Updating
the opinion related to the revision of
Annexes II and III to Council Directive
91/414/EEC concerning the placing of plant
protection products on the market
Prepared
by the Panel on Plant Protection Products
and their Residues
Environmental Fate and Behaviour studies [1]
Question number: EFSA-Q-2009-00616Adopted: 18 June 2009Summary (0.1Mb)
Summary
Opinion (0.1Mb)
The European Food Safety Authority (EFSA) asked its Panel on Plant Protection Products and their Residues to review the Opinions of the PPR Panel issued in 2006 and 2007 related to the revision of Annexes II and III to Council Directive 91/414/EEC (data requirements) concerning the placing of plant protection products on the market.
If not otherwise stated, the findings and recommendations given in the adopted EFSA 2007 Fate and Behaviour opinion (EFSA, 2007b) remain valid and applicable.
The Panel is of the opinion that the data requirement methodologies should not be too prescriptive. Also, new data may be needed due to the current development and updating of guidance documents by the Panel and other instances or due to new regulations which may include additional requirements in order to allow the application of new developments in risk assessment.
Some extra remarks and recommendations are given taking into consideration the comments provided by the Panel in its relevant Opinions made after its previous review (EFSA, 2007b):
- that data requirements for exposure calculations should not to be too detailed in the Annex II and III .
- that the recommendations related to the use of compound-specific Q10 values in the EFSA opinion (EFSA, 2007c) should be taken into consideration
- that the Panel’s conclusion that the trigger value (10%) for the formation percentages for environmental metabolites is a risk management decision should be taken into consideration
- that future developments in the area of nanomaterials used as/in plant protection products need to be considered and appropriately taken into account
Published: 20 July 2009[1] For citation purposes: Updating the opinion related to the revision of Annexes II and III to Council Directive 91/414/EEC concerning the placing of plant protection products on the market – Environmental Fate and Behaviour studies. The EFSA Journal (2009) 1173, 1-8.
Analytical methods [1]
Question number: EFSA-Q-2009-00618Adopted: 18 June 2009Summary (0.1Mb)
Summary
Opinion (0.1Mb)
The European Food Safety Authority (EFSA) asked its Panel on Plant Protection Products and their Residues to review the Opinions of the PPR Panel issued in 2006 and 2007 related to the revision of Annexes II and III to Council Directive 91/414/EEC (data requirements) concerning the placing of plant protection products on the market.
The PPR Panel considers that since the publication of it previous opinion, one OECD guidance document in the field of analytical methods has become available. This merits consideration.
Guidance Document on Pesticide Residue Analytical Methods (Series on Pesticides, No. 39; Series on Testing and Assessment, No. 72) (OECD, 2007).
The OECD document contains more detailed information concerning validation parameters e.g. on number of samples for fortification experiments. Under confirmatory techniques e.g. the characteristics of the UV spectrum, it is mentioned that samples should be spiked at the limit for quantification. The OECD (2007) document should therefore be referenced in the Annexes.
The PPR Panel cannot at present give a definitive opinion on whether or not the data requirements given in Annex II and III are sufficient to gauge risks of nanopesticides, since such an assessment would require substantial scientific efforts and time which could not be provided within the frame of the present mandate.
The PPR Panel emphasises that the recommendations given in the previous opinion are still valid.
Published: 20 July 2009[1] For citation purposes: Updating the opinion related to the revision of Annexes II and III to Council Directive 91/414/EEC concerning the placing of plant protection products on the market – Analytical methods. The EFSA Journal (2009) 1174, 1-6.
Ecotoxicological studies [1]
Question number: EFSA-Q-2009-00556
Adopted: 18 June 2009Summary (0.1Mb)
Opinion (0.1Mb)The European Food Safety Authority (EFSA) asked its Panel on Plant Protection Products and their Residues to review the Opinions of the PPR Panel issued in 2006 and 2007 related to the revision of Annexes II and III to Council Directive 91/414/EEC (data requirements) concerning the placing of plant protection products on the market.
The present opinion amends the existing opinion on Annex II & III: Ecotoxicological studies (EFSA, 2007c), revising certain aspects and adding further comments and recommendations. If not otherwise stated, the findings and recommendations given in EFSA 2007 remain valid and applicable. Therefore, the present opinion should be read together with the opinion issued in 2007 (EFSA, 2007c). The Panel reemphasises that the data requirements should be flexible enough to allow new risk assessment developments to be considered when available.
The present opinion focuses in particular on the number of animals (vertebrates) used in testing, the harmonisation of risk assessment quotients, ECx versus NOEC, risk assessment for honeybees, aquatic plants, and various issues that should be considered in future risk assessment.
Published: 15 July 2009
[1] For citation purposes: Scientific Opinion of the Panel on Plant Protection Products and their Residues on a request from EFSA on updating the opinion related to Annex II & III: Ecotoxicological studies. The EFSA Journal (2009) 1165, 1-25.
Physical and Chemical Properties [1]
Question number: EFSA-Q-2009-00619Adopted: 18 June 2009Summary (0.1Mb)
Summary
Opinion (0.1Mb)
The European Food Safety Authority (EFSA) asked its Panel on Plant Protection Products and their Residues to review the Opinions of the PPR Panel issued in 2006 and 2007 related to the revision of Annexes II and III to Council Directive 91/414/EEC (data requirements) concerning the placing of plant protection products on the market.
The present opinion is an update to the existing opinion on Annex II and III – Physical and Chemical Properties (EFSA, 2006).
The PPR Panel considers that there are no relevant new scientific findings, test guidelines or guidance documents in the field of identity, physical chemical properties and further information collectively called “physical and chemical properties” that presently merit an update of the previous opinion. Consequently an in-depth review is neither needed nor is it feasible considering the short timeline given for the mandate.
In this context the PPR Panel refers to the planned revision of the “Manual on development and use of FAO and WHO specifications for pesticides”. The data requirements for describing the identity and physical and chemical properties of pesticide active ingredients and preparations in Annex II and III refer to this Manual. The new version is expected to be available in 2010 and will have bearing on the corresponding chapters in Annex II and III, respectively.
Furthermore, the new framework regulation on pesticides may have an impact on data requirements concerning physical and chemical properties.
The PPR Panel notes that the present data requirements on Physical and Chemical Properties would not underpin a risk assessment on nanopesticides, if such products would be developed and submitted for registration. A specific mandate to cover nanopesticides as well as nanoformulations would be appropriate, but this would be a resource intensive task.
The PPR Panel emphasises that the recommendations in its previous opinion still stand.
Published: 20 July 2009[1] For citation purposes: Updating the opinions related to the revision of Annexes II and III to Council Directive 91/414/EEC concerning the placing of plant protection products on the market – Chemical and Physical Properties. The EFSA Journal (2009) 1172, 1-6.
Residues [1]
Question number: EFSA-Q-2009-00617Adopted: 18 June 2009Summary (0.1Mb)
Summary
Opinion (0.1Mb)
The European Food Safety Authority (EFSA) asked its Panel on Plant Protection Products and their Residues to review the Opinions of the PPR Panel issued in 2006 and 2007 related to the revision of Annexes II and III to Council Directive 91/414/EEC (data requirements) concerning the placing of plant protection products on the market.
The present opinion is an update to the existing opinion on Annex II & III – Residues (EFSA, 2006).
The PPR Panel notes that since the publication of it previous opinion, eight OECD test guidelines and four OECD guidance documents in the field of residues have become available and recommends this new information be thoroughly considered in the establishment of the data requirements in annexes II and III to Directive 91/414/EC .
Moreover, when the new Regulation of the European Parliament and of the Council on the placing of plant protection products on the market is in place, it may again be necessary to define additional requirements to address certain issues e.g. pesticides which may disrupt the endocrine system, safeners and synergists, co-formulants.
In addition, the PPR Panel cannot at present give a definitive statement on whether or not the data requirements given in Annex II and III are sufficient to gauge risks of nanopesticides, since such an assessment would require substantial scientific efforts and time which could not be provided within the frame of the present mandate.
The PPR Panel emphasises that the recommendations in its previous opinion still stand.
Published: 20 July 2009[1] For citation purposes: Updating the opinion related to the revision of Annexes II and III to Council Directive 91/414/EEC concerning the placing of plant protection products on the market - Residues. The EFSA Journal (2009) 1171, 1-6.