Statutory Order on Pesticides 1

Transcription

1 Statutory Order on Pesticides 1 The following shall be laid down pursuant to sections 4 a, 5, 6, 7 a, 10(4), 10 a, 20, 22(2) to (4), 22 a, 22 c, 23, 25(4), 27, 30(1), 31, 33(2), (3) and (8), 34, 35, 36(2), 37, 38 e, 38 f, 42(1) and (2), 42 a, 43, 43 a, 45, 46, 51 c, 56 and 59(4) and (5) of the Danish Chemicals Act, see Consolidated Act No. 878 of 26 June 2010 as amended by Act No. 294 of 11 April 2011, Act No. 161 of 28 February 2012, Act No. 277 of 19 March 2013 and Act No. 489 of 21 May 2013: Part 1 Scope and definitions 1.-(1) This Statutory Order applies to pesticides, see section 33 of the Danish Chemicals Act, in so far as they are subject to authorisation under the pesticide regulations, see section 2, item 1), as well as certain pesticides not covered by said regulations. (2) This Statutory Order lays down rules supplementing those contained in the pesticide regulations, see section 2, item 1), on the authorisation, manufacture, import, sale, use, possession and supervision of pesticides. This Statutory Order also lays down rules for national authorisation of biocidal products, see section 35(1) of the Chemicals Act, and for extended protection of data in this respect. (3) This Statutory Order applies to pesticides in the form in which they are transferred to the user, see, however, subsection (4). (4) This Statutory Order does not apply in relation to 1) transport of pesticides, 1 This Statutory Order contains provissions implementing Council Directive 92/32/EEC of 30 April 1992 amending for the seventh time Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, Official Journal 1992, no. L 154, page 15; Directive 1999/45/EC of the European Parliament And of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations, Official Journal 1999, no. L 200, page 1; parts of Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market, Official Journal 2006, no. 376, page 36; and parts of 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, Official Journal 2009, no. L 309, page 71. This Statutory Order includes certain provisions from Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market, Official Journal 2007, no. L 325, page 3; 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, Official Journal 2009, L 309, page 1; Regulation (EU) No 528/2012 Of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products, Official Journal 2012, no. L 167, page 1. Pursuant to Article 288 of the TFEU Treaty, a Regulation applies immediately in each Member State. The reproduction of these provisions in this Statutory Order is therefore exclusively due to practical considerations and does not affect the direct applicability of the relevant regulations in Denmark.

2 2) pesticides traded between manufacturers and importers, or among manufacturers, see, however, sections 14, 28 and 29; or 3) export of pesticides, see, however, sections 25, 26 and 29(2). 2. In this Statutory Order, the following terms have the following meanings: 1) The pesticide regulations: The Biocidal Products Regulation, see item 3), and the Plant Protection Products Regulation, see item 14). 2) The Biocidal Products Directive: European Parliament and Council Directive 98/8/EC of 16 February 1998 Concerning the Placing of Biocidal Products on the Market. 3) The Biocidal Products Regulation: European Parliament and Council Regulation (EC) No. 528/2012 of 22 May 2012 for Making Available on the Market and Use of Biocidal Products. 4) Biocidal product (biocidal agents): As defined in Article 3(1)(a) of the Biocidal Products Regulation, see item 3), as well as substances, mixtures and other products not covered by the Biocidal Products Regulation or other legislation, see Article 2(2) of the Biocidal Products Regulation, but which have the properties referred to in paras (a) to (c): a) Any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by any means other than mere physical or mechanical action. b) Any substance or mixture, generated from substances or mixtures which do not themselves fall under para (a), and which are intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by any means other than mere physical or mechanical action. c) Treated articles, as defined in Article 3(1)(l) of the Biocidal Products Regulation, with a primary biocidal function. 5) Mixture: As defined in Article 2, item 8) of the Classification Regulation (CLP). 6) Toxic pesticides: Pesticides (plant protection products and biocidal products) which are classified as toxic in accordance with the Statutory Order on Classification or as acutely toxic in category 3 under the Classification Regulation (CLP). 7) Very toxic pesticides: Pesticides (plant protection products and biocidal products) classified as highly toxic in accordance with the Statutory Order on Classification or acutely toxic in category 1 or 2 or meet the specific target organ toxicity classification in category 1 (STOT SE 1) under the Classification Regulation (CLP). 8) Agriculture: Agricultural holdings covered by the Danish Customs and Tax Administration SKAT s land use code 05 (agriculture, developed), 06 (separately assessed forest and plantation), 07 (orchard,

3 horticulture and nursery garden), or 17 (undeveloped agricultural plot, etc.), or 01 (dwelling), in respect of properties which hold the characteristics of agriculture or horticulture. 9) Statutory Order on Classification: Statutory Order on the Classification, Packaging, Labelling, Sale and Storage of Chemical Substances and Products 10) Classification Regulation (CLP): European Parliament and Council Regulation (EC) No. 1272/2008 of 16 December 2008 on Classification, Labelling and Packaging of Substances and Mixtures, amending and repealing Directive 67/548/EEC and 1999/45/EC and amending Regulation (EC) No. 1907/ ) Microorganism: As defined in Article 3(1)(b) of the Biocidal Products Regulation, as regards biocidal products and Article 3, item 15) of the Plant Protection Products Regulation as regards plant protection products. 12) Plant protection product: As defined in Article 2(1) of the Plant Protection Products Regulation, see item 13), in the form in which they are transferred to the user, and consisting of or containing active substances, safeners or synergists, and intended for the following purposes: a) Protecting plants or plant products against all harmful organisms, unless the main purpose of the product in question is deemed to be of hygienic nature, rather than the protection of plants or plant products. b) Affecting plant life processes, e.g., by impacting plant growth in any way other than as a nutrient. c) Preserving plant products, in so far as such substances or products are not subject to special Community provisions on preservatives. d) Destroying undesired plants or parts of plants, except algae, unless the products are used on soil or water to protect plants. e) Curbing or preventing undesired growth of plants, except algae, unless the products are used on soil or water to protect plants. 13) The Plant Protection Products Directive: Council Directive 91/414/EEC of 15 July 1991 Concerning the Placing of Plant Protection Products on the Market. 14) The Plant Protection Products Regulation: European Parliament and Council Regulation (EC) No. 1107/2009 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. 15) Sale: Any transfer of a pesticide, whether in return for payment, as defined in Article 3(1)(i) and (j) of the Biocidal Products Regulation and Article 3, item 9) of the Plant Protection Products Regulation. 16) Substance: As defined in Article 2, item 7) of the Classification Regulation (CLP). 17) The Statutory Order on Substances: Statutory Order on the Use of Chemical Substances and Mixtures in Pesticides. 18) Amending Act: Section 6 of Act No. 294 of 11 April 2011 on the Amendment of the Act on Chemical Substances and Products as well as other acts.

4 Part 2 Authorisation of pesticides General rules 3. Application for and authorisation of active substances and plant protection products follow the rules laid down in the Plant Protection Products Regulation. 4.-(1) Application for and authorisation of active substances and biocidal products follow the rules laid down in the Biocidal Products Regulation, see, however, subsections (2) and (3) as well as sections 15 and 65. (2) Treated articles, see Article 3(1)(l) of the Biocidal Products Regulation, which are treated with an active substance still under evaluation within one of the product types mentioned in section 15(3) and (4), shall, in the event of sale, be marked in accordance with Article 58(3)-(6) of the Biocidal Products Regulation. Biocidal products authorised under section 65 shall be applied when treating such articles. (3) In the event that the Danish Environmental Protection Agency determines other tolerances in connection with a specific biocidal product authorisation, the uncertainty connected with manufacture and analysis shall fall within the tolerances specified in Annex (1) Application in accordance with sections 3, 4 or 15 shall be submitted in Danish or English. (2) Application under section 15 shall be submitted using a form drawn up by the Danish Environmental Protection Agency, and shall follow the instructions provided by the Danish Environmental Protection Agency. 6. The Danish Environmental Protection Agency carries out, with the exceptions set out in section 57, the tasks which according to the pesticides regulations are conferred on the national competent authorities, including evaluating competent authorities. The Danish Environmental Protection Agency also authorises biocidal products subject to authorisation under section 15. Classification of pesticides 7.-(1) Anyone submitting an application for authorisation of a pesticide shall provide information as to whether the pesticide may be designated as hazardous under the rules set out in the Statutory Order on Classification or the Classification Regulation (CLP). If the product can be designated as hazardous, it shall be classified as well. (2) Until 30 June 2015, classification of pesticides shall comply either with the rules set out in the Statutory Order on Classification or the Classification Regulation (CLP). As from 1 June 2015, classification

5 shall comply with the rules set out in the Classification Regulation (CLP). When submitting the application, the applicant shall specify the classification rules being applied to the relevant pesticide. 8. Where an application is submitted before 30 May 2015 for renewed authorisation of a pesticide, the applicant shall choose whether to have its pesticide classified according to the rules set out in the Statutory Order on Classification or according to the rules set out in the Classification Regulation (CLP). The rules set out in section 7 apply mutatis mutandis. 9.-(1) Anyone reclassifying or updating the classification of an authorised pesticide shall submit information on the new classification. (2) The Danish Environmental Protection Agency may determine that the submitted new classification in accordance with subsection (1) is to equate with an entirely new application for authorisation. Requirements for active substances contained in pesticides 10.-(1) Active substances covered by sections 15 and 65 shall be classified, packaged and labelled in accordance with the Classification Regulation (CLP) before sale for use in biocidal products. (2) The requirement referred to in subsection (1) does not apply to active substances to be used for experimental testing, see section 41. Packaging, labelling, etc., of pesticides 11. Biocidal products must be packaged and labelled in accordance with Article 69 of the Biocidal Products Regulation. 12. Plant protection products must be packaged and labelled in accordance with Articles 64 and 65 of the Plant Protection Products Regulation 13.-(1) Together with the application, proposals must be submitted for the design of packaging for and labelling of the product, as well as proposals for brochures, package inserts or the like to be handed out with the pesticide for which authorisation is applied for. (2) The Danish Environmental Protection Agency may require additional information, including on the fact that the applicant is conducting further studies in accordance with the Agency's instructions. (3) The label, other marking of the packaging and brochures, package inserts or the like to be handed out together with a pesticide must be drawn up in Danish, if the product is to be marketed on the Danish market. (4) It will appear on the label whether a plant protection product may only be purchased and used by professionals (commercial) users, or whether it may be purchased and used by non-professionals (private)

6 users; see the detailed instructions for manufacturers, etc., (authorisation holders) in the Danish Environmental Protection Agency's guidance on the preparation of labels (label instructions). 14. Pesticides which are only traded between manufacturers and importers, or among manufacturers shall, in addition to marking according to the rules laid down in the Statutory Order on Classification or the Classification Regulation (CLP), should be clearly marked with name of substance, name and percentage content of each active substance, the name and address of the manufacturer or importer and a text which unambiguously specifies: Must not be handed out to consumers. Only for further manufacturing (repacking). Part 3 Authorisation of biocidal products not covered by the Biocidal Products Regulation 15.-(1) Anyone wanting to import, sell or make use of a biocidal product covered by subsection (3) or (4) shall submit an application to the Danish Environmental Protection Agency for authorisation of the active substance, and the biocidal product(s) to comprise the active substance, even if the active substance is not subject to authorisation under the Biocidal Products Regulation. Application is, however, not required under this provision if the active substance and the biocidal product have been authorised under other EU legislation or included in mixtures covered by such authorisation. (2) Together with the application for authorisation, the applicant shall indicate whether the biocidal product may be designated as hazardous in accordance with the Statutory Order on Classification or the Classification Regulation (CLP), see section 7. If the biocidal product can be designated as hazardous, it shall be classified as well. (3) Biocidal products subject to authorisation under subsection 1 comprise biocidal products intended to control 1) wood-destroying fungi, 2) algae growth, 3) slime-forming organisms in pulp, 4) rabbits, mice and rats, as well as 5) the following lower animals: a) vermin on domestic animals, including cage birds. b) Textile pests. c) Pests in timber and woodwork. d) Insects, snails and slugs, mites and the like. e) Earthworms.

7 (4) The duty to obtain authorisation under subsection (1) also covers active substances intended to prevent damage caused by those referred to in subsection (3), items 4) and 5), as well as wild mammals and birds, or which are intended to keep said animals away from places where they are not wanted. (5). Authorised active substances appear from the Statutory Order on Substances (1) The application for authorisation under section 15 shall contain the information referred to in Annex 1. (2) The Danish Environmental Protection Agency may require additional information, including on the fact that the applicant is conducting further studies in accordance with the Agency's instructions. 17.-(1) Authorisation in accordance with section 15 is granted for a maximum period of ten years from the date of the Danish Environmental Protection Agency's decision, unless the Agency as a result of the health or environmental properties of the active substance or biocidal product sets a shorter deadline. (2) The Danish Environmental Protection Agency may allow an authorisation to be conditional upon the applicant carrying out before a specified deadline detailed studies of the health and environmental properties of the active substance or biocidal product. 18.-(1) Simultaneously with the authorisation of a biocidal product under section 15, the Danish Environmental Protection Agency approves the design of the biocidal product label proposed by the applicant. The label shall contain the information referred to in Annex 2, and the Danish Environmental Protection Agency may determine that further information shall be applied to the label, just as the Danish Environmental Protection Agency may require that a particular wording be used. (2) The Danish Environmental Protection Agency may permit that the information to appear from the label be applied directly on the packaging instead. The Danish Environmental Protection Agency may also permit that part of the information on the label or packaging appears from a brochure, a package insert or the like to be handed out together with the biocidal product. (3) The information referred to in sections 1 and 2 shall be in Danish, placed in a clear spot and written in text which cannot be deleted. Part 4 Sale and possession, etc., of pesticides Sale 19. The provisions set out in section 24(1) and (2) and section 25(1) and (3) of the Chemicals Act do not apply to pesticides covered by this Statutory Order.

8 20.-(1) Pesticides may only be sold in the unopened original packing in which the product is delivered from the manufacturer, importer or holder of the authorisation forming the basis of the sale. (2) Open packages of pesticides may not be found on business premises, storage rooms or other premises where pesticides are located for the purpose of sale to users. Advertising, etc. 21.-(1) A biocidal product covered by sections 15 and 65 shall be placed on the market according to the rules set out in subsections (2) to (5). (2) Sale of biocidal products shall not take place under circumstances suited to mislead the users as to the product's use or the risk which may be associated with the product. (3) In case of sale and advertising of biocidal products, reference may not be made to the product in a way which is misleading with respect to the product's risks to human health, animal health or the environment, or its efficacy. Advertisement for a biocidal product shall under no circumstances include indications such as ' low-risk biocidal product ', ' non-toxic ', ' harmless ', ' natural ', ' eco-friendly ', ' animalfriendly ' or the like. Other than the term biocides, expressions containing words such as bio or combinations thereof can only be used in connection with the sale of microbiological biocidal products. (4) Packaging used for hazardous biocidal products, see section 7, shall not be presented in a way or carry a designation which is used for food, animal feed, medicinal products or cosmetics. (5) Packaging of hazardous biocidal products, see section 7, which are sold retail to the general public shall not be designed or decorated so as to attract children's active curiosity or mislead the consumers. 22.-(1) Advertisements for a biocidal product covered by sections 15 and 65 shall contain information on the product's indication of danger and the content of active substances as well as unambiguous information to the effect that biocidal products shall be used with caution, and that the label and instructions for use shall be read before the product is taken into use. (2) If the advertisement for a biocidal product offers a consumer the opportunity to conclude a purchase contract without first seeing the label of the product, the advertisement shall refer to the hazard classes indicated on the label. (3) An advertisement shall not contain statements or similar to the effect that a biocidal product contains or may have the effect of a plant nutrient. Possession 23. Possession of a plant protection product is subject to it having been authorised in Denmark in accordance with the Plant Protection Products Regulation and to it having been provided with a label in Danish, see, however, Article 28(2) of the Plant Protection Products Regulation. Possession of plant

9 protection products is also allowed if the aim of such possession is to take advantage of a derogation under Article 53 of the Plant Protection Products Regulation. Possession may be subject to a time limit, if a product is included in the Statutory Order on Substances. 24.-(1) Possession of a biocidal product is subject to it having been authorised in Denmark, either by way of a Danish authorisation or an authorisation under the rules set out in the Biocidal Products Regulation on EU authorisation or a simplified procedure, and to it being provided with a label in Danish. Possession of a biocidal product is, however, also allowed if the aim of such possession is to take advantage of a derogation or permit granted in accordance with the Biocidal Products Regulation or the law. (2) Where a use-by date is set for a biocidal product, the product may only be held until such date. (3) Possession of a biocidal product covered by subsection (1) is also allowed if the aim of such possession is to take advantage of a derogation or permit granted in accordance with the Chemicals Act. 25. The prohibition set out in section 24 against possession does not include biocidal products which are manufactured abroad and which only pass through the country as transit goods. In addition, the prohibition does not apply to enterprises which legally manufacture substances and mixtures intended for export. 26.-(1) Pesticides must be stored in the original packaging and with proper labelling. (2) Pesticides must be stored with due care for the environment and health and out of reach of children. The pesticides must not be stored with or near food, animal feed, medicinal products or the like. (3) Pesticide residues and empty packaging shall be stored as specified in subsection (2). (4) Spray liquids and other mixtures ready-mixed of pesticides shall not be left unattended. Part 5 Special provisions for pesticides used for control of rats 27. Chemical control of rats may only be carried out by an authorised person; see Statutory Order on the Prevention and Control of Rats. 28. Pesticides used on rats may only be handed out to and be in the possession of an authorised person. Special provisions for toxic and very toxic pesticides Possession, storage and sale 29.-(1) Very toxic and toxic pesticides, see section 2, items 6) and 7), may only be in the possession of anyone holding a permit to manufacture, sell or use such pesticide.

10 (2) In addition to the requirements for storage referred to in section 26, very toxic and toxic pesticides, see section 2, items 6) and 7), must be stored under lock and key. (3) Anyone who manufactures, imports or sells very toxic and toxic pesticides, see section 2, items 6) and 7), must store such pesticides in a separate and locked cabinet or room clearly marked with a warning sign according to the rules thereon in the Statutory Order on Classification. The poison cabinet or poison room located at anyone selling very toxic or toxic pesticides may only be used for such pesticides. (4) If an enterprise or institution stores very toxic and toxic pesticides, see section 2, items 6) and 7), in a total quantity exceeding 125 ml, to which more than five persons have access, it shall designate one or more persons who on behalf of the enterprise or the institution shall ensure that the said pesticides are stored in accordance with sections 26 and 29(1) to (3) and that no unauthorised persons have access to the pesticides. 30.-(1) Very toxic and toxic pesticides, see section 2, items 6) and 7), may only be sold by the authorisation holder for the product in question, or the person who, under specified terms, has been granted a permit to conduct such sale by the Danish Environmental Protection Agency. (2) A permit covers a place of sale. The permit can be restricted to only include toxic pesticides. Permits may be withdrawn by the Danish Environmental Protection Agency, if the holder of the permit repeatedly stores the pesticides in a wrong manner, sells the pesticides to persons who are not entitled to buy the pesticides or abstains from booking the sale in accordance with section (1) Very toxic and toxic pesticides, see section 2, items 6) and 7), may only be sold to 1) enterprises covered by section 30, 2) anyone who can provide proof of having completed a course in toxicology, see section 35(2), and 3) anyone who can present a permit granted by the Danish Environmental Protection Agency to buy and use such pesticide. (2) Toxic pesticides, see section 2, item 6), may also be sold to anyone who, under section 35(1) is permitted to use such pesticides. 32. Very toxic and toxic pesticides, see section 2, items 6) and 7), may only be sold in return for the buyer s receipt in his own hand. 33.-(1) Anyone selling very toxic pesticides, see section 2, item 7), must keep books for each purchase and sale of such pesticides. (2) Book-keeping shall be carried out immediately after the transaction has taken place and shall include the date, the name and address of the purchaser, the trade name of the pesticides and the number as well as the size of the packages.

11 (3) When posting, the dealer's inventory of the pesticides referred to in subsection (1) shall at any time appear clearly in the book or of a transcript of the dealer's regular accounting conducted in a way that can be approved by the Danish Environmental Protection Agency. (4) The book with vouchers shall be kept for five years from transcript. If books are kept electronically or by means of a loose-leaf system, books shall be kept for the last five calendar year. 34. Very toxic and toxic pesticides, see section 2, items 6) and 7), shall not be entrusted to persons who are likely to cause harm to themselves or their surroundings. Use 35.-(1) Toxic pesticides, see section 2, item 6), may only be used by 1) anyone who uses the pesticides commercially in his own business, 2) anyone who performs control activities for others; or 3) employees of those mentioned in items 1) and 2). (2) Very toxic pesticides, see section 2, item 7), may be used only by persons who are covered by subsection (1) and who can provide evidence of having completed a course in toxicology, see subsection (3), relating to the field of application. (3) The course in toxicology referred to in subsection (2) shall be arranged or acknowledged by the Danish Environmental Protection Agency. (4) The Danish Environmental Protection Agency may lay down detailed rules for the use of groups of very toxic pesticides. 36.-(1) Anyone who is covered by section 35(2), and who commercially performs control activities for others using very toxic pesticides, shall inform the person for whom control activities are performed of the fact that the Danish Environmental Protection Agency has organised or recognised the course in toxicology which the person in question has completed, as well as provide contact information of the Danish Environmental Protection Agency and information on the electronic contact point (quick-service desk) of the Danish Ministry of Economic and Business Affairs), see section 16 of the Act on Services in the Internal Market. (2) The information referred to in subsection (1) shall be made available to anyone for whom the control activities are performed or be communicated to such person clearly and unambiguously and well in advance of concluding an agreement on such control activities or, in the absence of a written agreement, prior to performing such control activities.

12 37.-(1) The Danish Environmental Protection Agency shall establish and publish its deadlines for the processing of applications for the recognition of a completed course in toxicology. Deadlines are counted from the time when the applicant has submitted all the information required from the applicant. (2) The Danish Environmental Protection Agency may extend the deadline referred to in subsection (1) if the complexity of the case so warrants. The Danish Environmental Protection Agency will give the applicant notice of the extension and the duration thereof before expiry of the deadline set out in subsection (1). The notice shall contain a reason for the extension and its duration. (3) Notwithstanding the deadlines laid down in subsections (1) and (2), the applicant is not permitted to begin the control activities using very toxic pesticides before the Danish Environmental Protection Agency has taken a decision on the recognition of the completed course in toxicology. 38. The Danish Environmental Protection Agency shall, as soon as possible, acknowledge receipt of an application for the recognition of the completed course in toxicology. The receipt shall contain the following information: 1) The published deadline for the processing of the application and the possibility that the deadline may be extended once, see section 37. 2) Information to the effect that the applicant is not permitted to begin the control activities using very toxic pesticides before the Danish Environmental Protection Agency has taken its decision, regardless of whether the published deadline or a subsequent announced deadline has been complied with. 3) Information about the administrative complaint procedure in respect of the decision taken. 39.-(1) Very toxic and toxic pesticides, see section 2, items 6) and 7), must not be used in private gardens, public areas, and similar areas accessible to the public, areas around housing, childcare centres and the like, or for the treatment of plantings in boundaries against public roads or private gardens, see, however, subsection (2). (2) An exception to the provision set out in subsection (1) is the use of very toxic and toxic pesticides for the control of rats, water voles and moles on the condition that such control activities are carried out by a person who has completed a course in toxicology, see section 35(2). Part 6 Special rules for plant protection products 40. In order to ensure that the user is aware of the dangers of, exposure to, and proper storage, handling, application and safe disposal, etc., of a plant protection product, the dealer shall, when selling such products to a private user, inform the user that the user will need to: 1) read the label before use of the plant protection product, etc.,

13 2) use the plant protection product in accordance with the provisions set out on the label, and 3) follow the instructions for use of the plant protection product during and after use. Part 7 Experimental testing of biocidal products 41.-(1) A biocidal product not covered by the Biocidal Products Regulation may according to the rules laid down in subsections (2) to (4) be imported, transferred, stored, used and disposed of for use in experimental testing. (2) The person responsible for testing or experiments in accordance with subsections (3) and (4) shall draw up lists comprising the following information: 1) Detailed information on the identity of the biocidal product or active substance, labelling data, quantities supplied, and the names and addresses of the recipients of the biocidal product or active substance. 2) All available data on possible effects on human and animal health and on the environment. (3) When performing scientific experiments, analyses or chemical research under controlled conditions, including determination of the substance's properties, performance and efficacy as well as scientific studies in relation to product development, the person responsible for testing shall prepare and keep the information referred to in subsection (2) and make it available upon request for the Danish Environmental Protection Agency. (4) In connection with further development of a substance, during which its fields of application are tested by means of pilot or manufacturing experiments, the person responsible for the experiments shall, before the experiments are launched, forward the information referred to in subsection (2) to the Danish Environmental Protection Agency. (5) If the activities referred to in subsections (3) and (4) may involve or lead to a release of the biocidal product or active substance into the environment, launch of the activities is subject to permission from the Danish Environmental Protection Agency. The application shall contain the information referred to in subsection (2), and the Danish Environmental Protection Agency may give detailed instructions in respect of the application and its contents. Part 8 Consultation on national action plan 42.-(1) Prior to the preparation or revision of the national plan of action for a reduction in the use and dependence on plant protection products, see section 44a of the Chemicals Act, the Danish Environmental Protection Agency shall consult the public.

14 (2) The Danish Environmental Protection Agency will make a public announcement of a proposal for a national action plan or a revision thereof in order to offer the public the opportunity of expressing its opinion at an early stage and in an efficient manner before a decision is reached on the plan. The announcement should at least contain information on: 1) The Danish Environmental Protection Agency's address. 2) A statement to the effect that everyone has the right to view the proposal for the national action plan or the revision thereof. 3) A statement that everyone has the right to comment on the proposal before a specific deadline of at least eight weeks from the announcement, as well as information as to where comments and questions may be directed. (3) The Danish Environmental Protection Agency will make a public announcement of the adoption of the national action plan and of the reasons and considerations underlying the adoption of the action plan, including in respect of the process of public participation. The national action plan shall be publicly available and disseminated to the public by electronic means, see the Statutory Order on Active Dissemination of Environmental Information. Part 9 Charges, fees, etc. Payment of charges, annual statement 43. The charge referred to in section 36 of the Chemicals Act falls due on 1 January and must be paid to the Danish Environmental Protection Agency by 1 February. 44. Anyone who according to section 36 of the Chemicals Act is obliged to pay a charge shall no later than 1 February submit an annual statement covering the previous calendar year to the Danish Environmental Protection Agency. The statement shall include the quantity sold of each product and shall, together with the necessary background information for the statement, be drawn up in a form that can be approved by the Danish Environmental Protection Agency. Foreign authorisation holders shall quantify the total amount set aside for use in Denmark. Fees charged for permits to sell certain pesticides 45.-(1) Anyone having been granted a permit to deal in toxic pesticides, see section 2, item 6), shall for each place of sale covered by the permit pay the following fee to cover in part any expenses incurred by the Danish Environmental Protection Agency in the administration of the permits granted:

15 1) DKK 1,500 per year, if the permit includes pesticides classified as very toxic or pesticides classified as acutely toxic in category 1 or 2, or which meet the specific target organ toxicity classification in category 1 (STOT SE 1), or 2) DKK 750 per year if the permit only includes pesticides classified as toxic or as acutely toxic in category 3. (2) Fees fall due on 1 January, the first time on 1 January in the year following the year in which the permit was granted. (3) The fee must be paid no later than 1 February. If the fee is paid after this date, interest will be charged in accordance with the Danish Act on Interest Rates in Case of Late Payment, etc. (4) The fees set out in subsection (1) are adjusted annually on 1 January on the basis of the published price and wage index most recently published in the Economic-Administrative Guidelines issued by the Ministry of Finance. The current fees are published on the Danish Environmental Protection Agency's website Fees charged for the authorisation of active substances in pesticides 46.-(1) Anyone applying for inclusion of an active substance under the Biocidal Products Regulation is charged a fee to cover any costs incurred by the Danish Environmental Protection Agency when reviewing the applications. The fee is set out in Annex 3. (2) Anyone applying under the Plant Protection Products Regulation or Commission Regulation (EU) No. 1141/2010 for the evaluation of an active substance for the purpose of inclusion in the list of authorised active substances for the Plant Protection Products Regulation, is charged a fee to cover any costs incurred by the Danish Environmental Protection Agency in connection with such evaluation. The fee is set out in Annex 5. (3) If the application for the active substance pursuant to subsection (2) is submitted in Denmark, the fee falls due for payment when Denmark is appointed rapporteur Member State. If the application for the active substance is submitted in another Member State, the fee falls due for payment when Denmark is appointed co-rapporteur Member State. (4) Of the fee, see subsections (1) and (2), DKK 15,000 falls due for payment at the time of submission of the application. The remainder of the fee is to be paid to the Danish Environmental Protection Agency according to further instructions. However, in the event that an application is submitted for an active substance for evaluation within more than one product type under the Biocidal Products Regulation or section 65, DKK 15,000 must be paid for each product type. (5) The Danish Environmental Protection Agency will reduce the fee if consideration of the case has required less resources than the assumed resource consumption forming the basis of calculation of the fee. The fee may also be reduced in specific cases, where an application is withdrawn by the applicant before a

16 decision has been taken on authorisation. The reduction shall match saved costs in connection with the consideration of the case. Amounts of DKK 15,000 or less will not be refunded. Fee for authorisation of biocidal products and plant protection products 47.-(1) Anyone applying for authorisation or amended authorisation of a biocidal product where the active substance or substances has/have been authorised in accordance with the Biocidal Products Regulation or section 65 for the use applied for, and anyone applying for a permit to conduct parallel trade or for a derogation in respect of a biocidal product is charged a fee to cover any costs incurred by the Danish Environmental Protection Agency when reviewing the application. (2) Anyone applying for authorisation or amended authorisation of a plant protection product, or for a permit to conduct parallel trade or for a derogation in respect of a plant protection product, in accordance with the Plant Protection Products Regulation, is charged a fee to cover any costs incurred by the Danish Environmental Protection Agency when reviewing the application. (3) The amount of the fee referred to in subsection (1) appears from Annex 2 and from subsection (2) of Annex 5 and depends on the type and content of the application. (4) Fees charged in accordance with subsections (1) and (2) must be paid to the Danish Environmental Protection Agency at the time of submission of the application for authorisation in accordance with the Agency s further instructions. Of fees exceeding DKK 60,000, DKK must be paid at the time of submission of the application. The remainder of the fee is to be paid to the Danish Environmental Protection Agency in accordance with its further instructions once the application has been accepted. (5) If the application is not accepted due to insufficient documentation in connection with the recognition, the application is rejected. No additional fee is charged in connection with rejections due to insufficient documentation, and fees already paid will not be refunded, see subsection (4). Generally about fees 48.-(1) Fees referred to in sections 46 and 47 are charged for applications received no later than 31 December Fees charged for applications submitted after this date are subject to annual adjustment as at 1 January on the basis of the price and wage index most recently published in the Economic- Administrative Guidelines issued by the Danish Ministry of Finance. The current fee rate is published on the Danish Environmental Protection Agency s website (2) Fees charged under section 47(1) are reimbursed in part, if the applicant does not, within the specified time limit, submit the required information, see Article 80(3)(b) of the Biocidal Products Regulation. The reduction is assessed in each case in relation to the work performed. Amounts of DKK 15,000 or less will not be refunded.

17 Part 10 Duty of registration of biocidal products 49.-(1) Anyone responsible for sale in Denmark of a biocidal product containing an active substance under re-evaluation, see Article 89 of the Biocidal Products Regulation, but where the active substance and the product are not subject to authorisation under section 65, shall arrange for registration in the Danish Working Environment Authority s and the Danish Environmental Protection Agency's register of substances and materials (Product Register) of the following, see, however, subsection (2): 1) Name and address of the natural or legal person responsible for the sale. 2) The product's commercial name. 3) Application. 4) Product type according to Annex V to the Biocidal Products Regulation. 5) Chemical composition. For each individual ingredient in the product, the following details shall be provided: a) CAS No. b) Chemical name. (c)) The active ingredient s share of the product in percentage weight or other unit. d) R phrases (H phrases according to the Classification Regulation (CLP)). 6) The classification and labelling of the product. 7) Any suggestions for first aid in case of accident. (2) If the product as a result of other legislation has already been registered in the Product Register and has been assigned a PR Number, the information requested under subsection (1) is no required. Part 11 Data protection and data-sharing for biocidal products 50.-(1) Data submitted together with an application for authorisation of an active substance or a biocidal product in accordance with section 15, or a biocidal product pursuant to section 65, may only be used for the benefit of a subsequent applicant, when: 1) the subsequent applicant submits a permit to access the current data, or 2) the deadline for data protection has expired, see section 52. (2) If the relevant person does not own the data, the applicant for a permit under section 15 shall also provide the name and contact information of the owner of the data sent, as well as present a permit to use the data submitted. (3) The applicant shall inform the Danish Environmental Protection Agency of any change in the copyrights to such data as soon as any such change takes place.

18 (4) The Danish Environmental Protection Agency may make the information provided available to the scientific advisory committees established in accordance with Commission decision 2004/210/EC of 3 March 2004 setting up scientific committees in the field of consumer safety, public health and the environment. 51.-(1) Data covered by section 50 is protected for the period specified in subsection (3). The protection period shall start when the data is presented for the first time, see, however, see subsection (2). (2) The protection period for data presented with a view to obtaining authorisation of an existing active substance is calculated from the first day of the month following the date of the Danish Environmental Protection Agency's authorisation of the relevant active substance for the product type in question. (3) The protection period in accordance with subsections (1) and (2) is: 1) ten years for data for use for the purpose of obtaining authorisation of an existing active substance or products with one or more existing active substances, 2) fifteen years for the authorisation of new active substances, including products with a new active substance, as referred to in Article 3(1)(e) of the Biocidal Products Regulation, and 3) five years for new data presented in connection with the renewal of a previously granted authorisation. 52.-(1) When the data protection period has expired, see section 51, the applicant for an authorisation of new active substances or products may request that data submitted by another applicant is taken into account for the application. The active substance or product should be technically equivalent to the active substance or product for which the data protection period has expired, inter alia, with regard to the degree of purity and the nature of relevant impurities. (2) An applicant under subsection (1) shall present 1) all necessary data for identification of the biocidal product, including its composition, 2) all data necessary to identify the active substance and to establish technical equivalence, and 3) the data needed to demonstrate that the biocidal product involves the same risk and has the same efficacy as the authorised biocidal product. 53.-(1) The owner of the relevant data shall, in a permit granting others a right to use such data, specify 1) name and contact details of the owner of the data and the beneficiary, 2) name of the active substance or biocidal product the data of which access is given 3) date of the entry into force of the permit, and 4) a list of the submitted data which the permit confers the right to quote. (2) Revocation of a permit to make use of data does not affect the validity of the authorisation granted on the basis of the permit in question. Data on animal experiments

19 54.-(1) Experiments involving vertebrate animals for documentation of the health or environmental effects of an biocidal active substance or product shall be subject to prior permission from the Danish Environmental Protection Agency. (2) Permission under subsection (1) is only granted if, in connection with the application, evidence is presented to the effect that no information has previously been submitted to the Danish Environmental Protection Agency or the European Chemicals Agency ECHA about experiments or studies. 55. Anyone intending to use experiments involving vertebrate animals as evidence of the health or environmental effects of an active substance or a product, shall, at their own expense, obtain information from ECHA as to whether information is available on such experiments. If information is available, and the information is subject to data protection, see section 51, the person in question shall contact the owner of the relevant information and in accordance with the guidelines set out in Article 63 of the Biocidal Products Regulation enter into agreement on their use. Part 12 Administrative provisions Supervision, derogation and complaint 56.-(1) The Danish Environmental Protection Agency carries out, with the exceptions set out in section 57, the supervisory tasks which according to the pesticides regulations and other regulations are conferred on the national competent authorities, including evaluating competent authorities, with regard to pesticides. (2) The local council assists the Danish Environmental Protection Agency with the supervision of compliance with the rules governing the possession and use of pesticides at professional users not covered by the supervision specified in section 57. (3) The local council assists the Danish Environmental Protection Agency in connection with supervision of compliance with the storage and labelling rules at retailers, and the like. 57. The Danish AgriFish Agency carries out the supervision of storage, possession and use as well as registration of the use of plant protection products on farms as regards observance of the following rules: 1) Article 28(1), Article 55 and Article 67(1) of the Plant Protection Products Regulation. 2) Section 10(2) of the Chemicals Act. 3) Section 23, 24, 26 and 29(1), (2) and (4) and section 35 of this Statutory Order. 58.-(1) Statens Serum Institute (SSI) (the Danish State Serum Institute) and the Department of Agroecology at Aarhus University assist the Danish Environmental Protection Agency in evaluating the efficacy of pesticides.