Efficacy guidelines for the placing of plant protection active substances and products on the market in Ireland
Data on the efficacy of an active substance (AS) or Plant Protection Product (PPP) is a fundamental component of the regulatory and decision-making process facilitating the placing of the same on the market in Ireland. The data is required to establish the benefit arising from the use of the AS in PPP and must be balanced against the risks their uses pose to humans and the environment. Detailed rules regarding the data are set down in EU legislation and guidance documents.
Legislation & Guidance Documents
Active Substances (AS)
Commission Regulation (EU) No 283/2013 outlines the data requirements for AS, in accordance with Regulation (EC) No 1107/2009, implemented in Ireland by SI No. 159 of 2012
SANCO/10054/2013 (rev. 3) - Guidance document on data requirements on efficacy for the dossier to be submitted for the approval of new active substances contained in plant protection products
SANCO/2012/11251 (rev. 4) - Guidance document on the renewal of approval of active substances to be assessed in compliance with Regulation (EU) No 844/2012 (the Renewal Regulation)
Plant Protection Products (PPP)
Commission Regulation (EU) No 284/2013 outlines the data requirements for PPP, in accordance with Regulation (EC) No 1107/2009, implemented in Ireland by SI No. 159 of 2012
SANCO/10055/2013 (rev 4) - Guidance document on the efficacy composition of core dossier and national addenda submitted to support the authorisation of plant protection products under Regulation (EC) No. 1107/2009 of the EU Parliament and Council on placing of plant protection products on the market
SANCO/2010/13170 (rev 14) - Guidance Document on the Renewal of Authorisations according to Article 43 of Regulation (EC) No 1107/2009
Generation of efficacy data to support authorisations of PPP
Efficacy data requirements for PPP authorisation are outlined in section 6 of Regulation (EU) No 284/2013. Under current EU legislation, the design, analysis, conduct and reporting of efficacy trials must be in accordance with the standards outlined by the European and Mediterranean Plant Protection Organisation (EPPO) and includes compliance with the principles of Good Experimental Practice (GEP). Efficacy trials must be conducted by officially recognised testing facilities to ensure that trial protocols are harmonised across all testing facilities (national and international), and carried out to the very highest standard. The data provided must show the efficacy of an AS used in PPP and must be adequate to permit an evaluation of a representative product incorporating that AS. The testing of both effectiveness and phytotoxicity are the focus in the evaluation of a PPP submitted for approval. The target organism to be controlled (weeds, pests, pathogens) should be reduced to an economically justifiable level, but the treated plants and the crops must not be adversely affected.
An application should include i) a comprehensive Biological Assessment Dossier (BAD), summarised in Part B section 3 of the draft registration report (dRR), and ii) any trials required to address specific EU Member State national addenda. [In Ireland there are specific requirements for ‘wet weather’ fungal diseases – click here. These documents are evaluated by DAFM experts according to international standards (including Regulation (EC) No. 1107/2009 and EPPO guidelines). The data provided must provide information on the following:
- preliminary tests
- minimum effective dose
- effectiveness
- resistance and management measures
- crop safety
The PPP can have no significant negative impact on
- succeeding and adjacent crops
- non-target organisms
Special studies on cleaning will also be required. The data provided must justify the application sought as outlined in the GAP Table. The applicant must demonstrate that the PPP is effective and suitable for its intended use when applied according to its instructions of use. The specified directions of use dictate which crop, what quantity, at what time, how often and with which application method a plant protection product may be applied (these guidelines form the basis for the evaluations performed by other evaluating departments, e.g. Chemistry, Ecotoxicology, Toxicology, Environmental Fate and Behaviour).
Article 34 - Authorisation of generic plant protection products
The applicant must submit information/data to demonstrate technical equivalence of the AS and comparability of the formulation to a reference product of technical equivalence (currently on the market in Ireland). Out of protection data held by the DAFM may also be used to support an Article 34 application – see Article 34 of Regulation (EC) No 1107/2009.
Article 40 - Mutual Recognition
There are specific efficacy requirements for Irish based trials on wet weather fungal diseases in relation to the authorisation of a PPP – click here
Quick Links
SANCO Guidance Documents
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SANCO/13169/2010 rev. 9 - 11 July 2014
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Guidance document on zonal evaluation and mutual recognition under Regulation (EC) No 1107/2009
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SANCO/6896/2009 rev 1 - 2 October 2009
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Guidance document on a process for intra & Inter-zonal work-sharing to facilitate the Registration and re-registration of plant Protection products following inclusion of an Active substance in Annex I of council directive 91/414/EEC
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SANCO/6895/2009 rev 2.2 - 26 January 2018
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Technical guidelines on the presentation and evaluation of plant protection product dossiers in the format of a (draft) Registration Report
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SANCO/12638/2011 - 20 November 2012 rev. 2
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Guidance document on significant and non-significant changes of the chemical composition of authorised plant protection products under Regulation (EC) No 1107/2009 of the EU Parliament and Council on placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC
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SANCO/11244/2011 rev. 5 - 14 March 2011
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Guidance document on the preparation and submission of dossiers for plant protection products according to the “risk envelope approach”
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