inspections to producers, warehouses, contractors, outsourced parties, etc. with specific points dedicated to the mitigation measures taken by the suppliers themselves.
    • Carries out a risk plan on the field based on the situation of each border, also following the TR of the operator or the Certification Body, with specific indications on the management of edges (for fruit and vegetables).
    • Indicates the active substances to search for and the type of the different matrices (soil, leaves, fruit, seedlings for transplantation, substrates, other technical means, irrigation water, etc.) depending on the sampling plan.
    • Identifies the practical measures (corrective and preventive actions) to be implemented when each type of suspicion of presence is detected, whether confirmed or not (e.g. this practice).

It is essential that these measures are proportionate and appropriate to identify and avoid the risks of contamination (in the production, processing and packaging of organic products) with unauthorised products or substances and that these same measures are regularly reviewed, revised and adapted to the needs and circumstances. This risk analysis must be shared – evaluated and approved – during the inspection visit with their Certification Body.

SUSPICION OF NON-COMPLIANCE

The laboratory conducting the analyses must be accredited, as well as the molecule test, and there must be confirmation of the batch analyzed. In case of suspicion of non-compliance based on the presence of an unauthorised substance, provided that the analytical result and sampling are verified as correct and relevant, the operator must follow appropriate procedures, as specified in art. 27 and 28 of Regulation (EU) 2018/848. The specific product must be identified, separated, and isolated. It must not be marketed as an organic product.

The operator is responsible for checking whether the suspicion can be justified or eliminated. According to the Italian leg. decree 148/2023 the operator is obliged to notify its Certification Body. Instead, in our opinion the operator should make the first assessment to determine whether the suspicion can be eliminated or proven. This degree of flexibility is outlined in Article 28, paragraph 2, specifically in point b) and in the implementing regulation (EU) 2021/279, Article 1. This possibility is crucial as it suggests that the presence of unauthorized substances does not always trigger an investigation by the Certification Body.

The operator shall inform the CB or the CA only when the suspicion cannot be eliminated or is proven. This helps operators save resources and relieves certification bodies and competent authorities from investigating common environmental pesticides and other well-known contaminants that are not relevant to organic production.

Operators are required to adopt internal decision-making strategies (systems of quality, legality and authenticity assurance) agreed and controlled by the certification authority that could be complemented by shared (but not mandatory) guidance tools. Certification bodies and competent authorities should prioritize the inspection and monitoring of this comprehensive system of guarantees in their controls.

PRINCIPLES TO BE APPLIED

In accordance to art. 27 and 28 par. 2 of the basic regulation and art. 1. of Reg. 2021/279 the internal evaluation of each operator (as also established in article 38 of Reg. 2018/848) could be supplemented by a guidance tool based on the experience of other surveys and scientific studies. This tool could predict, for example:

  1. identification of the main and/or secondary source or cause of contamination
  2. verification of a potentially intentional contamination (unauthorised, off-market, withdrawn products, mixing with other products)
  3. verification of a potentially accidental contamination (verifiable deviations, presence in soil, metabolisation during various processes, uselessness)
  4. context study: pollution of air, surface water and groundwater, the area, the neighbouring area, the various manipulations carried out
  5. compatibility with the crop (both as a type and as a period) or alternative uses and purposes of the same active substance
  6. verification of the mitigation measures implemented by each manufacturer to protect against deviations and other potential contamination.
  1. acquisition of all necessary information, including relevant details or documents, including from producers and suppliers internal and external to the facts
  2. collection of all available scientific documentation and also the latest statistics on the subject (from laboratories, research, media, etc.)
  3. analysis of transport, storage, conditioning, process, packaging, supply chain and other aspects involved
  4. verification of known cases of fraud (or other breaches of security, legality and authenticity of the product)
  5. collection of information available on the net (Google Alert) or from associations (Assobio, Federbio, etc.), on the protagonists involved

SHARED CASES

The operator, only at this point, should notify the presence to the CB/CA if there is a well-founded suspicion or if the suspicion cannot be eliminated. If suspicion is dispelled after following the prescribed steps, which may include using a guidance tool, the operator must record the findings and rationale for the decision, such as referencing scientific literature. The product may then be used or marketed as organic, provided there are no other risks to human health. It is the task of the CB/CA to verify during the regular checks whether the case is properly documented and whether the suspicion has been removed for valid reasons.

GUIDE TOOL

Operators can alleviate suspicion by documenting the case and circumstances thoroughly, considering the following elements:

  • the detected substance is present naturally in the product or derives from a processing technique
  • the detected substance is used against a non-existent disease in the crop species concerned
  • the substance detected is not allowed in the cultivated species concerned – whereas the authorisation of a pesticide for a specific crop may vary from country to country – or is not allowed at all in the EU
  • proven cases of false positive laboratory results
  • environmental pollution from POPs (persistent organic pollutants)
  • detection of substances derived from human health measures/products used or from water treatment
  • proven and well-documented cases of systematic and inevitable contamination due to deviations of the conventional

POSSIBLE DEVELOPMENTS

It is clear that what provided until now mainly involves the operators. However, operators would greatly benefit from a standardized approach to evaluating waste cases, particularly in collaboration with their certification bodies. These shared guidelines should also take into account the experience gained during investigations, the continuously advancing scientific findings and national and international statistics on residue cases.

Operators, as well as CBs/CAs, technical inspectors, testing laboratories, and all customers and consumers, would find a new guidance tool extremely useful in directing their actions. This tool could assist in determining, using universally accepted criteria, whether a suspect can be removed in a justified manner.

This guidance tool should meet the following criteria:

  • predicting, observing, measuring the most common residues detected and their origin, by crop species
  • analysing the most recent available agronomic insights: – Does the active substance being analyzed have practical application in the relevant culture or food, meaning, does its usage make sense in terms of agriculture or technology? – Are there several possible uses/purposes for the active substance? – What other sources of the active substance are possible?
  • having recent scientific studies available
  • monitoring the frequency of contamination
  • studying the characteristics of national/regional contamination in the environment
  • adopting specific criteria (applicable to specific operators), e.g. – regional soil and climatic conditions, – production criteria (transport, storage, supply chain), – known cases of fraud
  • considering transformation factors, when applicable
  • finally, the tool must be available free of charge for operators and CBs/CAs.

CASES WHERE SUSPICION MAY BE REMOVED BY THE OPERATOR

  1. the substance is naturally present in the product or derives from a processing technique

  2. the substance is used for a non-existent pathogen in the species concerned

  3. the substance is not allowed in the cultivated species concerned or is not allowed in the EU

  4. proven cases of false positive laboratory results

  5. environmental pollution from POPs (persistent organic pollutants)

  6. substances from human health products or water treatment

  7. proven and documented cases of deviation from near to short and long distance

  8. the substance is contained but not declared in technical means available on the market

  9. the substance is derived from known structural conditions (and regulated by derogations)