European Communities (Authorization, Placing on the Market, Use and Control of Biocidal Products) (Amendment) Regulations 2006
Source: Iris Oifigiúl 2006-08-15

num: 5
paragraphs: If the biocidal product action is known to be partly or entirely due to the effect of a toxin/metabolite, or if significant residues of toxins/metabolites are to be expected not related to the effect of the active micro-organism, a dossier for the toxin/metabolite shall be submitted in accordance with the requirements of Annexes IIA and, where specified, the relevant parts of Annex IIIA.
Dossier requirements
SECTIONS
I
Identity of the micro-organism
II
Biological properties of the micro-organism
III
Further information on the micro-organism
IV
Analytical methods
V
Effects on human health
VI
Residues in or on treated materials, food and feed
VII
Fate and behaviour in the environment
VIII
Effects on non-target organisms
IX
Classification and labelling
X
Summary and evaluation of sections I to IX including conclusions of the risk assessment and recommendations
The following data will be required to support submissions on the above points.
I
IDENTITY OF THE MICRO-ORGANISM
num: 1
paragraphs: 1
Applicant
num: 1
paragraphs: 2
Manufacturer
num: 1
paragraphs: 3
Name and species description, strain characterisation
num: 1
paragraphs: 3.1
Common name of the micro-organism (including alternative and superseded names)
num: 1
paragraphs: 3.2
Taxonomic name and strain indicating whether it is a stock variant, a mutant strain or a genetically modified organism (GMO); for viruses, taxonomic designation of the agent, serotype, strain or mutant
num: 1
paragraphs: 3.3
Collection and culture reference number where the culture is deposited
num: 1
paragraphs: 3.4
Methods, procedures and criteria used to establish the presence and identity of the micro-organism (e.g. morphology, biochemistry, serology, etc.)
num: 1
paragraphs: 4
Specification of the material used for manufacturing of formulated products
num: 1
paragraphs: 4.1
Content of the micro-organism
num: 1
paragraphs: 4.2
Identity and content of impurities, additives, contaminating micro-organisms
num: 1
paragraphs: 4.3
Analytical profile of batches
II
BIOLOGICAL PROPERTIES OF THE MICRO-ORGANISM
num: 2
paragraphs: 1
History of the micro-organism and its uses. Natural occurrence and geographical distribution
num: 2
paragraphs: 1.1
Historical background
num: 2
paragraphs: 1.2
Origin and natural occurrence
num: 2
paragraphs: 2
Information on target organism(s)
num: 2
paragraphs: 2.1
Description of the target organism(s)
num: 2
paragraphs: 2.2
Mode of action
num: 2
paragraphs: 3
Host specificity range and effects on species other than the target organism
num: 2
paragraphs: 4
Development stages/life cycle of the micro-organism
num: 2
paragraphs: 5
Infectiveness, dispersal and colonisation ability
num: 2
paragraphs: 6
Relationships to known plant or animal or human pathogens
num: 2
paragraphs: 7
Genetic stability and factors affecting it
num: 2
paragraphs: 8
Information on the production of metabolites (especially toxins)
num: 2
paragraphs: 9
Antibiotics and other anti-microbial agents
num: 2
paragraphs: 10
Robustness to environmental factors
num: 2
paragraphs: 11
Effects on materials, substances and products
III
FURTHER INFORMATION ON THE MICRO-ORGANISM
num: 3
paragraphs: 1
Function
num: 3
paragraphs: 2
Field of use envisaged
num: 3
paragraphs: 3
Product type(s) and category of users for which the micro-organism should be listed in Annex I, IA or IB
num: 3
paragraphs: 4
Method of production and quality control
num: 3
paragraphs: 5
Information on the occurrence or possible occurrence of the development of resistance of the target organism(s)
num: 3
paragraphs: 6
Methods to prevent loss of virulence of seed stock of the micro-organism
num: 3
paragraphs: 7
Recommended methods and precautions concerning handling, storage, transport or fire
num: 3
paragraphs: 8
Procedures for destruction or decontamination
num: 3
paragraphs: 9
Measures in case of an accident
num: 3
paragraphs: 10
Procedures for waste management
num: 3
paragraphs: 11
Monitoring plan to be used for the active micro-organism including handling, storage, transport and use
IV
ANALYTICAL METHODS
num: 4
paragraphs: 1
Methods for the analysis of the micro-organism as manufactured
num: 4
paragraphs: 2
Methods to determine and quantify residues (viable or non-viable)
V
EFFECTS ON HUMAN HEALTH
TIER I
num: 5
paragraphs: 1
Basic information
num: 5
paragraphs: 1.1
Medical data
num: 5
paragraphs: 1.2
Medical surveillance on manufacturing plant personnel
num: 5
paragraphs: 1.3
Sensitisation/allergenicity observations
num: 5
paragraphs: 1.4
Direct observation, e.g. clinical cases
num: 5
paragraphs: 2
Basic studies
num: 5
paragraphs: 2.1
Sensitisation
num: 5
paragraphs: 2.2
Acute toxicity, pathogenicity, and infectiveness
num: 5
paragraphs: 2.2.1
Acute oral toxicity, pathogenicity and infectiveness
num: 5
paragraphs: 2.2.2
Acute inhalation toxicity, pathogenicity and infectiveness
num: 5
paragraphs: 2.2.3
Intraperitoneal/subcutaneous single dose
num: 5
paragraphs: 2.3
In vitro genotoxicity testing
num: 5
paragraphs: 2.4
Cell culture study
num: 5
paragraphs: 2.5
Information on short-term toxicity and pathogenicity
num: 5
paragraphs: 2.5.1
Health effects after repeated inhalatory exposure
num: 5
paragraphs: 2.6
Proposed treatment: first aid measures, medical treatment
num: 5
paragraphs: 2.7
Any pathogenicity and infectiveness to humans and other mammals under conditions of immunosuppression
END OF TIER I
TIER II
num: 5
paragraphs: 3
Specific toxicity, pathogenicity and infectiveness studies
num: 5
paragraphs: 4
Genotoxicity — In vivo studies in somatic cells
num: 5
paragraphs: 5
Genotoxicity — In vivo studies in germ cells
END OF TIER II
num: 5
paragraphs: 6
Summary of mammalian toxicity, pathogenicity and infectiveness and overall evaluation
VI
RESIDUES IN OR ON TREATED MATERIALS, FOOD AND FEED
num: 6
paragraphs: 1
Persistence and likelihood of multiplication in or on treated materials, feedingstuffs or foodstuffs
num: 6
paragraphs: 2
Further information required
num: 6
paragraphs: 2.1
Non-viable residues
num: 6
paragraphs: 2.2
Viable residues
num: 6
paragraphs: 3
Summary and evaluation of residues in or on treated materials, food and feed
VII
FATE AND BEHAVIOUR IN THE ENVIRONMENT
num: 7
paragraphs: 1
Persistence and multiplication
num: 7
paragraphs: 1.1
Soil
num: 7
paragraphs: 1.2
Water
num: 7
paragraphs: 1.3
Air
num: 7
paragraphs: 2
Mobility
num: 7
paragraphs: 3
Summary and evaluation of fate and behaviour in the environment
VIII
EFFECTS ON NON-TARGET ORGANISMS
num: 8
paragraphs: 1
Effects on birds
num: 8
paragraphs: 2
Effects on aquatic organisms
num: 8
paragraphs: 2.1
Effects on fish
num: 8
paragraphs: 2.2
Effects on freshwater invertebrates
num: 8
paragraphs: 2.3
Effects on algae growth
num: 8
paragraphs: 2.4
Effects on plants other than algae
num: 8
paragraphs: 3
Effects on bees
num: 8
paragraphs: 4
Effects on arthropods other than bees
num: 8
paragraphs: 5
Effects on earthworms
num: 8
paragraphs: 6
Effects on soil micro-organisms
num: 8
paragraphs: 7
Further studies
num: 8
paragraphs: 7.1
Terrestrial plants
num: 8
paragraphs: 7.2
Mammals
num: 8
paragraphs: 7.3
Other relevant species and processes
num: 8
paragraphs: 8.
Summary and evaluation of effects on non-target organisms
IX
CLASSIFICATION AND LABELLING
The dossier shall be accompanied by a reasoned proposals for allocating an active substance which is a micro-organism to one of the risk groups specified in Article 2 of Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (1) together with indications on the need for products to carry the biohazard sign specified in Annex II to that Directive.
X
SUMMARY AND EVALUATION OF SECTIONS I TO IX INCLUDING CONCLUSIONS OF THE RISK ASSESSMENT AND RECOMMENDATIONS