Kasvinsuojeluteollisuus ry
KASTE
Kasvinsuojeluteollisuus ry KASTE seuraa lainsäädäntö- ja muita toimenpiteitä, niiden valmistelua ja täytäntöönpanoa sekä muuta kehitystä ja tapahtumia, joilla on kasvinsuojeluainealalle merkitystä.
ID: 871889015169-23
Lobbying Activity
Response to Criteria to identify endocrine disruptors for plant protection products
27 Jul 2016
Comments of the Finnish Crop Protection Association KASTE and the Finnish Seed Traders´ Association:
We support the Commission proposal, that in risk assessment under the derogations, both exposure and hazard shall be considered. We agree, that risk management overall falls in the mandate of the Commission, and because risk management is dependent on technical and scientific development and knowledge, the Commission has mandate for the proposed derogations. Risk assessment is a vital part of assessing the properties (e.g. ED) of an AS.
We believe, the EDs should be assessed considering risk elements as stated by EFSA Scientific committee and the BfR consensus paper.
The purpose of 1107/2009 is to maintain high level of protection for human health and the environment. When assessing an AS, the focus is what effects the PPP product may have when it is actually used. Legal security and proportionality aspects require, that hazard based approach without risk assessment and the application of cut off –criteria shall be used only when it is evident, “acte eclaire”, that the AS does not qualify for approval in the EU. Thus, only if there would be no safe use for the product after any risk mitigation measures.The ratio of hazard based approach under PPPR is to save costs by taking off those AS, which for sure would not qualify in risk assessment to be approved as PPP for any safe use. Hazard based approach and the cut off-procedure should not be applied, if the outcome by carrying out the risk assessment would be different.
Assessing ED (or other characteristics of a compound) for statistical or toxicological purposes, the assessor may use the pure hazard based approach or any sort of classification, and ignore the hazard characterization elements (severity, reversibility, lead toxicity) which are linked to actual risk. However, using the results for decision making on an active ingredient – yes or no -, risk (exposure X hazard) should be the final criterion, and in the characterization of hazard, those elements which are linked to risk (potency, severity, reversibility, lead toxicity) shall be taken into account. WHO definition on ED is based on the i) presence of an adverse effect, ii) the mode of action and iii) the causal link between adverse effect and the mode of action. This approach, however, fits for characterization of compounds per se, but is not good enough for decision making – approval under 1107/2009 – where all the risk elements, inter alia potency and exposure, shall be taken into consideration
We believe that when determining hazard, not only the adverse effect(s), but also potency, severity, reversibility and lead toxicity shall be taken into account.
We believe the EDs defined in accordance with WHO definition, are so wide and diffuse group of compounds, which it is not possible to administer in regulatory systems (PPPR, BPR) without a comprehensive risk assessment, AS by AS, where all elements influencing the actual risk are considered.
We are very concerned that unless the risk assessment is not fully implemented, the Finnish farmers will be left without the tools they need for growing cereals potato. Furthermore, we are of the opinion, that the consequences of the risk assessment must be reasonable from the social impacts point of view. The society (EU) must not deprive farmers their livelihood.
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