Chapter 1	Scope and definitions
Chapter 2	Approval of control agents
Chapter 3	Approval of biocidal products which are not covered by the biocidal Regulation
Chapter 4	Lettling and holding etc. of control agents
Chapter 5	Special provisions applicable to the control of rats
Chapter 6	Special rules for plant protection products
Chapter 7	Test for biocidal products in the field of biocidal products
Chapter 8	Consultation of national action plan
Chapter 9	Charges, fees, etc.
Chapter 10	Notification obligation for biocidal products
Chapter 11	Data protection and data exchange for biocidal products
Chapter 12	Administrative provisions
Chapter 13	Punishment
Chapter 14	Entry into force
Chapter 15	Transitional provisions
Appendix 1	Requirements for the application for approval after section 15 of a chemical biocidal product
Appendix 2	Information on the label, cf. § 17, paragraph 1. 1
Appendix 3	Summary of the basic fee and the additional fee for processing matters of biocidal products
Appendix 4	Allowed manufacturing and analysis tolerances for biocidal products, cf. § 4
Appendix 5	Table 1.

Completion of control measures

In accordance with § 4 a, § 5, § 6, § 7 a, § 10, paragraph 10. 4, section 10 a, section 20, section 22, paragraph 22, 2-4, section 22 a, section 22 c, section 23, section 25, paragraph 25. 4, section 27, section 30, paragraph 30. Paragraph 1, section 31, section 33 (3). 2, 3 and 8, section 35, section 36, paragraph 2, section 37, section 38 e, section 38 f, paragraph 1. Paragraph 1, section 42, paragraph. 1 and 2, § 42 a, § 43, § 43 a, § 45, § 46, § 51 c, § 56, and § 59 (3). 4 and 5, in the law of chemicals, cf. Law Order no. 878 of 26. June 2010 as amended by law no. 294 of 11. April 2011, lov nr. 161 of 28. February, 2012, lov # 277 of 19. March, 2013 and Law No. 489 of 21. May 2013 :

Chapter 1

Scope and definitions

§ 1. This notice shall apply to control measures, cf. the section 33 of chemicals, to the extent that they are subject to the obligation to control the mean regulations, in accordance with the provisions of the control of the fight against the regulations. § 2, nr. 1, as well as certain control measures not covered by these Regulations.

Paragraph 2. The decision shall lay down rules to complement the rules of control for the control of the provisions of the provisions of the provisions of the measures, § 2, nr. 1, concerning the approval, production, import, sale, use, and possession of, and control of control agents ;. The notice also lays down rules for the national approval of biocidal products, cf. the section 35 of the chemical code section. 1 and on enhanced protection of data in this connection.

Paragraph 3. The notice shall apply to control agents in the form in which they are transferred to the user, cf. however, paragraph 1 4.

Paragraph 4. The notice shall not apply in the context of

1) means of transport of control measures,

2) the means of control negotiated between producers and importers, or between producers themselves, cf. however, sections 14, 28 and 29, or

3) export of control agents, cf. however, section 25, 26 and section 29 (4). 2.

§ 2. For the purposes of this notice :

1) The measures for the fight against the regulations : the Biocidal Regulation, cf. no. 3, and the Plant Protection Products Regulation, cf. no. 14.

2) Biocides Directive : Directive 98 /8/EC of the European Parliament and of the Council of 16. February 1998 on the placing on the market of biocidal products.

3) Biocides Regulation : Regulation of the European Parliament and of the Council (EU) No 528/2012 of 22. May 2012 on the availability of goods on the market and the use of biocidal products.

4) Biocidal product (biocidal product) as defined in Article 3 (3). 1 (a) of the biocidal Regulation, cf. no. 3, as well as substances, mixtures and other products not covered by the biocidal Regulation or any other legislation, cf. the biocidal Regulation referred to in Article 2 (1). 2, but have the characteristics referred to in (a-c :

a) Substances or mixtures in the form in which they are delivered to the user consisting of, contain or generate one or more active substances which are intended to destroy, discourage, neutralise, prevent the effect of or control the impact of : harmful organisms other than physical or mechanical effects.

b) Substances or mixtures generated from substances or mixtures which are not in themselves products in the sanity referred to in point (a) and which are intended to destroy, discourage, neutralize, prevent the impact of or control the impact of : harmful organisms other than physical or mechanical effects.

c) Treat Articles as defined in Article 3 (3). 1 (1) (l) of the biocidal Regulation, with a primary biocidal product.

5) Mixture : as defined in the classification Regulation, Article 2 (2), 8.

6) Toxic control agents : Fighting products (plant protection products and biocidal products) which are classified as toxic according to the classification notice or as acute toxic in category 3 after the classification Regulation.

7) Very toxic control agents : Fighting products (plant protection products and biocidal products) which are classified as highly toxic according to the classification notice or as acute toxic in categories 1 or 2 or as specific ; the target organ toxic in category 1 (STOT SE 1) after the classification Regulation.

8) " Ground farms " subject to SKAT's use code 05 (Agriculture, Built), 06 (separately rated forest and plantation), 07 (fruit plantation, gardenneri and nursery), or 17 (unbuilt agricultural claim, etc.), or 01 (inhabitable), or 01 (inhabitable), for such a place as such in the case of buildings with the nature of agriculture or gardenneri.

9) Classification Notice : Publication of classification, packaging, marking, sale and storage of substances and mixtures.

10) Regulation (EC) No 1272/2008 of 16 of the European Parliament and of the Council : Regulation (EC) No 1272/2008. December 2008 on the classification, labelling and packaging of substances and mixtures and amending and repealing Directive 67 /548/EEC and 1999 /45/EC and amending Regulation (EC) No 1907/2006.

11) Micro-organism : as defined in the biocidal Regulation, Article 3 (1). 1 (b) as regards biocidal products, and the plant protection product, Article 3 (2), 15, in the case of plant protection products.

12) Plant protection product as defined in Article 2 (2). 1, in the plant protection product Regulation, cf. no. 13, in the form in which they are transferred to the user, consisting of or containing activings, safes or synergists, intended for the following purposes :

a) Protecting plants or plant products against all harmful organisms, unless the main objective of the product in question may be considered to be of a hygienic nature, rather than the protection of plants or plant products.

b) To influence the life processes of plants, for example, by incorporating the growth of plants in a different way other than as nutrient.

c) To be used to produce plant products as far as the substances or products concerned are not covered by special Community provisions on preservatives.

d) To destroy unwanted plants or parts of plants other than algae unless the products are used on soil or water to protect plants.

(e) To brake or to prevent undesirable growth of plants, except algae, unless the products are used on soil or water to protect plants.

13) Directive 91 /414/EEC of 15, of the Directive : Council Directive 91 /414/EEC. July 1991 on the marketing of plant protection products.

14) Regulation (EC) No 1107/2009 of 21 of the European Parliament and of the Council of 21. Oct 2009 on the placing of plant protection products on the market and repealing Council Directive 79 /117/EEC and 91 /414/EEC.

15) Sales : Any transfer of a control agent, whether the transfer takes place against payment, as defined in Article 3 (3) of the Biocidal Regulation. Paragraph 1 (i) and (j) and Article 3 of the plant protection product, 9.

16) ' Stof : as defined in the classification Regulation, Article 2 (2), 7.

17) Substatement : Conventing of the use of chemical substances and mixtures in control agents.

18) Amendment No 6 in Law No 294 of 11. April 2011 on the amendment of the law on chemical substances and products and different laws.

Chapter 2

Approval of control agents

General rules

§ 3. Application for and approval of activings and plant protection products shall comply with the rules of the plant protection product Regulation.

§ 4. The application for and approval of activates and biocidal products shall comply with the rules of the biocidal Regulation, cf. however, paragraph 1 2 and 3 as well as sections 15 and 65.

Paragraph 2. Treat articles, cf. Article 3 (3) of the biocidal product. 1 (1) (l) treated with an active substance which is still under evaluation within one of the 15 (1) of the Article 15 (1). For the purposes of Article 58 (4) of the biocidal product, the product types shall be marked in accordance with the provisions of Article 58 (3) of this Regulation. 3-6. For the treatment of such articles, biocidal products shall be used which have been approved in accordance with section 65.

Paragraph 3. If the EPA in a specific approval of a biocidal product does not provide for other tolerances, the manufacturing and analysis uncertainty must be within the tolerances referred to in Annex 4.

§ 5. Applications for sections 3, 4 or 15 shall be submitted in Danish or English.

Paragraph 2. The application for section 15 must be submitted on a schedule drawn up by the EPA and, by the way, the application shall follow the instructions provided by the Environmental Management Board.

§ 6. The Committee on the Environment, Public Health and Food Safety shall be responsible for the derogations set out in section 57, the tasks of which the anti-control regulations have been put into force by the competent national authorities, including the competent authorities. The Environmental Management Board shall also approve biocidal products which are subject to the approval of section 15.

Classification of control resources

§ 7. The applicant for the approval of a control agent shall indicate whether the product may be classified as dangerous by the rules of classification or classification. The remedy may also be classified as dangerous.

Paragraph 2. Until the 30. In May 2015, the classification of pesticides must be classified either according to the rules of the classification publication or in the classification Regulation. From the 1. June 2015, classification must be classified according to the rules laid down in the classification regulation. Applause indicates when the application is submitted, which classification rules have been used for the control agent concerned.

§ 8. Searched there before the 30. In May 2015, the renewal of an anti-control instrument shall choose whether it wishes to classify its anti-control instrument in accordance with the rules laid down in the classification notice or by the rules of the classification Regulation. The provisions of section 7 shall apply mutatis mutis.

§ 9. The re-classifying or updating the classification of an approved control agent shall be provided with information on the new classification.

Paragraph 2. The Environmental Management Board may decide that the submitted new classification shall be submitted in accordance with paragraph 1. The first is to equate with a completely new application for approval.

Requirements for activators which are included in control agents

§ 10. Asset Substances, covered by § 15 and Clause 65 shall be classified, packaged and labelled in accordance with the classification regulation before sale to use in biocidal products.

Paragraph 2. The requirement of paragraph 1. Paragraph 1 shall not apply to active substances which are to be used for experimental testing, cf. section 41.

Packaging, labelling, etc. of control agents

§ 11. Biocidal products are packaged and labelled in accordance with Article 69 of the biocidal Regulation.

§ 12. The plant protection products are packaged and labelled in accordance with Articles 64 and 65 of the plant protection product Regulation.

§ 13. Together with the application, proposals to design packaging and labelling of the product and the proposal for brochures, loading or similar leaflets, together with the instrument of control, shall be accompanied by the instrument of the instrument of the instrument of the instrument.

Paragraph 2. The Environmental Management Board may require additional information, including the application of examinations carried out in accordance with the direction of the board.

Paragraph 3. The label, the second mark of packaging and brochures, leaflets, or similar to extradition, together with a control instrument, shall be drawn up in Danish if the product is to be marketed in the Danish market.

Paragraph 4. It will appear on the label of a plant protection product only and is used by professionals (professional) users, or whether it may be bought and used by non-professional users (private) users, cf. the detailed instructions for producers, etc. (Approval holders) in the Environmental Management Board ' s guidance on the preparation of labels.

§ 14. Fighting measures negotiated only between producers and importers, or between producers, must, in addition to labelling under the rules laid down in the classification notice or the classification Regulation, be clearly marked with the centre's name, the name and percentage content (w/w) and the metric units of each asset, the name and address of the manufacturer or the importer, and a text that is unambiguously indicating : may not be extraditionable to consumers. Only for further fabrication (repackaging).

Chapter 3

Approval of biocidal products which are not covered by the biocidal Regulation

§ 15. The one who wishes to import, sell or use a biocidal product subject to paragraph 1. 3 or 4 shall submit an application to the Environmental Management Board on the approval of the active substance and the biocidal product or the biocidal product, even if the asset is not subject to the consent of the biocidal Regulation. However, the application shall not be necessary in accordance with this provision if the active substance and biocidal product is approved in accordance with other EU legislation or in mixtures that are subject to such approval.

Paragraph 2. In the case of the application for approval, the applicant shall indicate whether the biocidal product may be designated as dangerous according to the rules of classification or classification as laid down in the classification Regulation. § 7. If the biocidal product is referred to as hazardous, it must also be classified.

Paragraph 3. The approval obligation under paragraph 1. 1 includes biocidal products intended to control :

1) Tradey fungus.

2) Algeal growth.

3) Slim-building organisms in paper pulp.

4) Rabbits, mice and rats.

5) The following lower animals :

a) Inclothes in livestock, including stingy bone.

b) Textile vermin.

c) Vermin in timber and wood.

d) Insects, snails, mites and stuff.

(e) Regnorme.

Paragraph 4. The approval obligation under paragraph 1. Paragraph 1 shall also include active substances which are intended to prevent harm caused by the products referred to in paragraph 1. 3, no. 4 and 5, mentioned vermin, and of wild mammals and birds, or which are intended to keep these animals away from where they are not wanted.

Paragraph 5. Approved active substances are apparent from the notice of the substance.

§ 16. The application for approval under section 15 shall contain the information referred to in Annex 1.

Paragraph 2. The Environmental Management Board may require additional information, including the application of examinations carried out in accordance with the direction of the board.

§ 17. The approval of Article 15 shall be granted for a period of not more than ten years from the date of decision of the Environment Management Board, unless the management of the board, as a result of the health or environmental characteristics of the biocidal product or the biocidal product, lays down a shorter period of time ; deadline.

Paragraph 2. The Environmental Management Board may permit an approval to be subject to the application by a specified period of time for further examination of the health or environmental characteristics of the activity of the biocidal product or of the biocidal product.

§ 18. At the same time, with the approval of a biocidal product, after Section 15, the Environmental Management Board shall accept the design of the label of the biocidal product as proposed by the applicant. The label shall include the particulars referred to in Annex 2 and the Environmental Management Board may provide for further information to be applied, as well as the Environmental Management Board may require a specific wording.

Paragraph 2. The Environmental Management Board may allow the information to be indicated on the label, instead, to be directly on the packaging. The Environmental Management Board may also permit a share of the information on the label or packaging, as a brochure, a leadsheet or similar leaflet, or similar in the case of the biocidal product.

Paragraph 3. The people in paragraph 3. The information referred to in paragraph 1 and 2 shall be in Danish, and shall be clearly and without indelible words.

Chapter 4

Lettling and holding etc. of control agents

Sales

§ 19. The provisions of Article 24 (2) of the chemical above. One and two, and section 25 (2). Paragraph 1 and 3 shall not apply to control measures covered by this notice.

20. Combating agents may only be sold in the unusable original packaging provided for by the goods by producer, importer or holder of the approval which is due to the sale.

Paragraph 2. Open wrappers shall not be provided in premises, storerooms, storerooms and other premises where the control agents are stored for sale to users.

Reclamation and so on.

§ 21. A biocidal product which is subject to section 15 and section 65 shall be placed on the market in accordance with the provisions of paragraph 5 of this Article. 2-5 said rules.

Paragraph 2. The sale of biocidal products shall not, in any case, suitable for misleading users in terms of the use of the product or the risk that may be associated with the product.

Paragraph 3. In the case of sale and advertising of biocidal products, no reference shall be made to the product in a manner which is misleading in terms of the risks to the product to human health, animal health or the environment or its effectiveness. Advertising for a biocidal product must in no circumstances contain indications as 'biocidal product', 'not toxic', 'harmless', 'natural', 'environmentally friendly', 'animal-friendly', or similar. In addition to the term biocide, phrases such as bio or composition shall be used only in the case of the sale of microbiological biocidal products.

Paragraph 4. Packaging of hazardous biocidal products, cf. Section 7 shall not have a presentation or a label intended to be used for food, animal feed, medicinal products or cosmetics.

Paragraph 5. Packaging of hazardous biocidal products, cf. Section 7, which is sold a detail to the public, must not be designed or decorated so that it attracts children's active curiosity or mislead the consumer.

§ 22. Advertising for a biocidal product subject to section 15 and section 65 must include information on the indication of the product's indication of the indication and content of active substances and the unambiguous indication that biocidal products should be used with care and that labels and usage instructions must be read before the product is used.

Paragraph 2. If the advertising of a biocidal product allows a consumer to enter into a meat contract without first having seen the product's label, refer to the advertises indicated on the label.

Paragraph 3. A commercial may not contain statements or similar products that a biocidal product contains or may have an effect as a plant-sleeve.

Possession

-23. A plant protection product may be possessed only if it has been approved in Denmark under the plant protection product Regulation, and it bears an approved label in Danish, cf. however, Article 28 (3) of the plant protection product is 2. The plant protection products must also be possessed if it is to make use of an exemption under Article 53 of the plant protection product. Possession may be subject to time limits if a remedy is included in the substance notice.

§ 24. A biocidal product may be possessed only if it has been approved for use in Denmark, either in a Danish authorisation or by approval of the rules of the biocidal regulation on EU authorisation or simplified procedure, and bearing a label in Danish. However, a biocidal product may also be possessed as part of the exploitation of a derogation or authorisation granted under the biocidal Regulation or by law.

Paragraph 2. Where a final use date of a biocidal product is fixed, the product may be held only until that date.

Paragraph 3. A biocidal product which is subject to paragraph 1. 1 may also be possessed if it is to take advantage of a derogation or authorisation granted under the law of chemicals.

§ 25. The prohibition in section 24 for possession does not include biocidal products manufactured abroad and carried out only through the country as transit goods. The prohibition shall also apply to undertakings which legally produce substances and mixtures for export.

SECTION 26. Fighting funds shall be stored in the original packaging and with proper labelling.

Paragraph 2. Fighting resources shall be stored in an environment and public health and inaccessible to children. The funds must not be stored with or in the presence of foodstuffs, feedingstuffs, medicinal products or the like.

Paragraph 3. Rests of control agents and empty packaging must be kept as specified in paragraph 1. 2.

Paragraph 4. Spray fluids and other mixtures that are pre-mixed with control agents must not be left unattended.

Chapter 5

Special provisions applicable to the control of rats

§ 27. Chemical control of rats must be carried out only by an authorised person, cf. the prevention and control of rats.

§ 28. The fight against rats against rats shall be handed down only to and possessed by an authorized person.

Special provisions for toxic and highly toxic control agents

Possession, storage and sale

§ 29. Very toxic and toxic waste products, cf. § 2, nr. 6 and 7. 7, may only be possessed by the person authorized to manufacture, sell or use such a remedy.

Paragraph 2. In addition to the retention requirements referred to in section 26, the storage of very toxic and toxic control measures referred to in paragraph 26 shall be kept in accordance with : § 2, nr. 6 and 7. 7, under lock.

Paragraph 3. The manufacturer, imports or sells very toxic and toxic methods of control, cf. § 2, nr. 6 and 7. 7, keep these funds in a separate and locked closet or spaces that are clearly marked by warning labels in accordance with the rules of the classification notification. The poison or marriage of the one selling very toxic and toxic pesticides must contain only those control measures.

Paragraph 4. Where a company or institution stores very toxic and toxic control agents, cf. § 2, nr. 6 and 7. 7, in a total quantity of more than 125 ml to which more than five persons have access, it shall designate one or more persons who, on behalf of the establishment or the institution, have to ensure that the storage of the relevant control funds is carried out in accordance with section, Twenty-six and twenty-nine, paragraph. 1 3, and that unauthorized access to funds are not available.

-$30. Very toxic and toxic waste products, cf. § 2, nr. Amendments Nos 6 and 7 may be sold only by the holder of the authorization for the instrument concerned, or the subject of the authorisation to be granted to the Environmental Management Board shall be authorised to do so.

Paragraph 2. A permit includes a place of sale. The authorization may be restricted to the use of toxic control measures. Permissions may be revoked by the Environmental Management Board if the holder of the authorization repeatedly holds the control funds wronged, sells the funds for persons who are not entitled to the purchase of the funds or not to book sales after paragraph 33.

§ 31. Very toxic and toxic waste products, cf. § 2, nr. 6 and 7. 7 may only be sold to

1) establishments covered by Section 30,

2) the one that can document the completion of a Tax Course, cf. § 35, paragraph. 2, and

3) the authorization of the EPA to purchase and use such a remedy.

Paragraph 2. Toxic control measures, cf. § 2, nr. 6 may also be sold to the one in accordance with section 35 (5). 1, must use these control resources.

§ 32. Sales of very toxic and toxic control agents, cf. § 2, nr. 6 and 7. 7, may only take place against the buyer ' s own receipts.

§ 33. The one that sells very toxic control measures, cf. § 2, nr. 7 shall keep the book above each purchase and sale of these funds.

Paragraph 2. Accounting shall be carried out immediately after the operation has taken place and shall include information on the date, the name and address of the buyer, the traits name and the number and size of the packages.

Paragraph 3. In the accounts, the distributor ' s position shall be taken by the negotiator in paragraph 1. Paragraph 1 of the said means shall be clearly stated in the book or by a printout from the reseller ' s regular accounts, in a manner acceptable to the Environmental Management Board.

Paragraph 4. The book with supporting documents must be kept for five years after being discharged. If the accounts are carried out electronically or by means of a release system, the bookstore must be kept five calendar years.

§ 34. Very toxic and toxic waste products, cf. § 2, nr. 6 and 7. 7 must not be left to persons who may be presumed to cause harm to themselves or to their surroundings.

Use

$35. Toxic control measures, cf. § 2, nr. 6, may only be used by

1) the commercial use of the funds in its own holdings,

2) the professional fighting for others ; or

3) employees at the no. 1 and 2.

Paragraph 2. Very toxic control measures, cf. § 2, nr. 7 may be used only by the one subject to paragraph 1. 1 and which have proof of having undergone a course of marriage, cf. paragraph 3, for the area in question,

Paragraph 3. The one in paragraph 1. The Danish Agency for the Environment, Public Health and Consumer Policy shall be subject to the name of the Agency for

Paragraph 4. The Committee on the Environment may lay down detailed rules for the use of very toxic control agents.

§ 36. Persons covered by Section 35 (1). 2, and as a business one to combat the other with highly toxic pesticides, it shall inform it that the fight is carried out, as to whether the Environmental Management Board has organised or recognised the course of conduct carried out by the person concerned, and contact information for the Environmental Management Board or the Office ' s Office ' s electronic contact point (points of contact) (on the point of contact), cf. Section 16 of the Single Market Services Act.

Paragraph 2. Information referred to in paragraph 1 1 shall be made available to the measures in which the fight is carried out, or shall be communicated to it clearly and unequivocally and in good time prior to the conclusion of the Agreement on control or before the fight against the execution of the fight against the non-written agreement.

§ 37. The Environmental Management Board shall lay down and publish its deadlines for the processing of applications for the recognition of the course of the course of marriage. The time limits shall be taken into account when the applicant has submitted all the information it falls to it to submit.

Paragraph 2. The Environmental Management Board may extend the period in paragraph 1. 1 once, if the complexity of the case justifies it. The Committee on the Environment, Public Health and Food Safety, shall notify the applicant for the extension and the duration thereof before the expiry of the time limit 1. The notification must contain a reason for the extension and its duration.

Paragraph 3. Notwithstanding the deadlines set out in paragraph 1 1 and 2 the applicant must not start the fight against very toxic control measures before the Environmental Management Board has taken a decision on the recognition of the course taken.

§ 38. The Environmental Management Board shall, as soon as possible, be more acknowledgement of the receipt of an application for the recognition of the course of The receipt shall include the following information :

1) The published date for the examination of the application in question and the possibility that the period may be extended once, cf. § 37.

2) Information that the applicant must not start the fight against very toxic control measures before the Environmental Management Board has taken its decision, regardless of whether the published deadline or a subsequent notification period has been complied with.

3) Enlightenment for the administrative redress for the decision in question.

§ 39. Very toxic and toxic waste products, cf. § 2, nr. 6 and 7 shall not be used in private gardens, in public areas and similar areas that are accessible to the public, areas surrounding housing, child institutions and similar or the treatment of plantations in the public sector or private gardens, cf. however, paragraph 1 2.

Paragraph 2. Except for the provision in paragraph 1. 1 is the use of very toxic and toxic methods of control against rats, mosepigs and moles subject to the condition that the fight is carried out by a person who has undergone a course of marriage in accordance with the course of the course of the year. Section 35 (5). 2.

Chapter 6

Special rules for plant protection products

§ 40. In order to ensure that the user is aware of dangers, exposure to and sound storage, handling, delivery and safe disposal, etc. of a plant protection product, the distributor shall, by means of sale of funds to a private user, must : the person concerned,

1) read the plant protection product label before use, etc.,

2) use the plant protection product according to its provisions ; and

3) following the production of the plant protection product, during and after use.

Chapter 7

Test for biocidal products in the field of biocidal products

§ 41. A biocidal product which is not covered by the biocidal Regulation may in accordance with the rules laid down in paragraph 1. 2-4 is imported, transferred, stored, used and disposed of for testing purposes.

Paragraph 2. The person responsible for testing or testing in accordance with paragraph 1. The following information shall be drawn up by 3 and 4 of the following information :

1) Detailed information on the identity of the biocidal product or the asset ' s identity, labelling data, supplied quantities and names and addresses of the recipients of the biocidal product or asset.

2) All available data on possible effects on human and animal health, and on the environment.

Paragraph 3. In the case of scientific tests, analyses or chemical research under controlled conditions, including the determination of the properties, performance and efficacy of the substance and scientific studies relating to product development, the one which is be responsible for the preparation and storage of the tests referred to in paragraph 1. The information referred to in paragraph 2 and request shall be made available to the Environmental Management Board.

Paragraph 4. For the further development of a substance in which its applications are tested by means of pilot experiments or in experiments, it shall be responsible for the tests carried out before the tests are carried out in accordance with the provisions of paragraph 1. 2 mentioned information to the Environmental Management Board.

Paragraph 5. If they are in paragraph 3. The activity of 3 and 4 may involve or lead to the authorisation of the biocidal product in question to the biocidal product or to the environment, or the environmental management authority may be used. The application shall contain the information set out in paragraph 1. 2, and the Environment Agency may provide detailed instructions for the application and its content.

Chapter 8

Consultation of national action plan

§ 42. In the preparation or review of the National Action Plan for Reducing the use and dependence of plant protection products, cf. The Danish Agency for the Environment, Public Health and Food Safety, Section 44 (a), shall consult

Paragraph 2. The Environmental Management Board shall make a public announcement of a proposal for a national action plan or a review of this in order to allow the public at an early stage and in an effective manner to express their views before a decision is taken on the plan. The announcement shall at least include the following information :

1) The address of the environmental management board.

2) Information that everyone has the right to see the proposal for a national action plan or the revision of it.

3) Information that everyone has the right to comment on the proposal within a fixed period of eight weeks from the announcement, as well as information on to which comments and questions can be addressed.

Paragraph 3. The Environmental Management Board shall make public announcement of the adoption of the national action plan and of the reasons and considerations which undergo the adoption of the action plan, including the process of public participation. The National Action Plan must be publicly available and disseminated electronically to the public, cf. the announcement of the active dissemination of environmental information.

Chapter 9

Charges, fees, etc.

Payment of tax, annual tax return

§ 43. The amount of the levy referred to in the chemical code section 36 shall be due to the 1. January and shall be paid to the EPA by the 1. Feb.

§ 44. The payment of the levy shall be that of the levy, which shall be paid by the chemical overhead, at the latest of 1. February of the previous calendar year for the Environmental Management Board shall submit an annual statement to the Committee on Environmental Protection. The inventory shall comprise the quantity sold for each product and shall, together with the necessary background information for the inventory, be prepared in a form which may be approved by the EPA. Foreign acceptance holders shall make up the total quantity set aside for the purpose of the use in Denmark.

Fees for authorisation to negotiate certain control measures

§ 45. The authorisation for the negotiation of toxic control agents, cf. § 2, nr. 6, for each place of sale to which the authorization includes, to a partial coverage of the Environmental Management Agency ' s expenditure on the authorisation of the notified authorisations, shall pay a fee ;

1) $1,500. per this year if the permit includes control measures which are classified as highly toxic or pesticides which are classified as acute toxic in categories 1 or 2 or as a specific target organic toxic in category 1 (STOT SE 1), or

2) 750 kroner. per this year, if the authorization alone includes control measures classified as toxic or acute toxic in category 3.

Paragraph 2. Charges shall be payable on 1. January, first time on 1. January the following year after the authorisation has been granted.

Paragraph 3. The fee shall be paid no later than 1. Feb. If the fee is paid after this date, interest shall be levied under the rules of the interest of late payment and so on.

Paragraph 4. The fees referred to in paragraph 1. 1 is regulated annually by the 1. On the basis of the most recent published price and salary index in the Finance-Administrative Guidance from the Ministry of Finance. The current fee rate shall be published on the website of the Environment Management website : www.mst.dk.

Fees for the approval of active substances in control agents

§ 46. The applicant for the inclusion of an active substance within the biocidal Regulation shall pay a fee to cover the costs incurred by the Environmental Management Board in the examination of applications. The size of the goat is shown in Appendix 3.

Paragraph 2. The applicant, under the plant protection product Regulation or Commission Regulation (EU) No 1141/2010, apply for a stock for appraisal for inclusion in the list of authorised active substances for the plant protection product Regulation, pay a fee to cover the costs incurred by the Environmental Management Agency for the administrative treatment in respect of this assessment. The size of the goat shall be shown in Appendix 5.

Paragraph 3. Where the asset is referred to in paragraph 1. 2 is requested in Denmark, the fee shall be paid when the country is designated as Rapporteur Member State. Where the asset is requested in another Member State, the fee shall be paid when the country is designated as a Member State of the Member State.

Paragraph 4. Of the fee, cf. paragraph 1 and 2, DKK 15,000. at the time of submission of the application. The remainder of the fee shall then be paid to the Environmental Management Board after further instructions. However, if an active substance is requested for evaluation within more than one product type under the Bibiocidal Regulation or § 65, however, DKK 15,000 is paid. for each product type

Paragraph 5. The Environmental Management Board shall reduce the fee if the case handling has been less than that of a resource than that for which the fee is calculated on the basis of. The fee may also be specifically reduced in cases where an application is withdrawn by the applicant before a decision has been taken on approval. The reduction must correspond to the cost of the costs involved in the process of handling this matter. Amount of 15,000 kroner. or thereunder is not being recovered.

Chargeal for the approval of biocidal product and plant protection product

§ 47. The holder who seeks approval or modified the approval of a biocidal product where the asset or substances are approved in accordance with the biocidal Regulation or section 65 of the application of the application, or seeking permission for parallel trade or exemption ; in the case of a biocidal product, a fee shall be paid to cover the costs incurred by the environmental management during the examination of the application.

Paragraph 2. The one seeking approval or modified approval of a plant protection product, or permission for a parallel trade or derogation for a plant protection product under the plant protection product Regulation, shall pay a fee, coverage of the costs incurred by the Environmental Management Board for the examination of the application.

Paragraph 3. Size of the goat in paragraph 1. 1 is given in Appendix 3 and in paragraph 1. 2 of Annex 5, and shall depend on the type and content of the application.

Paragraph 4. Fees in accordance with paragraph 1 1 and 2 shall, at the time of submission of the application for approval, shall be paid to the Environmental Management Board after the Management Board shall be given a detailed report. By fee, greater than $60,000. $15,000 is paid for. at the time of submission of the application. The remainder of the fee shall then be paid to the EPA to be more detailed after the application has been accepted.

Paragraph 5. If the application is not accepted as a result of a lack of evidence in connection with the recognition, the application shall be rejected. In the exception of incomplete documentation, no additional charges shall be levior and no refund shall be paid for the late payment fee, cf. paragraph 4.

In general for the fees,

§ 48. The fees referred to in § § 46 and 47 shall apply to applications received no later than 31. December 2014. The rates for subsequent applications shall be regulated annually per year. 1. On the basis of the most recent published price and salary index in the Finance-Administrative Guidance from the Ministry of Finance. The current fee rate shall be published on the website of the Environment Management website : www.mst.dk.

Paragraph 2. The fees shall be provided in accordance with section 47 (3). 1 shall be repaid in part if the applicant does not submit the required time limit, in accordance with the required information, cf. the biocidal Regulation referred to in Article 80 (3). 3 (b). The reduction shall be assessed in each case in relation to the work carried out. Amount of 15,000 kroner. or thereunder is not being recovered.

Chapter 10

Notification obligation for biocidal products

§ 49. The person responsible for the sale in Denmark of a biocidal product containing a stock item under review, cf. the Article 89 of the biocidal Regulation, but where stock and product are not subject to Article 65, carry out registration in the Work with the Work with the Products and the Environment Management Registry of Substances and Materials of the Products (Product Register) of the following, cf. however, paragraph 1 2 :

1) Name and address of the person responsible for the sale of responsible natural or legal persons.

2) The trade name of the product.

3) Applicable.

4) Product type in accordance with Annex V of the biocidal Regulation.

5) Chemical composition. For each substance in the product, the following information shall be provided :

a) CAS No

b) Chemical name.

c) weight of the content of the content of the product, by weight, or other unit.

d) R-phrases (H-phrases after the classification Regulation).

6) Classification and labelling of the product.

7) Any suggestions for first aid by accident.

Paragraph 2. If the product as a result of other legislation is notifiable to the Product Register and then notifies then notification shall be subject to paragraph 1. 1 not necessary.

Chapter 11

Data protection and data exchange for biocidal products

$50. Data submitted with an application for approval of an active substance or biocidal product after Article 15 or a biocidal product after Section 65 may only be used in the interests of a subsequent applicant when :

1) the subsequent applicant provides an access rights to the current data, or

2) Data Privacy timed out, cf. § 52.

Paragraph 2. If the person in question does not own these, then the applicant for a permit after Article 15 also provide information and contact information on the person who submitted the data, and shall provide a permit to use the data submitted.

Paragraph 3. The applicant shall notify the Environmental Management Board of any amendments to the copyright of such data as soon as they are carried out.

Paragraph 4. The Environmental Management Board may provide information to the Advisory Scientific Committee set up pursuant to Commission Decision 2004 /210/EC of 3. March 2004 on the creation of scientific committees in the field of consumer safety, public health and the environment.

§ 51. The data referred to in section 50 shall be protected during the period specified in paragraph 1. 3. The period of protection begins when the relevant data is submitted for the first time, cf. however, paragraph 1 2.

Paragraph 2. The protection period for the data submitted for the purpose of approving an existing asset ' s data shall be taken from the first day of the month following the date of approval of the relevant asset for the relevant stock for the relevant product type.

Paragraph 3. The protection period provided for in paragraph 1. 1 and 2 are on

1) 10 years of data for the approval of an existing asset or product with one or more existing stock substances ;

2) 15 years for the approval of new stock substances, including products containing a new stock, cf. Article 3 (1). 1 (e) of the biocidal Regulation, and

3) five years for new data being presented in connection with the renewal of an earlier authorisation for approval.

§ 52. When the data protection period has expired, cf. Section 51, the applicant for the approval of new assets or products, may request that data submitted by another applicant shall be submitted to the application. The active substance or product must be technically equivalent to the asset or product for which the data protection period has expired, including the degree of purity and nature of relevant impurities.

Paragraph 2. An applicant for paragraph 1. 1 shall present :

1) any necessary data for the identification of the biocidal product, including its composition,

2) all data required to identify the active substance and to establish the technical equivalence of the equivalence, and

3) the data necessary to demonstrate that the biocidal product involves the same risk and shall have the same effectiveness as the approved biocidal product.

§ 53. The owner of the data in question must, in a permit, that other people may use these, enter :

1) the name and contact information of the data owner and the beneficiary ;

2) the name of the active substance or biocidal product whose data is given access to,

3) the date of entry into force of the permit

4) a list of the data provided to which the authorization gives the right to quote.

Paragraph 2. The revocation of a permit to use data does not affect the validity of an approval issued on the basis of the authorisation in question.

Animal testing data

§ 54. Tests with vertebrates for the evidence of the health or environmental effects of a biocidal product or biocidal product may only be used in accordance with the authorization of the Environmental Management Board.

Paragraph 2. Authorisation pursuant to paragraph 1. 1 shall be granted only if the application is shown in respect of the application that the Agency for the Environment, Public Health and Food Safety has not been submitted to the EPA or the EU Chemical Agency (ECHA) in the case of studies or studies submitted to it.

§ 55. The person who wishes to use vertebrates as evidence of the health or environmental effects of an active substance or product must, on its own account, obtain information from the ECHA on the existence of any information on such tests. If information is available and this information is subject to data protection, cf. § 51, the person concerned shall contact the owner of the current information and the guidelines contained in Article 63 of the Biocidal Regulation, which shall apply.

Chapter 12

Administrative provisions

Supervision, dispensation and complaint

§ 56. The EPA shall, with the exceptions as set out in section 57, the supervisory tasks which, in accordance with the regulations and other Regulations, have been attributed to the competent national authorities, including the competent authorities of the matter, in so far as they are concerned ; in the field of control measures.

Paragraph 2. The Municipality Management Board shall assist the Environmental Management Board with the supervision of compliance with the rules governing the possession and use of pesticides in professional users not covered by the surveillance provided for in section 57.

Paragraph 3. The Municipality Management Board shall assist the Environmental Management Board at the supervision of compliance with the retention and labelling rules of retailers and the like.

§ 57. The Management Board shall supervise the storage, possession and use, as well as the registration of the use of plant protection products on soil use as regards compliance with the following rules :

1) Article 28 (2) of the Planting Protection Regulation, Paragraph 1, Article 55 and Article 67 (4). 1.

2) The Kemikalielskys section 10, paragraph 10. 2.

3) ~ § 23, 24, 26, and ~ 29 ~ 1, 2 and 4, as well as section 35 of this notice.

§ 58. The State Serum Institute and the Institute of Agroecology at Aarhus University are assisted by the Environmental Management Board at the evaluation of the effectiveness of the control centre.

Paragraph 2. The FDA shall assist the Environmental Management Board for the evaluation of residues in food and feed.

Paragraph 3. The Institute of Agroecology at Aarhus University recognises test units which in Denmark carry out studies of the efficacy of plant protection products.

Paragraph 4. The Institute of Agroecology, Aarhus University, may charge a basic fee and an annual fee for the expenses incurred in respect of the recognition of laboratories and the monitoring of compliance with the terms of these conditions.

$59. The Environmental Management Board may, in exceptional cases, take a decision which derogates from the rules in the notice or allow the rules to be waisted.

§ 60. Decisions taken following this notice of the Environmental Management Board and the authorities referred to in sections 56 and 57 may not be complained to the second administrative authority.

Police Review

§ 61. Businesses shall report to the police on grounds of suspicion of the theft of substances and mixtures classified

1) After the classification notice as highly toxic with R-statement R26, R27, or R28 or as toxic with R-statement R23, R24 or R25, or

2) according to the classification Regulation, as acute toxic in category 1, with the family of H300, H310 or H330 or as acute toxic in category 3, with the faction of H301, H311 or H331.

Paragraph 2. The notification pursuant to paragraph 1. 1 shall contain information on :

1) Designation or trade name of the substance or mixture.

2) Statements or R-phrases for the substance or mixture.

3) For single substances, the CAS number of the substance.

4) For mixtures : the CAS number of the substance or substances which have given rise to the classification of the mixture, cf. paragraph 1.

5) Any other characteristics, such as serial numbers or production numbers.

6) The stolen quantity.

Publication and maintenance of metabolists

§ 62. The Environmental Management Board shall publish and maintain lists of :

1) substances which are permitted in certain mixtures or mixtures for special use, cf. the section 32 section of the chemical code. 2, and

2) substances and mixtures which are subject to control by means of control measures, as set out in the fight against control. the section 35 of the chemical code section. 1, no. 5.

Chapter 13

Punishment

§ 63. Unless higher penalties are inflited on other legislation, penalty shall be penalised by the penalty which :

1) Avoiging an application for approval after sections 3, 4, 15 or 65.

2) Avoiding new classification for classification, cf. § 9.

3) Benytes a packaging that is not approved violates terms for the design of a label or market means without an approved label, cf. § 18.

4) Sell control agents in open or unoriginal packaging, cf. Section 20 (2). 1.

5) Keep open packaging, including empty packaging, in violation of section 20 (3). 2.

6) Selling stock substances for biocidal products or biocidal products in violation of section 21.

7) Sell or perform advertising in violation of sections 21 and 22.

8) Determines plant protection products in violation of section 23.

9) Marketplace, possesses or uses biocidal products in violation of section 24.

10) Retaining or unsupervised control means, in violation of section 26.

11) Retains toxic or very toxic control agents, cf. § 2, nr. 6 and 7, contrary to section 29 (3). 1-3.

12) Avoiding the person responsible for the storage of toxic or highly toxic control agents, cf. § 2, nr. paragraphs 6 and 7, and section 29 (4). 4.

13) Selling poisonous or very toxic control agents, cf. § 2, nr. 6 and 7, in violation of section 30-34.

14) Apples poisonous or very toxic control agents, cf. § 2, nr. 6 and 7, in violation of section 35 or section 39.

15) Selling funds for chemical control of rats to other than authorised persons, cf. § 28.

16) Determines for the chemical control of rats without authorization for the fight against the rat fight, cf. § 28.

17) Sell plant protection products in violation of section 40.

18) Predict experimental testing, including anal and possessor such biocidal products, in violation of section 41.

(19) Override terms associated with an approval or permission after the control mean regulations, cf. § 15 or § 59.

20) I'm sorry to file a police report after Section 61.

21) Avoic-illus about activities, etc., cf. § 36.

(22) Avoiding annual tax return on the sale of authori-able control funds to the Environmental Management Board, cf. § 44.

23) Do not register and report data on plant protection products, cf. Article 67 (1). 1 and 2 of the plant protection product Regulation.

24) Incidentally, provisions on control measures, laid down in the anti-regulation regulations or other EU regulations, are laid down.

Paragraph 2. The sentence may go to prison for two years if the infringement has been committed intentionally or by gross negligence and if there is a breach of the infringement proceedings ;

1) damage to human or animal life or animal health or, therefore, hazard,

2) damage to the environment or caused, or

3) obtained or intended to be economically advancuable, including in the case of savings, for the person concerned or others.

Paragraph 3. For infringements of sections 10, 11, 13, 17, 26 and 29, and for the sale of a biocidal product without approval after section 15, producer, importer or operator may be subject to liability, even if the infringement cannot be attributable to this ; for intentional or negligent. Such executor liability shall not be subject to the conversion penalty.

Paragraph 4. Companies can be imposed on companies, etc. (legal persons) punishable by the rules of the penal code 5. Chapter.

Paragraph 5. For infringements covered by paragraph 1. 1-4 shall be the period of limitation of liability for five years.

Chapter 14

Entry into force

§ 64. The announcement shall enter into force on 1. January 2014, cf. however, § 68.

Paragraph 2. Publication no. 1088 of 6. September 2013 on control remedies shall be deleted, cf. however, sections 66 and 67.

Chapter 15

Transitional provisions

Approval of certain biocidal products during reevaluation

§ 65. Where an active substance is listed in Annex II to Commission Regulation (EC) No 1451/2007, and the substance is subject to an assessment in one of the provisions of section 15 (3). 3, and 4, mentioned product types, shall authorise the Environmental Management Board for biocidal products after Article 15 before import, sale or use.

Transitional provisions relating to the processing of plant protection products covered by the transitional arrangements of the plant protection product

§ 66. Treatment of applications for the approval of new plant protection products and for the renewal of plant protection products, including amendments and retraction covered by the amendment of the amendment, cf. § 2, nr. 17, shall take place in accordance with the rules in section 4-16 of the notice. 242 by 18. March 2011 on control measures.

Transitional provisions on plant protection products and labelling rules

§ 67. Packaging and labelling for applications for the authorisation of plant protection products, which are, until 14. June 2015 must be dealt with in accordance with the rules of the change law, cf. § 2, nr. 17, irrespective of the provisions on classification and labelling in section 7 (4). 2, and section 8, in accordance with the rules in section 19 to 27 of the notice. 242 by 18. In March 2011, on control measures, cf. however, paragraph 1 2.

Paragraph 2. The applicant for approval or re-approval of a plant protection product subject to the amendment of the amendment may request that packaging and labelling be applied in accordance with the rules to this in the plant protection product Regulation, after which it considers : use.

§ 68. Text of the legal user group label, cf. Section 13 (1). 4, for plant protection products approved in the future by the EPA, or whose label approval holder shall in the future be changed, shall show no later than 26. November, 2015.

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Appendix 1

Requirements for the application for approval after section 15 of a chemical biocidal product

The requirements of this Annex shall be lodged with an application for the approval of chemical biocidal products where no one or only part of the asset is listed in Annex I or IA to the biocidal Directive to the application of the application.

a. DATE REQUIREMENTS FOR ACTIVE SUBSTANCES

1. the name and address of the applicant.

2. Information concerning the identity of the asset ;

2.1. Name according to IUPAC nomenclature

2.2. Other names (ISO names, trade name, code name)

2.3. Commercial names of other products containing the substance in so far as they are known to the applicant

2.4. CAS No!

2.5. Gross formula

2.6. Structural formula

2.7. Molweight.

3. Information on the Asset as a technical product

3.1. Exceeding RUnit

3.2. Designation and quantity (% weight by weight) of significant impurities, including isomers, synthesis by-products, degradation products and the like, according to IUPAC or CA as well as CAS No

3.3. Nature and quantity of any additives, stabilisers, inhibitors or other additives in% or ppm.

4. Information concerning the determination of the asset

4.1. Spectral data (UV, IR, NMR, MS, and similar.)

4.2. The methods of detection and determination. Description of the used control methods for qualitative and quantitative determination of the substance in products (control agents), soil, water, air and in biological material (plant tissue and animal tissue, urine, faeces and, where appropriate, milk).

5. Information relating to the origin and manufacture of the stock-related matter

5.1. Name / company name and address of the supplier of the asset

5.2. Sketch of the manufacturing process of the stock-life process.

6. Physical and physico-chemical properties of the asset ;

The information on condition, refractory index, melting point, boiling point, vapour pressure, density and solubility must be given both to the technical product used for the formulation, as pure substance,

6.1. Description of the substance

6.1.1. Mode of Mode

6.1.2. Colour, smell, etc.

6.2. Refractive Index

6.3. Melting point (sublimationpoint, decomposition temperatures)

6.4. Boiling point 4

6.5. Density D 20

6.6. Damppress, possibly steam pressure curve

6.7. Surface tension

6.8.1. Water solubility

6.8.2. Constant strength constant (dissociation constant) for substances with acid or bayproperties

6.9. Fedtopranbility

6.10. Partition coefficient n / octanol/water

6.11. Solubility in methanol, hexane, dichloromethane. Solubility in other organic solvents.

6.12. Hydrolysis stability in :

6.12.1. Water

6.12.2. Visions

6.12.3. Alkali

6.13. Stability

6.13.1. Photostability

6.13.2. Thermostability

6.14. Flash point

6.15. Igability

6.16.1. Oxidising properties

6.16.2. Explosion

6.17. the splitting or other reaction to heating, incineration or blow,

6.18. Other characteristics that the applicant may have knowledge of.

7. Acute toxicity

7.1. Oral

7.2. Through Skin

7.3. Inhalation

7.4. Other injections

7.5. Skin irritation

7.6. Irritation of the eyes

7.7. Skin sensitizing effects.

8. Sub-chronic toxicity

8.1. 90-day study on rats

8.2. Three or six months of investigation on a non-rodent (other than rat and mouse)

8.3. Any studies with other applications, animals or periods of time.

9th Chronic Toxicity

Animal feed test at least two mammals.

10. Carcinogenicity

Investigation of at least two mammals.

11 Mutagenicity

11.1. Mutations, in vitro and in vivo

11.2. Chromosomal changes.

12. Other mutagenicity studies

If one or more of the above tests are positive : tests for the effects of carbon scels.

13. Reproduction studies

At least two generations by two litter per litter. generation.

14th Teratogenicity studies

Investigation of at least two mammals.

15. Neurotoxicity.

16. Toxic to metabolites, degradation products and impurities.

17 Metabolism in animals

17.1. Absorption, distribution and excretion in mammals

17.1.1 at a one-time flow

17.1.2 on multiple admittals

17.2. Biotransformation in mammals

17.3. Other studies on mammals (haematology, liver and kidney function examinations, enzymes, etc.)

17.4. Any absorption, distribution and separation of other animal species

17.5. Proxic mode of action.

18. Toxicity to humans.

Any experience gained during the production process, in practical use or in connection with poisoning cases. Countermeasures with poison.

19 Metabolism and persistence in or on plants

Recording, transport, nature and quantity of degradation products.

20. Examination of residues in relevant edible parts of plants, as well as in products of animal origin

Degradation curves and half-life for the active substance and essential metabolites (at least 3 sampling).

21. Importation in soil

21.1. Transformation and degradation

Earth Flat-Surface Photosis

Decomp rate in three soil types under aerobic conditions

In a soil type : metabolic, degradation rate at two temperatures and at two dosage, degradation rate dependency of moisture content, degradation velocity in sterile soil and under anaerobic conditions

21.2. Transport and movement

At least the soil-level washing-out test in three soil types and with the aged active substance in a soil type.

21.3. Adsorption / desorption

21.4. Cumulation in soil of active substance and essential metabolites

21.5. Evaporation from Earth.

22. Importation in water

22.1. Degradation, biotic. At least BOD value and the relationship BOD/COD

22.2. Adsorption for organic material (hover and sediment), cumulation in sediment

22.3. In the case of funds derived from purification plants, the effect of the operation of the facilities, including the ability of the active capacity to remove organic matter.

23. Toxic effects on aquatic organisms

23.1. Acute toxicity to fish (on two fish species)

23.1.1. Acute toxicity on daphnia

23.1.2. Daphnia reproduction test

23.1.3. Acute Toxicity on algae

23.1.4. Toxic effects on other aquatic organisms

23.2. Study of bio-accumulation in aquatic ecosystems, if the distribution coefficient n-octanol/water is greater than 103, cf. Act. 6.10.

24th Toxic effect on soil organisms

24.1. Acute toxicity and other influences of earthworms

24.2. Effect on soil respiration

24.3. Effect on ammonium

24.4. Efficiency on nitrification

24.5. Effect on asymbiotic N-fixation and, in some cases, the effect of symbiotic N-fixation.

25. Toxic effects on birds

25.1. Acute food toxicity at least two species of bird with different food bases

25.2. Reproductive test of at least one bird species.

26th Effect on bees.

27. Any information about toxic effects on other freshmen.

28. Other information on the fate or impact of the asset product or its degradation products in the environment.

29th, physical toxicity.

Thirty, Resistance-forming properties.

31. Toxic impact mechanism in target organism. Reason for selectivity.

Thirty-two. Recommended security measures in connection with :

32.1. Handling

32.2. Replagring

32.3. Transport

32.4. Fire hazard.

33 of the substance of the substance ;

Any connections and quantities to be used to get a rapid intake of tiresome leftovers or the like.

34. other precautions, if any, in the case of any kind of accident or misuse of the environment.

Recording, classification, processing deadlines and allowable residues in other countries.

Thirty-six, literature references.

Thirty-seven. Numbered list of documents.

b. DATAK RAW FOR MIDLET

1. Enterprise and trade name

1.1. Name of the applicant (company), address and telephone, as well as SE no.

1.2. Name / company name and address of the manufacturer of the product

1.3. Name of the centre (trade name) and code name.

2. Information about the remedy

2.1. Fighting Middle Type

2.2. Nature of operation

2.3. Asset Substances (Nature and Percentage)

2.4. Mid Pamps

2.5. The shape of the mid-level.

3. Midlet's use

3.1. Scope of the centre

3.2. Means of laxation and use of the centre

3.3. Mid-boarding

3.4. Mimixing of the funds

3.5. Effectiveness.

4. Packaging of the centre

4.1. Proposals for label and use instruction, cf. Annex 2

4.2. The packaging of the means.

5. Toxicological data for the product

5.1. Acute oral toxicity

5.2. Acute toxicity through skin

5.3. Acute inhalation toxicity

5.4. Skin irritation

5.5. Irritation of the eyes

5.6. Other toxicological data for the product

5.7. Toxicological data for non-active components.

6. Ecotoxicological studies of the product

6.1. Content of substances dangerous to bees

6.2. Other ecotoxicological effects

6.3. Ecotoxicological effects of non-active components.

7. Physical and technical characteristics of the funds

7.1. Free acidity or alkalinity

7.2. Density of density (for liquids)

7.3. Particle size (for powders and powders)

7.4. Suspension or emulator properties

7.5. Storage shmability, including the coal destabilisation

7.6. Corrosive properties

7.7. Steam pressure

7.8. Flash point

7.9. Warming and Fire Properties

7.10. Any other relevant information.

8 Additional information for use for classification and labelling

8.1. Classification for Fire Farliness

8.2. Classification of transport.

9. Destruction method.

10. Analytical method.

11. Information for usage of Work in Business

11.1. Safeguard equipment

11.2. Regulation (s) by fire, including proposals for suitable extinguishing agents.

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Appendix 2

Information on the label, cf. § 17, paragraph 1. 1

1. Labels of a biocidal product, in addition to the information required by the classification notice, shall include the following information :

1) The identity and concentration of all active substances in metric units and percentage by weight.

2) The number of the approval given by the competent authority of the biocidal compound.

3) Preparate type (e.g. liquid concentrate, granules, powdered, chemical, etc.).

4) Approved uses of the biocidal mixture (e.g. tree impregnation, disinfecting, anti-fouling, etc.).

5) Use instructions and dosage, expressed in metric units, for each of the uses used for approval.

6) Individual effects on probable, direct or indirect side effects and any instructions for first aid.

7) Ambiguous reference to the appended instructions for use when such an enclosed is attached.

8) Indications for the sound disposal of the biocidal product and the packaging, including, where necessary, any prohibition on the reuse of the packaging.

9) the batch number or designation of the parte and the expiry date of normal storage conditions.

10) Information on :

a) the time it takes before the biocidal product works,

b) the amount of time to be used between the use of the biocidal product on the product concerned or between the use and the next use of the product treated ;

c) the amount of time to be used until the next access of humans or animals to the area where the biocidal product has been used, including information on decontamination agents and measures and the duration of the necessary ventilation of the areas treated ;

d) adequate cleaning of equipment ;

(e) preventive measures in the use, storage and transport, such as protective suits and equipment for persons, measures to protect against fire, covered furniture, removal of food and feed ; and

(f) the way in which animals are to be exposed to the product concerned.

2. To the extent necessary, labels shall be subject to the following markings :

1) The category of users that the biocidal product is limited to.

2) Information on any particular hazards to the environment, in particular on the protection of non-target organisms and preventing the contamination of water.

3) In the case of microbiological biocidal products, any additional labelling requirements as per Work shall be published on biological agents and the working environment.

The information in paragraph 1, no. 3, 5, 6, 8, 9 and 10 and in paragraph 2, no. 2, with the permission of the Environment Management Board, may, in each case, be included in a brochure, a leadsheet or similar leaflet, which shall be handed down together with the biocidal product.

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Appendix 3

Summary of the basic fee and the additional fee for processing matters of biocidal products

I. Decision of the biocidal Regulation and the amendment of authorisations or authorisations granted under the biocidal directive or the biocidal Regulation

Where a reference is made to an Article without further reference, reference shall be made to the biocidal Regulation.

The term ' family ` means as defined in the biocidal Regulation, Article 3 (1). in the case of a group of biocidal products with uniform applications, if active substances have the same specifications and with specified variations in their composition, which do not have a negative impact on the level of risk of the products or in significantly reduce the efficiency of the products '.

II. Decision on the approval or modification of the approval of biocidal products where the stock continues to be under the evaluation of the biocidal Regulation, cf. section 66, or where the asset does not have to be approved in accordance with the Biocidal Regulation, but in accordance with Danish rules, cf. § 15

III. Fees for case processing where the asset is not evaluated according to the Biocidal Regulation. Evaluation of active substances according to the rules of the biocidal directive or the biocidal Regulation, including the approval of active substances for inclusion in Annex I to the Regulation ;

LV. Additional charges

For some ratings, a supplementary fee is paid. This payment shall be granted for each additional assessment.

The fee shall be charged for the additional service in question, where the letter is specified in the tables above.

The supplementary fee of the Food Management Assessment of the MRLs for maximum residue levels (MRLs) can be complied with.

The fee shall be charged for the work of assessing the limit values for biocidal products used in such a way as to ensure that they come in contact with food, feed or potable for animals, or are used in the vicinatial area ; directly on animals used as food or food production.

Provided that a new limit value for food, feed or water for animals is to be established for animals, the Food Authority shall be subject to this.

B : $25,200. but only DKK 10.100 for the approval under Title II (approval of national Danish rules, highlighted B-i table).

Facility fee B for the assessment of each additional asset.

The fee shall apply to biocidal products with more than one asset ' s active substance.

C : Kr. 25,200.

Facility fee C for assessment of each additional scope.

The fee shall apply to products containing biocidal products with a number of applications.

Per 45.300.

A supplementary charge D for comparative assessment.

The fee shall apply to biocidal products with an active substance candidate for substitution. Gees for each Asset Candidate for substitution.

E. Kr. 765,000.

A supplementary fee E for the evaluation of new or partial new dossier for an active substance or micro-organism.

The fees shall apply where the applicant does not have the right to use the file that is evaluated in connection with the approval of the asset. Gees for each file.

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Appendix 4

Allowed manufacturing and analysis tolerances for biocidal products, cf. § 4

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Appendix 5

Table 1. Summary of the basic fee and additional fee for processing of cases of plant protection products

I. Gees for the approval of stock-stock

II. Chemical plant protection products

All charges in DKK

III. Microbiological plant protection products

LV. Confederal charges for different administrative changes (chemical and microbiological plant protection products)

For all three sections of Table 1, additional charges shall be levion, where a reference has been inserted.

The supplementary fee shall be charged only when the relevant service is supplied in the current case. The supplementary fee is subject to specific assessments and, on the other hand, the work on changes to a already submitted application resulting from the additional time consumption will result in such changes.

The supplementary charges shall comprise :

A : Premium fee for the evaluation of residues in food and feed (MRLs)

B : Premium Pay Charge for Efficiency Assessment, performed by Aarhus University (Department of Agroecology)

C : The environmental management assessment of the stock in a plant protection product (for each active substance in the product)

D : The equivalence of the environmental control unit (for each Asset Substance)

E : Substitution, valuation of active substance (for each Asset ' s stock)

Am1 : The Agency for the Environmental Management Board ' s assessment of amendments to the application

Am2 : for the evaluation of changes to the application for the Food Management Board

Am3 : Geurr of Aarhus University Institute of Agroecology (Agroecology) Assessment of changes to the application

The amount of the individual supplementary fee depends on the work of the authority or institution concerned, and hence of the type of application.

In Table 2 the amount of the additional fee referred to in Table 1 is specified.

Summary of abbreviations :

RR : Registration Report : Registration Report (Evaluation)

ZRMS : Zonal Reporteur Member State : The Member State making the assessment for the Zonen.

IZRMS : Inter Zonal Reporteur Member State : The Member State making the assessment for all three zones in Europe.

CMS : Concerned Member State : Member State making national evaluation on the basis of an assessment by either ZRMS or the IRMS.

DAR : Draft report report : EU assessment of the active substance.

Table 2. The size of the supplementary fee in Table 1

All charges in DKK