use of micro-organisms in biological plant protection
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Use of Micro-organisms in Biological Plant Protection ndash
Potential and Regulation
Ralf-Udo Ehlers E-nema GmbH
24223 Schwentinental Germany ehlerse-nemade
wwwe-nemade
Rhizobacteria from oil seed rape root system
Microbial biodiversity in the rhizosphaere
Bacillus sp
bull gram-positive soil bacterium bull 6 x 108 cellsg ca 10 tha
Bacillus subtilis Mode of Action
Increased plant health
lsquodisease escapersquo
Induction of plant resistance Competition Antibiosis
Plant
Growth Promotion Production of plant hormones
enzymatic P mobilisation
= Increasing yields
Bacillus subtilis
Biological Control of Seed Borne Diseases
Seed treatment of cereals with formulated bacteria
Pseudomonas chlororaphis
CedomonCeral
bull Pseudomonas chlororaphis seed treatment bull BCA against seed-borne diseaeses in barley
and wheat bull Already used on 2 million ha in Scandinavia
Bacillus amyloliquefaciens Increase in yields
untreated treated
Bacillus amyloliquefaciens Increase in yields
Tomato varieties
02468
1012141618
Increase in yields ()
Bacillus sp Antibiosis
Antibiose
bull Antibiotic metabolites and enzymes with activity against plant pathogens
Bacillus subtilis
Fusarium oxysporum
Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
Coiling of Trichoderma hyphae around the plant pathogen Rhizoctonia solani
G catenulatum can produce cell-wall degrading enzymes such as szlig-13-glucanases and other chitinolytic enzymes
Many strains are very capable of colonizing roots of many species of plants They can colonize the entire root system for an extended period of time following application to seeds roots or soil
Rhizosphere Competence
Bakterien
Potential for MBCAs
Source (Waldner W Frutta e Vite 2009)
Maximal pesticide Residue Level requested by Supermarket chains in Italy
Maximal pesticide Residue Level requested by Supermarket chains in Germany
100 Legal MRL 100 Legal MRL
50
40
30 33
70
80
Regulation 2020 Stagnancy or new perspectives
for biological control
Should EU regulation + directive be implemented there is a market for BCAs
- Directive 2009128EC aims to achieve a sustainable use of pesticides
- Article 14 says that ldquothe Member States shall
take all necessary measures to promote low pesticide-input pest management giving wherever possible priority to non-chemical methods so that professional users of pesticides switch to practices and products with the lowest risk to human health and the environment
The Regulation (EC) No 11072009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market replaced 91414EEC from 14 June 2011 Article 55 explicitly implies the promotion of the use of non-chemical and natural alternatives
The road is paved for introduction of more biocontrol
Regulation of MBCAs in Europe
Regulation (EC) No 11072009 is the legislation concerning the placing of plant protection products (PPPs) on the market in the European Union Procedure
1Application to an EU country called Rapporteur Member State (RMS) 2RMS verifies if the application is admissible (completeness check) 3RMS prepares a draft assessment report (DAR) 4EFSA issues its conclusions 5Standing Committee for Food Chain and Animal Health votes on approval or non-approval 6Adoption by the Commission 7Publication of a Regulation in the EU Official Journal
Under the new EU rules it takes 25 to 35 years from the date of admissibility of the application to the publication of a Regulation approving a new active substance
EU and Zonal regulation
Active Substance (ai) Microorganisms at strain level (except granulose viruses)
Formulated Product with specific indication
EuCom DG Sante
RMS 3 Zones
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4
Annex II AS submission
RMS DAR
Approval AS
Timelines 11072009
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
MR Approval
Active Substance
PPP
these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4 Year 5
Annex II AS submission
Final DAR
Approval AS
Timelines 11072009 (realistic example case with request for additional information)
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
Mutual recognition
Approval
Active Substance
PPP these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year For 3 years only by the RMS Zonal applications procedures
Low-risk as based PPP
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3
Annex II AS submission
DAR
Full Approval
AS
Timelines 11072009 (proposed low-risk case )
Annex III PPP submission
ZRMS
Provisional Zonal Approval PPP
Mutual recognition Application amp approval
Low-risk Active Substance
Low-risk as based PPP
Completeness Check Incl low-risk status
Provisional low-risk as approval
Full Zonal Approval PPP
Stagnacy No things are moving hellip Slowly IBMA outreach for professional support in lobbying NL presidency will pick up our low risk approach Next step by IBMA Data requirements
It takes a life time of a man (or more) to adapt regulation of BCAs to the real risks
Summary
Progress in Regulation Process
EC has further improved legislation (Reg 11072009) EC produced Dir 1282009 Sustainable Use Directive EC has provided further guidance documents for BCAs Authorities are much more relaxed about risks and provide waivers on data requirements (sometimes) EU Expert Group on bdquoBiopesticidesldquo and bdquoLow Risk Criterialdquo In general everyone in Brussels is in favour of adapting regulation of MBCAs to the real risks buthellip
Data requirements ndash Micro-organism 200136EC Annex IIB
Identity bull Strain level bull Methods to identify and determine content bull Impurities - contaminating micro-organisms - relevant metabolites - culture medium
Biological properties bull Origin and natural occurrence bull Target bull Mode of action bull Specificity bull Dispersal and colonisation ability bull Genetic stability bull Production of metabolites
Human health TIER I bull Medical data bull Sensitisation (inhalation and skin) bull Acute toxicity pathogenicity and infectivity (single exposure) A Oral B Inhalation C Intraperitonealsubcutaneous bull Genotoxicity (metabolites) bull Short term toxicity and pathogenicity (repeated exposure) bull First aid measures
Human health TIER II bull In vivo studies in somatic cells bull in vivo studies in germ cells
Data requirements ndash Micro-organism 200136EC Annex IIB
Residues bull Persistence and multiplication bull Non viable residues bull Viable residues Fate and behaviour in the environment bull Persistence and multiplication (soil water air) bull Mobility Effect on non-target organisms bull Birds bull Aquatic organisms (fish algae) bull Bees and other arthropods bull Earthworms bull Non-target soil micro-organisms
Data requirements ndash Micro-organism 200136EC Annex IIB
Data on application bull Intended use bull Mode of action bull Application rate bull Methods number and timing of application bull Proposed instructions for use
Physical chemical technical properties of the ppp bull Storage stability - shelf life bull Particle size distribution bull Etc
Identity bull Trade name bull Composition
Data requirements ndash Micro-organism 200136EC Annex IIIB
Human health bull Oral toxicity bull Inhalation toxicity bull Percutaneous toxicity bull Skin and eye irritation bull Skin sensitisation
Efficacy data
Further information bull Re-entry periods bull Cleaning of application equipment bull Measures in case of an accident
Data requirements ndash Micro-organism 200136EC Annex IIIB
Fate and behaviour in the environment
Residues
Exposure under the proposed condition of use
Effect on non-target organisms
Data requirements ndash Micro-organism 200136EC Annex IIIB
- Use of Micro-organisms in Biological Plant Protection ndash Potential and Regulation
- Slide Number 2
- Slide Number 3
- Slide Number 4
- Biological Control of Seed Borne Diseases
- Slide Number 6
- Slide Number 7
- Slide Number 8
- Slide Number 9
- Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- EU and Zonal regulation
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Summary
- Slide Number 22
- Data requirements ndash Micro-organism200136EC Annex IIB
- Slide Number 24
- Data requirements ndash Micro-organism200136EC Annex IIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Slide Number 28
-
Rhizobacteria from oil seed rape root system
Microbial biodiversity in the rhizosphaere
Bacillus sp
bull gram-positive soil bacterium bull 6 x 108 cellsg ca 10 tha
Bacillus subtilis Mode of Action
Increased plant health
lsquodisease escapersquo
Induction of plant resistance Competition Antibiosis
Plant
Growth Promotion Production of plant hormones
enzymatic P mobilisation
= Increasing yields
Bacillus subtilis
Biological Control of Seed Borne Diseases
Seed treatment of cereals with formulated bacteria
Pseudomonas chlororaphis
CedomonCeral
bull Pseudomonas chlororaphis seed treatment bull BCA against seed-borne diseaeses in barley
and wheat bull Already used on 2 million ha in Scandinavia
Bacillus amyloliquefaciens Increase in yields
untreated treated
Bacillus amyloliquefaciens Increase in yields
Tomato varieties
02468
1012141618
Increase in yields ()
Bacillus sp Antibiosis
Antibiose
bull Antibiotic metabolites and enzymes with activity against plant pathogens
Bacillus subtilis
Fusarium oxysporum
Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
Coiling of Trichoderma hyphae around the plant pathogen Rhizoctonia solani
G catenulatum can produce cell-wall degrading enzymes such as szlig-13-glucanases and other chitinolytic enzymes
Many strains are very capable of colonizing roots of many species of plants They can colonize the entire root system for an extended period of time following application to seeds roots or soil
Rhizosphere Competence
Bakterien
Potential for MBCAs
Source (Waldner W Frutta e Vite 2009)
Maximal pesticide Residue Level requested by Supermarket chains in Italy
Maximal pesticide Residue Level requested by Supermarket chains in Germany
100 Legal MRL 100 Legal MRL
50
40
30 33
70
80
Regulation 2020 Stagnancy or new perspectives
for biological control
Should EU regulation + directive be implemented there is a market for BCAs
- Directive 2009128EC aims to achieve a sustainable use of pesticides
- Article 14 says that ldquothe Member States shall
take all necessary measures to promote low pesticide-input pest management giving wherever possible priority to non-chemical methods so that professional users of pesticides switch to practices and products with the lowest risk to human health and the environment
The Regulation (EC) No 11072009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market replaced 91414EEC from 14 June 2011 Article 55 explicitly implies the promotion of the use of non-chemical and natural alternatives
The road is paved for introduction of more biocontrol
Regulation of MBCAs in Europe
Regulation (EC) No 11072009 is the legislation concerning the placing of plant protection products (PPPs) on the market in the European Union Procedure
1Application to an EU country called Rapporteur Member State (RMS) 2RMS verifies if the application is admissible (completeness check) 3RMS prepares a draft assessment report (DAR) 4EFSA issues its conclusions 5Standing Committee for Food Chain and Animal Health votes on approval or non-approval 6Adoption by the Commission 7Publication of a Regulation in the EU Official Journal
Under the new EU rules it takes 25 to 35 years from the date of admissibility of the application to the publication of a Regulation approving a new active substance
EU and Zonal regulation
Active Substance (ai) Microorganisms at strain level (except granulose viruses)
Formulated Product with specific indication
EuCom DG Sante
RMS 3 Zones
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4
Annex II AS submission
RMS DAR
Approval AS
Timelines 11072009
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
MR Approval
Active Substance
PPP
these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4 Year 5
Annex II AS submission
Final DAR
Approval AS
Timelines 11072009 (realistic example case with request for additional information)
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
Mutual recognition
Approval
Active Substance
PPP these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year For 3 years only by the RMS Zonal applications procedures
Low-risk as based PPP
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3
Annex II AS submission
DAR
Full Approval
AS
Timelines 11072009 (proposed low-risk case )
Annex III PPP submission
ZRMS
Provisional Zonal Approval PPP
Mutual recognition Application amp approval
Low-risk Active Substance
Low-risk as based PPP
Completeness Check Incl low-risk status
Provisional low-risk as approval
Full Zonal Approval PPP
Stagnacy No things are moving hellip Slowly IBMA outreach for professional support in lobbying NL presidency will pick up our low risk approach Next step by IBMA Data requirements
It takes a life time of a man (or more) to adapt regulation of BCAs to the real risks
Summary
Progress in Regulation Process
EC has further improved legislation (Reg 11072009) EC produced Dir 1282009 Sustainable Use Directive EC has provided further guidance documents for BCAs Authorities are much more relaxed about risks and provide waivers on data requirements (sometimes) EU Expert Group on bdquoBiopesticidesldquo and bdquoLow Risk Criterialdquo In general everyone in Brussels is in favour of adapting regulation of MBCAs to the real risks buthellip
Data requirements ndash Micro-organism 200136EC Annex IIB
Identity bull Strain level bull Methods to identify and determine content bull Impurities - contaminating micro-organisms - relevant metabolites - culture medium
Biological properties bull Origin and natural occurrence bull Target bull Mode of action bull Specificity bull Dispersal and colonisation ability bull Genetic stability bull Production of metabolites
Human health TIER I bull Medical data bull Sensitisation (inhalation and skin) bull Acute toxicity pathogenicity and infectivity (single exposure) A Oral B Inhalation C Intraperitonealsubcutaneous bull Genotoxicity (metabolites) bull Short term toxicity and pathogenicity (repeated exposure) bull First aid measures
Human health TIER II bull In vivo studies in somatic cells bull in vivo studies in germ cells
Data requirements ndash Micro-organism 200136EC Annex IIB
Residues bull Persistence and multiplication bull Non viable residues bull Viable residues Fate and behaviour in the environment bull Persistence and multiplication (soil water air) bull Mobility Effect on non-target organisms bull Birds bull Aquatic organisms (fish algae) bull Bees and other arthropods bull Earthworms bull Non-target soil micro-organisms
Data requirements ndash Micro-organism 200136EC Annex IIB
Data on application bull Intended use bull Mode of action bull Application rate bull Methods number and timing of application bull Proposed instructions for use
Physical chemical technical properties of the ppp bull Storage stability - shelf life bull Particle size distribution bull Etc
Identity bull Trade name bull Composition
Data requirements ndash Micro-organism 200136EC Annex IIIB
Human health bull Oral toxicity bull Inhalation toxicity bull Percutaneous toxicity bull Skin and eye irritation bull Skin sensitisation
Efficacy data
Further information bull Re-entry periods bull Cleaning of application equipment bull Measures in case of an accident
Data requirements ndash Micro-organism 200136EC Annex IIIB
Fate and behaviour in the environment
Residues
Exposure under the proposed condition of use
Effect on non-target organisms
Data requirements ndash Micro-organism 200136EC Annex IIIB
- Use of Micro-organisms in Biological Plant Protection ndash Potential and Regulation
- Slide Number 2
- Slide Number 3
- Slide Number 4
- Biological Control of Seed Borne Diseases
- Slide Number 6
- Slide Number 7
- Slide Number 8
- Slide Number 9
- Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- EU and Zonal regulation
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Summary
- Slide Number 22
- Data requirements ndash Micro-organism200136EC Annex IIB
- Slide Number 24
- Data requirements ndash Micro-organism200136EC Annex IIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Slide Number 28
-
Bacillus sp
bull gram-positive soil bacterium bull 6 x 108 cellsg ca 10 tha
Bacillus subtilis Mode of Action
Increased plant health
lsquodisease escapersquo
Induction of plant resistance Competition Antibiosis
Plant
Growth Promotion Production of plant hormones
enzymatic P mobilisation
= Increasing yields
Bacillus subtilis
Biological Control of Seed Borne Diseases
Seed treatment of cereals with formulated bacteria
Pseudomonas chlororaphis
CedomonCeral
bull Pseudomonas chlororaphis seed treatment bull BCA against seed-borne diseaeses in barley
and wheat bull Already used on 2 million ha in Scandinavia
Bacillus amyloliquefaciens Increase in yields
untreated treated
Bacillus amyloliquefaciens Increase in yields
Tomato varieties
02468
1012141618
Increase in yields ()
Bacillus sp Antibiosis
Antibiose
bull Antibiotic metabolites and enzymes with activity against plant pathogens
Bacillus subtilis
Fusarium oxysporum
Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
Coiling of Trichoderma hyphae around the plant pathogen Rhizoctonia solani
G catenulatum can produce cell-wall degrading enzymes such as szlig-13-glucanases and other chitinolytic enzymes
Many strains are very capable of colonizing roots of many species of plants They can colonize the entire root system for an extended period of time following application to seeds roots or soil
Rhizosphere Competence
Bakterien
Potential for MBCAs
Source (Waldner W Frutta e Vite 2009)
Maximal pesticide Residue Level requested by Supermarket chains in Italy
Maximal pesticide Residue Level requested by Supermarket chains in Germany
100 Legal MRL 100 Legal MRL
50
40
30 33
70
80
Regulation 2020 Stagnancy or new perspectives
for biological control
Should EU regulation + directive be implemented there is a market for BCAs
- Directive 2009128EC aims to achieve a sustainable use of pesticides
- Article 14 says that ldquothe Member States shall
take all necessary measures to promote low pesticide-input pest management giving wherever possible priority to non-chemical methods so that professional users of pesticides switch to practices and products with the lowest risk to human health and the environment
The Regulation (EC) No 11072009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market replaced 91414EEC from 14 June 2011 Article 55 explicitly implies the promotion of the use of non-chemical and natural alternatives
The road is paved for introduction of more biocontrol
Regulation of MBCAs in Europe
Regulation (EC) No 11072009 is the legislation concerning the placing of plant protection products (PPPs) on the market in the European Union Procedure
1Application to an EU country called Rapporteur Member State (RMS) 2RMS verifies if the application is admissible (completeness check) 3RMS prepares a draft assessment report (DAR) 4EFSA issues its conclusions 5Standing Committee for Food Chain and Animal Health votes on approval or non-approval 6Adoption by the Commission 7Publication of a Regulation in the EU Official Journal
Under the new EU rules it takes 25 to 35 years from the date of admissibility of the application to the publication of a Regulation approving a new active substance
EU and Zonal regulation
Active Substance (ai) Microorganisms at strain level (except granulose viruses)
Formulated Product with specific indication
EuCom DG Sante
RMS 3 Zones
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4
Annex II AS submission
RMS DAR
Approval AS
Timelines 11072009
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
MR Approval
Active Substance
PPP
these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4 Year 5
Annex II AS submission
Final DAR
Approval AS
Timelines 11072009 (realistic example case with request for additional information)
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
Mutual recognition
Approval
Active Substance
PPP these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year For 3 years only by the RMS Zonal applications procedures
Low-risk as based PPP
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3
Annex II AS submission
DAR
Full Approval
AS
Timelines 11072009 (proposed low-risk case )
Annex III PPP submission
ZRMS
Provisional Zonal Approval PPP
Mutual recognition Application amp approval
Low-risk Active Substance
Low-risk as based PPP
Completeness Check Incl low-risk status
Provisional low-risk as approval
Full Zonal Approval PPP
Stagnacy No things are moving hellip Slowly IBMA outreach for professional support in lobbying NL presidency will pick up our low risk approach Next step by IBMA Data requirements
It takes a life time of a man (or more) to adapt regulation of BCAs to the real risks
Summary
Progress in Regulation Process
EC has further improved legislation (Reg 11072009) EC produced Dir 1282009 Sustainable Use Directive EC has provided further guidance documents for BCAs Authorities are much more relaxed about risks and provide waivers on data requirements (sometimes) EU Expert Group on bdquoBiopesticidesldquo and bdquoLow Risk Criterialdquo In general everyone in Brussels is in favour of adapting regulation of MBCAs to the real risks buthellip
Data requirements ndash Micro-organism 200136EC Annex IIB
Identity bull Strain level bull Methods to identify and determine content bull Impurities - contaminating micro-organisms - relevant metabolites - culture medium
Biological properties bull Origin and natural occurrence bull Target bull Mode of action bull Specificity bull Dispersal and colonisation ability bull Genetic stability bull Production of metabolites
Human health TIER I bull Medical data bull Sensitisation (inhalation and skin) bull Acute toxicity pathogenicity and infectivity (single exposure) A Oral B Inhalation C Intraperitonealsubcutaneous bull Genotoxicity (metabolites) bull Short term toxicity and pathogenicity (repeated exposure) bull First aid measures
Human health TIER II bull In vivo studies in somatic cells bull in vivo studies in germ cells
Data requirements ndash Micro-organism 200136EC Annex IIB
Residues bull Persistence and multiplication bull Non viable residues bull Viable residues Fate and behaviour in the environment bull Persistence and multiplication (soil water air) bull Mobility Effect on non-target organisms bull Birds bull Aquatic organisms (fish algae) bull Bees and other arthropods bull Earthworms bull Non-target soil micro-organisms
Data requirements ndash Micro-organism 200136EC Annex IIB
Data on application bull Intended use bull Mode of action bull Application rate bull Methods number and timing of application bull Proposed instructions for use
Physical chemical technical properties of the ppp bull Storage stability - shelf life bull Particle size distribution bull Etc
Identity bull Trade name bull Composition
Data requirements ndash Micro-organism 200136EC Annex IIIB
Human health bull Oral toxicity bull Inhalation toxicity bull Percutaneous toxicity bull Skin and eye irritation bull Skin sensitisation
Efficacy data
Further information bull Re-entry periods bull Cleaning of application equipment bull Measures in case of an accident
Data requirements ndash Micro-organism 200136EC Annex IIIB
Fate and behaviour in the environment
Residues
Exposure under the proposed condition of use
Effect on non-target organisms
Data requirements ndash Micro-organism 200136EC Annex IIIB
- Use of Micro-organisms in Biological Plant Protection ndash Potential and Regulation
- Slide Number 2
- Slide Number 3
- Slide Number 4
- Biological Control of Seed Borne Diseases
- Slide Number 6
- Slide Number 7
- Slide Number 8
- Slide Number 9
- Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- EU and Zonal regulation
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Summary
- Slide Number 22
- Data requirements ndash Micro-organism200136EC Annex IIB
- Slide Number 24
- Data requirements ndash Micro-organism200136EC Annex IIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Slide Number 28
-
Bacillus subtilis Mode of Action
Increased plant health
lsquodisease escapersquo
Induction of plant resistance Competition Antibiosis
Plant
Growth Promotion Production of plant hormones
enzymatic P mobilisation
= Increasing yields
Bacillus subtilis
Biological Control of Seed Borne Diseases
Seed treatment of cereals with formulated bacteria
Pseudomonas chlororaphis
CedomonCeral
bull Pseudomonas chlororaphis seed treatment bull BCA against seed-borne diseaeses in barley
and wheat bull Already used on 2 million ha in Scandinavia
Bacillus amyloliquefaciens Increase in yields
untreated treated
Bacillus amyloliquefaciens Increase in yields
Tomato varieties
02468
1012141618
Increase in yields ()
Bacillus sp Antibiosis
Antibiose
bull Antibiotic metabolites and enzymes with activity against plant pathogens
Bacillus subtilis
Fusarium oxysporum
Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
Coiling of Trichoderma hyphae around the plant pathogen Rhizoctonia solani
G catenulatum can produce cell-wall degrading enzymes such as szlig-13-glucanases and other chitinolytic enzymes
Many strains are very capable of colonizing roots of many species of plants They can colonize the entire root system for an extended period of time following application to seeds roots or soil
Rhizosphere Competence
Bakterien
Potential for MBCAs
Source (Waldner W Frutta e Vite 2009)
Maximal pesticide Residue Level requested by Supermarket chains in Italy
Maximal pesticide Residue Level requested by Supermarket chains in Germany
100 Legal MRL 100 Legal MRL
50
40
30 33
70
80
Regulation 2020 Stagnancy or new perspectives
for biological control
Should EU regulation + directive be implemented there is a market for BCAs
- Directive 2009128EC aims to achieve a sustainable use of pesticides
- Article 14 says that ldquothe Member States shall
take all necessary measures to promote low pesticide-input pest management giving wherever possible priority to non-chemical methods so that professional users of pesticides switch to practices and products with the lowest risk to human health and the environment
The Regulation (EC) No 11072009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market replaced 91414EEC from 14 June 2011 Article 55 explicitly implies the promotion of the use of non-chemical and natural alternatives
The road is paved for introduction of more biocontrol
Regulation of MBCAs in Europe
Regulation (EC) No 11072009 is the legislation concerning the placing of plant protection products (PPPs) on the market in the European Union Procedure
1Application to an EU country called Rapporteur Member State (RMS) 2RMS verifies if the application is admissible (completeness check) 3RMS prepares a draft assessment report (DAR) 4EFSA issues its conclusions 5Standing Committee for Food Chain and Animal Health votes on approval or non-approval 6Adoption by the Commission 7Publication of a Regulation in the EU Official Journal
Under the new EU rules it takes 25 to 35 years from the date of admissibility of the application to the publication of a Regulation approving a new active substance
EU and Zonal regulation
Active Substance (ai) Microorganisms at strain level (except granulose viruses)
Formulated Product with specific indication
EuCom DG Sante
RMS 3 Zones
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4
Annex II AS submission
RMS DAR
Approval AS
Timelines 11072009
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
MR Approval
Active Substance
PPP
these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4 Year 5
Annex II AS submission
Final DAR
Approval AS
Timelines 11072009 (realistic example case with request for additional information)
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
Mutual recognition
Approval
Active Substance
PPP these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year For 3 years only by the RMS Zonal applications procedures
Low-risk as based PPP
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3
Annex II AS submission
DAR
Full Approval
AS
Timelines 11072009 (proposed low-risk case )
Annex III PPP submission
ZRMS
Provisional Zonal Approval PPP
Mutual recognition Application amp approval
Low-risk Active Substance
Low-risk as based PPP
Completeness Check Incl low-risk status
Provisional low-risk as approval
Full Zonal Approval PPP
Stagnacy No things are moving hellip Slowly IBMA outreach for professional support in lobbying NL presidency will pick up our low risk approach Next step by IBMA Data requirements
It takes a life time of a man (or more) to adapt regulation of BCAs to the real risks
Summary
Progress in Regulation Process
EC has further improved legislation (Reg 11072009) EC produced Dir 1282009 Sustainable Use Directive EC has provided further guidance documents for BCAs Authorities are much more relaxed about risks and provide waivers on data requirements (sometimes) EU Expert Group on bdquoBiopesticidesldquo and bdquoLow Risk Criterialdquo In general everyone in Brussels is in favour of adapting regulation of MBCAs to the real risks buthellip
Data requirements ndash Micro-organism 200136EC Annex IIB
Identity bull Strain level bull Methods to identify and determine content bull Impurities - contaminating micro-organisms - relevant metabolites - culture medium
Biological properties bull Origin and natural occurrence bull Target bull Mode of action bull Specificity bull Dispersal and colonisation ability bull Genetic stability bull Production of metabolites
Human health TIER I bull Medical data bull Sensitisation (inhalation and skin) bull Acute toxicity pathogenicity and infectivity (single exposure) A Oral B Inhalation C Intraperitonealsubcutaneous bull Genotoxicity (metabolites) bull Short term toxicity and pathogenicity (repeated exposure) bull First aid measures
Human health TIER II bull In vivo studies in somatic cells bull in vivo studies in germ cells
Data requirements ndash Micro-organism 200136EC Annex IIB
Residues bull Persistence and multiplication bull Non viable residues bull Viable residues Fate and behaviour in the environment bull Persistence and multiplication (soil water air) bull Mobility Effect on non-target organisms bull Birds bull Aquatic organisms (fish algae) bull Bees and other arthropods bull Earthworms bull Non-target soil micro-organisms
Data requirements ndash Micro-organism 200136EC Annex IIB
Data on application bull Intended use bull Mode of action bull Application rate bull Methods number and timing of application bull Proposed instructions for use
Physical chemical technical properties of the ppp bull Storage stability - shelf life bull Particle size distribution bull Etc
Identity bull Trade name bull Composition
Data requirements ndash Micro-organism 200136EC Annex IIIB
Human health bull Oral toxicity bull Inhalation toxicity bull Percutaneous toxicity bull Skin and eye irritation bull Skin sensitisation
Efficacy data
Further information bull Re-entry periods bull Cleaning of application equipment bull Measures in case of an accident
Data requirements ndash Micro-organism 200136EC Annex IIIB
Fate and behaviour in the environment
Residues
Exposure under the proposed condition of use
Effect on non-target organisms
Data requirements ndash Micro-organism 200136EC Annex IIIB
- Use of Micro-organisms in Biological Plant Protection ndash Potential and Regulation
- Slide Number 2
- Slide Number 3
- Slide Number 4
- Biological Control of Seed Borne Diseases
- Slide Number 6
- Slide Number 7
- Slide Number 8
- Slide Number 9
- Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- EU and Zonal regulation
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Summary
- Slide Number 22
- Data requirements ndash Micro-organism200136EC Annex IIB
- Slide Number 24
- Data requirements ndash Micro-organism200136EC Annex IIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Slide Number 28
-
Biological Control of Seed Borne Diseases
Seed treatment of cereals with formulated bacteria
Pseudomonas chlororaphis
CedomonCeral
bull Pseudomonas chlororaphis seed treatment bull BCA against seed-borne diseaeses in barley
and wheat bull Already used on 2 million ha in Scandinavia
Bacillus amyloliquefaciens Increase in yields
untreated treated
Bacillus amyloliquefaciens Increase in yields
Tomato varieties
02468
1012141618
Increase in yields ()
Bacillus sp Antibiosis
Antibiose
bull Antibiotic metabolites and enzymes with activity against plant pathogens
Bacillus subtilis
Fusarium oxysporum
Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
Coiling of Trichoderma hyphae around the plant pathogen Rhizoctonia solani
G catenulatum can produce cell-wall degrading enzymes such as szlig-13-glucanases and other chitinolytic enzymes
Many strains are very capable of colonizing roots of many species of plants They can colonize the entire root system for an extended period of time following application to seeds roots or soil
Rhizosphere Competence
Bakterien
Potential for MBCAs
Source (Waldner W Frutta e Vite 2009)
Maximal pesticide Residue Level requested by Supermarket chains in Italy
Maximal pesticide Residue Level requested by Supermarket chains in Germany
100 Legal MRL 100 Legal MRL
50
40
30 33
70
80
Regulation 2020 Stagnancy or new perspectives
for biological control
Should EU regulation + directive be implemented there is a market for BCAs
- Directive 2009128EC aims to achieve a sustainable use of pesticides
- Article 14 says that ldquothe Member States shall
take all necessary measures to promote low pesticide-input pest management giving wherever possible priority to non-chemical methods so that professional users of pesticides switch to practices and products with the lowest risk to human health and the environment
The Regulation (EC) No 11072009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market replaced 91414EEC from 14 June 2011 Article 55 explicitly implies the promotion of the use of non-chemical and natural alternatives
The road is paved for introduction of more biocontrol
Regulation of MBCAs in Europe
Regulation (EC) No 11072009 is the legislation concerning the placing of plant protection products (PPPs) on the market in the European Union Procedure
1Application to an EU country called Rapporteur Member State (RMS) 2RMS verifies if the application is admissible (completeness check) 3RMS prepares a draft assessment report (DAR) 4EFSA issues its conclusions 5Standing Committee for Food Chain and Animal Health votes on approval or non-approval 6Adoption by the Commission 7Publication of a Regulation in the EU Official Journal
Under the new EU rules it takes 25 to 35 years from the date of admissibility of the application to the publication of a Regulation approving a new active substance
EU and Zonal regulation
Active Substance (ai) Microorganisms at strain level (except granulose viruses)
Formulated Product with specific indication
EuCom DG Sante
RMS 3 Zones
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4
Annex II AS submission
RMS DAR
Approval AS
Timelines 11072009
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
MR Approval
Active Substance
PPP
these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4 Year 5
Annex II AS submission
Final DAR
Approval AS
Timelines 11072009 (realistic example case with request for additional information)
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
Mutual recognition
Approval
Active Substance
PPP these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year For 3 years only by the RMS Zonal applications procedures
Low-risk as based PPP
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3
Annex II AS submission
DAR
Full Approval
AS
Timelines 11072009 (proposed low-risk case )
Annex III PPP submission
ZRMS
Provisional Zonal Approval PPP
Mutual recognition Application amp approval
Low-risk Active Substance
Low-risk as based PPP
Completeness Check Incl low-risk status
Provisional low-risk as approval
Full Zonal Approval PPP
Stagnacy No things are moving hellip Slowly IBMA outreach for professional support in lobbying NL presidency will pick up our low risk approach Next step by IBMA Data requirements
It takes a life time of a man (or more) to adapt regulation of BCAs to the real risks
Summary
Progress in Regulation Process
EC has further improved legislation (Reg 11072009) EC produced Dir 1282009 Sustainable Use Directive EC has provided further guidance documents for BCAs Authorities are much more relaxed about risks and provide waivers on data requirements (sometimes) EU Expert Group on bdquoBiopesticidesldquo and bdquoLow Risk Criterialdquo In general everyone in Brussels is in favour of adapting regulation of MBCAs to the real risks buthellip
Data requirements ndash Micro-organism 200136EC Annex IIB
Identity bull Strain level bull Methods to identify and determine content bull Impurities - contaminating micro-organisms - relevant metabolites - culture medium
Biological properties bull Origin and natural occurrence bull Target bull Mode of action bull Specificity bull Dispersal and colonisation ability bull Genetic stability bull Production of metabolites
Human health TIER I bull Medical data bull Sensitisation (inhalation and skin) bull Acute toxicity pathogenicity and infectivity (single exposure) A Oral B Inhalation C Intraperitonealsubcutaneous bull Genotoxicity (metabolites) bull Short term toxicity and pathogenicity (repeated exposure) bull First aid measures
Human health TIER II bull In vivo studies in somatic cells bull in vivo studies in germ cells
Data requirements ndash Micro-organism 200136EC Annex IIB
Residues bull Persistence and multiplication bull Non viable residues bull Viable residues Fate and behaviour in the environment bull Persistence and multiplication (soil water air) bull Mobility Effect on non-target organisms bull Birds bull Aquatic organisms (fish algae) bull Bees and other arthropods bull Earthworms bull Non-target soil micro-organisms
Data requirements ndash Micro-organism 200136EC Annex IIB
Data on application bull Intended use bull Mode of action bull Application rate bull Methods number and timing of application bull Proposed instructions for use
Physical chemical technical properties of the ppp bull Storage stability - shelf life bull Particle size distribution bull Etc
Identity bull Trade name bull Composition
Data requirements ndash Micro-organism 200136EC Annex IIIB
Human health bull Oral toxicity bull Inhalation toxicity bull Percutaneous toxicity bull Skin and eye irritation bull Skin sensitisation
Efficacy data
Further information bull Re-entry periods bull Cleaning of application equipment bull Measures in case of an accident
Data requirements ndash Micro-organism 200136EC Annex IIIB
Fate and behaviour in the environment
Residues
Exposure under the proposed condition of use
Effect on non-target organisms
Data requirements ndash Micro-organism 200136EC Annex IIIB
- Use of Micro-organisms in Biological Plant Protection ndash Potential and Regulation
- Slide Number 2
- Slide Number 3
- Slide Number 4
- Biological Control of Seed Borne Diseases
- Slide Number 6
- Slide Number 7
- Slide Number 8
- Slide Number 9
- Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- EU and Zonal regulation
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Summary
- Slide Number 22
- Data requirements ndash Micro-organism200136EC Annex IIB
- Slide Number 24
- Data requirements ndash Micro-organism200136EC Annex IIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Slide Number 28
-
CedomonCeral
bull Pseudomonas chlororaphis seed treatment bull BCA against seed-borne diseaeses in barley
and wheat bull Already used on 2 million ha in Scandinavia
Bacillus amyloliquefaciens Increase in yields
untreated treated
Bacillus amyloliquefaciens Increase in yields
Tomato varieties
02468
1012141618
Increase in yields ()
Bacillus sp Antibiosis
Antibiose
bull Antibiotic metabolites and enzymes with activity against plant pathogens
Bacillus subtilis
Fusarium oxysporum
Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
Coiling of Trichoderma hyphae around the plant pathogen Rhizoctonia solani
G catenulatum can produce cell-wall degrading enzymes such as szlig-13-glucanases and other chitinolytic enzymes
Many strains are very capable of colonizing roots of many species of plants They can colonize the entire root system for an extended period of time following application to seeds roots or soil
Rhizosphere Competence
Bakterien
Potential for MBCAs
Source (Waldner W Frutta e Vite 2009)
Maximal pesticide Residue Level requested by Supermarket chains in Italy
Maximal pesticide Residue Level requested by Supermarket chains in Germany
100 Legal MRL 100 Legal MRL
50
40
30 33
70
80
Regulation 2020 Stagnancy or new perspectives
for biological control
Should EU regulation + directive be implemented there is a market for BCAs
- Directive 2009128EC aims to achieve a sustainable use of pesticides
- Article 14 says that ldquothe Member States shall
take all necessary measures to promote low pesticide-input pest management giving wherever possible priority to non-chemical methods so that professional users of pesticides switch to practices and products with the lowest risk to human health and the environment
The Regulation (EC) No 11072009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market replaced 91414EEC from 14 June 2011 Article 55 explicitly implies the promotion of the use of non-chemical and natural alternatives
The road is paved for introduction of more biocontrol
Regulation of MBCAs in Europe
Regulation (EC) No 11072009 is the legislation concerning the placing of plant protection products (PPPs) on the market in the European Union Procedure
1Application to an EU country called Rapporteur Member State (RMS) 2RMS verifies if the application is admissible (completeness check) 3RMS prepares a draft assessment report (DAR) 4EFSA issues its conclusions 5Standing Committee for Food Chain and Animal Health votes on approval or non-approval 6Adoption by the Commission 7Publication of a Regulation in the EU Official Journal
Under the new EU rules it takes 25 to 35 years from the date of admissibility of the application to the publication of a Regulation approving a new active substance
EU and Zonal regulation
Active Substance (ai) Microorganisms at strain level (except granulose viruses)
Formulated Product with specific indication
EuCom DG Sante
RMS 3 Zones
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4
Annex II AS submission
RMS DAR
Approval AS
Timelines 11072009
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
MR Approval
Active Substance
PPP
these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4 Year 5
Annex II AS submission
Final DAR
Approval AS
Timelines 11072009 (realistic example case with request for additional information)
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
Mutual recognition
Approval
Active Substance
PPP these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year For 3 years only by the RMS Zonal applications procedures
Low-risk as based PPP
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3
Annex II AS submission
DAR
Full Approval
AS
Timelines 11072009 (proposed low-risk case )
Annex III PPP submission
ZRMS
Provisional Zonal Approval PPP
Mutual recognition Application amp approval
Low-risk Active Substance
Low-risk as based PPP
Completeness Check Incl low-risk status
Provisional low-risk as approval
Full Zonal Approval PPP
Stagnacy No things are moving hellip Slowly IBMA outreach for professional support in lobbying NL presidency will pick up our low risk approach Next step by IBMA Data requirements
It takes a life time of a man (or more) to adapt regulation of BCAs to the real risks
Summary
Progress in Regulation Process
EC has further improved legislation (Reg 11072009) EC produced Dir 1282009 Sustainable Use Directive EC has provided further guidance documents for BCAs Authorities are much more relaxed about risks and provide waivers on data requirements (sometimes) EU Expert Group on bdquoBiopesticidesldquo and bdquoLow Risk Criterialdquo In general everyone in Brussels is in favour of adapting regulation of MBCAs to the real risks buthellip
Data requirements ndash Micro-organism 200136EC Annex IIB
Identity bull Strain level bull Methods to identify and determine content bull Impurities - contaminating micro-organisms - relevant metabolites - culture medium
Biological properties bull Origin and natural occurrence bull Target bull Mode of action bull Specificity bull Dispersal and colonisation ability bull Genetic stability bull Production of metabolites
Human health TIER I bull Medical data bull Sensitisation (inhalation and skin) bull Acute toxicity pathogenicity and infectivity (single exposure) A Oral B Inhalation C Intraperitonealsubcutaneous bull Genotoxicity (metabolites) bull Short term toxicity and pathogenicity (repeated exposure) bull First aid measures
Human health TIER II bull In vivo studies in somatic cells bull in vivo studies in germ cells
Data requirements ndash Micro-organism 200136EC Annex IIB
Residues bull Persistence and multiplication bull Non viable residues bull Viable residues Fate and behaviour in the environment bull Persistence and multiplication (soil water air) bull Mobility Effect on non-target organisms bull Birds bull Aquatic organisms (fish algae) bull Bees and other arthropods bull Earthworms bull Non-target soil micro-organisms
Data requirements ndash Micro-organism 200136EC Annex IIB
Data on application bull Intended use bull Mode of action bull Application rate bull Methods number and timing of application bull Proposed instructions for use
Physical chemical technical properties of the ppp bull Storage stability - shelf life bull Particle size distribution bull Etc
Identity bull Trade name bull Composition
Data requirements ndash Micro-organism 200136EC Annex IIIB
Human health bull Oral toxicity bull Inhalation toxicity bull Percutaneous toxicity bull Skin and eye irritation bull Skin sensitisation
Efficacy data
Further information bull Re-entry periods bull Cleaning of application equipment bull Measures in case of an accident
Data requirements ndash Micro-organism 200136EC Annex IIIB
Fate and behaviour in the environment
Residues
Exposure under the proposed condition of use
Effect on non-target organisms
Data requirements ndash Micro-organism 200136EC Annex IIIB
- Use of Micro-organisms in Biological Plant Protection ndash Potential and Regulation
- Slide Number 2
- Slide Number 3
- Slide Number 4
- Biological Control of Seed Borne Diseases
- Slide Number 6
- Slide Number 7
- Slide Number 8
- Slide Number 9
- Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- EU and Zonal regulation
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Summary
- Slide Number 22
- Data requirements ndash Micro-organism200136EC Annex IIB
- Slide Number 24
- Data requirements ndash Micro-organism200136EC Annex IIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Slide Number 28
-
Bacillus amyloliquefaciens Increase in yields
untreated treated
Bacillus amyloliquefaciens Increase in yields
Tomato varieties
02468
1012141618
Increase in yields ()
Bacillus sp Antibiosis
Antibiose
bull Antibiotic metabolites and enzymes with activity against plant pathogens
Bacillus subtilis
Fusarium oxysporum
Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
Coiling of Trichoderma hyphae around the plant pathogen Rhizoctonia solani
G catenulatum can produce cell-wall degrading enzymes such as szlig-13-glucanases and other chitinolytic enzymes
Many strains are very capable of colonizing roots of many species of plants They can colonize the entire root system for an extended period of time following application to seeds roots or soil
Rhizosphere Competence
Bakterien
Potential for MBCAs
Source (Waldner W Frutta e Vite 2009)
Maximal pesticide Residue Level requested by Supermarket chains in Italy
Maximal pesticide Residue Level requested by Supermarket chains in Germany
100 Legal MRL 100 Legal MRL
50
40
30 33
70
80
Regulation 2020 Stagnancy or new perspectives
for biological control
Should EU regulation + directive be implemented there is a market for BCAs
- Directive 2009128EC aims to achieve a sustainable use of pesticides
- Article 14 says that ldquothe Member States shall
take all necessary measures to promote low pesticide-input pest management giving wherever possible priority to non-chemical methods so that professional users of pesticides switch to practices and products with the lowest risk to human health and the environment
The Regulation (EC) No 11072009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market replaced 91414EEC from 14 June 2011 Article 55 explicitly implies the promotion of the use of non-chemical and natural alternatives
The road is paved for introduction of more biocontrol
Regulation of MBCAs in Europe
Regulation (EC) No 11072009 is the legislation concerning the placing of plant protection products (PPPs) on the market in the European Union Procedure
1Application to an EU country called Rapporteur Member State (RMS) 2RMS verifies if the application is admissible (completeness check) 3RMS prepares a draft assessment report (DAR) 4EFSA issues its conclusions 5Standing Committee for Food Chain and Animal Health votes on approval or non-approval 6Adoption by the Commission 7Publication of a Regulation in the EU Official Journal
Under the new EU rules it takes 25 to 35 years from the date of admissibility of the application to the publication of a Regulation approving a new active substance
EU and Zonal regulation
Active Substance (ai) Microorganisms at strain level (except granulose viruses)
Formulated Product with specific indication
EuCom DG Sante
RMS 3 Zones
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4
Annex II AS submission
RMS DAR
Approval AS
Timelines 11072009
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
MR Approval
Active Substance
PPP
these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4 Year 5
Annex II AS submission
Final DAR
Approval AS
Timelines 11072009 (realistic example case with request for additional information)
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
Mutual recognition
Approval
Active Substance
PPP these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year For 3 years only by the RMS Zonal applications procedures
Low-risk as based PPP
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3
Annex II AS submission
DAR
Full Approval
AS
Timelines 11072009 (proposed low-risk case )
Annex III PPP submission
ZRMS
Provisional Zonal Approval PPP
Mutual recognition Application amp approval
Low-risk Active Substance
Low-risk as based PPP
Completeness Check Incl low-risk status
Provisional low-risk as approval
Full Zonal Approval PPP
Stagnacy No things are moving hellip Slowly IBMA outreach for professional support in lobbying NL presidency will pick up our low risk approach Next step by IBMA Data requirements
It takes a life time of a man (or more) to adapt regulation of BCAs to the real risks
Summary
Progress in Regulation Process
EC has further improved legislation (Reg 11072009) EC produced Dir 1282009 Sustainable Use Directive EC has provided further guidance documents for BCAs Authorities are much more relaxed about risks and provide waivers on data requirements (sometimes) EU Expert Group on bdquoBiopesticidesldquo and bdquoLow Risk Criterialdquo In general everyone in Brussels is in favour of adapting regulation of MBCAs to the real risks buthellip
Data requirements ndash Micro-organism 200136EC Annex IIB
Identity bull Strain level bull Methods to identify and determine content bull Impurities - contaminating micro-organisms - relevant metabolites - culture medium
Biological properties bull Origin and natural occurrence bull Target bull Mode of action bull Specificity bull Dispersal and colonisation ability bull Genetic stability bull Production of metabolites
Human health TIER I bull Medical data bull Sensitisation (inhalation and skin) bull Acute toxicity pathogenicity and infectivity (single exposure) A Oral B Inhalation C Intraperitonealsubcutaneous bull Genotoxicity (metabolites) bull Short term toxicity and pathogenicity (repeated exposure) bull First aid measures
Human health TIER II bull In vivo studies in somatic cells bull in vivo studies in germ cells
Data requirements ndash Micro-organism 200136EC Annex IIB
Residues bull Persistence and multiplication bull Non viable residues bull Viable residues Fate and behaviour in the environment bull Persistence and multiplication (soil water air) bull Mobility Effect on non-target organisms bull Birds bull Aquatic organisms (fish algae) bull Bees and other arthropods bull Earthworms bull Non-target soil micro-organisms
Data requirements ndash Micro-organism 200136EC Annex IIB
Data on application bull Intended use bull Mode of action bull Application rate bull Methods number and timing of application bull Proposed instructions for use
Physical chemical technical properties of the ppp bull Storage stability - shelf life bull Particle size distribution bull Etc
Identity bull Trade name bull Composition
Data requirements ndash Micro-organism 200136EC Annex IIIB
Human health bull Oral toxicity bull Inhalation toxicity bull Percutaneous toxicity bull Skin and eye irritation bull Skin sensitisation
Efficacy data
Further information bull Re-entry periods bull Cleaning of application equipment bull Measures in case of an accident
Data requirements ndash Micro-organism 200136EC Annex IIIB
Fate and behaviour in the environment
Residues
Exposure under the proposed condition of use
Effect on non-target organisms
Data requirements ndash Micro-organism 200136EC Annex IIIB
- Use of Micro-organisms in Biological Plant Protection ndash Potential and Regulation
- Slide Number 2
- Slide Number 3
- Slide Number 4
- Biological Control of Seed Borne Diseases
- Slide Number 6
- Slide Number 7
- Slide Number 8
- Slide Number 9
- Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- EU and Zonal regulation
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Summary
- Slide Number 22
- Data requirements ndash Micro-organism200136EC Annex IIB
- Slide Number 24
- Data requirements ndash Micro-organism200136EC Annex IIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Slide Number 28
-
Bacillus amyloliquefaciens Increase in yields
Tomato varieties
02468
1012141618
Increase in yields ()
Bacillus sp Antibiosis
Antibiose
bull Antibiotic metabolites and enzymes with activity against plant pathogens
Bacillus subtilis
Fusarium oxysporum
Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
Coiling of Trichoderma hyphae around the plant pathogen Rhizoctonia solani
G catenulatum can produce cell-wall degrading enzymes such as szlig-13-glucanases and other chitinolytic enzymes
Many strains are very capable of colonizing roots of many species of plants They can colonize the entire root system for an extended period of time following application to seeds roots or soil
Rhizosphere Competence
Bakterien
Potential for MBCAs
Source (Waldner W Frutta e Vite 2009)
Maximal pesticide Residue Level requested by Supermarket chains in Italy
Maximal pesticide Residue Level requested by Supermarket chains in Germany
100 Legal MRL 100 Legal MRL
50
40
30 33
70
80
Regulation 2020 Stagnancy or new perspectives
for biological control
Should EU regulation + directive be implemented there is a market for BCAs
- Directive 2009128EC aims to achieve a sustainable use of pesticides
- Article 14 says that ldquothe Member States shall
take all necessary measures to promote low pesticide-input pest management giving wherever possible priority to non-chemical methods so that professional users of pesticides switch to practices and products with the lowest risk to human health and the environment
The Regulation (EC) No 11072009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market replaced 91414EEC from 14 June 2011 Article 55 explicitly implies the promotion of the use of non-chemical and natural alternatives
The road is paved for introduction of more biocontrol
Regulation of MBCAs in Europe
Regulation (EC) No 11072009 is the legislation concerning the placing of plant protection products (PPPs) on the market in the European Union Procedure
1Application to an EU country called Rapporteur Member State (RMS) 2RMS verifies if the application is admissible (completeness check) 3RMS prepares a draft assessment report (DAR) 4EFSA issues its conclusions 5Standing Committee for Food Chain and Animal Health votes on approval or non-approval 6Adoption by the Commission 7Publication of a Regulation in the EU Official Journal
Under the new EU rules it takes 25 to 35 years from the date of admissibility of the application to the publication of a Regulation approving a new active substance
EU and Zonal regulation
Active Substance (ai) Microorganisms at strain level (except granulose viruses)
Formulated Product with specific indication
EuCom DG Sante
RMS 3 Zones
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4
Annex II AS submission
RMS DAR
Approval AS
Timelines 11072009
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
MR Approval
Active Substance
PPP
these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4 Year 5
Annex II AS submission
Final DAR
Approval AS
Timelines 11072009 (realistic example case with request for additional information)
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
Mutual recognition
Approval
Active Substance
PPP these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year For 3 years only by the RMS Zonal applications procedures
Low-risk as based PPP
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3
Annex II AS submission
DAR
Full Approval
AS
Timelines 11072009 (proposed low-risk case )
Annex III PPP submission
ZRMS
Provisional Zonal Approval PPP
Mutual recognition Application amp approval
Low-risk Active Substance
Low-risk as based PPP
Completeness Check Incl low-risk status
Provisional low-risk as approval
Full Zonal Approval PPP
Stagnacy No things are moving hellip Slowly IBMA outreach for professional support in lobbying NL presidency will pick up our low risk approach Next step by IBMA Data requirements
It takes a life time of a man (or more) to adapt regulation of BCAs to the real risks
Summary
Progress in Regulation Process
EC has further improved legislation (Reg 11072009) EC produced Dir 1282009 Sustainable Use Directive EC has provided further guidance documents for BCAs Authorities are much more relaxed about risks and provide waivers on data requirements (sometimes) EU Expert Group on bdquoBiopesticidesldquo and bdquoLow Risk Criterialdquo In general everyone in Brussels is in favour of adapting regulation of MBCAs to the real risks buthellip
Data requirements ndash Micro-organism 200136EC Annex IIB
Identity bull Strain level bull Methods to identify and determine content bull Impurities - contaminating micro-organisms - relevant metabolites - culture medium
Biological properties bull Origin and natural occurrence bull Target bull Mode of action bull Specificity bull Dispersal and colonisation ability bull Genetic stability bull Production of metabolites
Human health TIER I bull Medical data bull Sensitisation (inhalation and skin) bull Acute toxicity pathogenicity and infectivity (single exposure) A Oral B Inhalation C Intraperitonealsubcutaneous bull Genotoxicity (metabolites) bull Short term toxicity and pathogenicity (repeated exposure) bull First aid measures
Human health TIER II bull In vivo studies in somatic cells bull in vivo studies in germ cells
Data requirements ndash Micro-organism 200136EC Annex IIB
Residues bull Persistence and multiplication bull Non viable residues bull Viable residues Fate and behaviour in the environment bull Persistence and multiplication (soil water air) bull Mobility Effect on non-target organisms bull Birds bull Aquatic organisms (fish algae) bull Bees and other arthropods bull Earthworms bull Non-target soil micro-organisms
Data requirements ndash Micro-organism 200136EC Annex IIB
Data on application bull Intended use bull Mode of action bull Application rate bull Methods number and timing of application bull Proposed instructions for use
Physical chemical technical properties of the ppp bull Storage stability - shelf life bull Particle size distribution bull Etc
Identity bull Trade name bull Composition
Data requirements ndash Micro-organism 200136EC Annex IIIB
Human health bull Oral toxicity bull Inhalation toxicity bull Percutaneous toxicity bull Skin and eye irritation bull Skin sensitisation
Efficacy data
Further information bull Re-entry periods bull Cleaning of application equipment bull Measures in case of an accident
Data requirements ndash Micro-organism 200136EC Annex IIIB
Fate and behaviour in the environment
Residues
Exposure under the proposed condition of use
Effect on non-target organisms
Data requirements ndash Micro-organism 200136EC Annex IIIB
- Use of Micro-organisms in Biological Plant Protection ndash Potential and Regulation
- Slide Number 2
- Slide Number 3
- Slide Number 4
- Biological Control of Seed Borne Diseases
- Slide Number 6
- Slide Number 7
- Slide Number 8
- Slide Number 9
- Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- EU and Zonal regulation
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Summary
- Slide Number 22
- Data requirements ndash Micro-organism200136EC Annex IIB
- Slide Number 24
- Data requirements ndash Micro-organism200136EC Annex IIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Slide Number 28
-
Bacillus sp Antibiosis
Antibiose
bull Antibiotic metabolites and enzymes with activity against plant pathogens
Bacillus subtilis
Fusarium oxysporum
Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
Coiling of Trichoderma hyphae around the plant pathogen Rhizoctonia solani
G catenulatum can produce cell-wall degrading enzymes such as szlig-13-glucanases and other chitinolytic enzymes
Many strains are very capable of colonizing roots of many species of plants They can colonize the entire root system for an extended period of time following application to seeds roots or soil
Rhizosphere Competence
Bakterien
Potential for MBCAs
Source (Waldner W Frutta e Vite 2009)
Maximal pesticide Residue Level requested by Supermarket chains in Italy
Maximal pesticide Residue Level requested by Supermarket chains in Germany
100 Legal MRL 100 Legal MRL
50
40
30 33
70
80
Regulation 2020 Stagnancy or new perspectives
for biological control
Should EU regulation + directive be implemented there is a market for BCAs
- Directive 2009128EC aims to achieve a sustainable use of pesticides
- Article 14 says that ldquothe Member States shall
take all necessary measures to promote low pesticide-input pest management giving wherever possible priority to non-chemical methods so that professional users of pesticides switch to practices and products with the lowest risk to human health and the environment
The Regulation (EC) No 11072009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market replaced 91414EEC from 14 June 2011 Article 55 explicitly implies the promotion of the use of non-chemical and natural alternatives
The road is paved for introduction of more biocontrol
Regulation of MBCAs in Europe
Regulation (EC) No 11072009 is the legislation concerning the placing of plant protection products (PPPs) on the market in the European Union Procedure
1Application to an EU country called Rapporteur Member State (RMS) 2RMS verifies if the application is admissible (completeness check) 3RMS prepares a draft assessment report (DAR) 4EFSA issues its conclusions 5Standing Committee for Food Chain and Animal Health votes on approval or non-approval 6Adoption by the Commission 7Publication of a Regulation in the EU Official Journal
Under the new EU rules it takes 25 to 35 years from the date of admissibility of the application to the publication of a Regulation approving a new active substance
EU and Zonal regulation
Active Substance (ai) Microorganisms at strain level (except granulose viruses)
Formulated Product with specific indication
EuCom DG Sante
RMS 3 Zones
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4
Annex II AS submission
RMS DAR
Approval AS
Timelines 11072009
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
MR Approval
Active Substance
PPP
these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4 Year 5
Annex II AS submission
Final DAR
Approval AS
Timelines 11072009 (realistic example case with request for additional information)
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
Mutual recognition
Approval
Active Substance
PPP these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year For 3 years only by the RMS Zonal applications procedures
Low-risk as based PPP
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3
Annex II AS submission
DAR
Full Approval
AS
Timelines 11072009 (proposed low-risk case )
Annex III PPP submission
ZRMS
Provisional Zonal Approval PPP
Mutual recognition Application amp approval
Low-risk Active Substance
Low-risk as based PPP
Completeness Check Incl low-risk status
Provisional low-risk as approval
Full Zonal Approval PPP
Stagnacy No things are moving hellip Slowly IBMA outreach for professional support in lobbying NL presidency will pick up our low risk approach Next step by IBMA Data requirements
It takes a life time of a man (or more) to adapt regulation of BCAs to the real risks
Summary
Progress in Regulation Process
EC has further improved legislation (Reg 11072009) EC produced Dir 1282009 Sustainable Use Directive EC has provided further guidance documents for BCAs Authorities are much more relaxed about risks and provide waivers on data requirements (sometimes) EU Expert Group on bdquoBiopesticidesldquo and bdquoLow Risk Criterialdquo In general everyone in Brussels is in favour of adapting regulation of MBCAs to the real risks buthellip
Data requirements ndash Micro-organism 200136EC Annex IIB
Identity bull Strain level bull Methods to identify and determine content bull Impurities - contaminating micro-organisms - relevant metabolites - culture medium
Biological properties bull Origin and natural occurrence bull Target bull Mode of action bull Specificity bull Dispersal and colonisation ability bull Genetic stability bull Production of metabolites
Human health TIER I bull Medical data bull Sensitisation (inhalation and skin) bull Acute toxicity pathogenicity and infectivity (single exposure) A Oral B Inhalation C Intraperitonealsubcutaneous bull Genotoxicity (metabolites) bull Short term toxicity and pathogenicity (repeated exposure) bull First aid measures
Human health TIER II bull In vivo studies in somatic cells bull in vivo studies in germ cells
Data requirements ndash Micro-organism 200136EC Annex IIB
Residues bull Persistence and multiplication bull Non viable residues bull Viable residues Fate and behaviour in the environment bull Persistence and multiplication (soil water air) bull Mobility Effect on non-target organisms bull Birds bull Aquatic organisms (fish algae) bull Bees and other arthropods bull Earthworms bull Non-target soil micro-organisms
Data requirements ndash Micro-organism 200136EC Annex IIB
Data on application bull Intended use bull Mode of action bull Application rate bull Methods number and timing of application bull Proposed instructions for use
Physical chemical technical properties of the ppp bull Storage stability - shelf life bull Particle size distribution bull Etc
Identity bull Trade name bull Composition
Data requirements ndash Micro-organism 200136EC Annex IIIB
Human health bull Oral toxicity bull Inhalation toxicity bull Percutaneous toxicity bull Skin and eye irritation bull Skin sensitisation
Efficacy data
Further information bull Re-entry periods bull Cleaning of application equipment bull Measures in case of an accident
Data requirements ndash Micro-organism 200136EC Annex IIIB
Fate and behaviour in the environment
Residues
Exposure under the proposed condition of use
Effect on non-target organisms
Data requirements ndash Micro-organism 200136EC Annex IIIB
- Use of Micro-organisms in Biological Plant Protection ndash Potential and Regulation
- Slide Number 2
- Slide Number 3
- Slide Number 4
- Biological Control of Seed Borne Diseases
- Slide Number 6
- Slide Number 7
- Slide Number 8
- Slide Number 9
- Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- EU and Zonal regulation
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Summary
- Slide Number 22
- Data requirements ndash Micro-organism200136EC Annex IIB
- Slide Number 24
- Data requirements ndash Micro-organism200136EC Annex IIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Slide Number 28
-
Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
Coiling of Trichoderma hyphae around the plant pathogen Rhizoctonia solani
G catenulatum can produce cell-wall degrading enzymes such as szlig-13-glucanases and other chitinolytic enzymes
Many strains are very capable of colonizing roots of many species of plants They can colonize the entire root system for an extended period of time following application to seeds roots or soil
Rhizosphere Competence
Bakterien
Potential for MBCAs
Source (Waldner W Frutta e Vite 2009)
Maximal pesticide Residue Level requested by Supermarket chains in Italy
Maximal pesticide Residue Level requested by Supermarket chains in Germany
100 Legal MRL 100 Legal MRL
50
40
30 33
70
80
Regulation 2020 Stagnancy or new perspectives
for biological control
Should EU regulation + directive be implemented there is a market for BCAs
- Directive 2009128EC aims to achieve a sustainable use of pesticides
- Article 14 says that ldquothe Member States shall
take all necessary measures to promote low pesticide-input pest management giving wherever possible priority to non-chemical methods so that professional users of pesticides switch to practices and products with the lowest risk to human health and the environment
The Regulation (EC) No 11072009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market replaced 91414EEC from 14 June 2011 Article 55 explicitly implies the promotion of the use of non-chemical and natural alternatives
The road is paved for introduction of more biocontrol
Regulation of MBCAs in Europe
Regulation (EC) No 11072009 is the legislation concerning the placing of plant protection products (PPPs) on the market in the European Union Procedure
1Application to an EU country called Rapporteur Member State (RMS) 2RMS verifies if the application is admissible (completeness check) 3RMS prepares a draft assessment report (DAR) 4EFSA issues its conclusions 5Standing Committee for Food Chain and Animal Health votes on approval or non-approval 6Adoption by the Commission 7Publication of a Regulation in the EU Official Journal
Under the new EU rules it takes 25 to 35 years from the date of admissibility of the application to the publication of a Regulation approving a new active substance
EU and Zonal regulation
Active Substance (ai) Microorganisms at strain level (except granulose viruses)
Formulated Product with specific indication
EuCom DG Sante
RMS 3 Zones
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4
Annex II AS submission
RMS DAR
Approval AS
Timelines 11072009
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
MR Approval
Active Substance
PPP
these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4 Year 5
Annex II AS submission
Final DAR
Approval AS
Timelines 11072009 (realistic example case with request for additional information)
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
Mutual recognition
Approval
Active Substance
PPP these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year For 3 years only by the RMS Zonal applications procedures
Low-risk as based PPP
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3
Annex II AS submission
DAR
Full Approval
AS
Timelines 11072009 (proposed low-risk case )
Annex III PPP submission
ZRMS
Provisional Zonal Approval PPP
Mutual recognition Application amp approval
Low-risk Active Substance
Low-risk as based PPP
Completeness Check Incl low-risk status
Provisional low-risk as approval
Full Zonal Approval PPP
Stagnacy No things are moving hellip Slowly IBMA outreach for professional support in lobbying NL presidency will pick up our low risk approach Next step by IBMA Data requirements
It takes a life time of a man (or more) to adapt regulation of BCAs to the real risks
Summary
Progress in Regulation Process
EC has further improved legislation (Reg 11072009) EC produced Dir 1282009 Sustainable Use Directive EC has provided further guidance documents for BCAs Authorities are much more relaxed about risks and provide waivers on data requirements (sometimes) EU Expert Group on bdquoBiopesticidesldquo and bdquoLow Risk Criterialdquo In general everyone in Brussels is in favour of adapting regulation of MBCAs to the real risks buthellip
Data requirements ndash Micro-organism 200136EC Annex IIB
Identity bull Strain level bull Methods to identify and determine content bull Impurities - contaminating micro-organisms - relevant metabolites - culture medium
Biological properties bull Origin and natural occurrence bull Target bull Mode of action bull Specificity bull Dispersal and colonisation ability bull Genetic stability bull Production of metabolites
Human health TIER I bull Medical data bull Sensitisation (inhalation and skin) bull Acute toxicity pathogenicity and infectivity (single exposure) A Oral B Inhalation C Intraperitonealsubcutaneous bull Genotoxicity (metabolites) bull Short term toxicity and pathogenicity (repeated exposure) bull First aid measures
Human health TIER II bull In vivo studies in somatic cells bull in vivo studies in germ cells
Data requirements ndash Micro-organism 200136EC Annex IIB
Residues bull Persistence and multiplication bull Non viable residues bull Viable residues Fate and behaviour in the environment bull Persistence and multiplication (soil water air) bull Mobility Effect on non-target organisms bull Birds bull Aquatic organisms (fish algae) bull Bees and other arthropods bull Earthworms bull Non-target soil micro-organisms
Data requirements ndash Micro-organism 200136EC Annex IIB
Data on application bull Intended use bull Mode of action bull Application rate bull Methods number and timing of application bull Proposed instructions for use
Physical chemical technical properties of the ppp bull Storage stability - shelf life bull Particle size distribution bull Etc
Identity bull Trade name bull Composition
Data requirements ndash Micro-organism 200136EC Annex IIIB
Human health bull Oral toxicity bull Inhalation toxicity bull Percutaneous toxicity bull Skin and eye irritation bull Skin sensitisation
Efficacy data
Further information bull Re-entry periods bull Cleaning of application equipment bull Measures in case of an accident
Data requirements ndash Micro-organism 200136EC Annex IIIB
Fate and behaviour in the environment
Residues
Exposure under the proposed condition of use
Effect on non-target organisms
Data requirements ndash Micro-organism 200136EC Annex IIIB
- Use of Micro-organisms in Biological Plant Protection ndash Potential and Regulation
- Slide Number 2
- Slide Number 3
- Slide Number 4
- Biological Control of Seed Borne Diseases
- Slide Number 6
- Slide Number 7
- Slide Number 8
- Slide Number 9
- Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- EU and Zonal regulation
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Summary
- Slide Number 22
- Data requirements ndash Micro-organism200136EC Annex IIB
- Slide Number 24
- Data requirements ndash Micro-organism200136EC Annex IIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Slide Number 28
-
Many strains are very capable of colonizing roots of many species of plants They can colonize the entire root system for an extended period of time following application to seeds roots or soil
Rhizosphere Competence
Bakterien
Potential for MBCAs
Source (Waldner W Frutta e Vite 2009)
Maximal pesticide Residue Level requested by Supermarket chains in Italy
Maximal pesticide Residue Level requested by Supermarket chains in Germany
100 Legal MRL 100 Legal MRL
50
40
30 33
70
80
Regulation 2020 Stagnancy or new perspectives
for biological control
Should EU regulation + directive be implemented there is a market for BCAs
- Directive 2009128EC aims to achieve a sustainable use of pesticides
- Article 14 says that ldquothe Member States shall
take all necessary measures to promote low pesticide-input pest management giving wherever possible priority to non-chemical methods so that professional users of pesticides switch to practices and products with the lowest risk to human health and the environment
The Regulation (EC) No 11072009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market replaced 91414EEC from 14 June 2011 Article 55 explicitly implies the promotion of the use of non-chemical and natural alternatives
The road is paved for introduction of more biocontrol
Regulation of MBCAs in Europe
Regulation (EC) No 11072009 is the legislation concerning the placing of plant protection products (PPPs) on the market in the European Union Procedure
1Application to an EU country called Rapporteur Member State (RMS) 2RMS verifies if the application is admissible (completeness check) 3RMS prepares a draft assessment report (DAR) 4EFSA issues its conclusions 5Standing Committee for Food Chain and Animal Health votes on approval or non-approval 6Adoption by the Commission 7Publication of a Regulation in the EU Official Journal
Under the new EU rules it takes 25 to 35 years from the date of admissibility of the application to the publication of a Regulation approving a new active substance
EU and Zonal regulation
Active Substance (ai) Microorganisms at strain level (except granulose viruses)
Formulated Product with specific indication
EuCom DG Sante
RMS 3 Zones
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4
Annex II AS submission
RMS DAR
Approval AS
Timelines 11072009
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
MR Approval
Active Substance
PPP
these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4 Year 5
Annex II AS submission
Final DAR
Approval AS
Timelines 11072009 (realistic example case with request for additional information)
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
Mutual recognition
Approval
Active Substance
PPP these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year For 3 years only by the RMS Zonal applications procedures
Low-risk as based PPP
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3
Annex II AS submission
DAR
Full Approval
AS
Timelines 11072009 (proposed low-risk case )
Annex III PPP submission
ZRMS
Provisional Zonal Approval PPP
Mutual recognition Application amp approval
Low-risk Active Substance
Low-risk as based PPP
Completeness Check Incl low-risk status
Provisional low-risk as approval
Full Zonal Approval PPP
Stagnacy No things are moving hellip Slowly IBMA outreach for professional support in lobbying NL presidency will pick up our low risk approach Next step by IBMA Data requirements
It takes a life time of a man (or more) to adapt regulation of BCAs to the real risks
Summary
Progress in Regulation Process
EC has further improved legislation (Reg 11072009) EC produced Dir 1282009 Sustainable Use Directive EC has provided further guidance documents for BCAs Authorities are much more relaxed about risks and provide waivers on data requirements (sometimes) EU Expert Group on bdquoBiopesticidesldquo and bdquoLow Risk Criterialdquo In general everyone in Brussels is in favour of adapting regulation of MBCAs to the real risks buthellip
Data requirements ndash Micro-organism 200136EC Annex IIB
Identity bull Strain level bull Methods to identify and determine content bull Impurities - contaminating micro-organisms - relevant metabolites - culture medium
Biological properties bull Origin and natural occurrence bull Target bull Mode of action bull Specificity bull Dispersal and colonisation ability bull Genetic stability bull Production of metabolites
Human health TIER I bull Medical data bull Sensitisation (inhalation and skin) bull Acute toxicity pathogenicity and infectivity (single exposure) A Oral B Inhalation C Intraperitonealsubcutaneous bull Genotoxicity (metabolites) bull Short term toxicity and pathogenicity (repeated exposure) bull First aid measures
Human health TIER II bull In vivo studies in somatic cells bull in vivo studies in germ cells
Data requirements ndash Micro-organism 200136EC Annex IIB
Residues bull Persistence and multiplication bull Non viable residues bull Viable residues Fate and behaviour in the environment bull Persistence and multiplication (soil water air) bull Mobility Effect on non-target organisms bull Birds bull Aquatic organisms (fish algae) bull Bees and other arthropods bull Earthworms bull Non-target soil micro-organisms
Data requirements ndash Micro-organism 200136EC Annex IIB
Data on application bull Intended use bull Mode of action bull Application rate bull Methods number and timing of application bull Proposed instructions for use
Physical chemical technical properties of the ppp bull Storage stability - shelf life bull Particle size distribution bull Etc
Identity bull Trade name bull Composition
Data requirements ndash Micro-organism 200136EC Annex IIIB
Human health bull Oral toxicity bull Inhalation toxicity bull Percutaneous toxicity bull Skin and eye irritation bull Skin sensitisation
Efficacy data
Further information bull Re-entry periods bull Cleaning of application equipment bull Measures in case of an accident
Data requirements ndash Micro-organism 200136EC Annex IIIB
Fate and behaviour in the environment
Residues
Exposure under the proposed condition of use
Effect on non-target organisms
Data requirements ndash Micro-organism 200136EC Annex IIIB
- Use of Micro-organisms in Biological Plant Protection ndash Potential and Regulation
- Slide Number 2
- Slide Number 3
- Slide Number 4
- Biological Control of Seed Borne Diseases
- Slide Number 6
- Slide Number 7
- Slide Number 8
- Slide Number 9
- Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- EU and Zonal regulation
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Summary
- Slide Number 22
- Data requirements ndash Micro-organism200136EC Annex IIB
- Slide Number 24
- Data requirements ndash Micro-organism200136EC Annex IIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Slide Number 28
-
Potential for MBCAs
Source (Waldner W Frutta e Vite 2009)
Maximal pesticide Residue Level requested by Supermarket chains in Italy
Maximal pesticide Residue Level requested by Supermarket chains in Germany
100 Legal MRL 100 Legal MRL
50
40
30 33
70
80
Regulation 2020 Stagnancy or new perspectives
for biological control
Should EU regulation + directive be implemented there is a market for BCAs
- Directive 2009128EC aims to achieve a sustainable use of pesticides
- Article 14 says that ldquothe Member States shall
take all necessary measures to promote low pesticide-input pest management giving wherever possible priority to non-chemical methods so that professional users of pesticides switch to practices and products with the lowest risk to human health and the environment
The Regulation (EC) No 11072009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market replaced 91414EEC from 14 June 2011 Article 55 explicitly implies the promotion of the use of non-chemical and natural alternatives
The road is paved for introduction of more biocontrol
Regulation of MBCAs in Europe
Regulation (EC) No 11072009 is the legislation concerning the placing of plant protection products (PPPs) on the market in the European Union Procedure
1Application to an EU country called Rapporteur Member State (RMS) 2RMS verifies if the application is admissible (completeness check) 3RMS prepares a draft assessment report (DAR) 4EFSA issues its conclusions 5Standing Committee for Food Chain and Animal Health votes on approval or non-approval 6Adoption by the Commission 7Publication of a Regulation in the EU Official Journal
Under the new EU rules it takes 25 to 35 years from the date of admissibility of the application to the publication of a Regulation approving a new active substance
EU and Zonal regulation
Active Substance (ai) Microorganisms at strain level (except granulose viruses)
Formulated Product with specific indication
EuCom DG Sante
RMS 3 Zones
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4
Annex II AS submission
RMS DAR
Approval AS
Timelines 11072009
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
MR Approval
Active Substance
PPP
these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4 Year 5
Annex II AS submission
Final DAR
Approval AS
Timelines 11072009 (realistic example case with request for additional information)
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
Mutual recognition
Approval
Active Substance
PPP these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year For 3 years only by the RMS Zonal applications procedures
Low-risk as based PPP
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3
Annex II AS submission
DAR
Full Approval
AS
Timelines 11072009 (proposed low-risk case )
Annex III PPP submission
ZRMS
Provisional Zonal Approval PPP
Mutual recognition Application amp approval
Low-risk Active Substance
Low-risk as based PPP
Completeness Check Incl low-risk status
Provisional low-risk as approval
Full Zonal Approval PPP
Stagnacy No things are moving hellip Slowly IBMA outreach for professional support in lobbying NL presidency will pick up our low risk approach Next step by IBMA Data requirements
It takes a life time of a man (or more) to adapt regulation of BCAs to the real risks
Summary
Progress in Regulation Process
EC has further improved legislation (Reg 11072009) EC produced Dir 1282009 Sustainable Use Directive EC has provided further guidance documents for BCAs Authorities are much more relaxed about risks and provide waivers on data requirements (sometimes) EU Expert Group on bdquoBiopesticidesldquo and bdquoLow Risk Criterialdquo In general everyone in Brussels is in favour of adapting regulation of MBCAs to the real risks buthellip
Data requirements ndash Micro-organism 200136EC Annex IIB
Identity bull Strain level bull Methods to identify and determine content bull Impurities - contaminating micro-organisms - relevant metabolites - culture medium
Biological properties bull Origin and natural occurrence bull Target bull Mode of action bull Specificity bull Dispersal and colonisation ability bull Genetic stability bull Production of metabolites
Human health TIER I bull Medical data bull Sensitisation (inhalation and skin) bull Acute toxicity pathogenicity and infectivity (single exposure) A Oral B Inhalation C Intraperitonealsubcutaneous bull Genotoxicity (metabolites) bull Short term toxicity and pathogenicity (repeated exposure) bull First aid measures
Human health TIER II bull In vivo studies in somatic cells bull in vivo studies in germ cells
Data requirements ndash Micro-organism 200136EC Annex IIB
Residues bull Persistence and multiplication bull Non viable residues bull Viable residues Fate and behaviour in the environment bull Persistence and multiplication (soil water air) bull Mobility Effect on non-target organisms bull Birds bull Aquatic organisms (fish algae) bull Bees and other arthropods bull Earthworms bull Non-target soil micro-organisms
Data requirements ndash Micro-organism 200136EC Annex IIB
Data on application bull Intended use bull Mode of action bull Application rate bull Methods number and timing of application bull Proposed instructions for use
Physical chemical technical properties of the ppp bull Storage stability - shelf life bull Particle size distribution bull Etc
Identity bull Trade name bull Composition
Data requirements ndash Micro-organism 200136EC Annex IIIB
Human health bull Oral toxicity bull Inhalation toxicity bull Percutaneous toxicity bull Skin and eye irritation bull Skin sensitisation
Efficacy data
Further information bull Re-entry periods bull Cleaning of application equipment bull Measures in case of an accident
Data requirements ndash Micro-organism 200136EC Annex IIIB
Fate and behaviour in the environment
Residues
Exposure under the proposed condition of use
Effect on non-target organisms
Data requirements ndash Micro-organism 200136EC Annex IIIB
- Use of Micro-organisms in Biological Plant Protection ndash Potential and Regulation
- Slide Number 2
- Slide Number 3
- Slide Number 4
- Biological Control of Seed Borne Diseases
- Slide Number 6
- Slide Number 7
- Slide Number 8
- Slide Number 9
- Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- EU and Zonal regulation
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Summary
- Slide Number 22
- Data requirements ndash Micro-organism200136EC Annex IIB
- Slide Number 24
- Data requirements ndash Micro-organism200136EC Annex IIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Slide Number 28
-
Regulation 2020 Stagnancy or new perspectives
for biological control
Should EU regulation + directive be implemented there is a market for BCAs
- Directive 2009128EC aims to achieve a sustainable use of pesticides
- Article 14 says that ldquothe Member States shall
take all necessary measures to promote low pesticide-input pest management giving wherever possible priority to non-chemical methods so that professional users of pesticides switch to practices and products with the lowest risk to human health and the environment
The Regulation (EC) No 11072009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market replaced 91414EEC from 14 June 2011 Article 55 explicitly implies the promotion of the use of non-chemical and natural alternatives
The road is paved for introduction of more biocontrol
Regulation of MBCAs in Europe
Regulation (EC) No 11072009 is the legislation concerning the placing of plant protection products (PPPs) on the market in the European Union Procedure
1Application to an EU country called Rapporteur Member State (RMS) 2RMS verifies if the application is admissible (completeness check) 3RMS prepares a draft assessment report (DAR) 4EFSA issues its conclusions 5Standing Committee for Food Chain and Animal Health votes on approval or non-approval 6Adoption by the Commission 7Publication of a Regulation in the EU Official Journal
Under the new EU rules it takes 25 to 35 years from the date of admissibility of the application to the publication of a Regulation approving a new active substance
EU and Zonal regulation
Active Substance (ai) Microorganisms at strain level (except granulose viruses)
Formulated Product with specific indication
EuCom DG Sante
RMS 3 Zones
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4
Annex II AS submission
RMS DAR
Approval AS
Timelines 11072009
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
MR Approval
Active Substance
PPP
these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4 Year 5
Annex II AS submission
Final DAR
Approval AS
Timelines 11072009 (realistic example case with request for additional information)
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
Mutual recognition
Approval
Active Substance
PPP these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year For 3 years only by the RMS Zonal applications procedures
Low-risk as based PPP
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3
Annex II AS submission
DAR
Full Approval
AS
Timelines 11072009 (proposed low-risk case )
Annex III PPP submission
ZRMS
Provisional Zonal Approval PPP
Mutual recognition Application amp approval
Low-risk Active Substance
Low-risk as based PPP
Completeness Check Incl low-risk status
Provisional low-risk as approval
Full Zonal Approval PPP
Stagnacy No things are moving hellip Slowly IBMA outreach for professional support in lobbying NL presidency will pick up our low risk approach Next step by IBMA Data requirements
It takes a life time of a man (or more) to adapt regulation of BCAs to the real risks
Summary
Progress in Regulation Process
EC has further improved legislation (Reg 11072009) EC produced Dir 1282009 Sustainable Use Directive EC has provided further guidance documents for BCAs Authorities are much more relaxed about risks and provide waivers on data requirements (sometimes) EU Expert Group on bdquoBiopesticidesldquo and bdquoLow Risk Criterialdquo In general everyone in Brussels is in favour of adapting regulation of MBCAs to the real risks buthellip
Data requirements ndash Micro-organism 200136EC Annex IIB
Identity bull Strain level bull Methods to identify and determine content bull Impurities - contaminating micro-organisms - relevant metabolites - culture medium
Biological properties bull Origin and natural occurrence bull Target bull Mode of action bull Specificity bull Dispersal and colonisation ability bull Genetic stability bull Production of metabolites
Human health TIER I bull Medical data bull Sensitisation (inhalation and skin) bull Acute toxicity pathogenicity and infectivity (single exposure) A Oral B Inhalation C Intraperitonealsubcutaneous bull Genotoxicity (metabolites) bull Short term toxicity and pathogenicity (repeated exposure) bull First aid measures
Human health TIER II bull In vivo studies in somatic cells bull in vivo studies in germ cells
Data requirements ndash Micro-organism 200136EC Annex IIB
Residues bull Persistence and multiplication bull Non viable residues bull Viable residues Fate and behaviour in the environment bull Persistence and multiplication (soil water air) bull Mobility Effect on non-target organisms bull Birds bull Aquatic organisms (fish algae) bull Bees and other arthropods bull Earthworms bull Non-target soil micro-organisms
Data requirements ndash Micro-organism 200136EC Annex IIB
Data on application bull Intended use bull Mode of action bull Application rate bull Methods number and timing of application bull Proposed instructions for use
Physical chemical technical properties of the ppp bull Storage stability - shelf life bull Particle size distribution bull Etc
Identity bull Trade name bull Composition
Data requirements ndash Micro-organism 200136EC Annex IIIB
Human health bull Oral toxicity bull Inhalation toxicity bull Percutaneous toxicity bull Skin and eye irritation bull Skin sensitisation
Efficacy data
Further information bull Re-entry periods bull Cleaning of application equipment bull Measures in case of an accident
Data requirements ndash Micro-organism 200136EC Annex IIIB
Fate and behaviour in the environment
Residues
Exposure under the proposed condition of use
Effect on non-target organisms
Data requirements ndash Micro-organism 200136EC Annex IIIB
- Use of Micro-organisms in Biological Plant Protection ndash Potential and Regulation
- Slide Number 2
- Slide Number 3
- Slide Number 4
- Biological Control of Seed Borne Diseases
- Slide Number 6
- Slide Number 7
- Slide Number 8
- Slide Number 9
- Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- EU and Zonal regulation
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Summary
- Slide Number 22
- Data requirements ndash Micro-organism200136EC Annex IIB
- Slide Number 24
- Data requirements ndash Micro-organism200136EC Annex IIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Slide Number 28
-
Should EU regulation + directive be implemented there is a market for BCAs
- Directive 2009128EC aims to achieve a sustainable use of pesticides
- Article 14 says that ldquothe Member States shall
take all necessary measures to promote low pesticide-input pest management giving wherever possible priority to non-chemical methods so that professional users of pesticides switch to practices and products with the lowest risk to human health and the environment
The Regulation (EC) No 11072009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market replaced 91414EEC from 14 June 2011 Article 55 explicitly implies the promotion of the use of non-chemical and natural alternatives
The road is paved for introduction of more biocontrol
Regulation of MBCAs in Europe
Regulation (EC) No 11072009 is the legislation concerning the placing of plant protection products (PPPs) on the market in the European Union Procedure
1Application to an EU country called Rapporteur Member State (RMS) 2RMS verifies if the application is admissible (completeness check) 3RMS prepares a draft assessment report (DAR) 4EFSA issues its conclusions 5Standing Committee for Food Chain and Animal Health votes on approval or non-approval 6Adoption by the Commission 7Publication of a Regulation in the EU Official Journal
Under the new EU rules it takes 25 to 35 years from the date of admissibility of the application to the publication of a Regulation approving a new active substance
EU and Zonal regulation
Active Substance (ai) Microorganisms at strain level (except granulose viruses)
Formulated Product with specific indication
EuCom DG Sante
RMS 3 Zones
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4
Annex II AS submission
RMS DAR
Approval AS
Timelines 11072009
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
MR Approval
Active Substance
PPP
these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4 Year 5
Annex II AS submission
Final DAR
Approval AS
Timelines 11072009 (realistic example case with request for additional information)
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
Mutual recognition
Approval
Active Substance
PPP these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year For 3 years only by the RMS Zonal applications procedures
Low-risk as based PPP
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3
Annex II AS submission
DAR
Full Approval
AS
Timelines 11072009 (proposed low-risk case )
Annex III PPP submission
ZRMS
Provisional Zonal Approval PPP
Mutual recognition Application amp approval
Low-risk Active Substance
Low-risk as based PPP
Completeness Check Incl low-risk status
Provisional low-risk as approval
Full Zonal Approval PPP
Stagnacy No things are moving hellip Slowly IBMA outreach for professional support in lobbying NL presidency will pick up our low risk approach Next step by IBMA Data requirements
It takes a life time of a man (or more) to adapt regulation of BCAs to the real risks
Summary
Progress in Regulation Process
EC has further improved legislation (Reg 11072009) EC produced Dir 1282009 Sustainable Use Directive EC has provided further guidance documents for BCAs Authorities are much more relaxed about risks and provide waivers on data requirements (sometimes) EU Expert Group on bdquoBiopesticidesldquo and bdquoLow Risk Criterialdquo In general everyone in Brussels is in favour of adapting regulation of MBCAs to the real risks buthellip
Data requirements ndash Micro-organism 200136EC Annex IIB
Identity bull Strain level bull Methods to identify and determine content bull Impurities - contaminating micro-organisms - relevant metabolites - culture medium
Biological properties bull Origin and natural occurrence bull Target bull Mode of action bull Specificity bull Dispersal and colonisation ability bull Genetic stability bull Production of metabolites
Human health TIER I bull Medical data bull Sensitisation (inhalation and skin) bull Acute toxicity pathogenicity and infectivity (single exposure) A Oral B Inhalation C Intraperitonealsubcutaneous bull Genotoxicity (metabolites) bull Short term toxicity and pathogenicity (repeated exposure) bull First aid measures
Human health TIER II bull In vivo studies in somatic cells bull in vivo studies in germ cells
Data requirements ndash Micro-organism 200136EC Annex IIB
Residues bull Persistence and multiplication bull Non viable residues bull Viable residues Fate and behaviour in the environment bull Persistence and multiplication (soil water air) bull Mobility Effect on non-target organisms bull Birds bull Aquatic organisms (fish algae) bull Bees and other arthropods bull Earthworms bull Non-target soil micro-organisms
Data requirements ndash Micro-organism 200136EC Annex IIB
Data on application bull Intended use bull Mode of action bull Application rate bull Methods number and timing of application bull Proposed instructions for use
Physical chemical technical properties of the ppp bull Storage stability - shelf life bull Particle size distribution bull Etc
Identity bull Trade name bull Composition
Data requirements ndash Micro-organism 200136EC Annex IIIB
Human health bull Oral toxicity bull Inhalation toxicity bull Percutaneous toxicity bull Skin and eye irritation bull Skin sensitisation
Efficacy data
Further information bull Re-entry periods bull Cleaning of application equipment bull Measures in case of an accident
Data requirements ndash Micro-organism 200136EC Annex IIIB
Fate and behaviour in the environment
Residues
Exposure under the proposed condition of use
Effect on non-target organisms
Data requirements ndash Micro-organism 200136EC Annex IIIB
- Use of Micro-organisms in Biological Plant Protection ndash Potential and Regulation
- Slide Number 2
- Slide Number 3
- Slide Number 4
- Biological Control of Seed Borne Diseases
- Slide Number 6
- Slide Number 7
- Slide Number 8
- Slide Number 9
- Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- EU and Zonal regulation
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Summary
- Slide Number 22
- Data requirements ndash Micro-organism200136EC Annex IIB
- Slide Number 24
- Data requirements ndash Micro-organism200136EC Annex IIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Slide Number 28
-
The Regulation (EC) No 11072009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market replaced 91414EEC from 14 June 2011 Article 55 explicitly implies the promotion of the use of non-chemical and natural alternatives
The road is paved for introduction of more biocontrol
Regulation of MBCAs in Europe
Regulation (EC) No 11072009 is the legislation concerning the placing of plant protection products (PPPs) on the market in the European Union Procedure
1Application to an EU country called Rapporteur Member State (RMS) 2RMS verifies if the application is admissible (completeness check) 3RMS prepares a draft assessment report (DAR) 4EFSA issues its conclusions 5Standing Committee for Food Chain and Animal Health votes on approval or non-approval 6Adoption by the Commission 7Publication of a Regulation in the EU Official Journal
Under the new EU rules it takes 25 to 35 years from the date of admissibility of the application to the publication of a Regulation approving a new active substance
EU and Zonal regulation
Active Substance (ai) Microorganisms at strain level (except granulose viruses)
Formulated Product with specific indication
EuCom DG Sante
RMS 3 Zones
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4
Annex II AS submission
RMS DAR
Approval AS
Timelines 11072009
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
MR Approval
Active Substance
PPP
these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4 Year 5
Annex II AS submission
Final DAR
Approval AS
Timelines 11072009 (realistic example case with request for additional information)
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
Mutual recognition
Approval
Active Substance
PPP these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year For 3 years only by the RMS Zonal applications procedures
Low-risk as based PPP
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3
Annex II AS submission
DAR
Full Approval
AS
Timelines 11072009 (proposed low-risk case )
Annex III PPP submission
ZRMS
Provisional Zonal Approval PPP
Mutual recognition Application amp approval
Low-risk Active Substance
Low-risk as based PPP
Completeness Check Incl low-risk status
Provisional low-risk as approval
Full Zonal Approval PPP
Stagnacy No things are moving hellip Slowly IBMA outreach for professional support in lobbying NL presidency will pick up our low risk approach Next step by IBMA Data requirements
It takes a life time of a man (or more) to adapt regulation of BCAs to the real risks
Summary
Progress in Regulation Process
EC has further improved legislation (Reg 11072009) EC produced Dir 1282009 Sustainable Use Directive EC has provided further guidance documents for BCAs Authorities are much more relaxed about risks and provide waivers on data requirements (sometimes) EU Expert Group on bdquoBiopesticidesldquo and bdquoLow Risk Criterialdquo In general everyone in Brussels is in favour of adapting regulation of MBCAs to the real risks buthellip
Data requirements ndash Micro-organism 200136EC Annex IIB
Identity bull Strain level bull Methods to identify and determine content bull Impurities - contaminating micro-organisms - relevant metabolites - culture medium
Biological properties bull Origin and natural occurrence bull Target bull Mode of action bull Specificity bull Dispersal and colonisation ability bull Genetic stability bull Production of metabolites
Human health TIER I bull Medical data bull Sensitisation (inhalation and skin) bull Acute toxicity pathogenicity and infectivity (single exposure) A Oral B Inhalation C Intraperitonealsubcutaneous bull Genotoxicity (metabolites) bull Short term toxicity and pathogenicity (repeated exposure) bull First aid measures
Human health TIER II bull In vivo studies in somatic cells bull in vivo studies in germ cells
Data requirements ndash Micro-organism 200136EC Annex IIB
Residues bull Persistence and multiplication bull Non viable residues bull Viable residues Fate and behaviour in the environment bull Persistence and multiplication (soil water air) bull Mobility Effect on non-target organisms bull Birds bull Aquatic organisms (fish algae) bull Bees and other arthropods bull Earthworms bull Non-target soil micro-organisms
Data requirements ndash Micro-organism 200136EC Annex IIB
Data on application bull Intended use bull Mode of action bull Application rate bull Methods number and timing of application bull Proposed instructions for use
Physical chemical technical properties of the ppp bull Storage stability - shelf life bull Particle size distribution bull Etc
Identity bull Trade name bull Composition
Data requirements ndash Micro-organism 200136EC Annex IIIB
Human health bull Oral toxicity bull Inhalation toxicity bull Percutaneous toxicity bull Skin and eye irritation bull Skin sensitisation
Efficacy data
Further information bull Re-entry periods bull Cleaning of application equipment bull Measures in case of an accident
Data requirements ndash Micro-organism 200136EC Annex IIIB
Fate and behaviour in the environment
Residues
Exposure under the proposed condition of use
Effect on non-target organisms
Data requirements ndash Micro-organism 200136EC Annex IIIB
- Use of Micro-organisms in Biological Plant Protection ndash Potential and Regulation
- Slide Number 2
- Slide Number 3
- Slide Number 4
- Biological Control of Seed Borne Diseases
- Slide Number 6
- Slide Number 7
- Slide Number 8
- Slide Number 9
- Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- EU and Zonal regulation
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Summary
- Slide Number 22
- Data requirements ndash Micro-organism200136EC Annex IIB
- Slide Number 24
- Data requirements ndash Micro-organism200136EC Annex IIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Slide Number 28
-
Regulation of MBCAs in Europe
Regulation (EC) No 11072009 is the legislation concerning the placing of plant protection products (PPPs) on the market in the European Union Procedure
1Application to an EU country called Rapporteur Member State (RMS) 2RMS verifies if the application is admissible (completeness check) 3RMS prepares a draft assessment report (DAR) 4EFSA issues its conclusions 5Standing Committee for Food Chain and Animal Health votes on approval or non-approval 6Adoption by the Commission 7Publication of a Regulation in the EU Official Journal
Under the new EU rules it takes 25 to 35 years from the date of admissibility of the application to the publication of a Regulation approving a new active substance
EU and Zonal regulation
Active Substance (ai) Microorganisms at strain level (except granulose viruses)
Formulated Product with specific indication
EuCom DG Sante
RMS 3 Zones
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4
Annex II AS submission
RMS DAR
Approval AS
Timelines 11072009
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
MR Approval
Active Substance
PPP
these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4 Year 5
Annex II AS submission
Final DAR
Approval AS
Timelines 11072009 (realistic example case with request for additional information)
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
Mutual recognition
Approval
Active Substance
PPP these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year For 3 years only by the RMS Zonal applications procedures
Low-risk as based PPP
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3
Annex II AS submission
DAR
Full Approval
AS
Timelines 11072009 (proposed low-risk case )
Annex III PPP submission
ZRMS
Provisional Zonal Approval PPP
Mutual recognition Application amp approval
Low-risk Active Substance
Low-risk as based PPP
Completeness Check Incl low-risk status
Provisional low-risk as approval
Full Zonal Approval PPP
Stagnacy No things are moving hellip Slowly IBMA outreach for professional support in lobbying NL presidency will pick up our low risk approach Next step by IBMA Data requirements
It takes a life time of a man (or more) to adapt regulation of BCAs to the real risks
Summary
Progress in Regulation Process
EC has further improved legislation (Reg 11072009) EC produced Dir 1282009 Sustainable Use Directive EC has provided further guidance documents for BCAs Authorities are much more relaxed about risks and provide waivers on data requirements (sometimes) EU Expert Group on bdquoBiopesticidesldquo and bdquoLow Risk Criterialdquo In general everyone in Brussels is in favour of adapting regulation of MBCAs to the real risks buthellip
Data requirements ndash Micro-organism 200136EC Annex IIB
Identity bull Strain level bull Methods to identify and determine content bull Impurities - contaminating micro-organisms - relevant metabolites - culture medium
Biological properties bull Origin and natural occurrence bull Target bull Mode of action bull Specificity bull Dispersal and colonisation ability bull Genetic stability bull Production of metabolites
Human health TIER I bull Medical data bull Sensitisation (inhalation and skin) bull Acute toxicity pathogenicity and infectivity (single exposure) A Oral B Inhalation C Intraperitonealsubcutaneous bull Genotoxicity (metabolites) bull Short term toxicity and pathogenicity (repeated exposure) bull First aid measures
Human health TIER II bull In vivo studies in somatic cells bull in vivo studies in germ cells
Data requirements ndash Micro-organism 200136EC Annex IIB
Residues bull Persistence and multiplication bull Non viable residues bull Viable residues Fate and behaviour in the environment bull Persistence and multiplication (soil water air) bull Mobility Effect on non-target organisms bull Birds bull Aquatic organisms (fish algae) bull Bees and other arthropods bull Earthworms bull Non-target soil micro-organisms
Data requirements ndash Micro-organism 200136EC Annex IIB
Data on application bull Intended use bull Mode of action bull Application rate bull Methods number and timing of application bull Proposed instructions for use
Physical chemical technical properties of the ppp bull Storage stability - shelf life bull Particle size distribution bull Etc
Identity bull Trade name bull Composition
Data requirements ndash Micro-organism 200136EC Annex IIIB
Human health bull Oral toxicity bull Inhalation toxicity bull Percutaneous toxicity bull Skin and eye irritation bull Skin sensitisation
Efficacy data
Further information bull Re-entry periods bull Cleaning of application equipment bull Measures in case of an accident
Data requirements ndash Micro-organism 200136EC Annex IIIB
Fate and behaviour in the environment
Residues
Exposure under the proposed condition of use
Effect on non-target organisms
Data requirements ndash Micro-organism 200136EC Annex IIIB
- Use of Micro-organisms in Biological Plant Protection ndash Potential and Regulation
- Slide Number 2
- Slide Number 3
- Slide Number 4
- Biological Control of Seed Borne Diseases
- Slide Number 6
- Slide Number 7
- Slide Number 8
- Slide Number 9
- Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- EU and Zonal regulation
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Summary
- Slide Number 22
- Data requirements ndash Micro-organism200136EC Annex IIB
- Slide Number 24
- Data requirements ndash Micro-organism200136EC Annex IIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Slide Number 28
-
EU and Zonal regulation
Active Substance (ai) Microorganisms at strain level (except granulose viruses)
Formulated Product with specific indication
EuCom DG Sante
RMS 3 Zones
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4
Annex II AS submission
RMS DAR
Approval AS
Timelines 11072009
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
MR Approval
Active Substance
PPP
these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4 Year 5
Annex II AS submission
Final DAR
Approval AS
Timelines 11072009 (realistic example case with request for additional information)
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
Mutual recognition
Approval
Active Substance
PPP these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year For 3 years only by the RMS Zonal applications procedures
Low-risk as based PPP
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3
Annex II AS submission
DAR
Full Approval
AS
Timelines 11072009 (proposed low-risk case )
Annex III PPP submission
ZRMS
Provisional Zonal Approval PPP
Mutual recognition Application amp approval
Low-risk Active Substance
Low-risk as based PPP
Completeness Check Incl low-risk status
Provisional low-risk as approval
Full Zonal Approval PPP
Stagnacy No things are moving hellip Slowly IBMA outreach for professional support in lobbying NL presidency will pick up our low risk approach Next step by IBMA Data requirements
It takes a life time of a man (or more) to adapt regulation of BCAs to the real risks
Summary
Progress in Regulation Process
EC has further improved legislation (Reg 11072009) EC produced Dir 1282009 Sustainable Use Directive EC has provided further guidance documents for BCAs Authorities are much more relaxed about risks and provide waivers on data requirements (sometimes) EU Expert Group on bdquoBiopesticidesldquo and bdquoLow Risk Criterialdquo In general everyone in Brussels is in favour of adapting regulation of MBCAs to the real risks buthellip
Data requirements ndash Micro-organism 200136EC Annex IIB
Identity bull Strain level bull Methods to identify and determine content bull Impurities - contaminating micro-organisms - relevant metabolites - culture medium
Biological properties bull Origin and natural occurrence bull Target bull Mode of action bull Specificity bull Dispersal and colonisation ability bull Genetic stability bull Production of metabolites
Human health TIER I bull Medical data bull Sensitisation (inhalation and skin) bull Acute toxicity pathogenicity and infectivity (single exposure) A Oral B Inhalation C Intraperitonealsubcutaneous bull Genotoxicity (metabolites) bull Short term toxicity and pathogenicity (repeated exposure) bull First aid measures
Human health TIER II bull In vivo studies in somatic cells bull in vivo studies in germ cells
Data requirements ndash Micro-organism 200136EC Annex IIB
Residues bull Persistence and multiplication bull Non viable residues bull Viable residues Fate and behaviour in the environment bull Persistence and multiplication (soil water air) bull Mobility Effect on non-target organisms bull Birds bull Aquatic organisms (fish algae) bull Bees and other arthropods bull Earthworms bull Non-target soil micro-organisms
Data requirements ndash Micro-organism 200136EC Annex IIB
Data on application bull Intended use bull Mode of action bull Application rate bull Methods number and timing of application bull Proposed instructions for use
Physical chemical technical properties of the ppp bull Storage stability - shelf life bull Particle size distribution bull Etc
Identity bull Trade name bull Composition
Data requirements ndash Micro-organism 200136EC Annex IIIB
Human health bull Oral toxicity bull Inhalation toxicity bull Percutaneous toxicity bull Skin and eye irritation bull Skin sensitisation
Efficacy data
Further information bull Re-entry periods bull Cleaning of application equipment bull Measures in case of an accident
Data requirements ndash Micro-organism 200136EC Annex IIIB
Fate and behaviour in the environment
Residues
Exposure under the proposed condition of use
Effect on non-target organisms
Data requirements ndash Micro-organism 200136EC Annex IIIB
- Use of Micro-organisms in Biological Plant Protection ndash Potential and Regulation
- Slide Number 2
- Slide Number 3
- Slide Number 4
- Biological Control of Seed Borne Diseases
- Slide Number 6
- Slide Number 7
- Slide Number 8
- Slide Number 9
- Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- EU and Zonal regulation
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Summary
- Slide Number 22
- Data requirements ndash Micro-organism200136EC Annex IIB
- Slide Number 24
- Data requirements ndash Micro-organism200136EC Annex IIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Slide Number 28
-
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4
Annex II AS submission
RMS DAR
Approval AS
Timelines 11072009
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
MR Approval
Active Substance
PPP
these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4 Year 5
Annex II AS submission
Final DAR
Approval AS
Timelines 11072009 (realistic example case with request for additional information)
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
Mutual recognition
Approval
Active Substance
PPP these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year For 3 years only by the RMS Zonal applications procedures
Low-risk as based PPP
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3
Annex II AS submission
DAR
Full Approval
AS
Timelines 11072009 (proposed low-risk case )
Annex III PPP submission
ZRMS
Provisional Zonal Approval PPP
Mutual recognition Application amp approval
Low-risk Active Substance
Low-risk as based PPP
Completeness Check Incl low-risk status
Provisional low-risk as approval
Full Zonal Approval PPP
Stagnacy No things are moving hellip Slowly IBMA outreach for professional support in lobbying NL presidency will pick up our low risk approach Next step by IBMA Data requirements
It takes a life time of a man (or more) to adapt regulation of BCAs to the real risks
Summary
Progress in Regulation Process
EC has further improved legislation (Reg 11072009) EC produced Dir 1282009 Sustainable Use Directive EC has provided further guidance documents for BCAs Authorities are much more relaxed about risks and provide waivers on data requirements (sometimes) EU Expert Group on bdquoBiopesticidesldquo and bdquoLow Risk Criterialdquo In general everyone in Brussels is in favour of adapting regulation of MBCAs to the real risks buthellip
Data requirements ndash Micro-organism 200136EC Annex IIB
Identity bull Strain level bull Methods to identify and determine content bull Impurities - contaminating micro-organisms - relevant metabolites - culture medium
Biological properties bull Origin and natural occurrence bull Target bull Mode of action bull Specificity bull Dispersal and colonisation ability bull Genetic stability bull Production of metabolites
Human health TIER I bull Medical data bull Sensitisation (inhalation and skin) bull Acute toxicity pathogenicity and infectivity (single exposure) A Oral B Inhalation C Intraperitonealsubcutaneous bull Genotoxicity (metabolites) bull Short term toxicity and pathogenicity (repeated exposure) bull First aid measures
Human health TIER II bull In vivo studies in somatic cells bull in vivo studies in germ cells
Data requirements ndash Micro-organism 200136EC Annex IIB
Residues bull Persistence and multiplication bull Non viable residues bull Viable residues Fate and behaviour in the environment bull Persistence and multiplication (soil water air) bull Mobility Effect on non-target organisms bull Birds bull Aquatic organisms (fish algae) bull Bees and other arthropods bull Earthworms bull Non-target soil micro-organisms
Data requirements ndash Micro-organism 200136EC Annex IIB
Data on application bull Intended use bull Mode of action bull Application rate bull Methods number and timing of application bull Proposed instructions for use
Physical chemical technical properties of the ppp bull Storage stability - shelf life bull Particle size distribution bull Etc
Identity bull Trade name bull Composition
Data requirements ndash Micro-organism 200136EC Annex IIIB
Human health bull Oral toxicity bull Inhalation toxicity bull Percutaneous toxicity bull Skin and eye irritation bull Skin sensitisation
Efficacy data
Further information bull Re-entry periods bull Cleaning of application equipment bull Measures in case of an accident
Data requirements ndash Micro-organism 200136EC Annex IIIB
Fate and behaviour in the environment
Residues
Exposure under the proposed condition of use
Effect on non-target organisms
Data requirements ndash Micro-organism 200136EC Annex IIIB
- Use of Micro-organisms in Biological Plant Protection ndash Potential and Regulation
- Slide Number 2
- Slide Number 3
- Slide Number 4
- Biological Control of Seed Borne Diseases
- Slide Number 6
- Slide Number 7
- Slide Number 8
- Slide Number 9
- Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- EU and Zonal regulation
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Summary
- Slide Number 22
- Data requirements ndash Micro-organism200136EC Annex IIB
- Slide Number 24
- Data requirements ndash Micro-organism200136EC Annex IIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Slide Number 28
-
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4 Year 5
Annex II AS submission
Final DAR
Approval AS
Timelines 11072009 (realistic example case with request for additional information)
Annex III PPP submission ZRMS
Zonal Approval PPP
Mutual recognition Application
Mutual recognition
Approval
Active Substance
PPP these time lines do not take into account response time to Authority questions The time Applicant take to answer should be added realistically add at least another year For 3 years only by the RMS Zonal applications procedures
Low-risk as based PPP
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3
Annex II AS submission
DAR
Full Approval
AS
Timelines 11072009 (proposed low-risk case )
Annex III PPP submission
ZRMS
Provisional Zonal Approval PPP
Mutual recognition Application amp approval
Low-risk Active Substance
Low-risk as based PPP
Completeness Check Incl low-risk status
Provisional low-risk as approval
Full Zonal Approval PPP
Stagnacy No things are moving hellip Slowly IBMA outreach for professional support in lobbying NL presidency will pick up our low risk approach Next step by IBMA Data requirements
It takes a life time of a man (or more) to adapt regulation of BCAs to the real risks
Summary
Progress in Regulation Process
EC has further improved legislation (Reg 11072009) EC produced Dir 1282009 Sustainable Use Directive EC has provided further guidance documents for BCAs Authorities are much more relaxed about risks and provide waivers on data requirements (sometimes) EU Expert Group on bdquoBiopesticidesldquo and bdquoLow Risk Criterialdquo In general everyone in Brussels is in favour of adapting regulation of MBCAs to the real risks buthellip
Data requirements ndash Micro-organism 200136EC Annex IIB
Identity bull Strain level bull Methods to identify and determine content bull Impurities - contaminating micro-organisms - relevant metabolites - culture medium
Biological properties bull Origin and natural occurrence bull Target bull Mode of action bull Specificity bull Dispersal and colonisation ability bull Genetic stability bull Production of metabolites
Human health TIER I bull Medical data bull Sensitisation (inhalation and skin) bull Acute toxicity pathogenicity and infectivity (single exposure) A Oral B Inhalation C Intraperitonealsubcutaneous bull Genotoxicity (metabolites) bull Short term toxicity and pathogenicity (repeated exposure) bull First aid measures
Human health TIER II bull In vivo studies in somatic cells bull in vivo studies in germ cells
Data requirements ndash Micro-organism 200136EC Annex IIB
Residues bull Persistence and multiplication bull Non viable residues bull Viable residues Fate and behaviour in the environment bull Persistence and multiplication (soil water air) bull Mobility Effect on non-target organisms bull Birds bull Aquatic organisms (fish algae) bull Bees and other arthropods bull Earthworms bull Non-target soil micro-organisms
Data requirements ndash Micro-organism 200136EC Annex IIB
Data on application bull Intended use bull Mode of action bull Application rate bull Methods number and timing of application bull Proposed instructions for use
Physical chemical technical properties of the ppp bull Storage stability - shelf life bull Particle size distribution bull Etc
Identity bull Trade name bull Composition
Data requirements ndash Micro-organism 200136EC Annex IIIB
Human health bull Oral toxicity bull Inhalation toxicity bull Percutaneous toxicity bull Skin and eye irritation bull Skin sensitisation
Efficacy data
Further information bull Re-entry periods bull Cleaning of application equipment bull Measures in case of an accident
Data requirements ndash Micro-organism 200136EC Annex IIIB
Fate and behaviour in the environment
Residues
Exposure under the proposed condition of use
Effect on non-target organisms
Data requirements ndash Micro-organism 200136EC Annex IIIB
- Use of Micro-organisms in Biological Plant Protection ndash Potential and Regulation
- Slide Number 2
- Slide Number 3
- Slide Number 4
- Biological Control of Seed Borne Diseases
- Slide Number 6
- Slide Number 7
- Slide Number 8
- Slide Number 9
- Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- EU and Zonal regulation
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Summary
- Slide Number 22
- Data requirements ndash Micro-organism200136EC Annex IIB
- Slide Number 24
- Data requirements ndash Micro-organism200136EC Annex IIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Slide Number 28
-
Low-risk as based PPP
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3
Annex II AS submission
DAR
Full Approval
AS
Timelines 11072009 (proposed low-risk case )
Annex III PPP submission
ZRMS
Provisional Zonal Approval PPP
Mutual recognition Application amp approval
Low-risk Active Substance
Low-risk as based PPP
Completeness Check Incl low-risk status
Provisional low-risk as approval
Full Zonal Approval PPP
Stagnacy No things are moving hellip Slowly IBMA outreach for professional support in lobbying NL presidency will pick up our low risk approach Next step by IBMA Data requirements
It takes a life time of a man (or more) to adapt regulation of BCAs to the real risks
Summary
Progress in Regulation Process
EC has further improved legislation (Reg 11072009) EC produced Dir 1282009 Sustainable Use Directive EC has provided further guidance documents for BCAs Authorities are much more relaxed about risks and provide waivers on data requirements (sometimes) EU Expert Group on bdquoBiopesticidesldquo and bdquoLow Risk Criterialdquo In general everyone in Brussels is in favour of adapting regulation of MBCAs to the real risks buthellip
Data requirements ndash Micro-organism 200136EC Annex IIB
Identity bull Strain level bull Methods to identify and determine content bull Impurities - contaminating micro-organisms - relevant metabolites - culture medium
Biological properties bull Origin and natural occurrence bull Target bull Mode of action bull Specificity bull Dispersal and colonisation ability bull Genetic stability bull Production of metabolites
Human health TIER I bull Medical data bull Sensitisation (inhalation and skin) bull Acute toxicity pathogenicity and infectivity (single exposure) A Oral B Inhalation C Intraperitonealsubcutaneous bull Genotoxicity (metabolites) bull Short term toxicity and pathogenicity (repeated exposure) bull First aid measures
Human health TIER II bull In vivo studies in somatic cells bull in vivo studies in germ cells
Data requirements ndash Micro-organism 200136EC Annex IIB
Residues bull Persistence and multiplication bull Non viable residues bull Viable residues Fate and behaviour in the environment bull Persistence and multiplication (soil water air) bull Mobility Effect on non-target organisms bull Birds bull Aquatic organisms (fish algae) bull Bees and other arthropods bull Earthworms bull Non-target soil micro-organisms
Data requirements ndash Micro-organism 200136EC Annex IIB
Data on application bull Intended use bull Mode of action bull Application rate bull Methods number and timing of application bull Proposed instructions for use
Physical chemical technical properties of the ppp bull Storage stability - shelf life bull Particle size distribution bull Etc
Identity bull Trade name bull Composition
Data requirements ndash Micro-organism 200136EC Annex IIIB
Human health bull Oral toxicity bull Inhalation toxicity bull Percutaneous toxicity bull Skin and eye irritation bull Skin sensitisation
Efficacy data
Further information bull Re-entry periods bull Cleaning of application equipment bull Measures in case of an accident
Data requirements ndash Micro-organism 200136EC Annex IIIB
Fate and behaviour in the environment
Residues
Exposure under the proposed condition of use
Effect on non-target organisms
Data requirements ndash Micro-organism 200136EC Annex IIIB
- Use of Micro-organisms in Biological Plant Protection ndash Potential and Regulation
- Slide Number 2
- Slide Number 3
- Slide Number 4
- Biological Control of Seed Borne Diseases
- Slide Number 6
- Slide Number 7
- Slide Number 8
- Slide Number 9
- Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- EU and Zonal regulation
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Summary
- Slide Number 22
- Data requirements ndash Micro-organism200136EC Annex IIB
- Slide Number 24
- Data requirements ndash Micro-organism200136EC Annex IIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Slide Number 28
-
Stagnacy No things are moving hellip Slowly IBMA outreach for professional support in lobbying NL presidency will pick up our low risk approach Next step by IBMA Data requirements
It takes a life time of a man (or more) to adapt regulation of BCAs to the real risks
Summary
Progress in Regulation Process
EC has further improved legislation (Reg 11072009) EC produced Dir 1282009 Sustainable Use Directive EC has provided further guidance documents for BCAs Authorities are much more relaxed about risks and provide waivers on data requirements (sometimes) EU Expert Group on bdquoBiopesticidesldquo and bdquoLow Risk Criterialdquo In general everyone in Brussels is in favour of adapting regulation of MBCAs to the real risks buthellip
Data requirements ndash Micro-organism 200136EC Annex IIB
Identity bull Strain level bull Methods to identify and determine content bull Impurities - contaminating micro-organisms - relevant metabolites - culture medium
Biological properties bull Origin and natural occurrence bull Target bull Mode of action bull Specificity bull Dispersal and colonisation ability bull Genetic stability bull Production of metabolites
Human health TIER I bull Medical data bull Sensitisation (inhalation and skin) bull Acute toxicity pathogenicity and infectivity (single exposure) A Oral B Inhalation C Intraperitonealsubcutaneous bull Genotoxicity (metabolites) bull Short term toxicity and pathogenicity (repeated exposure) bull First aid measures
Human health TIER II bull In vivo studies in somatic cells bull in vivo studies in germ cells
Data requirements ndash Micro-organism 200136EC Annex IIB
Residues bull Persistence and multiplication bull Non viable residues bull Viable residues Fate and behaviour in the environment bull Persistence and multiplication (soil water air) bull Mobility Effect on non-target organisms bull Birds bull Aquatic organisms (fish algae) bull Bees and other arthropods bull Earthworms bull Non-target soil micro-organisms
Data requirements ndash Micro-organism 200136EC Annex IIB
Data on application bull Intended use bull Mode of action bull Application rate bull Methods number and timing of application bull Proposed instructions for use
Physical chemical technical properties of the ppp bull Storage stability - shelf life bull Particle size distribution bull Etc
Identity bull Trade name bull Composition
Data requirements ndash Micro-organism 200136EC Annex IIIB
Human health bull Oral toxicity bull Inhalation toxicity bull Percutaneous toxicity bull Skin and eye irritation bull Skin sensitisation
Efficacy data
Further information bull Re-entry periods bull Cleaning of application equipment bull Measures in case of an accident
Data requirements ndash Micro-organism 200136EC Annex IIIB
Fate and behaviour in the environment
Residues
Exposure under the proposed condition of use
Effect on non-target organisms
Data requirements ndash Micro-organism 200136EC Annex IIIB
- Use of Micro-organisms in Biological Plant Protection ndash Potential and Regulation
- Slide Number 2
- Slide Number 3
- Slide Number 4
- Biological Control of Seed Borne Diseases
- Slide Number 6
- Slide Number 7
- Slide Number 8
- Slide Number 9
- Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- EU and Zonal regulation
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Summary
- Slide Number 22
- Data requirements ndash Micro-organism200136EC Annex IIB
- Slide Number 24
- Data requirements ndash Micro-organism200136EC Annex IIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Slide Number 28
-
Progress in Regulation Process
EC has further improved legislation (Reg 11072009) EC produced Dir 1282009 Sustainable Use Directive EC has provided further guidance documents for BCAs Authorities are much more relaxed about risks and provide waivers on data requirements (sometimes) EU Expert Group on bdquoBiopesticidesldquo and bdquoLow Risk Criterialdquo In general everyone in Brussels is in favour of adapting regulation of MBCAs to the real risks buthellip
Data requirements ndash Micro-organism 200136EC Annex IIB
Identity bull Strain level bull Methods to identify and determine content bull Impurities - contaminating micro-organisms - relevant metabolites - culture medium
Biological properties bull Origin and natural occurrence bull Target bull Mode of action bull Specificity bull Dispersal and colonisation ability bull Genetic stability bull Production of metabolites
Human health TIER I bull Medical data bull Sensitisation (inhalation and skin) bull Acute toxicity pathogenicity and infectivity (single exposure) A Oral B Inhalation C Intraperitonealsubcutaneous bull Genotoxicity (metabolites) bull Short term toxicity and pathogenicity (repeated exposure) bull First aid measures
Human health TIER II bull In vivo studies in somatic cells bull in vivo studies in germ cells
Data requirements ndash Micro-organism 200136EC Annex IIB
Residues bull Persistence and multiplication bull Non viable residues bull Viable residues Fate and behaviour in the environment bull Persistence and multiplication (soil water air) bull Mobility Effect on non-target organisms bull Birds bull Aquatic organisms (fish algae) bull Bees and other arthropods bull Earthworms bull Non-target soil micro-organisms
Data requirements ndash Micro-organism 200136EC Annex IIB
Data on application bull Intended use bull Mode of action bull Application rate bull Methods number and timing of application bull Proposed instructions for use
Physical chemical technical properties of the ppp bull Storage stability - shelf life bull Particle size distribution bull Etc
Identity bull Trade name bull Composition
Data requirements ndash Micro-organism 200136EC Annex IIIB
Human health bull Oral toxicity bull Inhalation toxicity bull Percutaneous toxicity bull Skin and eye irritation bull Skin sensitisation
Efficacy data
Further information bull Re-entry periods bull Cleaning of application equipment bull Measures in case of an accident
Data requirements ndash Micro-organism 200136EC Annex IIIB
Fate and behaviour in the environment
Residues
Exposure under the proposed condition of use
Effect on non-target organisms
Data requirements ndash Micro-organism 200136EC Annex IIIB
- Use of Micro-organisms in Biological Plant Protection ndash Potential and Regulation
- Slide Number 2
- Slide Number 3
- Slide Number 4
- Biological Control of Seed Borne Diseases
- Slide Number 6
- Slide Number 7
- Slide Number 8
- Slide Number 9
- Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- EU and Zonal regulation
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Summary
- Slide Number 22
- Data requirements ndash Micro-organism200136EC Annex IIB
- Slide Number 24
- Data requirements ndash Micro-organism200136EC Annex IIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Slide Number 28
-
Data requirements ndash Micro-organism 200136EC Annex IIB
Identity bull Strain level bull Methods to identify and determine content bull Impurities - contaminating micro-organisms - relevant metabolites - culture medium
Biological properties bull Origin and natural occurrence bull Target bull Mode of action bull Specificity bull Dispersal and colonisation ability bull Genetic stability bull Production of metabolites
Human health TIER I bull Medical data bull Sensitisation (inhalation and skin) bull Acute toxicity pathogenicity and infectivity (single exposure) A Oral B Inhalation C Intraperitonealsubcutaneous bull Genotoxicity (metabolites) bull Short term toxicity and pathogenicity (repeated exposure) bull First aid measures
Human health TIER II bull In vivo studies in somatic cells bull in vivo studies in germ cells
Data requirements ndash Micro-organism 200136EC Annex IIB
Residues bull Persistence and multiplication bull Non viable residues bull Viable residues Fate and behaviour in the environment bull Persistence and multiplication (soil water air) bull Mobility Effect on non-target organisms bull Birds bull Aquatic organisms (fish algae) bull Bees and other arthropods bull Earthworms bull Non-target soil micro-organisms
Data requirements ndash Micro-organism 200136EC Annex IIB
Data on application bull Intended use bull Mode of action bull Application rate bull Methods number and timing of application bull Proposed instructions for use
Physical chemical technical properties of the ppp bull Storage stability - shelf life bull Particle size distribution bull Etc
Identity bull Trade name bull Composition
Data requirements ndash Micro-organism 200136EC Annex IIIB
Human health bull Oral toxicity bull Inhalation toxicity bull Percutaneous toxicity bull Skin and eye irritation bull Skin sensitisation
Efficacy data
Further information bull Re-entry periods bull Cleaning of application equipment bull Measures in case of an accident
Data requirements ndash Micro-organism 200136EC Annex IIIB
Fate and behaviour in the environment
Residues
Exposure under the proposed condition of use
Effect on non-target organisms
Data requirements ndash Micro-organism 200136EC Annex IIIB
- Use of Micro-organisms in Biological Plant Protection ndash Potential and Regulation
- Slide Number 2
- Slide Number 3
- Slide Number 4
- Biological Control of Seed Borne Diseases
- Slide Number 6
- Slide Number 7
- Slide Number 8
- Slide Number 9
- Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- EU and Zonal regulation
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Summary
- Slide Number 22
- Data requirements ndash Micro-organism200136EC Annex IIB
- Slide Number 24
- Data requirements ndash Micro-organism200136EC Annex IIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Slide Number 28
-
Human health TIER I bull Medical data bull Sensitisation (inhalation and skin) bull Acute toxicity pathogenicity and infectivity (single exposure) A Oral B Inhalation C Intraperitonealsubcutaneous bull Genotoxicity (metabolites) bull Short term toxicity and pathogenicity (repeated exposure) bull First aid measures
Human health TIER II bull In vivo studies in somatic cells bull in vivo studies in germ cells
Data requirements ndash Micro-organism 200136EC Annex IIB
Residues bull Persistence and multiplication bull Non viable residues bull Viable residues Fate and behaviour in the environment bull Persistence and multiplication (soil water air) bull Mobility Effect on non-target organisms bull Birds bull Aquatic organisms (fish algae) bull Bees and other arthropods bull Earthworms bull Non-target soil micro-organisms
Data requirements ndash Micro-organism 200136EC Annex IIB
Data on application bull Intended use bull Mode of action bull Application rate bull Methods number and timing of application bull Proposed instructions for use
Physical chemical technical properties of the ppp bull Storage stability - shelf life bull Particle size distribution bull Etc
Identity bull Trade name bull Composition
Data requirements ndash Micro-organism 200136EC Annex IIIB
Human health bull Oral toxicity bull Inhalation toxicity bull Percutaneous toxicity bull Skin and eye irritation bull Skin sensitisation
Efficacy data
Further information bull Re-entry periods bull Cleaning of application equipment bull Measures in case of an accident
Data requirements ndash Micro-organism 200136EC Annex IIIB
Fate and behaviour in the environment
Residues
Exposure under the proposed condition of use
Effect on non-target organisms
Data requirements ndash Micro-organism 200136EC Annex IIIB
- Use of Micro-organisms in Biological Plant Protection ndash Potential and Regulation
- Slide Number 2
- Slide Number 3
- Slide Number 4
- Biological Control of Seed Borne Diseases
- Slide Number 6
- Slide Number 7
- Slide Number 8
- Slide Number 9
- Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- EU and Zonal regulation
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Summary
- Slide Number 22
- Data requirements ndash Micro-organism200136EC Annex IIB
- Slide Number 24
- Data requirements ndash Micro-organism200136EC Annex IIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Slide Number 28
-
Residues bull Persistence and multiplication bull Non viable residues bull Viable residues Fate and behaviour in the environment bull Persistence and multiplication (soil water air) bull Mobility Effect on non-target organisms bull Birds bull Aquatic organisms (fish algae) bull Bees and other arthropods bull Earthworms bull Non-target soil micro-organisms
Data requirements ndash Micro-organism 200136EC Annex IIB
Data on application bull Intended use bull Mode of action bull Application rate bull Methods number and timing of application bull Proposed instructions for use
Physical chemical technical properties of the ppp bull Storage stability - shelf life bull Particle size distribution bull Etc
Identity bull Trade name bull Composition
Data requirements ndash Micro-organism 200136EC Annex IIIB
Human health bull Oral toxicity bull Inhalation toxicity bull Percutaneous toxicity bull Skin and eye irritation bull Skin sensitisation
Efficacy data
Further information bull Re-entry periods bull Cleaning of application equipment bull Measures in case of an accident
Data requirements ndash Micro-organism 200136EC Annex IIIB
Fate and behaviour in the environment
Residues
Exposure under the proposed condition of use
Effect on non-target organisms
Data requirements ndash Micro-organism 200136EC Annex IIIB
- Use of Micro-organisms in Biological Plant Protection ndash Potential and Regulation
- Slide Number 2
- Slide Number 3
- Slide Number 4
- Biological Control of Seed Borne Diseases
- Slide Number 6
- Slide Number 7
- Slide Number 8
- Slide Number 9
- Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- EU and Zonal regulation
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Summary
- Slide Number 22
- Data requirements ndash Micro-organism200136EC Annex IIB
- Slide Number 24
- Data requirements ndash Micro-organism200136EC Annex IIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Slide Number 28
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Data on application bull Intended use bull Mode of action bull Application rate bull Methods number and timing of application bull Proposed instructions for use
Physical chemical technical properties of the ppp bull Storage stability - shelf life bull Particle size distribution bull Etc
Identity bull Trade name bull Composition
Data requirements ndash Micro-organism 200136EC Annex IIIB
Human health bull Oral toxicity bull Inhalation toxicity bull Percutaneous toxicity bull Skin and eye irritation bull Skin sensitisation
Efficacy data
Further information bull Re-entry periods bull Cleaning of application equipment bull Measures in case of an accident
Data requirements ndash Micro-organism 200136EC Annex IIIB
Fate and behaviour in the environment
Residues
Exposure under the proposed condition of use
Effect on non-target organisms
Data requirements ndash Micro-organism 200136EC Annex IIIB
- Use of Micro-organisms in Biological Plant Protection ndash Potential and Regulation
- Slide Number 2
- Slide Number 3
- Slide Number 4
- Biological Control of Seed Borne Diseases
- Slide Number 6
- Slide Number 7
- Slide Number 8
- Slide Number 9
- Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- EU and Zonal regulation
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Summary
- Slide Number 22
- Data requirements ndash Micro-organism200136EC Annex IIB
- Slide Number 24
- Data requirements ndash Micro-organism200136EC Annex IIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Slide Number 28
-
Human health bull Oral toxicity bull Inhalation toxicity bull Percutaneous toxicity bull Skin and eye irritation bull Skin sensitisation
Efficacy data
Further information bull Re-entry periods bull Cleaning of application equipment bull Measures in case of an accident
Data requirements ndash Micro-organism 200136EC Annex IIIB
Fate and behaviour in the environment
Residues
Exposure under the proposed condition of use
Effect on non-target organisms
Data requirements ndash Micro-organism 200136EC Annex IIIB
- Use of Micro-organisms in Biological Plant Protection ndash Potential and Regulation
- Slide Number 2
- Slide Number 3
- Slide Number 4
- Biological Control of Seed Borne Diseases
- Slide Number 6
- Slide Number 7
- Slide Number 8
- Slide Number 9
- Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- EU and Zonal regulation
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Summary
- Slide Number 22
- Data requirements ndash Micro-organism200136EC Annex IIB
- Slide Number 24
- Data requirements ndash Micro-organism200136EC Annex IIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Slide Number 28
-
Fate and behaviour in the environment
Residues
Exposure under the proposed condition of use
Effect on non-target organisms
Data requirements ndash Micro-organism 200136EC Annex IIIB
- Use of Micro-organisms in Biological Plant Protection ndash Potential and Regulation
- Slide Number 2
- Slide Number 3
- Slide Number 4
- Biological Control of Seed Borne Diseases
- Slide Number 6
- Slide Number 7
- Slide Number 8
- Slide Number 9
- Mycoparasitism Gliocladium catenulatum or Trichoderma harzianum
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- EU and Zonal regulation
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Summary
- Slide Number 22
- Data requirements ndash Micro-organism200136EC Annex IIB
- Slide Number 24
- Data requirements ndash Micro-organism200136EC Annex IIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Data requirements ndash Micro-organism200136EC Annex IIIB
- Slide Number 28
-
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