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The Rules On The Placing Of Plant Protection Products On The Market, In Accordance With Regulation No 1107/2009

Original Language Title: Noteikumi par augu aizsardzības līdzekļu laišanu tirgū saskaņā ar Regulu Nr.1107/2009

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Cabinet of Ministers Regulations No. 509 in Riga on 24 July 2012 (pr. No 41 47) rules on the placing of plant protection products on the market, in accordance with Regulation No 1107/2009 Issued under the plant protection act, article 5 (2) (I). General questions 1. determines the order in which the State plant protection service (hereinafter service) recorded chemical and micro-organisms containing plant protection products (hereinafter referred to as plant protection product) and authorise the placing on the market in accordance with the European Parliament and of the Council of 21 October 2009. Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market repealing Council Directive 79/117/EEC and 91/414/EEC (hereinafter Regulation No 1107/2009). 2. grant of Regulation No 1107/2009 article 28, paragraph 1 of article 30 and 40 referred to in placing the plant protection product on the market and use (hereinafter referred to as the authorisation), the service recorded at plant protection plant protection products in the register (hereinafter register).
3. a plant protection product shall not be included in the register, if the permit: 3.1 in accordance with Regulation No 1107/2009 article 52 plant protection products granted parallel trade; 3.2. in accordance with Regulation No 1107/2009 article 53 shall be granted for plant protection products for use in emergency situations to protect plants; 3.3. in accordance with Regulation No 1107/2009 article 54 shall be granted for a plant protection product research and development.
II. The granting of authorisation of plant protection products and the inclusion in the register 4. Regulation No 1107/2009 referred to in article 33 the application and required documentation to receive services shall prepare and send the person an invoice for the preparation of the evaluation of a plant protection product for inclusion in the register in accordance with the service provided by the paid service price list. 5. If the plant protection product meets Regulation No 1107/2009 article 29 requirements, service under Regulation No 1107/2009 article 36 and 37 of the decision on the authorisation of the plant protection product and included in the registry. 6. If the plant protection product does not comply with the provisions of Regulation No 1107/2009 article 29 requirements, Service decides not to grant permission and a plant protection product shall not be included in the register. 7. The application of the other country authorised the recognition procedure, service, allow the placing on the market of plant protection product and included in the register in accordance with Regulation No 1107/2009 of the paragraph 1 article 41. 8. When deciding on the authorization, service under Regulation No 1107/2009 article 31 defines the requirements for placing the plant protection product on the market and use of plant protection products as well as the particulars on the label. 9. Depending on the nature of the plant protection product and the requirements for use service it is granted registration class.
10. at the request of the person in the service of the plant protection product are recorded in the third class of registration, if it is packed in a container, the contents of which can handle no more than 5000 square meters area, using plant protection products registered in the minimum dose, and if it complies with the rules in paragraph 11 of the said criteria. 11. a plant protection product are recorded in the third class of registration, provided that: 11.1. in accordance with the legislation on chemical substances and chemical product classification, labelling and packaging procedures that are not classified as: 11.1.1 toxic or very toxic (R23-R28); 11.1.2. the first, second or third category of carcinogens (R40, R45, R49); 11.1.3. the first, second or third category mutagenic (R46, R68); 11.1.4. reproductive toxic first, second or third category (R60, R61, R63 R62,); 11.1.5. feature, which can cause serious damage to eyes (R41); 11.1.6. feature that can harm the child breastfed (R64); 11.1.7. feature, which can cause serious damage to health by prolonged exposure (R48) or where there is the use of cumulative impacts of harmful threats (R33); 11.2. in accordance with European Parliament and Council of 16 December 2008, Regulation (EC) no 1272/2008 on classification, labelling and packaging of substances and mixtures, and amending and repealing directives 67/548/EEC and 1999/45/EC and Regulation (EC) No 1907/2006 is not classified as: 11.2.1. for acute toxicity (if humans come to oral) first, second or third category (if swallowed H300-death; -Toxic if swallowed H301); 11.2.2. acute toxicity (if the human body through skin) first, second or third category (– H310 then coming into contact with the skin, a human death; H311 – toxic, if come into contact with the skin); 11.2.3. acute toxicity (inhalation of the gas and dust or mist) first, second or third category (H330-inhalation death; H331 – toxic by inhalation); 11.2.4. acute toxicity (inhalation vapours) the first or second category (H330-inhalation death; H331 – toxic by inhalation); 11.2.5.1A, 1B, and category 2 carcinogen (may cause cancer H350: specify the exposure, if it is clearly demonstrated that other exposure do not present a hazard; H351-suspect that can cause cancer: specify the exposure, if it is clearly demonstrated that other exposure does not cause danger); 11.2.6.1A, 1B, and category 2 mutagenic (H340 – can cause genetic damage: specify the exposure, if it is clearly demonstrated that other exposure do not present a hazard; H341-suspect that can cause genetic damage: specify the exposure, if it is clearly demonstrated that other exposure does not cause danger); 11.2.7. toxic to reproductive 1A, 1B, and the second category (H360F-can negatively affect fertility; H361f-suspect that negatively affect fertility; H360D may damage to the unborn child; H361d-suspect that could potentially harm your unborn baby); 11.2.8. the feature that causes serious eye damage (H318;) 11.2.9. the feature that may cause injury to the breast suckling child (H362); 11.2.10. the toxic effects of repeated exposure to irradiation (stot RE 1 and 2, category); 11.3. the use of the plant protection product risk estimation results show that the risks which may come into contact with the plant protection product use during and after use, do not use personal protective equipment, not to exceed the permissible exposure level by a specific composition of a plant protection product within the active substance review report in accordance with Regulation No 1107/2009 of annex II has been approved by the European Commission. 12. If, in accordance with the legislation on chemical substances and chemical product classification, labelling and packaging procedures the plant protection product is classified as harmful: may cause lung if swallowed (R65) – damage, it is recorded in the third class of registration, if its packaging is provided with open design, which can not be opened. 13. If, in accordance with the legislation on chemical substances and chemical product classification, labelling and packaging procedures the plant protection product is classified as harmful, extremely or highly flammable, it is recorded in the third class of registration, if the packaging is marked with a hazard warning tactile symbols. 14. The first class of registration recorded in the plant protection product, if some specific properties or, if not properly handled or used improperly, can cause increased hazards. Plant protection products in accordance with these regulations is not being filed in the first or third class, recorded the second registration class. 15. the decision on the registration of plant protection products for 10 days after it has been taken forward to the person. 16. the inclusion of plant protection products on duty of the register of plant protection product issued the registration certificate (hereinafter certificate). 17. the Department shall issue a certificate of entry in the registry and then, when the person has paid the State fee, and service has been approved by the plant protection product label text with the Commission's June 8 2011 Regulation No. 547/2011 implementing European Parliament and Council Regulation (EC) No 1107/2009 as regards the labelling of plant protection products to the requirements of article 1. 18. The registration certificate shall bear the following information: 18.1. the registration certificate holder's name, surname or name; 18.2. the name of the plant protection product; 18.3. type of preparation; 18.4. registration number; 18.5. Preparatory form; 18.6. the registration class; 11.6. the volume or weight of the packaging for distribution in Latvia; 12.8. the composition of the plant protection product in the name of the active substance content, purity; 11.7. the decision on the authorisation of the plant protection product Award (number); 18.10. the date of the registration; 18.11. the period of validity of the certificate of registration; 18.12. date of issue of the registration certificate. III. the withdrawal of authorisation or Amendment 19 service within one month of receiving the application and the documents that justify an extension of the field of use, plant protection products assessed compliance with Regulation No 1107/2009 article 51, paragraph 2 of the said conditions. If the plant protection product meets Regulation No 1107/2009 article 51, paragraph 2 of the said conditions, the service makes changes to the registry and confirm the registration submitted by the owner of the plant protection product label project with additions. 20. A change in the owner of the registration certificate, the period of validity of the certificate remains unchanged. 21. for the registration certificate is transferred to another person, the holder of the registration certificate in the service application and add documents to your own and the next card holder signature, specifying therein: 21.1. included in the register of plant protection product trade name or names, the number of the certificate of registration and registration of plant protection products on the date; 21.2. the current registration certificate the name and address of the owner and the licence holder's name and address; 21.3. the document certifying the registration of plant protection products on the dossiers and its availability for the next owner of the certificate; 21.4. the date on which the current owner of the registration certificate shall transfer all MAH's duties the next card holder. 22. the service within one month of this provision, paragraph 21, of receipt of documents, decide on changes in the registration certificate, notify the current and the next owner of the registration certificate, issue a new certificate of registration and the amendment of the register. IV. The granting of authorisation shall not be included in plant protection product register 23. Service within one month of the application and Regulation No 1107/2009 article 54, paragraph 2, of the receipt of the document to assess the plant protection product on the possible risks to health and the environment and of Regulation No 1107/2009 article 54 the authorisation shall be issued to the plant protection product for research and development purposes. 24. the authorisation of plant protection products in parallel with the trade, the person shall provide the service of Regulation No 1107/2009 article 52 the information referred to in paragraph 4. Service within one month of receipt of this information to assess the identity of the plant protection product and shall take a decision on the authorisation of parallel trade. 25. If the plant protection product is not identical to Regulation No 1107/2009. paragraph 3 of article 52, the service shall take a decision on the refusal to issue the authorisation of plant protection products in parallel trade. At the request of the person in this case decide on the authorisation in accordance with the provisions of chapter II. 26. If the application of this provision in paragraph 23 or 24 that permit identified gaps, service set a time limit for correcting it. If the lack of conformity remedied within the time limit set, the service shall decide on the appropriate authorisation. If the lack of conformity within the time limit set, the service will not take a decision on the refusal to issue a permit. 27. the Department within 10 days after the decision sends the decision to the person on the 23 and 24 of the rules referred to in the authorization or refusal to issue the permit, together with the invoice for the preparation of the assessment. 28. If, in accordance with the evaluation of a plant protection product intended for use in trials or experiments for research and development purposes, can lead to harmful effects on human or animal health or adverse effects on the environment, service authorization determines the limits of the experimental or research pursuant to Regulation No 1107/2009 article 54 (1) of the regulation.
29. the decision on the authorisation of plant protection products for use in the research and development service provides: 29.1. the period of validity of the authorisation; 29.2. distribution and use of plant protection products authorised. 3. use the authorized size of the area; 18.3. conditions of use for users and the plant protection product; 29.5. If necessary, the requirement of experiment or research in food and animal feed used in the plant or plant product; 18.4. about the use of plant protection products to the responsible person. 30. the use of the authorized size of the area service is determined on the basis of the experiment or study the offender's request and the results of the evaluation, but may not exceed 20 per hectare per year of trials in the field or two hectares a year to cover the trial areas. 31. The period of validity of the authorization service down not more than two years, on the basis of the experiment or study the offender's request and the results of the evaluation. 32. in order to extend the period of validity of the authorisation, the authorisation-holder not later than two months before the expiry date of the authorisation shall submit a request in the service validity term extension. Service will extend the period of validity of the authorisation in accordance with the experiment or study a reviewer's request if there is a valid need for the continuation of the experiment or study. V. concluding questions 33. This rule 11.2. subparagraph shall enter into force on 1 June 2015. 34. This provision, as well as paragraph 11.1. paragraphs 12 and 13 are in force until 1 June 2015. Informative reference to European Union Directive provisions included in the law arising from the European Parliament and of the Council of 21 October 2009. directive 2009/128/EC establishing a Community system for the sustainable use of pesticides. Prime Minister-Minister of welfare of the farming Minister Viņķel I L. the Rapidity