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Real Decree 699/1995, On April 28, Which Updates The Fees Relating To The Registration Of Products And Plant Material, Issuance Of Certificates And Granting.

Original Language Title: Real Decreto 699/1995, de 28 de abril, por el que se actualiza las tasas relativas al registro de productos y material fitosanitario, expedición de certificaciones y concesión de autorizaciones.

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TEXT

Law 14/1986, of 25 April, General of Health, establishes in Article 40 (5) the competence of the General Administration of the State for the regulation, authorization and registration or approval of all those products that, because they affect the human being, can pose a risk to the health of people.

The health risks arising from the use of plant protection products and in particular the risks of harmful effects on human health which may result from their placing on the market, without having been examined or officially approved, make the existence of a centralised register necessary.

The Central Official Register of Plant Health Products and Material, under the Ministry of Agriculture, Fisheries and Food's Directorate General for Agricultural Production, was created by the Decree of 19 September 1942, on the manufacture of plant protection products. This rule has already established the obligation to register any plant protection product as a prerequisite for the manufacture, sale or movement of plant protection products, which also extends to foreign plant protection products. to proceed with its importation.

The registration of plant material and products, at its origin was free of charge, as can be deduced from the absence of any reference to the payment of some kind of tribute in the Order of 16 December 1942 for compliance with the provisions of the Decree of 19 September 1942.

However, this situation varies with the publication of Decree 496/1960 of 17 March, which validates the rates for technical and optional management of agronomic services, 21.09, whose regulation and management was subject to exclusively to the Law on Parafiscal Fees and Exactions of 26 December 1958 and whose management was attributed to the Ministry of Agriculture. The bases and the rate of charge were set at rates, annexed to the Decree, in accordance with paragraph 5 of the same the amount to be paid to register a product in the Register.

This amount has only been updated through the respective General Budget Laws of the State for its adequacy to the general index of consumer prices, which has generated a gap that does not allow for compliance with the Article 7 of Law 8/1989 of 13 April 1989 on Public Fees and Prices, under which the fees will be used to cover the cost of the service or activity constituting the taxable event.

On the other hand, the need to update the services provided by the Registry, as well as the level of fees, is a consequence of the increased complexity of the studies and trials required for the marketing authorisation of the the pesticides required by Council Directive 91 /414/EEC of 15 July concerning the placing of plant protection products on the market. This Community Directive requires a more thorough and thorough assessment of the risks, not only for the health of people, but also for the health of animals and the environment.

Royal Decree No 2163/1994 of 4 November 1994 imposing a harmonised Community system of authorisation to place plant protection products on the market and use plant protection products and the Order of 4 August 1993 laying down the requirements for applications for the authorisation of plant protection products, as amended by the Order of 20 September 1994, which transpose Directive 91 /414/EEC, provide that the person concerned must present all the documentation relating to the plant protection products; the possible risks, but it is up to the Administration to study and evaluate the applications.

Accordingly, this Royal Decree is dictated to adapt the corresponding rates to the Register of plant protection products and material and to establish the corresponding to the issue of certifications and concession In accordance with the abovementioned Community legislation, all of this under the provisions of Article 10 of Law 8/1989 of 13 April 1989 on Public Fees and Prices.

In its virtue, on the proposal of the Ministers of Agriculture, Fisheries and Food and of Economy and Finance, in agreement with the Council of State and after deliberation of the Council of Ministers at its meeting of 28 April 1995,

D I S P O N G O:

Article 1. Amount of fees.

The fixed rate rates for the Central Official Register of Plant Health Products and Material, certifications, authorizations, and other administrative acts regulated by Royal Decree 2163/1994, will be the following:

Pesetas

1. For examination and processing of applications for the Community acceptance of new active substances, in particular for inclusion in Annex I to Directive 91 /414/EEC/250,000

2. For the authorisation of plant protection products containing an active substance not yet accepted by the European Community/500,000

3. For the authorisation of plant protection products containing active substances already accepted by the European Community, including the old active substances until their review:

a) For new/200,000 formulations

b) By known formulations or old/75,000 active substances

4. For recognition of authorisations granted in other Member States/75,000

5. For the authorisation of plant protection products whose active substances have not yet been regulated by Community legislation:

a) By formulations or active substances usable by their biocidal action to combat harmful agents/100,000

b) By formulations or active substances useful for other properties/50,000

6. For the authorisation of new uses of plant protection products already placed on the market:

a) For applications or larger crops/40,000

b) For applications or minor crops/10,000

7. For the authorisation of changes in the composition of plant protection products or active substances:

(a) Require the revaluation of existing studies or, where appropriate, the evaluation of new studies/100,000

b) requiring a partial revaluation of studies/25,000

c) Not to increase by less than 0.2 per 100 the content of toxic or very toxic substances and in less than 5 per 100 the content of harmful or corrosive substances/10,000

8. For the authorisation of other amendments to the conditions or registration data for plant protection products or active substances:

a) Relative to a single product/10,000

b) Relative to the application holder or others that may affect a product group/25,000

9. By issuing certifications on data or information from the Official Register of Plant Protection Products:

a) Relative to a single product, use or holder/5,000

b) Relative to Multiple Products/10,000

10. For authorisation to carry out field tests with a plant protection product containing new active substances not yet authorised in the European Community/25,000

11. For the generic authorisation to carry out field tests with the products referred to in paragraph 10, excluding the cost of the inspections, audits or interventions of the competent entities or bodies/100,000

12. For the authorisation to carry out officially recognised tests with plant protection products, excluding the cost of inspections, audits or interventions of competent entities or bodies/200,000

13. For the authorisation to carry out tests under the principles of good laboratory practice (GLP) with plant protection products, excluding the cost of inspections, audits or interventions of competent entities or bodies/200,000

14. For the granting of second or subsequent authorisations to place plant protection products on the market or to carry out tests with them:

(a) For renewal of the authorisations referred to in paragraphs 5 and 11/30,000

b) By renewing the other authorization classes/75,000

c) By interim authorizations in the two previous cases/10,000

Article 2. Liabilities subject.

Any natural or legal person shall be liable for the fees to those who affect or benefit, personally or in his or her property, the public services or activities which constitute the taxable event, without prejudice to the Article 18 of Law 8/1989.

Article 3. Accrual.

The fees shall be payable when the application initiating the action or the file is submitted, which shall not be carried out or processed without the payment being made.

Article 4. Self-validation and payment.

Rates shall be subject to self-settlement by the taxable person. Your payment will be made in cash, your amount entered into deposit entity authorized by the Ministry of Economy and Finance.

Article 5. Levy.

The charge for the fees is for the Ministry of Agriculture, Fisheries and Food.

Single repeal provision. Regulatory repeal.

As many provisions of the same or lower rank are repealed, they are contrary to the provisions of this Royal Decree.

Final disposition first. Faculty of development.

The Ministers of Agriculture, Fisheries and Food and the Economy and Finance Ministers are empowered to make, in the field of their respective powers, the necessary provisions for the application of the provisions of this Royal Decree.

Final disposition second. Entry into force.

This Royal Decree shall enter into force on the day following that of its publication in the "Official Gazette of the State".

Given in Madrid to April 28, 1995.

JOHN CARLOS R.

The Minister of the Presidency,

ALFREDO PEREZ RUBALCABA