Amendments To The Cabinet Of 15 April 2003, Regulations No. 184 "requirements For Transactions With Biocides"

Original Language Title: Grozījumi Ministru kabineta 2003.gada 15.aprīļa noteikumos Nr.184 "Prasības darbībām ar biocīdiem"

Read the untranslated law here: https://www.vestnesis.lv/ta/id/160967

Cabinet of Ministers Regulations No. 511 in 2007 (24 July. No 42) amendments to the Cabinet of 15 April 2003, regulations No. 184 "requirements for transactions with biocides" Issued under the chemicals and chemical products Act article 9 the seventh subparagraph 1. make Cabinet of 15 April 2003, regulations No. 184 "requirements for transactions with biocides" (Latvian journal, 2003, 83 no; 2005, nr. 102) the following amendments: 1. replace the text of rule: 1.1.1 the word "importer" (fold) with the words "importer from another country" (fold); 1.1.2. the word "import" (fold) with the words "to import from another country" (fold); 1.1.3. the word "import" (fold) with the words "import from another country" (fold); 1.1.4. the word "imported" by the words "imported from another country"; 1.2. make 10 introductory paragraph as follows: "10. Biocidal products or active substances on the market-put-delivery for a fee or free shipping, storage after delivery (if it is not sent from storage in the customs territory) or destruction and introduction into the customs territory (hereinafter – trade), as well as biocides or active substance production is allowed only if:"; 1.3. to replace in paragraph 10.3. numbers and the words "in paragraphs 5 and 6" with numbers and the words "in paragraphs 12 and 13; 1.4. replace paragraph 17.2.1., the words "the Minister of the environment approved the list of dangerous chemicals" with the words "regulations for dangerous chemical substances list"; 1.5. to supplement 21.1. subparagraph after the word "the" in the list of active substances with a number and the word "(2.1)"; 1.6. make 28 the following: 28. If the manufacturer authorized representative is not confided to the limited availability of information, the manufacturer, the authorised representative shall submit with the application the Agency of access-restricted access information of the owner of the signed document that the Agency may use the information to issue licence or a registered biocide in accordance with these rules. "; 1.7. to replace 31.3. in subparagraph the words "approved by the Minister of the environment laboratory chemicals and chemical products, physical, chemical, toxicological or ecotoxicological methods for the determination of the characteristics of" with the words "method in accordance with the laws and regulations on laboratory methods for chemicals and chemical products, physical, chemical, toxicological or ecotoxicological properties detection"; 1.8. to replace the words "in paragraph 26.2. not more than 10 years" with the words "not exceeding 10 years from the date on which the active substance was first included that provision repeatedly or 2.1 (but not longer than until the last time for the active substance specified on the list of active substances)"; 1.9. to replace the words "paragraph 26.3. not more than 10 years" with the words "not exceeding 10 years from the date on which the active substance was first included that provision repeatedly or 2.1 (but not longer than until the last time for the active substance specified on the list of active substances)"; 1.10. in paragraph 73 deleted the word "product"; 1.11. the introductory part of paragraph 106 be expressed as follows: "106. During the period, while the European Union is undergoing examination of active substances for inclusion in the list of active substances, up to 14 May 2010 by biocidal active substances and counting. The manufacturer or the person or biocidal active substance being imported into the territory of Latvia, shall submit to the Agency an application containing the following information: "; 1.12. the deletion of 106.8 and 106.9. section; 1.13. supplement with 106.10. subparagraph by the following: "the model label. 106.10."; 1.14. supplement with 106.1 points by the following: "agency submissions look 106.1 15 days and counting number issued. Counting number specifies the label. '; 1.15. in paragraph 108 deleted word and figure "and 106.10."; 1.16. supplement with 110 points as follows: "110. This provision of the annex table 2.1 paragraph (1) shall enter into force by 1 January 2009, 2-1 March 2009."; 1.17. make informative reference to European Union directives as follows: "Informative reference to European Union directives, the regulations include provisions resulting from: 1) of the European Parliament and of the Council of 16 February 1998 Directive 98/8/EC concerning the placing of biocidal products on the market; 2) Commission of 29 May 2006, Directive 2006/50/EC amending Annexes IVA and IVB to European Parliament and Council Directive 98/8/EC concerning the placing of biocidal products on the market; 3) Commission 20 December 2006 the directive 2006/140/EC amending Directive 98/8/EC of the European Parliament and of the Council to include the active substance in annex I of the sulfuryl fluoride; 4) Commission of 3 April 2007 of Directive 2007/20/EC amending Directive 98/8/EC of the European Parliament and of the Council to include dichlofluanid as an active substance in annex I. "; 1.18. replace the words "the provisions of the annexes to the Latvian Environment Agency" (fold) with the words "Latvian environment, geology and Meteorology Agency" (fold); 1.19. supplement with 2.1 as follows: Annex "annex 2.1 Cabinet of 15 April 2003, the Regulation No 184 active substances no PO box trade name IUPAC name, identification numbers active substances the minimum degree of purity on the market in biocidal James deploys inclusion date expiration must ensure compliance with the requirements of this Regulation (except for products containing several active substances, where that period is determined by the last decision of inclusion relating to the composition of existing active substances) expiry date of the inclusion of the release you way to the conditions of use of sulfuryl fluoride in the EC sulfuryl fluoride 1 no: 220-281-5 CAS No.: 2699-79-8 > 994 g/kg in 2009 January 1, 2010 December 31, 2018 31 dec 8 by bris. 1) product can be sold to professional users who are trained to use it, and you can only use the following user 2) are included in the authorisation for appropriate risk reduction measures for workers 3) in the Troposphere sulfuryl fluoride concentration of 2-fluanīd N-Dihl (Dichloro-fluormetilti)-N ' , N '-fenilsulfamīd EC No: 214-118-7 CAS No: 1085-98-9 mass part 96% of 2009 > on 1 March 2011 28 February 2019. February 28, 8.1) use of the products, designed for industrial and professional users, use appropriate personal protective equipment 2) in the light of the risks identified in relation to soil, reduction of risk take appropriate soil protection measures 3) Industrial uses for the product label or safety data sheet specifies that just treated wood storage after processing on the tight, sealed surface, to avoid leaching the soil. Any leakage of the collected re-use or elimination of note. By January 1, 2009 review of sulfuryl fluoride concentrations in the troposphere results of monitoring of permissions the recipients shall be forwarded to the European Commission every fifth year. "

1.20. make 7. attachment as follows: "Annex 7 Cabinet of 15 April 2003, the Regulation No 184 technical report for the active substance if the active substance is a micro-organism fungus or virus 1. applications for the active substance. 2. The manufacturer of the active substance. 3. Micro-organisms, including fungi and viruses (hereinafter-the micro-organism), identity: 3.1 name (also alternative and former names) and a description of the species; 3.2. taxonomic name and strain characterisation (mutant, mutant mutant or genetically modified organism). Viruses indicates proposing, serotype, strain or mutant mutant taxonomic designation; 3.3. collection and culture reference number deposited; 3.4. micro-organism detection and identification methods, procedures and criteria (e.g. morphology, biochemistry, serology). 4. a micro-organism in the material used in the Production of specifications: 4.1 composition; 4.2. the impurities, additives and contaminating micro-organisms identity and composition; 4.3. analytical composition of the party. 5. Biological properties of the micro-organism: a micro-organism and use 5.1 history; 5.2. origin and natural occurrence, geographic distribution; 5.3. information on target organism: 5.3.1.; 5.3.2. exposure type; 5.4. specified host range and effects on species other than the target organism; 5.5. development stages or life cycle; 5.6. infectivity, distribution and colony formation ability; 5.7. the relationship with the plant, animal or human pathogens; 5.8. genetic stability and factors affecting it; 5.9. metabolites (especially toxins); 5.10. antibiotics and other antimicrobial substances; 5.11. robustness to environmental factors; 5.12. effects on materials, substances and products. 6. Further information on the micro-organism: 6.1. function; 6.2. field of use envisaged; 6.3. product type and user categories according to annex these provisions 2.1; 6.4. method of production and quality control; 6.5. the occurrence of resistance in the formation or possible formation; 6.6. a micro-organism inoculum virulence loss prevention methods; 6.7. recommended methods and precautions to be taken in handling the storage and transport of microorganisms, as well as the action in the event of fire; 6.8. the destruction or decontamination (pollution prevention); 6.9. measures in the event of an accident; 6.10. the micro-organism's waste around Syme joke; 6.11. the active organism monitoring plan, which also includes the handling, storage, transport and use. 7. analytical methods: 7.1 industrial methods for the analysis of the micro-organism; 7.2. a micro-organism residues (viable or non-viable) methods to determine and quantify. 8. Micro-organisms effects on human health: the basics: 8.1 8.1.1. medical data; 8.1.2. the shop floor staff health surveillance; 8.1.3. observations on sensitization or allergenicity; 8.1.4. direct observation, e.g. clinical cases; 8.2. basic studies: 8.2.1. sensitization; 8.2.2. acute toxicity, pathogenicity and infectivity: 8.2.2.1. acute oral toxicity, pathogenicity and infectivity; 8.2.2.2. acute inhalation toxicity, pathogenicity and infectivity; 8.2.2.3. intraperitoneal or subcutaneous dose; 8.2.3. in vitro genotoxicity testing; 8.2.4. cell culture studies; 8.2.5. information on short-term toxicity and pathogenicity-health effects after repeated inhalatory exposure; 8.2.6. the recommended treatment-emergency measures, treatment; 8.2.7. pathogenicity and ability to infect humans and other mammals under conditions of immunosuppression; 8.3. studies on specific toxicity, pathogenicity and infectivity; 8.4. genotoxicity-studies in somatic cells in vivo; 8.5. genotoxicity — in vivo studies in germ cells; 8.6. Summary and evaluation. 9. A micro-organism residues in or on treated materials, food and feed: 9.1. persistence and multiplication; 9.2. non-viable residues; 9.3. viable residues; 9.4. Summary and evaluation. 10. movement of the micro-organism in the environment: 10.1. persistence and multiplication: 10.1.1. soil; 10.1.2. the water; 10.1.3 in the air; 10.2. mobility; 10.3. Summary and evaluation. 11. the impact of the micro-organisms on non-target organisms: 11.1. birds; 11.2. the aquatic organisms: 11.2.1. fish; 11.2.2. freshwater invertebrates; 11.2.3. algal growth; 11.2.4. plants other than algae; 11.3. bees; 11.4. arthropods other than bees; 11.5. earthworms; 11.6. the soil micro-organisms; 7.3. additional studies: 11.7.1. for terrestrial plants; 11.7.2. of mammals; 11.7.3. for other species and processes; 7.3. Summary and evaluation. 12. proposals and the reasons for active substances (micro-organism) classification in risk groups, in view of its ability to cause health problems, in accordance with the laws and regulations that govern the labour protection requirements when dealing with biological substances. Guidance on whether the products should be labelled with biohazard warning sign. 13. Summary and evaluation of information obtained by studying the micro-organism, including risk assessment, conclusions and recommendations provided. 14. prior to the application of any of the micro-organism, the inclusion of the active substance in the list or the list of parent prepare relevant data and available at called information in literature. Information related to the identification and characterisation of the micro-organism (also route of exposure), it is particularly important and form the basis for the assessment of potential effects on human health and the environment. 15. This provision 22 shall apply if the information about the specific type of micro-organisms is required. 16. the nature of the micro-organism at the strain level, if there is no information to suggest that the species according to its characteristics is known as sufficiently uniform, or if the applicant submitted other arguments in accordance with the provisions of point 22. 17. where the micro-organism has been genetically modified in accordance with the laws and regulations on genetically modified organisms in contained use and deliberate release into the environment and market, as well as monitoring genetically modified organisms shall provide procedures for data evaluation copy on the risk to the environment. 18. If you know that the effects of the biocidal products fully or partially affected by toxins or metabolites, or if the expected significant toxins or metabolites residues, submitted materials for toxins or metabolites in accordance with the provisions of annex 3, or (in some cases) of annex 5. "; 1.21. Annex 8 to be expressed as follows: "Annex 8 Cabinet of 15 April 2003, the Regulation No 184 technical report on biocides, if the biocidal active substance contained in the micro-organisms, fungi or has a virus 1. Application of a biocide. 2. Biocides and producer of micro-organisms. 3. the identity of the biocidal products: 3.1. trade name or proposed trade name and manufacturer's development code number assigned; 3.2. detailed information on the quantitative and qualitative composition; 3.3. physical state and nature; 3.4. function. 4. Biocides in the physical, chemical and technical characteristics: 4.1. organoleptic characteristics (colour and odour); 4.2. stability during storage and shelf life: 4.2.1. effects of light, temperature and humidity on technical characteristics of the biocidal products; 4.2.2. other factors affecting stability; 4.3. eksplozivitāt and the ability to become oxidised; 4.4. flash point and other indications of flammability or spontaneous ignition; 4.5. acidity, alkalinity and pH value; 4.6. viscosity and surface tension; 4.7. technical characteristics: 4.7.1. wetting; 4.7.2. foam stability; 4.7.3. suspensibility and suspension stability; 4.7.4. dry and wet sieving test; 4.7.5. particle size distribution (dustable and wettable powders, granules), dusty or content of fine particles (granules), attrition and friability between particles (granules); 4.7.6. Re-emulsifiability, the emulsifiability, emulsion stability; 4.7.7. flowability, pourability (skalojamīb) and dustiness; 4.8. chemical and biological compatibility with other products, including biocides, with which to allow or to register a particular use of biocides: 4.8.1. physical compatibility; 4.8.2. chemical compatibility; 4.8.3. biological compatibility; 4.9. Summary and evaluation. 5. the use of Biocides: 5.1. field of use envisaged; 5.2. mode of action; 5.3. details of intended use; 5.4. the use of dose; 5.5. content of micro-organism in material used (e.g. the use of the device or bait); 5.6. method of use; 5.7. number of times of use and time, duration of the exposure; 5.8. necessary waiting times or other precautions to avoid adverse effects on the environment and human and animal health; 5.9. proposed instructions for use; 5.10. category of users; 5.11. information on the possible emergence of resistance; 5.12. effects on the materials to be processed or products. 6. Further information on biocides: 6.1. packaging and compatibility of the preparation with proposed packaging materials; 6.2. use of equipment cleaning procedures; 6.3. re-entry periods, necessary waiting periods or other precautions to protect man, livestock and the environment; 6.4. recommended methods and precautions to be taken in handling the biocides, storage and transport of biocides, or action in the event of fire; 6.5. the measures in the event of an accident; 6.6. biocides and packaging cleaning or disposal procedures: 6.6.1. controlled incineration; 6.6.2. other methods; 6.7. the active micro-organism and other micro-organism in the biocides for the monitoring plan, which also includes the handling, transport and use. 7. analytical methods: 7.1. methods for the analysis of biocides; 7.2. the biocide residues and their determination methods. 8. information on the efficacy of the biocidal products. 9. the Biocidal effect on human health: 9.1. acute toxicity studies: 9.1.1 acute oral toxicity; 9.1.2. acute toxicity by inhalation; 9.1.3. the acute toxicity, exposure through the skin; 9.2. additional acute toxicity studies: 9.2.1. skin irritation; 9.2.2. eye irritation; 9.2.3. skin sensitisation; 9.3. details of exposure; 9.4. the available toxicological data on active substances; 9.5. additional studies on biocidal combinations; 9.6. Summary and evaluation. 10. the Biocide residues in or on treated materials, food and feed. 11. Biocidal products within the environment. 12. the Biocidal effect on non-target organisms: 12.1. birds; 12.2. the aquatic organisms; 12.3. bees; 12.4. arthropods other than bees; 12.5. earthworms; 12.6. soil organisms; 12.7. additional studies on additional species or higher tier studies (for example, on selected non-target organisms): 12.7.1. for terrestrial plants; 12.7.2. of mammals; 12.7.3. for other species and processes; 12.8. Summary and evaluation. 13. classification of Biocides, packaging and labelling in accordance with the provisions of chapter V: 13.1. justification for the classification and labelling of chemicals according to their characteristics, which is the composition of the biocidal products, including: 13.1.1. hazard symbol; 13.1.2. hazard explanation; 13.1.3. the nature of exposure to a substance; 13.1.4. safety requirements for designation; 13.2. the micro-biological hazard symbol and risk group in accordance with the laws and regulations governing labour protection requirements when dealing with biological substances; 13.3. proposals for packaging and labelling; 13.4. proposals on the safety data sheet (if necessary); 8.4. details of packaging (type, materials, size) packaging and compatibility of the biocidal products with packing material. 14. information on the evaluation and summary of the biocides, risk assessment also provides conclusions and recommendations. 15. prior to the application of biocides, which are designed to prepare the base of micro-organisms, of the available relevant data and references to information in literature. 16. paragraph 22 of these rules apply if the information about the specific type of biocidal products is required. 17. In order to minimise animal testing, information can be obtained from existing data sources, if an application shall be submitted to the Agency under this provision, paragraph 65. 18. when testing, reports detailed the material used and its impurities, according to the description of this paragraph 4 of the annex. If necessary, those provisions 4 and 5. the data referred to in annex of the toxicological or ecotoxicological concern important chemical constituents, particularly when components are potentially dangerous substances. 19. New biocides is permissible under the rules, extrapolation, annex 7, if assessed the potential impact of all components, especially on pathogenicity and infectivity. " 2. This provision subparagraph 1.20 and 1.21 shall enter into force by 1 January 2008.
Prime Minister a. Halloween Environment Minister r. vējonis