Workshop Assessment of Persistent, Bioaccumulative and Toxic (PBT) substances in different EU legislations

Transcription

1 Workshop Assessment of Persistent, Bioaccumulative and Toxic (PBT) substances in different EU legislations Assessment under the Plant Protection Products Regulation Brussels, 17 December 2014

2 PBT assessment under EU legislation on Plant Protection Products Scope of this presentation is to illustrate: A. How PBT properties are assessed for Plant Protection Products B. Differences with REACH and Biocides C. Approaches for harmonization across sectors 2

3 Reg. (EC) N. 1107/2009 on Plant Protection Products A two steps process: Active substances evaluated for possible approval at EU level Plant Protection Products (i.e. formulations containing approved active substances) assessed for possible authorization at Member State level 3

4 Applicant PBT assessment of Plant Protection Product RMS Dossier on active substance and representative use Draft Assessment report (DAR) Assessment of PBT properties (exclusion criteria AND risk assessment) MS/EFSA EFSA Conclusion COM Legislative proposal SFCoFCAH Vote Applicant Dossier on supported uses MS Risk Assessment (considering PBT properties) Active substance approved or non-approved Plant protection product authorized or non-authorized 4

5 Reg. (EC) N. 1107/2009 & PBT assessment 1. Exclusion criteria: active substances identified as PBT are not approved (no derogations applicable) 2. Substitution criteria: active substances meeting 2outof3PBTcriteriaare approved as candidates for substitution 3. Risk assessment: if 1) & 2) not met P, B and T properties are anyhow evaluated to assess whether the active substance shall be approved or not 5

6 1. Exclusion criteria Criteria to identify PBT, persistent organic pollutants (POP) and very persistent very bioacculative (vpvb) substances are set in Annex II to Reg. 1107/2009 for active substances, synergists and safeners If the PBT, POP or vpvb criteria are met Risk assessment is not carried out in further details Substance not approved 6

7 2. Substitution criteria Meeting 2 out of 3 of the PBT criteria triggers inclusion in list of candidates for substitution Regulatory consequences: Approved for 7 years instead of 10 years Shorter period of authorization Exception to mutual recognition MS must carry out comparative assessment of products containing active substances included in list of candidates for substitution 7

8 3. Peer-reviewed risk assessment & Rapporteur Member State, Member States and EFSA evaluate P, B and T properties in various sections of peer-reviewed risk assessment to check if criteria for approval are met Metabolites are considered for their relevance 8

9 SANCO working document on the evidence needed to identify POP, PBT and vpvb properties for pesticides Following 2 expert meetings, the working document was noted at Standing Committee for Food Chain and Animal Health, November 2012 It contains different recommendations on how to assess PBT properties for: initial establishment of a list of candidates for substitution peer-reviewed risk assessment of Plant Protection Products 9

10 Which recommendations are given in the SANCO working document? Recommendations on when/how to use specific type of studies, data, values, models, averages, normalization E.g. for: Field dissipation/laboratory studies Hydrolisis/biodegradation/photolysis data Geomean/worst case values Single 1st order kinetics Temperature normalization (20 C/12 C) 10

11 Criteria PBT identification: REACH, Pesticides and Biocides Criteria substantially the same Differences in way criteria are applied, i.e. in evidence used to identify PBT Reasons : 1) regulatory framework 2) data requirements (amount & type of data) differ among sectors 11

12 1) Different regulatory framework among sectors REACH: even SVHC will undergo a risk assessment Biocides: important derogations to the exclusion criteria apply (i.e. in case of negligible risk or of disproportionate negative impact on society) Plant protection products: PBT identification triggers hazard-based exclusion criteria (no derogations) 12

13 1) Different regulatory frameworks explain one the main differences among sectors: Reg. 1107/2009: metabolites not considered for identification of substance as PBT Reason: a minor metabolite (e.g. with irrelevant exposure to humans/environment) would trigger ban of safe parent compound, as no exposure considerations are foreseen in hazard-based exclusion criteria However, metabolites are considered in the risk assessment and, when relevant, they trigger non-approval of the parent compound 13

14 2) Specific data requirements for Plant Protection Products explain other important differences among sectors: Temperature: depending whether old/new data requirements apply, T is normalized at 20 C or not normalized (reference to ECHA GD for water systems) Animal species considered for bioconcentration: Annex II to Reg. 1107/2009 considers exclusively aquatic species, while update of REACH in 2011 extends consideration to terrestrial vertebrates 14

15 Approaches for harmonization across the various chemical sectors When a same substance undergoes evaluation under different sectorial legislation, ECHA and EFSA are working to maximise communication between the 2 Agencies "synchronize" as much as possible the timelines of PBT assessment 15

16 Synchronized assessment of PBT under ECHA and EFSA Applicant Data submission RMS Risk characterization PBT proposal EFSA DAR submission to EFSA EFSA consultation EFSA Peer-review EFSA Conclusion Applicant Data submission ECHA, MS or COM PBT factsheet submission to ECHA PBT EG ECHA PBT EG peer-review Annex XV dossier submission Commenting phase DG SANCO Decision on approval/non approval 16 Member State Committee Decision on identification as PBT

17 Thank you for your attention! For further questions please contact: Laura Fabrizi 17