SCC GmbH – Regulatory Guidance – Efficacy and Product Performance

Regulatory guidance

Efficacy

Guidance in a Nutshell: Efficacy and Product Performance

Safety evaluation of plant protection products in the European Union includes the evaluation of product effectiveness, phytotoxicity effects or adverse effects on food processing. Due to the variable climatic and agricultural conditions in the European Member States, efficacy evaluation requires special attention in the registration process of plant protection active substances and products. Some of these topics to be observed are highlighted in the following:

» Efficacy for Plant Protection: Active Substances

» Plant Protection: EPPO Zones

» Plant Protection: 3-Dimentional Crops and Leaf Wall Area

» Plant Protection: Low Risk Products

» Plant Protection: Product re-authorisations (Article 43)

» Precision and Digital Farming, Forecast Models and Decision Support Systems (DSS)

» Plant Protection: Integrated Pest Management (IPM)

» Plant Protection: Resistance

» Global Efficacy

» Biological Assessment Dossier (BAD)

» Efficacy Data Evaluation Tools

» Candidate for Substitution (CfS) and Comparative Assessment

» Plant Protection. Fast Track Approval for Products with New Active Subtance under Article 37(3)

» Plant Protection: Good Agriculture Practice – GAP = Use

» Good Experimental Practice (GEP)

» Minor and Major Uses in Efficacy Context

» Intergrated Production (IP) / Integrated Farming (IF)

» Efficacy Requirements for Fertilising Products Including Plant Biostimulants

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AD-67 Safener								Not a plant protection product
Cloquintocet mexyl Safener					No	Not assessed		Not a plant protection product.
Ethanol					No	Not assessed		Not a plant protection product.
Extender Synergist					No	Not assessed		Not a plant protection product.
Fenchlorazole-ethyl Safener Other					No	Not assessed		Not a plant protection product.
Fenclorim Safener Other					No	Not assessed		Not a plant protection product.
Flurazole Safener Other					No	Not assessed		Not a plant protection product.
Grease (bands, fruit trees) IN Other					No	Not assessed		Not a plant protection product.
Mefenpyr Safener Other					No	Not assessed		Not a plant protection product.
N,N-Diallyl-2,2-dichloroacetamide Safener Other					No	Not assessed		Not a plant protection product.
N-Acetyl thiazolidin-4-carboxylic acid Other					No	Not assessed		Not a plant protection product.
N-octyl bicycloheptene dicarboximide Synergist Other					No	Not assessed		Not a plant protection product.
Piperonyl butoxide Synergist Other					No	Not assessed		Not a plant protection product.
Sulfaquinoxaline Synergist Other					No	Not assessed		Not in the scope Dir. 91/414/EEC (not a plant protection product)
Ammonium thiocyanate Synergist Other					No	Not assessed		Not in the scope Dir. 91/414/EEC (not a plant protection product)
Benoxacor Safener Other					No	Not assessed		Not a plant protection product
Mercuric oxide Other					No	Not assessed	9:79/117	Banned
Mercurous chloride (calomel) Other					No	Not assessed	9:79/117	Banned
Plant oils / Citronellol 91/414 list 4	Approved	31/08/2019					2008/127/EC
Acequinocyl AC Other	Approved	2024-08-31			No	Not assessed
Methomyl 91/414 list 2 IN Other	Approved	2022-08-31		AIR 4 G4	Yes - low ADI / ARfD / AOEL	Not assessed	2:2009/115	Initially non included by Decision 2007/628. Included as from Sep. 2009 following re-submission for inclusion according to Reg. 33/2008.
Fatty acid/Fatty acid potassium salt-Potassium oleate, Fatty acid/Pelargonic acid 91/414 list 4	Approved				No	Not assessed		See Fatty Acids C7 to C20
Trichoderma atrovide (formerly T. harzianum) 91/414 list 4 Other	Approved	2023-05-31			No	Not assessed	Commission Implementing Regulation (EU) NO. 17/2013
Aminopyralid 91/414 New HB Other	Approved	2024-12-31			No	Not assessed	2:2014/891	COMMISSION IMPLEMENTING REGULATION (EU) No 891/2014
Chitosan hydrochloride new	Approved				No	Not assessed	Regulation No. 563/2014
Calcium carbide 91/414 list 4 RE Other	Approved	2022-08-31		AIR 4 G4	No	Not assessed	2:2008/127	Regulation (EU) No. 369/2012 amends conditions of approval
Fluopicolide 91/414 New FU Other	Approved	2023-05-31		AIR 4 G4	Yes - two PBT criteria	Not assessed	2:2010/15 3:2017/1527
Chlorsulfuron 91/414 list 3 HB Other	Approved	2021-12-31		AIR 4 G4	No	Not assessed	2:2009/77
Isaria fumosorosea Apopka strain 97 (formely Paecilomyces fumosoroseus) 1107/2009 New IN Low risk	Approved	2030-12-31			No	Not assessed	2:2015/306
Diethofencarb 91/414 list 3 FU Other	Approved	2023-05-31		AIR 4 G4	No	Not assessed	2:2011/26	Reverses non-inclusion Directive 2008/934/EC
Dodemorph 91/414 list 3 FU Other	Approved	2022-08-31		AIR 4 G4	No	Not assessed	2:2008/125
Etridiazole 91/414 list 3 FU Other	Approved	2023-05-31		AIR 4 G4	No	Not assessed	2:2011/29	Reverses non-inclusion Directive 2008/934/EC
Magnesium phosphide 91/414 list 3 IN,RO Other	Approved	2022-08-31		AIR 4 G4	No	Not assessed	2:2008/125
Malathion 91/414 list 2 IN,AC Other	Approved	2022-04-30		AIR 4 G4	No	Not assessed	2:2010/17 3:2017/1527	Initially non included by Decision 2007/389. Included as from 1 May 2010 following re-submission for inclusion according to Reg. 33/2008.
Metamitron 91/414 list 3 HB Other	Approved	2022-08-31		AIR 4 G4	No	Not assessed	2:2008/125
Metosulam 91/414 list 3 HB Other	Approved	2024-04-30		AIR 4 G4	No	Not assessed	2:2010/91	Amends Decision 2008/934/EC
Napropamide 91/414 list 3 HB Other	Approved	2023-12-31		AIR 4 G4	No	Not assessed	2:2010/83 5:540/2011	Reverses decision 2008/902.
Spodoptera exigua nuclear polyhedrosis virus 91/414 New IN Other	Approved	2017-11-30		AIR 3 G3 B9	No	Not assessed	2:2007/50
Pepper 91/414 list 4 RE Other	Approved	2020-08-31		AIR 4 G2	No	Not assessed	2:2008/127	Regulation (EU) No. 369/2012 amends conditions of approval
Trichoderma atroviride strain SC1 1107/2009 New FU Low risk	Approved	2031-07-06			No	Not assessed	2:2016/951
Ammonium acetate 91/414 list 4 AT Other	Approved	2018-12-31		AIR 3 G4 B10	No	Not assessed	2:2008/127
2,5-Dichlorobenzoic acid methylester 91/414 list 3 FU, PG Other	Approved	2022-08-31		AIR 4 G4	No	Not assessed	2:2008/125
Acetic acid 91/414 list 4 HB Other	Approved	2022-08-31		AIR 4 G4	No	Not assessed	2:2008/127	2013/790 changed the conditions of approval.
Aclonifen 91/414 list 3 HB Other	Approved	2022-07-31		AIR 4 G4	Yes - two PBT criteria	Not assessed	2:2008/116
Aluminium phosphide 91/414 list 3 IN, RO Other	Approved	2022-08-31		AIR 4 G4	No	Not assessed	2:2008/125
Ethylene 91/414 list 4 PG Other	Approved	2022-08-31		AIR 4 G4	No	Not assessed	2:2008/127	Change in specific provisions of registration (indoor use as plant growth regulator by professional users only). 2013/187 conditions of approval.
Plant oils / Spearmint oil 91/414 list 4 Other	Approved	2022-08-31		AIR 4 G4	No	Not assessed	2008/127	Conditions for aproval amended by Regulation (EU) No 608/2012 - risk mitigation measures necessary.
Putrescine (1,4-Diaminobutane)) 91/414 list 4 AT Other	Approved	2022-08-31		AIR 4 G4	No	Not assessed	2:2008/127	2012/571 changed the conditions of approval.
Pyrethrins 91/414 list 4 IN Other	Approved	2022-08-31		AIR 4 G4	No	Not assessed	2:2008/127	2013/798 changed the conditions of approval.
Quizalofop-P 91/414 list 3 HB Other	Approved	2021-11-30		AIR 4 G4	No	Not assessed	2:2009/37
Substance name Existing / New a.s. Category (fungicide, herbicide etc.) Type (basic / low risk / other)	Approval status	Expiry of inclusion	Withdrawal date (non inclusion)	1107/2009 (AIR)	CfS	Cut off	Legislation (by column number)	Specific remarks

Substance name

Category (fungicide, herbicide etc.)

Type (basic / low risk / other)

Approval status

Expiry of
inclusion

Withdrawal date
(non inclusion)

1107/2009
(AIR)

CfS

Cut off

Legislation
(by column number)

Specific remarks

AD-67

Safener

Not a plant protection product

Cloquintocet mexyl

Safener

Not assessed