cut-offs and candidates for substitution: member state view

Cut-Offs and Candidates for Substitution:

Member State view

13.03.2014 Seite 2BVL, Abteilung Pflanzenschutz, Dr. Martin Streloke

Outline

• Regulatory framework for plant protection products (PPP)

• Endocrine disruptors (ED),

• PBT, vPvB, POP

• Groundwater, Honeybees

• Candidates for Substitution

• Comparative Assessment

• Conclusions


• New pesticide regulation entered into force in June 2011

- 1107/2009/EC – Approval actives/Authorisation products,

- Annex II – Approval criteria for actives = cut-offs and for Candidates for Substitution (CfS),

- No approval of a.s. at EU-level if cut-offs fulfilled (e.g. 3 PBT),

- Less hazardous compounds – CfS (e.g. 2 PBT)

- Regularly authorisations at zonal level but

- Comparative Assessment at MS-level (Art. 50).

IntroductionIntroduction


•Activities at EU and national level,

•DG Environment has the lead at EU-level for all types of compounds,

•But differences between groups of compounds to be considered; e.g.

a.s. of PPP are data rich!

•Assessment scheme was expected for the end of 2013 but impact

assessment still underway,

•Additional data requirements for some compounds have been raised

in DE,

•But no final identification as ED and subsequently no authorisation in

DE so far.

Endocrine disruptorsEndocrine disruptors


•Assessment by mammalian toxicologists first,

•If ED-specific properties but no negative decision to be taken in this area, environmental evaluation is triggered,

•Only if endocrine endpoint most sensitive it should become relevant for decision making,

•According to DE approach substances with intended endocrine MoA in non-vertebrates (e.g. insect growth regulators) not regarded as EDs because selectivity of products is preferred,

•Preliminary evaluations of some substances were presented at SETAC in Milan,

•In DE a paper summarising all ED-activities (health and environment) was prepared and sent to DG Env.

•Overall situation currently not really clear.

Endocrine disruptorsEndocrine disruptors


•Activivities in OECD-group on PBTs have not made too much

progress, but new start announced,

•PBT-evaluation has been made over the last years for industrial

chemicals at EU-level, guidance exists,

•To which extent must approaches amongst industrial chemicals,

biocides, plant protection products be harmonised?

•Again, PPP are data rich and all data should be used if appropriate,

•Implications for decision-makings different; only for PPP „cutoff“-criteria.

PBT and other cutoffsPBT and other cutoffs


•Items under discussion:

-Annex II of 1107/2009 don‘t follow a compartment approach,

-Use of data from field studies for P-evaluation unclear,

•Other cut-offs unclear e.g.:

-UP criteria for groundwater must be fulfiled,

-What to do if monitoring data are continously above 0.1 µg/l in

a considerable number of cases ?

-Honeybees – only UP must be fulfilled ?

PBT and other cutoffsPBT and other cutoffs


•Preliminary criteria were developed in a small group of COM

and MS in 2012,

•In 2013 consultant worked through endpoint lists of active

substances of products on the market at the end of 2012,

•Report was made available until autum 2013,

•Authorisation holders and MS checked results of study,

•COM will present list of CfS in March meeting of standing committee.

Candidates for Substitution (CfS)Candidates for Substitution (CfS)


•From the draft study report it is clear that PBT criteria are

most important for identifying CfS,

•Approximately 80-100 compounds will become CfS,

•Depending on transitional periods work for MS on

Comparative Assessment (CA) will start by end of 2014,

•SWE has used CA for decision-making over a long time,

•Some MS have started with case studies (e.g. NL) or even

circulated national guidance for conducting CA (UK),

•National paper on CA in DE will be prepared subsequently

to finalisation of EU-Guidance.

Candidates for SubstitutionCandidates for Substitution


•Final version of EU-GD will be made available by COM in March meeting of standing committee,

•Role of applicants not really clear,

•Each use of product with CfS must be evaluated,

•First step: Looking for alternatives in efficacy area,

• Other products or non-chemical methods are available?

• Resistance management, IPM relevance, importance of CfS for minor uses are important,

•EPPO guidance available but more detailed criteria may be needed in future,

Comparative Assessment (CA)Comparative Assessment (CA)


•How many minor uses for example balance critical major crops?

•What are economic advantages/disadvantages (e.g. non-chemical methods; hoeing - herbicide)?

•High number of uses/products with no alternative expected,

•If alternatives are available:- relative risk to health and environment,- first look to areas of concern decisive for identifying CfS,- strength of risk mitigation measures important.

•Clear differences to alternative must be determined

•Otherwise no substitution

•Lot of work for MS expected

Comparative AssessmentComparative Assessment


•“Cut-off”-criteria for approval of actives under 1107/2009 to

be specified,

•Endocrine disruption and PBT… important, not too much work

on other parameter underway,

•Some cut-off criteria are important for identifying CfS too,

•Preliminary list of CfS will be made available by COM soon,

•EU-GD are nearly finalised,

•CA will be conducted at MS-level,

•MS have started with work on conducting CA.

ConclusionsConclusions


Thank you for you

attention!

contact:BVL, Dienststelle Braunschweig Messeweg 11/1238104 BraunschweigTelefon: 0531 / 299-3609E-Mail: [email protected]: www.bvl.bund.de

contact:BVL, Dienststelle Braunschweig Messeweg 11/1238104 BraunschweigTelefon: 0531 / 299-3609E-Mail: [email protected]: www.bvl.bund.de

cut-offs and candidates for substitution: member state view

Documents

abteilung pflanzenschutz

martin streloke assessment

martin streloke activities

martin streloke activivities

martin streloke items

martin streloke prelimina

introduction slide

data rich