Cabinet of Ministers Regulations No. 184 in 2003 Riga, April 15 (pr. No 21, § 44) requirements for transactions with biocides are Issued according to the chemicals and chemical products, article 9 of law seventh part i. General questions 1. determines the requirements must be followed when operating with biocides, excluding transactions with the chemicals and chemical products, or other products and features, which is the same as biocides or similar, but that is: 1.1. medicines, pharmaceutical and other medical products;
1.2. the veterinary pharmaceutical products, including homeopathic and immunological products;
1.3. food additives;
1.4. animal feedingstuffs and feed additives;
1.5. plant protection products.
2. The active substance is a chemical or virus, fungi or other microorganisms used biocides for making and acting on harmful organisms.
3. the residues are substances that have a biocidal composition and left over from the use of biocidal products, including these substances in the degradation and metabolism products (metabolites) and products resulting from the reaction to them.
4. The harmful organism is an organism whose presence is unwanted or which has harmful effects on humans, animals or the environment to products that are produced or used, or to economic activity.
5. is the target harmful organism, which is intended to destroy or otherwise affect, by acting on it with the biocides. The target species is a pest species that is intended to destroy or otherwise affect, by acting on it with the biocides.
6. Composition of the joint is more characteristics of the biocidal composition, if relevant biocides have the same use, identical effectiveness against target organisms, active substance with the same characteristics and other components, impurities or additives that do not reduce the efficacy of the biocidal products and does not increase the risks of biocides to man or the environment (including the percentage reduction of the active substance in the biocidal, not of one or more of the active substances in biocidal content changes, as well as pigments, dyes and odor replacement with other similar substances that performs the same functions), and use the same user groups.
7. assay is a chemical that is used in most cases other than the destruction of harmful organisms or influencing, and not marketed as biocides, but which is mentioned in the list of basic substances, which can be used as a biocide (without adjuvant) or as biocidal active substance in, if AIDS is not potentially dangerous substances.
8. Potentially hazardous substance means a substance which is not the active substance, but is a dangerous chemical, hazardous chemical product or other substance, or the product has such properties that may cause adverse effect on humans, animals or the environment, and in the composition of the biocidal or creating a concentration to create such effects.
9. Low-risk biocides are biocidal that does not contain potentially hazardous substances and conditions for use without risk or pose a minimal risk to humans, animals and the environment, and where the active substance is listed by the European Community of low-risk biocidal product in the list of existing active substances (hereinafter referred to as a low-risk biocidal products list), if you take into account the conditions referred to in this list.
10. Biocidal products or active substances, including the import into the customs territory, selling or otherwise supply against payment or free of charge and storage after the sale or delivery, except for the disposal or transit operations the customs surveillance (trade) and production is allowed only if: 10.1. the existing active substance (trade launched before 14 May 2000) or (which contains one or more existing active substances) records , counting and registration or authorisation of biocidal products or active substances use (hereinafter authorisation) according to the provisions in chapters II, III and IV, with the requirements of the Latvian Environment Agency agreed deadlines. Registration or authorisation is not required, if the active substance and the biocidal composition is assay is not potentially hazardous substances;
10.2. explore new active substances (trade launched after 14 May 2000) or (which contains one or more new active substances) the effects on the environment and animal and human health, as well as a temporary registration, registration or permission received in accordance with these provisions in chapters II, III and IV. Temporary registration, registration or authorisation is not required, if the active substance and the biocidal composition is assay is not potentially hazardous substances;
10.3. with a new active substance (trade launched after 14 May 2000) or that contains a new active substance, conducted scientific experiments or studies or make new active substance or manufacture, the experimental scientific experiments, experimental production or research complies with the provisions of paragraphs 5 and 6.
11. The Latvian Environment Agency (hereinafter Agency): 11.1 recorded if biocides are low risk biocidal biocides;
11.2. use permit shall be issued, if the active substance is included in the European Community a biocidal product to be used for the manufacture of active substances (hereinafter referred to as a list of active substances), taking into account the relevant conditions referred to in the list for a particular biocidal products or active substance;
11.3. take the temporary registration of biocidal products where: 11.3.1. biocidal products and active substances not listed in the list of active substances to the list of basic or low-risk biocidal products list;
11.3.2. the active substance is listed in the list of the parent, but the biocidal products containing one or more potentially hazardous substances;
11.4. upon request, provide the necessary information on the low-risk biocidal products and active substances of the assay, as well as a list of those lists those conditions.
12. in carrying out scientific research, experiments or pilot production, performer: 12.1. shall draw up and maintain records showing: 12.1.1. biocidal products or active substances identity, classification and labelling;
12.1.2. purchased produced, imported, and used in biocidal products or active substances;
12.1.3. details of persons who receive or biocidal active substance (name, address, and phone number);
12.1.4. biocidal products group and type according to the rules of annex 1;
12.1.5. biocidal or provided for the use of the active substance in the field or industry, or a planned production of biocides, which uses the active substance;
12.1.6. additional conditions to be followed in carrying out the activity to the active substance or biocidal products;

12.2. the document and saves the results of the research on active substance of the biocidal or possible effects on human health, animals and the environment; 12.3. If the process is provided for research, the research submitted to the Agency before the commencement of this provision and 12.2 12.1. information referred to in (a);
12.4. the agencies of the State environment inspectorate or the national sanitary inspection request indicates that rule 12.1 and 12.2 of the information referred to in subparagraph;
12.5. comply with the precautionary principle and other environmental conditions, determining the active substance in the biocidal or permissible concentrations or the quantity of emissions in the environment, the working environment or discarded depending on the active substance in the biocidal or the degree of hazard.
13. If it is intended to conduct a scientific experiment or research with new biocides or active substance, or one of those active substances in biocidal or experimental production, which causes or is likely to cause the biocidal products or active substances spread in the environment, the performer shall submit to the Agency an application describing the proposed research, experiments or production and the use of Agency issued the permit, certificate of registration or provisional registration certificate the conditions referred to in the experimental production.
14. The Agency provides a centre of toxicology poisoning information center, with all of the information available about registered, registered or authorised biocidal products and active substances. The Centre of toxicology poisoning information center uses this information, providing information about the poisoning symptoms, prevention, first aid, and emergency treatment measures in cases where other poisoning accident and emergency or in the event of an emergency.
15. Trade in biocides or active substances classified as very toxic, toxic, category 1 or 2 carcinogen, category 1 or 2 mutagen, or as a category 1 or 2. reproductive toxic, is allowed only for professional use.
16. Transport of biocides or active substances, they packed and labelled in accordance with the laws and regulations governing the transport of dangerous goods, classification, packaging and labelling.
17. the performer shall take or biocidal active substances keep records showing the following information: 17.1. the trade name of the biocidal, with which it will be sold in Latvia;
17.2. the names of the active substances: 17.2.1. name, specified by the Minister of the environment approved the list of dangerous chemical substances (hereinafter list of dangerous chemical substances) or, if the substance is not listed in the list of dangerous chemicals, the international theoretical and practical chemistry associations (IUPAC) nomenclature, common name and registration number of the Chemical Abstracts Service registry Journal of Chemistry Chemical Abstracts (CAS number), if the active substance is a chemical substance;
17.2.2. scientific and common name, as well as the taxonomic affiliation, if the active substance is a chemical substance;
17.3. types of actions taken and indicating the quantity produced, imported, sold, stored, or disposed of biocides used in quantity for each facility, site or territory;
17.4. the safety data sheet.
18. This provision requirements controls: 18.1. State sanitary inspection, trade and professional use disinfection, pest control and pest extermination;
18.2. the State Labour Inspectorate for labour protection requirements by carrying out activities with biocides or active ingredients;
18.3. The State environment inspectorate, in other cases.
 
II. Submission of application 19. Biocidal products or active substances the manufacturer or importer: 19.1. to register for biocidal products or active substances, classifies the biocides or active substance and shall submit to the Agency: 19.1.1 accounting or inventory data;
19.1.2. information certifying that the transaction with biocides or active substance is performed before 14 May 2000;
19.1.3. in accordance with the provisions of annex 2 (written and electronic);
19.2. to register for biocidal products or active substances or for usage permission determines the biocides or active substance characteristics and assesses their effects on human health and the environment the conditions for use, as well as classified the biocides or active substance and shall submit to the Agency an application in accordance with the provisions of annex 2 (written and electronic).
20. Application of biocides or active substance submitted to: 20.1. biocidal products or active substances manufacturer, biocides or active substance produced in the territory of the country;
20.2. importing, or other performer, which is authorized by the manufacturer to sign up or biocidal active substances the placing of the market (hereinafter referred to as the manufacturer's authorised representative) if biocides or active substance produced outside the national territory.
21. the application shall be accompanied by the following information: 21.1. If the active substance is listed in the list of active substances or biocidal products low-risk list: 21.1.1. technical report (annex 3 to these rules) on the active substance if the active substance is a chemical substance;
21.1.2. a technical report (in accordance with annex 4 to these rules) for biocides, if contained in biocidal active substance is a chemical substance;
21.1.3. technical report (in accordance with annex 5 of these rules) on the active substance if the active substance is a chemical, but the applicant has to carry out additional studies in accordance with the provisions of subparagraph; 29.3.
21.1.4. technical report (annex 6 of these rules) for biocides, if contained in biocidal active substance is a chemical, but the applicant has to carry out additional studies in accordance with the provisions of subparagraph; 29.3.
21.1.5. technical report (according annex 7 of these rules) on the active substance if the active substance is fungi, micro-organisms or viruses;
21.1.6. technical report (pursuant to annex 8 of these rules) for biocides, if the biocidal active substance contained in the micro-organisms are fungi or viruses;
21.2. the information required to identify biocides or active substance, and a technical report (in accordance with Annex 9 of these rules), if the active substance or biocidal products not mentioned in the list of active substances, low-risk biocidal products list or list;
21.3. the justification for the research methods, analyses, tests, experiments and research (hereinafter research) description, research methods used or a bibliographical reference to the description of the research methods used;
21.4. proposals and their justification: classification of biocides 21.4.1. required packaging and labelling;
21.4.2. the safety data sheet;

21.5. packaging, labels and instructions, samples, models or drafts of (requested by the Agency);
21.6. the information necessary to evaluate the risks to the environment and human health or life, or preliminary risk assessment according to annex 10 of these regulations;
21.7. If the biocidal products or active substances produced outside the national territory, the statement of the manufacturer that the applicant is the manufacturer's authorized representative.
22. The applicant shall submit to the Agency a reasonable explanation if this provision of the information referred to in paragraph 21, technically it is not possible to obtain or if the information is not required, because it does not describe the characteristics of biocides, transactions with this novel or its effects on the environment or human health.
23. where a biocidal active substance and referred to a low-risk biocidal products list, additional information or studies on biocides (annex 6) are required.
24. After consulting the Agency, the application does not need to specify information which is not necessary, in the light of the information known about a biocide (biocidal a frame-formulation, characteristics of biocides or intended use).
25. The applicant technical report prepared, taking account of available scientific and technical information, and complement the technical report, if there are new scientific or technical information or new data on the active substance or biocidal properties or effects on the environment or human health.
26. in order to avoid duplication of information, the applicant may submit to the Agency in a Member State of the European Union (hereinafter referred to as Member States) the opinion of the competent institution and the institution of a copy of the application submitted to the officially approved use of first issued a copy of the permit, as well as translations of these documents in the language of the country if biocides or active substance is produced or are logged in one of the Member States.
27. The applicant justified and in the application or additional information indicates the information that he considered the limited availability information: 27.1. biocidal active substances or temporary registration, registration or authorisation of use;
27.2. constantly.
28. If the manufacturer authorized representative is not confided to the limited availability of information, the manufacturer's authorised representative shall submit with his application a written agency producer's assurance that the manufacturer upon request by the Agency to immediately provide the Agency with the required restricted access information.
29. The applicant submitted additional information in the Agency if: 29.1. the information provided in the application or the previous risk assessment does not meet the requirements of this regulation;
29.2. the information provided does not provide risk assessment or the decision about permission, certificate of registration or provisional registration certificate issuance activities with biocides or active substance;
29.3. the applicant, in accordance with the Agency's reasonable request to take additional research to determine the effects of the active substance or substances potentially dangerous effects on the environment or human health, or research that does not require an additional assessment of risk;
29.4. the need to change the permissions, the registration certificate or temporary certificate of registration in these conditions;
29.5. the implementation of these provisions of paragraph 45 of these developments (before the change);
18.4. the applicant's evidence that the proposed research will not have the expected results or that are suitable for alternative research.
30. the Agency shall have the right not to require the applicant to conduct separate studies allow to replace the proposed research with other research, if the applicant submits a reasoned that the envisaged research will not have the expected results or that alternative research is appropriate to a particular biocidal active substances or characteristics or effects on humans or the environment.
 
III. evaluation of Application 31. Agency (if necessary by experts): 19.3. assess whether the application is drawn up according to the requirements of these provisions, checks the completeness of the data submitted and the scientific merits and assess whether the information submitted shall allow the assessment of the active substance or biocidal effects on human health and the environment, taking into account the provisions laid down in annex 10 risk assessment contents and efficacy criteria, as well as to the target organism;
31.2. checks whether the active substance or biocidal products is mentioned in the list of active substances in the low-risk biocidal products list, or the list of parent;
31.3. check that the Environment Ministers approved used laboratory chemicals and chemical products, physical, chemical, toxicological or ecotoxicological methods for the determination of the characteristics or other standardised methods (the methods approved or standardized) and assess whether the most appropriate analysis, used for experimentation and research methods. If trade in biocidal products or active substances commenced before 14 May 2000, also take into account the results of the studies carried out by other methods;
19.5. checks whether the active substance or biocidal classification meets the identified hazardous characteristics;
31.5. If necessary and possible, the frame-formulation and communicate it to the applicant;
19.6. assess whether the applicant has proposed the all necessary measures to minimize or biocidal active substances created unwanted effects or adverse effects on the environment and human health (restrictions on use);
19.7. checks on the label or accompanying the biocides instruction provides the information you need for using biocides, minimize the risks and effects on human health, animals and the environment, except for the effects on target organism;
19.8. According to this provision, paragraph 34 and annex 10 to assess the risk to the environment and animal and human health or life, as well as the previous risk assessment submitted by the applicant;
19.8. checks whether the applicant intends or biocidal active substances the dangerous characteristics of appropriate packaging to prevent biocidal active substance or get out of the packaging, thus endangering human life or health, or the environment; 31.10. examine whether the applicant has designated the environment and people safe or biocidal active substance or of the waste containing the recovery of packaging waste, recycling or disposal;
31.11. used for preparation of an opinion of the competent institution of a Member State an opinion or permission and use this application to the institution of a technical report or summary, if the following documents are attached to the application;

31.12. If necessary, require the applicant for additional information necessary to evaluate the application and risk to human health or the environment;
31.13. prepares proposals for biocidal products or active substances or potentially hazardous substances for further consideration;
31.14. determine the requirements, conditions or restrictions of biocidal products or active substances;
31.15. prepares proposals for additional measures necessary to reduce or biocidal active substances created unwanted effects or adverse effects on human health and life, animals or the environment; 31.16. shall make recommendations to the authorities for biocidal control and risk reduction, including the active substance in the biocidal or marketing or use restrictions, precautions, emergency or avārijgatavīb measures, as well as the types and methods as active biocidal or of rendering the substance harmless.
32. the Agency shall forward to the State Agency "public health agency" (hereinafter referred to as the public health agency) a copy of the application, additional information or information submitted to extend the authorization of the use of a certificate of registration or provisional registration certificate or examine, review and change the permissions or the relevant conditions referred to in the certificate. The public health agency to assess whether the biocidal active substances the resulting risks to human health and to give an opinion. The opinion provides the following time period: 32.1.30 days, if the application is submitted or biocidal active substances for registration;
32.2. the 30 days, if the application for authorization and the use of biocides (for which the application is filed) is made on the basis of an agreed composition, and if the biocidal properties and effects on human health and the environment have been assessed in advance of known and with the approved methods or standardised;
32.3. If, within 60 days of the application for authorisation of the use of the active substance or biocidal or temporary registration.
33. in the opinion of the public health agency indicates a biocide used in the risk assessment criteria (according to annex 10 of these rules) and the methods for human health risk assessment results, valid conclusions, as well as proposals on the necessary accompanying measures and recommendations to the Agency for a decision.
34. The risk assessment, the Agency and the public health agency in accordance with these rules and deadlines specific competences take into account specified in the application or in addition to the information submitted, and all the measures necessary to protect man, animals and the environment of biocidal products intended use and expected at the time of the adverse event, poisoning or accidents as well: assessing study used 34.1. methods of compliance, efficiency and effectiveness of biocidal active substances or potentially hazardous substances for detection of hazardous characteristics to determine the adverse effects or the effects on human health and the environment, which the biocidal active substance contained in or potentially dangerous substance causes or may cause its intrinsic hazardous properties (hazard identification);
21.3. the active substance or substances potentially hazardous effects on human health and the environment and its consequences, depending on the biocidal active substances or potentially dangerous dose or concentration of the substance, if possible, determine the severity or frequency of the effects and each contained in biocidal active substances and potentially hazardous substances most dose, or concentration which does not create unwanted effects or adverse effects (hereinafter referred to as the no-observed-adverse-effect level) or concentration of which less concentration does not give rise to any exposure and effects (not effective concentration);
3. determine the active substance in the biocidal or possible emissions and biocidal active substances or movement, movement speed, transformation or degradation of the environment and assess the concentration or dose and the manner in which the active substances of biocidal, or potentially dangerous substance or may interact with groups of people — manufacturers, professional users, non-professional users and citizens (people who are not users of the biocides, but biocides or active substance may act indirectly with the environment), as well as the environment (hereinafter referred to as the exposure assessment);
21.4. down the active substances of biocidal or actual or predicted exposure to be created in the course of the potential adverse effects or undesirable effects of the prevalence, incidence and severity of (risk profile). If necessary, determine the risk characteristics, calculation, numerical evaluation of risk. The risks of the biocidal products is determined by evaluating all contained in biocidal active substances or potential risks of hazardous substances, separately for each substance and a common risk. Risk assessment and the risk characterisation shall be carried out for the active substance or biocidal use of real events and development variant that, performing or biocidal active substances or material treated with it production, storage, transport, use, recycling, destruction or disposal may lead to the most serious consequences for the environment and people;
34.5. determine whether the applicant's proposed risk reduction measures are appropriate and useful to the biocidal products or active substances for the hazards and the intended use, or they effectively prevent or reduce the risk to humans and the environment;
21.5. make recommendations for reducing the risk of the applicant, other performers or biocidal products or active substances;
21.6. prepare recommendations on amendments or biocidal active substances classification, labelling or safety data sheet according to the rules and requirements of the laws — especially when amended or biocidal active substances classification, labelling or safety data sheet necessary to protect employees and other users.
 
IV. Biocidal products or active substances or the use of the registration permit and the certificate of registration or permit to use the extension or cancellation 35. Agency reaches a decision on the biocidal active substances or temporary registration, registration, or permit the use of, or the refusal to register or biocidal active substances or to issue permissions for, take note: 21.8. results of risk assessment, in particular the relationship between exposure to the active substance or biocidal products and the effects it produces or effects;

35.2. undesirable effects and effects on the environment type, severity, and frequency;
35.3. or have a low-risk biocidal products;
35.4. the applicable risk control and management;
22.1. the use of biocides;
35.6. the biocidal effectiveness on the target organism;
22.2. the physical properties of the biocidal products;
22.2. the need for the use of biocidal products and the benefits of the use of biocides;
22.3. research conducted by the applicant of the results, assumptions, uncertainties and interpretations;
35.10. possible effects on citizens and user groups (professional users, non-professional users and citizens) which is or may be exposed to direct or indirect or biocidal active substance;
35.11. the safety factor determined in accordance with the provisions of annex 10;
35.12. environment that is or can be exposed to biocides or exposure of the active substance or its consequences;
35.13. If the biocide is within a frame-formulation, the biocidal properties of frame-risk and exposure assessment results;
69.35. other biocides or active substance with the same or similar effects risk assessment results.
36. the Agency shall, taking into account the conditions referred to in this chapter, shall adopt one of the following decisions (giving reasons for each decision or biocidal active substance and for each area of use of biocidal products, for which the application is made): 36.1. issue authorisation (annex 11), biocides or active substance registration certificate (annex 12) or biocidal active substances or a temporary registration certificate (annex 13) indicate, where appropriate, specific conditions, requirements or restrictions;
36.2. refusal to provide written register of biocidal products or active substances or to issue permissions, specifying one of the following grounds: 36.2.1. biocidal products or active substances may cause severe consequences or negative effects on human health or the environment (hereinafter referred to as the unacceptable risk);
36.2.2. a decision to require additional information on biocides or active substance or for the intended application or activities with biocides or active substance.
37. The biocidal active substances or a certificate of registration or provisional registration certificate, or authorization of use shall only be issued when: 37.1. biocidal products or active substances of physical and chemical properties have been determined by a validated or standardised methods and match the intended use, as well as storage and transport requirements;
37.2. it is possible to detect the biocidal active substances all toxicological or ecotoxicological hazardous impurities, adjuvants and residue properties, movement, speed of movement, transformation or degradation in the environment and taking into account the exposure assessment, the quantity and exposure in accordance with requirements of this regulation;
37.3. the evaluation has been carried out and technical report drawn up in the light of available scientific and technical information and the biocidal products or active substances and of the consequences for the conditions of disposal;
23.2. the risk assessment carried out in accordance with this provision, paragraph 34 and annex 10, shows that the biocides: 37.4.1. effective enough on the target organism;
37.4.2. mērķorganismo will not cause unwanted effects (including unwanted resistance or the associated resistance) or unnecessary suffering and pain to animals, especially vertebrates;
37.4.3. biocidal active substance or residues do not cause unacceptable risks or direct or indirect (through drinking water, air pollution work, food or animal feed) the adverse effects on human health, animals or surface or ground water;
37.4.4. a biocidal active substance or residues do not cause unacceptable risks or adverse effects on the environment (also on non-target organisms). The evaluation shall take into account the stability of biocides or transformation and movement in the environment, in particular resulting in surface or ground water contamination.
38. the Agency does not issue permission to use or refuse the registration or provisional registration (with the exception of those provisions referred to in paragraph 40 cases) where: 38.1. the application or additional information does not meet the requirements of this regulation;
38.2. the risk assessment (in accordance with the rules referred to in annex 10 of the criteria and principles), taking into account the intended use and the actual events scenario that can lead to the most serious consequences for the environment and people, confirms that the active substance or biocidal product or residue degradation causes an unacceptable risk of direct or indirect adverse effects on human health, animals or the environment (including with respect to surface or ground waters , sediment, soil, air, or organisms that are not the target);
23.8. providing risk reduction measures, it is not possible to reduce exposure to the active substance or biocidal generated effects or consequences to the biocides or active substance does not cause significant effects on human health or the environment; 23.9. biocides designed as a remedy for vertebrates, causing no death at the slump in the animal unconscious death occurs immediately, or it will not reduce the function of life gradually, without obvious signs of distress and repellent effect of products do not cause without unnecessary suffering and pain for the target (vertebrate);
38.5. the use of biocidal products in accordance with the conditions specified on the label, and under the authorisation or registration conditions referred to in the certificate, not the effect on the target organism;
24.0. biocidal products classified as very toxic, toxic, category 1 or 2 carcinogen, 1 or 2 or mutagenic category 1 or category 2 reproductive toxic, is intended for non-professional users, and the only possible method to reduce the harmful effects of biocides or risk to users, is the personal protection.
39. the Agency shall have the right not to grant permission to use or refuse registration or temporary registration, or not to renew the temporary registration certificate, a certificate of registration or permit of use if: 24.3. biocidal products registered in another country as a low-risk biocidal products, according to the scientific information, or in connection with the local conditions of risk. In this case, the Agency shall notify its refusal to the competent authority of the country, which registered biocides as a low-risk biocides and justify why the biocide risk;
24.4. has become known that the target information is unwanted or resistance, tolerance to biocides.

40. If the biocidal use required in cases of emergency, epidemics or other adverse event stop and limit the effects or, but the effects on the environment of biocidal products, animal and human health are not assessed or does not meet the requirements of this regulation, the Agency shall, for a period not exceeding 120 days, to allow the use of biocides can do trade in biocides, limiting its field of application and the necessary control measures.
41. In preparing the conditions to specify the active substance in the biocidal or temporary registration certificate, registration certificate or authorization of use, the Agency shall assess the measures required to reduce or biocidal active substances the adverse effects and unwanted consequences for each group of people or ecosystems, taking into account the fact that some of the measures which limit the adverse effects on one group of people or ecosystems, may increase the risk of another group of people or ecosystems. Based on the assessment, the active substance in the biocidal or temporary registration certificate, registration certificate or authorization of use shall indicate: 25.5. any risk reduction measures to all groups of people (manufacturers, professional users, non-professional users and citizens), the environment and all its ecosystems, the risk would be minimal;
41.2. what additional research, information or risk reduction measures are required for each unwanted effects or consequences to any ecosystem or a group of people, as well as a justification for such research, information or action is necessary.
42. If the Agency decides to register for biocidal products or active substances or allow its use, it shall issue a temporary registration: 42.1. the licence, for a period not exceeding three years, which may be extended for not more than a year, if the production of biocides or trade in any of the Member States of the European Union launched after 14 May 2000, not later than 120 days after the day on which the applicant has submitted all the information necessary to evaluate the application and assess the risks to human health and the environment;
26.2. a certificate of registration, for a period not exceeding 10 years, not later than 60 days after the day on which the applicant has submitted all information required to evaluate the application and assess the risks to human health and the environment;
26.3. usage rights for a period not exceeding 10 years, not later than 120 days after the day on which the applicant has submitted all information required to evaluate the application and assess the risks to human health and the environment;
26.3. the registration certificate or authorization of use for a period not exceeding 10 years, not later than 60 days after the day on which the applicant has submitted all the necessary information for the assessment, if the biocide (applied for) is made on the basis of an agreed composition, and if the biocidal properties and effects on human health and the environment have been assessed in advance of known and approved or standardised methods.
43. the Agency's temporary registration certificate, registration certificate or authorization of use in accordance with these rules 11, 12 and 13 of the annex indicates or biocidal active substances of risk characteristics (including an assessment of the potential adverse effects or undesirable effects of gravity, the prevalence or frequency) and the applicant's proposed risk reduction measures.
44. Expenses related to the services of experts for the evaluation of the application and risk to human health or the environment, shall be borne by the applicant for evaluation.
45. each authorized, registered or provisionally registered or biocidal active substances the applicant shall inform the Agency in writing: 45.1. on the new additional information about biocidal products or active substances effects on people or the environment, which was not known, and the application of the precautionary measures to be taken to reduce the adverse effects of the newfound;
45.2. If the biocidal products or active substances, label or accompanying leaflet or advertisement of the active substance is such biocidal active substances or uses that are not mentioned in the temporary registration certificate, registration certificate or authorization of use;
45.3. the changes in raw materials, active substance or manufacture;
28.2. where the production of biocides are planning to use the active substance, which is specified by the manufacturer in the application or in the technical report;
28.3. for changes in the composition of the biocidal products;
28.3. for the development of resistance;
28.4. the changes in the package;
28.5. about other changes that may adversely affect the environment and human health or safety or may affect the temporary registration certificate, registration certificate or authorization of use of extension or relevant certificate, or authorization of use of the conditions referred to in the Exchange.
46. the Agency shall review the permissions for, registration or provisional registration if: 46.1. in accordance with the provisions of paragraph 45 of the biocidal products or active substances the applicant shall provide the relevant information;
46.2. biocidal products or active substances the temporary registration certificate, registration certificate or permit expired;
46.3. on the basis of scientific and technical information, as well as to protect human health and the environment, it is necessary to change the permissions, the registration certificate or temporary certificate of registration in these conditions (also with regard to the active substance or biocidal use or dose);
46.4. for biocidal products or active substances, label or accompanying leaflet or advertisement of the active substance contains such biocidal active substances or uses that are not mentioned in the temporary registration certificate, registration certificate or authorization of use;
46.5. the applicant submits a written request to change permissions, the registration certificate or temporary certificate of registration in these conditions, specifying: 46.5.1. reasonable reasons why you need to change these conditions;
46.5.2. assessment of the planned changes, indicating that it does not increase the risk to human health or the environment;
46.5.3. is there a need for amendments to the list of active substances to the list of basic or low-risk biocidal products list. If such amendments are required, the applicant in accordance with the provisions of Chapter VII shall be made more active substance evaluation and prepare documentation;

46.6. following the amendment of the list of active substances to the list of basic or low-risk biocidal products in the list is the need to change the permissions, the registration certificate or temporary certificate of registration in these conditions;
29.0. need to change the permissions, the registration certificate or temporary certificate of registration in these conditions for other reasons (for example, if the permissions, the certificate of registration or provisional registration certificate does not expire, but there is information that does not comply with the requirements of this regulation or usage rights, registration certificate or temporary certificate of registration in those conditions).
47. Information submitted to review and extend or change the permissions on the certificate of registration or provisional registration certificate in these conditions, the Agency and the public health agency assessed in chapter III of these rules.
48. the Agency shall, on the basis of the information submitted by the applicant and an assessment carried out: 29.9. extended permission, certificate of registration or provisional registration certificate validity period or change the permissions on the certificate of registration or provisional registration certificate, if these conditions are met in these rules the conditions referred to in paragraph 37;
48.2. change permissions, the certificate of registration or provisional registration certificate and authorization conditions referred to the active substance or biocidal uses, which were not mentioned in the temporary registration certificate, registration certificate or authorization of use, but are mentioned in the list of active substances;
48.3. If these provisions are complied with the conditions referred to in paragraph 38:48.3.1. not extended permission, certificate of registration or provisional registration certificate validity period;
48.3.2. stopping or biocidal active substances registration, provisional registration or authorisation, if the authorisation of the use of the certificate of registration or provisional registration certificate does not expire;
48.3.3. revoke the biocidal active substances or a temporary registration certificate, registration certificate or authorization of use, if that rule 48.3.1.,.,., or 50.1.3 50.1.1 50.1.2. the conditions referred to in (a);
30.1. If this rule 39.1. the conditions referred to in point: 48.4.1. extension of the active substance in the biocidal or permission, certificate of registration or provisional registration certificate validity period, put additional conditions on risk reduction measures, including restrictions on certain types of use (especially in connection with the use of local conditions);
48.4.2. do not use biocides in the renewed licence, certificate of registration or provisional registration certificate validity period, if the active substance or biocidal cause unacceptable risks to human or animal health or the environment;
30.1. without extending the provisional authorisations of biocidal products, the certificate of registration or provisional registration certificate validity period, if the occurrence of an undesirable tolerance or resistance to biocides.
49. If necessary, the Agency extended permission, certificate of registration or provisional registration certificate validity period to the minimum possible time required to: the applicant complete the new 30.5. the application or additional information;
30.6. the Agency shall evaluate the application or additional information and prepare the permissions, the certificate of registration or provisional registration certificate amendment of these conditions, use permits, certificate of registration or provisional registration certificate validity of the extension or refusal to extend the authorization of use of the certificate of registration or provisional registration certificate validity period;
30.6. the applicant will develop and execute a plan for biocidal products or active substances (intended to revoke the temporary registration certificate, registration certificate or authorization of use) use, disposal, destruction or other disposal of existing stocks. The applicant in developing and executing the plan, follow the usage rights, registration certificate or temporary certificate of registration in these conditions and grounds for revocation, the rules and regulations governing waste management, as well as hazardous chemical substances and hazardous chemical product use and trade restrictions and prohibitions.
50. the Agency rescinds: permission to use, 50.1. a certificate of registration or provisional registration certificate if: 50.1.1. it has been found that the use of the authorization, the certificate of registration or provisional registration certificate was granted based on false or misleading information in the application or additional information;
50.1.2. these provisions are not complied with and paragraph 42 37 these conditions or usage rights, registration certificate or temporary certificate of registration in those conditions;
50.1.3. biocidal products or active substances cause unacceptable risks to human health, animals or the environment;
50.1.4. the applicant submits a written request to revoke the authorisation or temporary registration certificate, stating the reasons therefor;
50.2. permission to use, if the active substance is removed from the list of active substances;
50.3. a certificate of registration, if the active substance is removed from the low-risk biocidal products list.
50.4. temporary registration certificate, registration certificate or authorization of use of biocidal products for general use non-professional users, if this provision is 24.0. the conditions referred to in subparagraph and biocide cause unacceptable risks to human health.
51. If the Agency has information that biocidal products or active substances can cause unacceptable risks or adverse effects to human health or the environment, the Agency shall take a decision on the need for additional information or to continue the risk assessment. The Agency shall have the right to suspend the licence of use, registration or temporary registration, or limit or biocidal active substances or the use of trade to the time required for additional information.

52. the Agency two weeks before a decision on refusal of registration of biocidal products or active substances or for temporary registration certificate, registration certificate or permit or the extension of its validity, as well as before the temporary registration certificate, registration certificate or authorization of use or withdrawal of suspension of the applicant gives an opportunity to provide clarification or additional information.
53. the Agency, stating the reasons, in writing, advise the applicant that the use permit, certificate of registration or provisional registration certificate will be issued or not will not be extended within the period of validity or the temporary registration certificate, registration certificate or authorization of use will be stopped, or that the licence or permit will be cancelled.
54. the Agency shall establish and maintain a database on the applied biocides and active substances. The database shall contain the following information: 54.1. details of the applicant;
54.2. the date of filing the application;
54.3. biocidal products and active substances;
54.4. the information on the application or additional information, compliance with the requirements of this regulation and the decision of the Agency in accordance with the provisions of paragraph 35;
54.5. biocidal products or active substances the temporary registration certificate, registration certificate or authorization number, date of issue and date of expiry;
54.6. biocidal products or active substances in the experimental production of the temporary registration certificate, registration certificate or authorization number, date of issue and period of validity, if these rules are met the conditions referred to in paragraph 13;
54.7. biocidal products and active substances classification and labelling.
55. applications for biocidal products or active substances, temporary registration certificates, registration certificates and authorizations of use for 10 years.
56. the Agency shall, on the basis of the temporary registration certificate, registration certificate or authorization of use of said conditions, draw up and submit to the state sanitary inspection, the State environment inspectorate, State Labour Inspectorate, State fire and rescue service, regional environmental authorities and the environmental impact assessment State Office (hereinafter the Office), as well as, where appropriate, other public authorities information and recommendations on the control and reduction of risks, including recommendations for biocides or active substances or the use of trade restrictions precaution, emergency or emergency measures, as well as the types and methods as biocides or active of rendering the substance harmless.
57. information on biocidal products or active substances with hazardous properties, the effects on human health or the environment, safety, precautionary and protection measures and emergency measures to be taken if the poisoning took place, as well as on the ways and methods of active biocidal or of rendering the substance harmless, not limited access information.
58. the biocidal active substances or a temporary registration certificate, registration certificate or authorization of use of restricted access information (in addition to the provisions referred to in paragraph 57 of the conditions) is not considered to be the following: 58.1. name and address of the applicant;
58.2. biocidal products manufacturer's name and address;
58.3. the active substance name and address of the manufacturer;
58.4. biocidal products and active substance names, content of active substances in biocidal products;
58.5. hazardous chemicals list contained in biocidal products of dangerous chemical names (especially if the presence of the substance concerned in the biocides may affect the classification of biocides);
58.6. biocidal active substance and physical and chemical properties;
58.7. types and methods as active biocidal and of rendering the substance harmless;
58.8. test and study results summary (conclusion), taken to a certain biocidal products or active substances on the occurrence of the efficacy, ability to create resistance and effect on humans, animals and the environment, fire protection, explosion safety 58.9., job security and other security or precautionary measures, techniques or best practices that should be followed to reduce the risk by taking actions with a biocide;
58.10. the safety data sheet;
58.11. biocidal products or active substances with hazardous properties and effects on human health or the environment, detection methods and the methods by which you can determine or biocidal active substance in the body and environment (or active biocidal substance emissions or emergency discharges);
58.12. conditions of waste biocides and packaging waste or recycling;
58.13. emergency measures to be taken if the poisoning took place biocidal active substances, or fire, do not place intended or biocidal active substance leaks or other adverse event or accident.
59. the Agency and the public health agency's employees have the right to obtain information on the limited access the studies carried out by the applicant, or get information on the active substance or biocidal and refer to their opinion or biocidal active substances or a temporary registration certificate, registration certificate or authorization of use.
60. national regulatory authorities shall ensure that the information on the limited access of biocidal products or active substances is not available and will not be disclosed (except for those rules and regulations governing the confidentiality of the information, in certain cases).
61. the Agency the Agency's website on the internet and the biocidal active substances for which a temporary registration certificate issued, the certificate of registration and usage permissions, as well as provide the necessary information to the public.
62. If the applicant believes that the information in the application or in addition to the information provided referred to as restricted access information, no longer limited by the availability of information, he shall notify the Agency in writing.
63. the Agency shall have the right to use the applicant's limited access information provided by the applicant for the other applications and preparing a temporary registration certificate, registration certificate or authorization of use only if: the applicant has previous 39.2. written authorization that may be used in an application or additional information about biocidal products or active substances;
39.3. biocidal products or active substances have been trading before 14 May 2000: information may be used by 14 May 2010;

63.3. active substance that have not been trading before 14 May 2000, is mentioned in the list of active substances or low-risk biocidal products list for at least 15 years;
63.4. for biocidal products containing the active substance was not on the trade before 14 May 2000 or 14 May 2000, but at least 10 years are registered or authorised in a Member State, may use only the information on biocides;
63.5. have passed this rule 39.3. and 63.3. the time limits referred to and at least five years after the first submission of the additional information on biocides or active substance — may use this additional information.
64. in order to prevent the physical and chemical properties of the test or the toxicological or ecotoxicological research duplication, next or biocidal active substances the applicant may rely on the test or the results of the studies that the Agency of the first applicant if: 64.1. next the applicant can prove that: 64.1.1. log on the active substance is identical if the active substance applied (by assessing the degree of purity and nature of impurities) or logged is similar to a biocidal products (biocidal products containing the same active and potentially hazardous substances) registered or allowed to biocidal products;
64.1.2. There is no need to make analog studies or tests;
64.2. the first applicant has consented in writing that is used in the submitted studies.
65. in order to eliminate analog experiments with animals (particularly vertebrate animals): 65.1. the applicant for at least two months before the biocidal products or active substances shall submit to the Agency an application in the application to see if it is registered or authorised active substance identical or similar to the biocides. The application of these provisions indicate the 65.1.1. or 65.1.2. information referred to in point and 65.1.3. information referred to in: 65.1.1. piesakām active substance name, molecular formula, structural formula and news about the quantity of the active substance which is intended to produce or import, and for what types of biocidal active substances concerned can be used;
65.1.2. piesakām biocidal composition of name, biocides, including biocidal active substance in and potentially dangerous substance names, molecular formula, structural formula, and news about the quantity of biocidal products intended to be manufactured or imported;
65.1.3. verification that the applicant intends to make an application and he is already prepared other necessary information in the application;
65.2. the week the Agency shall inform the applicant of the earlier applicant, with the name and address, as well as inform in writing the applicant of the earlier applicant, specifying its name and address;
65.3. where possible, the applicant and the previous applicant shall cooperate and provide each other with information in order to prevent an analog experiment with animals (particularly vertebrate animals).
66. If the applicant is not the applicant and previous agreed on cooperation to prevent analogue experiments with animals, the Agency is entitled to request for the exchange of information, specifying the conditions and the procedures to be followed in carrying out the information exchange.
 
V. requirements for the labelling of biocidal products, packaging, safety data sheet, for marketing and advertising of authorised trade 67. with biocides or active ingredients that are in the package and meet the following conditions: 67.1. packaging is resistant to the manufacturer for use and storage conditions;
67.2. packaging material will not form chemical compounds by packed biocides or active substance and not subject to it;
67.3. packaging design and materials is that during transport and storage, as well as after it closed there loss of contents;
41.9. marked on the packaging in accordance with the provisions of chapter V;
67.5. biocides or active substances which can hold for food, drink or feedingstuff substances shall be packed so as to avoid or minimise the chance of these biocides or active substances to mix with food, as well as add the ingredients to discourage their use for purposes not envisaged if biocides are intended for General (non-professional) use;
67.6. biocidal products or active substances prohibited to be stored with food or animal feed. Retail sites or biocides or active substance placed at least 1.5 m height (except packaging which can not be opened children).
68. Trade in biocidal products or active substances is prohibited if: 68.1. a biocidal active substance is not marked and the biocidal products or active substances have not been added to the package instructions or on the label or packaging is not an indication of biocides or active substance-containing waste and the safe management of packaging waste or recycling according to this provision and waste management laws and regulatory requirements.
68.2. biocidal products or active substances labelling or packaging does not comply with the authorization of the use, or the temporary registration certificate as specified in the registration certificate.
69. An active substance that is a chemical, and biocides, which is a chemical or chemical product or which contain chemicals or chemical products, classified, labelled and packaged in accordance with the laws and regulations governing chemical and chemical product classification, labelling and packaging.
70. Biocidal products or active substances: 70.1. used according to its label or in the accompanying instructions in the instructions, taking all the precautions necessary for human safety and health and environmental protection;
70.2. using the minimum required amount with appropriate techniques and in combination with other methods, intended to destroy, deter and make harmless harmful organisms, prevent exposure or otherwise affect them;
70.3. using the work, comply with the laws and regulations governing the protection of health;
70.4. it is prohibited to use professional users, if this is not available or biocidal active substance safety data sheet in accordance with the provisions of chapter V.
71. the biocides or active substances include: 71.1. biocidal products or active substances and trade name of the biocidal each existing active substances of biocidal identity and concentration, expressed in the international system of measurement units;

71.2. usage permission, certificate of registration or provisional registration certificate number. While the use of the permit not issued, the certificate of registration or provisional registration certificate, existing active substance (trade launched before 14 May 2000) or that contains one or more existing active substances, counting the number of points according to the information submitted to the Agency;
71.3. permitted uses of biocidal products in accordance with Annex 1 of these rules;
71.4. biocidal products or active substances and the preparatory nature of the physical (solution, granules, powder, solid);
71.5. terms of use and use levels for each type of use in accordance with the permit, certificate of registration or provisional registration certificate specified conditions;
71.6. detailed information about the likely direct or indirect adverse side effects and instructions on first aid for poisoning cases with biocides or active substance;
instructions or 71.7. biocidal products containing the active substance in the waste and the safe management of packaging waste, recycling or the prohibition of the use of the packaging again;
44.6. date until which the biocides or active substance is valid for the intended application of the relevant active substance in the biocidal or storage conditions;
71.9. biocides serial or lot (while made with the same biocidal composition and equal use and the types of preparatory) number or designation;
71.10. biocidal effects on target organism requires the time and interval to be observed between: time to use biocides 71.10.1.;
71.10.2. product or subject to a treatment with biocides and processed product or object;
71.10.3. the use of biocides and human or animal stays in the territory of a room or other place where the biocides has been used;
71.11. detailed information about the treatment and the use of biocides in the follow-up, as well as with biocide-treated equipment, facilities or premises needed airing duration;
No 71.12. information about the necessary cleaning and cleaners;
71.13. information about safety and precautionary measures of the use, storage and transport (also for personal protective clothing and equipment, fire safety measures, equipment or inventory, apsegšan, food and animal nutrients removal) and instructions on how to protect the animals from the biocidal effect;
71.14. information that the biocide use is restricted or banned a certain user group (for example, non-professional users);
71.15. information about dangers to the environment of biocidal products and the necessary measures for the reduction of the hazard in question (in particular — to protect the organisms for destruction of biocides is not meant, and prevent water pollution);
71.16. for biocidal active substances which are fungi, micro-organisms or viruses — classification and instructions for the protection of employees in accordance with the laws and regulations governing labour protection requirements when dealing with biological substances;
71.17. the manufacturer, importer or supplier's name, address and phone number.
72. If the label or the packaging space is too small for the posting, this rule 71.4, 71.5 71.3.,.,.,., 71.6 71.7 44.6., 71.9, 71.10.,.,., no 71.12 71.11 71.13, 71.14 and 71.15.. the information referred to in point can be specified in the instructions. Instruction is part of the marking. If added to the instruction, the label must bear the indication "before use, read the attached instructions!".
73. Biocidal products or active substances label may not be misleading. The active substance of the biocidal or labels may not be an indication that the biocides or active substance does not pose any threat to humans, animals or the environment (for example, "low-risk biocidal product ', ' non-toxic ', ' non-hazardous ', ' harmless ').
74. The Agency, in considering the applications, has the right to require that, before the start of trading or biocidal active substances the applicant shall prepare and submit to the packaging, labelling or the instructions for samples, models or drafts of, if necessary, to prevent a threat to people, animals or the environment.
75. The applicant, in accordance with the legislation, which lays down the requirements for chemical and chemical product safety data sheets shall be prepared and sent to the safety data sheet if biocides or biocidal active substance contained in or potentially dangerous substance is classified as a hazardous chemical substance or dangerous chemical product or, if the biocidal active substance or potentially dangerous substance, which is a chemical or chemical product , defines the maximum level of contamination or concentration.
76. If the biocidal active substance contained in classified according to chemical and chemical product classification and uses it only for biocidal, the applicant prepares a safety data sheet in accordance with the provisions of annex 14.
77. the classification and labelling of pretkaitēkļ feature (insecticide, acaricide, rodenticides, avicīd or moluskicīd), which is registered, classified and labelled as plant protection and biocidal products authorised or registered, are allowed to use the same classification and labelling as a plant protection product, if such classification or marking is inconsistent with the use of biocides in the permit, certificate of registration or provisional registration certificate specified conditions. Insecticide, acaricide, rodenticides, avicīd or moluskicīd in the classification and labelling of the altered use of biocides in the authorisation, in the registration certificate or temporary certificate of registration in those conditions, if the pretkaitēkļ classification or labelling of products as plant protection product does not meet the requirements of these rules or use permit, certificate of registration or provisional registration certificate specified conditions.
78. The biocidal advertising includes instructions "use biocides safely! Before use, always read the label and product information! ". These instructions must be clearly visible and distinguishable.
79. The biocides, the word "biocides" allowed to replace with a biocide reklamējam type description (such as "wood preservatives, disinfectants).

80. Biocidal products or active substances prohibited in advertising to describe the form of biocides, which are likely to mislead consumers, and specify that the novel does not pose any risk to people or the environment, that is a low-risk biocidal products concern or that the biocides or active substance is toxic.
 
Vi. the inclusion of the active substances in the list of active substances in the low-risk biocidal products list, or the list of parent and the withdrawal from that list To 81. active substance or additional information on the active substance included in the list of active substances, low-risk biocidal products list, or the list of parent: 81.1. the applicant shall prepare and submit to the Agency an application for active substances and for at least one biocidal, containing the active substance concerned (according to available scientific and technical information, and according to annex 2 of these rules) as well as: 81.1.1. a technical report on the active substances (according to annex 3 of these regulations, if the active substance is a chemical, or Annex 7, if the active substance is a chemical substance) and upon request by the Agency, additional information in accordance with annex 5 of these regulations;
81.1.2. technical report on biocides (according to annex 4 to these regulations, if the biocidal active substance contained in it is a chemical, or, if the annex 8 contained in biocidal active substance is a chemical meets this provision in paragraph 37 above, but is not low risk);
81.2. the Agency and the public health agency, taking into account this provision 86. the conditions referred to in paragraph 1 shall examine the application of this provision in the order laid down in chapter III;
81.3. If needed, the Agency requires the applicant for additional information and be informed of this request to the European Commission and the competent authorities of all the Member States, as well as inform the European Commission and the competent authorities of the Member States on: 81.3.1. additional information submitted by the applicant;
81.3.2. the fact that the applicant has not submitted the additional information within a period of 12 months from the date of despatch;
81.4. If necessary, the Agency shall, upon request of the competent authority of the Member State shall submit it for assessment technical report submitted by the applicant.
82. the Agency, in the light of this rule 81.2. evaluation and referred to 85, 86, 87 and 88.. point these conditions, do one of the following: 82.1. If the application is drawn up according to the requirements of these provisions and the active substance does not pose an unacceptable risk to human health or the environment, accept the technical reports on the biocides and active substance and, in agreement with the applicant, shall submit to the European Commission and the competent authorities of all the Member States that report summary as well as the recommendations and the conditions for the inclusion of the active substances, low-risk biocidal products list, or the list of parent;
82.2. The European Commission and the competent authorities of all the Member States, technical report and summary of the reasons why the relevant active substance cannot be included in the list of active substances, low-risk biocidal products list or list or to be deleted from that list, as well as a proposal for the implementation of this decision.
83. where necessary to assess whether the biocidal active substances risks under conditions of Latvia, the Agency requires the competent institution of the Member State of a technical report on the active substance or of any new information on the active substance concerned, the inclusion of the active substances, low-risk biocidal products or basic substance list.
84. the Agency shall be assessed in accordance with the provisions of paragraph 83 technical messages and received no later than 12 months after the technical report, forwarded to the applicants, the European Commission and the competent authorities of all the Member States the assessment and recommendation on the inclusion of the active substances, low-risk biocidal products list, or the list of parent or a justification why this active substance cannot be included in the list of active substances, low risk biocidal or basic substance list.
85. In considering an application for the inclusion of the active substances, low-risk biocidal products list, or the list of parent, determine: 85.1. where necessary, permissible occupational exposure levels;
85.2. If necessary, the permissible daily dose, which do not give rise to adverse effects on human health;
85.3. maximum permissible limits the quantity, volume or other limits;
85.4. biocidal products or active substances movement, transformation and movement of the environment and impact on non-target organisms;
85.5. requirements for the purity of the active substance, an indication of the minimum degree of purity;
85.6. requirements of impurities and their maximum content in active substance or biocidal;
53.3. types of biocides, which allowed for the manufacture of the active substance concerned in the light of that active substance may be used only by this provision in annex 1 types of biocidal products, for which the application is made and, if necessary, additional information in accordance with this provision, the conditions laid down in chapter II;
85.8. field of use of biocidal products, the conditions prescribed for use and conditions of use for certain groups of users (manufacturers, professional users or power users).
53.4. special conditions arising from technical reports, applications, or other information submitted according to the requirements of this regulation, and evaluation results;
85.10. maximum and minimum concentration in which the active substance may be, if such biocidal active substances concentration necessary to specify low-risk biocidal products list;
No 85.11. period (not exceeding 10 years) to which it is advisable to include the active substance in the list of active substances, low risk biocidal or basic substance list.
86. The Agency shall, in accordance with the provisions of section 81.1. recommends to include the active substance in the list of active substances in the low-risk biocidal products, the list or lists if the biocidal products containing the active substance complies with the provisions referred to in paragraph 37 of the conditions, taking into account the one containing active substances of biocidal cumulative effects, including recommending the inclusion of the active substance: 86.1. a low-risk biocidal products in the list, if the active substance poses a minimal risk to humans and the environment;
86.2. include a list of the parent, if the active substance is assay.
87. The Agency shall, in accordance with the provisions of paragraph 81.2 recommends not to include active substances in the low-risk biocidal products list, where, in accordance with the laws and regulations governing chemical and chemical product classification, labelling and packaging, the substance is classified as carcinogenic, mutagenic, toxic to reproduction, sensitising or bioaccumulative system and difficult to degrade.

88. The Agency shall, in accordance with the provisions of paragraph 81.2 recommends not to include the active substance in the list of active substances, low-risk biocides in the list or the list of parent or from this list if: 88.1. application for the inclusion of the active substance list assessment and risk assessment carried out in accordance with the requirements of this regulation, shows that the use of biocides in the circumstances for its use, the risk to human health or the environment and increase the biocidal produces significantly greater risk to human health or the environment than 88.2. these provisions in the active substances;
88.2. active substances, low-risk biocidal products list, or the list of parent's other active substances: 88.2.1. used the same type of biocidal;
88.2.2. in accordance with the conclusions of the study results and causes significantly less risk to human health or the environment;
88.2.3. which are sufficiently numerous to be able to select the number of active substances with different chemical properties and structure, acting on the relevant occurrence.
89. before providing recommendations concerning the non-inclusion of the active substances, low-risk biocidal products or basic substance list or exclusion from this list the Agency: 89.1. applicant gives the ability to test the active substances concerned, the conditions for use, if such tests have not been carried out previously, depending on the time required for the trial, but not for more than two months;
89.2. evaluate other 88.2. these provisions in this active substance properties, exposure and risk for man and the environment to show that: 89.2.1. their effectiveness against target organisms is similar;
89.2.2. their use does not increase the risk to human health and the environment;
89.2.3. does not permanently damage the economic and practical nature of the loss of the active substance users;
89.3. those provisions referred to be. an assessment of the European Commission and forward it for consideration by the competent authorities of all the Member States.
90. If necessary, the Agency shall submit to the European Commission recommendation: 90.1. review period to which the active substance is included in the list of active substances, low-risk biocidal products list or list;
90.2. shorten the term to which the active substance is included in the list of active substances, low-risk biocides in the list or the list of the parent, if it is found that the active substance poses unacceptable risks to people and the environment, or if the implementation or not are not met, the list of active substances in the low-risk biocidal products list, or the list of basic conditions;
90.3. renew or extend the time limit where the active substance is included in the list of active substances, low-risk biocides in the list or the list of parent: 90.3.1. for a period not exceeding 10 years;
90.3.2. for the period necessary to the applicant for further information and agency assess the application or additional information.
 
VII. Provision of information to the European Commission and the Member States of the authorisation or the registration agency of 91. recognition, based on the competent institution of the Member State (which first issued the permission to use or registered the biocides or active substance) officially approved the registration or use of a copy of the permit and the application of evaluation in question in accordance with the requirements of this regulation which provides for the recognition of a licence or registration. The application must contain a summary of the technical report (low-risk biocidal products) or technical report (the active substance and the biocidal products, which is not a low-risk biocidal products).
92. the Agency shall evaluate this rule 91, paragraph or biocidal active substances or the use of the registration permit if: 57.2. active substance is listed in the list of active substances or biocidal products low-risk list;
92.2. you run the list of active substances, low-risk biocidal products list, or the list of basic conditions for the active substance or biocidal products;
92.3. biocidal products or active substances not present unacceptable risks for human health and the environment.
93. the Agency shall evaluate the biocides or active substance registration or authorisation and shall decide on the recognition or the refusal to provide its recognition: 93.1. not later than 60 days after the receipt of the summary of the technical report — low risk biocidal products;
93.2. not later than 120 days after the technical report and authorized the first authorisation issued the receipt copy of the active substance or biocidal products, which is not a low-risk biocidal products.
94. the Agency, recognizing the use of an authorisation or registration, specify additional conditions if: 94.1. evaluating establishes that the target species is not present in those articles in quantities to be able to cause adverse effects on human health, animals, the environment, or use of products produced or economic activities;
94.2. evaluating establishes that the novel presents an unacceptable tolerance or resistance of the target organism;
58.6. the biocidal use conditions (climate or breeding period of the target species) significantly different from those in the Member State which issued the first permit and therefore the use of biocide can cause unwanted risk to humans or the environment;
necessary measures 94.4. arising from other laws (including laws on the protection of health) requirements relating to biocidal products or active substances production, marketing or use, to protect the biocidal active substances or dealer, the user or employee health or the environment. 95. The Agency, in support of its decision, have the right to refuse permission to use or invalidation of the registration for the following types of biocides: 95.1. avicīd (15. type of product in accordance with the provisions of annex 1);
95.2. piskicīd (17. type of product in accordance with the provisions of annex 1);
95.3. destruction of vertebrates (23. type of product in accordance with the provisions of annex 1).
96. If the Agency considers that the active substance or biocidal products authorised or registered in a Member State does not comply with this provision (in particular paragraph 37) requirements: 96.1. submit reasonable objections to the European Commission and the Member State in which the competent institution is registered or authorised the biocidal active substance;
96.2. proposes to refuse the authorisation or the registration or to impose additional requirements or limits, performing actions with biocides or active substance, and in writing notify the applicant, the Commission and all the Member States, stating its reasons, as well as the active substance or the name of the composition, the characteristics of the components and the environment or human health characteristics.

97. where a biocidal, registered in a Member State as a low-risk biocidal products, the risks, the Agency shall notify its refusal to the competent institution of the Member State that established the biocides as a low-risk biocidal products, stating why the biocide risk, and if 90 days have not been agreed with the relevant competent authority shall notify the European Commission. The Agency registers the biocides as a low-risk biocidal products, the European Commission confirms the initial registration.
98. If the Agency has registered biocides as a low-risk biocides and has received a refusal from a Member State to register the biocides as a low-risk biocidal products, the registration of the report in the light of this refusal, and, if necessary, require the applicant for additional information. The Agency of the decision taken, report registration, shall inform the Member State that issued the denial, and the European Commission.
99. the Agency shall inform the European Commission and the Member States: 99.1. within a month of the end of each quarter, for all authorisations issued or refusal of the registration and to register active substances or biocides or grant permissions, indicating at least: 99.1.1. the applicant's company name and address;
99.1.2. active biocidal or the trade name of the substance;
99.1.3. biocidal products or active substances and biocidal composition of each active substance name and quantity, as well as classification, where the active substance is a dangerous chemical substance;
99.1.4. type and biocides or biocidal active substances permitted uses;
99.1.5. the production of biocides;
99.1.6. limitations or other conditions for the residue of the biocides or concentration;
99.1.7. use of the authorisation or registration conditions, which must be followed when operating with biocides or active substance and, where appropriate, the authorisation or registration conditions change or the reasons for the cancellation;
99.1.8. indication that the biocides is a low-risk biocidal products or biocides that has fixed-frame-formulation;
99.2. prior to use permit-confirmation that: 99.2.1. permission to use or registration certificate contains the requirements for the intended or prohibited use or scope;
99.2.2. biocidal products or active substances classification, labelling, and safety data sheet shall be drawn up in accordance with the requirements of these regulations;
99.3. for other decisions concerning the authorisations issued or refusal of the registration and to register active substances or biocides or grant permissions;
about 99.4. new information about the possible adverse effects of the active substance or biocidal effects on human health or the environment, as well as with a similar composition of biocides (including its active substances, impurities, co-Formulants or residues);
99.5. If it is considered a technical report or a summary of it wrong or incomplete, immediately announcing his observations, why technical report or summary is incorrect or incomplete, the competent institution of the Member State concerned, which first issued the permission to use or registered the biocides or active substance;
99.6. for the calendar time authorised or registered active substances or biocides, presented each year to the national territory of the biocidal products authorised or registered in the list;
for biocides, which 99.7. does not meet the requirements of this regulation, but is allowed under this provision, paragraph 40;
99.8. If the Agency is defined by the additional requirements or restrictions, stopped the registration certificate or authorization of use or has withdrawn the said licence or permission, as the information become known that the active substance of the biocidal or pose unacceptable risks to human or animal health or the environment;
If you have been issued or 99.9. prolonged use permit or registration certificate of the active substance, which is not mentioned in the list of active substances, low risk biocidal or assay list because you have completed the technical report;
99.10. for its actions over a period of three years (including the information on poisoning cases with biocides) last year — up to 30 November.
 
VIII. draft decision of the Agency and the applicant to the appeal procedure, as well as 100. any natural or legal person whose health, safety, or property may affect the decision of the Agency on biocidal active substances or temporary registration, registration, or use of, the permit within one month of the day on which the party concerned became aware of it, but not later than one year from the date of entry into force of the decision may be referred to the Office of a refusal to issue a permit of use permission to use, or registration or refusal to recognise the authorisation or registration.
101. If the Bureau for a decision requires additional information, it shall ask the agency or the applicant to prepare the necessary information. In this case, the decision shall be taken no later than three months from the date of submission of the complaint.
102. The applicant has the right to conduct separate studies or replace the required studies with other research, if he proves that the Agency requested studies will not produce the necessary results or that alternative research is appropriate to a particular biocidal active substances or characteristics or effects on people or the environment. 103. If the Office, in evaluating the information submitted, it is concluded that, in accordance with the permissions granted, registration or provisional registration is not guaranteed to human life, health or safety or the environment are not taken into account in the law, it shall adopt a decision to cancel the decision of the Agency and asking the Agency to reconsider the issue.
104. If the Office, in evaluating the information submitted, it is concluded that, in accordance with the permissions granted, registration or provisional registration laws are complied with, it shall take a decision to reject the complaint.
105. the Office's decision may appeal to the Court of law.
 
IX. Closing questions 106. Biocidal products or active substances (with which trade is launched until July 1, 2003), the manufacturer or importer to January 1, 2004 to provide the Agency with the following information: 106.1. the manufacturer or importer of the legal address and location;
106.2. the manufacturer or importer, the name and registration number of the commercial register, as well as the value added tax code;

106.3. physical person who is responsible for the provision of information about biocidal products or active substances (position, name, surname, telephone and fax numbers, electronic mail address);
106.4. plant location and the name of the manufacturer, if the active substance or biocidal is imported;
106.5. biocides and the name of the active substance in accordance with the requirements of this regulation;
106.6. biocidal products or active substances intended or existing uses;
total imported or 106.7. production of biocides or active substance level;
106.8. evidence (if that is possible) that the active substance or biocidal products has been on the market before 14 May 2000;
106.9. time schedule for carrying out the study, as well as the development and the application for submission to the Agency, if the active substance or biocidal products in one of the Member States has not been identified or reported to the European Commission for inclusion in the list of active substances to the list of basic or low-risk biocidal products list;
106.10. agreement with the applicant, which the European Commission has made a biocide or the inclusion of the active substances in the list of active substances to the list of basic or low-risk biocidal products in the list, if the active substance is identified in one of the Member States.
107. The active substances with which trade is initiated until 14 May 2000, or for biocidal containing these active substances and for which the Agency has submitted information in accordance with this provision, paragraph 106 to 14 May 2010 does not require registration or authorization of use.
108. the Provisions of annexes II, III, IV, VI, VII and VIII, chapters 10 and 11, as well as 71.2. and 106.10. subparagraph shall enter into force with special cabinet rules.
109. The entry into force of the provisions by July 1, 2003.
 
Informative reference to European Union directive rules included provisions resulting from Directive 98/8/EC.
Prime Minister e. Repše Environment Minister r. vējonis Editorial Note: rules shall enter into force on July 1, 2003.
 
 
1. the annex to Cabinet of 15 April 2003, the Regulation No 184 types of Biocides and their descriptions no PO box
The type of Biocidal product description 1 2 3 major group 1. Disinfectants and General biocidal products in This group are not included in the cleaning products that are not intended for the biocidal effect, including detergent and powder 1.
Human hygiene biocidal products provided for this type of product are biocidal products used for human hygiene 2.
Residential, public and private buildings and sites of this type disinfectants are biocidal products used for the disinfection of air, surfaces, materials, equipment and furniture which are not intended for direct contact with foodstuffs or animal feed in private, public and industrial sector, including hospitals, as well as features that use algae disposal. Use of the swimming pool, Aquarium, bath and other procedures for higiēniskaj water disinfection, air conditioning systems, wall and floor disinfection health and other authorities, as well as to disinfect toilets, waste water, hospital waste, soil, soil or substrate (e.g., playgrounds).
Residential, public and private buildings in the territory and disinfectants shall be divided into the following subgroups: swimming pools and other water biocides used to disinfect (2.02), air conditioning equipment used for biocides (1.0.1), biocides, waste water or toilets, hospital waste processing (2.04) and other biocides that type (2.05) 3.
Veterinary hygiene biocidal products for this type of product are biocidal products used for veterinary hygiene, including products used in places where there are housed, or transport animals 4.
Food and feed production and circulation use this type of disinfectants are biocidal products used for consumer articles or supplies, equipment, containers or other packaging, pipeline systems and surface disinfection, involving food, feed or drink (including drinking water) production, extraction, processing, handling, transport, storage and consumption of 5.
Drinking water disinfectants are biocidal products of this type are used for drinking water, and the water needs of the animals, disinfecting 2. major group. Preservatives 6.
Packaged product of this type of preservative products are used in biocidal products canning jars, barrels, or other packaging that is not food or animal feed, to ensure their shelf life, protecting against microbial induced deterioration.
Boxed product preservatives shall be divided into the following subgroups: detergent preservatives (6.01) and other packaged products, preservatives (6.02) 7.
Film preservatives products of this kind are biocides used in film or coating, protecting against microbial induced deterioration, to protect the surface of the original properties of paints, plastics, adhesive tape, adhesives, binders, wallpaper, illustrations or other similar materials, surfaces or items 8.
Wood preservatives products of this kind are biocides used for wood or wood preservation products (also at sawmills, protecting against wood or deplete distortionary organisms). Wood preservatives used for prevention and for the treatment and recovery of wood.
Wood preservatives shall be divided into the following subgroups: industrial pre-treatment (pressure or vacuum impregnating equipment) use wood preservatives (8.01) and other wood preservatives (8.02) 9.
Fibre, leather, rubber and polymerised materials preservatives, this kind of products is used in biocidal fibrous or polymerised materials, leather products, rubber, paper or textile preservation by protecting against deterioration caused by microbes.
Fibre, leather, rubber and polymerised materials preservatives shall be divided into the following subgroups: textile and leather preservative (9.01), preservatives (9.02), rubber and polymerised materials preservatives, as well as the rest of the ninth product type biocides (9.03) 10.
Masonry preservatives products of this kind are biocides used in masonry construction, masonry or other materials, except lumber, curing and processing, to clean out the microbes and algae or protect against microbes and algal growth 11.
Cooling and technological equipment or system-fluid preservatives

This type of biocidal products are used in cooling and technological equipment or systems used in water or other liquids to protect against microbes, algae, molluscs and other harmful aquatic organisms. This product does not include drinking water disinfectants.
Cooling and technological equipment or system liquid preservatives shall be divided into the following subgroups: fluxgate systems preservatives (11.01.) and the circulation system of the preservatives (11.02) 12.
Slimicides this type of biocidal products, which are used to remove the slime growth on structures, equipment and materials used in industry (such as wood or paper pulp or pulp, porous sand layer oil extraction), or to protect the premises, equipment and materials to slime growth.
Slimicīd are divided into the following subgroups: of slimicides pulp (12.01), slimicides for oil extraction (12.02) and other slimicides (12.03) 13.
Metalworking-fluid preservatives products of this kind are biocides used in metalworking fluids, including technological solution for protection against microbial contamination caused by major group 3. Products against pests 14.
Rodenticides are this type of products, biocides, which are used for protection against mice, rats or other rodents, 15.
Avicides this type of biocidal products are used for protection against birds, 16.
Molluscicides to this type of product are biocides that are used for protection against molluscs, 17.
Piskicīd of this type of product are biocides that are used for protection against fish, except medicinal products for the treatment of fish diseases 18.
Insecticides, acaricides and products to control other arthropods, this kind of products are biocides that are used for protection against arthropods (e.g. insects, zirnekļveidīg and crustaceans).
Insecticide, acaricide and products to control other arthropods divided into subgroups, depending on which users will use them: professional use (18.01.), the use of non-professional users (18.02.) 19.
Repellents and Attractants to this type of product are biocides that are used for protection against harmful organisms, including invertebrates (for example, bugs), and vertebrates (e.g. birds), or attempting to put off. This product also includes a biocide that directly or indirectly from the use of human or veterinary hygiene.
Repellent and attractant are divided into the following subgroups: repellents you use directly on human or animal skin (19.01), Attractants and repellents not applied directly on human or animal skin (19.02.) 4. major group. Other biocides 20.
Food or feed preservatives products of this kind are biocides used for food or animal feed, feed storage, also for protection against harmful organisms 21.
Antifouling products products of this kind are biocides, which are used to prevent fouling organisms (microbes and plant or animal species) and the formation of colonies growing in containers, aquaculture equipment or other structures used in water 22.
Balzamēšan and taxidermy liquids products of this kind are biocides that are used in human and animal corpses, or parts of disinfection and preservation 23.
Means of disposal in vertebrates this kind products are biocides that are used for protection against insects, rats and other vertebrate animals that are harmful organisms Environment Minister r. vējonis Environment Minister r. vējonis annex 3 Cabinet of 15 April 2003, the Regulation No 184 technical report on the content of the active substance if the active substance is a chemical 1. details of the manufacture of the active substance: 1. manufacturer's name, legal address and location;
1.2. tests or research caller name;
1.3. plant location.
2. the importer's name and address.
3. Identity of the active substance: 3.1 name according to IUPAC nomenclature;
3.2. International Organization for Standardization (ISO) approved denomination or name that recommended approval of ISO and synonyms;
3.3. the manufacturer code (number or other designation given by the manufacturer of the active substance);
3.4. the CAS number, the registration number of the chemical in the European Community in the existing commercial chemical substances (EINECS) or European Community applied for the list of chemical substances (ELINCS) (EC number), if the active substance is listed in the list;
3.5. Molecular and structural formula, including information on types of isomers and molar weight;
3.6. the active substance production method (short outline of the production process);
3.7. specification of purity of the active substance (in g/kg or g/l);
3.8. the impurities or additives (e.g. stabilizers), their structure and the possible impurity or additive quantity (in g/kg or g/l), specifying the minimum and maximum quantity or range;
3.9. the natural active substance or active substances the original origin (materials, plants or organisms, from which the active substance; for example, flower extract);
3.10. information on exposure, including information on the effect of the active substance: 3.10.1. for people (including employees) health;
3.10.2. environment, including information on whether the legal substance recognized as especially dangerous or hazardous to the aquatic environment or on priority substances.
4. active physico-chemical properties of the substance: 4.1. melting point, boiling point, relative density;
4.2. the vapour pressure of purified active substances (Pa);
4.3. physical state and color;
4.4. spectral analysis of data (ultra-violet (UV), infrared (IR), nuclear magnetic resonance (NMR) or visible light spectrometry or mass spectrometry and the extinction coefficient, which characterizes the molar extinction (molar absorption) wavelengths);
4.5. solubility in water, including the observed effects, if the pH is between 5 and 9, and the effect of temperature on solubility;
4.6. partition coefficient: solubility of the substance concerned in relation to n-octanol solubility in water, including the observed effects, if the pH is 5 to 9, depending on temperature;
4.7. thermal stability, identity of relevant breakdown products;
4.8. the burning capability, including the auto-ignition temperature and identity of combustion products;
4.9. the flash point;
4.10. the surface tension;
4.11. explosive properties (the ability to explode);
4.12. oksidētspēj;
4.13. the ability to react with the packaging material.
5. Analytical methods for the active substance detection and identification of:

5.1. analytical methods for the determination of pure active substance and, where appropriate, relevant degradation products, isomers of active substances, impurities and additives (e.g. stabilizers);
5.2. analytical methods and its active substance residues or organisms in the environment, indicating for each environment, or body and method-specific applicability or the detection limit of the test and the frequency of medium renewal or period, including analytical methods and the residue of the active substance: 5.2.1 soil;
5.2.2. in the air;
5.2.3. water, giving the choice of the method and specifying the sensitivity of selected methods that ensure that the method to determine the active substance and its degradation products in all the water with the same reliability and accuracy required in determining or verifying compliance with requirements for human consumption water quality or safety (for example, the maximum rate of the active substance in water);
5.2.4. animal and human body fluids and tissues.
6. on the occurrence of the harmful impact and intended uses: 6.1. biocidal products (which uses the configurations of active substances) or group name or characteristics according to the intended use or exposure (e.g. fungicide, rodenticide, insecticide, bactericide);
6.2. the destructive occurrence that need to destroy, render harmless distract or otherwise affect, and products, organisms, objects or other objects that are to be protected;
6.3. effects on harmful occurrence and the possible use of concentration or dose;
6.4. types of exposure, including exposure, which can occur after a period of time;
6.5. field of use or industry — existing or planned;
6.6 users — industry, professional or non-professional users;
4.2. information on the generation and development of resistance and of the measures needed to be taken if there is a resistance;
6.8. projected sales, tonnes per year.
7. Toxicological studies on acute toxicity, which can cause the active substance when it enters the oral or inhaled or if contact with the skin, the skin determines irritancy eye irritancy (except when there is a certain PEP) and skin sensitivity. Acute toxicity of active substances assessed as follows: 7.1 acute toxicity active substances other than gases shall be assessed at least two methods (one of them, by entering the oral route). The second valuation method chosen according to the characteristics of the active substance and the possible effects on humans;
7.2. acute toxicity of active substances, which are gas or volatile liquid, evaluate the inhalation.
8. other toxicological studies: 8.1. metabolism studies in mammals, including toxicokinetic and skin absorption studies;
8.2. short-term repeated dose toxicity study (28 days) does not need to have available subchronic studies in rodents;
8.3. subchronic toxicity study: 90-day study, two species, one of which is a rodent, but the other is not rodents;
8.4. chronic toxicity study in two species, one of which is a rodent, the other-other mammalian species;
8.5. mutagenicity studies: 8.5.1. gene mutation study in bacteria under laboratory conditions (in vitro), using a bacteriological (reverse mutation);
8.5.2. citogenitāt studies of mammalian cells, laboratory (in vitro);
8.5.3. gene mutation assay in mammalian cells, laboratory (in vitro);
8.5.4. further study of gene mutation in Vivo: bone-marrow (chromosomal damage or not) or micronuclei studies, if any, of this annex. 8.5.2 or 8.5.3 8.5.1.. the checks referred to in point results are positive. The micronucleus test of substances that cause cytogenetic damage which the formation of micronuclei containing detained chromosome fragments or whole chromosomes;
8.5.5. additional in vivo studies to check whether other tissues (bone marrow) mutagenicity or DNA is (DNA) damage if this annex 8.5.4. the results of the studies referred to are negative, but one of this annex, or 8.5.1 8.5.2 8.5.3... the checks referred to in point results are positive;
8.5.6. studies of exposure to germ cells (mammalian spermatogonial chromosome aberration test) or embryonic cells (rodent dominant lethal test factors), if this annex 8.5.4. the results of the studies referred to are positive and if necessary;
8.6. carcinogenicity study, two species, one of which is a rodent, the other-other mammalian species. These studies may be grouped with this annex 8.5. referred to in research;
8.7. the studies on the toxicity of the active substance: 8.7.1 reproductive teratogenic studies, rabbits and one rodent species;
8.7.2. two-generation reproductive toxicity study to see the effect of the active substance on one species, male and female reproductive capacity;
8.8. the research required in accordance with this annex 8.2., 8.3., 8.4., 8.5., 8.6 and 8.7. section. Studies are conducted, the active substances entering the oral, except where appropriate is another way of execution of the study;
8.9. the long-term toxicity and carcinogenicity studies may be omitted if all toxicological studies point to the fact that the active substance is not mutagenic, carcinogenic or toxic exposure.
9. medical information respecting the data protection requirements if the relevant information is available: 9.1. information concerning on-site medical surveillance of employees, including the medical checkup data;
9.2. information on direct observation, including clinical cases and poisoning;
9.3. the medical examination reports or opinions on the shop floor or in the health status of the population;
9.4. information on observations related to the exposure of the active substance, and the epidemiological research data;
9.5. information on poisoning cases and their diagnosis, showing signs of poisoning and specific clinical test results;
9.6. the expected effects of poisoning forecast;
9.7. information on observations related to sensitivity and allergy.
10. information on actions and emergency assistance, if a man poisoned with the active substance, including first aid, funds to be used to reduce the exposure of the active substance, and method of treatment (if known).

11. Summary of toxicological studies, including the no-observed-adverse-effect level, any no-observed-effect level, a general description of the study and the results of the evaluation, taking into account all toxicological data and any other specific information concerning active substances, as well as suggestions for necessary measures to be employed and other active substances for the protection of the user.
12. Ecotoxicological studies on: 12.1. acute toxicity to fish;
12.2. Daphnia acute toxicity (Daphnia magna);
12.3. the delay in algal growth (inhibition);
12.4. microbiological activity inhibition;
12.5. bioakumulēšano;
12.6. the movement of the active substance in the environment, providing a general description and in active substances, mobility, stability (stability), or other modification of the degradation of the environment;
12.7. the degradation of the active substance: 12.7.1. biodegradability, biological degradation, and complete, if possible, the inherent biodegradability;
12.7.2. abiotic degradation: hydrolysis rate is determined depending on the pH of the water, and to investigate also the identity transformation products;
adsorption and desorption of 12.8 and additional studies in accordance with the provisions of annex 5, if the test results show that research is required;
12.9. the summary, stating the findings on the ecotoxicology of the active substance, its movements and behaviour in the environment.
13. Measures necessary to protect man, animals and the environment: 13.1. recommended methods, techniques, precautionary and security measures in the production, storage, management, moving or performing other operations to the active substance, as well as in the event of fire;
13.2. special protection measures in the event of fire, depending on the possible chemical reactions between the substance and exposure, as well as the reaction product or the combustion characteristics of gas or other negative effects;
13.3. the measures of the accident, an accident or emergency;
13.4. measures emergency leaks into the environment (air, water (including drinking water) or soil) prevention, collection and treatment;
13.5. the active substance and its waste management or professional users: 13.5.1. the possibility of active substances used as recycling or reuse;
13.5.2. opportunity to avoid or reduce adverse effects or harmful effects;
13.5.3. conditions of waste disposal, waste water discharge and monitoring, including the monitoring of emissions and the pollution;
13.5.4. conditions of waste incineration and its monitoring;
13.6. observations on undesirable or unexpected side effects to other organisms that are not harmful to the target.
14. The proposals and the grounds concerning the classification and labelling of the substance according to the laws and regulations governing chemical and chemical product classification, labelling and packaging, and marking the date with reference to: 14.1. hazard symbols;
14.2. the hazard explanations;
14.3. the characteristics of exposure to a substance;
14.4. safety requirements for designation.
15. The evaluation and summary of information obtained in carrying out studies on the active substance, which is a chemical.
Minister for the environment r. vējonis annex 4 Cabinet of 15 April 2003, the Regulation No 184 technical report on biocides, if contained in biocidal active substance is a chemical message of 1 and biocidal active substances production: 1.1. biocidal products and active substances manufacturer name, legal address and location;
1.2. tests or research caller name;
1.3. plant location.
2. the importer's name and address.
3. the identity of the biocidal products: 3.1. trade name or proposed trade name and manufacturer's code (number or other designation given by the manufacturer of the biocides);
3.2. detailed information on biocides is the quantitative and qualitative composition, including active substances, impurities, additives and other ingredients inertaj and information on whether the legal substance recognized as especially dangerous or hazardous to the aquatic environment or on priority substances;
3.3. the biocidal preparatory way (the way it examines the biocides delivered or sold to the consumer (for example, solution, wet powder, emulsifiable concentrate)) and properties that are specific to or are directly associated with the preparatory nature of the biocides.
4. Biocides in the physico-chemical and mechanical properties: 4.1 physical state and color;
4.2. the ability to explode;
4.3. oksidētspēj;
4.4. flash point and other information about burning or pašuzliesmošano;
the acidity or alkalinity of 4.5 and if necessary pH value (1% water solution);
4.6. relative density;
4.7. stability during storage and shelf life. Light, temperature and humidity on the biocidal properties (particularly on mechanical characteristics), the ability to react with the packaging material;
4.8. biocides and other mechanical characteristics (for example, wet, foaming characteristics (stable foam formation), flowability, pourability and dustiness);
4.9. physical and chemical compatibility with other products including other biocidal products with which you want to apply the biocides.
5. identification of biocidal products and the methods of analysis, which is specified in accordance with the provisions of annex 3 requirements: 5.1. analytical methods for the determination of the concentration of active substances in biocidal products;
5.2. analytical methods for the determination of biocidal components it environments and organisms which are ecotoxic, irritating, pungent, sensitising, carcinogenic, mutagenic, harmful, toxic or very toxic effect, indicating for each environment, or body and method-specific applicability or the detection limit of the test and the frequency of medium renewal or period, including analytical methods for the determination of biocidal components: 5.2.1 soil;
5.2.2. in the air;
5.2.3. water (including drinking water);
5.2.4. animal and human body fluids and tissues;
5.2.5. the treated food or feed.
6. The biocidal efficacy on harmful occurrence and intended uses: 6.1. biocides and for use in industry;
6.2. the use of methods and techniques, including a description of the action to be taken;

6.3. processing time to biocide treatment dose and duration, if necessary, and biocidal active substances or residue concentration in a product, system or the territory in which the products will be used (e.g. cooling water, surface water, water heating systems);
6.4. the number of times you need to undergo treatment with biocides, duration of treatment with biocides and other conditions relating to the duration of treatment with biocides, or time. If necessary, detailed information on the geographic and climatic diversity, as well as whether necessary waiting periods to protect man and animals (such as between product treatment with biocides and processed product, things, equipment, surfaces, structures or sites);
6.5. biocidal or group name or characteristics according to the intended use or exposure (e.g. fungicide, rodenticide, insecticide, bactericide);
6.6 destructive occurrence that it is necessary to destroy, render harmless distract or otherwise affect, and products, organisms, materials, or other items that need to be protected from the effects of the target organism;
6.7. effects on target organism;
6.8. types of exposure, including exposure, which can occur after a period of time;
4.3. user — industry, professional or non-professional users;
6.10. the proposals and the justification of the content of the tag, depending on the results of the study, taking into account also the biocidal efficacy studies and the available protocols and reports on laboratory and field trials;
6.11. information on other factors impact on the efficacy of the biocidal products, also for the generation and development of resistance.
7. Toxicological studies on acute toxicity, which can cause the biocides, oral administration or inhaling or contact with the skin, the skin determines irritancy eye irritancy (except if it is established or PEP is shown to have potential corrosive properties) and skin sensitivity. If you need to use two or more biocides, studies on the acute toxicity and skin and eye irritancy, if possible, take the appropriate blend of biocides. Acute toxicity of biocides assessed the following: 7.1 acute toxicity of biocides, which are not gas, valued at least two methods (one of them, by entering the oral route). The second valuation method chosen according to the characteristics of the active substance and the possible effects on humans;
7.2. acute toxicity of biocides, which are gas or volatile liquid, evaluate the inhalation.
8. other toxicological studies or information on: 8.1. skin absorption of biocides;
8.2. the biocidal effect on humans who come into contact with a biocide or biocides can be exposed indirectly via the environment, including the effects on workers of biocides;
8.3. other substances that are not the biocidal composition and active substances, in particular on the potential toxic effects of hazardous substances. Toxicological studies of potentially dangerous substances, which is the composition of the biocidal products and active substances not in accordance with this annex 9, 10, 11, 12 and 13, if the nature of the substance, structure, or other indications that it can be very toxic, toxic, carcinogenic, toxic for reproduction or mutagenic system.
9. Toxicological studies on acute toxicity, which can cause a potentially dangerous substance, if the oral administration or inhaling as well, if it makes contact with the skin, the skin determines irritancy eye irritancy (except if there is a certain PEP) and skin sensitivity. Acute toxicity of potentially dangerous substances assessed as follows: 9.1. acute toxicity of potentially dangerous substances other than gases shall be assessed at least two methods (one of them, entering the oral route). The second valuation method chosen on potentially hazardous substances and possible effects on humans;
9.2. acute toxicity of potentially dangerous substances, which is gas or volatile liquid, evaluate the inhalation.
10. other toxicological studies: 10.1. metabolism studies in mammals, including toxicokinetic and skin absorption studies;
10.2. short-term repeated dose toxicity study (28 days) does not need to have available subchronic studies in rodents;
6.4. subchronic toxicity study: 90-day study, two species, one of which is a rodent, but the other is not rodents;
10.4 chronic toxicity study in two species, one of which is a rodent, the other-other mammalian species;
10.5:10.5.1. mutagenicity studies gene mutation study in bacteria under laboratory conditions (in vitro), using a bacteriological (reverse mutation);
10.5.2. citogenitāt studies of mammalian cells, laboratory (in vitro);
10.5.3. gene mutation assay in mammalian cells, laboratory (in vitro);
10.5.4. further study of gene mutation in Vivo: bone-marrow (chromosomal damage or not) or micronuclei studies, if any of this annex 10.5.1, 10.5.2, or 10.5.3... the checks referred to in point results are positive. The micronucleus test of substances that cause cytogenetic damage which the formation of micronuclei containing detained chromosome fragments or whole chromosomes;
10.5.5. additional in vivo studies to check whether other tissues (bone marrow) mutagenicity or DNA is (DNA) damage if this annex 10.5.4. the results of the studies referred to are negative, but one of this annex 10.5.1, 10.5.2, or 10.5.3... the checks referred to in point results are positive;
10.5.6. studies on exposure to the germ cells (mammalian spermatogonial chromosome aberration test) or embryonic cells (rodent dominant lethal test factors), if this annex 10.5.4. the results of the studies referred to are positive and if necessary;
10.6. carcinogenicity studies in two species, one of which is a rodent, the other-other mammalian species. These studies may be grouped with 10.5. this annex referred to research;
10.7. research on potentially hazardous substances reproductive toxicity: 10.7.1. teratogenicity studies, rabbits and one rodent species;
10.7.2. two-generation reproductive toxicity study, to identify potentially hazardous substances exposure of females of the same species and the males reproductive ability of the representatives and reproduction;

10.8. the research required in accordance with this annex 10.2., 10.3, 10.4, 10.5, 10.6 and 10.7.., takes the potentially hazardous substances entering the oral, except where appropriate is another way of execution of the study;
10.9. the long-term toxicity and carcinogenicity studies may be omitted if all toxicological studies indicate that potentially dangerous substance is not mutagenic, carcinogenic or toxic exposure.
11. medical information respecting the data protection requirements (if the information is available): 11.1. information about potentially hazardous substances in the production of medical surveillance, including the medical checkup data;
11.2. information on direct observation, including clinical cases and poisoning;
11.3. the medical examination or opinion on the Protocol factory, producing potentially dangerous substances, employed or the health status of the population;
11.4. information on observations related to population exposure to potentially hazardous substances exposure and epidemiological research data;
11.5. information on poisoning cases and their diagnosis, showing signs of poisoning and specific clinical test results;
11.6. expected poisoning with potentially hazardous effects of forecast;
7.3. information on observations related to sensitivity and allergy.
12. Information on actions and emergency assistance, if a man poisoned with biocides, including first aid, use features to reduce the harmful effects of biocides, and methods of treatment (if known).
13. Summary of toxicological studies, including the no-observed-adverse-effect level, any no-observed-effect level, a general description of the study and the results of the evaluation, taking into account all toxicological data and any other specific information related to potentially dangerous substances, as well as recommendations for the necessary action man (biocides, employed in the manufacture of professional users, non-professional users and residents) for protection against the biocides, in particular — to potentially dangerous substances, potential adverse effects.
14. Ecotoxicological studies or information on: 14.1. the manner in which the biocides in the environment (e.g. emission in water with rainwater, air, soil, debris). The evaluation shall be carried out on the basis of the intended use;
14.2. the biocidal active substances generated ecotoxicological effects where this cannot be determined on the basis of the results of research carried out on the properties of the active substance and effects;
14.3. other substances present in the biocidal composition (active substances), in particular the ecotoxicology of potentially dangerous substances the ecotoxicology. Information about potentially hazardous substances the ecotoxicology of points based on the safety data sheet information.
15. measures necessary to protect man, animals and the environment: 15.1 recommended methods, techniques, precautionary and security measures in the production, storage, management, moving or performing other actions with a biocide, as well as in the event of fire;
15.2. the specific protection measures in the event of an emergency and first aid if someone tampered with biocides, including features that are used to reduce the harmful effects of biocides, and treatments, if these measures are not mentioned in annex 3 to the rules 10 and 13 points (for example, if the poisoning was caused by a potentially dangerous substance that is composed of the biocides);
15.3. containers or equipment used cleaning conditions, if treated with biocides or plant substance, product, material or thing that is in the machine or tank, or if the transactions with biocides require special equipment or containers;
15.4. special protection measures in the event of fire, depending on the most important characteristics of the combustion products and the effects on human health and the environment; 15.5. conditions of waste biocides and packaging waste management, recycling or reuse and the conditions for waste water discharges, waste disposal and monitoring: 15.5.1.;
15.5.2. for professional users;
15.5.3. non professional users;
15.6. the emergency measures emissions or leaks into the environment (air, water (including drinking water) or soil) prevention, collection and treatment;
15.7. observations on undesirable or unexpected side effects to other organisms that are not destructive occurrence;
15.8. specific measures in respect of the nature and composition of the biocides — specifies the components of biocides, which eliminates or reduces the ability of the repellents be deterred or other biocide poisonous (toxic) or adverse effects on organisms that are not harmful to the target.
16. classification of Biocides, packaging and labelling, in accordance with the provisions of chapter V: 16.1. proposals for packaging and labelling;
16.2. the justification for the classification and labelling of: 16.2.1. hazard symbol;
16.2.2. the hazard statement;
16.2.3. characterization of exposure to a substance;
16.2.4. safety requirements for designation;
16.3. the proposal for the safety data sheet, if required;
16.4. packaging (shape, material, size), compatibility with possible biocidal packaging material.
17. the evaluation of the information and summary, obtained by research on biocides.
Note the.
Information or studies are not required, if the active substance is a low-risk biocidal products mentioned in the list.
Minister for the environment r. vējonis annex 5 Cabinet of 15 April 2003, the Regulation No 184 additional information or studies on the active substance if the active substance is a chemical active substances 1 physical and chemical properties: 1.1. solubility of organic solvents, including the temperature dependence of the solubility. Check out pure active substance with a certain degree of purity (%), characteristics and conditions;
1.2. the most important degradation product identity and stability in organic solvents used in biocidal. Check out the crude to the active substance, which is a certain impurities or the degree of purity (%) and properties.
2. Analytical methods for the active substance and its residues on food or feedstuffs and other products (to the surface), indicating for each specific application or method detection limit and test the frequency of medium renewal or period if necessary.
3. Toxicological and metabolic studies:

3.1. neurotoxicity studies, carried out active substances that are organophosphorus compounds or other chemicals, or chemical products, for which there are indications that they may have neurotoxic properties. Test species has increased vista (except where the active substances concerned, the neurotoxic effects of exploration is another more appropriate test species). If necessary, also delayed neurotoxicity that is active substances created long-term neurotoxic effects, the symptoms of which may appear after some time. If established that the active substance is a antiholīnesterāz effect, blocking the enzyme, cholinesterase (also acetilholīnesterāz), an inspection found the reaktivator (substances which restores blocked the operation of the acetilholīnesterāz) by the response;
3.2. toxic effects on livestock and pets;
3.3. studies on the active substances that may be used for food and animal feed production, use or storage, this annex made in accordance with paragraph 6;
3.4. the exposure of the active substance evaluation and research concerning the effects on human health, if such research is required and possible exposure shows the results of the studies previously made or special features (the nature of the substance or structure);
3.5. studies on the metabolism of plant products (metabolites) toxic effects, which are different from animals in certain toxic effects if the biocidal products containing the active substance is to be used for processing plant;
3.6. other studies are needed to clarify the previous toxicity studies and specific exposure characteristics.
4. Ecotoxicological studies: 4.1. acute toxicity study on non target organisms and aquatic organisms;
4.2. the study under this section, annex 8.4. — If the inherent biodegradability test (carried out in accordance with the provisions of annex 7.8) the result is negative, but requires the active substance in the waste water treatment and disposal;
4.3. any other biodegradability studies. If the previous study, the active substance in the biodegradability test (which met in accordance with the provisions of annex 7.8) the evaluation of the results of the studies concerned;
4.4. additional biodegradation study according to 7.1.1. of this annex, section 7.2.1. and 7.3. Studies will be carried out if: 4.4.1 previous active substances biodegradation study (carried out in accordance with the provisions of annex 3 paragraph 12.6., or 4.3 of this annex) the evaluation of the results of the studies concerned;
4.4.2. active substance abiotic non-biodegradable biodegradable or weak;
4.5. phototransformation in air (estimation method), including identification of breakdown products;
4.6. other studies in accordance with this annex, point 7 and 8, — if the previous results of the ecotoxicological studies and the intended use of the active substance indicate the relevant active substances hazardous to the environment.
5. measures necessary to protect man, animals and the environment, in particular, in accordance with the laws and regulations on the emission of pollutants in the water, on the surface and ground water quality and the water management of the active substance (or residues thereof) is recognized as a particularly dangerous or hazardous to the aquatic environment or on priority substances.
6. additional studies on food and animal feed, on human health of exposure to treated or contaminated with active substance: 6.1. active substances for the degradation and reaction products and of metabolites of the discovery with the active substance concerned in the treated or contaminated food or feedstuffs;
6.2. the study of the degradation products of the active substance, its metabolites and residues (if necessary), spreading, decomposition, excretion (excretion) or other transformation in food or animal feed, treated or contaminated with the active substance concerned. Study on the degradation products of the active substance and metabolites residues, leaking out from under the food or feed concerned also about release kinetics;
6.3. the study of active substances the effects on human and animal health, depending on the active substances content of residues in food or animal feed, including: 6.3.1 use the active substance of universal balance, also residues of the active substance or in foodstuffs or animal feed, depending on the properties of the active substance concerned, the application rate, type and other conditions;
6.3.2. experimental data concerning the effects on human and animal health, depending on the active substances content in foodstuffs or animal feed;
6.3.3. grounds (taking into account this annex 6.3.1 and 6.3.2. information referred to in point) that the active substance will not have an adverse effect on human or animal health;
6.4. active substances of actual or potential exposure assessment, taking in food or other means of contact with food or feed treated or contaminated with active substance;
6.5. feeding and metabolism studies in livestock, if residues of the active substance remain permanently or accumulate in animal feedingstuffs — evaluate the corresponding residues of the active substance and the maximum quantities of food of animal origin;
6.6. a study on the residue of the active substance and the amount depending on the foodstuff or animal feed preparation, also depending on whether food or feed is produced or prepared in industrial conditions in the home;
4.2. grounds and proposals concerning the way of pollution or residue and maximum residue level which may be in food or animal feed;
6.8. other available and relevant information or studies concerning the effects on human and animal health, depending on its content in foodstuffs or animal feed;
4.3. Summary and evaluation of active substances the effects on human and animal health, depending on the content of residues in food or animal feed.
7. additional studies on the movement of the active substance in the environment: 7.1. studies concerning the movement, transformation and degradation in soil:

7.1.1. a study on the degradation of the active substance and the type of speed-down all the degradation processes and products (including metabolites) in at least three soil types under conditions identical to the use of the active substance;
7.1.2. study on absorption of active substances and desorption in at least three soil types. If necessary, also the metabolites and degradation products of absorption and desorption;
7.1.3. a study on mobility in at least three soil types. If necessary, also the metabolites and degradation products of mobility;
7.1.4. balance of volume and related properties;
7.2. studies concerning the movement, transformation and degradation in water — is determined: 7.2.1. degradation of the active substance in water speed and the way all the degradation products and metabolites, if they are not determined in accordance with rule 3.12.6. the requirements referred to in subparagraph;
7.2.2. the absorption of the active substance and of the sediments, sediment stripping or other soil or soil layer, which is the body of water on the seabed or other water. If necessary, also the metabolites and degradation products of absorption and desorption;
7.3. studies concerning the movement, transformation and degradation in the air. Determine the speed and type of degradation, where this is not determined in accordance with section 4.5 of this annex to the requirements of and where: 7.3.1. the active substance is to be used in disinfectant products;
7.3.2. intends to use the spraying method;
7.3.3. the active substance is volatile;
7.3.4. other information or previous research indicates a need to determine the speed and type of degradation in the air;
7.4. a summary of the additional studies and evaluation of the active substance in the environment.
8. additional ecotoxicological studies: 8.1. effects on birds: 8.1.1. acute oral toxicity, if not carried out studies with some species of birds in accordance with section 4.1 of this annex to the requirements of;
8.1.2. short-term toxicity — determined by the eight-day study of at least one species (other than chickens), if the active substance is taken with food (oral);
8.1.3. studies on the effects on growth;
8.2. effects on aquatic organisms: 8.2.1. prolongēt toxicity studies to an appropriate species of fish;
8.2.2. studies on the exposure of an appropriate species of fish reproduction and growth rate;
8.2.3. bioaccumulation test appropriate species of fish;
8.2.4. studies on Daphnia (Daphnia magna) reproduction and growth rates;
8.3. effects on other organisms, other than the target organism: 8.3.1. studies on the acute toxicity to honeybees and other beneficial arthropods (e.g., harmful organisms for natural enemies (predators)). Study the selection of organisms for which no studies in accordance with point 4.1 of this annex to the requirements of;
8.3.2. studies on toxicity to earthworms and soil macro-organisms other than the target organism;
8.3.3. studies on the effects on other soil organisms other than the target organism;
8.3.4. studies on exposure to other organisms that are not the target (flora and fauna), where the active substance may lead to adverse risk of exposure to these organisms;
8.4. other effects — activated sludge respiration inhibition testing;
8.5. additional ecotoxicological studies summary and evaluation.
Minister for the environment r. vējonis annex 6 Cabinet of 15 April 2003, the Regulation No 184 additional information or studies on biocides, if contained in biocidal active substance is a chemical 1. additional studies on biocidal effects on human health: 1.1. studies on food and feed of the effects on human health, if said products and feedingstuffs treated or contaminated with active substance : 1.1.1. feeding and metabolism studies in livestock if the biocide residues remain in the long term or accumulate in animal feedingstuffs — evaluate the biocide residues and their maximum levels and food of animal origin;
1.1.2. a study on the characteristics and limits of the biocides quantity depending on production, also depending on whether food or feed is produced or prepared in industrial conditions in the home;
1.2. the exposure assessment of biocidal products and biocidal study of effects on human health, if such research is required and the potential effects of biocides shows previous studies (on the biocides contained in biocidal products or active substances) or special features (such as the nature of the substance or structure).
2. additional studies on the movement of biocidal products in the environment. Making of annex 5, the provisions referred to in paragraph 7, the study determined the movement of biocidal components, transformation and degradation of soil, water and air, which are the ecotoxicological effects.
3. additional ecotoxicological studies: studies on biocides 3.1 exposure to birds — determines the acute oral toxicity, if not carried out studies in accordance with annex 4, paragraph 14 of these requirements.
3.2. studies on the effects on aquatic organisms, if biocides used in water, on the water or close to the water surface: 3.2.1. detailed research on the effects on fish and other aquatic organisms;
3.2.2. study of the active substance and its metabolites residues in fish, which are or may be toxic or dangerous to the environment, or you can create, cause or contribute to the toxic or environmentally hazardous compounds formation;
3.2.3. research on potentially dangerous substances or other key ingredients of biocides, which is not the active substance — this Appendix 3.6. referred to studies, if the Latvian Environment Agency, in accordance with rule 25.3. section has indicated that the studies are to be carried out;
3.3. field trial (study outdoors under natural conditions or conditions that are close to natural, under the proposed conditions of use of biocidal products and conditions) of the biocidal efficacy and risk to aquatic organisms if the biocide sprayed close to the water surface and if the Latvian Environment Agency, in accordance with rule 25.3. section has indicated that the study should be carried out;
3.4. studies on exposure to other organisms that are not the target: 3.4.1. studies on the toxic effects on terrestrial ecosystems vertebrates other than birds;
3.4.2. studies on the acute toxicity to honeybees;
3.4.3. studies on the effects on other beneficial arthropods other than bees;

3.4.4. studies on the toxic effects on earthworms and soil macro-organisms that are not the target, if the biocide may create adverse risks of exposure to these organisms;
3.4.5. studies on the effects on other soil organisms other than the target organism;
3.4.6. studies on the effects on other organisms (flora and fauna), which is not the target, if the biocide may create adverse risks of exposure to these organisms;
3.5. If the biocide is designed as pellets or bait, out: 3.5.1. field experiments and observations to assess the risk of non target organisms, their living environment;
3.5.2. the study on the impact on the body of the biocides barošano, if there is a risk that the biocides are causing adverse effects on the organism barošano, not the target. The study determines what is the impact of biocides in the organism, or barošano, and their use is permitted;
3.6. research on effects on aquatic organisms: 3.6.1. prolongēt toxicity studies to an appropriate species of fish;
3.6.2. studies on the exposure of an appropriate species of fish reproduction and growth rate;
3.6.3. bioaccumulation test appropriate species of fish;
3.6.4. studies on Daphnia (Daphnia magna) reproduction and growth rates.
4. Summary and evaluation of the information obtained by additional ecotoxicological studies and studies on biocidal effects on human health and the environment of biocidal products.
Minister for the environment r. vējonis annex 7 Cabinet of 15 April 2003, the Regulation No 184 technical report on the content of the active substance if the active substance is a fungus, micro-organism or virus 1. details of active substances, micro-organisms, fungi, or viruses (hereinafter referred to as the active organism) — production: 1.1. manufacturer's name, legal address and location;
1.2. tests or research caller name;
1.3. plant location.
2. the importer's name and address.
3. Identity of the active organism: 3.1 General name and other names;
3.2. taxonomic name and strain indicating whether it is a stock Variant or a mutant strain (strain mutated) virus-serotype or proposing the mutant mutant taxonomic name;
3.3. inventory and cultural item identification number, if culture is stored;
3.4. the active presence and identity of the organism detection, morphology, serology, biochemistry and other methods, procedures and criteria.
4. the origin of the active organism and acquisition: 4.1 in the natural or artificially created;
4.2. the active organism or active strain distribution methods;
4.3. the cultivation methods;
4.4. production technology and techniques, including detailed information on the procedures and measures for ensuring quality and uniform collection of active organism material. If the active organism is a strain of mutant, provides detailed information about the acquisition, retention, and the unbundling process, specifying all known differences between the mutant mutant and wild strain and the strain;
4.5. the final active organism material composition, properties, purity, identity, and the nature of impurities and extraneous organisms active content in the body;
4.6. methods to prevent raw materials or issue cultural contamination or pollution and loss of virulence;
4.7. waste management.
5. Methods of analysis: 5.1 the active presence and identity of the organism detection methods;
5.2. methods of raw materials (which produces active organisms) for determining the identity and purity of the test results, too, and the test conditions and variability of results;
5.3. methods of active organism prepared microbiological purity detection and control, to ensure that the active organism impurities and extraneous organisms active organism culture does not exceed the allowable asset level of contamination of the organism, including the test results and test conditions and variability of results;
5.4. methods of human or other mammalian pathogens pollution detection active organisms, including fungi and protozoa to the determination of different temperatures (35 ° C and other temperatures, specific to pathogen pollution formation and development process);
5.5. If necessary, the method of viable and non-viable (e.g. toxins) residues determination by the active organism in treated products, foodstuffs, feedingstuffs, animal and human body fluids and tissues, soil, water and air (soil, water, structures, organisms, products or surface).
6. Biological properties of active organism and description: 6.1. origin and its existing and previous (also natural origin, incidence and, if necessary, geographical distribution);
6.2 affinity and relationship with vertebrates, invertebrates, plants or other organisms pathogenic agents;
6.3. effects on target organism. Information about the antagonism of the host, or that the active organism is pathogenic host. Detailed information about the hosts and their characteristics;
6.4. the infectious dose, route of exposure and transmission capacity to spread or to other organisms (stickiness). Indicates if the active organism composed of toxins or they are not, even if it can produce toxins. Describes the identity of toxins, chemical structure (composition and structure formula), physico-chemical properties, stability, toxicity and risk of intoxication, especially the active organism under the proposed conditions of use, if necessary;
6.5. possible effects on non target organisms, but which have similar characteristics, susceptibility to infectious diseases, infectious disease transmission and pathogenicity, or they are related to the target organism;
6.6. stickiness other organisms other than the target organism;
4.2. other adverse changes in biological organisms, which is not the target, if the active organism to properly use under the proposed conditions of use;
4.2. contamination and physical stability under the proposed conditions of use;
4.3. genetic stability (e.g. mutation rate) under the proposed conditions of use, taking into account the climate and environmental conditions and other factors;
6.10. the effects of pathogens or the ability to infect humans and animals under conditions of immunosuppression;
6.11. the ability of the pathogen effect or infect specific parasites or predators of the target species.
7. on the occurrence of the harmful impact and intended uses:

7.1. the destructive occurrence that need to destroy, render harmless distract or otherwise affect, and products, substances, organisms, objects, or other objects to be protected or treated with the active organism;
7.2. uses envisaged (e.g. fungicide, rodenticide, insecticide, bactericide);
7.3. observations and information concerning undesirable or unintended side-effects on other organisms that are not harmful occurrence, which causes the active organism in addition to effects on target organism;
7.4. information on the generation and development of resistance and the necessary measures, if there was a resistance;
7.5. effectiveness against target organisms;
4.7. user — industry, professional or non-professional users.
8. Toxicological studies on acute toxicity, which can cause the active organism, if: 8.1. active organism oral administration;
8.2. the active organism inhales; If necessary, also be respiratory sensitization;
8.3. active body in contact with the skin, the skin determines the sensitivity and excitability;
8.4. the active organism can get into the eyes, down the eye irritancy;
8.5. the active organism a virus or viroid, in addition to this annex 8.1, 8.2, 8.3 and 8.4. the studies referred to in cell culture studies using purified infective, for viruses and mammalian, avian and fish cells in primary cell cultures.
9. If, in carrying out studies on the acute toxicity in accordance with paragraph 8 of this annex, one dose or one test is not enough to determine the ability of infection, toxins, or other active organism or its balance in the highly toxic substances and their effects, perform additional tests or checks.
10.40-day study, two species (one species is rodents, other are not rodents) for subchronic toxicity, which can cause the active organism, if: 10.1 active organism oral administration;
10.2. "inhaling the active organism (if necessary);
10.3. the active body in contact with the skin (if necessary);
10.4. the active organism a virus or viroid, in addition, this appendix 10.1 10.2 and 10.3. the studies referred to determine the ability of contamination using bioassay or suitable cell culture at least seven days after administration of the test animals.
11. other toxicological studies: 11.1. study two species (one is, the other rodents — other mammalian species) on chronic toxicity, which can cause the active organism, if the oral administration (unless there are other more appropriate type of the study on the chronic toxicity);
11.2. carcinogenicity study in two species (one is, the other rodents — other mammalian species). These studies may be grouped with this annex 7.3. studies referred to;
11.3. mutagenicity studies in accordance with the provisions of Annex 8.5. section;
11.4. studies on the toxicity of the active organism reproductive: 11.4.1. teratogenicity studies, rabbits and one rodent species;
11.4.2. two-generation reproductive toxicity study to see the effect of the active substance to one species of reproductive capacity and growth;
11.5. metabolism studies in mammals, including toxicokinetic evaluation, studies of absorption (skin absorption) distribution and excretion (excretion) of the mammalian organism indicating organs that occurs in the main metabolic and toxic metabolites concentration;
11.6. neurotoxicity studies, carried out when the active body structure, characteristics or other specific signs that active organism can be antiholīnesterāz effect or other neurotoxic properties. If necessary, determine the delayed neurotoxicity adult hens;
7.3. immunotoxicity (such as allergies).
12. emergency spills or accidental exposure and possible adverse exposure assessment, if the active organism intended for biocidal use where produced, prepared, consumed or stored food or animal feed, and the people, livestock or pets are likely to come into contact with the treated sites of biocides, structures, equipment or materials.
13. The following medical news, without giving details of the persons (if available): 13.1. production of the active organism in the medical surveillance, including medical checkup data;
13.2. direct observation (e.g., clinical cases, poisoning incidents);
13.3. news for professional users and other persons who are or have been in contact with other active organisms (e.g. carriers);
13.4. the medical examination or opinion on the Protocol factory (producing the active organism), employed the power users or the health status of the population;
13.5. observations on exposure of the population of the active organism and the epidemiological research data;
13.6. poisoning incidents and their diagnosis, including specific signs of poisoning and clinical tests;
8.5. the expected effects of poisoning the forecast.
14. Summary and conclusions on the toxicological effects on mammals, including the no-observed-adverse-effect level, any no-observed-effect level, the acceptable daily intake (man), information and evaluation results for all types of toxicological effects, pathogenicity and infection, as well as other information concerning the active organism and suggestions for necessary measures to be employed and the protection of others.
15. Ecotoxicological studies: 15.1. acute toxicity to fish;
15.2. Daphnia acute toxicity (Daphnia magna);
15.3. algal growth delay (inhibition) test;
15.4. acute toxicity for one species of organisms that live in water and not the target organism;
15.5. pathogenicity and infection of medusbit and earthworms;
15.6. acute toxicity or pathogenicity and infection capabilities in relation to organisms that are not the target, if the active organism can cause adverse effects on the risk of these organisms;
15.7. other research on the effects on flora and fauna;
15.8.3. these provisions 12.1., 12.2, 12.3, 12.4 and 12.5.. the studies referred to in regard to toxins, if the active organism can produce toxins;
15.9. the active organism spread, mobility, multiplication and stability in the air, soil and water;
15.10. This provision 3.12.6., 12.7, 12.8 and 12.9. in these studies and summary for toxins, if the active organism can produce toxins.

16. Measures necessary to protect man, non-target organisms and the environment: 16.1. recommended methods, techniques, precautionary and security measures, the manufacture, use, storage, transport or performing other actions with the active organism, as well as accident or in the event of fire;
16.2. circumstances or environmental conditions under which you may not use the active organism or take other actions with it;
16.3. ability and measures or methods to reduce or eliminate the contamination of the active organism;
16.4. air, soil and water (in particular drinking water) pollution;
16.5. actions, an accident or emergency;
16.6. the active organism waste management (including measures for surface run-off and seepage from waste disposal and water pollution control);
16.7. measures in cases where the accident leaks of the environment (air, water (including drinking water) or soil), — collection and purification, disposal or remediation.
17. The proposals and the reasons for the classification of the active organism, due to its ability to cause a health risk in accordance with the laws and regulations governing labour protection requirements when dealing with biological substances.
18. The evaluation and summary of information obtained by research on the active organism.
Minister for the environment r. vējonis Annex 8 Cabinet of 15 April 2003, the Regulation No 184 technical report on biocides content if the biocidal active substance contained in the active organism (fungus, micro-organism or virus) 1. News on biocides and the production of the active organism: 1.1. biocides and the manufacturer of the active organism name, legal address and location;
1.2. tests or research caller name;
1.3. plant location.
2. the importer's name and address.
3. the identity of the biocidal products: 3.1. trade name or proposed trade name and manufacturer's code (number or other designation given by the manufacturer of the biocides);
3.2. detailed quantitative and qualitative information on the composition of the biocidal products, including active organisms, extraneous organisms, inertaj and other ingredients;
3.3. the biocidal preparatory way and physical state or other physical properties related to the preparatory nature (for example, wet powder emulsion concentrate);
3.4. the concentration of active organism in raw materials.
4. Biocides of physico-chemical, mechanical and biological characteristics: 4.1 appearance, colour and odour;
4.2. stability during storage and shelf life. Temperature, packaging, storage conditions and methods, and the effects of other factors on biological biocidal activity and its preservation;
4.3. biocides and other similar mechanical properties: 4.3.1. ability to moistened (wettability);
4.3.2. foaming characteristics (stable foam formation);
4.3.3. suspensibility and suspension stability;
4.3.4. wet sieve test and dry sieve test;
4.3.5. particle size and characteristics of the biocidal composition depending on the particle size (including dust and fine particle content in the biocides), friction between particles and friability;
4.3.6. Pellet sieving test and the nature of the biocidal composition depending on the mass of granules, specifying the particle content of the biocides. Be sure to include the content of particulate matter in the biocides that exceed millimetres;
4.3.7. the content of the active organism with biocidal products, biocides or treated materials or products treated with biocides or surface material (specify biocides, made as pellets or bait);
4.3.8. the ability of the emulsion, the emulsion degradability, emulsion stability;
4.3.9. flowability, pourability and dustiness;
4.4. physical and chemical compatibility with other products (also with other biocides, with which to use the biocides);
4.5 samirkšan and sticking, as well as the movement of biocidal products or elsewhere in the environment after its use;
4.6. the biological properties of active organism change after the inclusion of biocidal active organism in composition (especially pathogenic or infection can change).
5. Methods for identification and analysis of the biocides: 5.1. analytical methods for determining the composition of the biocidal products;
5.2. methods for determining residues (such as bioassays);
5.3. methods of microbiological purity of the biocidal detection and control;
5.4. methods of human and mammalian pathogens and determining the biocidal control of pathogens;
5.5. methods for detection of other pathogens and control of biocidal products, if necessary. Defines and controls the environment hazardous pathogens and pathogens that are dangerous organisms other than the target organism;
5.6. the techniques of biocides uniformity and uniformity of the biocides, methods and quality control.
6. The biocidal efficacy on harmful occurrence and intended uses, as well as: 6.1. types of biocides under the provisions of this annex and intended use;
6.2. details of intended use (for example, apkarojam the harmful organisms, materials to be, a product, equipment or space);
6.3. characteristics of one-use (such as biocides used to process a dose);
6.4. conditions for the use of biocides (taking into account the results of the studies and conclusions), also in the context of climatic or other environmental conditions;
6.5. the environmental or other specific conditions (factors), which, in the light of the results and conclusions of the studies, you may not use biocides;
6.6. the use of methods and techniques;
6.7. the number of times you need to undergo treatment with biocides, duration of treatment with biocides and other conditions relating to the duration of treatment with biocides or time;
6.8. proposal to the instructions for use;
6.9. studies on treatment with biocides or use intervals;
6.10. experiment or trial in field conditions;
6.11. information on the generation and development of resistance;
6.12. impact on product, process, equipment, material or surface quality.
7. Toxicological studies, which, in addition to studies on the toxicity of the active organism, carried out in accordance with the provisions of annex 7:7.1 single dose oral administration;
7.2. the single dose is administered under the skin;
7.3 biocides inhaling;
7.4 biocides in contact with the skin, the skin determines the sensitivity and excitability;
7.5. the biocides can get into the eyes, down the eye irritancy.

8. Toxicological studies or information on other substances contained in biocidal products (other than active organisms) toxic effects, especially on potentially toxic effects of hazardous substances.
9. Biocides for exposure and effects on human health are assessed: 9.1. depending on the preparation of biocidal products or production methods and use techniques: 9.1.1 subcutaneous absorption;
9.1.2. If the biocidal inhaling;
9.2. the conduct of the trial in field conditions and the effects on workers under the proposed conditions of use. If necessary, the exposure assessed numerically and determines the permissible occupational exposure levels.
10. information or ecotoxicological studies to be carried out in addition to the studies carried out in accordance with the provisions of annex 7:10.1. observations on undesirable or unintended side-effects (for example, to organisms that are not the target);
10.2. stability in the environment if necessary.
11. Measures necessary to protect man, animals and the environment: 11.1. recommended methods, techniques, precautionary and security measures in the production, storage, management, moving or performing other actions with a biocide;
11.2. the precautionary and safety measures to protect people and animals, also the period during which the product must be observed between the treatment with biocides and the use of the product treated, or the use of biocides and between human or animal into or stay in the area, room or other place where biocide used;
11.3. risk reduction measures in cases of emergency and emergency relief measures;
11.4. the biocidal waste management;
11.5. the biocidal packaging waste (packaging, recycling or disposal cleaning).
12. classification of Biocides, packaging and labelling in accordance with the provisions of Chapter VI: 12.1. justification for the classification and labelling of chemicals, depending on their properties, which is the composition of the biocidal products, including: 12.1.1. hazard symbol;
12.1.2. hazard explanation;
12.1.3. characterisation of exposure;
12.1.4. safety requirements for designation;
12.2. the active organism the biological hazard symbol and risk group in accordance with the laws and regulations governing labour protection requirements when dealing with biological substances;
12.3. packaging and labelling proposals;
12.4. the proposal for the safety data sheet, if required;
12.5. packaging (type, materials, size), packaging and compatibility of the biocidal products with packing material.
13. Information on the evaluation of biocides and summary.
Minister for the environment r. vējonis Annex 9 in the Cabinet of 15 April 2003, the Regulation No 184 technical content of the message, if the application for registration of temporary i. General questions 1. proof that the applicant: 1. the information supplied is correct and true;
1.2. the information presented is based on research results;
1.3. he undertakes to submit complete information and documentation (also on the ongoing trials or ordering).
2. evidence that the active substance or biocidal have been trading before 14 May 2000 (in accordance with this annex 2.1 or 2.2): 2.1. Proof that the substance is used as an active substance in the biocidal composition is the biocide (which has been a trade before 14 May 2000) used or label that indicates the name of the active substance;
2.2. a Member State, if the active substance is identified or for the active substance and the biocidal has notified the Commission of the European Union, a reference to the identification or notice.
3. Accounting or inventory data on biocides or active substance if: 3.1. applicant is manufacturer-submitted information on trade volumes each year during the period from 1998 to 2002. The information includes details of biocidal products and active substances, specifying the quantity of the active substance of each type that is mentioned in the novel, this provision in the annex and containing the active substance concerned;
3.2. the applicant who imports or take other actions (other than a production) to the active substance, — specify information about trading with active substance levels in each year during the period from 1998 to 2002;
3.3. the applicant who imports or take other actions (except production) with biocides, — specify the information on the volume of trade in biocides in each year during the period from 1998 to 2002.
4. information on ongoing research or ordered (required to evaluate the biocides or active substance use and the effects on human health and the environment) due dates. The applicant also indicates if any research or information he considers necessary for effects on human health and the environment, the evaluation and risk assessment.
5. If the active substance is active body, in that the information required for the active substance shall, taking into account the specific characteristics of the active organism specified in annex 7 of these rules. Information that is not referred to in annex 7 of these regulations, may not specify.
6. the end of the study mērķindikator can not specify if information about them is not necessary to describe the type of biocidal products in the piesakām area of use or biocides or active substance effects for human health or the environment, based on the study of why the information did not provide mērķindikator endnotes (such that this point is not possible or is not necessary to establish).
 
II. Information on biocidal products and active substances manufactured or imported 7. News about the production of the active substance if the active substance is applied: 7.1 the manufacturer name, legal address and location;
7.2. inspection or research caller name;
7.3. plant location.
8. details of biocidal active substances and production log on biocides: 8.1 and biocidal active substances manufacturer name, legal address and location;
8.2. tests or research caller name;
8.3. the location of the production facilities.
9. the importer's name and address.
 
III. Information on the active substance 10. Identity of the active substance: 10.1 name according to IUPAC nomenclature;
10.2. The International Organization for Standardization (ISO) approved denomination or name that recommended approval of ISO and synonyms;
10.3. the manufacturer code (number or other designation given by the manufacturer of the active substance);
10.4. The CAS number, the registration number of the chemical in the European Community in the existing commercial chemical substances (EINECS) or European Community applied for the list of chemical substances (ELINCS) (EC number), if the active substance is listed in the list;

10.5. Molecular and structural formula;
10.6. the active substance production method (shortened synthesis process of the active substance in the presentation);
10.7. specification of purity of the active substance (in g/kg or g/l);
10.8. the impurities or additives (e.g. stabilizers), their structure and the possible impurity or additive quantity (in g/kg or g/l), specifying the minimum and maximum quantity or range;
10.9. the natural active substance or active substances the original origin (product materials, plants or organisms, as derived from the active substance).
11. the active substance in the physico-chemical properties: 11.1. melting point, boiling point, relative density;
11.2. the vapour pressure of purified active substance (Pa);
11.3. solubility in water, including the observed effects, if the pH is between 5 and 9, and the effect of temperature on solubility;
11.4. partition coefficient: solubility of the substance concerned in relation to n-octanol solubility in water.
12. Toxicological studies on acute toxicity, which can cause the active substance if the active substance: 12.1 oral administration;
12.2. inhaling the active substances;
12.3. active substance in contact with the skin, the skin determines the sensitivity and excitability;
12.4. active substances can get into the eyes, down the eye irritancy.
13. other toxicological studies: 8.1. metabolism studies in mammals, if any are required and available;
13.2. subchronic toxicity 90-day study. If the 90-day subchronic toxicity studies are not available, it may be submitted in place of short-term repeated dose toxicity study (28 days). If short-term repeated dose toxicity study (28 days) is available, it does not perform;
13.3. chronic toxicity studies, if any, are necessary and available;
13.4. mutagenicity studies: 13.4.1. gene mutation study in bacteria under laboratory conditions (in vitro), using mutant reversion method;
13.4.2. citogenitāt studies of mammalian cells, laboratory (in vitro);
13.4.3. gene mutation assay in mammalian cells, laboratory (in vitro);
13.4.4. gene mutations in additional in vivo studies, if any, of this annex. 13.4.3 13.4.1 or 13.4.2.. the checks referred to in point is positive;
13.4.5. gene mutation in vivo study, if this annex 13.4.4. the results of the studies referred to are negative, but the laboratory (in vitro) study results are positive;
13.4.6. studies of exposure to germ cells (mammalian spermatogonial chromosome aberration test) or embryonic cells (rodent dominant lethal mutation test) If this annex 13.4.4. the results of the studies referred to are positive and if necessary;
13.5. carcinogenicity study, if any are required and available;
13.6. studies on the toxicity of the active substance: reproductive 13.6.1. teratogenicity studies, if any, are necessary and available;
13.6.2. fertilitāt studies, if any, are necessary and available;
8.5. observations on population exposure of the active substance and the epidemiological research data, if any, are necessary and available.
14. Ecotoxicological studies: 14.1. acute toxicity to fish;
14.2. Daphnia acute toxicity (Daphnia magna);
14.3. algal growth delay (inhibition) test;
14.4. microbiological activity inhibition test;
14.5. bioconcentration (bioaccumulation) studies, if any, are necessary and available;
14.6. the degradation of the active substance: 14.6.1. complete biodegradability;
14.6.2. inherent biodegradability (where such studies are necessary and available);
14.6.3. abiotic degradation, determining hydrolysis rate, depending on the pH and the identity transformation products;
14.6.4. determined by abiotic degradation, to investigate the water and transformation products identity (if such studies are necessary and available);
14.7. adsorption and desorption of the assay.
15. The proposals and the grounds concerning the classification and labelling of the substance according to the laws and regulations governing chemical and chemical product classification, labelling and packaging, and for labelling, including: 15.1 the hazard symbols;
15.2. the hazard explanations;
15.3. the characteristics of exposure to a substance;
15.4. safety requirements for designation.
16. If this appendix 13.1., 13.2, 13.3, 13.5, 13.4.6.,.,., 13.6.1, 14.5 13.6.2 8.5., and 14.6.4 14.6.2. the studies referred to the need for and possible exposure shows the results of the studies previously made or special features (such as the nature of the substance or structure), but they have not been taken or are not available, the application shall indicate, when such a study will be carried out.
17. the information on the active substance evaluation and summary.
 
IV. Information on biocides 18. information in accordance with the provisions of the annex, if contained in biocidal active substance is a chemical, or these rules, annex 8 if the biocidal active substance contained in the active organism.
19. If the provisions of this annex or in annex 8. research is required and the potential effects of biocides, shows the results of the studies previously made or special features, but studies have not been taken or available, the application shall indicate, when such a study will be carried out.
20. Information on the evaluation of biocides and summary.
Minister for the environment r. vējonis annex 10 of the Cabinet of Ministers of 15 April 2003, the Regulation No 184 biocides risk assessment criteria, principles and contents i. contents of risk assessment of Biocides, general principles and criteria 1. Risk assessment includes risk assessment human health risk assessment the risk assessment of the animals and the environment. Each risk (the risk to human health, animals and the risk of environmental risk) assessment: hazard identification 1.1 content and, where possible, the no-observed-adverse-effect levels;
1.2. an assessment of the adverse effects or undesirable effects of gravity and frequency dependence of the concentration or dose size;
1.3. exposure assessment;
1.4. the risk characterisation.
2. biocidal products and active substances risk assessment, the following general principles: 2.1 the risk assessment assessed the potential effects on human health, animals and the environment, which may occur by using biocides, and the risks of exposure. The risk assessment also assess other unwanted effects and consequences of the use of biocides could cause property or business activities;
2.2. the hazard identification shall take all biocides and active substances;

2.3. the risk assessment shall examine what possible effects using biocides, can lead to severe consequences for human health, animals and the environment, and the consequences of such penetration, and the likelihood of the occurrence of the hazard;
2.4. to characterize the risk: it evaluates the numeric 2.4.1, but if this is not possible, risk assessed quality;
2.4.2. determining the acceptable risk;
2.5. assess killing of vertebrate the time necessary to obtain the death of the target vertebrate and the conditions, if the intended effect of the biocides are vertebrates (which is the target) death;
2.6. in order to determine the risks of the biocidal products, assess the components of biocides (especially active substances and any potentially hazardous substances) the risk to human health, animals and the environment;
2.7. the risk assessment shall take into account the biocide components (especially the active substances and potentially hazardous substances) as a mutual synergy effects, unless the substance amplifies the effects of other substances;
2.8. the results of the risk assessments carried out an impact assessment and for the following effects: 2.8.1. biocidal effect on people;
2.8.2. the biocidal effect on animals;
2.8.3. the effects of the biocidal product on the environment; 2.8.4. undesirable effects;
2.9. the overall effect of the biocides and the resulting risks to human health, animals and the environment shall be assessed, taking into account the results of the risk assessments and conclusions on the composition of the existing biocidal active substances and potentially dangerous substances;
2.10. is not permitted the use of biocides, if then, subject to the authorization of use, registration certificate or temporary certificate of registration in these conditions, there is no such effect on the target organism, on the label or in the instructions for use. Biocidal efficacy to the target must be identical or similar to the biocidal efficacy benchmark (if used for the assessment of benchmark sample biocides) or must be verifiable by other means. Conclusions the biocidal efficacy indicates for any intended use of biocides, except where indicated on the label of the biocides that biocide intended for use in specific circumstances. Determining the efficacy of the biocidal products, shall assess whether the intended dose is the smallest dose that produces the desired effect on the target organism, evaluating research data on induced responses depending on the dose of biocides;
2.11. is not permitted the use of biocidal products, if it is possible to evolve resistance to the biocidal active substance, which can be reduced by adopting special measures;
2.12. If it is not possible to carry out a risk assessment using the applicant's technical report submitted, the applicant shall provide a minimum risk assessment the additional information required;
2.13. in applying the criteria referred to in this annex and the principles, evaluate any significant undesirable consequences, the effects of the biocidal products, the use of biocides need and determine whether you can authorize the use of biocidal products or active substances, or the need to set restrictions on use or other conditions.
3. Biocidal products and active substances of general risk assessment criteria are: 3.1 the veracity of the information submitted by the applicant, the completeness and adequacy of the risk assessment needs;
3.2. biocidal products or active substances would cause adverse effects and undesired consequences, their severity, distribution, as well as biocides or active substance, the degree of risk. Assessment of biocidal products and active substances, shall take into account, or the active substance of the biocidal or give rise to significant risks to human health, animals or the environment;
3.3. adverse effects and undesirable effects of gravity or the prevalence of addiction or biocidal active substances exposure;
3.4. the people, animals and the environment the maximum level of protection against or biocidal active substances risks;
3.5. the biocidal efficacy on the occurrence, based on the study of the development and manufacture of biocides. Biocides must be sufficiently powerful to destroy chemical or biological, deter or render harmless, prevent the occurrence of the effect or influence it otherwise;
3.6. benefits, their nature and extent, provided the use of biocidal products, and biocides for use in the field or industry;
3.7. the occurrence of the failure to develop a resistance to the biocidal active substance. Note that the target may not develop resistance to the biocidal active substance;
3.8. the unnecessary pain and suffering without causing animals (particularly vertebrate animals). Intended to control vertebrates, the use of biocides is not permissible if: 3.8.1. death is simultaneous with the loss of consciousness;
3.8.2. death is not immediate;
3.8.3. vital functions does not fall without explicit signs of suffering.
 
II. risk assessment of biocidal products to human health content and principles 4. Biocidal active substances, or potentially hazardous substances risk assessment human health include: 4.1 such exposure assessment: 4.1.1. acute and chronic toxicity;
4.1.2. irritant effects;
4.1.3. the PEP;
4.1.4. sensitising effects;
4.1.5. repeated dose toxicity;
4.1.6. mutagenic effects;
4.1.7. carcinogenic effects;
4.1.8. reproductive toxicity;
4.1.9. toxic effects on the nervous system (neurotoxicity);
4.1.10. the physico-chemical properties induced adverse effects and consequences;
4.1.11. the specific active substances or potentially hazardous substances the adverse effects;
4.2. health risk assessments for the following groups of people that are or may be subjected or biocidal active substances: 4.2.1 workers or professional users;
4.2.2. consumers or professional users;
4.2.3. the people on which the biocidal active substance worked indirectly via the environment.
5. Evaluating biocidal active substances, or potentially hazardous substances for risks to human health, the following principles shall apply: 5.1 determine adverse effects or undesirable effects of gravity and frequency dependence of the concentration or dose, exposure assessment and risk characterisation determines if the active substance in the biocidal composition is 2, 3 or group 4 biological agent, or if the active substance or a substance is potentially hazardous properties which biocides will be classified as a hazardous chemical product;
5.2. the risk characterisation, without adverse effects or undesirable effects of dependence on concentration or dose, if biocides and its residue can cause undesirable effects on human health or the environment, but it is not possible to determine the effects of exposure to or dependence on concentration or dose;

5.3. the risk characterisation determines if, based on the results of the studies carried out with appropriate approval study method or another standardized method, it is not possible to identify the hazards and effects of biocides is not classified as a hazardous chemical product, the active substance in the biocidal composition no 2, group 3 or 4 biological agent and biocide and its residue can cause undesirable effects on human health or the environment; 5.4. repeated dose toxicity and toxic effects on reproductive system determines each contained in biocidal active substances and potentially dangerous substance. To determine the repeated-dose toxicity and toxic effects on the reproductive system, the no-observed-adverse-effect level or the lowest dose or concentration that produces unwanted effects or adverse effects (lowest-observed-adverse-effect level);
5.5. to evaluate the acute toxicity, irritancy or corrosivity adverse effects or undesirable effects of dependence on concentration or dose size is determined by: 5.5.1. no observed adverse effect level or the lowest observed adverse effect level, when possible, using approved methods;
5.5.2. acute toxicity for — lethal doses (LD50, mg/kg), the lethal concentration (LC50 mg/l), or, if the acute toxicity used in determining the fixed dose method — specific discriminatory dose;
5.5.3. corrosivity or irritancy, or an active substance or a substance is potentially hazardous properties, which causes or is likely to cause these effects;
5.6. to assess active substances or potentially hazardous substances of mutagenicity and carcinogenicity of the adverse effects or undesirable effects of dependence on concentration or dose size is determined by: 5.6.1. no observed adverse effect level or the lowest-observed-adverse-effect level, if the active substance or potentially dangerous substance is a carcinogen, but not genetically toxic;
5.6.2 or active substance or potentially dangerous substance has properties which causes or may cause such effects;
5.7. determine whether during use of the biocidal products contained in biocidal active substance or potentially dangerous substance has properties which can cause skin or respiratory sensitization, if it is not possible to determine the dose, or concentration, of which the lower dose or concentration will not cause adverse effects, sensitization takes place;
5.8. evaluation of biocides or active substance, take into account the available medical data and information on the toxic effects of biocides on people, including observations of the employed population or the exposure of the active substance and the epidemiological research data;
5.9. the biocidal products or active substances the exposure assessment for each of the human populations (professional users, non-professional users and humans, to which a biocidal active substance exposed indirectly via the environment) that may come into contact with the active substance of the biocidal or its intended conditions of use;
5.10. the exposure assessment, or quantitatively characterize the dose, or concentration, and the way in which the biocidal active substance contained in or potentially dangerous substance or likely to be exposed to during use of the biocidal products;
5.11. the exposure assessment shall take into account: 5.11.1. adequate observation and measurement data of biocides or active substances with the same or similar use, characteristics and exposure or effects;
5.11.2. the type of biocidal products;
5.11.3. the preparatory nature of the biocides;
5.11.4. the methods, the conditions (e.g., duration of use and the use of biocides in the interval between the times) and the doses to be used;
5.11.5. physico-chemical characteristics of biocides;
5.11.6 indeed, exhibit or the manner in which a biocidal active substance exposed or likely to be exposed to (e.g., oral, in contact with skin) and biocidal products or active substances move paths, transformation or degradation in the environment, the potential for absorption;
5.11.7. the different exposure or exposure duration, frequency, volume and distribution;
5.11.8. the information that describes a group of people on which the biocidal active substance exposed or likely to be exposed to, indicating the number of people, age, gender, and group composition (workers, consumers, the people, to which a biocidal active substance exposed indirectly via the environment) if such information is available;
5.11.9. other applications (especially technical) information provided and any other available and relevant information;
5.12. If the biocidal products or active substances the exposure assessment, require an assessment of the technical modeling or calculation method, use the method: 5.12.1. which, taking into account realistic parameters and assumptions, gives better and more accurate assessment of all possible circumstances, transactions with biocides or active substance, conditions and processes (also with regard to the active substance or biocidal movement, transformation or degradation in the environment);
5.12.2. where it is possible to assess, in the light of the uncertainty;
5.12.3. the results are confirmed, making measurements (measurements and comparison is carried out on the main areas of use);
5.12.4. which is valid to evaluate the biocides or active substance use conditions and conditions;
5.13. each group of people that are or may be exposed to biocides or active substance, indicate the active substance or biocidal dose or concentration (with which the active substance or biocidal effect) compared to the no-observed-adverse-effect level or the lowest observed adverse effect level of this annex, the exposure referred to in 4.1. If possible, indicate the numeric comparison;
5.14. the findings of the risk assessment results compared with the previous risk assessment (assess for identical or similar exposure risk) results and determine the appropriate safety factor. The numeric value of the safety factor adopted depending on the biocidal active substances or dangerous characteristics and effects (especially given the critical toxicological effect). Commonly used safety factor of 100;

5.15. If this annex 4.1. exposure referred to in the ways it is not possible to determine the no-observed-adverse-effect level, the lowest-observed-adverse-effect level, or other numerical characteristics of the exposure, the Group noted the adverse effects or undesirable effects the relative seriousness and probability distribution;
5.16. the biocides are not recorded and its use is not permitted if the risk assessment (assess realistically possible events development variant with the heaviest consequences) results show that the intended use of the present unacceptable risks for human health.
 
III. risk Biocidal animals assessment principle 6. risks of biocidal products animal health evaluated similar to how risks to human health, taking into account this annex 4 and 5 above.
 
IV. Effects of the environment risk assessment principles 7. Evaluation of the risk to the environment, take into account the following principles: 7.1. evaluate any adverse effects or unwanted consequences of flora and fauna, which can lead to the use of biocides;
7.2. to identify hazards, evaluate the biocides biocidal active substance in and potentially dangerous properties of substances and any adverse effects or adverse effects that may result from exposure to the active substance or potentially dangerous substance;
7.3. If the active substance in the biocidal composition is 2, 3 or group 4 biological agent, or if the active substance or a substance is potentially dangerous characteristics which are to be classified as a biocide chemical product dangerous, determined by the unfavorable effects or undesirable effects of gravity and frequency dependence of the concentration or dose, exposure assessment and risk characterisation;
7.4. does not represent a risk characterisation if, based on the results of the studies carried out with the most appropriate research method, it is not possible to identify biocides danger, biocides are not classified as hazardous chemical product, the active substance in the biocidal composition no 2, group 3 or 4 biological agent and biocide and its residue can cause undesirable effects on human health or the environment. 7.5. risk characterisation shall be drawn up, if the biocide, identifying the hazards is: 7.5.1. signs of possible biocides (also active substances or potentially hazardous substances) bioaccumulation potential;
7.5.2. signs of possible biocides (also active substances or potentially hazardous substances) stability in the environment;
7.5.3. ecotoxicological studies of exposure, toxic effects and found time relevance (curve "toxicity/time" form);
7.5.4. on the basis of toxicity studies on biocides (active substance or potentially dangerous substance) classified as very toxic, toxic or mutagenic, as well as harmful to the characterization of the exposure "of serious damage to health by prolonged exposure ' or ' possible risk of irreversible effects";
7.5.5. information on biocides with a similar composition and for the active substances and potentially dangerous substances with similar structures that indicate the potential hazards of biocides;
7.5.6. information on biocidal effects on the endocrine system;
7.6. in assessing adverse effects or undesirable effects of gravity and frequency dependence of the concentration or dose that determines the concentration below which the concentration does not lead to adverse consequences or exposed to water, air, terrestrial ecosystems or other parts of the environment (hereinafter referred to as the forecasted effective concentration not);
7.7. the estimated effective concentration shall not active substance or potentially dangerous substance on the basis of an application or additional information about ecotoxicological studies carried out and the results of research on the efficacy of the harmful occurrence;
7.8. If the active substance or potentially hazardous substance not effective concentration estimated it is impossible to determine the number, adverse effects or undesirable effects of gravity and frequency dependence of the concentration or dose relative assessment;
7.9. in calculating the estimated effective concentration, not used for such studies for dose ecotoxicological or concentration: 7.9.1. any no-observed-effect level or concentration;
7.9.2. lowest-observed-effect level or concentration;
7.9.3. lethal doses (usually determined the LD50, mg/kg);
7.9.4. lethal concentration (LC50 is determined, usually mg/l);
7.9.5. effective (effective) concentration (EC50);
7.9.6. concentration that causes a specific function, parameter or properties development delay (usually fixed (immediate) inhibitory concentration (IC50)) in the organisms being studied;
7.10. in calculating the estimated effective concentration, not taking into account the uncertainty factor. Uncertainty factor is used to extrapolate the results of the studies conducted with one or more species, and predict the biocides (also active substances or potentially hazardous substances) the effects on the environment; 7.11. determine the uncertainty factor numeric value, taking into account the relevant parts of the environment-specific parameters, the number of the species studied, the duration of the studies carried out, the credibility of the alleged inaccuracy or uncertainty, as well as other available information (for better information and more research because less uncertainty factor). Uncertainty factor determines such factors as new chemicals under the laws governing the new chemicals risk assessment;
7.12. determine the environment in which the biocides for emissions or predicted its propagation, transformation or degradation, as well as the environment, by which a biocidal may come into contact, producing, storing, using, storing or performing other actions with a biocide or unwanted event, and the assessed exposure to air, soil, water, water channels, also flora and fauna;
7.13. in assessing exposure, follow this annex or 7.13.1.7.13.2. the principle referred to: 7.13.1. where possible, the active substances or potentially hazardous substance concentration that is or may be in the air, soil, water, water channels, also flora and fauna (hereinafter referred to as the expected environmental concentration);
7.13.2. determines the relative exposure characteristics for each environmental compartment to which it is not possible to determine the predicted environmental concentration;
7.14. the predicted environmental concentrations or relative exposure, take into account:

7.14.1. observation and measurement data of biocides or active substances with the same or similar use, characteristics and exposure or effects;
7.14.2. the type of biocidal products;
7.14.3. the preparatory nature of the biocides;
7.14.4. methods, conditions (e.g., duration of use and the use of biocides in the interval between the times) and the doses to be used;
7.14.5. physico-chemical characteristics of biocides;
7.14.6. biocidal degradation and transformation of environment degradation and transformation products also;
7.14.7. exposure or the manner in which a biocidal active substance or may act on the environment (flora and fauna) and biocidal active substances or paths of movement, transformation or degradation in the environment, as well as absorption or desorption potential;
7.14.8. different exposure or exposure duration and frequency;
7.15. If the biocidal products or active substances the exposure assessment, require an assessment of the technical modeling or calculation method, use the method: 7.15.1. which, taking into account realistic parameters and assumptions, gives better and more accurate assessment of all possible circumstances, transactions with biocides or active substance, conditions, processes (particularly in relation to biocidal products or active substances movement, transformation or degradation in the environment) and the effect on flora and fauna;
7.15.2. which can be judged, in the light of the uncertainty;
7.15.3. the results are confirmed, making measurements (measurements and comparison is carried out on the main areas of application);
7.15.4. What is valid for evaluating biocidal active substances or conditions of use and conditions;
7.16. the risk characterisation indicating the predicted concentrations in the environment compared with the forecast not effective concentration (also calculated the expected environmental concentration against the predicted concentrations are not effective);
7.17. If it is not possible to calculate the predicted environmental concentration of pollution and the predicted concentration for ineffective, consider that the exposure or estimated for the exposure conditions can appear an adverse effect on the environment or unwanted consequences;
7.18. accident or adverse events (which results in a polluted environment) the possibility should be minimal. Biocidal products or active substances in the instructions for use shall adopt measures or an adverse event likelihood and consequence.
 
V. risk assessment of specific Biocides criteria 8. Assessing the risks to human health, the criteria is this annex form referred to in point 4.1 of the severity of the adverse effect, prevalence and frequency, as well as the adverse effects of addiction or biocidal active substances the exposure concentration or dose size. Risk to human health is not permissible if: 8.1 dose or concentration is greater than the active substance in the biocidal or no-observed-adverse-effect level or the lowest-observed-adverse-effect level;
8.2. on the basis of adverse effects or undesirable effects of the relative assessment, it can be concluded that the active substance or biocidal products will cause adverse effects with an unacceptably heavy consequences.
9. Animal health risk assessment criteria is adverse effects (including toxicity, neurotoxicity, irritation, corrosivity, sensitisation, mutagenic, carcinogenic or other effects) the severity, prevalence and frequency, as well as the adverse effects of addiction or biocidal active substances the exposure concentration or dose size. Not permitted the use of biocides, if the risk assessment confirms that the biocides presents an unacceptable risk to non-target animals.
10. environmental risk assessment criteria are contained in the biocidal active substances or potentially hazardous substances, biocides or limits its breakdown or reaction products resulting in adverse effects, unwanted consequences or risks to the environment. Not permitted the use of biocides, if the risk assessment confirms that the biocide present unacceptable risks to air, water (including water channels), soil and land-dwelling organisms that are not the target.
11. the main environmental risk criteria is the predicted environmental concentrations relative to estimated effective concentration, if not: 11.1 the predicted environmental concentrations and the predicted concentration for ineffective is one or less than one, does not require any additional risk reduction measures and additional information until you increased or biocidal active substances sales or other changes;
11.2. the predicted environmental concentrations and the predicted concentrations are not effective ratio is greater than one, the risk to the environment is unacceptable. Based on environmental concentrations and the predicted concentration for ineffective and 7.5 of this annex referred to in point features, determine whether: 11.2.1. need more information;
11.2.2. requires additional risk reduction measures;
11.2.3. is not permissible or biocidal active substances;
11.3. no predicted environmental concentrations and the predicted concentration for ineffective numerical assessment — gives the predicted or biocidal active substance in a relative assessment. The risk to the environment is not permissible, if the predicted or biocidal active substance in relative assessment shows that the biocides or active substance can cause adverse effects, with very serious consequences.
12. risks to the aquatic environment are not allowed and the use of biocides is not allowed if: 12.1. using biocides according to the proposed conditions of use, predicted the biocidal active substances or potentially hazardous substances, metabolites, degradation or reaction products in water or water channels can lead to undesirable effects on aquatic species other than the target organism (including marine, coastal or transitional waters environment), except when the experimental field conditions found that the adverse effects are not;
12.2. using biocides according to the proposed conditions of use, predicted the biocidal active substances or potentially hazardous substances, metabolites, degradation or reaction products in groundwater exceeds the concentration:

12.2.1. quality standards for ground water used for the abstraction of drinking water and laid down in accordance with the laws and regulations on the quality of groundwater, except when the field experiments established that relevant quality laws, are not exceeded;
12.2.2. the maximum concentration, which, based on toxicological information, certain active substances, assay or a low-risk biocidal products list, except if the field experiments found that the lowest concentration is not exceeded;
12.3. using biocides according to the proposed conditions of use, predicted the biocidal active substances or potentially hazardous substances, metabolites, degradation or reaction products in water or sediment (water channels): 12.3.1. concentration, defined as the quality of drinking water in accordance with the laws and regulations on surface and groundwater quality, if biocides can be used in places where you can get drinking water, except when the experimental field conditions found that concentration is not exceeded;
12.3.2. a concentration that creates adverse effects or unintended consequences, other than the target organism, except when the field experiments established that the concentration is not exceeded.
13. the Risk of soil is not allowed and the use of biocides is not permissible if it is possible not desirable soil pollution with biocides and after its use of biocidal active substances or potentially dangerous substance: 13.1. non-biodegradable in soil for more than one year (determined by testing under field conditions);
13.2. after 100 days constitutes a non-extractable residues (70% and more of the initial dose) with a mineralization less than 5% (determined by testing laboratory);
13.3. produces unintended consequences or effects on non-target organisms;
13.4.13.1. of this annex, and 13.2 13.3. subparagraphs above shall not be taken into account if the trial in field conditions shows that's not likely unwanted biocides accumulation in the soil.
14. the Risk of air environment is unacceptable, and the use of biocides is not permissible if it is projected the possible undesired effects, except where experiments in field conditions found that there is an unacceptable effect of biocides in the air.
15. the Risk of organisms other than the target organism, is not allowed and the use of biocides is not permissible if: 15.1 the organism is expected (not target) exposure with a biocide and its active substances or potentially hazardous substances: 15.1.1. the predicted environmental concentrations and the predicted ineffective concentration ratio is greater than one, except in the case where a risk assessment has demonstrated that the use of biocides under the proposed conditions of use real conditions by the use of biocides are not adverse effect or unwanted consequences;
15.1.2. vertebrate (other than the target organism) fat tissue the bioconcentration factor is greater than one, except in the case where a risk assessment has demonstrated that the use of biocides under the proposed conditions of use, the real conditions by the use of biocidal products there shall be no direct or indirect exposure to adverse or unwanted consequences;
15.2. the aquatic organisms are expected (and seas, coastal waters and transitional waters aquatic organisms) exposure with a biocide and its active substances or potentially hazardous substances: 15.2.1 the predicted environmental concentrations and the predicted ineffective concentration ratio is greater than one, except in the case where a risk assessment has demonstrated that the use of biocides under the proposed conditions of use, the real conditions of the biocides not threatened aquatic organisms (including seas and estuaries-dwelling organism) viability;
15.2.2. bioconcentration factor which completely biodegradable, is greater than 1000 or bioconcentration factor for substances that are not completely biodegradable, is greater than 100, except when the risk assessment has shown that the use of biocides under the proposed conditions of use, the real conditions of the biocides not threatened aquatic organisms (including seas and estuaries-dwelling organism) viability;
15.3. it is possible that a biocidal effect on urban waste water treatment plant for microorganisms (activated sludge) when biocidal active substances potentially hazardous substances, metabolites, breakdown or reaction products to be expected environmental concentrations and the predicted ineffective concentration ratio is greater than one, except in the case where a risk assessment has demonstrated that under field conditions is not direct and indirect adverse effects on urban waste water treatment plant micro-organism viability.
16. The advantages of the use of biocides can be considered more important than the risk of this annex referred to in paragraph 15.2. organisms if biocides are intended for use as an anti-fouling agent to trade, State institutions and transporters and is permitted to use anti-fouling products for 2008, taking into account the resolutions of the International Maritime Organization and guidance, and if the equivalent control of deposits cannot be achieved by other means to be used.
Minister for the environment r. vējonis annex 14. Cabinet of 15 April 2003, the Regulation No 184 of the safety data sheet contains a biocide, which existing active substance is not classified according to chemical substances and the classification of chemical products and is used only for biocidal 1. Biocides and identification of the active substance and the details of the active substance and the biocidal products producers, importers or suppliers: 1.1. name and code;
1.2. news about the company: 1.2.1 manufacturer;
1.2.2. the importer;
1.2.3. the supplier;
1.2.4. other action by the contractor biocides;
1.2.5. company registration number;
1.2.6. address, phone number, fax number, electronic mail address;
1.3. the call recipient in an emergency: 1.3.1. medical assistance;
1.3.2. the manufacturer.
2. The biocidal composition and details of its components: 2.1 description (intended use);
2.2. messages about the harmful ingredients: 2.2.1. identification code;
2.2.2. the component name;
2.2.3 concentration;
2.2.4. warning symbols, risk factors, etc.
3. Hazardous characteristics.
4. First aid measures: 4.1 General information and specific guidance;
4.2. If the biocide is inhaled;
4.3. where a biocidal gets on the skin;

4.4. where a biocidal penetrating eyes;
4.5. If the biocide is swallowed.
5. Fire and explosion safety measures: 5.1 recommended extinguishing media;
5.2 extinguishing media which are prohibited from use;
5.3. additional information.
6. the emergency measures to be taken: 6.1 personal protection;
6.2. environmental protection;
6.3. collection methods;
6.4. special instructions.
7. storage and usage rules: 7.1;
7.2. storage.
8. Safety rules: 8.1 technical features;
8.2. the concentrations in the air at the place of work;
8.3 personal protection: 8.3.1. General requirements;
8.3.2. respiratory protection;
8.3.3. hand protection;
8.3.4. eye protection;
8.3.5. other instructions.
9. Physical, chemical, mechanical and biological properties.
10. stability and reactivity: 10.1 compatibility, including organisms, materials, substances and products, with whom contact should be avoided;
10.2. hazardous decomposition products.
11. Toxicological information: 11.1 acute toxicity;
11.2. excitability and PEP;
11.3. the vulnerability;
11.4. the empirical information on the exposure of people: 11.4.1. inhalation;
11.4.2. contact with the skin;
11.4.3. contact with the eyes;
11.4.4. other effects.
12. Ecological information, including information on toxic effects on the organisms and plants.
13. possible recycling or recovery: 13.1. biocides containing wastes;
13.2. the packaging waste.
14. information on transport.
15. information on the laws and regulations governing: 15.1;
15.2. transactions with biocides.
16. Other information: 16.1. the intended use;
16.2. the operating instructions and restrictions;
16.3. in other news.
Minister for the environment r. vējonis