JUAN CARLOS I REY OF SPAIN

To all who present it and understand it.

Sabed: That the General Courts have approved and I come to sanction the following Law.

EXPLANATORY STATEMENT

I

One of the basic purposes of the national plant health policy is the existence of an appropriate legal framework to protect plants and their products against the damage caused by pests, in order to maintain them, by human intervention, at economically acceptable population levels, and to prevent the introduction and extension of those from other geographical areas.

The current legislation on plant health, which has its origin in the Law of Pest of the Field, of 21 May 1908, and in the Law of 20 December 1952, of defense of the mountains against forest pests, is based on mainly in the Community legislation incorporated in Spanish legislation through the corresponding legal provisions.

II

The adoption of a new legal framework for plant health is based on the double need to adapt it to the many changes that have affected its scope, as well as to adapt it to the configuration of the State. Spanish as a regional state and as a Member State of the European Union.

In fact, it is necessary to regulate in a standard of appropriate range the basic principles of action of the different public administrations competent in the field of plant health and to establish concrete aspects that allude to the exclusive powers of the General Administration of the State relating to trade and external health.

This regulation takes into account the fundamental aspects of the European Union's legislation on the subject, which have already been the subject of development in our national law through various provisions of a different nature. general, which will remain in force following the entry into force of the Act.

Consequently, the purpose of the Law is to establish a uniform framework that provides legal cover for the set of rules currently in force in the field of plant health, in accordance with the current distribution of powers between the State and the Autonomous Communities derived from the block of constitutionality, and the commitments made by Spain as a Member State of the European Union and as a result of the subscription of international conventions.

III

From another point of view, consideration must be given to the development of criteria that have occurred in society with regard to food safety, occupational health and the protection of the environment. Therefore, the Law should provide for aspects relating to the means used in the fight against pests, in particular plant protection products, in order to ensure that in their handling and application there are no harmful effects on health. the consumer or the applicator, for the animals or for the environment.

In this sense, the corresponding official authorizations of the means of phytosanitary defense are the instrument of this guarantee, which must not be reduced to the field of the plant health, but must transcend to the health public and environmental.

The complexity of the procedure for granting authorisations and the dynamics of enlargement to new uses, with the corresponding management of the establishment of maximum residue limits for the European Union or Even worldwide, it determines the need for a single competent authority to grant authorisations, as provided for in Community legislation.

However, these guarantees have been strengthened following the recent creation of the Spanish Food Safety Agency by Law 11/2001 of 5 July, incorporating a new instrument to ensure the safety of the food which must necessarily be taken into account in the provisions of this Law.

Also, without prejudice to the measures already provided for in this standard to ensure the health of those involved in the process of manufacturing and applying plant protection products, the forecasts must be met. General provisions of Law 31/1995 of 8 November 1995 on the prevention of occupational risks.

IV

This Law articulates the applicable criteria and actions in the field of plant health, in general, and of prevention and control of pests, in particular, both the State and the Autonomous Communities.

With this aim, it is intended to establish homogeneous basic criteria for addressing the problems of the occurrence of pests in a given territory and to enable the rapid adoption of control measures. The requirements for the adoption of official measures against a pest for eradication, to avoid its spread, to reduce its populations or its effects, are also clarified.

On the other hand, the possibility of the competent administration to qualify its compulsory struggle as "public utility" or the plague of "phytosanitary emergency" is regulated, which will entail a greater degree of severity and intervention of the official measures, as well as the application of different economic compensation in the form of aid and compensation to those affected by the application of the measures.

In the field of the obligations of individuals, farmers are responsible for the surveillance and control of pests, crops and materials which are the subject of their activity, as well as for the execution of their duties. compulsory official measures to be laid down in regulation. With regard to exports to third countries, it is for the individual to apply at the border inspection points for the inspections necessary for the issue of the relevant phytosanitary certificate and the responsibility for the the case of exporting without the required documentation. In addition, the obligations and responsibilities of producers, holders of authorisations, distributors, sellers and other operators of plant protection products and the responsibility of users of such products are determined. following the usage recommendations. Finally, the obligations of natural and legal persons to whom an official inspection is carried out are set out.

In view of the increase in the last years of the importation and release of biological control organisms, in the absence of a community regulation, the legal basis is established to permit a normative development in which the the responsibilities of the administrations concerned and the individuals involved in this activity, and ensure their effective and safe use, minimising the risks to human health and the environment.

In the same sense of preventing the risks cited, there is a growing demand from consumers to promote plant production systems that take into account good plant health practices and, to fight in common against the pests are encouraged by the groups of farmers that include among their objectives those practices.

It is also foreseen that the different public administrations, within the scope of their respective competences, carry out the necessary inspections to ensure compliance with this Law and are granted the authority to plant health inspectors, determining their powers.

Finally, a regime of infractions and sanctions is established in the subject matter of this Law, making the first one according to its seriousness, determining the responsibilities of the offenders and fixing the sanctions corresponding. Also, a fee regime is created, with the taxable persons, the ratio of taxable facts and the amounts of the respective fees.

This Law is issued under the terms of Article 149.1.10.a, 13.a, 16. and 23. of the Constitution, which reserves the State exclusive competence in matters of foreign trade, bases and coordination of the general planning of the economic activity, general bases and coordination of health and external health, and basic legislation on environmental protection, respectively.

TITLE I

General provisions

Article 1. Object and purpose.

1. The purpose of this Law is to lay down the basic rules and the rules of coordination in the field of plant health.

2. They are the purposes of this Law:

a) Protect plants and plant products from damage caused by pests.

(b) To protect the national territory and that of the European Union, in accordance with the Community plant health rules, of the introduction of quarantine pests for plants and plant products or other objects, and to avoid the propagation of existing ones.

(c) Protect animals, plants and micro-organisms which cancel or limit the activity of organisms harmful to plants and plant products.

(d) Prevent risks to the health of humans and animals and the environment from the use of plant protection products.

e) Ensure that the plant health protection means meet the appropriate conditions of utility, efficacy and safety.

Article 2. Definitions.

For the purposes of this Law:

(a) Marketing: any delivery, whether for consideration or free of charge, including the act of import and excluding export.

(b) Plants: live plants and live parts thereof, including fresh fruits and seeds.

(c) Plant products: products of non-processed plant origin or which have undergone a simple preparation.

(d) Other objects: materials or products, other than plant products, liable to be affected by harmful organisms or to be used as a vehicle.

e) Plague: a harmful organism of any species, plant or animal or animal or pathogenic agent harmful to plants or plant products.

(f) Quarantine Plague: a pest which may have potential economic significance and which is on the Community list or has been qualified by the Ministry of Agriculture, Fisheries and Food.

g) Control of a pest: application of plant health measures to prevent the spread of a pest, reduce its population or its effects, or to eradicate it.

h) Official declaration of existence of a plague:

official recognition of the presence of a pest, defining the causal organism, the affected area and the phytosanitary measures to be taken.

i) Establishment of a plague: perpetuation of a plague for the foreseeable future, within an area after its entry.

j) Eradication of a pest: application of phytosanitary measures to eliminate a pest from an area.

(k) Biological control body: natural enemy antagonist or competitor or other biotic entity capable of reproducing, used for pest control, with the exception of the micro-organisms and viruses referred to in the paragraph n).

l) Exotic biological control body:

biological control body that does not exist in all or part of the national territory.

(m) Plant protection means: products, organisms, equipment, machinery for application, design and components intended to control harmful organisms, to avoid their effects or to affect the vital process of the plants differently than nutrients.

n) active substances: substances or micro-organisms, including viruses, which exercise general or specific action against pests or plants, parts of plants or plant products.

(o) Plant protection products: active substances and preparations containing one or more active substances presented in the form in which they are offered for distribution to users, intended to protect plants or plant products against pests or to avoid the action of pests, to improve the conservation of plant products, to destroy undesirable plants or parts of plants, or to influence the vital process of such products in a different manner as they act nutrients.

p) Waste of a plant protection product: the substance or substances present in plants, plant products or their processed products, edible products of animal origin, or in the environment, which constitute the remains of the plant use of a plant protection product, including its metabolites and products resulting from its degradation or reaction.

q) Maximum residue limit (MRL): maximum concentration of residues of a legally permitted plant protection product on the surface or internal part of products intended for human or animal feed.

r) Integrated fight: the rational application of a combination of biological, biotechnological, chemical, crop or plant selection measures, so that the use of plant protection products is limited to a minimum necessary for the control of the pests.

s) Good phytosanitary practices: use of plant protection products and other means of plant health protection under the conditions of use authorised.

t) Competent authority: the bodies of the Autonomous Communities, the Ministry of Agriculture, Fisheries and Food and the Ministry of Health and Consumer Affairs, within the scope of their respective powers, without prejudice to the functions which may correspond to other Departments of the General Administration of the State and the Spanish Food Safety Agency.

u) Competent technician: qualified professional for the development of activities in the different areas covered by this Law, which, in addition to fulfilling the requirements established by the legal system for the professional exercise, must be in possession of an enabling university degree, which will be determined by the legal provisions in force for each profession, according to their respective specialties and specific competencies.

Article 3. Scope of application.

The scope of this Law includes:

a) Vegetables, whether grown or spontaneous, and plant products.

(b) Soil and land, mobs, hammers, sprouts and other materials, installations and media used or intended for the cultivation, production, handling, processing, conservation, marketing or disposal of plants and its products.

(c) Plant protection products and other means of plant health protection, as well as facilities and facilities for their production, distribution, marketing and application.

d) Animals, plants and microorganisms existing in the natural environment, which cancel or limit pests.

e) the activities of persons and public and private entities, as soon as they relate to the objectives and objectives referred to in Article 1.

Article 4. Duty of information.

The public administrations will act in accordance with the principle of institutional loyalty, providing the other public administrations with the information they need about the activity they carry out in the exercise of their own powers, in particular with regard to the incidence and intensity of quarantine pests and those identified in their territorial scope which have a particular impact, as well as the phytosanitary measures taken.

TITLE II

Prevention and control of pests

CHAPTER I

Prevention

Article 5. Obligations of individuals.

Farmers, foresters, traders, importers and professionals engaged in plant health protection activities should:

(a) To monitor their crops, plantations and crops, plants and plant products, as well as the forest masses, the natural environment and related materials traded.

(b) Facilitate any information on the plant health status of plantings, plants or plant products, where required by the competent bodies.

(c) Notify the competent authority of the Autonomous Community or, in the case of importers, the Ministry of Agriculture, Fisheries and Food any atypical occurrence of harmful organisms or disease symptoms for plants and plant products.

Article 6. Records of vegetable producers and traders.

1. Natural or legal persons who produce or market plants and plant products that are potential spreaders of quarantine pests shall be registered in the relevant official register. The list of plant products and plant products referred to above, as well as the basic requirements for registration, shall be established.

2. A National Register of Plant Producers and Traders will be created, the function of which will be merely informative, which will collect the information to be submitted by the corresponding official records of the Autonomous Communities.

Article 7. Limitations on the introduction and movement of plants.

1. For the purposes of preventing the risks posed by the possible introduction or spread of quarantine pests in the national territory and the movement of certain plants and plant products and other objects likely to be carriers of the same, in accordance with Community rules and, where appropriate, those laid down in regulation, the introduction and movement of harmful organisms, plants, plant products and other objects shall be subject to the conditions and prohibitions that in each case are set to the following relationships of:

(a) Quarantine plates, the introduction and spread of which is prohibited in the national territory or in the free zones thereof to be determined. The same treatment shall be carried out for non-related organisms which have been classified as quarantine pests by the Ministry of Agriculture, Fisheries and Food after having first appeared on the national territory, after consultation the Ministry of the Environment in the case of forest species.

(b) Plants, plant products and other objects, the introduction of which is prohibited in the national territory or parts thereof to be determined, where they originate in certain third countries.

(c) Plants, plant products and other objects, as well as, where necessary, their packaging or other materials related to those, for which they are introduced or circulated in the national territory or parts thereof which are The compliance with specific phytosanitary conditions is required.

(d) Plants, plant products and other objects, whatever their origin, for the circulation of which a plant protection document is required, issued under conditions to be determined.

2. The Ministry of Agriculture, Fisheries and Food may derogate from paragraph 1, provided that they do not involve the risk of the spread of the quarantine pests.

Article 8. Pest-free zones.

When in an area of the national territory or in its entirety, and with respect to one or more quarantine pests, it is known that they are not endemic or established, the Ministry of Agriculture, Fisheries and Food, at the initiative of the Autonomous Communities concerned may propose to the European Union the declaration of that zone as free from these pests. The declaration shall specify the requirements to be met by plants and plant products and other objects for introduction and circulation through the free zone.

In the case of pests affecting forest species, a report from the Ministry of the Environment will be sought.

Article 9. Plant health protection measures.

1. The Ministry of Agriculture, Fisheries and Food, when it considers that the entry of certain plants and plant products and other objects into or in part of national territory from third countries represents an imminent danger the introduction or spread of pests which may have potential economic significance or significant environmental impacts, shall immediately take the necessary measures to protect the areas in danger, after consultation of the Ministry of the Environment Environment in the case of forest species.

2. Where the plants come from a Member State of the European Union, the Ministry of Agriculture, Fisheries and Food shall, in advance, request the European Commission to take the necessary measures to be taken. If the Autonomous Communities concerned are not adopted by the latter, they may be provisionally established until the European Commission determines the appropriate measures.

3. The Ministry of Agriculture, Fisheries and Food shall inform the European Commission and the other Member States of the measures it has taken or will adopt in accordance with paragraphs 1 and 2 of this Article.

CHAPTER II

Exchanges with third countries

Article 10. Border inspections.

1. The introduction into national territory of plants, plant products and other objects referred to in Article 7 (1) (d), whatever their subsequent customs use, from third countries, shall be carried out only through the points of entry approved by the Ministry of Agriculture, Fisheries and Food.

Where there are reasonable grounds that plants, plant products and other objects, other than those referred to in Article 7 (1) (d), may be affected by pests of potential, economic or environmental importance, or have infringed the provisions of this Law, the Ministry of Agriculture, Fisheries and Food may establish for these the same requirement of the preceding paragraph.

2. The products referred to in paragraph 1 shall be inspected and the plant health inspections or tests shall be carried out at the border inspection points or in other centres approved by the Ministry of Agriculture, Fisheries and Power. In any case, the corresponding phytosanitary authorisation will be required to be cleared by customs.

3. The provisions of this Article shall be without prejudice to the powers of the Ministry of Health and Consumer Affairs.

Article 11. Introduction into the national territory.

1. The landing or introduction into the national territory of plants, plant products and other objects originating in third countries, the introduction of which is prohibited, as well as the evidence or suspicion established for the non-prohibited that they are affected by pests which may be of economic or environmental importance, or which plants or plant products contain residues exceeding the maximum permitted limits, shall give rise to the adoption by the competent authority and, where appropriate, by plant health inspectors, from one of the following measures:

a) The immediate re-dispatch of the same.

b) Their destruction.

(c) Their confinement in the places and conditions determined by the Ministry of Agriculture, Fisheries and Food.

d) Any other measure of those included in Article 49.1.a).

2. All expenditure incurred as a result of the implementation of these measures shall be borne by the introducer. However, provided that the level of health or environmental guarantee is not affected, the introducer shall be granted the possibility of choosing to apply that level of the measures referred to in the previous paragraph which it considers to be more appropriate.

3. Plants, plant products or other objects originating in third countries which comply with the requirements laid down in Article 7.1 of this Law may be introduced into national territory and shall apply the same rules as to national products.

Article 12. Export.

1. Inspections or plant health checks on plants, plant products and other objects under export arrangements shall be carried out at the border inspection points or at other inspection centres which have been carried out by the Ministry of Agriculture, Fisheries and Food, the corresponding phytosanitary certificate should be expiated where appropriate. Such inspections shall be carried out at the request of the data subject.

2. Where the performance of other tests or official plant health checks prior to those laid down in paragraph 1 is required, or by the requirements of a third importing country, the same shall be carried out by the third country concerned. Ministry of Agriculture, Fisheries and Food, directly or through public or private entities accredited for this purpose.

3. The export without the prior obtaining of the phytosanitary certificate, when required by the country of destination, shall be the responsibility of the exporter.

CHAPTER III

Pest control

Article 13. Obligations of individuals.

1. It corresponds to the holders of the holdings or other areas covered by plant cover:

(a) Maintain their crops, plantations and crops, as well as the forest masses and the natural environment, in good plant health for the defence of their own and external productions.

(b) Apply the mandatory phytosanitary measures to be established as a result of the declaration of existence of a pest.

2. Traders and importers shall maintain in good plant health the plants, plant products and other objects of their economic activity and, where appropriate, implement the mandatory phytosanitary measures to be established.

Article 14. Immediate actions and declaration of existence of a plague.

1. In the event of the first occurrence of a pest in the national territory or part thereof, or the suspicion of its existence, which may be of economic or environmental importance, the competent authority shall verify the presence and importance of the pest. the infestation and shall immediately take any previous precautionary phytosanitary measures which it considers necessary to prevent the spread of such pest.

2. Without prejudice to the immediate actions referred to in paragraph 1, the presence of a pest may give rise to the declaration of its existence by the competent authority of the Autonomous Community and, where appropriate, to the declaration of pest quarantine by the Ministry of Agriculture, Fisheries and Food, after consulting the Ministry of the Environment in the case of forest species, which will involve the adoption of some of the phytosanitary measures provided for in Article 18. Such measures, which may include obligations for individuals, shall be of such a nature as to exercise control over the pest and, in respect of the type of pest, to achieve at least the following objectives:

a) An unknown quarantine plague on or in part of the national territory: its eradication or, if not possible, its spread.

b) A known quarantine plague in the national territory: prevent its spread.

(c) Not considered quarantine plaga for a given area to which phytosanitary measures are applied: to reduce its population or its effects.

3. The competent authority of the Autonomous Community may declare the existence of a pest when it produces or may cause economic damage or damage of such intensity, extent or nature as necessary for the compulsory struggle as a means of effective in combating it, or that the control measures need to be applied in continuous areas or when the pest is a possible dispersion.

4. Where an Autonomous Community declares the existence of a pest on its territory, it shall immediately inform the Ministry of Agriculture, Fisheries and Food of that declaration and of the phytosanitary measures taken.

Article 15. Public utility rating of the fight against a pest.

1. Public administrations may qualify as a public utility the fight against a particular pest where the cases referred to in Article 14 may have significant repercussions at national level or in a Autonomous Community and present any of the following circumstances:

(a) That because of its required intensity, extent or techniques, its struggle requires the use of extraordinary means not assumed by private individuals or is to be combated through biological or self-directed fighting practices.

b) That their population and diffusion levels show an increasing pace, that they make provision for the possibility of reaching important extensions and be the cause of severe economic losses.

c) That it is a pest of new occurrence in the national territory or in parts of it until then unaffected.

d) That by its characteristics it could be eradicated in all or part of the national territory.

e) That due to its special characteristics of evolution and dispersion, it is necessary to combat it in states, locations or phases in which the realization of treatments have no direct interest for the owners affected by economically affect their productions or properties.

f) Affecting mountains and natural spaces whose conservation is of interest for environmental reasons or as a means of production or social welfare.

g) Which affects plants or their products usually intended for export and which is internationally subject to quarantine measures.

h) That the measures taken as a result of the official declaration of their existence have been ineffective, or the plague has spread beyond the limits of such a declaration.

2. The Autonomous Community may lay down additional plant health measures against a pest, in respect of those adopted when its existence was declared, in the provision in which the fight against such pest is declared to be of public use.

The government may establish the corresponding national program for the eradication or control of the pest, if the intensity of the pest requires it.

Article 16. Phytosanitary emergency situation.

In exceptional situations where there is a serious danger of the spread of a pest in the territory of the country, the declaration of its existence by the competent authority shall entitle the General Administration of the State to exercise, where appropriate, the necessary functions for the adoption of urgent measures designed to effectively prevent its transmission and spread to the rest of the national territory, as well as to ensure the proper implementation, coordination and monitoring of until the restoration of plant health in the whole territory national.

Article 17. Restrictions on the mandatory fight against a plague.

When in the fight against a plague, the individual action can interfere with the collective with risk of its effectiveness or is necessary the adoption of special measures or the use of extraordinary means, the Autonomous Communities or, If necessary, the Ministry of Agriculture, Fisheries and Food may establish the obligation to carry out collectively by organizations officially recognized or directly by the Administration, in which case the interested parties They shall refrain from carrying out any other individual action, if so set.

Article 18. Plant health measures.

Under the provisions of this Law, the following phytosanitary measures may be adopted:

(a) Conditioning or prohibiting in particular areas the planting or cultivation of species or varieties susceptible to certain pests or which may act as transmitters of such pests.

(b) Disinfecting, disinfecting, immobilizing, destroying, transforming, burying or subjecting to any other prophylactic measure the plants and their products, as well as the material with which they are related, which is or may be a vehicle of pests.

(c) Disinfecting or disinfecting the premises, tools and machinery used in the production, handling, processing, storage or preservation of plants and their products, as well as the means for the transport thereof; which contain or may be a pest vehicle.

(d) Establish storage and storage conditions for certain plants and plant products in order to prevent damage to pests as well as the spread of pests.

e) Determine the dates of commencement and termination of the cultivation work, including forest harvesting and harvesting, whose time of execution may influence the development of a pest.

(f) Confining at appropriate facilities, for as long as necessary, plants from third countries likely to be carriers of harmful organisms and useful organisms intended for biological control.

g) Start abandoned plantations when they constitute a plant health risk for neighbouring plantations or for the control of a particular pest.

h) Establish any other measure that is technically or scientifically justified as necessary in the control of the pest.

Article 19. Implementation of plant health measures.

As long as it is not established otherwise, the plant health measures adopted, among those referred to in Article 18, shall be implemented by the persons concerned, with the costs arising from them being borne by them.

CHAPTER IV

Aid and compensation in the fight against pests

Article 20. Aid in the fight against pests.

Those affected by the obligation to fight against a pest will benefit from technical assistance and financial assistance which, if necessary, will be determined in the relevant standard.

Article 21. Compensation in the compulsory struggle.

Where the measures established for the control of a pest involve the destruction, deterioration or misuse of private or public property or property, the competent authority which has declared the pest shall compensate those injured by the appropriate compensation, the amount of which will be assessed in accordance with the scales to be laid down. No compensation shall be granted where such measures have been made necessary as a result of transgressions to this Law or to the provisions enacted in its development.

Article 22. Financial collaboration.

The Ministry of Agriculture, Fisheries and Food will be able to collaborate, in accordance with the available budgetary resources, with the Autonomous Communities in the financing of the control programmes to be established, especially in those referring to quarantine pests not established in the national territory. These programmes shall determine, where appropriate, the financial contribution conditions of the Ministry of Agriculture, Fisheries and Food.

TITLE III

Phytosanitary defense media

CHAPTER I

Common Provisions

Article 23. General conditions of marketing and use.

1. The means for plant health protection shall comply with the following general conditions for placing on the market and use:

(a) Be authorised in accordance with the provisions of this Law, except for the exceptions provided for in Articles 44 and 45 of this Law, in which the prior communication to the competent authority shall be sufficient.

b) Be labelled, where appropriate, including at least the necessary information about their identity, risks, precautions to be taken and for their proper use.

(c) Where, by their nature, their labelling does not correspond, they must be accompanied by the information necessary for proper use and maintenance.

(d) The information specified in paragraphs (b) and (c) shall be expressed, at least, in the official Spanish language of the State.

2. For the purposes of the requirement of prior authorization referred to in paragraph 1 not to affect the single internal market, the rules for recognition of the single internal market shall be laid down in accordance with the specific Community rules. authorisations granted in other Member States, where appropriate with the appropriate conditions or adaptations, provided that:

(a) The Member State in which it has been granted has the same or comparable requirements and criteria for the granting of such authorisations.

(b) The agricultural, plant health and environmental conditions of the other Member State are comparable to the Spanish in the regions to be considered.

c) There is no reason to restrict or refuse authorisation, considering that the plant protection medium in question constitutes a risk to human or animal health or to the environment, or to require the applicant for further testing or testing.

3. Authorization to place on the market or to test plant protection products or other means of plant health protection consisting of or containing genetically modified organisms shall require prior authorisation to release them in the medium. In accordance with the provisions of Law 15/1994 of 3 June 1994 establishing the legal system for the contained use, voluntary release and placing on the market of genetically modified organisms.

4. The means of plant health protection shall be adequately used, taking into account good plant health practices and other conditions determined in their authorisation and, where appropriate, in accordance with the principles of integrated control defined in paragraph (r) of Article 2.

5. The content of the labels, the training requirements for those who market or use the means of plant health protection and those relating to research and development activities shall comply with the regulatory standards corresponding.

Article 24. Record and information on phytosanitary protection means.

1. Authorisations, communications and decisions for the recognition of authorisations referred to in Article 23 (1) and (2) shall be entered in the Official Register of Plant Health Products and Material attached to the Ministry of Agriculture, Fisheries and Food.

2. The register shall keep up to date the information concerning the legally usable means of defence in Spain, of their possible uses, of the characteristics and conditions which limit their use and of the requirements which determine good plant health practices.

3. The registration and functioning of the register, as well as the information supply system, shall comply with the relevant regulatory standards.

Article 25. Rationalisation of the use of phytosanitary defence means.

In order to create favorable conditions so that the means of phytosanitary protection can be used adequately in accordance with the general conditions set out in the previous article, particularly for subordinate their use to the health of people and animals and their compatibility with the development of environmentally friendly sustainable agriculture, public administrations will be able to promote:

(a) Plant production systems which, in the control of pests, rationally use cultural practices and natural regulation mechanisms, as well as chemical, biological, physical or material means, in order to obtain economic results, yields, qualities and costs of production of the crops that are acceptable from the social and environmental points of view.

(b) Farmers ' groups to jointly fight against pests, which include the application of the production systems referred to in paragraph (a) or any other measures for the reduction or reduction of the pests; the optimization of the use of plant protection media.

(c) Training and specialisation programmes in the use of plant protection products for users and distributors who train them for the safe and rational use of such products. Responsibility for such programmes shall be the responsibility of competent technicians, leading to the use of good agricultural practices which limit or tend to eliminate, as far as possible, the use of plant protection products.

(d) Research programmes for the search for technically and economically viable alternatives that enable the resolution of problems of a phytosanitary nature.

CHAPTER II

Active Substances

Article 26. Inclusion of active substances in the Community list.

1. In order to be used as components of plant protection products, the active substances must be included in the Community list where the list of active substances authorised by the European Union is collected and the conditions laid down established for each of them.

2. Applications for inclusion in the Community list shall be addressed to the competent authority of the Ministry of Agriculture, Fisheries and Food, together with the documentation laid down for each active substance and one or more plant protection products containing it. Applications must be in the official Spanish language of the State.

3. If the European Commission decides that the documentation provided is sufficient, and designates Spain as rapporteur in the process of inclusion, this will determine for the Ministry of Agriculture, Fisheries and Food the obligation to instruct the application. The Ministry of Agriculture, Fisheries and Food and the Ministry of Health and Consumer Affairs will coordinate their participation in the evaluation of the documentation, as well as the corresponding Community actions.

The evaluation of the documentation provided may be carried out by the General Administration of the State directly or through scientific entities expressly accredited for this purpose by the Ministry of Agriculture, Fisheries and Food, after a binding report from the Ministries of Health and Consumer Affairs and the Environment, on the aspects of their respective competencies, and the Committee on the Evaluation of Plant Protection Products is heard. The cost of this assessment shall be borne by the applicant.

Article 27. Authorisation of active substances.

1. Without prejudice to the provisions of the foregoing Article, the active substances authorised in accordance with the national rules laid down in accordance with national legislation may be used as components of plant protection products unless it has been expressly refused to be included in the Community list or prohibited to be incorporated in plant protection products.

2. The authorisation of active substances covered by national legislation shall be in accordance with the same procedure as the authorisation of plant protection products.

Article 28. Marketing of active substances.

Active substances may be placed on the market only if they comply with the existing rules on the declaration of new substances, classification, packaging and labelling of dangerous substances. In addition, in the case of active substances which were not on the market before 26 July 1993, the documentation referred to in Article 26.2 shall have been submitted to the European Commission and the other Member States unless it is for active substances intended for the purposes referred to in Article 43.

CHAPTER III

Plant protection products

Article 29. Authorisation and registration of plant protection products.

1. Plant protection products may be placed on the market only if they have previously been authorised by the Ministry of Agriculture, Fisheries and Food and entered in the Official Register of Plant Health Products and Material.

2. Any renewal, extension of use and any other modification of the authorisations, as well as their extinction, shall also be authorised and registered in the register.

Article 30. General conditions of the authorization.

1. The authorisation referred to in the previous Article shall be conditional on:

(a) The active substances containing the product are included in the Community list or, where appropriate, are authorised in accordance with the State rules.

(b) In the state of scientific knowledge, its identity, characteristics and other properties, as well as its residues, can be verified by generally accepted methods or techniques.

(c) In the state of scientific knowledge, they may, under certain conditions, solve one or more plant health problems and that the crops or products on which they have been applied are acceptable, particularly in the content of the plant protection product residues.

d) They may be used without risk to humans or to animals of species normally fed and bred or consumed by man.

e) They may be used under the conditions without an unacceptable impact on the environment.

f) Where appropriate, the degree of dangerousness of the packaging may be determined, after use.

g) Where appropriate, maximum residue limits have been established.

2. Verification of the conditions of the preceding paragraph shall be carried out in the state of scientific knowledge by means of official or officially recognised tests and analyses, which shall be carried out by competent technicians and, in their Case-law, under uniform criteria. To this end, the Ministry of Agriculture, Fisheries and Food shall publish annually a detailed list of laboratories that can carry out tests and analyses on an official basis.

Article 31. Duration of the authorization.

1. Authorisations shall be for a maximum duration of 10 years, without prejudice to their possible renewal.

2. The authorisations may be reviewed where there are indications that any of the requirements that were taken into account for their granting are no longer met, that the information contained in the aid contained false or misleading elements or because the evolution of scientific and technical knowledge determines that its conditions of use may be modified.

Article 32. Exceptional limitations of an authorized product.

1. When determined by the Ministry of Health and Consumer Affairs or the Environment, or because there are other reasonable grounds for considering that an authorised product may constitute a risk to human, animal or environmental health, the Ministry of Health and the Environment Agriculture, Fisheries and Food shall take the measures to restrict or provisionally prohibit their placing on the market and use, in accordance with Community rules, where appropriate. These limitations may be maintained until the end of the procedure for the review of the authorisation of the plant protection product.

2. The Autonomous Communities may propose any restrictions or prohibitions that they consider to be from the provisions of the previous paragraph.

Article 33. Provisional authorisations.

The Ministry of Agriculture, Fisheries and Food may authorise, provisionally and for a maximum period of three years, the placing on the market of a plant protection product containing some new active substance not included in the the Community list, where the European Commission has determined that the documentation provided is adequate and provided that the conditions of efficacy, selectivity and safety required in paragraphs 1 (b) to (g) of the first subparagraph are sufficiently fulfilled. Article 30.

Article 34. Exceptional authorizations.

When an unforeseeable danger is present that cannot be controlled by other means, the Ministry of Agriculture, Fisheries and Food may authorize for a period of not more than one hundred and twenty days the marketing of products plant protection for controlled and limited use, in accordance with Community rules, where appropriate.

Article 35. Authorization procedure.

1. The application for authorisation of a plant protection product shall be addressed to the competent authority of the Ministry of Agriculture, Fisheries and Food by the natural or legal person intending to place it on the market for the first time in Spain, accompanied by Regulated documentation of the active substance and of the

substance

product. The application and a supporting document must be in the official Spanish language of the State.

When in the examination of an application for authorisation of plant protection products there is any active substance produced by another person or by a manufacturing process other than those specified in the documentation in the active substance in question has been included in the Community list, the European Commission shall be informed thereof, including details of its identity and impurities. In any event, the authorisation of the application shall be conditional upon verification that the active substance complies with the requirements laid down for inclusion in the Community list.

2. The application for authorisation shall be informed by the Ministries of Health and Consumer Affairs and the Environment, in the aspects of their respective competences, and by the Commission for the Evaluation of Plant Protection Products.

3. The authorization resolution must define the conditions of use which determine good plant health practices and contain the specific conditioning for the marketing and use of the product to be met effectiveness and safety, including warnings and indications corresponding to their classification by the various aspects of danger and, where appropriate, the restriction to certain classes or categories of users.

4. The maximum duration of the procedure shall be 12 months from the time the complete documentation referred to in paragraph 1 has been submitted.

5. After the previous period without any express resolution, the person concerned may understand the application for authorisation, without prejudice to the legal obligation of the Administration to issue it.

Article 36. Confidentiality and data protection.

1. The detailed composition, the procurement procedure and other information, for which the applicant requests and warrants that it constitutes industrial or commercial secrecy, shall be confidential in so far as it is accepted by the Administration, except that required by the provisions relating to labelling, or is essential for the identification and control of the plant protection product and its active substance, or for the knowledge of the different aspects of danger and of the measures to be taken to prevent risks and in the event of an accident.

Confidentiality does not exclude the examination by the Administration of such information, when it is necessary to determine whether there are significant differences with a plant protection product or an active substance that is the subject of another application. back.

2. The studies, tests and the rest of the documentation provided by the applicant shall be protected, for the purposes of their use in favour of a subsequent applicant, unless:

a) The first applicant has expressly authorized it.

(b) Hayan more than 10 years after the first marketing authorisation granted on the basis of that documentation in Spain or another Member State, as appropriate in accordance with the rules community.

(c) The time limit for data protection established by Community legislation has elapsed, in the case of documentation relating to an active substance.

Article 37. Access to documentation to avoid repetition of experiments with vertebrate animals.

1. In the case of active substances included in the Community list, experiments on vertebrate animals shall not be unnecessarily repeated for compliance with the requirements laid down in Article 30 (2) in the submission of new products. applications, renewals, revisions or modifications to the authorisation of plant protection products or active substances for the maintenance of existing ones.

To that end, it is declared of social interest, in accordance with Articles 12 and 13 of the Law of 16 December 1954, of Compulsory Expropriation, the exclusive use of the corresponding data contained in the documentation required to obtain, modify, renew, revise or maintain the authorisations of plant protection products referred to in Article 36 (2) and to the sole effect that it may be used by the Administration in favour of the beneficiaries.

2. The beneficiaries of the expropriation, in the terms laid down in that Law, are declared to be beneficiaries in obtaining, modifying, renewing, reviewing or maintaining authorizations for the manufacture and/or marketing of active substances and plant protection products containing them, to which the data referred to in paragraph 1 may be applicable.

3. For the fixing of the corresponding economic compensation, account shall be taken of the provisions of the Compulsory Expropriation Act.

Article 38. Access to the remaining documentation.

1. For the purposes of preventing the impairment of free competition in cases of monopoly, it is declared of social interest, in accordance with Articles 12 and 13 of the Law on Compulsory Expropriation, the exclusive use of the data contained in the documentation applicable to the maintenance of authorisations for plant protection products, other than that referred to in the previous Article, for the sole purpose of being shared by those who have authorisations to manufacture or to place on the market the active substances and the plant protection products containing them and resulting affected by Community directives determining the need to review such authorisations.

In this sense, it is a monopoly situation where, if the information is not shared, a single company would act as the exclusive holder of the rights of manufacture or marketing of a product. plant protection for which no other products are authorised for the treatment of a plant protection problem of significant importance.

2. Beneficiaries of the expropriation, in accordance with the terms laid down in this Law, are declared to have authorisations to manufacture or to place on the market the active substances and plant protection products containing them, when agreed their inclusion in Annex I to Directive 91 /414/EC, or rules which amend or replace it, without being able to give up their right or share it with any other natural or legal person who does not have that character as a beneficiary.

Article 39. Documentation access procedure.

1. For compliance with the provisions of Articles 37 and 38, in the case of rights of exclusive use of the documentation to be protected

in accordance with Article 36 (2), the parties concerned must seek to reach an agreement with the person who holds such rights so that the documentation can be used in their favour.

2. If an agreement has not been reached for the shared use of the documentation prior to the initiation of the expropriatory file, the Ministry of Agriculture, Fisheries and Food shall urge the parties concerned to carry out the necessary steps to reach an agreement within 15 days to avoid unnecessary repetition of the relevant tests and studies.

3. In the light of the impossibility of the parties for the shared use of the documentation, it will be resolved in each case, by agreement of the Council of Ministers, on the proposal of the Minister of Agriculture, Fisheries and Food, on the necessity of use such information, in so far as is strictly necessary for the purpose of the expropriation and taking into account the reasonable balance between the interests of the parties concerned.

When the expropriation relates to the non-exclusive use of the data contained in the documentation required to review or maintain the authorisations of plant protection products or active substances other than the The Council of Ministers shall, in each case, assess the need for such information to be used in experiments and tests on vertebrate animals in order to avoid the occurrence of the situations described in Article 38 (1).

Before the Council of Ministers decides on the declaration of social interest, the Ministry of Economy and Science and Technology should report the dossier and give a hearing to all interested parties.

4. The cases of compulsory expropriation to which this Law will take place shall be dealt with by the urgency procedure of Article 52 of the Law on Forced Expropriation.

5. The deposit prior to the use and the amount fixed definitively as Justiprice, as well as the expenses arising from the file of expropriation initiated in accordance with the provisions of this Law, shall be of account of the beneficiaries of the expropriation.

Article 40. Obligations relating to the production and placing on the market of plant protection products.

1. The holders of the authorisations, when they are also the manufacturers of plant protection products, without prejudice to compliance with the existing rules on industry, are obliged to:

a) Dispose of suitable facilities and laboratories.

b) Register all batch production operations and control their quality.

(c) Meet the requirements and conditions taken into account for their authorisation, including those relating to packaging.

d) Meet the labelling requirements, providing all the necessary information about potential risks, as well as the correct handling, use and disposal of packaging.

e) Provide a safety data sheet in accordance with the requirements that are set out in regulation.

2. The holder of the authorization which does not manufacture the plant protection product shall be responsible to the Administration for the fulfilment of the obligations of paragraphs (a), (b) and (e) of the previous paragraph by the manufacturer and to comply with the obligations of the paragraphs (c) and (d) of that paragraph.

Final packaging and labelling, in the manner in which the product is offered to the user, must be recorded in the same way as the rest of the production operations, as specified in paragraph 1.b), the transfer or any other operation in which the seals on the packaging are broken or the original labelling is lost, unless they are carried out by the holder of the authorisation or under his own control.

3. Without prejudice to paragraph 2, in the case of the inclusion of information on the distributor and in the case of parallel imports, overlabelling may be carried out in accordance with the regulatory requirements of a different person. of the holder of the authorisation, provided that the plant protection product is kept in its original packaging, with the seals intact and the parts of the label where the identifying data of the product and the holder of the product are displayed. approval or, where appropriate, of the manufacturer. In addition, the additional label shall contain the identifying data of the person who carries out the overlabelling, which shall be responsible for compliance with paragraph 1 (d).

4. Distributors, vendors and other commercial operators of plant protection products shall:

(a) Be in possession of the enabling university degree to exercise as a competent technician in the field of plant health or to have personnel who possess it, in both cases complying with the requirements laid down by the legal order for professional practice.

b) Meet the requirements for storage and marketing.

(c) To supply plant protection products only to persons or entities that in their status as users comply with the legally enforceable conditions and requirements for their tenure or use.

5. Manufacturers of plant protection products and those who hold the authorisation of such products, as well as distributors, vendors and other operators involved in their marketing, are obliged to:

a) Meet the requirements for registration and control of your establishments and activities.

(b) Provide the competent bodies with the necessary information on the production, placing on the market and use of plant protection products and other aspects related thereto, for statistical purposes and in terms of establish legislation on this matter.

(c) Immediately communicate to the competent authority any new information on the potentially hazardous effects of its products on human or animal health or the environment, as well as on its effects. phytotoxic.

Article 41. Use of plant protection products.

1. Users and those handling plant protection products shall:

(a) Be informed of the indications or warnings contained in the labels and instructions for use or, where appropriate, by appropriate advice, on all aspects relating to custody, appropriate handling and correct use of these products.

(b) Apply good plant health practices, taking into account the indications or warnings referred to in paragraph (a).

c) Meet the training requirements established by the current regulations, depending on the hazard categories or classes of plant protection products.

d) To observe, where appropriate, the principles of integrated struggle that are applicable.

e) Comply with the provisions regarding the disposal of empty containers in accordance with the conditions laid down and, in any case, with those that appear on their labels.

2. Those who provide services for the application of plant protection products, in addition to the general requirements referred to in paragraph 1 of this Article and those laid down in Article 40 (5),

:

a) Dispose of personnel with the levels of training required.

b) Dispose of the appropriate means of application and maintain a regime of periodic reviews of the operation of the same.

(c) In each case, make a contract in which they must contain at least the data of the application to be made and the subsequent conditions which, if appropriate, correspond to the service user.

Article 42. Maximum residue limits.

1. Plants, plant products and their processed products, intended for human or animal nutrition, may not contain, from the time of their first marketing after harvest, or from the disposal of the warehouse in the case of treatment post-harvest, residues of plant protection products at levels exceeding the maximum limits laid down by regulatory standards, following a report from the Joint Commission on Waste of Plant Protection Products.

2. The provisions of the above paragraph shall not apply to plants, plant products and their processed products intended for planting or planting or the manufacture of products not intended for human or animal consumption.

3. The fixing of maximum residue limits shall ensure that they do not pose a risk to the health of consumers. However, without prejudice to the fact that the maximum levels corresponding to safeguard the health of persons may be higher, the maximum residue limits shall be established in accordance with the levels resulting from tests carried out in the the conditions of good plant health practices, in order to ensure that the content of waste is as low as possible. It may also be established by extrapolation of comparable test results, in terms of crop affinity, plant health practices or environmental conditions, particularly in the case of minor uses, as such those whose area of use is restricted to crops, or to small areas of crops, which have little significance in relation to the agricultural area as a whole or whose production does not have a significant share in the diets food.

4. The provisions of paragraph 1 in relation to the ceilings apply to products intended for export to third countries, except that:

(a) The third country of destination requires special treatment to prevent the introduction into its territory of pests, or (b) the treatment is necessary to protect plant products during transport to the third country of destination and storage therein, in accordance with international standards for plant health quarantine or legislation in force in that country.

Article 43. Special system for the authorisation of tests.

The use of plant protection products in field trials, for research and development purposes, will require the corresponding official authorisation after verification that, under the proposed conditions, they cannot be to derive risks for human, animal or environmental health, except where it is to be carried out by authorised entities with a generic character for this activity. These authorisations, as well as the official recognition of the tests and analysis of plant protection products for the purposes referred to in Article 30 (2), shall be subject to a special regime laid down in regulation.

CHAPTER IV

Biological media and other phytosanitary means of defence

Article 44. Biological means.

1. The introduction into the national territory, distribution and release of exotic biological control organisms will require prior authorization from the Ministry of Agriculture, Fisheries and Food, prior to the Ministry of Environment's report on the potential environmental impact and impact on biodiversity, both where the aim is to carry out field trials for research and development, such as release for biological control or use as a plant protection product biological, in accordance with the regulations that are regulated.

2. Breeding or production and the distribution, marketing and release of non-exotic biological control organisms shall require prior communication to the Ministry of Agriculture, Fisheries and Food, in accordance with the rules governing the production and release of non-exotic biological control organisms. set.

3. The authorisations referred to in paragraph 1 and the prior communications referred to in paragraph 2 shall be entered in the Official Register of Plant Health Products and Material.

Article 45. Other means of phytosanitary protection.

1. Plant protection means other than plant protection products and biological control bodies referred to in the preceding Articles, including models or prototypes of the means of application of plant protection products, they must comply with the requirements which they regulate are laid down to ensure their proper conduct under the conditions of good plant health practice and to prevent, by their nature or functioning, risks for the health of humans or animals, the environment or crops or their crops; productions.

2. The marketing of the means referred to in the preceding paragraph shall require prior communication to the competent authority of the Autonomous Community, and shall transfer it to the Ministry of Agriculture, Fisheries and Food for registration in the Official Register of Plant Health Products and Material, unless the prior authorisation requirement applies to them.

Such communications and authorisations shall be carried out in accordance with the rules referred to in the previous paragraph.

TITLE IV

Inspections, Violations and Sanctions

CHAPTER I

Inspection and control

Article 46. Competencies.

It is up to the various public administrations, in the field of their respective competences, to carry out the necessary controls and inspections to ensure compliance with the provisions of this Law.

Article 47. Controls.

1. Official controls shall be established by the competent bodies of public administrations to ensure compliance with the provisions of this Law. Such checks may be systematic at border inspection points and in the premises where plants, plant products and other objects are grown, produced, stored or marketed, and occasional, at any time and place where they circulate or where such products are.

2. Systematic inspections and programmes of surveillance in the manufacture, placing on the market and use of the means of plant health protection, in particular compliance with good plant health practices, as well as surveillance of levels of residues present in plants, plant products and their processed products, and in foods prepared from them, which correspond to the competent bodies of the Autonomous Communities, shall be coordinated by the Administration General of the State, establishing, for that purpose, the national control plans or programmes.

3. As instruments of support for carrying out the checks to be carried out by public administrations, the competent bodies of the public administrations shall designate:

(a) At least one plant protection laboratory in its territory for the diagnosis and identification of pests and biological control organisms.

(b) Official or officially recognised laboratories, which are appropriate for:

1. Conduct the analysis and testing of samples taken in the implementation of the surveillance programmes referred to in paragraph 2 of this Article.

2. Conduct, where appropriate, the tests and analyses referred to in Article 30 (2).

3. To participate in the coordinated programmes of harmonization of the techniques and methods to be used.

(c) Technical inspection centres of the means of application, official or officially recognised, which are appropriate for the periodic reviews referred to in Article 41 (2) (b).

(d) Test centres or stations of the means of application and other elements or equipment, officially or officially recognised, that are appropriate to carry out the necessary tests and trials for the purposes set out in this Law.

4. The Ministry of Agriculture, Fisheries and Food shall have reference laboratories, designated by the previous or other recognised laboratories, with the functions of harmonizing the methods and techniques to be used, national pest prospecting programmes, to issue preceptively report prior to the declaration of existence of a quarantine pest first appeared on the national territory, to carry out the activities related to the compliance the programmes for the implementation of good laboratory practice which fall within their competence, participate in the coordinated programmes and carry out the analyses or tests which, for the purposes of arbitration or for other purposes, are requested.

5. The Ministry of Agriculture, Fisheries and Food shall keep up-to-date, at the disposal of the persons concerned, a list of the official or officially recognised laboratories and the technical inspection centres referred to in paragraph 3, (b) and (c) of this Article. For this purpose, the Autonomous Communities shall send the relevant information of those laboratories and test centres or stations in their respective territorial areas to that Department.

Article 48. Precautionary measures.

The precautionary measures that can be taken will be as follows:

a) Destruction of goods or, where appropriate, burial.

b) Reissuing of goods introduced.

c) Reshipping goods from one zone to another.

(d) Mobilization and, where appropriate, confinement of goods.

e) Precinct or temporary closure of equipment, facilities, premises or establishments.

f) Temporary suspension of authorizations and enrollments in official records.

g) Change or restrictions on the use or destination of the goods, with or without transformation.

h) Disinfection or disinfection.

i) Seizure of documents.

Article 49. Adoption of precautionary measures.

1. The competent bodies and, where appropriate, accredited inspectors may take a reasoned view of the precautionary measures specified in the following cases:

(a) In the case of goods from third countries, the introduction of which is prohibited or in respect of which there is a suspicion of being affected by pests which may be of economic importance or contain residues exceeding the maximum permitted limits referred to in paragraphs (a), (b), (d) and (g), (h) and (i) of the previous Article, giving the person concerned, where possible, the choice of any of these measures.

(b) For other goods, if there is evidence or suspected risk of adverse consequences for crops or their production, for the health of humans or animals or for the environment, or due to authorisation, any of the measures set out in the previous Article, except paragraphs (b) and (f).

(c) In the case of establishments, equipment, installations or premises which do not comply with the requirements laid down at risk for crops or their production, for the health of humans or animals or for the environment, or do not have the right to self-rization, as provided for in paragraphs (e), (h) and (i) of the previous Article.

(d) Where the effectiveness of the measures taken may be diminished by the existence of an official authorisation or registration, the adoption of the measure provided for in paragraph (f) of the Regulation may be proposed to the authority concerned. Previous article.

2. Where the precautionary measures are taken by the inspectors, they shall be notified immediately to the competent body for the initiation of the sanctioning procedure, which shall proceed within 15 days, by means of a reasoned decision, to ratify, amend or lift them and, where appropriate, supplement them with other than those laid down in the previous Article which it considers appropriate.

3. The precautionary measures shall be adjusted in intensity, proportionality and technical requirements to the objectives which are intended to be ensured in each specific case, and their duration shall not exceed that of the risk situation or lack of authorisation which has been given to them. motivated.

Article 50. Powers of the inspectors.

Staff at the service of public administrations carrying out the inspection duties provided for in this Law shall have the status of authority and may:

a) Access any place, installation, or dependency, of public or private ownership. In the case of direct addresses, the consent of the holder or the judicial decision shall be required.

b) Get the minimum samples required for further examination or analysis in specialized centers.

c) Require the information and presentation of evidence documents that are regulated.

d) Adopt the precautionary measures of Article 48.

Article 51. Inspection report.

1. The inspector shall draw up the record of the data relating to the undertaking inspected, the person to whom the inspection is carried out, the measures which he has ordered and all the relevant facts of the inspection, in particular those which may be impact on an eventual sanctioning procedure.

2. The inspection report shall have a probative value of the facts contained therein, without prejudice to any other means admitted to law which may be provided.

3. The minutes shall be forwarded to the body responsible for initiating the sanctioning procedure.

Article 52. Obligations of persons inspected.

The natural or legal persons to whom an inspection is practiced shall be obliged to:

a) Provide all kinds of information about facilities, products, or services, allowing for verification by the inspectors.

b) Facilitate copying or reproduction of the documentation.

c) Allow the timely testing or taking of free samples of the goods or goods in the strictly necessary quantities.

d) And, in general, consent to the conduct of the inspection.

CHAPTER II

Violations

Article 53. Rating of infringements.

The violations contained in this chapter are classified as mild, severe, and very serious.

Article 54. Minor infractions.

The following administrative violations will be considered minor:

(a) The exercise of production, marketing or service activities, subject to the requirement of official authorisation, after the expiry of the requirement without having requested in time and form its update or renewal, provided that such non-compliance is not typified as a serious or very serious fault.

(b) Failure to comply with the requirements laid down for manufacture or production and placing on the market, including storage, packaging and labelling, of plants, plant products and plant protection means, that the non-compliance is not typified as a serious or very serious fault.

(c) The production, packaging or placing on the market of plants, plant products or their processed products, the residue content of which exceeds the maximum limits laid down, provided that their levels are not significant toxicology.

(d) Failure to comply with the requirements set out in respect of books, invoices, accompanying documents and other required documents, provided that such non-compliance is not classified as serious or very serious.

e) The neglect of plant health care, forest and natural mass.

(f) The use and handling of plant health protection means without observing the conditions of use or other requirements required where this does not endanger human health, animal health or the environment.

g) Failure to comply with the obligation to communicate to the competent public administration the occurrence of organisms harmful to plants or disease symptoms for plants and their products, where they are not known in the zone, provided that such non-compliance is not typified as serious.

h) Hinder the inspection by any action or omission that disturbs or delays the same.

i) Failure to comply with the requirements regarding the qualification or qualification of personnel, where this is established for the production, marketing and management or use of the phytosanitary means of defence, that such non-compliance is not typified as serious.

Article 55. Serious infringements.

Serious violations will be considered:

(a) The exercise of production, manufacturing and placing on the market of plant protection products without the corresponding administrative authorisation.

(b) The provision of false or inaccurate documents or data, in such a way as to induce public administrations to grant authorisations for plant health protection activities, establishments or means of defence without meeting the requirements or conditions set for this.

(c) The manufacture and placing on the market of plant protection means of which nature, composition or quality, or of their packaging, differ significantly from the conditions of their authorisation.

d) The placing on the market of plant protection means of defence with a labelling, or information or publicity which could mislead the user about the uses and conditions for which they were authorised, on the requirements for the disposal of packaging or not to identify the person responsible for placing them on the market.

(e) The placing on the market of plant protection products in packaging that produce leaks or breakages, significant loss of labelling or mandatory information, closures or broken seals or which have been transferred.

(f) The production, packaging or placing on the market of plants, plant products or their processed products containing residues of plant protection products at levels exceeding the maximum limits established and their excess significance at the toxicological level.

g) Do not have the necessary documentation to verify the existence or not of serious or very serious infractions, or to carry it in a way that prevents the verification from being carried out.

h) Failure to comply with the requirement of public administrations to report on the plant health status of crops or to provide false information.

i) the handling or use of unauthorised plant health protection means, or of the authorised means of defence without respecting the requirements laid down for this purpose, including in their case those relating to the management of packaging, where this is necessary; represents a risk to human health, animal health or the environment.

j) Failure to comply with the requirements for the qualification or qualification of personnel, where this is established for the production, placing on the market and the handling or use of the phytosanitary means of defence, represents a risk to human or animal health or the environment.

k) Failure to communicate to the competent public administration the occurrence of a quarantine pest.

l) Prevent the action of duly accredited inspectors.

m) Failure to comply with plant health measures to combat a pest, or to prevent or hinder its compliance.

n) The introduction, circulation, possession and handling of plant products, organisms and related material in the national territory of plants, plants, organisms and related material, or without prior authorisation when required.

or) The introduction into national territory of plants, plant products, organisms and related material through points of entry other than those authorised.

p) Break the precautionary measures in place, provided that such violation is not typified as very serious.

q) The obtaining of grants, and, in general, any type of aid provided for in this Law, based on false data, as well as to target them for purposes other than those provided for.

r) Not to declare the presence, in a shipment in foreign trade or transit within the national territory, of those plants, plant products and related material that must be inspected compulsorily, as well as indicate, hide or distort the true origin of the same.

Article 56. Very serious infringements.

The following violations will be considered very serious:

(a) The concealment to the Administration of information regarding the danger of plant protection products by those who manufacture or market them.

(b) The manufacture or placing on the market of unauthorised plant protection products or with labelling, information or advertising which hides their danger.

c) Failure to comply with the measures laid down by the competent authority to combat pests of an extraordinarily serious nature, or to mitigate its effects.

d) To break the precautionary measures by putting the immobilized goods or goods into circulation.

e) the handling and use or use of unauthorised plant health protection means, or of the authorised non-compliance with the requirements laid down for that purpose, including, where appropriate, those relating to the disposal of packaging, where this poses a very serious risk to human health, animal health or the environment.

Article 57. Liability for violations.

1. Natural or legal persons who commit them, even in the form of simple negligence, are responsible for the acts constituting the offences established in this Law.

2. However, where the object of the infringement is a product or other commodity, it shall be presumed responsible:

(a) For infringements in packaged and duly sealed products, the natural or legal person whose name or social reason is on the label, unless proof of falsification or miskeeping by the holder is proven, the storage conditions are known or specified in the packaging.

(b) For infringements in bulk products or without the seals of origin, the holder of the goods shall, except where the holder is able to prove the responsibility of a previous holder.

(c) In any event, if the alleged responsible proves that the infringement has occurred because of erroneous information, or for lack of information that is regulated, and that the person responsible for such information is identified information, the infringement shall be imputed to the latter.

3. The administrative responsibility for the offences referred to in this Law shall be independent of civil, criminal or other liability which, where appropriate, may be required, in the terms laid down in the legal order.

CHAPTER III

Sanctions

Article 58. Types of penalties.

1. The offences provided for in this Law shall be punishable by fines falling within the following limits:

a) Minor infractions, from 300 to 3,000 euros.

b) Serious infractions, from 3,001 to 120,000 euros.

c) Very serious infractions, from 120.001 to 3,000,000 euros.

2. The Government is authorised to update the amount of the above penalties in accordance with the National Statistics Institute's consumer price indices.

3. In any event, the upper limit of the penalties provided for in this Article may be exceeded up to the amount of the benefit obtained by the infringer when this benefit exceeds that limit.

Article 59. Graduation of the penalty.

1. The penalty will be graduated according to the following criteria: the recidivism, the intentionality of the offender, the failure to comply with previous warnings, the damage and the damages caused, the profits obtained and the social change that could be occur.

2. Where infringements endanger human health, animal health or the environment, the penalties shall be increased by 50 per 100.

3. Where a single event is a constituent of two or more infringements, it shall be punished only for the most serious offence.

Article 60. Ancillary sanctions.

1. The competent body may, as a by-product, agree to the confiscation of the goods which may pose a serious risk to plant or animal health or to the environment, or to any type of risk to human health.

Such goods must be destroyed if their use or consumption constitutes a danger to public health. In other cases, the final destination of the goods shall be determined.

The expenses incurred by the operations of intervention, deposit, confiscation, transport and destruction shall be on behalf of the infringer.

In the event that the seizure is not possible, it may be replaced by the payment of the amount of its value by the infringer.

2. In the case of offences committed by persons who carry out an activity subject to administrative authorisation or communication, the competent body may agree as a sanction to the cessation or interruption of the production activity, the marketing or services of the infringer or, where appropriate, propose to the competent authority the review, declaration of extinction, suspension, withdrawal or non-renewal of the relevant records or administrative authorisations.

3. In the case of serious infringements, the temporary closure of the undertaking, holding or premises may be agreed for a maximum period of five years, and additional measures may be taken for the full effectiveness of the decision. adopted.

4. In the case of an infringement provided for in Article 55.q), it is established as an ancillary sanction to be disallowed for grants or public aid for a maximum period of five years.

Article 61. Advertisement of the sanctions.

Whenever any of the circumstances of public health risk, recidivism in offences of a similar nature or an intentional infringement of the offence, the body that resolves the file may agree to the publication of the penalties imposed as a result of the provisions of this Law when they have become firm.

Article 62. Sanctioning powers.

Where the competence is from the General Administration of the State, the initiation of the file shall be carried out by the Directorate-General responsible for plant health and the resolution shall be the responsibility of the Director-General for the minor offences, to the Secretary-General of Agriculture for the serious and to the Minister for Agriculture, Fisheries and Food for the very serious up to the maximum amount of EUR 600 000, with the Government being responsible for the imposition of the higher than the quantity.

The authority initiating the sanctioning procedure may agree on the grounds for the adoption of the precautionary measures deemed necessary to ensure the effectiveness of the resolution that may be placed on it.

CHAPTER IV

Execution media and other metrics

Article 63. Periodic penalty payments.

1. Where the person concerned does not carry out the obligations laid down in this Law or the competent authority decides to apply the measures provided for in Article 18 or the adoption of the precautionary measures provided for in Article 48, he may require the parties concerned to ensure that they are in sufficient time to comply with them, with a warning that, if not, a periodic penalty payment will be imposed, indicating the amount of the penalty in each case and up to a maximum of EUR 3 000, without prejudice to the applicable penalties, where appropriate.

2. The competent authority may, in the event of non-compliance, carry out successive requirements, increasing the periodic penalty payment by 20 per 100 of the one agreed in the previous requirement.

3. The time limits granted must be sufficient to enable the measure concerned to be carried out and to avoid any damage that may arise from failure to implement the measure in due time.

4. Irrespective of the nature of the penalty, the sanctioning body may agree to the imposition of periodic penalty payments in accordance with Article 99 of Law No 30/1992 of 26 November 1992 on the legal system of Public administrations and the Common Administrative Procedure, after the deadlines set out in the relevant requirement have elapsed. The amount of each of those fines shall not exceed 20 per 100 of the fine fixed for the corresponding infringement.

Article 64. Subsidiary execution.

In the event that those affected do not execute in due time and form the measures or obligations to which they are required under this Law, or when the Administration deems it necessary to act immediately, the authority The competent authority shall carry out the duties of the competent authority of the Member State in which the competent authority is responsible for the application of this

.

Article 65. Other measures.

The competent authority may apply the following measures, which shall not be sanctioning:

(a) The closure or closure of undertakings, facilities, holdings, premises or means of transport, which do not have the necessary authorisations or registers, or the suspension of their operation until such time as they are rectified; defects or the requirements for your authorisation are met.

(b) The drawback of the aid or grants unduly paid.

TITLE V

Phytosanitary rates

Article 66. Legal regime.

The fees set out in this Title shall be governed by this Law and by the other regulatory sources as set out in Article 9 of Law 8/1989, of 13 April, of Public Fees and Prices.

Article 67. Taxable fact and amounts.

The taxable fact and the amount of the fees shall, in each case, be as set out in

following paragraphs:

1. (a) By the plant health inspection referred to in Article 12.1 for the export of plants, plant products and related objects to third countries where the phytosanitary certificate is not required:

Three EUR per tonne, with a minimum of EUR 30 for each phytosanitary certificate.

(b) For each issue of copy of the phytosanitary certificate or due diligence: without consultation of the dossier, EUR 10, and with reference to the dossier, EUR 20.

(c) By official pre-export tests and controls as provided for in Article 12.2. Processing requests and performing the first control:

1. Arboreal or bushland crops: 150 euros/hecta/variety.

2. Non-arboreal crops in the open air: 75 euros/hecta/variety.

3. Forced crops: 100 euros/hecta/variety.

4. Forced crop facilities: 100 euros/hectare.

(d) By pre-export official tests and controls as provided for in Article 12.2. Carrying out the necessary set of tests and controls, other than those set out in paragraph (c):

1. Arboreal or bushland crops: 100 euros/hecta/variety.

2. Non-arboreal crops in the open air: 100 euros/hecta/variety.

3. Forced crops: 300 euros/hecta/variety.

4. Forced crop facilities: 100 euros/hectare.

2. For the processing of applications relating to active substances:

a) Inclusion in the Community list: EUR 2,400.

b) Equal to others included in the Community list:

1,080 euros.

c) Modification of community specifications:

900 euros.

d) National authorisation: EUR 1,440.

e) Equal to others with national authorization:

960 euros.

f) Modification of national specifications: 480 euros.

g) Setting maximum residue limits:

540 euros.

3. For the processing of applications for the first authorisation of plant protection products subject to harmonised Community legislation:

a) Provisional authorisation: EUR 3,300.

b) New preparations: EUR 1,800.

c) Authorization recognition: 1,200 euros.

d) Comparable to other authorised: EUR 1,200.

e) Generics equal to other authorized:

720 euros.

f) Exceptional entitlements: 1,200 euros.

4. For the processing of applications for the first authorisation or registration of plant health protection means subject to the requirements of national legislation:

a) New preparations: EUR 1,500.

b) Assimilated to other authorized preparations:

900 euros.

c) Generics equal to other authorized:

600 euros.

d) Exotic biological control bodies:

600 euros.

e) Other means that require authorization:

600 euros.

f) Other means that require communication:

180 euros.

5. For the processing of applications for the modification of authorisations for plant protection products subject to harmonised Community legislation:

a) Extension to new uses: 720 euros.

b) Extension to secondary uses in crops or applications already authorised: EUR 240.

c) Extension to minor uses: EUR 300; with public interest: EUR 120.

d) Conditions of use: EUR 300.

e) Content in active substances: EUR 480.

f) Content or replacement of co-formulants:

360 euros.

g) Other types of modifications: 240 euros.

6. For the processing of requests for modification of authorisations of plant health protection means subject to the requirements of national legislation:

a) New uses of preparations: EUR 480.

b) Secondary preparations: 180 euros.

c) Lower preparations: 240 euros; with public interest: 120 euros.

d) Conditions for use of preparations:

180 euros.

e) Content in active substances: EUR 240.

f) Content or replacement of co-formulants:

180 euros.

g) Other modifications relating to plant protection means: 180 euro.

7. For the processing of applications for authorisation to carry out tests with plant protection means:

a) For a single trial or test plan:

180 euros.

b) For one or more types of generic tests:

600 euros; officially recognized: 900 euros; with good laboratory practice: 900 euros.

c) Authorization conditioning modification: 120 euros.

8. For the processing of requests for modification of the name of the holder or the manufacturer of plant protection means:

a) By name or social naming change:

120 euros.

(b) By transfer between two parts of the rights of a phytosanitary means of defence: EUR 180; by transfer of two or more means of plant health protection: EUR 300.

(c) By transfer between more than two parts of the rights of a phytosanitary protection means: EUR 300; by transfer of two or more means of plant health protection: EUR 480.

9. For the processing of applications for renewal and provisional extension of authorizations, registrations and communications, as referred to in the preceding paragraphs, in cases where they do not require other acts specifically typified as a fact taxable:

(a) For plant protection products: EUR 480.

b) For testing: 360 euros.

c) Other Phytosanitary Means of Defense:

180 euros.

d) Provisional extensions of authorisation:

120 euros.

10. For the issue of certificates or simple notes on authorisations, labelling texts and other supporting documents or information of facts or actions on which there is evidence of registration of defence means Phytosanitary:

(a) Official recognition certificates or good laboratory practice in testing with plant protection means: 180 euro.

(b) Certifications or labelling texts relating to an authorisation or registration: EUR 90.

(c) Certifications relating to authorisations granted to a holder: EUR 120.

d) Other certifications that require two or more files to be consulted: 180 euros.

e) Simple notes regarding an authorization or registration: 30 euros.

(f) Simple notes relating to authorisations granted to a holder: EUR 60.

g) Other simple notes that require you to consult two or more files: 90 euros.

11. For the regulatory inspection, including the lifting of the corresponding report and drafting of the report:

a) Requirements compliance: 180 euros.

b) Compliance with requirements and procedures:

240 euros.

Article 68. Taxable persons in charge.

Any natural or legal persons to whom, personally or in their property, the public services or activities that constitute the event, shall be subject to the duties set out in this Title. taxable.

Article 69. Accrual, payment and management.

1. The fees shall be payable when the application initiating the action or the file is submitted. Payment of fees shall be a necessary condition for the commencement of administrative action, except for renewals of authorisation requiring the performance of other acts which are classified as taxable events, in which case the applicant shall initially make the payment of the fee for the renewal and subsequently the payment of the other fee, where the additional act that proceeds is notified to it.

2. The payment shall be made in cash, the amount of which is entered into the deposit institution authorized by the Ministry of Finance.

3. The Ministry of Agriculture, Fisheries and Food is responsible for the management and collection of the fees of the previous article, without prejudice to the powers that, if any, correspond to the Ministry of Public Administration.

4. The fees shall be subject to self-settlement by the taxable person.

Single additional disposition. Records.

The Official Register of Plant Protection Products and Material and the National Register of Plants and Vegetable Producers referred to in this Law will be taken into account with the personal and material resources available in the the General Administration of the State, without any increase in public expenditure.

First transient disposition. Import and release of exotic biological control agents.

As long as no rules are laid down for the import, distribution and liberalisation of exotic biological control organisms, the Ministry of Agriculture, Fisheries and Food shall exercise its functions, taking into account the principles set out in the Code of Conduct for the Import and Release of Exotic Agents of Biological Control of the World Food and Agriculture Organization (FAO).

Second transient disposition. Procedure for inspections and penalties.

Until specific procedures for inspections and sanctions are established, the provisions of Royal Decree 1945/1983 of 22 June 1983 on the protection of defence offences and penalties shall apply. of the consumer and of agri-food production, except as otherwise provided for by Law No 30/1992 of 26 November 1992 on the Legal Regime of Public Administrations and the Common Administrative Procedure, without prejudice to the powers of the Autonomous Communities.

Transitional provision third. Regulatory standards for plant health.

1. As long as the provisions of this Law do not dictate new provisions on the respective matters, all those who declare the fight against certain pests are in force; those governing the importation, export, transit and internal movement of plants and plant products; those governing the manufacture, sale and use of plant protection products and material, and those fixing the maximum tolerances or limits for the presence of residues of plant protection products in plants and plant products.

2. In particular, the following provisions remain in force:

Articles 1 to 4 of the Decree of 19 September 1942 on the manufacture and trade of plant protection products and their implementing rules.

Royal Decree 3349/1983, of 30 November, approving the technical-sanitary regulations for the manufacture, marketing and use of pesticides, and their development regulations.

Royal Decree 2071/1993 of 26 November 1993 on protective measures against the introduction and dissemination in the national territory and the European Economic Community of organisms harmful to plants or products plants, as well as for export and transit to third countries, and their development regulations.

Royal Decree 280/1994 of 18 February laying down maximum residue limits for pesticides and their control on certain products of plant origin and their development regulations.

Royal Decree 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 their implementing rules.

Royal Decree 401/1996 of 1 March 1996 laying down the conditions for the introduction into the national territory of certain noci vos organisms, plants, plant products and other objects for testing purposes, scientists and for variety selection activity, and their development regulations.

Royal Decree 1190/1998 of 12 June, governing the national programmes for the eradication or control of organisms harmful to plants not yet established in the national territory, and their development regulations.

Royal Decree 1201/1999, of 9 July, establishing the national program for the eradication and control of bacterial fire of the rosaceas, and its development regulations.

Royal Decree 1644/1999 of 22 October 1999 on the control of the harmful organism called 'Ralstonia solanacearum (Smith) Yabuuchi et al' and its implementing legislation.

Order of 5 May 1971 on the terminology and characteristics of azufres for plant protection purposes.

Order of 31 January 1973 on supplementary classification of plant protection products as regards their danger to the annual wildlife life (as amended by Order of 9 December 1975).

Order of 8 October 1973 regulating the use of hormonal herbicides.

Order of 12 August 1976 for the classification of agrochemical products for the purposes of registration.

Order of 7 October 1976 on protective treatments for wood.

Order of 26 May 1979 on the use of plant protection products.

Order of 28 February 1986 prohibiting the placing on the market and use of plant protection products containing certain active substances.

Order of 28 February 1986 on the prevention and control of the potato cyst nematode, in application of Directive 69 /465/EEC of the Council of the European Communities.

order of 28 February 1986 on the fight against the greening of potatoes, in application of Directive 69 /464/EEC of the Council of the European Communities.

Order of 12 March 1987 establishing for the Canary Islands plant health rules concerning the import, export and transit of plants and plant products.

Order of 17 November 1989 establishing a programme for the promotion of the integrated fight against the pests of different crops through clusters for integrated treatment in agriculture (ATRIAS).

Order of 17 May 1993 establishing the standardisation of plant passports intended for the circulation of certain plants, plant products and other objects within the Community, and for which it is establish the procedures for the issue of such passports and the conditions and procedures for their replacement.

Order of 17 May 1993 laying down the obligations to which producers, traders and importers of plants, plant products and other objects are subject, as well as the detailed rules for their registration in an official register.

Order of 4 August 1993 laying down the requirements for applications for authorisations for plant protection products.

Order of 31 January 1994 laying down the detailed rules for the studies to be carried out in the framework of the recognition by the European Union of protected areas in Spain, which are exposed to specific plant health risks.

Order of 15 February 1994 laying down rules for the movement of certain plants, plant products and other objects by a protected zone and for the movement of such plants, plant products and products other objects from such a protected zone within the same.

Order of 22 March 1994 on the fight against bacterial necrosis of potatoes, in application of Directive 93 /85/EEC of the Council of the European Communities.

Order of 16 December 1994 laying down provisional phytosanitary measures for the control of the minator of the citrus fruit sprouts "Phyllocnistis citrella Stainton" in the field of Spanish territory.

Order of 1 March 1995 laying down the procedure for the notification of the interception of consignments or bodies from third countries which present an imminent danger of plant health.

Order of 29 November 1995 laying down uniform principles for the assessment and authorisation of products.

Order of 11 December 1995 laying down provisions concerning the authorisations of tests and experiences with plant protection products.

Order of 28 March 1996 laying down rules for the assessment of active substances of plant protection products for inclusion in the Community list in Annex I to Directive 91 /414/EEC.

Order of 20 February 1997 regulating the authorisation and development of plant health inspections to be carried out in the packaging warehouses for the export and re-export to third countries of plants and plant products.

Order of 31 March 1997 laying down the prohibition on imports of fresh fruit from kiwis "Actinidia chinensis" originating in New Zealand in the Canary Islands.

Order of 12 November 1997 establishing aid for the consolidation of citrus fruit plantations affected by the virus of sadness.

Order of 14 April 1999 establishing Annex I to Royal Decree 2163/1994.

Order of 28 February 2000 laying down provisional measures for the protection of the ferruginous curculionide of palm trees ["Rhynchophorus ferrugineus" ("Olivier") ].

Unique degoratory disposition. Regulatory repeal.

The provisions of this Law and, expressly, the following provisions shall be repealed:

The Law of May 21, 1908, of Field Pest and Defense against the Same.

Articles 6 and 9 of the Royal Decree-Law of 20 June 1924 on the reorganization of agricultural services.

The Law of December 20, 1952, of Defense of the Mountains against Forest Pests.

Chapter II of Title IV of the Law of Mountains, of 8 June 1957.

Decree 496/1960 of 17 March, for which fees for technical and optional management of agronomic services are validated.

Royal Decree 699/1995, of 28 April, for the updating of the fees relating to the registration of plant protection products and material, issuing of certifications and granting of authorizations.

Final disposition first. Basic character.

The provisions of this Law have the character of basic regulations, in accordance with the provisions of Article 149.1.13.a, 16. and 23. of the Constitution, which attributes to the State exclusive competence on the basis and coordination of the general planning of economic activity, general bases and coordination of health and basic legislation on environmental protection, respectively. The regulation contained in Articles 10, 11 and 12 of this Law, which are dictated by the provisions of Article 149.1.10. and 16.a, first indent, of the Constitution, which attributes the State to the State, is exceptioned from this basic regulation. exclusive competence in the field of external trade and external health, respectively.

Final disposition second. Faculty of development.

The Government shall, in the field of its powers, approve the rules for the application and development of this Law.

Therefore, I command all Spaniards, individuals and authorities, to keep and keep this Law.

Madrid, 20 November 2002.

JOHN CARLOS R.

The President of the Government,

JOSÉ MARÍA AZNAR LÓPEZ