Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed)

EU Regulation No 544/2011 · Adopted 10 June 2011 · Extends to United Kingdom

F1Commission Regulation (EU) No 544/2011

of 10 June 2011

implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances

(Text with EEA relevance) (repealed)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, and in particular the first sentence of Article 8(4) thereof,

After consulting the Standing Committee on the Food Chain and Animal Health,

Whereas:

(1)

In accordance with Regulation (EC) No 1107/2009, the dossier to be submitted for the approval of an active substance or for the authorisation of a plant protection product is to fulfil the same requirements in respect of the data requirements for the plant protection product as under the previously applicable rules which are set out in Annexes II and III to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market.

(2)

It is therefore necessary for the implementation of Regulation (EC) No 1107/2009 to adopt a regulation containing those data requirements for active substances. Such a regulation is not to include any substantial modification,

HAS ADOPTED THIS REGULATION:

Annotations to the whole text

Textual amendments

F1: Repealed (subject to transitional measures in Arts. 3, 4) by Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market Text with EEA relevance.

A1Scope and interpretation
1Article 1
2Article 2 Repealed
Signature
Annex: DATA REQUIREMENTS FOR ACTIVE SUBSTANCES, AS PROVIDED FOR IN ARTICLE 8(1)(b) OF REGULATION (EC) No 1107/2009
INTRODUCTION
1Division 1
Test and analyses
2.1Division 2.1
2.2By way of derogation from point 2.1, the competent authority may provide that tests and analyses, performed on their constituent territory in order to obtain data on the properties and/or safety of the active substances with respect to honey-bees and beneficial arthropods other than bees shall be conducted by official or officially-recognised testing facilities or organisations which satisfy at least the requirements as set out under points 2.2 and 2.3 of the introduction to the Annex to Commission Regulation (EU) No 545/2011.
2.3By way of derogation from point 2.1, the competent authority may provide that supervised residue trials performed on their constituent territory in accordance with Section 6 ‘Residues in or on treated products, food and feed’ on plant protection products containing active substances already on the market on or before 25th July 1993 shall be conducted by official or officially-recognised testing facilities or organisations which satisfy at least the requirements under points 2.2 and 2.3 of the introduction to the Annex to Regulation (EU) No 545/2011.
2.4Division 2.4
Part A: CHEMICAL SUBSTANCES
1Identity of the active substance
1.1Applicant (name, address, etc.)
1.2Manufacturer (name, address, including location of plant)
1.3Common name proposed or ISO-accepted, and synonyms
1.4Chemical name (IUPAC and CA nomenclature)
1.4.1Division 1.4.1
1.5Manufacturer’s development code number(s)
1.6CAS, EC and CIPAC numbers (if available)
1.7Molecular and structural formula, molecular mass
1.8Method of manufacture (synthesis pathway) of the active substance
1.9Specification of purity of the active substance in g/kg
1.10Identity of isomers, impurities and additives (e.g. stabilisers), together with the structural formula and the content expressed as g/kg
1.11Analytical profile of batches
Physical and chemical properties of the active substance
(i)The information provided, must describe the physical and chemical properties of active substances and together with relevant information, must serve to characterise them. In particular, the information provided must permit:
(ii)Division (ii)
(iii)Division (iii)
(iv)In certain specified instances, tests must be conducted using purified active substance of stated specification. In such cases the principles of the method(s) of purification must be reported. The purity of such test material, which must be as high as can be achieved using the best available technology, must be reported. A reasoned justification must be provided in cases where the degree of purity achieved is less than 980 g/kg.
Melting point and boiling point
2.1.1Division 2.1.1
2.1.2Division 2.1.2
2.1.3Division 2.1.3
2.2Relative density
Vapour pressure (in Pa), volatility (e.g. Henry’s law constant)
2.3.1Division 2.3.1
2.3.2Division 2.3.2
Appearance (physical state, colour and odour; if known)
2.4.1Division 2.4.1
2.4.2Division 2.4.2
Spectra (UV/VIS, IR, NMR, MS), molecular extinction at relevant wavelengths
2.5.1Division 2.5.1
2.5.2Division 2.5.2
2.6Solubility in water including effect of pH (4 to 10) on solubility
2.7Solubility in organic solvents
2.8Partition coefficient n-octanol/water including effect of pH (4 to 10)
Stability in water, hydrolysis rate, photochemical degradation, quantum yield and identity of breakdown product(s), dissociation constant including effect of pH (4 to 9)
2.9.1Division 2.9.1
2.9.2Division 2.9.2
2.9.3Division 2.9.3
2.9.4Division 2.9.4
2.10Stability in air, photochemical degradation, identity of breakdown product(s)
Flammability including auto-flammability
2.11.1Division 2.11.1
2.11.2Division 2.11.2
2.12Flash point
2.13Explosive properties
2.14Surface tension
2.15Oxidising properties
Further information on the active substance
(i)Division (i)
(ii)Division (ii)
(iii)Division (iii)
(iv)Division (iv)
(v)Division (v)
3.1Function, e.g. fungicide, herbicide, insecticide, repellent, growth regulator
Effects on harmful organisms, e.g. contact poison, inhalation poison, stomach poison, fungitoxic, etc. systematic or not in plants
3.2.1Division 3.2.1
3.2.2Division 3.2.2
3.3Field of use envisaged, e.g. field, protected crops, storage of plant products, home gardening
Harmful organisms controlled and crops or products protected or treated
3.4.1Division 3.4.1
3.4.2Division 3.4.2
3.4.3Division 3.4.3
Mode of action
3.5.1Division 3.5.1
3.5.2Division 3.5.2
3.5.3Division 3.5.3
3.6Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies
3.7Recommended methods and precautions concerning handling, storage, transport or fire
Procedures for destruction or decontamination
3.8.1Controlled incineration
3.8.2Others
3.9Emergency measures in case of an accident
Analytical methods
Introduction
4.1Methods for the analysis of the active substance as manufactured
(i)Specificity
(ii)Linearity
(iii)Accuracy
(iv)Precision
4.1.1Division 4.1.1
4.1.2Division 4.1.2
Specificity, linearity, accuracy and repeatability
4.1.3.1Division 4.1.3.1
4.1.3.2Division 4.1.3.2
4.1.3.3Division 4.1.3.3
4.1.3.4Division 4.1.3.4
4.2Methods for the determination of residues
(i)Specificity
(ii)Precision
(iii)Recovery
(iv)Limit of determination
4.2.1Residues in and/or on plants, plant products, foodstuffs (of plant and animal origin), feedingstuffs
4.2.2Residues in soil
4.2.3Residues in water (including drinking water, ground water and surface water)
4.2.4Residues in air
4.2.5Residues in body fluids and tissues
Toxicological and metabolism studies
Introduction
(i)The information provided, taken together with that provided for one or more preparations containing the active substance, must be sufficient to permit an evaluation to be made as to the risks for man, associated with the handling and use of plant protection products containing the active substance, and the risk for man arising from residual traces remaining in food and water. In addition, the information provided must be sufficient to:
(ii)Division (ii)
(iii)Division (iii)
(iv)Division (iv)
(v)Division (v)
(vi)Division (vi)
(vii)Division (vii)
(viii)Division (viii)
5.1Studies on absorption, distribution, excretion and metabolism in mammals
Circumstances in which required
Test guideline
5.2Acute toxicity
Oral
Circumstances in which required
Test guideline
Percutaneous
Circumstances in which required
Test guideline
Inhalation
Circumstances in which required
Test guideline
Skin irritation
Aim of the test
Circumstances in which required
Test guideline
Eye irritation
Aim of test
Circumstances in which required
Test guidelines
Skin sensitisation
Aim of test
Circumstances in which required
Test guideline
5.3Short-term toxicity
Oral 28-day study
Circumstances in which required
Test guideline
Oral 90-day study
Circumstances in which required
Test guidelines
Other routes
Circumstances in which required
Test guidelines
Genotoxicity testing
Aim of the test
In vitro studies
Circumstances in which required
Test guidelines
In vivo studies in somatic cells
Circumstances in which required
Test guidelines
In vivo studies in germ cells
Circumstances in which required
Long-term toxicity and carcinogenicity
Aim of the test
Circumstances in which required
Test conditions
Test guideline
5.6Reproductive toxicity
Multi-generation studies
Aim of the test
Circumstances in which required
Test guideline
Supplementary studies
Developmental toxicity studies
Aim of the test
Circumstances in which required
Test conditions
Test guideline
Delayed neurotoxicity studies
Aim of the test
Circumstances in which required
Test guidelines
Other toxicological studies
5.8.1Toxicity studies of metabolites as referred to in the introduction, point (vii)
5.8.2Supplementary studies on the active substance
5.9Medical data
5.9.1Medicinal surveillance on manufacturing plant personnel
5.9.2Direct observation, e.g. clinical cases and poisoning incidents
5.9.3Observations on exposure of the general population and epidemiological studies if appropriate
5.9.4Diagnosis of poisoning (determination of active substance, metabolites), specific signs of poisoning, clinical tests
5.9.5Proposed treatment: first aid measures, antidotes, medical treatment
5.9.6Expected effects of poisoning
5.10Summary of mammalian toxicity and overall evaluation
Residues in or on treated products, food and feed
Introduction
(i)The information provided, taken together with that provided for one or more preparations containing the active substance, must be sufficient to permit an evaluation to be made as to the risks for man, arising from residues of the active substance and relevant metabolites, degradation and reaction products remaining in food. In addition, the information provided must be sufficient to:
(ii)Division (ii)
(iii)Division (iii)
(iv)Division (iv)
(v)Stability of residues during storage.
Metabolism, distribution and expression of residue in plants
Aim of the tests
Circumstances in which required
Test conditions
Metabolism, distribution and expression of residue in livestock
Aim of tests
Circumstances in which required
Residue trials
Aim of the tests
Circumstances in which required
Test conditions
Livestock feeding studies
Aim of the tests
Circumstances in which required
Test conditions
Effects of industrial processing and/or household preparations
Circumstances in which required
Effects on the nature of the residue
Aim of the tests
Test conditions
Effects on the residue levels
Aim of the tests
Test conditions
Residues in succeeding crops
Aim of the test
Circumstances in which required
Test conditions
6.7Proposed maximum residue levels (MRLs) and residue definition
6.8Proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods, in the case of post-harvest uses
6.9Estimation of the potential and actual exposure through diet and other means
6.10Summary and evaluation of residue behaviour
Fate and behaviour in the environment
Introduction
(i)Division (i)
(ii)In particular, the information provided for the active substance, together with other relevant information, and that provided for one or more preparations containing it shall be sufficient to:
(iii)A detailed description (specification) of the material used, as provided for under point 1.11 must be provided. Where testing is done using active substance the material used shall be of that specification that will be used in the manufacture of preparations to be authorised except where radio-labelled material is used.
(iv)Division (iv)
(v)Division (v)
(vi)Where relevant, tests shall be designed and data analysed using appropriate statistical methods.
7.1Fate and behaviour in soil
Route and rate of degradation
Route of degradation
Aim of the tests
Aerobic degradation
Circumstances in which required
Test conditions
Test guideline
Supplementary studies
Anaerobic degradation
Circumstances in which required
Test conditions and test guideline
Soil photolysis
Circumstances in which required
Test guideline
Rate of degradation
Laboratory studies
Aim of the tests
Aerobic degradation
Circumstances in which required
Test conditions
Test guideline
Anaerobic degradation
Circumstances in which required
Test conditions
Test guideline
Field studies
Soil dissipation studies
Aim of the test
Circumstances in which required
Test conditions
Test guideline
Soil residue studies
Aim of the test
Circumstances in which required
Test conditions
Test guideline
Soil accumulation studies
Aim of the tests
Circumstances in which required
Test conditions
Adsorption and desorption
Aim of the test
Circumstances in which required
Test conditions
Test guideline
Mobility in the soil
Column leaching studies
Aim of the test
Circumstances in which required
Test guideline
Aged residue column leaching
Aim of the test
Circumstances in which required
Test conditions
Test guideline
Lysimeter studies or field leaching studies
Aim of the tests
Circumstances in which required
Test conditions
Lysimeter studies
Test conditions
Field leaching studies
Test conditions
Test guideline
Fate and behaviour in water and air
Aim of the tests
Route and rate of degradation in aquatic systems (as far as not covered by point 2.9)
Aim of the tests
Hydrolytic degradation
Circumstances in which required
Test conditions and test guideline
Photochemical degradation
Circumstances in which required
Test conditions and test guideline
Biological degradation
‘Ready biodegradability’
Circumstances in which required
Test guideline
Water/sediment study
Circumstances in which required
Test guideline
Degradation in the saturated zone
Circumstances in which required
Test conditions
7.2.2Route and rate of degradation in air (as far as not covered by point 2.10)
7.3Definition of the residue
7.4Monitoring data
Ecotoxicological studies
Introduction
(i)Division (i)
(ii)In particular, the information provided for the active substance, together with other relevant information, and that provided for one or more preparations containing it, shall be sufficient to:
(iii)Division (iii)
(iv)Division (iv)
(v)Division (v)
Test substance
(vi)Division (vi)
(vii)Division (vii)
(viii)In the case of studies in which dosing extends over a period, dosing shall preferably be done using a single batch of active substance if stability permits.
(ix)Division (ix)
(x)Division (x)
Test organisms
(xi)Division (xi)
Effects on birds
Acute oral toxicity
Aim of the test
Circumstances in which required
Test conditions
Test guideline
Short-term dietary toxicity
Aim of the test
Circumstances in which required
Test conditions
Test guideline
Subchronic toxicity and reproduction
Aim of the test
Circumstances in which required
Test guideline
8.2Effects on aquatic organisms
Acute toxicity to fish
Aim of the test
Circumstances in which required
Test conditions
Test guideline
Chronic toxicity to fish
Circumstances in which required
Chronic toxicity test on juvenile fish
Aim of the test
Test conditions
Fish early life stage toxicity test
Aim of the test
Test guideline
Fish life cycle test
Aim of the test
Test conditions
Bioconcentration in fish
Aim of the test
Circumstances in which required
Test guideline
Acute toxicity to aquatic invertebrates
Aim of the test
Circumstances in which required
Test guideline
Chronic toxicity to aquatic invertebrates
Aim of the test
Circumstances in which required
Test conditions
Test guideline
Effects on algal growth
Aim of the test
Circumstances in which required
Test guideline
Effects on sediment dwelling organisms
Aim of test
Circumstances in which required
Test conditions
8.2.8Aquatic plants
Effect on arthropods
Bees
Acute toxicity
Aim of the test
Circumstances in which required
Test guideline
Bee brood feeding test
Aim of the test
Circumstances in which required
Test guideline
Other arthropods
Aim of the test
Circumstances in which required
Test conditions
Test guideline
Effects on earthworms
Acute toxicity
Aim of the test
Circumstances in which required
Test guideline
Sublethal effects
Aim of the test
Circumstances in which required
Test conditions
Effects on soil non-target micro-organisms
Aim of the test
Circumstances in which required
Test conditions
Test guideline
8.6Effects on other non-target organisms (flora and fauna) believed to be at risk
8.7Effects on biological methods for sewage treatment
Summary and evaluation of Sections 7 and 8
10Proposals including justification for the proposals for the classification and labelling of the active substance in accordance with Regulation (EC) No 1272/2008
A dossier as referred to in Part A of the Annex to Regulation (EU) No 545/2011, for a representative plant protection product
Part B: MICRO-ORGANISMS INCLUDING VIRUSES
Introduction
(i)Active substances are defined in Article 2(2) of Regulation (EC) No 1107/2009 and include chemical substances and micro-organisms including viruses.
(ii)For all micro-organisms that are subject to application all available relevant knowledge and information in literature should be provided.
(iii)Division (iii)
(iv)Where testing is done, a detailed description (specification) of the material used and its impurities, in accordance with point 1.4, must be provided. The material used shall be of that specification that will be used in the manufacture of preparations to be authorised.
(v)Division (v)
(vi)Division (vi)
(vii)In the case of studies in which dosing extends over a period, dosing shall preferably be done using a single batch of the micro-organism, if stability permits.
(viii)Division (viii)
1Identity of the micro-organism
1.1Applicant
1.2Producer
Name and species description, strain characterisation
(i)Division (i)
(ii)Each micro-organism that is subject to the application shall be identified and named at the species level. The scientific name and taxonomic grouping, i.e. family, genus, species, strain, serotype, pathovar or any other denomination relevant to the micro-organism, must be stated.
(iii)Division (iii)
(iv)Division (iv)
(v)Division (v)
Specification of the material used for manufacturing of formulated products
1.4.1Content of the micro-organism
1.4.2Identity and content of impurities, additives, contaminating micro-organisms
1.4.3Analytical profile of batches
Biological properties of the micro-organism
2.1History of the micro-organism and its uses. Natural occurrence and geographical distribution
2.1.1Historical background
2.1.2Origin and natural occurrence
Information on target organism(s)
2.2.1Description of the target organism(s)
2.2.2Mode of action
2.3Host specificity range and effects on species other than the target harmful organism
2.4Development stages/life cycle of the micro-organism
2.5Infectiveness, dispersal and colonisation ability
2.6Relationships to known plant or animal or human pathogens
2.7Genetic stability and factors affecting it
2.8Information on the production of metabolites (especially toxins)
2.9Antibiotics and other anti-microbial agents
Further information on the micro-organism
Introduction
(i)Division (i)
(ii)Division (ii)
(iii)Division (iii)
(iv)Division (iv)
3.1Function
3.2Field of use envisaged
3.3Crops or products protected or treated
3.4Method of production and quality control
3.5Information on the occurrence or possible occurrence of the development of resistance of the target organism(s)
3.6Methods to prevent loss of virulence of seed stock of the micro-organism
3.7Recommended methods and precautions concerning handling, storage, transport or fire
3.8Procedures for destruction or decontamination
3.9Measures in case of an accident
Analytical methods
Introduction
4.1Methods for the analysis of the micro-organism as manufactured
4.2Methods to determine and quantify residues (viable or non-viable)
Effects on human health
Introduction
(i)Division (i)
(ii)The information provided, taken together with that provided for one or more preparations containing the micro-organism, must be sufficient to permit an evaluation to be made as to the risks for man, directly and/or indirectly associated with the handling and use of plant protection products containing the micro-organism, and the risk for man handling treated products, and the risk for man arising from residual traces or contaminants remaining in food and water. In addition, the information provided must be sufficient to:
(iii)Division (iii)
(iv)Division (iv)
(v)Evaluation of the micro-organism shall be carried out in a tier-wise manner.
TIER I
5.1Basic information
5.1.1Medical data
5.1.2Medical surveillance on manufacturing plant personnel
5.1.3Sensitisation/allergenicity observations, if appropriate
5.1.4Direct observation, e.g. clinical cases
5.2Basic studies
Sensitisation
Aim of the test
Circumstances in which required
5.2.2Acute toxicity, pathogenicity and infectiveness
Acute oral toxicity, pathogenicity and infectiveness
Circumstances in which required
Acute inhalation toxicity, pathogenicity and infectiveness
Circumstances in which required
5.2.2.3Intraperitoneal/subcutaneous single dose
Circumstances in which required
Genotoxicity testing
Circumstances in which required
Aim of the test
Test conditions
In vitro studies
Circumstances in which required
5.2.4Cell culture study
Information on short-term toxicity and pathogenicity
Aim of the test
Circumstances in which required
5.2.5.1Health effects after repeated inhalatory exposure
Circumstances in which required
5.2.6Proposed treatment: first aid measures, medical treatment
TIER II
5.3Specific toxicity, pathogenicity and infectiveness studies
In vivo studies in somatic cells
Circumstances in which required
Genotoxicity — In vivo studies in germ cells
Aim of the test and test conditions
Circumstances in which required
5.6Summary of mammalian toxicity, pathogenicity and infectiveness and overall evaluation
Residues in or on treated products, food and feed
Introduction
(i)Division (i)
(ii)In addition, the information provided must be sufficient to:
(iii)Division (iii)
6.1Persistence and likelihood of multiplication in or on crops, feedingstuffs or foodstuffs
6.2Further information required
6.2.1Non-viable residues
6.2.2Viable residues
Summary and evaluation of residue behaviour resulting from data submitted under points 6.1 and 6.2
Fate and behaviour in the environment
Introduction
(i)Information on the origin, the properties, and the survival of the micro-organism and its residual metabolites as well as its intended use form the basis for an assessment of environmental fate and behaviour.
(ii)Division (ii)
(iii)In particular, the information provided shall be sufficient to:
(iv)Any relevant metabolites (i.e. of concern for human health and/or the environment) formed by the test organism under any relevant environmental conditions shall be characterised. If relevant metabolites are present in or produced by the micro-organism, data as outlined under Section 7 of Part A of this Annex may be required, if all of the following conditions are met:
(v)Division (v)
(vi)Division (vi)
7.1Persistence and multiplication
7.1.1Soil
7.1.2Water
7.1.3Air
7.2Mobility
Effects on non-target organisms
Introduction
(i)The information on identity, biological properties and further information in Sections 1, 2, 3 and 7 is central to the assessment of impact on non-target species. Additional useful information may be found on fate and behaviour in the environment in Section 7 and on residue levels in plants in Section 6 which, together with information on the nature of the preparation and its manner of use, defines the nature and extent of potential exposure. The information submitted in accordance with Section 5 will provide essential information as to effects to mammals and the mechanisms involved.
(ii)Division (ii)
(iii)Division (iii)
(iv)In particular, the information provided for the micro-organism, together with other relevant information, and that provided for one or more preparations containing it, shall be sufficient to:
(v)Division (v)
(vi)Division (vi)
(vii)Division (vii)
(viii)Division (viii)
(ix)Division (ix)
Effects on birds
Aim of the test
Effects on aquatic organisms
Aim of the test
Effects on fish
Aim of the test
Effects on freshwater invertebrates
Aim of the test
Effects on algae growth
Aim of the test
Effects on plants other than algae
Aim of the test
Effects on bees
Aim of the test
Effects on arthropods other than bees
Aim of the test
Effects on earthworms
Aim of the test
8.6Effects on non-target soil micro-organisms
8.7Additional studies
9Summary and evaluation of environmental impact

Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed)

Annotations to the whole text

Textual amendments

Contents