Cabinet Regulation No. 949 of 2011 on Placing of Plant Protection Products on the Market

Translation © 2012 Valsts valodas centrs (State Language Centre) Republic of Latvia Cabinet Regulation No. 949 Adopted 13 December 2011 Regulations Regarding the Placing of Plant Protection Products on the Market Issued pursuant to Section 5, Clause 23 and Section 9, Paragraph two of the Plant Protection Law I. General Provisions 1. This Regulation prescribes the requirements for the placing of plant protection products on the market, the criteria to be set for sales locations, the requirements for trading, bringing in, bringing out, storage and transportation of plant protection products, the duties of vendors thereof and plant protection advisors, the procedures for the provision of information to a purchaser of a plant protection product and the content thereof, as well as the procedures for the control of the handling of plant protection products. Matters related to the provision of authorisation for the placing of plant protection products on the market shall be regulated by Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. 2. Supervision and control of compliance with this Regulation shall be performed by the State Plant Protection Service (hereinafter – Service). II. Placing of Plant Protection Products on the Market 3. The import of plant protection products from a state other than a Member State of the European Union (hereinafter – third country), shall be controlled by the Food and Veterinary Service at a border control point or customs warehouse (depending on the location of customs clearance). The customs procedure shall be drawn up according to the control specified at this point. 4. A licence owner shall, within seven working days after import of a plant protection product into Latvia, inform the Service thereof, submitting to the Service a quality assurance document of the plant protection product issued by the producer of the plant protection product. 5. A plant protection product shall be sent back to the third country from which it was imported to Latvia, if: 5.1. the plant protection product has not been registered in Latvia; 5.2. the term of validity of the plant protection product has expired; Translation © 2012 Valsts valodas centrs (State Language Centre) 2 5.3. the plant protection product has not been classified, labelled or packaged in accordance with the regulatory enactments regarding the classification, labelling and packaging of plant protection products; 5.4. the plant protection product is not packed in the original packaging or it does not have the producer’s labelling in the Latvian language. 6. A plant protection product not registered in Latvia, which is intended for movement to another European Union Member State, shall be sent back to the European Union Member State or third country, from which it was imported, if the plant protection product: 6.1. has not been registered in the European Union Member State, to which it is intended to be moved; 6.2. has not been classified, packaged or labelled in accordance with the requirements of Sub-paragraph 7.2 of this Regulation. 7. It is permitted to bring in, manufacture, store or transport an unregistered plant protection product to Latvia, if it is intended for use: 7.1. in any of the European Union Member States and has been registered in the European Union Member State to which it is intended to be moved; 7.2. in any of the European Union Member States and has been classified, labelled and packaged in accordance with the regulatory enactments regarding the classification, labelling and packaging of plant protection products, except the requirement regarding labelling in the official language; 7.3. in a third country, and within five working days after export of the plant protection product the licence owner informs the Service regarding each batch of the plant protection product exported from Latvia. 8. Unregistered plant protection products, until the movement thereof to another European Union Member State or export to a third country, may be stored in the warehouse of a sales location, the owner or lawful possessor of which has received a special authorisation (licence) for the placing of plant protection products on the market. 9. The licence owner shall, within 10 working days after bringing in of such unregistered plant protection product to the place of storage, which is intended for movement to another European Union Member State, submit information to the Service in writing, indicating: 9.1. the European Union Member State from which the plant protection product is being brought in, the name, address and registration number of the legal person which is sending the plant protection product; 9.2. the European Union Member State to which the plant protection product is to be moved, the name, address and registration number of the legal person receiving the plant protection product; 9.3. the batch number, the name, quantity and size of packaging of the plant protection product. 10. A licence owner shall have the following documents at his or her disposal regarding the unregistered plant protection product to be moved: 10.1. a document certifying the quality of the plant protection product; 10.2. a document certifying the registration of the plant protection product in the relevant European Union Member State; 10.3. a document containing the following information: 10.3.1. the European Union Member State from which the plant protection product is being brought in, and the name, address and registration number of the legal person receiving the plant protection product; Translation © 2012 Valsts valodas centrs (State Language Centre) 3 10.3.2. the European Union Member State to which the plant protection product is to be transferred, and the name, address and registration number of the legal person receiving the plant protection product; and 10.3.3. the batch number, name of the plant protection product, quantity and size of the packaging. 11. The person responsible for the movement of an unregistered plant protection product to another European Union Member State shall ensure: 11.1. a copy of the document certifying the quality of the plant protection product for each batch; and 11.2. a document certifying the registration of the plant protection product in the relevant European Union Member State to which it is intended to be transferred. 12. The licence owner shall: 12.1. ensure that any batch of a plant protection product has a document certifying the quality, if he or she is the importer of the relevant batch of the plant protection product; 12.2. ensure for each plant protection product a safety data sheet in accordance with the regulatory enactments regarding the procedures for the completion and sending of safety data sheets for chemical substances and chemical products; 12.3. ensure the opportunity for a Service inspector to become acquainted with the inventory data referred to in Paragraphs 29 and 31 of this Regulation, as well as to control the sales locations and places of storage; 12.4. keep the quality assurance documents of a plant protection product and the information referred to in Paragraphs 29 and 31 of this Regulation for at least five years; 12.5. ensure that an employee is present at the sales or storage location who has received a certificate of plant protection product trader or a certificate regarding the right to advise on the use of plant protection products and who, when selling a plant protection product, could advise the purchaser in accordance with the requirements of Chapter V of this Regulation; 12.6. prior to further distribution of an imported plant protection product shall inspect whether there are any significant non-conformities referred to in Paragraph 15 of this Regulation on the plant protection product labelling; and 12.7. within 24 hours of a non-conformity being determined on the labelling information of a plant protection product (hereinafter – non-compliant labelling), inform the Service and the representative of the plant protection product registration certificate owner regarding the non-compliant labelling and file a submission with the Service regarding the possible method of rectifying the non-conformity. The Service shall evaluate the submission and take a decision within 15 working days from the receipt of the submission in accordance with Paragraph 17 of this Regulation. 13. Upon the request of the licence owner the person importing the plant protection product shall immediately hand over thereto a copy of the quality assurance document of the plant protection product. 14. It is prohibited for a licence owner to: 14.1. distribute a plant protection product to persons under 18 years of age; 14.2. distribute first and second registration class plant protection products to persons not having a special authorisation (licence) for the distribution of plant protection products or a licence regarding the right to advise on the use of plant protection products, or a licence regarding the right to use plant protection products; 14.3. distribute a plant protection product, the packaging of which is damaged (except the case referred to in Paragraph 70 of this Regulation) or without labelling, as well as where Translation © 2012 Valsts valodas centrs (State Language Centre) 4 the labelling is illegible, damaged, non-compliant or corrected (partially erased, supplemented), if the decision of the Service referred to in Paragraph 17 of this Regulation has not been received; 14.4. transfer or pour plant protection products into another packaging; 14.5. distribute a plant protection product, the term of validity of which has expired, unless the Service has taken a decision on issuing an authorisation for the distribution of such plant protection product. 15. Labelling shall be considered to be significantly non-compliant, if: 15.1. the text of the labelling is not in the Latvian language; 15.2. the active substances indicated are not registered in the Latvian Register of Plant Protection Products; or 15.3. the use of a plant protection product not registered in Latvia is indicated. 16. A licence owner who has brought in a batch of a plant protection product into Latvia with the significantly non-compliant labelling referred to in Paragraph 15 of this Regulation, shall recall the batch from distribution in accordance with the procedures referred to in Paragraph 20 of this Regulation, and bring it out from Latvia within two months after the day when the non-compliant labelling was determined or hand it over for disposal in accordance with the regulatory enactments regarding waste management and submit a certification to the Service regarding the bringing out from Latvia or handing over for disposal of the batch of the plant protection product. 17. It is permitted to distribute a batch of a plant protection product, for which non-compliant labelling is determined, with corrected labelling, if the non-compliance is not significant in accordance with Paragraph 15 of this Regulation and the Service has taken a decision on permission to correct the labelling of the plant protection product (hereinafter – Service decision). 18. The licence owner shall keep a copy of the Service decision in each place of distribution of the plant protection product and ensure the correction of the labelling of the plant protection product within seven working days after receipt of the Service decision. 19. The representative of a plant protection product registration licence owner has a duty to inform without delay other licence owners who have brought in the relevant batch of the plant protection product with non-compliant labelling into Latvia. 20. In order to recall from distribution a batch of a plant protection product with non compliant labelling or a batch, the distribution of which is prohibited by the Service, the licence owner shall send a notification to other licence owners, whose specific batch of the plant protection product has been distributed. The notification shall indicate: 20.1. the name of the plant protection product, the registration number in the Latvian Register of Plant Protection Products, the size of the packaging and the batch number; 20.2. the reason for the distribution prohibition; 20.3. the place of distribution at which the plant protection product is to be returned, the working hours thereof and the telephone number of the responsible employee. 21. In order for an inspector of the Service to be able to participate in the collection of a sample of a plant protection product, the term of validity of which has expired, the licence owner shall, at least five working days prior to taking of the sample, submit the relevant submission (Annex) to the Service. Translation © 2012 Valsts valodas centrs (State Language Centre) 5 22. The licence owner shall submit to the Service a submission for the taking of the decision referred to in Sub-paragraph 14.5 of this Regulation, to which the results of analysis of the plant protection product sample by an accredited laboratory shall be attached. 23. On the basis of the documents referred to in Paragraph 22 of this Regulation, the Service shall take a decision on extending the time period for distribution of a plant protection product, the term of validity of which has expired, for one year from the day when the results of analysis of the plant protection product sample have been signed, if in accordance with these the composition of the plant protection product still conforms with the composition of the registered plant protection product. 24. If in accordance with the results of analysis of the plant protection product samples the composition of the plant protection product does not conform with the composition of the registered plant protection product, the Service shall refuse the issuance of an authorisation for the distribution of the plant protection product the term of validity of which has expired. 25. It is prohibited to distribute plant protection products: 25.1. using automatic vending machines or self-serve systems; 25.2. at exhibitions and other public events, street sales locations and in markets. 26. It is prohibited to sell food products, animal feed, household chemical goods and medicinal products at a sales location of plant protection products unless the plant protection products are located in separate premises. 27. Plant protection products intended for sale shall be stored separately from other goods in a locked cupboard or shelf. This requirement shall not apply to the following third registration class registration plant protection products: 27.1. plant protection products of plant and animal origin; 27.2. microbiological plant protection products. 28. Volatile plant protection products may be stored only in well-ventilated premises. 29. A licence owner shall record the following in the registration journal: 29.1. the plant protection products received, as well as the plant protection products which are damaged or the term of validity of which has expired, specifying: 29.1.1. for purchased plant protection products – the date of receipt, the name of the plant protection product, the size of the packaging and quantity; 29.1.2. for plant protection products which are in a warehouse – the name, quantity, the size of the packaging, the quantity issued from the warehouse, as well as the remaining amounts; 29.1.3. for plant protection products the term of validity of which has expired – the name, quantity, the size of the packaging, the expiry date, the date of taking of the sample, the date of taking of the decision on authorisation to distribute the plant protection product the term of validity of which has expired; 29.1.4. for plant protection products the packaging of which has been damaged – the name, the size of the packaging and nature of the damage; 29.2. the unregistered plant protection products which have been received and brought out from the warehouse: 29.2.1. for purchased plant protection products – the date of receipt, the name, quantity, the size of the packaging and the batch number; 29.2.2. for plant protection products stored in a warehouse – the name, quantity, the size of the packaging and the batch number; Translation © 2012 Valsts valodas centrs (State Language Centre) 6 29.2.3. for brought out plant protection products – the date of bringing out, name, quantity, the size of the packaging and the batch number. 30. The record-keeping referred to in Paragraph 29 of this Regulation may be performed electronically. 31. The licence owner shall register the first or second registration class plant protection products distributed to persons in the registration journal referred to in Paragraph 29 of this Regulation, noting the given name, surname of the purchaser, or the name and registration number of the license regarding the right to use a plant protection product or to advise regarding the use of plant protection products, or the number of the special authorisation (licence) for the distribution of plant protection products, the name and quantity of the plant protection product sold. 32. A person who has acquired a plant protection product shall certify the information referred to in Paragraph 31 of this Regulation with his or her signature in the registration journal. III. Storage of Plant Protection Products 33. Plant protection products shall be stored in a specially equipped warehouse or part of the warehouse of the sales location (hereinafter – storage place) in compliance with the storage conditions and temperature regimen specified by the producer of the plant protection product. 34. If several licence owners have been designated the same sales location in the special authorisation (licence), the storage place shall be equipped so that the distributor of the plant protection products and the plant protection products belonging thereto may be identified. 35. It is prohibited to use fuel warehouses, residential or administrative premises, animal holdings, buildings with an evident risk of flooding or cellars, except those which are built above the ground, as storage places for plant protection products. 36. In order to ensure work safety, operations with first and second registration class plant protection products shall be carried out at the storage place by at least two persons concurrently. 37. It is prohibited for unauthorised persons to be at the storage place. 38. It is prohibited to keep food products, animal feed and medicinal products at the storage place. 39. First registration class plant protection products shall be stored in a locked, ventilated room separately from other plant protection products. 40. If other goods are kept together with plant protection products at the storage place, the plant protection products shall be isolated from the other goods or placed in cupboards, ensuring adequate ventilation. This requirement shall not apply to the following third registration class plant protection products: 40.1. plant protection products of plant and animal origin; 40.2. microbiological plant protection products. 41. Plant protection products shall be placed onto shelves (fixed shelving) or on trays leaving an aisle of at least one metre between the rows of shelving or trays. Translation © 2012 Valsts valodas centrs (State Language Centre) 7 42. If the plant protection products: 42.1. are placed on a shelf (with or without trays), the height of the stack on one shelf shall not exceed 2.5 metres; 42.2. are placed with trays upon the floor, the height of the stack on any single tray shall not exceed 1.6 metres; 42.3. are placed with trays one on top of the other, the total height of the stack shall not exceed 2.6 metres. 43. The storage place shall be equipped in conformity with the following technical requirements: 43.1. the flooring shall be laid of waterproof material or concrete; 43.2. ventilation with appropriate air circulation shall be installed; and 43.3. a water pipe or special handwashing facility shall be installed. 44. The storage place shall be equipped in conformity with fire safety regulations. 45. Clearly visible written signs upon a white background in lettering of a dark red colour not less than 10 cm high –“WARNING--PESTICIDES” and “NO SMOKING, NO EATING, NO DRINKING”– shall be displayed in the storage place. 46. In addition to the signs referred to in Paragraph 45 of this Regulation, clearly visible written signs upon a white background in lettering of a dark red colour not less than 10 cm high – “UNREGISTERED PLANT PROTECTION PRODUCTS” – shall be displayed in the storage place of unregistered plant protection products. 47. Plant protection products, the term of validity of which has expired or the quality of which does not conform with the registration requirements, or the labelling of which does not conform with the requirements of the regulatory enactments regulating the registration procedures for plant protection products, or the packaging of which is damaged, shall be stored separately. A written sign upon a white background in lettering of a dark red colour not less than 10 cm high – “SALE PROHIBITED” – shall be displayed at the storage place for such products. Plant protection products, the packaging of which has been damaged, shall be disposed of in accordance with the regulatory enactments regarding waste management. 48. The following shall be ensured at a storage place: 48.1. personal protective equipment (for example, respirator, protective glasses, protective clothing, gloves); 48.2. absorbent material (for example, dry sawdust or peat); 48.3. a separate inventory (broom, bucket, shovel) necessary for rescue measures in case any plant protection products pour or spill out. 49. Clearly visible instructions shall be displayed at the storage place regarding the provision of first aid, as well as the surname, address and telephone number of the person to be contacted if an accident or emergency has occurred. 50. Unregistered plant protection products shall be stored in separate premises, in accordance with the requirements referred to in Paragraphs 36, 37, 38, as well as 41, 42, 43, 44, 45 and 46 of this Regulation. Translation © 2012 Valsts valodas centrs (State Language Centre) 8 IV. Transportation of Plant Protection Products 51. Plant protection products shall be carried: 51.1. in the original, undamaged and labelled packaging; 51.2. in local or transit transport operations in accordance with regulatory enactments regulating the carriage of hazardous goods. 52. It is prohibited to transport plant protection products in one cargo consignment together with food products, animal feed and medicinal products. V. Duties of Vendors and Plant Protection Advisors 53. A vendor of plant protection products or an advisor who has acquired the certificate referred to in Sub-paragraph 12.5 of this Regulation shall provide a purchaser with information compliant with the regulatory enactments regulating plant protection and the labelling of the registered plant protection product regarding: 53.1. the potential risk caused by the particular plant protection product to human health and the environment, especially regarding the hazards and harmful effects thereof; 53.2. the requirements for use and storage of the plant protection product and safe disposal of the used packagings of plant protection products; 53.3. other opportunities for the restriction of harmful organisms with low risk; 53.4. other matters of interest to the purchaser. 54. A vendor of plant protection products or an advisor shall provide the information referred to in Paragraph 53 of this Regulation to a purchaser who has acquired a third registration class product and is not a professional user of plant protection products, and information upon the request to a professional user of the plant protection product. 55. If a plant protection advisor has provided consultations not compliant with regulatory enactments, the registered conditions for use of the plant protection product or the principles of good plant protection practice specified by European and Mediterranean Plant Protection Organisation (published on the website of the State Plant Protection Service), the person is entitled to turn to the Service. VI. Control of the Circulation of Plant Protection Products 56. When controlling the circulation of plant protection products, the Service shall take samples from plant protection products, soil, plants, plant products, working fluids prepared for plant protection products and items which may have been in contact with plant protection products. Samples shall be analysed in an accredited laboratory, in which the quality system “Good Laboratory Practice” has been introduced in the field of pesticide detection. 57. In order to inspect the quality of plant protection products, the Service shall take the control package. 58. The control package is one packaging unit of one batch of plant protection product, which the Service shall submit to the laboratory referred to in Paragraph 56 of this Regulation for the quality analysis of the plant protection product. 59. At least 200 millilitres of the plant protection product shall be used for the sample to be analysed. If the volume of the plant protection product package is less than 200 millilitres, then several control packages shall be taken. Translation © 2012 Valsts valodas centrs (State Language Centre) 9 60. The Service shall take the control package with the participation of the plant protection product owner. If the plant protection product owner refuses to participate in the procedure of taking the control package, the Service inspector shall take a sample without the presence of the plant protection product owner and make a note in the inspection act regarding the refusal of the owner to participate in the inspection. 61. The Service inspector shall draw up a deed regarding taking the sample or control package, in three copies. One copy of the deed shall be inserted in the wrapping together with the sample or control package. The wrapping shall be sealed in such a way as to prevent it from being opened without damaging it. The second copy of the deed shall remain with the Service inspector, and the third copy – with the owner of the plant protection product. 62. Until the handing over to the laboratory the control package shall be stored in compliance with the requirements for storage of the plant protection product. 63. On the basis of the analysis results issued by the laboratory referred to in Paragraph 56 of this Regulation, the Service shall, within three working days after receipt of results, prepare an opinion on the conformity of the composition of the plant protection product with the composition of the registered plant protection product. 64. The opinion on conformity of the composition of the plant protection product with the composition of the registered plant protection product shall be applicable to the entire batch of the plant protection product. 65. If in accordance with the opinion the composition of the plant protection product conforms with the composition of the registered plant protection product, the Service shall, within three working days after signing of the opinion, issue copies of the opinion to the owner of the plant protection product and the representative of the plant protection product registration owner in Latvia. 66. If the Service takes a decision to suspend the distribution or use of the plant protection product in Latvia temporarily until the quality of the plant protection product is ascertained completely, the Service shall, within three working days after signing of the opinion referred to in Paragraph 63 of this Regulation: 66.1. send the decision to the owner of the plant protection product and the representative of the plant protection product registration in Latvia; 66.2. send a control package for repeat analysis of the plant protection product to another laboratory, which complies with the requirements referred to in Paragraph 56 of this Regulation. 67. If, in accordance with the opinion, after results of repeat analysis the composition of the plant protection product conforms with the composition of the registered plant protection product, the Service shall, within three working days after signing of the opinion, revoke the decision on suspending the distribution or use of the batch of the plant protection product in Latvia. The decision shall be sent to the owner of the plant protection product and the representative of the plant protection product registration in Latvia. 68. If in accordance with the results of repeat analysis the composition of the plant protection product does not comply with the composition of the registered plant protection product, the Service shall take a decision to prohibit the distribution or use of the batch of the plant protection product in Latvia and impose the obligation to bring the batch of the plant Translation © 2012 Valsts valodas centrs (State Language Centre) 10 protection product out from Latvia or dispose of it. The decision shall be sent to the owner of the plant protection product and to the representative of the plant protection product registration within three working days after signing of the decision, and shall also be published in the newspaper Latvijas Vēstnesis [the official Gazette of the Government of Latvia] and on the website of the Service www.vaad.gov.lv. 69. If, when performing analyses, a plant protection product has not been used entirely or destroyed, the Service shall return the part of the control package to the owner of the plant protection product, drawing up a deed accordingly in two copies. One copy of the deed shall remain with the Service inspector and the other – with the owner of the plant protection product. 70. The part of the control package referred to in Paragraph 69 of this Regulation, together with one copy of the deed, shall be inserted in the packaging and sealed so that it could not be opened without damaging it. It is permitted to distribute such packaging of the plant protection product. 71. If the Service has taken a decision to prohibit the distribution of a non-qualitative batch of the plant protection product, the owner of the plant protection product and other licence owners who have brought in and distributed the plant protection product in Latvia, shall recall this batch of the plant protection product from distribution and, within two months after receipt of the Service decision referred to in this Paragraph, shall bring it out from Latvia or hand it over for disposal in accordance with the regulatory enactments regarding waste management. The licence owners shall, within five working days after execution of the Service decision referred to in this Paragraph, submit a document to the Service certifying the bringing out of the batch of the plant protection product from Latvia or handing over thereof for disposal. 72. In order to recall a batch of a non-qualitative plant protection product from distribution, the licence owner shall send a notification to the persons to which the relevant batch of the plant protection product has been distributed. The notification shall indicate: 72.1. the name of the plant protection product, the registration number in the Latvian Register of Plant Protection Products, the packaging size and batch number; 72.2. the reason for the distribution prohibition; and 72.3. the place of distribution at which the plant protection product is to be returned, the working hours thereof, the telephone number of the responsible employee and other information which is essential in the particular case. 73. If the Service has taken a decision on prohibition of use of a non-qualitative batch of the plant protection product, the user of the plant protection product shall hand over the particular plant protection product, which has not been used, to the licence owner within two months after coming into effect of this decision. The licence owners shall, within five working days after execution of the Service decision referred to in this Paragraph, submit documents to the Service certifying the bringing out of the batch of the plant protection product from Latvia or handing over thereof for disposal. 74. The licence owner has a duty to accept the sold non-qualitative plant protection product from the purchaser and to cover the losses incurred thereby. Translation © 2012 Valsts valodas centrs (State Language Centre) 11 Informative Reference to the European Union Directive This Regulation includes norms arising from Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides. Prime Minister V. Dombrovskis Minister for Agriculture L. Straujuma Translation © 2012 Valsts valodas centrs (State Language Centre) 12 Annex Cabinet Regulation No. 949 13 December 2011 To the State Plant Protection Service Submission Regarding Taking of a Sample from a Plant Protection Product the Term of Validity of which has Expired Applicant (name, address) Place of distribution of the plant protection product (address) Special authorisation (licence) No. Plant protection product: name name of the active substance , quantity (%) , quantity % , quantity % registration number batch number size of packaging (l), (kg) Submission completed by (given name, surname) (signature*) Date* Application received by (position, given name, surname) (signature*) Note. * The details of the document “date” and “signature” shall not be completed if the electronic document has been prepared in accordance with the regulatory enactments regarding the drawing up of electronic documents. Minister for Agriculture L. Straujuma