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Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products Text with EEA relevance

COMMISSION REGULATION (EU) No 546/2011
of 10 June 2011
implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products
(Text with EEA relevance)
Article 1
Article 2
ANNEX
UNIFORM PRINCIPLES FOR EVALUATION AND AUTHORISATION OF PLANT PROTECTION PRODUCTS, AS PROVIDED FOR IN ARTICLE 29(6) OF REGULATION (EC) No 1107/2009
PART I
Uniform principles for evaluation and authorisation of chemical plant protection products
A. INTRODUCTION
B. EVALUATION
1.
General principles
2.
Specific principles
2.1.
Efficacy
2.2.
Absence of unacceptable effects on plants or plant products
2.3.
Impact on vertebrates to be controlled
2.4.
Impact on human or animal health
2.4.1.
Impact on human or animal health arising from the plant protection product
2.4.2.
Impact on human or animal health arising from residues
2.5.
Influence on the environment
2.5.1.
Fate and distribution in the environment
2.5.2.
Impact on non-target species
2.6.
Analytical methods
2.7.
Physical and chemical properties
C. DECISION-MAKING
1.
General principles
2.
Specific principles
2.1.
Efficacy
2.2.
Absence of unacceptable effects on plants or plant products
2.3.
Impact on vertebrates to be controlled
2.4.
Impact on human or animal health
2.4.1.
Impact on human or animal health arising from the plant protection product
2.4.2.
Impact on human or animal health arising from residues
2.5.
Influence on the environment
2.5.1.
Fate and distribution in the environment
2.5.2.
Impact on non-target species
2.6.
Analytical methods
2.7.
Physical and chemical properties
PART II
Uniform principles for evaluation and authorisation of plant protection products containing micro-organisms
A. INTRODUCTION
10.
Definitions and explanations of microbiological terms
B. EVALUATION
1.
General principles
2.
Specific principles
2.1.
Identity
2.1.1.
Identity of the micro-organism in the plant protection product
2.1.2.
Identity of the plant protection product
2.2.
Biological, physical, chemical, and technical properties
2.2.1.
Biological properties of the micro-organism in the plant protection product
2.2.2.
Physical, chemical and technical properties of the plant protection product
2.3.
Further information
2.3.1.
Quality control of the production of the micro-organism in the plant protection product
2.3.2.
Quality control of the plant protection product
2.4.
Efficacy
2.5.
Identification/detection and quantification methods
2.5.1.
Analytical methods for the plant protection product
2.5.1.1.
Non-viable components
2.5.1.2.
Viable components
2.5.2.
Analytical methods for the determination of residues
2.5.2.1.
Non-viable residues
2.5.2.2.
Viable residues
2.6.
Impact on human or animal health
2.6.1.
Effects on human or animal health arising from the plant protection product
2.6.2.
Effects on human or animal health arising from residues
2.6.2.1.
Non-viable residues
2.6.2.2.
Viable residues
2.7.
Fate and behaviour in the environment
2.8.
Effects on and exposure of non-target organisms
2.9.
Conclusions and proposals
C. DECISION-MAKING
1.
General principles
2.
Specific principles
2.1.
Identity
2.2.
Biological and technical properties
2.3.
Further information
2.4.
Efficacy
2.4.1.
Performance
2.4.2.
Absence of unacceptable effects on plants and plant products
2.5.
Identification/detection and quantification methods
2.6.
Impact on human and animal health
2.6.1.
Effects on human and animal health arising from the plant protection product
2.6.2.
Effects on human and animal health arising from residues
2.7.
Fate and behaviour in the environment
2.8.
Effects on non-target organisms