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Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (Text with EEA relevance)
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There are currently no known outstanding effects for the Regulation (EU) No 528/2012 of the European Parliament and of the Council, Division TITLE 2.
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Information required to support the approval of an active substance is listed in the table below.
Conditions for not requiring a specific test that are set out in the appropriate test methods in Regulation (EC) No 440/2008 that are not repeated in column 3, also apply.
[F1Column 1 Information required | Column 2 All data is CDS unless indicated as ADS | Column 3 Specific rules for adaption from Column 1] |
---|---|---|
1. APPLICANT | ||
1.1.Name and address | ||
1.2.Contact person | ||
1.3.Manufacturer (name, address and location of manufacturing plant) | ||
2. IDENTITY OF THE MICRO-ORGANISM | ||
2.1.Common name of the micro-organism (including alternative and superseded names) | ||
2.2.Taxonomic name and strain | ||
2.3.Collection and culture reference number where the culture is deposited | ||
[F22.4
Specification of the technical grade active ingredient.] | ||
[F32.4.1
Content of the active micro-organism and identity and content of relevant metabolites or toxins. | ||
2.4.2
Identity and content of impurities, additives, contaminating micro-organisms. | ||
2.4.3
Analytical profile of batches.] | ||
[F42.5
Method of production and quality control.] | ||
2.6.F5... | ||
2.7.F5... | ||
2.8.F5... | ||
2.9.F5... | ||
3. BIOLOGICAL PROPERTIES OF THE MICRO-ORGANISM | ||
3.1. General information on the micro-organism | ||
3.1.1.Historical background | ||
3.1.2.Historical uses | ||
3.1.3.Origin, natural occurrence and geographical distribution | ||
3.2.Development stages/life cycle of the micro-organism | ||
3.3.Relationships to known plant or animal or human pathogens | ||
3.4.Genetic stability and factors affecting it | ||
[F63.5
Information on the production of relevant metabolites and toxins.] | ||
3.6.Production and resistance to antibiotics and other anti-microbial agents | ||
3.7.Robustness to environmental factors | ||
3.8.Further information on the micro-organism | ||
4. METHODS OF DETECTION AND IDENTIFICATION | ||
[F74.1
Methods, procedures and criteria used to establish the presence and identity of the micro-organism.] | ||
[F84.2
Analytical methods for the analysis of the micro-organism as manufactured.] | ||
[F94.3
Methods used for monitoring purposes to determine and quantify residues (viable or non-viable).] | ||
5. EFFECTIVENESS AGAINST TARGET ORGANISM | ||
5.1.Function and mode of control e.g. attracting, killing, inhibiting | ||
5.2.Infectiveness, dispersal and colonisation ability | ||
5.3.Representative organism(s) controlled and products, organisms or objects to be protected | ||
5.4.Effects on representative target organism(s)Effects on materials, substances and products | ||
5.5.Likely concentration at which the micro-organism will be used | ||
5.6.Mode of action (including time delay) | ||
5.7.Efficacy data | ||
5.8. Any known limitations on efficacy | ||
5.8.1.Information on the occurrence or possible occurrence of the development of resistance of the target organism(s) and appropriate management strategies | ||
5.8.2.Observations on undesirable or unintended side effects | ||
5.8.3.Host specificity, range and effects on species other than the target organism | ||
5.9.Methods to prevent loss of virulence of seed stock of the micro-organism | ||
6. INTENDED USES AND EXPOSURE | ||
6.1.Field of use(s) envisaged | ||
6.2.Product-type(s) | ||
6.3.Detailed description of the use pattern(s) | ||
6.4.Category of users for which the micro-organism should be approved | ||
6.5. Exposure data applying, as appropriate, the methodologies described in Section 5 of Annex I to Regulation (EC) No 1907/2006 | ||
6.5.1.Information on human exposure associated with the intended uses and disposal of the active substance | ||
6.5.2.Information on environmental exposure associated with the intended uses and disposal of the active substance | ||
6.5.3.Information on exposure of food-producing animals and food and feeding stuffs associated with the intended uses of the active substance | ||
7.EFFECT ON HUMAN AND ANIMAL HEALTH | Information requirements in this Section may be adapted as appropriate in accordance with the specifications of Title 1 of this Annex. | |
7.1. Basic information | ||
7.1.1.Medical data | ||
7.1.2.Medical surveillance on manufacturing plant personnel | ||
7.1.3.Sensitisation/allergenicity observations | ||
7.1.4.Direct observation, e.g. clinical casesAny pathogenicity and infectiveness to humans and other mammals under conditions of immunosuppression | ||
7.2. Basic studies | ||
7.2.1.Sensitisation | ||
7.2.2. Acute toxicity, pathogenicity, and infectiveness | ||
7.2.2.1.Acute oral toxicity, pathogenicity and infectiveness | ||
7.2.2.2.Acute inhalatory toxicity, pathogenicity and infectiveness | ADS | |
7.2.2.3.Intraperitoneal/subcutaneous single dose | ADS | |
7.2.3.In vitro genotoxicity testing | ||
7.2.4.Cell culture study | ||
7.2.5.Information on short-term toxicity and pathogenicity | ADS | |
7.2.5.1.Health effects after repeated inhalatory exposure | ADS | |
7.2.6.Proposed treatment: first aid measures, medical treatment | ||
7.3.Specific toxicity, pathogenicity and infectiveness studies | ADS | |
7.4.Genotoxicity — in vivo studies in somatic cells | ADS | |
7.5.Genotoxicity — in vivo studies in germ cells | ADS | |
7.6.Summary of mammalian toxicity, pathogenicity and infectiveness and overall evaluation | ||
7.7.Residues in or on treated articles, food and feedingstuffs | ADS | |
7.7.1.Persistence and likelihood of multiplication in or on treated articles, feedingstuffs or foodstuffs | ADS | |
7.7.2.Further information required | ADS | |
7.7.2.1.Non-viable residues | ADS | |
7.7.2.2.Viable residues | ADS | |
7.8.Summary and evaluation of residues in or on treated articles, food and feedingstuffs | ADS | |
8.EFFECTS ON NON-TARGET ORGANISMS | Information requirements in this Section may be adapted as appropriate in accordance with the specifications of Title 1 of this Annex. | |
8.1. Effects on aquatic organisms | ||
8.1.1.Effects on fish | ||
8.1.2.Effects on freshwater invertebrates | ||
8.1.3.Effects on algae growth | ||
8.1.4.Effects on plants other than algae | ADS | |
8.2.Effects on earthworms | ||
8.3.Effects on soil micro-organisms | ||
8.4.Effects on birds | ||
8.5.Effects on bees | ||
8.6.Effects on arthropods other than bees | ||
8.7.Further studies | ADS | |
8.7.1.Terrestrial plants | ADS | |
8.7.2.Mammals | ADS | |
8.7.3.Other relevant species and processes | ADS | |
8.8.Summary and evaluation of effects on non-target organisms | ||
9. ENVIRONMENTAL FATE AND BEHAVIOUR | ||
9.1. Persistence and multiplication | ||
9.1.1.Soil | ||
9.1.2.Water | ||
9.1.3.Air | ||
9.1.4.Mobility | ||
9.1.5.Summary and evaluation of fate and behaviour in the environment | ||
10. MEASURES NECESSARY TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT | ||
10.1.Recommended methods and precautions concerning handling, storage, transport or fire | ||
10.2.Emergency measures in case of an accident | ||
10.3.Procedures for destruction or decontamination | ||
10.4.Procedures for waste management | ||
10.5.Monitoring plan to be used for the active micro-organism including handling, storage, transport and use | ||
11. CLASSIFICATION, LABELLING AND PACKAGING OF THE MICRO-ORGANISM | ||
11.1.Relevant risk group specified in Article 2 of Directive 2000/54/EC | ||
12.SUMMARY AND EVALUATIONThe key information identified from the endpoints in each subsection (2-12) is summarised, evaluated and a draft risk assessment is performed |
Textual Amendments
F1Words in Annex 2 Title 2 table substituted (6.4.2024) by The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024 (S.I. 2024/352), reg. 1(2), Sch. 1 para. 1(5)(a) (with reg. 3)
F2Annex 2 Title 2 table row 2.4 substituted (6.4.2024) by The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024 (S.I. 2024/352), reg. 1(2), Sch. 1 para. 1(5)(b) (with reg. 3)
F3Annex 2 Title 2 table rows 2.4.1-2.4.3 inserted (6.4.2024) by The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024 (S.I. 2024/352), reg. 1(2), Sch. 1 para. 1(5)(c) (with reg. 3)
F4Annex 2 Title 2 table row 2.5 substituted (6.4.2024) by The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024 (S.I. 2024/352), reg. 1(2), Sch. 1 para. 1(5)(d) (with reg. 3)
F5Annex 2 Title 2 table rows 2.6-2.9 omitted (6.4.2024) by virtue of The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024 (S.I. 2024/352), reg. 1(2), Sch. 1 para. 1(5)(e) (with reg. 3)
F6Annex 2 Title 2 table row 3.5 substituted (6.4.2024) by The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024 (S.I. 2024/352), reg. 1(2), Sch. 1 para. 1(5)(f) (with reg. 3)
F7Annex 2 Title 2 table row 4.1 substituted (6.4.2024) by The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024 (S.I. 2024/352), reg. 1(2), Sch. 1 para. 1(5)(g) (with reg. 3)
F8Annex 2 Title 2 table row 4.2 substituted (6.4.2024) by The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024 (S.I. 2024/352), reg. 1(2), Sch. 1 para. 1(5)(h) (with reg. 3)
F9Annex 2 Title 2 table row 4.3 inserted (6.4.2024) by The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024 (S.I. 2024/352), reg. 1(2), Sch. 1 para. 1(5)(i) (with reg. 3)
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