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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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