Decree No. 382 / 2007 Coll.
Decree amending Decree No. 305 / 2002 Coll., laying down the content of the application and detailed specifications of the data submitted before the placing on the market of the biocidal product or active substance
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Effective from 01.01.2008
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01.01.2008
31.12.2007
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382
DECLARATION
of 19 December 2007
amending Decree No. 305 / 2002 Coll., laying down the content of the application and the detailed specifications of the data submitted before the placing on the market of the biocidal product or active substance
The Ministry of Health provides pursuant to § 4 (7) of Act No. 120 / 2002 Coll., on the conditions for placing biocidal products and active substances on the market and amending certain related laws:
Decree No 305 / 2002 Coll., laying down the content of the application and the detailed specifications of the data submitted before the placing on the market of the biocidal product or active substance, shall be amended as follows:
1. In Section 1, the following paragraph 1 is inserted:
"(1) This decree implements the relevant provisions of the European Communities (1) and regulates the content of the application for authorisation to place a biocidal product on the market and the detailed specification of the biocidal product data and the active substance.
(1) Annexes II A, II B, III A, III B, IV A and IV B to Directive 98 / 8 / EC of the European Parliament and of the Council concerning the placing of biocidal products on the market. Commission Directive 2006 / 50 / EC of 29 May 2006 amending Annexes IV A and IV B to Directive 98 / 8 / EC of the European Parliament and of the Council concerning the placing of biocidal products on the market. ';
Paragraphs 1 to 6 shall be renumbered paragraphs 2 to 7.
footnote 1 shall be renumbered footnote 1a, including the footnote references.
2. the last sentence of Paragraph 1 (2), (6) and (7) shall be deleted;
3. Annex 3, including footnotes 11 to 17, reads as follows:
"Annex 3 to Decree No. 305 / 2002 Coll.
Basic data for the active substance - micro-organism (including viruses and fungi)
1. IDENTIFICATION OF APPLICANT AND MANUFACTURER
1.1. Identifying information of the applicant
Within the scope of § 4 (2) (a) of the Act, as well as telephone and fax numbers, e-mail address, ICO, if any.
1.2. Identification details of the active substance manufacturer, if not applicant
Within the scope of § 4 (2) (b) of the Act and the country of manufacture, telephone and fax numbers, e-mail address, IČO, if allocated and address of the production facility.
2. IDENTIFICATION OF THE ORGANISM
2.1. Name and description of species, strain characterisation
2.1.1. Common name of the micro-organism (including alternative and no longer used names)
2.1.2. Taxonomic name and strain indicating whether it is a basic variant, mutant strain or genetically modified organism (GMO); for viruses taxonomic name virus, serotype, strain or mutant
2.1.3. Reference number of collection and culture under which culture is stored
2.1.4. Methods, procedures and criteria used to determine the presence and identity of the micro-organism (e.g. morphology, biochemistry, serology)
2.2. Specifications of the material used for the manufacture of formulated products
2.2.1. Content or quantity of the micro-organism
2.2.2. Identity and content of impurities and additives contaminating micro-organisms
2.2.3. Analytical batch profile
3. BIOLOGICAL PROPERTIES OF THE MICRO-ORGANISM
3.1. History of the micro-organism and its use. Natural occurrence and geographical spread
3.1.1. Historical Background
3.1.2. Origin and natural occurrence
3.2. Information on the target organism or target organisms
3.2.1. Description of the target organism or target organisms
3.2.2. Method of action
3.3. Heading of hosts and effects on species other than the target organism
3.4. Development stages or life cycle of the micro-organism
3.5. Infectiveness, dissemination and colonisation capability
3.6. Relatives with known plant, animal or human pathogens
3.7. Genetic stability and factors affecting it
3.8. Information on the production of metabolites (especially toxins)
3.9. Antibiotics and other antimicrobial agents
3.10. Resistance to environmental factors
3.11. Effects on materials, substances and preparations
4. FURTHER INFORMATION ON MICRO-ORGANISM
4.1. Function
4.2. Field of intended use
4.3. Type or types of micro-organism and categories of users for which the micro-organism should be included in the lists issued under Section 3 (5) of the Act
4.4. Production methods and quality control
4.5. Information on the occurrence or possible occurrence of the development of resistance of the target organism or target organisms
4.6. Methods to prevent the loss of virulence of the parent (primary) culture of the micro-organism
4.7. Recommended methods and precautions concerning handling, storage, transport or fire
4.8. Decontamination or decomposition procedures
4.9. Accident measures
4.10. Waste management procedures
4.11. Monitoring plan to be used for the effective organism, including handling, storage, transport and use
5. ANALYTICAL METHODS
5.1. Methods for analysis of the micro-organism isolated from the final product
5.2. Methods for qualitative and quantitative determination of residues (viable or non-viable)
6. Effects on Human Health
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6.1. Basic information
6.1.1. Medical data
6.1.2. Medical supervision of factory workers
6.1.3. Sensitisation or allergenicity observation
6.1.4. Direct observation (e.g. clinical cases)
6.2. Basic Studies
6.2.1. Sensitisation
6.2.2. Acute toxicity, pathogenicity and infectiveness
6.2.2.1 Acute oral toxicity, pathogenicity and infectiveness
6.2.2.2 Acute inhalation toxicity, pathogenicity and infectiveness
6.2.2.3. Intraperitoneal or subcutaneous doses when administered
6.2.3. In vitro genotoxicity testing
6.2.4. Cell Culture Studies
6.2.5. Information on short-term toxicity and pathogenicity
6.2.5.1. Effects on health following repeated inhalation exposure
6.2.6. Suggested treatment: first aid, medical treatment
6.2.7. Any pathogenicity and infectiveness to humans and other mammals under immunosuppression conditions
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6.3 Specific toxicity, pathogenicity and infectiveness studies
6.4. Genotoxicity - in vivo studies in somatic cells
6.5. Genotoxicity - in vivo study in germ cells
_
6.6. Summary of data on toxicity, pathogenicity and infectivity for mammals and overall evaluation
7. RESIDENTS IN OR ON CATEGORY MATERIALS, FOOD OR FEED
7.1. Persistence and likelihood of propagation in, or on treated materials, food or feed
7.2. Further information required
7.2.1. Non-viable residues
7.2.2. Viable residues
7.3. Summary and evaluation of residues in or on treated materials, food and feed
8. DIFFERENCE AND ENVIRONMENTAL BEHAVIOUR
8.1. Persistence and multiplication
8.1.1. Soil
8.1.2. Water
8.1.3. Air
8.2. Mobility
8.3. Summary and assessment of environmental breakdown and behaviour
9. EFFECTS ON NON-ELECTRIC ORGANISMS
9.1. Effects on birds
9.2. Effects on aquatic organisms
9.2.1. Effects on fish
9.2.2. Effects on freshwater invertebrates
9.2.3. Effects on algae growth
9.2.4. Effects on plants other than algae
9.3. Effects on bees
9.4. Effects on arthropods other than bees
9.5. Effects on earthworms
9.6. Effects on soil micro-organisms
9.7. Further studies
9.7.1. Terrestrial plants
9.7.2. mammals
9.7.3. Other relevant species and processes
9.8. Summary and evaluation of effects on non-target organisms
10. GENERAL CLASSIFICATION AND LABELLING
The proposal and justification for the proposal for the inclusion of the active substance, the micro-organism, in the relevant group of biological agents according to the degree of risk of infection covered by the specific legislation on workers' health conditions at work11) and the indication of whether the biocidal product needs to be provided with a warning symbol and a written indication of the biological risk referred to in point 13 of this Annex.
11. SUMMARY AND EVALUATION OF THE DATA REFERRED TO IN POINT 1 TO 9 INCLUDING RISK ASSESSMENT AND RECOMMENDATION CONCLUSIONS
12. OTHER PARTICULARS
12.1. If the species concerned is not known to be sufficiently homogeneous in terms of its characteristics, the data referred to in Article 1 (5) shall be required at strain level.
12.2. If the micro-organism is a genetically modified micro-organism under a specific legislation on the management of genetically modified organisms and genetic products12), a copy of the evaluation of environmental risk assessment data under this specific legislation13 shall be submitted.
12.3. If the micro-organism is a high-risk biological agent under a specific biological and toxin weapon prohibition legislation (14), a copy of the authorisation issued by the Authority under this special legislature15 shall be submitted.
12.4. If the micro-organism is a risk biological agent under a specific biological and toxin weapon prohibition legislation16), copies of the declaration certified by the Authority under this specific legislature17 shall be submitted.
12.5. Where the effect of the micro-organism is known to be caused in part or in full by a toxin or metabolite, or significant residues of toxins or metabolites are expected to be unrelated to the effect of the active micro-organism, the data referred to in Annexes 1 or 5 to this Regulation shall be submitted.
13. WARNING SYMBOL AND DOCUMENT OF BIOLOGICAL RISK
Biological risk
11) Government Decree No. 178 / 2001 Coll., laying down conditions for the protection of workers' health at work, as amended
12) § 2 (e) of Act No. 78 / 2004 Coll., on the Treatment of Genetically Modified Organisms and Genetic Products, as amended.
13) § 7 of Act No. 78 / 2004 Coll.
14) § 2 (d) of Act No. 281 / 2002 Coll., on certain measures related to the prohibition of bacteriological (biological) and toxin weapons and on the amendment of the Trade Act, as amended
15) Article 6 (1) of Act No. 281 / 2002 Coll.
16) § 2 (e) of Act No. 281 / 2002 Coll.
17) § 17 paragraph 1 of Act No. 281 / 2002 Coll. '
4. Annex 4, including footnote 18, reads:
"Annex No 4 to Decree No. 305 / 2002 Coll.
Basic data for the biocidal product - micro-organism (including viruses and fungi)
1. IDENTIFICATION OF APPLICANT AND MANUFACTURER
1.1. Identifying information of the applicant
Within the scope of Section 4 (2) (a) of the Act, as well as telephone and fax numbers, e-mail address and IČO, if any.
1.2. Identifying information of the manufacturer of the biocidal product and micro-organism / micro-organism, if not the applicant
Within the scope of § 4 (2) (b) of the Act and the country of manufacture, telephone and fax numbers, e-mail address, IČO, if allocated and address of the production facility.
2. IDENTIFICATION OF THE BIOCIDE PRODUCT
2.1. Trade name or proposed trade name and manufacturer's development code number for the biocidal product
2.2. Detailed information on the quantitative and qualitative composition of the biocidal product
2.2.1. Physical status and nature of the biocidal product
2.2.2. Function
3. PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE BIOCIDAL PRODUCT
3.1. Appearance (colour and odour)
3.2. Storage stability and shelf life
3.2.1. Effects of light, temperature and humidity on the technical characteristics of the biocidal product
3.2.2. Other stability factors
3.2. Explosivity and oxidation properties
3.3. Point of ignition and other information on flammable or spontaneous ignition
3.4. Acidity, alkalinity and pH
3.5. Viscosity and surface tension
3.6. Technical characteristics of the biocidal product
3.6.1. Sprinkler
3.6.2. Persistent foaming
3.6.3. Suspension and stability
3.6.4. Dry net test and wet net test
3.6.5. Distribution of particle size (dustable and wettable powders, granules), dust content or fine particles (granules), abrasion and crumbling (granules)
3.6.6. Emulsibility, reemulsibility, emulsion stability
3.6.7. Fluid, porosity and dustability
3.7. Physical, chemical and biological compatibility with other products, including biocidal products with which the use of the biocidal product is to be authorised or registered
3.7.1. Physical compatibility
3.7.2. Chemical compatibility
3.7.3. Biological compatibility
3.8. Summary and evaluation of the physical, chemical and technical properties of the biocidal product
4. APPLIATION DATA
4.1. Field of intended use
4.2. Method of action
4.3. Details of intended use
4.4. Application dose
4.5. Concentration of the micro-organism in the material used (e.g. in application equipment or bait)
4.6. Application method
4.7. Number and dates of applications and duration of protection
4.8. Necessary waiting periods or other measures to avoid adverse effects on both human and animal health and the environment
4.9. Proposed Instructions for Use
4.10. User categories
4.11. Information on possible development of resistance
4.12. Effects on materials or products treated with a biocidal product
5. FURTHER INFORMATION ON THE BIOCIDAL PRODUCT
5.1. Packaging and tolerability of the biocidal product with the proposed packaging materials
5.2. Application equipment cleaning procedures
5.3. Time limits before entry, necessary waiting periods or other measures to protect persons, livestock and the environment
5.4. Recommended methods and precautions concerning: handling, storage, transport or fire
5.5. Measures in the event of an accident
5.6. Procedures for degradation or decontamination of the biocidal product and its packaging
5.7. Controlled combustion
5.8. Other
5.9. Monitoring plan to be used for the active micro-organism and other micro-organism or other micro-organisms contained in the biocidal product including handling, storage, transport and use
6. ANALYTICAL METHODS
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Regulation Information
| Citation | Decree No. 382 / 2007 Coll., amending Decree No. 305 / 2002 Coll., laying down the content of the application and detailed specifications of the data submitted before the biocidal product or active substance is placed on the market |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 31.12.2007 |
|---|---|
| Effective from | 01.01.2008 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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