PLANT PROTECTION PRODUCTS ACT - Ppps Act (Zffs-1)

12

No: 003-02-8/2012-8

Ljubljana, date: 2 November 2012

PLANT PROTECTION PRODUCTS ACT - PPPs Act (ZFfS-1)

I. GENERAL PROVISIONS

Article 1

(Subject)

(1) According to Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides (OJ L 309, 24.11.2009, p. 71) as last amended by Corrigendum to Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides (OJ L 161, 29.06.2010, p. 11) (hereinafter referred to as Directive 2009/128/EC), this Act is laying down the placing on the market and use of plant protection products (hereinafter referred to as PPPs), the National Action Plan for attaining the sustainable use of PPPs, the training in PPPs, the inspection of pesticide application equipment, the specific measures regarding the use of PPPs, the informing of the public concerning the PPPs, the professional, expert and research tasks involving PPPs, the data collections, data gathering and use of data, the laboratories, the penal provisions, and the powers of authorities responsible for implementing this Act and for official controls of its implementation and of regulations based thereon.

(2) This Act is further laying down the authorisation and granting of permits for PPPs, the fees, and the management of record keeping of the placing on the market and use of PPPs in implementing the Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1) (hereinafter referred to as Regulation (EC) 1107/2009).

Article 2

(Scope)

The aim of this Act is using the PPPs in a manner facilitating the development of sustainable and competitive agriculture; providing for a high level of protection of human and animal health and of the environment; instituting the mandatory integrated pest management; and promoting alternative approaches to pest control and techniques thereof.

Article 3

(Definitions)

For the purposes of this Act, the following definitions shall apply:

1. ‘professional user’ means any natural or legal person, using PPPs in the course of their professional activities;

2. ‘non-professional user’ means any natural or legal person, using PPPs that are authorised for non-professional use only;

3. ‘distributor’ means any natural or legal person involved in the wholesale and/or retail sale of PPPs;

4. ‘advisor on PPPs’ means any natural person, advising on pest management and the safe use of PPPs in the course of their professional activities;

5. ‘use of PPPs’ means any form of handling PPPs upon purchasing, including the keeping or storing of PPPs, and handling of spraying mixtures, PPP packaging and of PPP remnants;

6. ‘wholesale distribution in PPPs’ means the activities of purchasing, storage, sale and release into free circulation of PPPs;

7. ‘retail distribution in PPPs’ means the sale of PPPs to the particular natural or legal persons for their personal use or use in the course of their professional activities,

8. ‘PPP application equipment’ means any device specifically intended for the application of PPPs, including accessories that are essential for the effective operation of the equipment, such as nozzles, manometers, filters, strainers and cleaning devices for tanks;

9. ‘treatment’ means the application of PPPs on plants, plant products, into the soil or facilities in order to protect plants and plant products against harmful organisms, including weeds;

10. ‘good plant protection practice’ means the good plant protection practice as defined in Article 3 of Regulation (EC) 1107/2009;

11. ‘harmful organisms’ means the harmful organisms as defined in Article 3 of Regulation (EC) 1107/2009;

12. ‘risk indicator’ means the result of a method of calculation that is used to evaluate the risks of PPPs to human health and/or the environment;

13. ‘non-chemical methods’ means the non-chemical methods as defined in Article 3 of Regulation (EC) 1107/2009;

14. ‘surface water’ means inland waters, except groundwater; transitional waters and coastal waters, for which it shall also include territorial waters in respect of chemical status;

15. ‘groundwater’ means all water which is below the surface of the ground in the saturation zone and in direct contact with the ground or subsoil;

16. ‘PPPs’ means products in the form in which they are supplied to the user, and which are composed of active substances, safeners or synergists, or which contain such active substances, and are used for purposes as laid down in Article 2 of Regulation (EC) 1107/2009;

17. ‘active substances’ means the substances as defined in Article 2 of Regulation (EC) 1107/2009;

18. ‘safeners’ means the safeners as defined in Article 2 of Regulation (EC) 1107/2009;

19. ‘synergists’ means the synergists as defined in Article 2 of Regulation (EC) 1107/2009;

20. ‘good agricultural practice in sowing of seeds treated with PPPs’ means the practice where treated seeds are used in a manner complying with the labelled risk and safety warnings so as to avoid mechanical damage to treated seeds, to reduce the generation of pulverised seed-coat waste material during handling and sowing of treated seeds, with the ultimate aim of avoiding any negative impacts on human health and the environment;

21. ‘plants’ means the plants as defined in Article 3 of Regulation (EC) 1107/2009;

22. ‘plant products’ means the plant products as defined in Article 3 of Regulation (EC) 1107/2009;

23. ‘public area’ means an area that may under equal conditions be used by everyone, as for instance, the public road, square, market, playground, parking place, burial ground, park, green plot, recreation ground or similar area.

Article 4

(Prohibition or restriction)

Where the conditions as referred to in Article 49(2) and/or Article 69 of Regulation (EC) 1107/2009 should arise, the minister competent for agriculture (hereinafter referred to as Minister[1]) shall, in line with Article 71 of Regulation (EC) 1107/2009, adopt a Decree prohibiting or restricting the placing on the market or use of PPPs and/or seeds treated with PPPs.

II. EVALUATION OF ACTIVE SUBSTANCES AND REGISTRATION OF PPPs

Article 5

(Authorisation and granting of permits for PPPs)

(1) PPPs may be placed on the market and used within the territory of the Republic of Slovenia, provided that a relevant Decision authorising a particular PPP, or a relevant permit for use in an emergency situation, or a parallel trade permit, or a permit for the research and development trial purposes has been issued according to Regulation (EC) 1107/2009.

(2) The body competent for plant protection products (hereinafter referred to as Administration) within the Ministry competent for agriculture (hereinafter referred to as Ministry) shall decide on the authorisation as referred to in the preceding paragraph, based on consensus granted by the administrative body responsible for chemicals.

(3) The Administration shall decide on granting of permits as referred to in the first paragraph of this Article.

(4) Within eight days from the date of final Decision granting the authorisation or permit as referred to in the first paragraph of this Article, the Administration shall enter the relevant authorisation or permit data into the Register of PPPs, as referred to in Article 42 of this Act.

(5) For the implementation of the Regulation (EC) 1107/2009, the Government of the Republic of Slovenia (hereinafter referred to as Government) shall define the detailed conditions for the placing of PPPs on the market and for the use thereof.

Article 6

(Evaluation of active substances and PPPs)

(1) The Administration shall perform the evaluation of active substances and of PPPs according to Regulation (EC) 1107/2009.

(2) For performing particular expert tasks of evaluation of active substances and PPP the Administration may grant a public authorisation to a natural or legal person with university degree in an appropriate academic discipline, or has a person in place with a permanent employment contract and university degree in an appropriate academic discipline (hereinafter referred to as evaluator).

(3) The evaluator, meeting the conditions as referred to in the preceding paragraph, shall be selected by way of public tender, based on the following criteria: years of work experience, professional accomplishments, advanced professional study and training, and involvement in international organisations specialising in active substances and PPPs. The public tender shall specify the criteria in greater detail.

(4) The Administration shall authorise the evaluator by issuing within the administrative procedure a relevant Decision granting the public authorisation for conducting a particular expert task of evaluation of an active substance or a PPP within a period of five years. The mutual rights and obligations between the Administration and the evaluator shall be governed by a relevant contract.

(5) Where the evaluator is a legal person or a private entrepreneur, the Decision referred to in the preceding paragraph shall detail also the person complying with the professional education conditions, who shall perform the expert tasks of evaluation of active substances or of PPPs.

(6) The funds required for the particular expert tasks of evaluation of active substances or PPPs to be performed by the evaluators as referred to in this Article shall be procured from the budget of the Administration.

(7) Supervision and the official control of the evaluator under public authorisation shall be conducted by the Administration.

(8) Public authorisation of the evaluator shall expire in mutual agreement, or in cases where the evaluator fails to comply with the conditions as laid down by this Act or by regulations issued on its basis, or where the evaluator would act contrary to the agreement or regulations as referred to above, all of which shall be specified by the Administration in the form of a Decision issued within the administrative procedure.

(9) Expert tasks of evaluation of active substances and of PPPs, and conditions for university education in the appropriate academic discipline, shall be prescribed by the Minister.

Article 7

(PPP efficacy tests)

(1) Tests and analyses, which are conducted to obtain data on the efficacy of PPPs, and constituting an integral part of the dossier required for the authorisation of PPPs (hereinafter referred to as efficacy tests), shall be in the Republic of Slovenia performed by an entity for conducting the efficacy testing (hereinafter referred to as efficacy testing entity), complying with the following conditions:

- Natural or legal person with the registered agricultural or research activity within the agricultural sector;

- Compliance with the requirements as to the number, education and work experience of staff; premises, agricultural areas, and equipment; methods of conducting the standard operative procedures (SOPs) and efficacy testing.

(2) The Administration shall issue a relevant Decision designating the relevant efficacy testing entity for a period of five years.

(3) In order to be granted the designation as referred to in the preceding paragraph, an application in writing shall be submitted to the Administration, accompanied with all the relevant evidence on compliance with the conditions as required to in the first paragraph of this Article.

(4) Compliance with the conditions as required in this Article, based on relevant documents and on-the-spot inspection, shall be established by an ad hoc commission appointed by the Director of the Administration.

(5) The Administration shall keep a list of entities designated under this Article, accessible on its website. The list shall specify the business name and address of the entity, or the personal name and address of the entity in the case of a private entrepreneur, and the number and date of relevant Decision designating the relevant entity.

(6) Within 15 days from the date of any change arising, or of having learned thereof, the efficacy testing entity shall notify the Administration of any change of data that may affect the entity’s compliance with conditions for the designation.

(7) Efficacy test expenses shall be borne by the applicant of tests.

(8) The designation of an efficacy testing entity shall expire in mutual agreement, or in cases where the efficacy testing entity fails to comply with the conditions as laid down by this Act or by regulations issued on its basis, or where the efficacy testing entity would act contrary to regulations as referred to above, all of which shall be specified by the Administration in the form of a Decision issued within the administrative procedure.

(9) The particular conditions as referred to in the second indent of the first paragraph of this Article, and the particular purport of the application and of the pieces of evidence on compliance with the required conditions as referred to in this Article, shall be prescribed by the Minister.

Article 8

(Fees)

(1) A fee shall be payable by the applicant for expenses incurred in the Republic of Slovenia in conjunction with the evaluation of active substances, within the procedure of listing or renewal of listing of an active substance on the list of the approved active substances, the authorisation of PPPs, or permit granting procedure of PPP according to Regulation (EC) 1107/2009.

(2) Fees as referred to in the preceding paragraph shall be allocated as revenue to the budget of the Republic of Slovenia, and shall be remitted to the public finance receipts subaccount in accordance with the regulation governing the subaccounts and the methods of payment of mandatory contributions and other public finance receipts.

(3) The Government shall prescribe the type, level and method of payment of fees under this Article.

III. NATIONAL ACTION PLAN

Article 9

(National Action Plan)

(1) The Government shall adopt the National Action Plan for attaining the sustainable use of PPPs (hereinafter referred to as National Action Plan).

(2) National Action Plan shall specify the objectives, measures, indicators and deadlines for attaining the sustainable use of PPPs, so as to reduce the risks and impacts of use of PPPs on human health and on the environment, to reduce the need of using PPPs, and to promote using the PPPs which are not classified as hazardous substances for the aquatic environment according to regulations governing the classification, identification, labelling and packaging of hazardous preparations, and which do not contain any priority hazardous substances according to regulations governing the surface water status.

(3) National Action Plan shall be drawn up taking into account the health, social, economic and environmental impacts of measures envisaged, and the specific regional and local conditions.