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

1	2	3	4	5	6	7	8	9

Warfarin (aka coumaphene) 91/414 list 1 RO Other	Not approved		2014-03-31	AIR 3 G1 B1	No	Yes (restricted/rodenticide)	2:2014/186	Max. period of grace: 30/09/2015.
Cyclanilide new PG Other	Not approved		2013-10-31	AIR 2	No	Yes (mit Info)	2:2015/1475 2:2011/1022	Non renewal voted in Sep. 2011. Withdrawal authorisation by 30 Apr 2012. Max. period of grace (sale + distribution): 31 Okt. 2013.
Amitrole (aminotriazole) 91/414 list 1 HB Other	Not approved		2016-09-30	AIR 2	low ADI/ARfD/AOEL	Yes (endocrine)	2:2016/871 2:2015/1475 4:2015/1885 9:2016/871	Non-reveval of approval
Ethoxysulfuron 1107/2009 New HB Other	Not approved		2014-03-31	AIR 3 G1 B1	No	Yes (approval expired)	2:2014/186	Max. period of grace: 30/09/2015.
1,3-Dichloropropene (cis) 91/414 list 2 NE, HB Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
1,3-Diphenyl urea 91/414 list 3 PG Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
2,3,6-TBA 91/414 list 3 HB Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
2,4,5-T 91/414 list 2 HB Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
2-(dithiocyanomethylthio)-benzothiazol 91/414 list 2 FU Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
2-Aminobutane (aka sec-butylamine) 91/414 list 3 FU Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
2-Benzyl-4-chlorophenol 91/414 list 3 FU Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
4-Chloro-3-methylphenol 91/414 list 4 FU Other	Not approved		2004-12-31		No	Not assessed	2:2004/129
4-CPA (4-chlorophenoxyaceticacid = PCPA) 91/414 list 3 PG Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
4-t-Pentylphenol 91/414 list 2 BA Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Thidiazuron 91/414 list 3 PG Other	Not approved		2009-10-04		No	Not assessed	2:2008/296
1,1-dichloro-2,2-bis-(4-ethyl-phenyl-) ethane	Not approved				No	Not assessed		Never notified and authorised in the EU
Ancymidol 91/414 list 3 PG Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Anilazine 91/414 list 3 FU Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Anthracene oil 91/414 list 3 IN, AC, HB, RO Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Asulam 91/414 list 3 HB Other	Not approved		2012-12-31		No	Not assessed	2:2011/1044	Originally withdrawn under 2008/935/EC. Resubmission under accelerated procedure.
Azaconazole 91/414 list 3 IN, FU Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Azamethiphos 91/414 list 2 IN Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Aziprotryne 91/414 list 3 HB Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Barban 91/414 list 2 HB Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Barium fluosilicate 91/414 list 3 IN Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Barium polysulphide 91/414 list 3 IN, FU Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Benazolin 91/414 list 3 HB Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Bendiocarb 91/414 list 2 IN Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Benfuresate 91/414 list 3 HB Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Benodanil 91/414 list 3 FU Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Bensulide 91/414 list 3 HB Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Bensultap 91/414 list 3 IN Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002	Essential use 835/2004
Bentaluron 91/414 list 3 FU Other	Not approved		2002-12-31		No	Not assessed	2:2076/2002
Sodium p-t-amylphenoxide 91/414 list 4 FU other	Not approved		2004-12-31		no	Not assessed
Calcium carbonate (aka chalk) 91/414 list 3 other	Not approved		31/12/2003		no	Not assessed	2:2076/2002
Sulfentrazone HB Other	Not approved				No	Not assessed		Never notified and authorised in the EU
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.
Anilofos Other	Not approved				No	Not assessed		Never notified and authorised in the EU
Citrus extract	Not approved				No	Not assessed	9:Reg 647/2007	Never notified and authorised in the EU.
Clomeprop HB	Not approved				No	Not assessed		Never notified and authorised in the EU.
Cloquintocet mexyl Safener					No	Not assessed		Not a plant protection product.
Coumafos IN	Not approved				No	Not assessed		Never notified and authorised in the EU.
Cryolite IN Other	Not approved				No	Not assessed		Never notified and authorised in the EU.
Cyprosulfamide PG, Safener	Not approved				No	Not assessed
DDT Other	Not approved				No	Not assessed	9:2004/850	Banned
Didecyl-dimethylammonium chloride 91/414 list 4	Not approved		2013-06-20		No	Not assessed	Commission Implementing Regulation (EU) No. 175/2013	Originally included under 2009/70/EC - re-evaluation has resulted in withdrawal of approval
Etaconazole FU Other	Not approved				No	Not assessed		Never notified and authorised in the EU.
Ethanol					No	Not assessed		Not a plant protection product.
Ethychlozate Other	Not approved				No	Not assessed		Never notified and authorised in the EU.
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

Warfarin (aka coumaphene)

91/414 list 1

Other

Not approved

2014-03-31

AIR 3 G1 B1

Yes (restricted/rodenticide)

2:2014/186

Max. period of grace: 30/09/2015.

Cyclanilide

new

Other

Not approved

2013-10-31

AIR 2

Yes (mit Info)

2:2015/1475

2:2011/1022

Non renewal voted in Sep. 2011. Withdrawal authorisation by 30 Apr 2012. Max. period of grace (sale + distribution): 31 Okt. 2013.

Amitrole (aminotriazole)

91/414 list 1

Other

Not approved

2016-09-30

AIR 2

low ADI/ARfD/AOEL

Yes (endocrine)

Non-reveval of approval

Ethoxysulfuron

1107/2009 New

Other

Not approved

2014-03-31

AIR 3 G1 B1

Yes (approval expired)

2:2014/186

Max. period of grace: 30/09/2015.

1,3-Dichloropropene (cis)

91/414 list 2

NE, HB

Other

Not approved

2003-12-31

Not assessed

2:2076/2002

1,3-Diphenyl urea

91/414 list 3

Other

Not approved

2003-12-31

Not assessed

2:2076/2002

2,3,6-TBA

91/414 list 3

Other

Not approved

2003-12-31

Not assessed

2:2076/2002

2,4,5-T

91/414 list 2

Other

Not approved

2003-12-31

Not assessed

2:2076/2002

2-(dithiocyanomethylthio)-benzothiazol

91/414 list 2

Other

Not approved

2003-12-31

Not assessed

2:2076/2002

2-Aminobutane (aka sec-butylamine)

91/414 list 3

Other

Not approved

2003-12-31

Not assessed

2:2076/2002

2-Benzyl-4-chlorophenol

91/414 list 3

Other

Not approved

2003-12-31

Not assessed

2:2076/2002

4-Chloro-3-methylphenol

91/414 list 4

Other

Not approved

2004-12-31

Not assessed

2:2004/129

4-CPA (4-chlorophenoxyaceticacid = PCPA)

91/414 list 3

Other

Not approved

2003-12-31

Not assessed

2:2076/2002

4-t-Pentylphenol

91/414 list 2

Other

Not approved

2003-12-31

Not assessed

2:2076/2002

Thidiazuron

91/414 list 3

Other

Not approved

2009-10-04

Not assessed

2:2008/296

1,1-dichloro-2,2-bis-(4-ethyl-phenyl-) ethane

Not approved

Not assessed

Never notified and authorised in the EU

Ancymidol

91/414 list 3

Other

Not approved

2003-12-31

Not assessed

2:2076/2002

Anilazine

91/414 list 3

Other

Not approved

2003-12-31

Not assessed

2:2076/2002

Anthracene oil

91/414 list 3

IN, AC, HB, RO

Other

Not approved

2003-12-31

Not assessed

2:2076/2002

Asulam

91/414 list 3

Other

Not approved

2012-12-31

Not assessed

2:2011/1044

Originally withdrawn under 2008/935/EC. Resubmission under accelerated procedure.

Azaconazole

91/414 list 3

IN, FU

Other

Not approved

2003-12-31

Not assessed

2:2076/2002

Azamethiphos

91/414 list 2

Other

Not approved

2003-12-31

Not assessed

2:2076/2002

Aziprotryne

91/414 list 3

Other

Not approved

2003-12-31

Not assessed

2:2076/2002

Barban

91/414 list 2

Other

Not approved

2003-12-31

Not assessed

2:2076/2002

Barium fluosilicate

91/414 list 3

Other

Not approved

2003-12-31

Not assessed

2:2076/2002

Barium polysulphide

91/414 list 3

IN, FU

Other

Not approved

2003-12-31

Not assessed

2:2076/2002

Benazolin

91/414 list 3

Other

Not approved

2003-12-31

Not assessed

2:2076/2002

Bendiocarb

91/414 list 2

Other

Not approved

2003-12-31

Not assessed

2:2076/2002

Benfuresate

91/414 list 3

Other

Not approved

2003-12-31

Not assessed

2:2076/2002

Benodanil

91/414 list 3

Other

Not approved

2003-12-31

Not assessed

2:2076/2002

Bensulide

91/414 list 3

Other

Not approved

2003-12-31

Not assessed

2:2076/2002

Bensultap

91/414 list 3

Other

Not approved

2003-12-31

Not assessed

2:2076/2002

Essential use 835/2004

Bentaluron

91/414 list 3

Other

Not approved

2002-12-31

Not assessed

2:2076/2002

Sodium p-t-amylphenoxide

91/414 list 4

other

Not approved

2004-12-31

Not assessed

Calcium carbonate (aka chalk)

91/414 list 3

other

Not approved

31/12/2003

Not assessed

2:2076/2002

Sulfentrazone

Other

Not approved

Not assessed

Never notified and authorised in the EU

Acequinocyl

Other

Approved

2024-08-31

Not assessed

Methomyl

91/414 list 2

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.

Anilofos

Other

Not approved

Not assessed

Never notified and authorised in the EU

Citrus extract

Not approved

Not assessed

9:Reg 647/2007

Never notified and authorised in the EU.

Clomeprop

Not approved

Not assessed

Never notified and authorised in the EU.

Cloquintocet mexyl

Safener

Not assessed

Not a plant protection product.

Coumafos

Not approved

Not assessed

Never notified and authorised in the EU.

Cryolite

Other

Not approved

Not assessed

Never notified and authorised in the EU.

Cyprosulfamide

PG, Safener

Not approved

Not assessed

DDT

Other

Not approved

Not assessed

9:2004/850

Banned

Didecyl-dimethylammonium chloride

91/414 list 4

Not approved

2013-06-20

Not assessed

Commission Implementing Regulation (EU) No. 175/2013

Originally included under 2009/70/EC - re-evaluation has resulted in withdrawal of approval

Etaconazole

Other

Not approved

Not assessed

Never notified and authorised in the EU.

Ethanol

Not assessed

Not a plant protection product.

Ethychlozate

Other

Not approved

Not assessed

Never notified and authorised in the EU.

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

1	2	3	4	5	6	7	8	9
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

Warfarin (aka coumaphene) 91/414 list 1 RO Other	Not approved		2014-03-31	AIR 3 G1 B1	No	Yes (restricted/rodenticide)	2:2014/186	Max. period of grace: 30/09/2015.
Cyclanilide new PG Other	Not approved		2013-10-31	AIR 2	No	Yes (mit Info)	2:2015/1475 2:2011/1022	Non renewal voted in Sep. 2011. Withdrawal authorisation by 30 Apr 2012. Max. period of grace (sale + distribution): 31 Okt. 2013.
Amitrole (aminotriazole) 91/414 list 1 HB Other	Not approved		2016-09-30	AIR 2	low ADI/ARfD/AOEL	Yes (endocrine)	2:2016/871 2:2015/1475 4:2015/1885 9:2016/871	Non-reveval of approval
Ethoxysulfuron 1107/2009 New HB Other	Not approved		2014-03-31	AIR 3 G1 B1	No	Yes (approval expired)	2:2014/186	Max. period of grace: 30/09/2015.
1,3-Dichloropropene (cis) 91/414 list 2 NE, HB Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
1,3-Diphenyl urea 91/414 list 3 PG Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
2,3,6-TBA 91/414 list 3 HB Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
2,4,5-T 91/414 list 2 HB Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
2-(dithiocyanomethylthio)-benzothiazol 91/414 list 2 FU Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
2-Aminobutane (aka sec-butylamine) 91/414 list 3 FU Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
2-Benzyl-4-chlorophenol 91/414 list 3 FU Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
4-Chloro-3-methylphenol 91/414 list 4 FU Other	Not approved		2004-12-31		No	Not assessed	2:2004/129
4-CPA (4-chlorophenoxyaceticacid = PCPA) 91/414 list 3 PG Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
4-t-Pentylphenol 91/414 list 2 BA Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Thidiazuron 91/414 list 3 PG Other	Not approved		2009-10-04		No	Not assessed	2:2008/296
1,1-dichloro-2,2-bis-(4-ethyl-phenyl-) ethane	Not approved				No	Not assessed		Never notified and authorised in the EU
Ancymidol 91/414 list 3 PG Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Anilazine 91/414 list 3 FU Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Anthracene oil 91/414 list 3 IN, AC, HB, RO Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Asulam 91/414 list 3 HB Other	Not approved		2012-12-31		No	Not assessed	2:2011/1044	Originally withdrawn under 2008/935/EC. Resubmission under accelerated procedure.
Azaconazole 91/414 list 3 IN, FU Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Azamethiphos 91/414 list 2 IN Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Aziprotryne 91/414 list 3 HB Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Barban 91/414 list 2 HB Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Barium fluosilicate 91/414 list 3 IN Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Barium polysulphide 91/414 list 3 IN, FU Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Benazolin 91/414 list 3 HB Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Bendiocarb 91/414 list 2 IN Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Benfuresate 91/414 list 3 HB Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Benodanil 91/414 list 3 FU Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Bensulide 91/414 list 3 HB Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002
Bensultap 91/414 list 3 IN Other	Not approved		2003-12-31		No	Not assessed	2:2076/2002	Essential use 835/2004
Bentaluron 91/414 list 3 FU Other	Not approved		2002-12-31		No	Not assessed	2:2076/2002
Sodium p-t-amylphenoxide 91/414 list 4 FU other	Not approved		2004-12-31		no	Not assessed
Calcium carbonate (aka chalk) 91/414 list 3 other	Not approved		31/12/2003		no	Not assessed	2:2076/2002
Sulfentrazone HB Other	Not approved				No	Not assessed		Never notified and authorised in the EU
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.
Anilofos Other	Not approved				No	Not assessed		Never notified and authorised in the EU
Citrus extract	Not approved				No	Not assessed	9:Reg 647/2007	Never notified and authorised in the EU.
Clomeprop HB	Not approved				No	Not assessed		Never notified and authorised in the EU.
Cloquintocet mexyl Safener					No	Not assessed		Not a plant protection product.
Coumafos IN	Not approved				No	Not assessed		Never notified and authorised in the EU.
Cryolite IN Other	Not approved				No	Not assessed		Never notified and authorised in the EU.
Cyprosulfamide PG, Safener	Not approved				No	Not assessed
DDT Other	Not approved				No	Not assessed	9:2004/850	Banned
Didecyl-dimethylammonium chloride 91/414 list 4	Not approved		2013-06-20		No	Not assessed	Commission Implementing Regulation (EU) No. 175/2013	Originally included under 2009/70/EC - re-evaluation has resulted in withdrawal of approval
Etaconazole FU Other	Not approved				No	Not assessed		Never notified and authorised in the EU.
Ethanol					No	Not assessed		Not a plant protection product.
Ethychlozate Other	Not approved				No	Not assessed		Never notified and authorised in the EU.
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

Regulatory Guidance

Efficacy

Guidance in a Nutshell: Efficacy and Product Performance

Services Overview

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