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Screening approach for draft Commission Notice concerning a list of potentially low-risk active substances approved for use in plant protection
The screening approach on which the list of potentially low-risk substances is based was discussed with Member States in the Working Group on low-risk substances/PPP that met on 28 June and 15 November 2017, including two rounds of written comments. The approach described below is the result of the Working Group discussion.
Information used
Information on approved active substances was extracted from the EU pesticides database. Information was then added on the following items from the sources listed:
- Classification (EFSA conclusion and/or ECHA website)
- Natural occurrence
- Persistency, BCF (EFSA conclusion)
- Neurotox / immunotox, ED (EFSA conclusion or RMS assessment report)
- Multiple antimicrobial resistance (EFSA conclusion)
- Particular conditions to take into account (EFSA conclusion, COM review report)
- Conclusion on the need for specific risk mitigation measures
Only substances approved under requirements of Directive 91/414/EEC were selected. 400 substances of which 37 micro-organisms and 363 other active substances were selected for further screening.
Stepwisescreening approach to select substances as potentially low-risk
(only performedfurther analysis on a substance when it passedthe previous step):
A. For substances that are not microorganisms:
- Excluded all substances that are (proposed) classified according to the new low-risk criteria (criterion 5.1.1.a,c) (this also covers the interim criteria for endocrine disruptors) or that are listed as priority substance under Directive 2000/60/EC (criterion 5.1.1.b). Also excluded substances listed as candidate for substitution.
- Determined whether they are naturally occurring (criterion 5.1.2).
- If yes, continued to step 3
- If not, excluded all substances that are persistent in soil (DT50 soil, lab > 60)or have a bioaccumulation factor > 100.
- Excluded substances for which there are neurotoxic or immunotoxic effects reported in the EFSA conclusion (criterion 5.1.1.d)
- Excluded substances for which it can be expected that the product would require specific risk mitigation measures. (Article 22 in conjunction with 47(1))
Step 1: Information on classification was gathered from the EU pesticides database, EFSA conclusions and the ECHA website (CLP info, RAC opinion).
Step 2:Information was gathered from the EFSA Conclusions and in some cases the RMS Assessment Report. When data on laboratory studies was not conclusive, data of field studies was taken into account. When no data was available, the substances were analysed in subsequent steps.
Step 3Information on neurotoxicity/immunotoxicity was gathered from the EFSA Conclusions. When any neurotoxic or immunotoxic effect was reported, it was decided that the substance did not pass this criterion. However, in the cases where neurotoxic effects are reported they are reported at high levels and it is not clear whether this constitutes neurotoxicity in the sense of the low-risk criteria. Therefore, the four identified cases were also analysedin step 4. All required specific risk mitigation measures, strengthening the decision to exclude them from being potentially low-risk.
Step 4 considers whether it may be expected that PPP's based on the substance will meet the conditions in Article 47 on not needing specific risk mitigation measures. This is a legal requirement of Article 22.
Although there are authorisations for products that include substances and thus in theory it could be checked in the MS where such a product is authorised whether there are specific risk mitigation measures set, this is both a very cumbersome task and also is not proportionate in comparison to the situation where the Commission has to decide on a proposal for approving a new substance as low-risk, for which obviously no authorisations are granted yet and information on actual specific risk mitigation set in practice would not be available. In current practice when evaluating the low-risk status of a new substance, the Commission derives this from the EFSA conclusion and its review report.
For these reasons we used the same approach for this exercise and use the available information on risks identified and particular conditions set in the EFSA technical report and/or the Commission's review report.When particular conditions are set because of risks identified, then this indicates a need for setting specific risk mitigation measures for the product at Member State level. When particular conditions are set because of data gaps identified, then this may or may not indicate a need for specific risk mitigation measures. These substances required case-by-case analysis to determine whether they passed this criterion or not.
Special consideration: fatty acids group and SCLP group
Fatty acids are grouped under the name "Fatty acids C7 to C20". C7 and C8 are (proposed to be) classified as Skin Corrosive 1B resp. 1C so they cannot be designated as low-risk. This only applies to the free fatty acids. The methyl ester forms are not proposed to be classified according to the EFSA Conclusion.This restriction is indicated in the Commission Notice.
SCLP's (straight chain lepidopteran pheromones) are grouped under this name. Certain subgroups are proposed to be classified as Aquatic Acute 1 and Aquatic Chronic 1. Furthermore, SCLP's in the aldehyde and alcohol subgroups are proposed to be classified as Skin Sensitiser. Such classification would indicate that these SCLP's do not meet the low-risk criteria.
However, as laid down in recital 7 of Regulation (EU) No 2017/1432 "semio-chemicals which are substances emitted by plants, animals and other organisms which are used for intra- and inter-species communication, have a target-specific and non-toxic mode of action and are naturally occurring. They are generally effective at very low rates, often comparable to levels that occur naturally. In light of current scientific and technical knowledge it is also appropriate to provide that semio-chemicals should be considered as low-risk substances."
Therefore, it is justified to further consider their classification. Considering the physical and chemical properties of pheromones, since the criteria call for "appropriate standard tests", adapted to the properties of the substances (e.g. highly volatile) as foreseen also in ECHA guidance for CLH, this raises the question whether the current tests can be considered "appropriate standard tests" for SCLP's within the context of the low-risk criteria. Moreover, since the mode of application of SCLP's is by dispensers and at concentrations that do not exceed the background level, the sensitisation classification and the aquatic toxicity classification would pose no concern for SCLP's applied in such a way.This is supported by the Guidance Document on semio-chemical active substances and plant protection products (SANTE/12815/2014)that provides for detailed identification of cases where exposure is comparable to natural exposure levels and allows for a simplified non-testing strategy for these cases.
For the reasons given above, SCLP's are included into the potentially low-risk category, but only when applied from dispensers. This restriction is indicated in the Commission Notice.
B. Microorganisms
For micro-organisms the following stepwise approach was used:
- Included all baculoviruses (criterion 5.2.2)
- Excluded all MO's that have multiple resistance to antimicrobials (criterion 5.2.1).
- Excluded all MO's that need specific risk mitigation measures (Article 22 in conjunction with 47(1)).
Step 1: information on whether a substance is a baculovirus was available in the EFSA conclusions.
Step 2applies the proposed application of the criterion "multiple antibiotic resistance" as discussed in the WG on Biopesticides of 17-18 October 2017. A micro-organism fails this criterion if it is demonstrated that it is resistant to three or more antimicrobial agents from at least three different families or classes of antimicrobial agents used as human or veterinary medicine.
Cases where no information on resistance to individual antimicrobials was available were screened further. Microorganisms were included when EFSA reported no concern, when the microorganism was listed on the EFSA Qualified Presumption of Safety list or when information was available that no transfer of resistance was to be expected. The other cases were excluded.
Step 3: the same approach was used as for the other substances. As is current practice, the general precaution for micro-organisms as potential sensitisers was not regarded as a specific risk mitigation measure.
Conclusion
For chemicals and other non-micro-organisms, 27 substances would be expected to pass the low-risk criteria and are regarded as potentially low-risk substances. These are listed in the draft COM Notice.
For micro-organisms, 30 would be expected to pass the low-risk criteria and are regarded as potentially low-risk substances. These are listed in the draft COM Notice.
In total, 57 potentially low-risk substances have been identified (including SCLP group and part of fatty acid groups- both groups each are counted as one substance). This is about 15% of the total number of screened substances (400).
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