June 2008

Proposal for a Regulation to replace Directive 91/414/EEC

July 2008

T Lyall

June 2008

Proposal to Replace Directive 91/414/EEC

HISTORY:

Commission proposal adopted 12th July 2006

Parliament Plenary (1st reading) in October 2007 Council ‘political agreement’ in June 2008

–Parliament & Council 2nd reading in 1st half 2009

– Publication in mid 2009– Application 18 months after entry into force (Q1 2011)

June 2008

EU process (and timelines for Regulation)

Commission makes proposal

(July 2006)

1st reading

2nd reading

Parliament(October 2007)

Council of Ministers(June 2008)

Council of Ministers(April 2009?)

Parliament(February 2009?)

June 2008

Major issues

One issue has become the focus of industryCut-off criteria

Other issues of interest:Comparative assessmentData ProtectionZonal authorisation

June 2008

Cut-off criteria

Cut-off criteria:Ban on active substances classified as:POPsPBTvPvBCMR 1&2 (unless negligible exposure)Endocrine disruptors (unless negligible exposure)

Derogation for endocrine disruptors, and C-2 & R-2: 5 years authorisation for AS “necessary to control a serious danger to plant health”

– Derogation is however limited!!

June 2008

PSD evaluation of cut-offs - What impact...?

PSD evaluation of Commission proposalCut-off• Higher figure includes possible endocrine disruptors

PSD – EU PSD – UK ECPA

Insecticides 6-10 % 5-10 % 8-20 %

Fungicides 8-32 % 7-35 % 12-34 %

Herbicides 4-10 % 5-12 % 10-23 %

All PPPs 5-15 % 9-25 %

June 2008

PSD evaluation of cut-offs - What impact...?

PSD evaluation of Parliament proposalCut-off• Combined impact: cut-off OR substitution• Higher figure includes possible endocrine disruptors

PSD – EU ECPA

Insecticides 92 % 83-94 %

Fungicides 80 % 69-85 %

Herbicides 91 % 55-81 %

All PPPs 82 % 67-86 %

All PPPs chemical only 85 %

June 2008

What global impact?

According to current text, certain substances would be banned “...unless the exposure of humans to that active substance (...), under realistic proposed conditions of use, is negligible

Negligible is defined as •...the product is used in closed systems (...) and •where residues of the active substance (...) on food and feed do not exceed the default value set in accordance with Article 18(1) (b) of Regulation (EC) No 396/2005”.

Such a definition would potentially have a negative effect on third countries if the same definition is used in the setting of import tolerances. •ECPA currently discussing with US and other representatives

June 2008

Proposed Regulation (Point 3.6 of Annex II)“...unless the exposure of humans to that active substance (...), under realistic

proposed conditions of use, is negligible, i.e. the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance (...) on food and feed do not exceed the default value set in accordance with Article 18(1) (b) of Regulation (EC) No 396/2005”.

Regulation 396/2005 (Article 18.1(b)The products covered by Annex I shall not contain, from the time they are placed

on the market as food or feed, or fed to animals, any pesticide residue exceeding: 

(b) 0,01 mg/kg for those products for which no specific MRL is set out in Annexes II or III, or for active substances not listed in Annex IV unless different default values are fixed for an active substance in accordance with the procedure referred to in Article 45(2) while taking into account the routine analytical methods available. Such default values shall be listed in Annex V.

Key legislative areas

June 2008

Comparative Assessment & Substitution

Proposal:“Candidate for substitution" approved for 10 years by CouncilConditions for comparative assessment in MSs

ECPA View:Recognise political support for comparative assessment but need to minimise uncertainty

Few changes expected in final decision making process

June 2008

Data Protection

Proposal:Protection for data for 1st product (not AS) authorisation (incl. extensions)Study protected for 2.5 years for the review of a product (not AS) authorisationExtension of data protection provisions: 3 months for each additional minor use (max. 3 additional years)

ECPA View:No data protection for reviews will reduce investment. More protection needed to encourage minor crop uses.

Likely to be agreed with few changes

June 2008

Advocacy focus is now in the European Parliament

Cut-offs is key issue – food price discussion will help...

ECPA advocacy will include discussions with MEPs from 27 Member States

Conclusion