Order On Pesticides

Original Language Title: Bekendtgørelse om bekæmpelsesmidler

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Overview (table of contents)

Chapter 1

Scope and definitions


Chapter 2

Approval of pesticides


Chapter 3

Approval of biocidal products not covered by the Biocides


Chapter 4

Sales and possession etc. of pesticides


Chapter 5

Special provisions for toxic pesticides


Chapter 6

Special precautions for plant


Chapter 7

Experimental testing of biocidal products


Chapter 8

Consultation of the national action plan


Chapter 9

Taxes, fees, etc.


Chapter 10

Mandatory notification of biocidal products


Chapter 11

Data protection and data exchange


Chapter 12

Administrative provisions


Chapter 13

penalty


Chapter 14

Commencement


Chapter 15

Transitional provisions


Appendix 1

Requirements for application for approval in accordance with § 15 of a chemical biocidal product


Appendix 2

Information on the label, see. § 18 paragraph. 1


Appendix 3

Fees for application for approval of biocides


Appendix 4

Permitted manufacturing and analytical for biocides, see. § 4


The full text
notice bekæmpelsesmidler1)
Pursuant to § 4 a, § 5, § 6, § 7 a, § 10 paragraph. 4, § 10a, § 20, § 22, stk. 2-4, § 22a, § 22c, § 23, § 25 paragraph. 4, § 27, § 30 paragraph. 1, § 31, § 33 paragraph. 2, 3 and 8, § 34, § 35, § 36 paragraph. 2, § 37, § 38 e, f § 38, § 42 paragraph. 1 and 2, § 42a, § 43, § 43a, § 45, § 46, § 51 c, § 56 and § 59 paragraph. 4 and 5 of the Act on chemicals, see. Legislative Decree no. 878 of 26 June 2010 as amended by Act no. 294 of 11 April 2011, Law no. 161 of 28 February 2012, Law no. 277 of 19. March 2013, and law no. 489 of 21 May 2013 is set:

Chapter 1

Scope and definitions

§ 1. This Order shall apply for pesticides, cf.. Act § 33, to the extent they are subject to authorization under pesticide regulations, see. § 2, no. 1, as well as certain pesticides that are not covered by these regulations.

PCS. 2. This Order establishes rules that complement pesticide regulation the rules referred to. § 2, no. 1, for approval, production, import, sale, use and possession of and supervision of pesticides. The notice also provides rules for national authorization of biocidal products referred to in the Act. § 35 paragraph. 1, and enhance the protection of data in this regard.

PCS. 3. This Order shall apply to pesticides in the form in which they are supplied to the user, see. However paragraph. 4.

PCS. 4. The Order does not apply in connection with

1) transport of pesticides

2) pesticides that are negotiated between producers and importers, or between producers themselves, see. However, §§ 14 and 27, or

3) export of pesticides, cf.. However, § 25, § 26 and § 27 paragraph. 2.

§ 2. For the purposes of this Order:

1) Pesticide Regulations: Biocides meaning. No. 3, and plant protection Regulation foreseen. No. 13

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

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

4) The biocidal product: As defined in Article 3. 1, point a, in Biocides meaning. No. 3, and the substances, mixtures and other products not covered by the Biocides, but have specified in subparagraphs ac above characteristics:

a) A substance or mixture in the form in which they are 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 controlling effect on pests otherwise than mere physical or mechanical action.


b) A substance or mixture, generated from substances or mixtures not in themselves fall within the point a meaning, which is intended to destroy, deter, render harmless, prevent the action of or controlling effect on organisms harmful to other than mere physical or mechanical action.

c) Treated articles, as defined in Article 3. 1, point l, in Biocides, with a primary biocidal.

5) Mixing: As defined in the Classification Regulation, Article 2, no. 8

6) Toxic pesticides: Pesticides (plant protection and biocidal products) that are classified as very toxic or poisonous, and pesticides that are classified as acute toxicity category 1, 2 or 3, or as a specific target organ in Category 1 (STOT SE 1).

7) Agricultural: Agricultural Holdings are subject to SKAT use code 05 (agriculture, built), 06 (separately assessed forest and plantation), 07 (orchard, horticultural and nursery), or 17 (undeveloped landbrugslod, etc.), or 01 (residential ), with regard to properties in the nature of agriculture or horticulture.

8) Classification Executive Order on classification, packaging, labeling, sale and storage of substances and mixtures.

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

10) Micro-organism: As defined in the Biocides, Article 3. 1, point b, as far as biocidal products and plant protection Regulation, Article 3, no. 15, with regard to plant protection products.

11) Plant Protection Products: As defined in Article 2. 1 in plant protection Regulation foreseen. No. 13, in the form in which they are supplied to the user, consisting of or containing active substances, safeners or synergists, and intended for the following purposes:

a) To protect plants or plant products against all harmful organisms, unless the main purpose of these products is considered to be of hygiene rather than protection of plants or plant products.

b) To influence the life processes of plants, for example. by acting on the growth of plants other than as a nutrient.

c) To preserve plant products, in so far as such substances or products are not subject to special Community provisions on preservatives.

d) To destroy unwanted plants or parts of plants, except algae unless the products are applied on soil or water to protect plants.

e) To check or prevent undesired growth of plants, except algae unless the products are applied on soil or water to protect plants.

12) Plant Protection Products Directive Council Directive 91/414 / EEC of 15 July 1991 concerning the placing of plant protection products.

13) Plant Protection Products Regulation: European Parliament and Council Regulation (EC) No. 1107/2009 of 21 October 2009 concerning the placing of plant protection products and repealing Council Directive 79/117 / EEC and 91/414 / EEC.

14) Sales: Any transfer of a pesticide, whether the transfer is carried at cost, as defined in biocidforordningens Article 3. 1, point i and j, and plant protection of Article 3, no. 9.

15) Fabric: As defined in the Classification Regulation, Article 2, no. 7

16) Fabric Executive Order on the application of chemical substances and mixtures of pesticides.

17) Amendment Act, § 6 of the Law no. 294 of 11 April 2011 amending the Act on chemical substances and products and various other Acts.

Chapter 2

Approval of pesticides

General rules

§ 3. Application for and approval of plant protection products follow the rules of plant protection regulation.

§ 4. Application for and authorization of biocidal active substances and products follow the rules of Biocides meaning. However paragraph. 2 and 3 and §§ 15 and 66.

PCS. 2. Treated articles, see. Biocidforordningens Article 3. 1, point l, treated with an active substance, which is still under assessment within a specified in § 15 paragraph. 3 and 4, said product types, the sale must be labeled in accordance with biocidforordningens Article 58. 3-6. For the treatment of such articles to be used biocidal products authorized under § 66.


PCS. 3. If the Environmental Protection Agency in a specific authorization of a biocidal product determine different tolerances, the fabrication and measurement uncertainty must be within the tolerances specified in Annex 4.

§ 5. Application under §§ 3, 4, or 15 shall be submitted in Danish or English.

PCS. 2. Application according to § 15 shall be submitted on a form drawn up by the Environmental Protection Agency, and the application must also follow the instructions EPA allows.

§ 6. The Environmental Protection Agency is responsible, with the exceptions set out in § 55, the tasks for pesticide regulations conferred on national competent authorities, including evaluating competent authorities. EPA also approves the biocidal products that require authorization in accordance with § 15

Classification of pesticides

§ 7. The person who submits an application for approval of a pesticide must indicate whether the agent can be characterized as hazardous for classifying the Order or classification regulation rules. The agent may be classified as hazardous, it must also be classified.

PCS. 2. Until 30 May 2015 shall be classified either under the rules of classification notice or in the classification regulation. From June 1, 2015 shall be classified in accordance with the classification regulation. Applicants should specify when filing the application, which classification rules that are used for the control agent.

§ 8. If you apply by 30 May 2015 re-approval of a pesticide, the applicant must choose whether it wishes to classify its control agent under the rules of the classification order or under the rules of classification regulation. The rules in § 7 shall apply mutatis mutandis.

§ 9. Whoever reclassify or update the classification of an approved pesticide must submit information on the new classification.

PCS. 2. Environmental Protection Agency may decide that the submitted new classification in accordance with paragraph. 1 is comparable with a brand new application for approval.

Requirements for active substances used in pesticides

§ 10. Active substances covered by § 15 and § 66 shall be classified, packaged and labeled in accordance with the classification regulation in sales for use in biocidal products.

PCS. 2. The requirement of paragraph. 1 does not apply to active substances to be used for experimental testing, shareholder, see 39.

Packaging, Labeling, etc. of pesticides

§ 11. Biocidal products are packaged and labeled according to biocidforordningens Article 69.

§ 12. Plant protection products packaged and labeled in accordance with the plant protection Article 64 and 65

§ 13. The application, together with the proposal for the design of packaging and labeling of the product as well as suggestions for brochures, post leaves or the like for dispensing with the control agent to be approved.

PCS. 2. Environmental Protection Agency may require additional information, including the applicant conducts further investigation after the Board's instructions.

PCS. 3. The label other marking on packaging and brochures, post leaves or the like for dispensing with a pesticide must be written in Danish, if the product to be marketed in the Danish market.

§ 14. Pesticides that only negotiated between producers and importers, or between producers themselves, must, in addition to labeling in accordance with the classification order or classification regulation, clearly marked with the product's name, the name and percentage of each active substance, manufacturer's or importer's name and address and a text which unequivocally: Do not be distributed to consumers. Intended for further manufacturing (repackaging).

Chapter 3

Approval of biocidal products not covered by the Biocides

§ 15. A person wishing to import, sell or use a biocidal product that is covered by paragraph. 3 or 4, must submit an application to the EPA for approval of the active substance and or funds active substance is incorporated, although the active substance is subject to authorization requirement for Biocides. Application is not required under that provision, if the active substance and biocidal product authorized under other EU legislation or in mixtures that are covered by the permit.

PCS. 2. Together with the application for approval, the applicant must indicate whether the agent can be characterized as hazardous for classifying the Order or classification Regulation rules, see. § 7. Can the product deemed hazardous, it must also be classified.


PCS. 3. Approval obligation under paragraph. 1 comprises means intended for the control of

1) wood-destroying fungus

2) growth of algae

3) slime-forming organisms in pulp,

4) rabbits, mice, and rats, as well as

5) following lower animals:

a) vermin in domestic animals, including pet birds.

b) Textile Pest.

c) Pest in timber and woodwork.

d) Insects, snails, mites and the like.

e) Earthworms.

PCS. 4. Approval obligation under paragraph. 1 also includes active substances that are intended to prevent damage caused by the below paragraph. 3, Nos. 4 and 5, said vermin and wild mammals and birds or which are intended to keep these animals from places where they are not wanted.

PCS. 5. Approved active substances by drug order.

§ 16. Application for approval according to § 15 shall include those listed in Annex 1 information.

PCS. 2. Environmental Protection Agency may require additional information, including the applicant conducts further investigation after the Board's instructions.

§ 17. Approval by § 15 granted for a maximum period of ten years from the date of the Environmental Protection Agency's decision, unless the Agency as a result of the active substance or biocidmidlets health or environmental properties provides for a shorter period.

PCS. 2. Environmental Protection Agency may allow an approval be subject to the applicant within a specified period by carrying out detailed studies of the active substance or biocidmidlets health or environmental properties.

§ 18. When the authorization of a biocidal product in accordance with § 15 authorizes the Environmental Protection Agency the design of the product's label proposal by the applicant. The label shall include in Annex 2 shall, and Environmental Protection Agency may determine that the label must bear additional information, like the Environmental Protection Agency may require a particular wording is used.

PCS. 2. Environmental Protection Agency may allow the information to be included in the label, instead be printed directly on the packaging. Environmental Protection Agency may also allow some of the information on the label or packaging instead shown in a brochure, post blade or the like, distributed with the biocidal agent.

PCS. 3. The provisions of paragraph. 1 and 2 shall be in Danish and must be clearly and indelibly.

Chapter 4

Sales and possession, etc. of pesticides

Sales

§ 19. The provisions of § 24 paragraph. 1 and 2 and § 25 paragraph. 1 and 3 do not apply to pesticides covered by this Order.

§ 20. Pesticides may only be sold in the unbroken original packaging in which they are delivered from the manufacturer, importer or the holder of the authorization as underlying sales.

PCS. 2. Open packages of pesticides may not be available at business premises, warehouses and other premises where pesticides are stored for sale to users.

Advertising etc.

§ 21. A biocidal product that is covered by § 15 and § 66, to be marketed in accordance with paragraphs. 2-5 those rules.

PCS. 2. The sale of biocidal products shall not take place in circumstances that are apt to mislead users as to the product's use or the risk that may be associated with the agent.

PCS. 3. The sale of biocidal products do not use terms that may be suitable to provide users with the view that the product does not imply risk to humans or the environment, including expressions that indicate that the product is safe, non-toxic, not harmful, not subject to identification approved or tested for special circumstances, for example, allergies, or expressions containing words such as environment, eco, nature or combinations thereof. In addition to the term biocide must be expressed with words like bio or combinations thereof shall only be used in connection with the sale of microbiological biocidal products.

PCS. 4. The packaging of hazardous biocidal products referred to. § 7 may not have a presentation or bear a name used for food, feed, pharmaceuticals and cosmetics.

PCS. 5. The packaging of hazardous biocidal products referred to. § 7, which retailed to the general public, are not designed or decorated so that it attracts active curiosity of children or to mislead consumers.

§ 22. The advertising of a biocidal product covered by § 15 and § 66 shall include a statement about the danger indication and content of active substances and unequivocal statement that biocidal products should be used with caution, and that label and instructions for use should be read before the product is used.


PCS. 2. If the advertisement for a biocidal product gives the consumer the opportunity to enter into a contract for purchase without first having seen the product's label, the advertisement referring to the hazard classes listed on the label.

PCS. 3. An advertisement must not contain statements or similar that a biocidal product contains or may have the effect of plant nutrient.

possession

§ 23. A plant protection product may only be held if it is approved in Denmark under the plant protection regulation, and it bears a label in Danish, see. However, plant protection Article 28, paragraph. 2. Plant protection products must also be held if it happens to use a waiver for plant protection Article 53. Possession can be subject to a time limit if an agent entered in the drug order.

§ 24. A biocidal product may only be held if it is approved in Denmark or the EU and have a label in Danish. A biocidal product may also held as part of the utilization of a waiver or authorization granted in accordance with the Biocides or the law.

PCS. 2. How to fix a final date of use of a biocidal product, the agent only held until that date.

PCS. 3. A biocidal product that is covered by paragraph. 1 may also be held if it happens to use a waiver or permission granted pursuant to the Chemicals Act.

§ 25. The prohibition in § 24 against possession does not include biocidal products, manufactured abroad and only passed through the country as transit cargo. The prohibition also applies to establishments lawfully manufacture substances and mixtures for export.

§ 26. Pesticides should be stored in the original packaging, which must be equipped with the approved label.

PCS. 2. Pesticides must instance be stored securely and out of reach of children. The funds must not be stored together with or near food, feed, pharmaceuticals and the like.

PCS. 3. Surplus of pesticides and empty containers should be stored in compliance with paragraph. 2.

PCS. 4. Spray Liquids etc., Which is prepared by pesticides must not be left unattended.

Chapter 5

Special provisions for toxic pesticides

possession

§ 27. Toxic pesticides, see. § 2, no. 6 shall be held by the person who is authorized to manufacture, sell or use such means.

PCS. 2. In addition to those mentioned in § 26 storage requirements, the storage of toxic pesticides, see. § 2, no. 6, happen under lock.

PCS. 3. Any person who manufactures, imports or sells toxic pesticides, see. § 2, no. 6, must keep these funds in a separate, locked cabinet or room that is clearly marked with warning sign for Statutory Order on classification rules. Married cupboard or poison space at the selling toxic pesticides may contain only those pesticides.

PCS. 4. If a company or institution keep toxic pesticides, see. § 2, no. 6, in a total volume of about 125 ml which more than five persons have access, must designate one or more persons in the company or institution the President must ensure that the storage of such pesticides is done according to §§ 26 and 27, and that unauthorized persons do not have access to funds.

Sales

§ 28. Toxic pesticides, see. § 2, no. 6, may be sold by the holder of the authorization for that product, or that the specified conditions have been authorized by the Environmental Protection Agency.

PCS. 2. A license includes a sales outlet. The authorization may be restricted to only pesticides classified as toxic or pesticides that are classified as acute toxicity category 3. Permits may be revoked by the Environmental Protection Agency, if the permit holder has repeatedly retain the pesticides wrong, sell funds to people who are not entitled to acquire the funds, or fail to post sales according to § 31

§ 29. Toxic pesticides, see. § 2, no. 6, may be sold for

1) companies that are covered by § 28

2) the one who can document that they have completed a course in pesticides, see. § 34 paragraph. 1 and

3) the person who can show a permit from the Environmental Protection Agency to buy and use pesticides classified as very toxic, as acute toxicity category 1 or 2 or as specific target organ in Category 1 (STOT SE 1).


PCS. 2. Pesticides classified as toxic or as acute toxicity category 3 may also be sold to that pursuant to § 33 shall apply these pesticides.

§ 30. Sale of toxic pesticides, see. § 2, no. 6, may only take place at the buyer's unilateral acknowledgment.

§ 31. The selling pesticides classified as very toxic, as acute toxicity category 1 or 2 or as specific target organ in Category 1 (STOT SE 1) shall maintain a record of each purchase and sale of these agents.

PCS. 2. Accounting must be performed immediately after the transaction has taken place and must include the date, the name and address of the funds trade name, and number and size of the packages.

PCS. 3. The accounting must the retailer's holding in paragraph. 1 shall be always clearly stated in the book or an extract from the retailer's normal bookkeeping, made in a way that can be approved by the Environmental Protection Agency.

PCS. 4. The book documents must be kept for five years after being printed. If accounting takes place electronically or by means of a loose-leaf system, the accounting store five calendar year.

§ 32. Toxic pesticides, see. § 2, no. 6, should not be left to people who are likely to cause harm to themselves or their surroundings.

Use

§ 33. Pesticides classified as toxic or as acute toxicity category 3 may, with the exception set forth in § 34 paragraph. 2, for use by any person who

1) use the funds in an undertaking or

2) pest control for others.

§ 34. Pesticides classified as very toxic, as acute toxicity category 1 or 2 or as specific target organ in Category 1 (STOT SE 1) shall, with the exception specified in paragraph. 2, used only by the person who can document that they have completed an Environmental Protection Agency arranged or approved married course of the agent's scope and commercial

1) use the funds in an undertaking or

2) Moreover, pest control for others.

PCS. 2. The § 33, paragraph. 1 shall pesticides may also be used by an employee in paragraph. 1 persons mentioned.

§ 35. Toxic pesticides, see. § 2, no. 6, may be in private gardens, in areas around housing, child care centers and the like as well as in public areas and similar areas that are accessible to the public, including bordering public roads or private gardens, used only by combating rats, voles and moles of a person who has undergone a married course, see. § 34 paragraph. 1.

Special rules for means to combat rats

§ 36. Chemical control of rats must be performed by an authorized person, cf. Order on prevention and control rats.

§ 37. Pesticides against rats may only be supplied to and held by an authorized person, see. § 36.

Chapter 6

Special precautions for plant

§ 38. In order to ensure that the user knows the hazards, exposure and proper storage, handling, application and safe disposal, etc. of a plant protection product, the dealer when selling them to a private user inform that the party concerned to be

1) read the plant label before use etc.,

2) use of plant protection for the label's provisions and

3) follow the plant protection instructions during and after use.

Chapter 7

Experimental Testing of biocidal products

§ 39. A biocidal product or an active substance of biocidal products not covered by the Biocides may be provided by paragraph. 2-4 imported, transferred, stored, used and disposed of for use in experimental testing.

PCS. 2. Whoever is responsible for testing or studies following paragraph. 3 and 4 should manage lists the following information:

1) Detailed information about biocidmidlets or active substance, labeling data, quantities supplied and the names and addresses of the recipients of the biocidal agent or the active substance.

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

PCS. 3. For scientific experimentation, analysis or chemical research carried out under controlled conditions, including the determination of intrinsic properties, performance and efficacy as well as scientific investigation related to product development, the person who is responsible for conducting prepare and store in paragraph. 2 above information and upon request make them available for the Environmental Protection Agency.


PCS. 4. By further development of a substance which its application tested through pilot or production trials, it must be responsible for the trials before trials carried forward in paragraph. 2 that information to the Environmental Protection Agency.

PCS. 5. If in paragraphs. 3 and 4 activities may involve or lead to the biocidal product or active substance released into the environment, the activity only undertaken with the Environmental Protection Agency's permission. The application must contain the information referred to in paragraph. 2, and the Environmental Protection Agency may provide guidance on the application and its content.

Chapter 8

Consultation of National Action Plan

§ 40. Within the preparation or review of the national action plan for reducing the use and dependency on plant protection products,. Law § 44 a, the Environmental Protection Agency to consult the public.

PCS. 2. Environment Agency will make public announcement of a proposal for a national action plan or a review of this order to allow the public early and effective way to express an opinion before deciding on the plan. The announcement must contain at least the following information:

1) Environmental Protection Agency's address.

2) Information that everyone has the right to see the draft national action plan or revision.

3) Information that everyone has the right to comment on the proposal within a set time limit of at least eight weeks of the announcement, as well as information on which comments and questions may be addressed.

PCS. 3. Environment Agency will make public announcement of the NAP adoption and the reasons and considerations underlying the action plan was adopted, including the public participation process. The NAP should be publicly available and communicated electronically to the public, cf. Order on active dissemination of environmental information.

Chapter 9

Taxes, fees, etc.

Payment of fees, annual statement

§ 41. The Act § 36 that tax is due on 1 January must be paid to the Environmental Protection Agency by 1 February.

§ 42. Whoever accordance with § 36 must pay tax must be later than 1 February submit an annual tax return for the previous calendar year to the Environmental Protection Agency. The statement shall include the quantity sold for each product and, together with the necessary background information for the statement made in a form that can be approved by the Environmental Protection Agency. Foreign authorization holders must calculate the total amount allocated for use in Denmark.

Fee for authorization to sell certain pesticides

§ 43. The person who has received authorization to sell toxic pesticides, see. § 2, no. 6 used per outlet for which authorization, to cover part of the Environmental Protection Agency's expenditure on administration of the authorizations granted, pay a fee of

1) 1.500 kr. Per. year if the authorization covers pesticides classified as very toxic, or pesticides that are classified as acute toxicity category 1 or 2 or as specific target organ in Category 1 (STOT SE 1), or

2) 750 kr. Per. year if the authorization covers only pesticides classified as toxic or as acute toxicity category 3.

PCS. 2. The fees due to be paid on January 1, the first on 1 January of the year after the permit is issued.

PCS. 3. The fee must be paid no later than 1 February. If the fee is paid after this date will be charged interest under the Act on interest on late payment etc.

PCS. 4. The fee rates in paragraph. 1 adjusted annually. 1 January on the basis of the latest published price and wage index in Economic-Administrative Instructions from the Ministry of Finance. The current fee rate published on the EPA website www.mst.dk.

Fee for approval of pesticides

§ 44. The applicant for inclusion of an active substance for Biocides and seeking approval or changed authorization of a biocidal product where the active substance or substances authorized under the Biocides or § 66 to the claimed use, must pay a fee to cover the Environmental Protection Agency's costs of processing applications. The fee depends on the contents of the application and shown in Annex 3.


§ 45. Whoever under the plant protection regulation or Commission Regulation (EU) No. 1141/2010 review of an active substance for evaluation for inclusion on the list of approved active substances for plant protection product regulation, must pay a fee of 1.768 million kr. To cover DEPA costs of the administrative proceedings in connection with this assessment.

PCS. 2. If the active substance in accordance with paragraph. 1 reported in Denmark, the fee when Denmark is designated as Rapporteur Member State. If the active substance notified in another member country, paid the fee when Denmark is designated as co-rapporteur Member State.

§ 46. The fee rates in § 44 and § 45, paragraph 1, applies to notifications received by 31 December 2013. For recent reviews adjusted rates per year. 1 January on the basis of the latest published price and wage index in Economic-Administrative Instructions from the Ministry of Finance. The current fee rate published on the EPA website www.mst.dk.

PCS. 2. Fee according to §§ 44 and 45, at the time of submission of the application for approval shall be paid to the Environmental Protection Agency after agency's detailed instructions. For fee greater than 500,000 kr payable 10,000 kr. At the time of submission of the notification. If an active substance is notified for evaluation within more than one product under the Biocides or § 66, must be paid out 10,000 kr. For each product type. The remainder of the fee paid then to the Environmental Protection Agency for its detailed instructions.

PCS. 3. Environmental Protection Agency reducing the fees if proceedings have been less costly than what the fee is calculated on the basis of. The fee can also be concretely reduced in cases where an application be withdrawn by the applicant before a decision is taken on authorization. The reduction shall equal the avoided costs of the proceedings. Amount of 10.000 kr. Or less will not be refunded.

Chapter 10

Notification of biocidal products

§ 47. Whoever is responsible for sales in Denmark of a biocidal product containing an active substance under review, see. Biocidforordningens Article 89 but where the active substance or agent is not subject to authorization in accordance with § 66, to a filing Working Environment Authority and the Environmental Protection Agency's register for substances and materials (Product Register) of the following, see. however paragraph. 2:

1) Name and address of the sales responsible natural or legal person.

2) Trade name.

3) Use.

4) Product under biocidforordningens Annex V.

5) Chemical composition. For each ingredient in the product stated:

a) CAS.

b) Chemical name.

c) Contents As a proportion of the product in weight or other device.

d) Risk phrases (H-phrases for classification regulation).

6) Classification and labeling of the product.

7) Any suggestions for first aid measures.

PCS. 2. If the product due to other legislation already registered in the Product Register and has been assigned a PR number, notification under paragraph. 1 is not necessary.

Chapter 11

Data protection and data exchange

§ 48. Data to be submitted with an application for approval of an active substance or a biocidal product in accordance with § 15, or a biocidal product in accordance with § 66 shall be used only for the benefit of a subsequent applicant when:

1) the subsequent applicant submits a letter of access to the current data, or

2) the time limit for data protection has expired. § 50.

PCS. 2. If the person did not own these, the applicant for a license under § 15 shall also indicate the name and contact information of the owner of the transmitted data, and present a license to use the submitted data.

PCS. 3. The applicant must provide the Environmental Protection Agency of any change of ownership of the data as soon as it occurs.

PCS. 4. Environmental Protection Agency may ask submitted information available to the Scientific Advisory Committee set up under Commission Decision 2004/210 / EC of 3 March 2004 setting up scientific committees in the field of consumer safety, public health and the environment.

§ 49. Data covered by § 48, are protected during the period specified in paragraph. 3. The protection period starts when the data submitted for the first time, see. However paragraph. 2.


PCS. 2. The protection period for data submitted for the approval of an existing active substance, calculated from the first day of the month following the date of the Environmental Protection Agency's approval of the relevant active substance for that product type.

PCS. 3. The protection period under subsection. 1 and 2 are on

1) ten years of data for approval of an existing active substance or products with one or more existing active substances

2) fifteen years for approval of new active ingredients, including products with a new active substance provided. Article 3. 1, point e, i Biocides and

3) five years for new data submitted in connection with the renewal of a previously granted approval.

§ 50. When the data exclusivity period has expired. § 49, the applicant for approval of new active substances or products, request that the data submitted by another applicant, being the basis for the application. The active ingredient or product must be technically equivalent to the active substance or product for which the data protection period has expired, among other things, the degree of purity and nature of relevant impurities.

PCS. 2. An applicant under subsection. 1 must provide

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

2) all data necessary to identify the active substance and to establish the technical equivalence and

3) the data needed to demonstrate that the biocidal product comparability of the risk from and efficacy as the authorized biocidal product.

§ 51. The owner of the data must be in a permit for other people to use them, set

1) name and contact details of the data owner and the beneficiary,

2) the name of the active substance or biocidal product if data access is granted to

3) the date of authorization of entry into force and

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

PCS. 2. Revocation of a license to use the data does not affect the validity of the authorization granted on the basis of the relevant permit.

Data on animal tests

§ 52. Testing on vertebrate animals for evidence of health or environmental effects of a biocidaktivstof aid or agent may be undertaken only after authorization from the Environmental Protection Agency.

PCS. 2. Authorisation under paragraph. 1 is granted only if it related to the application proof that there formerly the Environmental Protection Agency or the EU chemicals agency ECHA has submitted information about the tests or studies.

§ 53. Anyone wishing to use vertebrate animal tests as proof of the health or environmental effects of an active substance or product, at its own expense obtain information from ECHA whether there is information on such tests. If information is available, and that information is covered by data protection. See § 49, that person must contact the owner of the current information and following guidelines in biocidforordningens Article 63, agree to apply it.

Chapter 12

Administrative provisions

Supervision, derogations and complaints

§ 54. The Environmental Protection Agency is responsible, with the exceptions set out in § 55, the supervision tasks for pesticide regulations and other regulations conferred on national competent authorities, including evaluating competent authorities with regard to pesticides.

PCS. 2. The municipal council shall assist the Environmental Protection Agency to monitor the compliance with regulations on the possession and use of pro- fessional users who are not covered by the in § 55 specified supervision.

PCS. 3. The municipal council assists the Environmental Protection Agency in monitoring compliance with storage and labeling provisions by retailers and the like.

§ 55. Of Business Authority oversees the storage, possession, use and registration of the use of pesticides in agriculture, as regards compliance with the following rules:

1) Plant Protection Products Regulation Article 28. 1, Article 55 and Article 67. 1.

2) Act § 10 paragraph. 2.

3) §§ 23, 24 and 26, § 27 paragraph. 1 and 3, and §§ 33-35 of this Order.

§ 56. Statens Serum Institute and the National Center for Food and Agriculture at the University of Aarhus assist EPA in assessing control efficacity.

PCS. 2. Food Authority assists the Environmental Protection Agency in the evaluation of residues in food and feed.


PCS. 3. National Center for Food and Agriculture at Aarhus University recognizes experimental units in Denmark performs studies of plant protection products efficiency.

PCS. 4. National Center for Food and Agriculture, University of Aarhus, may charge a basic fee and an annual fee to cover costs associated with the accolades of laboratories and inspection of the conditions for these observed.

PCS. 5. National Center for Food and Agriculture, University of Aarhus, assisting in the assessment of plant protection hazard to bees, including setting requirements for labeling thereof.

§ 57. The Environmental Protection Agency may in special circumstances order derogating from the provisions of this Order, or allow for exemptions.

§ 58. Decisions made under this Order by the Environmental Protection Agency and in §§ 54 and 55 of the said authorities, etc. can not be appealed to any other administrative authority.

Police report

§ 59. Companies must submit a notification to the police by reasoned suspicion of theft of substances and mixtures classified

1) according to the classification order as very toxic R-phrase R26, R27 or R28 or as toxic with R phrase R23, R24 or R25, or

2) after grading regulation as acute toxicity category 1 hazard statement H300, H310 or H330 or as acute toxicity category 3 with the hazard statement H301, H311 or H331.

PCS. 2. The notification under subsection. 1 shall contain information about:

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

2) Hazard statements or R-phrases for the substance or mixture.

3) For individual substances: Substance CAS number.

4) For mixtures: CAS number for the substance, which has given rise to mixture classification, see. Paragraph. 1.

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

6) The stolen amount.

Obligation to publish certain information

§ 60. Persons who are covered by § 34 and commercial pest control for others in § 34 of the pesticides must give it, as the fight is carried out, information that the Environmental Protection Agency has arranged or approved the married course, as the have completed, as well as contact information to EPA or the Economic and Business Affairs' electronic contact point (one-stop shop), see. § 16 of the Act on services in the internal market.

PCS. 2. The information in paragraph. 1 shall be made available for those who fight performed or communicated this clearly and unambiguously and in good time before the conclusion of the agreement to combat or before carrying out the fight, if there is no written agreement.

§ 61. The Environmental Protection Agency shall establish and publish its deadline for processing applications for recognition of pesticide courses. The deadlines calculated from the time the applicant has submitted all the information, it is for that to submit.

PCS. 2. Environmental Protection Agency may extend the deadline in paragraph. 1 once, if the complexity of the situation so warrants. EPA gives the applicant notice of the extension and the duration thereof by the deadline in accordance with paragraph. 1. The notification shall include a justification for the extension and its duration.

PCS. 3. Notwithstanding the periods specified in paragraph. 1 and 2, the applicant must first start the fight with pesticides classified as very toxic pesticides or as acute toxicity category 1 or 2 or as specific target organ in Category 1 (STOT SE 1), when the Environmental Protection Agency's decision on the recognition of the completed marriage course .

§ 62. The Environmental Protection Agency shall promptly acknowledge receipt of an application for recognition of pesticide courses. The receipt must contain the following information:

1) The published deadline for examining the application in question and the possibility that the deadline can be extended once, see. § 61.

2) Information that the applicant must not start the fight with very toxic pesticides before than the Environmental Protection Agency of its decision, whether the published deadline or subsequently announced deadline is met.

3) Information on the administrative remedies for the decision.

Publication and maintenance of substance lists

§ 63. Environmental Protection Agency publishes and maintains lists

1) substances authorized for use in certain mixtures or blends for specific applications, see. Act § 32 paragraph. 2, and

2) substances and mixtures which are subject to regulation by the use of pesticides, cf.. Act § 35 paragraph. 1 pt. 5


Chapter 13

Penalty

§ 64. Unless a higher penalty is warranted under other legislation, punishable by fine who:

1) Failure to submit an application for approval under §§ 3, 4, 15 or 66.

2) Failure to submit information on the new classification, see. § 9.

3) Using a package that is not authorized, violates the terms of the design of a label or market products without approved label, see. § 18.

4) Seller pesticides in opened or non- original packaging, see. § 20 paragraph. 1.

5) Stores open containers, including empty containers, contrary to § 20 paragraph. 2.

6) Seller active substances in biocidal products or biocidal products in violation of § 21

7) Seller or make advertising in violation of §§ 21 and 22

8) Possess plant in violation of § 23

9) Market Operator, possession or use of biocidal products in violation of § 24

10) Keeps or leave pesticides unattended, in violation of § 26

11) Holds toxic pesticides, see. § 2, no. 6, contrary to § 27 paragraph. 1-3.

12) Fails to appoint a person responsible for the storage of toxic pesticides, cf. § 2, no. 6 and § 27 paragraph. 4.

13) Seller toxic pesticides, see. § 2, no. 6, in violation of §§ 28-32.

14) Applies toxic pesticides, see. § 2, no. 6, in violation of §§ 33-35.

15) Seller means for chemical control of rats to other than authorized individuals, see. § 37.

16) Possess means for chemical control of rats without authorization rodent control, see. § 37.

17) Seller plant in violation of § 38.

18) Making experimental testing, including obtaining and possessing such funds in violation of § 39.

19) disregards conditions linked to the approval or authorization by pesticide regulations, § 15 or § 57.

20) Fails to notify the police in accordance with § 59.

21) Failing to disclose activities etc., see. § 60.

22) Should the recording and reporting of data on plant protection products referred. Article 67. 1 and 2, in plant protection regulation.

23) Furthermore violate regulations on pesticides, set in pesticide regulations or other EU regulations.

PCS. 2. The penalty may increase to imprisonment for up to two years if the infringement was committed intentionally or through gross negligence and if the violation is

1) caused harm to human or domestic animal life or health or risk of harm,

2) damage to the environment or risk of harm, or

3) achieved or intended economic advantages, including savings, for the offender or others.

PCS. 3. For violations of §§ 10, 11, 13, 17, 26 and 27, as well as the sale of a biocidal product without approval under § 15 may be imposed on the manufacturer, importer or a company owner or user fine even though the violation can not be attributed this as intentional or negligent. For such fine shall be no alternative sentence.

PCS. 4. There can be imposed on companies etc. (legal persons) under the rules of the Penal Code Chapter 5.

PCS. 5. For offenses covered by paragraph. 1-4 is the period of limitation for criminal liability five years.

Chapter 14

Entry into force

§ 65. This Order shall enter into force on 11 September 2013.

PCS. 2. Order no. 702 of 24 June 2011 on pesticides termination. However, §§ 67 and 68.

Chapter 15

Transitional

Approval of certain biocidal products under review

§ 66. If an active substance listed in Annex II to Commission Regulation (EC) No. 1451/2007 and the substance being evaluated by one of the in § 15 paragraph. 3 and 4, said product types, the Environmental Protection Agency authorize biocidal products in accordance with § 15 before the import, sale or use.

Transitional provisions for dealing with cases of plant protection products covered by plant protection regulation transitional

§ 67. Processing of applications for approval of new plant protection and cases of re-authorization of plant protection products, including modifications and withdrawals, subject to modification Act, see. § 2, no. 17, takes place under the provisions of §§ 4-16 in Order no. 242 of 18 March 2011 on pesticides.

Transitional provisions for packaging and labeling requirements for plant protection


§ 68. Packaging and labeling for applications for authorization of plant protection products until 14 June 2015, under the rules of the amending law, see. § 2, no. 17, is carried out, notwithstanding the provisions on classification and labeling in § 7, PCS. 2 and § 8, under the provisions of §§ 19-27 of Executive Order no. 242 of 18 March 2011 on pesticides, cf.. However paragraph. 2.

PCS. 2. An applicant for authorization or re-authorization of a plant protection product covered by the amending law, may request that the packaging and labeling is done according to the rules of plant protection regulation, which this applies.

Environment Ministry, 6 September 2013
Ida Auken
/ Claus Torp



Appendix 1

Requirements for application for approval in accordance with § 15 of a chemical biocidal product
requirements of this Annex made an application for approval of chemical biocidal products where no or only a portion of the active substances authorized under the Biocides for the requested scope .
A. DATA REQUIREMENTS FOR ACTIVE SUBSTANCE
first The name and address.
Second Information on active substance identity
2.1. Name according to IUPAC nomenclature
2.2. Other names (ISO designations, trade name, codename)
2.3. Trade names of other products containing the substance to the extent known to the applicant
2.4. Substance CAS no.
2.5. Gross formula
2.6. Structural formula
2.7. Molecular weight.
Third Information on the active substance as manufactured
3.1. Purity in weight
3.2. Name and quantity (by weight) of significant impurities, including isomers, products of synthesis, decomposition products and the like, according to IUPAC or CA and CAS.
3.3. The nature and quantity of any additives, stabilizers, inhibitors or other additives in% or ppm.
Fourth Information concerning the determination of the active substance
4.1. Spectral data (UV, IR, NMR, MS, etc.)
4.2. Detection and determination methods. Description of usable methods for qualitative and quantitative determination of the substance in products (pesticides), soil, water, air and biological materials (plant and animal tissues, urine, faeces and possibly milk).
Fifth Information related to the active substance origin and manufacture
5.1. Name and address of the supplier of the active substance
5.2. Sketch of the active substance manufacturing process.
6th Active Physico-chemical properties
The information about state, refractive index, melting point, boiling point, vapor pressure, density and solubility must be provided both the technical product used in the formulation, as the pure substance
6.1. Description of the substance
6.1.1. State
6.1.2. Color, smell, etc.
6.2.
Refractive index of 6.3. Melting point (sublimationspunkt, decomposition)
6.4. Boiling point
6.5. Density
6.6. Vapor pressure, possibly vapor pressure curve
6.7. Surface tension
6.8.1. Water solubility
6.8.2. Strength Constant (dissociation constant) for substances with acid or base properties
6.9. Fat solubility
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. acid
6.12.3. Alkali
6.13. stability
6.13.1. Photostability
6.13.2. Thermostability
6.14. Flash point
6.15. Flammability
6.15.1. Combustible properties
6.15.2. Explosive
6.16. Fission or other reaction by heating (heating), combustion or stroke
6.17. Other characteristics, the applicant may have knowledge of.
7th Acute toxicity
7.1. Oral
7.2. Dermal
7.3. Inhalation
7.4. Other routes of administration
7.5. Irritation of the skin
7.6. Irritation of the eyes
7.7. Skin sensitizing effect.
8 thereof. Sub-chronic toxicity
8.1. 90 day study on rats
8.2. Three or six-month study on a non-rodent species (species other than the rat and mouse)
8.3. Possibly. studies with other application methods, animals or time.
9th Chronic toxicity
feeding studies on at least two mammalian species.
10th Carcinogenesis
Study at least two mammalian species.
11th Mutagenic effect
11.1. Gene mutations, in vitro and in vivo
11.2. Chromosomal aberrations.
12th Other mutagenicity
If one or more of the above tests is positive: test for the influence of germ cells.
13th Reproduction
Least attempts over two generations with two litters per. generation.

14th Teratogenicity
Study at least two mammalian species.
15th Neurotoxicity.
16th Toxicity of any metabolites, degradation products and impurities.
17th Metabolism in animals
17.1. Absorption, distribution and excretion in mammals
17.1.1. by one-off injection
17.1.2. repeated applications
17.2. Biotransformation in mammals
17.3. Other studies on mammals (hematology, liver and kidney function tests, enzymes etc.)
17.4. Possibly. absorption, distribution and elimination in other animal species
17.5. Assumed toxicological mechanism.
18th Toxicity to people
Experience gained during the production process, in practical use or in connection with the poisoning case. Countermeasures by poisoning.
19th Metabolism and persistence in or on plants
Admission, transport, nature and quantity of the degradation products.
20th Studies of residues in relevant edible plants and in products of animal origin
elimination curve and half-life of the active substance and significant metabolites (minimum three Tests).
21st Behavior in soil
21.1. Metabolism and degradation
Photolysis on the ground surface
degradation in three soil types under aerobic conditions
In a soil type: metabolism, degradation rate at two temperatures and at two dosages, rate of degradation depending on the moisture content, degradation in sterile soil, as well as under anaerobic conditions
21.2. Transport and movement
least leaching tests in soil column with the active substance in three soil types and aged active substance in a soil.
21.3. The adsorption / desorption
21.4. Accumulation in the soil of the active substance and significant metabolites
21.5. Evaporation from land.
22nd Behavior in water
22.1. Degradation, biotic. At least BOD value and BOD / COD
22.2. Adsorption of organic matter (plankton and sediment), accumulation of sediment
22.3. For products released for plants: effects on plant operation, including in the active sludge ability to remove organic matter.
23rd Toxic effect on aquatic organisms
23.1. Acute toxicity on fish (two species)
23.1.1. Acute toxicity on daphnia
23.1.2. Reproduction test on Daphnia
23.1.3. Acute toxicity to algae
23.1.4. Toxic effect on other aquatic organisms
23.2. Study of bioaccumulation in aquatic ecosystems if partition coefficient n-octanol / water is greater than 103, see. Section. 6.10.
24th Toxic effect on soil organisms
24.1. Acute toxicity and other effects on earthworms
24.2. Effect on soil respiration
24.3. Effect on ammonification
24.4. Effect on nitrification
24.5. Effect on asymbiotic N-fixation, and in some cases effect on symbiotic N-fixation.
25th Toxic effect on birds
25.1. Acute food toxicity in at least two species with different food resources
25.2. Reproduction test on at least one species of bird.
26th Effects on bees.
27th Any information about toxic effect on other predators.
28th Other information about aktivtoffets or its degradation products, fate or impact on the environment.
29th Phytotoxicity.
30th Resistance generating properties.
31 December. Toxic mechanism in the target organism. Cause of selectivity.
32nd Recommended safety measures for:
32.1. Handling
32.2. Storage
32.3. Transport
32.4. Fire hazard.
33rd Chemical demilitarization
Possible relations and quantities to be used to obtain a quick decomposition of residues or similar. The information concerning possible residues in food and feed as a result of using the product.
34th Other precautions for the possible spread into the environment in case of accidents or misuse.
35th Registration, classification, processing delays and permitted residues in other countries.
36th Information sources.
37th Numbered list of annexes.
B. DATA REQUIREMENTS FOR PROTECTION PRODUCT
first Company and trade name
1.1. Name of applicant (company), address and telephone and SE no.
1.2. Name and address of the manufacturer of the product
1.3. Name of the product (trade name and code).
Second Information about the product
2.1. Type of pesticide
2.2. Mode of function
2.3. Agent active ingredients (type and weight)
2.4. Agent fillers
2.5. Physical state of.
Third Application of the product
3.1. The agent application
3.2. Dosing and application concentration
3.3. The agent delivery
3.4. The agent miscibility
3.5. Efficiency.
Fourth The packaging of
4.1. Proposal for labeling and instructions referred to. Annex 2
4.2. The product's packaging.

Fifth Toxicological data for the product
5.1. Acute oral toxicity
5.2. Acute toxicity through the skin
5.3. Acute inhalation toxicity
5.4. Irritation of the skin
5.5. Irritation of the eyes
5.6. Other toxicological data for the product
5.7. Toxicological data of the non-active ingredients.
6th Ecotoxicological studies of the product
6.1. Content of substances dangerous to bees
6.2. Other ecotoxicological effects
6.3. Ecotoxicological effects caused by the non-active ingredients.
7th Product's physical and technical characteristics
7.1. Free acidity or alkalinity
7.2. Specific gravity (for liquids)
7.3. Particle size (for powder and powder)
7.4. Suspension or emulsification
7.5. Storage stability, including thermal stability
7.6. Corrosive properties
7.7. Vapour pressure
7.8. Flash point
7.9. Characteristics of heating and fire
7.10. Any other relevant information.
8 thereof. Additional information for classification and labeling
8.1. Flammability classification
8.2. Classification for transportation.
9th Method of destruction.
10th Analysis method.
11th Information about precautions for use.
11.1. Protective
11.2. Fire, including proposals for appropriate extinguishing media.



Appendix 2

Information on the label, see. § 18 paragraph. 1
first Labels for biocidal products shall, in addition to the information required by the Classification Order or klassificeringsforordningenn, include the following information:



1) All active substances identity and concentration in metric units.

2) The number of the permit granted by the competent authority gave the biocidal product.

3) Preparation Type (eg. Liquid concentrates, granules, powders, solids, etc.).

4) Approved uses of the biocidal product (eg. Wood preservation, disinfection, anti-fouling, etc.).

5) Sheets and dose rate, expressed in metric units, for each use of the authorization covers.

6) Details of likely direct or indirect adverse side effects and any directions for first aid.

7) Unambiguous reference to read the instructions for use when such is attached.

8) instructions for safe disposal of biocidproduktet and packaging, including, where relevant, any prohibition on reuse of packaging.

9) preparation batch number or designation and the expiry date under normal storage conditions.

10) Information on

a) the time it takes before the biocidal works

b) the length of time that must elapse between the use of biocidproduktet on the treated product or between application and the next use of the product treated

c) the length of time that must elapse before the next access by man or animals to the area where biocidproduktet used, including particulars concerning decontamination means and measures and duration of necessary ventilation of treated areas

d) adequate cleaning of equipment,

e) precautionary measures during use, storage and transport, for example, protective clothing and equipment to persons, measures for protection against fire, covering of furniture, removal of food and feed, and

f) how to prevent animals from being exposed to the agent.

Second Where necessary, the label must bear the following:



1) The category of users who biocidproduktet is limited.

2) information on any specific danger to the environment particularly concerning protection of non-target organisms and avoidance of contamination of water.

3) For microbiological biocidal products any additional labeling requirements under the Ministry of Employment Order on biological agents and working.

The information in section 1, no. 3, 5, 6, 8, 9 and 10 and paragraph 2, no. 2, the Danish Environmental Protection Agency permit in each case be included in a booklet, an inlay sheet or the like to be dispensed together with biocidproduktet.



Appendix 3

Fees for application for approval of biocides
This appendix contains fees for the approval of biocidaktivstoffer and biocidal products. All fees are quoted in Danish kroner (DKK). Fees paid only when given a letter.
In. Decision for Biocides and modification of authorizations or licenses granted by the Biocides or Biocides

Wherever reference is made to an article without further reference, the reference to Biocides.








A. EU decision on new chemical or biological biocidal products or renewal of an authorization under. Article 41 (Denmark are evaluating competent authority)


By biological products means products containing micro-organisms







Base fee, kr.




Fee




1. EU decision


300,000


A +


B


C


D


E



2. EU decision on product family


405,000


A +


B


C


D


E












B. Decision under the simplified procedure under. Article 25 (Denmark are evaluating competent authority)







Base fee, kr.




Fee




1. A product


55,000


A



2. A product family, see. Article 17. 3


105,000


A












C. National decision after Biocides meaning. Article 29 (Denmark are receiving competent authority (RMS))


New approval or renewal of a permit, whether communicated by Biocides Biocides or national Danish rules







Base fee, kr.




Fee




1. A product of one product (fee for each product type)


170,000


A +


B


C


D


E



2. A product family, see. Article 17. 3



280,000


A +


B


C


D


E












D. Decision on mutual recognition set. Article 32 (Denmark affected Member State (CMS))


New approval or renewal of a permit, whether communicated by Biocides Biocides or national Danish rules







Base fee, kr.




Fee




1. A product set. Articles 33 and 34


75,000


A


E



2. A product family, see. Article 17. 3


105,000


A


E












E. Other types of decisions for products







Base fee, kr.




Fee




1. Exemption (exceptions) etc., See. Article 55. 1


205,000








2. Exemption (exceptions) etc., See. Article 55. 1, based on previous assessments


12,000








3. Temporary authorization provided. Article 55. 2


205,000


A


B


C


D




4. Research and development (experimental testing) referred. Article 56


12,000








5. Parallel Trade, see. Article 53


12,000








6. Identical product set. Regulation (EU) No. 414/2013


12,000



A


B


C


D













F. Decision on change of product approvals for Biocides meaning. Articles 50 and Regulation (EU) No. 354/2013


The fees charged for each change, see. Regulation (EU) No. 354/2013, Article 4




Change Type



Base fee, kr.




Fee





1. Major change to the EU authorization provided. Regulation (EU) No. 354/2013, Article 13




a. For each simple product


125,000


A



b. For each product family


200,000


A




2. Major changes of national authorizations, mutual recognition and approvals granted by simplified procedure in accordance. Article 50 and Regulation No. 354/2013, Article 8 and Article 9a. 2, and the Annex, Section 3




a. Denmark is the assessment authority (RMS)
Single Products


70,000


A



b. Denmark is the assessment authority (RMS)
Product Family


135,000


A



c. Denmark is concerned member state (CMS)
Single Products


45,000




d. Denmark is concerned member state (CMS)
Product Family


90,000




e. Change for simplified procedure whereby Denmark has been evaluating competent authority (RMS), see. Regulation (EU) No. 354/2013, Article 9


10,000





3. Minor changes to national approvals and mutual recognitions and approvals granted by simplified procedure in accordance. Articles 50 and Regulation (EU) No. 354/2013, Article 7 and Article 9a. 2 and Annex, Section 2




a. Denmark is the assessment authority (RMS)
Single Products


30,000




b. Denmark is the assessment authority (RMS)
Product Family


60,000




c. Denmark is concerned member state (CMS)
single Products



25,000




d. Denmark is concerned member state (CMS)
Product Family


45,000




e. Change for simplified procedure whereby Denmark has been evaluating competent authority (RMS), see. Regulation (EU) No. 354/2013, Article 9


10,000













G. Charges for notification







Base fee, kr.




Fee




a. Administrative product changes requiring notification prior to implementation referred to. Regulation (EU) No. 354/2013, Article 6, Article 9, Article 9a. 1 and Annex, Section 1, Section 1


8,000




b. Administrative product changes that can be communicated after implementation referred to. Regulation (EU) No. 354/2013, Article 6, Article 9, Article 9a. 1 and Annex, Section 1, Section 2


5,000




c. Notification of a new product in a product family, see. Article 17. 6
Fee for each new product family


5,000




d. Notice that a product available under the simplified procedure under. Article 27
Fee for each product


5,000






II. Decision on approval or amendment of the authorization of biocidal products where the active substance still being evaluated after Biocides meaning. § 67, or where the active substance can not be approved under the Biocides, but according to Danish rules, see. § 15








Fees for processing, where the active ingredient is the assessment provided. Regulation (EU) No. 1451/2007, Annex II, § 66




Casework Type



Base fee, kr.




Fee




1. Approval of a product with a new active substance


55,000


A


B-



2. Approval of a product with the same active ingredient as an approved product (me too)


40,000


A




3. Temporary approval


55,000





4. Approval of the identical product


12,000






5. Approval of parallel imports, per. import country


12,000





6. Major changes at. product approval


25,000





7. Minor changes per. product approval


10,000





8. Approval of and modification of the label as well as other administrative changes


5,000





9. Technical equivalence first assessment


25,000





10. Technical equivalence based on previous assessments


12,000





11. Renewed approval


40,000


A




12. Exemption


55,000





13. Exemption based on previous assessments


12,000







III. Fees for processing, where the active substance has not been assessed for Biocides. Assessment of active substances for the Biocidal or biocidforordningens rules, including approval of active substances for inclusion in Annex I to Regulation







A. Assessment of the active substance or to be renewed






Fee, kr.




1. New rating or renewal of the authorization provided. Article 4 and Article 14. 2


1,459,000



2. Restricted assessment at renewal, per. active substance provided. Article 14. 1, 2nd paragraph


730,000



B. For the assessment of more than one product to a charge as indicated under A, and the following fee for each additional product






Fee, kr.




1. Full assessment


561,000



2. Restricted assessment


280,000





IV. Fees
For certain assessments paid a fee. This payment shall be granted for each further evaluation. The fee is charged for the extra service, which indicated a letter in the tables above.
A: Kr. 10,000, however kr. 40,000 for the assessment of MRLs at EU Decision (fee A +).

Fee DVFA assistance in the evaluation of residues in food and feed (MRL).
The fee is charged for the work of evaluating the residues in food of biocidal products used in such a way that there is a risk that they come into contact with food, feed or drinking water, or use near or directly of animals used as food or in food production. For each MRL.
B: Kr. 25,000, only kr. 10,000 for authorization in Title II (approval by national Danish rules, marked B in the table).
Fee for the assessment of each additional active substance.
The fee applies for biocidal products with more than one active substance.
C: Kr. 25,000.
Fee assessment for each additional scope.
The fee applies for biocidal products with multiple applications.
D: Kr. 45,000.
Fee for comparative assessment.
The fee applies for biocidal products containing an active substance that is a candidate for substitution. Fee for each active substance that is a candidate for substitution.
E: Kr. 760,000.
Fee for evaluation of new or partly new dossier for an active substance or microorganism.
The fee applies when the applicant does not have rights to use the dossier is evaluated in connection with the approval of the active substance. Fee for each dossier.



Appendix 4

Permitted manufacturing and analytical for biocides, see. § 4








Declared content in g / kg or g / l at 20 ° C




tolerances




To 25


± 15% homogeneous formulation



± 25% non-homogeneous formulation



Over 25 to 100


± 10%



Over 100 to and including 250


± 6%



Over 250 and 500


± 5%



Over 500


± 25 g / kg or ± 25 g / l





Official notes


1) The Order contains provisions that implement Council Directive no. 92/32 / EEC of 30 April 1992 on the seventh amendment of Directive 67/548 / EEC on the approximation of legislation on classification, packaging and labeling of dangerous substances Official 1992 , no. L 154, page 15, the European Parliament and Council Directive 1999/45 / EC of 31 May 1999 on the approximation of laws, regulations and administrative provisions on classification, packaging and labeling of dangerous substances, Official Journal 1999 No . L 200, page 1, parts of the European Parliament and Council Directive 2006/123 / EC of 12 december 2006 on services in the internal market, Official Journal 2006 no. L 376, page 36, and parts of the European Parliament and Council Directive 2009/128 / EC of 21 October 2009 establishing a framework for Community action to achieve a sustainable use of pesticides, Official Journal 2009, no. L 309, page 71. the order includes certain provisions of Commission Regulation ( EC) no. 1451/2007 of 4 december 2007 on the second phase of the ten-year work program referred to in Article 16. 2, the European Parliament and Council Directive 98/8 / EC concerning the placing of biocidal products Official 2007 no. L 325, page 3, the European Parliament and Council Regulation (EC) no. 1107/2009 of 21. October 2009 concerning the placing of plant and repealing Council Directive 79/117 / EEC and 91/414 / EEC, Official Journal 2009, no. L 309, page 1, the European Parliament and Council Regulation (EU) No. 528 / 2012 of 22 May 2012 concerning the making available on the market and use of biocidal products Official 2012 no. L 167, page 1. According to Article 288 TFEU, a regulation applicable in all Member States. The reproduction of these provisions in the Order are exclusively based on practical considerations and does not affect those regulations are directly applicable, in Denmark.