Law 43 / 2002, De 20 De November, Of Health Vegetable.

Original Language Title: Ley 43/2002, de 20 de noviembre, de sanidad vegetal.

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JUAN CARLOS I King of Spain to all that the present join together and act.

Know: That the Cortes Generales have approved and I come in to sanction the following law.

EXHIBITION of reasons I one of them purposes basic of it political national of health vegetable is the existence of a frame legal appropriate for protect to them vegetable and their products against them damage produced by them pest, to keep them, through the intervention human, in levels of population economically acceptable, and for prevent the introduction and extension of those from of others areas geographical.

The current legislation on health vegetable, that has its origin in it law of pest of the field, of 21 of mayo of 1908, and in the law of 20 of December of 1952, of Defense of them mountains against them pest forest, is based mainly in the normative community built-in to it legislation Spanish through them corresponding provisions legal.

II the approval of a new frame legal for it health vegetable is based in the double need of adapt it to them numerous changes that have affected to its field of application, as well as adapt it to the configuration of the State Spanish as State autonomic and as State member of the Union European.

Indeed, it is necessary to regulate in a suitable range standard the basic principles of action of the different competent public administrations in the field of plant health and establish specific aspects that refer to the exclusive powers of the General Administration of the State relating to trade and foreign health.

This regulation reflects the fundamental aspects of legislation issued by the European Union in this field, which have already been subject to development in our domestic law through various provisions of a general nature, which will remain in force after the entry into force of the law.

Accordingly, the purpose of the law is to establish a uniform framework that gives legal cover to the set of existing rules in the field of plant health, in accordance with the current distribution of powers between the State and the autonomous communities derived from block of constitutionality, and the commitments entered into by Spain as a Member State of the European Union and as a result of the signing of international agreements.

III from another point of view, there is the evolution of criteria that has occurred in the society regarding the food safety, occupational health and environmental protection. Therefore, the law should consider aspects relating to the means used to combat pests, particularly plant protection products, to ensure that there are no harmful effects for the health of the consumer or the applicator, for animals or for the environment in its handling and application.

In this sense, the corresponding official means of phytosanitary defense authorizations are the instrument of such security, which should not be reduced to the field of plant health, but should transcend the public health and the environment.

The complexity of the procedure of granting of authorizations and the dynamics of enlargement to new uses, with the corresponding management for the establishment of maximum residue limits for the EU or even global scope, determines the need for a single authority in the granting of authorisations, as established in Community legislation.

However, these guarantees have been reinforced following the recent creation of the Spanish food safety agency by law 11/2001, of 5 July, by incorporating a new instrument to ensure the safety of food that will necessarily be taken present in provisions that are handed down in development 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 manufacture and application of plant protection products, must be met forecasts General of law 31/1995, of 8 November, de Prevención de riesgos laborales.

IV the present law articulates them criteria and them actions applicable in matter of health vegetable, in general, and of prevention and fight against pests, in particular, both of the State as of them communities autonomous.

Therefore seeks to establish basic homogeneous criteria to address problems of occurrence of pests in a given territory and enable the rapid adoption of control measures. Also, clarified the requirements for the adoption of the official measures against a scourge for its eradication, prevent its spread, reduce their populations or their effects.

On the other hand, regulates the possibility of that the competent administration qualify his mandatory fight as "public utility" or "phytosanitary emergency" plague, which will lead to a higher degree of severity and intervention of the official measures, as well as the application of different financial compensation in the form of aid and compensation to those affected by the application of the same.

In the scope of the obligations of the individuals, responsible for farmers in the surveillance and control of pests, crops and materials object of its activity, as well as the execution in charge of compulsory official measures established by law. With respect to exports to third countries, corresponds to the particular request required inspections for the issuance of the appropriate phytosanitary certificate at border inspection points and on it the responsibility in the case of export without the mandatory documentation. In addition, the duties and responsibilities of producers, holders of authorizations, distributors, vendors and other operators of plant protection products and the responsibility of the users of these products employ them are determined following the recommendations of use. Finally, set the obligations of natural and legal persons who practice an official inspection.

Before the increase in recent years for the importation and release of biological control organisms, in the absence of a Community regulation sets the legal basis that allows a regulatory development which defined the responsibilities of affected administrations and individuals involved in this activity, and to ensure its effective and safe, use reducing to a minimum the risks to human health and the environment.

In the same direction to prevent these risks, the growing demand of consumers promoting crop production systems that take into account the good plant protection practice and to combat pests in common is collected, groupings of farmers that include foster among their targets such practices.

You are expected, also, that the different public administrations, in the field of their respective competencies, carried out the inspections necessary to ensure compliance with the present law and gives the character of authority plant health inspectors, determining their competence.

Finally, establishing a system of offences and sanctions in the matter subject to this Act, classifying the first according to their severity, determining the responsibilities of violators and setting up appropriate sanctions. Also creates a regime of fees, taxable persons, taxable relationship and the amounts of the respective rates.

The present law is dictates to the amparo of the article 149.1.10. to, 13.a, 16th and 23.ª of the Constitution, that book to the State the competition exclusive in matter of trade foreign, of bases and coordination of it planning general of it activity economic, bases and coordination general of the health and health outside, and legislation basic on protection of the environment respectively.

Title I General provisions article 1. Object and purpose.

1. the present law aims to establish the basic rules and coordination in the field of plant health standards.

2 are for purposes of this law: a) protecting plants and plant products from damage caused by pests.

(b) protect the national territory and that of the European Union, in accordance with the community phytosanitary regulations, in the introduction of pests of quarantine for plants and plant products or other objects, and prevent the spread of existing ones.

(c) to protect the animals, plants and microorganisms that cancelling or limiting the activity of organisms harmful to plants and plant products.

(d) preventing risks that may arise from the use of plant protection products for the health of people and animals and against the environment.

(e) ensure that phytosanitary defence means eligible due of utility, efficiency and security.

Article 2. Definitions.

For the purposes of this law means: to) marketing: any delivery, for payment or free, including the Act of importation and excluded export.

(b) plant: living plants and living parts thereof, including fresh fruit and seeds.

(c) vegetable products: products of plant origin, unprocessed or that they have been subjected to simple preparation.

(d) other items: materials or products, other than products plant, likely to be affected by harmful organisms or serve as a vehicle to them.


(e) plague: harmful organism of any species, race or biotype of plant or animal or pathogenic agent harmful to plants or plant products.

(f) pest of quarantine: the plague that may have potential economic importance, included in the Community list and has thus been qualified by the Ministry of agriculture, fisheries and food.

(g) a pest control: application of phytosanitary measures to prevent the spread of a plague, reducing its population or its effects, or to achieve its eradication.

(h) official statement of existence of a plague: official recognition of the presence of a pest, defining the causal organism, the affected area and phytosanitary measures to adopt.

(i) establishment of a pest: perpetuation of a plague for the foreseeable future, within an area after entry.

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

((k) biological control organism: natural enemy, antagonist or competitor or other biotic entity able to reproduce, used for the control of pests, with the exception of micro-organisms and viruses, referred to in paragraph n).

(l) exotic biological control organism: organism biological control that does not exist in all or part of the national territory.

(m) means of phytosanitary defense: products, bodies, equipment, machinery application, available devices and elements aimed at controlling harmful organisms, prevent its effects or impact on the vital process of plant nutrients differently.

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

(or) products plant protection: them substances active and them prepared that contain an or more substances active presented in it form in that is offer for its distribution to them users, destined to protect them vegetable or products vegetable against them pest or avoid the action of these, improve the conservation of them products vegetable, destroy them vegetable undesirable or parts of vegetable , or influence in the process vital of them same of form different to as acting them nutrients.

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

(q) limit maximum of waste (LMR): concentration maximum of waste of a product plant protection allowed legally in the surface or the part internal of products destined to the power human or animal.

(r) fight integrated: it application rational of a combination of measures biological, biotechnological, chemical, of cultivation or of selection of vegetable, so it use of products plant protection is limit to the minimum necessary for the control of the pest.

(s) good practices phytosanitary: use of them products plant protection and others media of Defense plant under the conditions of use authorized.

(t) competent authority: the bodies of the autonomous communities, the Ministry of agriculture, fishing and food and the Ministry of health and consumption, in the field of their respective competencies, without prejudice to the functions that could correspond to other departments of the General Administration of the State and the Spanish Agency for food safety.

(u) qualified technician: qualified for the development of activities in different matters referred to in this law, which, in addition to meeting the requirements established by law for professional practice, shall be in possession of enabling university degree, which will be determined by the legal regulations for each profession, in accordance with their respective specialties and specific competences.

Article 3. Scope of application.

The scope of this Act includes: to) plants, are cultivated or spontaneous, and plant products.

(b) soil and Lands, peat, mulch, manure and other materials, facilities and media that would serve or intended for cultivation, production, handling, processing, conservation, marketing or dumping of vegetables and their products.

(c) plant protection products and other means of plant defense, as well as the facilities and resources intended for their production, distribution, marketing and implementation.

(d) the animals, plants and microorganisms existing in the natural environment, which annul or limit pests.

(e) the activities of persons and public and private entities, insofar as they are related to the objectives and purposes specified in article 1.

Article 4. Duty of information.

Public authorities shall act in accordance with the principle of institutional loyalty, providing public administrations the information requiring activity that they developed in the exercise of its own powers, in particular as regards the incidence and intensity of pest of quarantine and other detected in its territorial area having special emphasis , as well as of the measures phytosanitary adopted.

Title II prevention and fight against pests chapter I prevention article 5. Obligations of individuals.

Farmers, foresters, traders, importers and professionals engaged in activities related to the phytosanitary defence must: to) watch their crops, plantations and crops, plants and plant products, as well as forests, the natural environment and related materials trade.

(b) provide all sorts of information on the phytosanitary status of plantations, plants or plant products, when required by the competent bodies.

(c) notify the competent body of the autonomous community or, in the case of importers, the Ministry of agriculture, fisheries and food all atypical occurrence of harmful organisms or symptoms of disease to plants and plant products.

Article 6. Registers of producers and traders of vegetables.

1. the natural or legal persons that produce or market vegetables and vegetable products which are potential spreaders of quarantine pests must be registered in the corresponding register. The relationship of plants and plant products is reference, as well as the basic requirements for registration, shall be established by law.

2. will create a national registry of producers and traders of vegetables, whose role will be purely informative, that will collect the information that must send you the appropriate official records of the autonomous communities.

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

1. for the purposes of preventing the risks presenting the possible introduction or spread of pests of quarantine in the country and the movement of certain plants, plant products and other objects likely to be carriers of the same, in accordance with Community rules and, where appropriate, those established by regulation, the introduction and circulation of harmful organisms (, plants, plant products and other objects shall be subject to the conditions and prohibitions which, in each case, focus on the following relationships: to) pests of quarantine, whose introduction and propagation is prohibited in the national territory or in the free zones which are determined. Those unrelated organisms that have been qualified as quarantine pests by the Ministry of agriculture, fisheries and food after having appeared for the first time in the national territory, after consultation with the Ministry of environment in the case of forest species will have the same treatment.

(b) plants, plant products and other objects the introduction of which is prohibited in the national territory or parts of it to be laid down, where they are originating 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 whose introduction or movement in the national territory or parts thereof to be determined require compliance with specific phytosanitary conditions.

(d) plants, plant products and other objects, matter what its origin, for whose circulation is required phytosanitary document, issued under conditions to be determined by regulation.

2. the Ministry of agriculture, fisheries and food may establish exceptions to the provisions of paragraph 1, provided that they do not involve a risk of spread of quarantine pests.

Article 8. Pest-free areas.

When in a part of the national territory or in its entirety, and with respect to one or more pests of quarantine, 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 Declaration of this area to be free from these pests. Requirements that will meet the plants and plant products and other objects for his introduction and circulation through the free zone shall be determined in the Declaration.


In the case of pests affecting forest species report from the Ministry of environment shall be sought.

Article 9. Phytosanitary measures of safeguard.

1. the Ministry of agriculture, fisheries and food, when it considers that the entry of certain plants and plant products and other objects in the national territory or in part of it from third countries represents an imminent danger of introduction or spread of pests which may have potential economic importance or significant environmental impact, will immediately adopt measures necessary to protect endangered areas prior consultation with the Ministry of environment in the case of forest species.

2 where the vegetables come from a Member State of the European Union, the Ministry of agriculture, fisheries and food asked previously to the Commission the adoption of the necessary measures that should be taken. In case of not being adopted by, heard the autonomous communities affected, you can set them provisionally until the Commission determines appropriate measures.

3. the Ministry of agriculture, fisheries and food informed the European Commission and to the other States members of the measures he is taking or will take in accordance with paragraphs 1 and 2 of this article.

Chapter II trade with third countries article 10. Border inspections.

1 the introduction into the national territory of the plants, plant products and other objects referred to in article 7(1). d), whichever your further destination customs, from third countries, will take place only through the points of entry authorised by the Ministry of agriculture, fisheries and food.

(When exist reasons founded of that vegetable, products vegetable and others objects, different of them referred in the article 7.1. d), can be affected by pest of importance potential, economic or environmental, or of that is have infringed the provisions of the present law, the Ministry of agriculture, fishing and power may establish for these the same requirement of the paragraph previous.

2. them products to is concerns the paragraph 1 must be inspected and the inspections or tests phytosanitary is held in them points of inspection border or in others centers also authorized by the Ministry of agriculture, fishing and power. In all case, will be required the corresponding authorization plant to be shipped by the customs.

3. the provisions of this article shall be without prejudice of competences that correspond to the Ministry of health and consumption.

Article 11. Introduction into the national territory.

1. the landing or introduction into the national territory of plants, plant products and other objects originating from third countries whose introduction is prohibited, as well as evidence or suspicion founded for the allowed that are affected by pests which could be important economic or environmental, or that the plants or plant products contain residues exceeding the permitted maximum limits (, it will lead to the adoption by the competent authority and, where appropriate, phytosanitary inspectors, any of the following measures: to) the immediate return of the same.

(b) their destruction.

(c) his confinement in places and conditions to be determined by the Ministry of agriculture, fisheries and food.

((d) any other measure of those included in article 49.1. to).

2. all costs arising as a result of the application of these measures shall be borne by the introducer. However, whenever the health or environmental assurance level is not affected, shall be granted to the introducer to choose to apply that one of the measures indicated in the preceding paragraph that deems most appropriate.

3. them vegetable, products plant u others objects originating of countries third that meet them requirements established in the article 7.1 of the present law may be introduced in territory national and les will be of application the same standards that to them products national.

Article 12. Export.

1. inspections or plant-health checks of plants, plant products and other objects in export scheme will be carried out at border inspection points or other inspection centres had submitted to it by the Ministry of agriculture, fisheries and food, issuing the phytosanitary certificate as appropriate. These inspections will be carried out at the request of the person concerned.

2 when he is established by law or by requirements of an importing third country required the realization of other evidence or official phytosanitary checks prior to that are established in paragraph 1, the same will be carried out by the Ministry of agriculture, fisheries and food, directly or through public or private bodies accredited for this purpose.

3. the export without prior obtaining the phytosanitary certificate, when this is required by the country of destination, is the responsibility of the exporter.

Chapter III fight against pests article 13. Obligations of individuals.

1 corresponds to the owners of farms or other surfaces with vegetation cover: to) maintain their crops, plantations and crops, as well as forests and the natural environment, good phytosanitary State for defense of the own and foreign productions.

(b) implement obligatory phytosanitary measures that are established as a consequence of the Declaration of the existence of a plague.

2. retailers and importers must keep in good plant protection plants, plant products and other objects subject of economic activity and, if necessary, run the obligatory phytosanitary measures established.

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

1. before the emergence for the first time of a plague in the national territory or in a part of the same, or the suspicion of its existence, that could have important economic or environmental, the competent authority shall verify the presence and importance of the infestation and immediately adopt the phytosanitary measures interim prior to that it considers necessary to prevent the spread of this scourge.

2. without prejudice to the immediate actions referred to in paragraph 1, the presence of a pest shall lead to the Declaration of its existence by the competent authority of the autonomous region and, where appropriate, the Declaration of pest of quarantine by the Ministry of agriculture, fisheries and food, after consulting the Ministry of environment in the case of forest species , which will involve the adoption of some of the measures phytosanitary established in the article 18. These measures, which may include obligations for individuals, will be of such a nature that they exercise control over the plague and that, with regard to the type of this, seek to achieve, at a minimum, the following objectives: to) plague quarantine unknown in the national territory or in part of it: its eradication or, if this is not possible, prevent their spread.

(b) known in the national territory quarantine pest: help prevent its spread.

(c) plague not considered in a given area quarantine that phytosanitary measures are applied: reduce its population or its effects.

3. the competent authority of the autonomous region may declare the existence of a plague when it produces or can produce economic damage or damage of such intensity, extension or nature that make necessary the mandatory fight as a more effective means of combating it, or requiring measures be applied in continuous areas or where the plague is dispersion possible focus.

4. when an autonomous region to declare the existence of a pest in its territory, you will notice immediately to the Ministry of agriculture, fisheries and food of this Declaration and the phytosanitary measures taken.

Article 15. Qualification of public utility in the fight against a scourge.

1 the public administrations will qualify public utility the fight against a certain pest when the cases referred to in article 14 can have a significant impact at the national level or an autonomous region and present any of the following circumstances: to) by its intensity, extension or required techniques, their struggle requires the use of extraordinary means not Assumable by individuals or will to fight through practices of biological or autocida.

(b) that their population and spread levels show a growing pace, which do provide for the possibility of achieving important extensions and cause serious economic losses.

(c) be plague emerging in the national territory or parts of it hitherto unaffected.

(d) that by their characteristics could be eradicated in all or part of the national territory.

(e) special characteristics of evolution and dispersal do necessary to combat it States, locations or phases that treatment do not have direct relevance to affected owners for not influence economically in their productions or properties.

(f) that affects mountains and natural areas whose conservation is of interest for environmental reasons or as a means of production or social welfare.

(g) that affect plants or their products normally destined for export and internationally is subject to quarantine measures.


(h) that have result ineffective them measures adopted as consequence of the statement official of its existence, or the plague is had extended more beyond of them limits that included such declaration.

2. the autonomous community may establish additional phytosanitary measures against a pest, with respect to those taken when declared its existence, on the provision that the fight against this scourge is grade public utility.

The Government may establish the corresponding program national of eradication or control of the plague, if the intensity of the same it requires.

Article 16. Situation of emergency plant.

In situations exceptional in which exist serious danger of extension of a plague in the territory was born nal, it statement of its existence by the authority competent shall entitle to it Administration General of the State for exercise, in his case, them functions necessary for it adoption of measures urgent aimed to prevent of way effective its transmission and spread to the rest of the territory national as well as ensuring the adequate implementation, coordination and monitoring of them until the re-establishment of normal plant throughout the national territory.

Article 17. Restrictions in the mandatory fight against a pest.

When in the fight against a scourge, individual action would interfere the collective risk of its effectiveness is required the adoption of special measures or the use of extraordinary means, the autonomous communities or, in your case, the Ministry of agriculture, fisheries and food may establish mandatory do it collectively by organizations recognized officially or directly by the Administration in which case affected stakeholders must refrain from performing any other individual action, if it were so established.

Article 18. Phytosanitary measures.

In implementation of the provisions of this law, the following phytosanitary measures may be adopted: to) condition or prohibit the planting or cultivation of species or varieties that are sensitive to certain pests in specific areas or which may act of transmitting them.

(b) bugging, disinfect, immobilize, destroy, transform, bury or undergo any other measure prophylactic plants and their products, as well as the related material with them, that is or may be vehicle of pests.

(c) bugging or disinfect premises, tools and machinery used in production, handling, processing, storage or conservation of vegetables and their products, as well as of the means of transport which contain or can be vehicles of pests.

(d) establish the conditions of storage and conservation of certain plants and plant products to prevent damage that may cause pests, as well as the spread of them.

(e) determine the dates of start and completion of them labors of cultivation, included them of collection and use forest, whose time of execution can influence in the development of a plague.

f) confined in appropriate facilities, for the time necessary, from third countries likely to be carriers of harmful organisms vegetables, and useful organisms for biological control.

(g) starting abandoned plantations when they constitute a plant-health risk for neighboring plantations or for a particular pest control.

(h) establish any other measure that be justified technically or scientifically as required in the control of the pest.

Article 19. Implementation of phytosanitary measures.

While not provided otherwise, the phytosanitary measures taken, from among those referred to in article 18, should be performed by stakeholders, being in charge the costs arising.

Chapter IV aid and compensation in the fight against pests article 20. Aid in the fight against pests.

Those affected by the obligatory nature of the fight against a scourge will benefit from technical assistance and economic aid which, in his case, determined in the relevant standard.

Article 21. Compensation in the mandatory fight.

When measures for the fight against a scourge entail destruction, deterioration or disablement of property or public or private property, the competent administration that has declared the plague will compensate those workers affected by the due compensation, which amount will be valued in accordance with the scales they settle. Compensation shall not be granted when such measures have been made necessary as a result of transgressions to this law or provisions enacted in the same development.

Article 22. Financial collaboration.

He Ministry of agriculture, fishing and power may collaborate, in accordance with the availability budget, with them communities autonomous in the funding of them programs of control that is established, especially in those that is relating to pest of quarantine not established in the territory national. In these programmes shall be determined, where appropriate, the financial collaboration of the Ministry of agriculture, fisheries and food conditions.

Title III chapter I provisions phytosanitary defence means common article 23. General conditions of marketing and use.

1 means for plant defense shall comply, for its marketing and use, the following general conditions: to) be authorized pursuant to the provisions of this law, subject to the exceptions provided for in articles 44 and 45 of this law, which shall be sufficient notice to the competent authority.

(b) be, in your case, labelled, including at least the necessary information on their identity, risks, precautions to take and for its correct use.

c) when, by its nature, not appropriate their labelling, shall submit the information necessary for its correct use and maintenance.

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

2 a effects that the requirement of authorization referred to in paragraph 1 does not affect the single market, will be established by law, in accordance with specific Community rules, rules for recognition of authorisations granted in other Member States, where appropriate with the conditions or adaptations that apply, provided that: a) the Member State where granted has established requirements and equal or comparable 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 corresponding to consider.

(c) there are no reasons to restrict or deny authorization, on the grounds that the means of phytosanitary defense concerned constitutes a risk to human or animal health or the environment, or to carry out the applicant's evidence or further trials.

3. the authorization to commercialize or to test plant protection products or other means of phytosanitary defense consisting of genetically modified organisms or containing will require prior authorization to release them into the environment, in accordance with determined in law 15/1994, of 3 June, which establishes the legal regime of the contained use deliberate release and marketing of genetically modified organisms.

(4. them means of Defense plant must be used properly, taking in has them good practices phytosanitary and others conditions certain in its authorization and, in his case, in accordance with them principles of the fight integrated defined in the paragraph r) of the article 2.

5. the content of the tags, training requirements for those placed on the market or use means of plant defense and those relating to research and development activities shall comply with the corresponding regulations.

Article 24. Registration and information about plant defence.

1. authorizations, communications and decisions of recognition of authorisations referred to in paragraphs 1 and 2 of article 23, shall be entered ex officio in the official register of products and plant Material attached to the Ministry of agriculture, fisheries and food.

2. in the registry will remain updated information concerning means of phytosanitary defense legally usable in Spain, its possible uses, characteristics and conditions that limit their use and requirements that determine good phytosanitary practice.

3. the system of registration and operation of the registry, as well as the system of provision of information, shall comply with the corresponding regulations.

Article 25. Rationalisation of the use of plant defence.

In order to create favourable conditions so that means of phytosanitary defense can be used properly according to the General conditions set out in the previous article, particularly to subordinate its use, its compatibility with the development of a sustainable agriculture respectful of the environment and the health of people and animals, public administrations will promote :


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

((b) groups of farmers to combat pests, which include among its objectives the implementation of systems of production referred to in paragraph in common to) or any other measures aimed at the reduction or the optimization of the use of plant defence.

(c) programmes of training and specialization in the use of plant protection products for users and distributors who trained them for a safe and rational application of these products. The responsibility of these programs will correspond to technical competent, promoting the use of good practices agricultural that limit or tend to eliminate, in the measure of it possible, the use of products plant protection.

(d) research programs for the search for technical and economically viable alternatives that make possible the resolution of phytosanitary issues.

Chapter II substances active article 26. Inclusion of active substances in the Community list.

1. in order to be used as components of plant protection products, active substances should be included in the Community list where the list of active substances authorised by the European Union collects and comply with the conditions laid down for each of them.

2. Requests for inclusion in the Community list shall be addressed to the competent body of the Ministry of agriculture, fisheries and food, accompanied by the documentation according to the rules established, on each active substance and one or more plant protection products containing it. Applications must be drawn up in the official Spanish language of the State.

3. If the Commission decides that the documentation provided is sufficient, and appoints Spain as rapporteur in the inclusion process, this will determine the obligation to instruct the application to the Ministry of agriculture, fisheries and food. The Ministry of agriculture, fisheries and food and the Ministry of health will coordinate their participation in the evaluation of the dossier as well as in Community actions that correspond.

The evaluation of the documentation provided can be made by the General Administration of the State directly or through accredited scientific entities expressly for this purpose by the Ministry of agriculture, fisheries and food, report binding of the ministries of health and environment, in aspects of their respective competencies, and heard the Commission's assessment of plant protection products. The cost of this evaluation will be paid by the applicant.

Article 27. Authorisation of active substances.

1. without prejudice to the provisions of the preceding article, may be used as components of pesticides active substances authorized in accordance with the regulations established by law, unless it has been expressly denied inclusion in the community or prohibited list incorporation in plant protection products.

2. the authorization of substances active regulated by the normative national is set to the same procedure that the authorization of products plant protection.

Article 28. Marketing of substances active.

Active substances may be marketed only if they comply with the provisions of the regulations on the Declaration of new substances, classification, packaging and labelling of dangerous substances. Also, when is try of substances active that not were marketed before 26 of July of 1993, is must have presented to the Commission European and to them others States members it documentation to is concerns the article 26.2, unless is try of substances active intended to them purposes provided in the article 43.

Chapter III products plant protection article 29. Authorization and registration of products plant protection.

1. plant protection products may be marketed only if it has previously been authorized by the Ministry of agriculture, fisheries and food and registered in the official register of products and plant Material.

2. also must be authorized and registered all renewal, expansion of applications and any modification of authorisations as well as its extinction.

Article 30. General terms and conditions of the authorization.

1 the authorization referred to in the previous article will be conditioned to that: to) active substances containing the product are included in the Community list or, where appropriate, are authorized in accordance with the State regulations.

(b) in the State of scientific knowledge, you can verify its identity, characteristics and other properties as well as its waste, using generally accepted methods or techniques.

(c) in the State of scientific knowledge they can, under certain conditions, solve one or more plant protection problems and that harvests or products on which have been applied are acceptable, particularly in terms of its content in residues of plant protection products.

(d) they can be used without risks for people or animals of species normally fed and kept or consumed by man.

(e) can be used in the conditions provided for without an impact unacceptable in the environment.

(f) where appropriate, the degree of endangerment of the containers, can be determined after used.

(g) where appropriate, the maximum residue limits have been established.

2. the checking of the conditions of the preceding paragraph shall be made in the State of scientific knowledge through trials and official or officially recognized tests which must be carried out by competent technicians and, where appropriate, under regulations established uniform criteria. For this purpose, the Ministry of agriculture, fisheries and food will annually publish a detailed list of the laboratories that can perform tests and analyses with official.

Article 31. Duration of the authorisation.

1. authorisations shall have a maximum duration of 10 years, without prejudice to its possible renewal.

2. authorisations may checked when there is evidence that was not already meets some of the requirements that were taken into account for granting, that information that sustained it contained false or misleading elements either because the evolution of scientific and technical knowledge, determine that they can modify their conditions of use.

Article 32. Exceptional limitations of an authorised product.

1. when determined by the Ministry of health and consumption or media environment, or because there are other grounds for considering that an authorized product may constitute a risk to human health, animal or the environment environment, the Ministry of agriculture, fisheries and food shall adopt the measures to restrict or prohibit provisionally the marketing and use, in accordance , where appropriate, with the Community rules. These limitations may be pending the procedure for revision of the authorisation of the plant protection product.

2. the autonomous communities may propose restrictions and bans that considered from in relation to the provisions of the preceding paragraph.

Article 33. Provisional authorisations.

The Ministry of agriculture, fisheries and food may authorize, provisionally and for a maximum three-year period, the marketing of a plant protection product containing a new active substance not included in the Community list, where the European Commission has determined that the documentation provided is appropriate and provided that they are sufficiently met the conditions of efficiency, selectivity and safety required in paragraphs b) g) of paragraph 1 of article 30.

Article 34. Exceptional authorizations.

When present an unforeseeable danger which cannot be contained by other means, the Ministry of agriculture, fisheries and food may authorize for a period not exceeding 120 days the marketing of plant protection products for use controlled and limited, in accordance, where appropriate, with the Community rules.

Article 35. Authorisation procedure.

1. the application for authorization of a plant protection product shall apply to the competent body of the Ministry of agriculture, fisheries and food by the physical or legal person that intends to market it for the first time in Spain, accompanied by the statutorily established documentation of the active substance and the product itself. The application and a memory supporting must be drafted in the language Spanish official of the State.

When in the examination of a request of authorization of products plant protection figure any substance active produced by another person or by a procedure of manufacturing different of which is specified in the documentation under which it substance active of that is try has been included in the list community, is will inform of this to the Commission European , including the data about their identity and impurities. In all case, the authorization of the request will be conditioned to the checking of that the substance active meets them requirements established for its inclusion in list community.


2. the request of authorization will be informed mandatorily by them ministries of health and consumption and of environment, in them aspects of their respective competences, and by the Commission of evaluation of products plant protection.

3. the resolution of authorization must define them conditions of use that determine them good practices phytosanitary and contain the conditioning specific so in it marketing and use of the product is meet them forecasts of efficiency and security, included them warnings e indications that correspond to its classification by them different aspects of endangerment and, in his case, the restriction to certain classes or categories of users.

4. the maximum duration of the procedure shall be twelve months from the moment in which the complete documentation referred to in paragraph 1 has been submitted.

5 once the previous period without relapse express resolution, the person concerned can understand rejected the application for authorisation, without prejudice to the legal obligation of the Administration to dictate it.

Article 36. Confidentiality and data protection.

1. the detailed composition, the procedure for obtaining and other information, for which the applicant ask for and justify that constitute secret industrial or commercial, will be confidential to the extent that is accepted by the Administration, except that it is required by the provisions relating to labelling, is essential for the identification and control of the plant protection product and its substance activates , or to the knowledge of different aspects of danger and the measures to be taken to prevent risks in case of accident.

Confidentiality does not exclude the consideration by the administration of that information, when it has to determine if significant differences with a plant protection product or an active substance subject to another subsequent application.

2 studies, trials and the rest of the documentation provided by the applicant will have the character of protected, for the purposes of its use in favor of another subsequent applicant, except: to) the first applicant has expressly authorised.

(b) after more than ten years since the first marketing authorisation granted on the basis on such documentation in Spain or in another Member State, as appropriate in accordance with the Community rules.

c) expiry of the term of protection of data established by Community legislation, in case of documentation relating to an active substance.

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

1. when in the case of active substances included in the Community list, will not be repeated unnecessarily experiments with vertebrate animals for compliance with the provisions of paragraph 2 of article 30 in the presentation of new applications, renewals, revisions, or modifications of authorisation of plant protection products or active substances for the maintenance of the existing ones.

To this end, is declared of social interest, in accordance with articles 12 and 13 of the law of December 16, 1954, of compulsory purchase, non-exclusivity of the corresponding information contained in the documentation required to obtain, modify, renew, review or maintain authorisations for plant protection products use to that referred to in paragraph 2 of article 36 and for the sole purpose of which can be used by the Administration in favor of the beneficiaries.

2 are declared beneficiaries of the expropriation, in the terms laid down in the Act, those interested in obtaining, modification, renewal, revision or maintenance of authorizations for manufacture and/or marketing of active substances and plant protection products containing them, to which may be applicable to the data referred to in paragraph 1.

3. for fixing the corresponding financial compensation be taken into account the provisions of the law on compulsory expropriation.

Article 38. Access to the remaining documentation.

1. for the purposes of avoiding that I will undermine free competition in cases of monopoly, declared of social interest, in accordance with articles 12 and 13 of the law on compulsory expropriation, non-exclusivity of the data contained in the applicable documentation to maintain authorisations for plant protection products, use other than provided for in the preceding article , for the sole purpose that can be shared by those who have authorization to manufacture or commercialize active substances and plant protection products which contain them and which are affected by Community directives that determine the need for revision of such authorizations.

In this sense, means that monopoly situation in which, not to share the information, a single company would act as exclusive rights owner of manufacturing or marketing of a plant protection product for which there are no other products approved for the treatment of a phytosanitary problem of some cultivation, which has significant importance.

2 are declared beneficiaries of the expropriation, in the terms established in this law, those who have authorization to manufacture or commercialize active substances and plant protection products containing them, when you remember their inclusion in annex I to Directive 91/414/EEC, or regulation that modifies it or substitute, unless they can transfer their right to nor share it with any other physical or legal person that does not have the character of beneficiary.

Article 39. Access to documentation procedure.

1. for the fulfilment of the provisions of articles 37 and 38, where there are rights of exclusive use of the documentation to be protected in accordance with paragraph 2 of article 36, stakeholders must try to reach an agreement with who holds these rights so that such documents could be used in their favor.

2. If not is had reached an agreement for it use shared of the documentation with prior to the initiation of the record expropriation, the Ministry of agriculture, fishing and power will urge to them parts affected to made all them steps appropriate for arrive, in the term of fifteen days, to an agreement that allow avoid it repetition unnecessary of them corresponding tests and studies.

3. before it evidence of the impossibility of them parts for it use shared of the documentation, is will solve in each case, by agreement of Council of Ministers, to proposed of the Minister of agriculture, fishing and power, on the need of use such information, in what is strictly indispensable for the end of the expropriation and taking in has the balance reasonable between them interests of them parts affected.

Where the expropriation relates to the use non-exclusive of the data contained in the documentation required to review or maintain authorisations for plant protection products or active substances other than those obtained in experiments and tests on vertebrate animals, the Council of Ministers will assess the need for such information, in order to prevent the situations described in paragraph 1 of article 38 in each case.

Before the Council of Ministers decide the Declaration of interest social, must inform the record them ministries of economy and of science and technology and give is audience to all those interested.

4. the records of compulsory purchase to take place this law will be processed by the urgency of article 52 of the law on compulsory expropriation procedure.

5 tank prior to use and the amount finally as fair price determined as well as the costs of expropriation record started as provided in this law, will be account of the beneficiaries of such expropriation.

Article 40. Obligations concerning the production and marketing of plant protection products.

1 the holders of authorisations, when they are also the manufacturers of plant protection products, without prejudice to compliance with the regulations in force in the field of industry, are obliged to: to) provide facilities and appropriate laboratories.

(b) record the operations of all the batch production and quality control.

(c) comply with the requirements and conditions taken into account for their approval, including those related to packaging.

(d) comply with the labelling requirements, providing all the necessary information about the potential risks, as well as that relating to its proper handling, use and disposal of packaging.

(e) provide a data sheet of safety in accordance with the requirements established by law.

(((((2. the holder of the authorization that not manufacture the product phytosanitary will be responsible before the administration of the compliance of the obligations of them paragraphs to), b) and e) of the paragraph previous by the manufacturer, and of meet by itself same them of them paragraphs c) and d) of said paragraph.

Concluding, in the form in which the product is offered the user the packaging and labelling, should be reported as well as the rest of the production operations, as specified in paragraph 1.b), being prohibited the transfer or any other operation in which to break the seals of the containers or the original labelling Miss unless they are carried out by the holder of the authorization or under their own control.


3. without prejudice to the provisions of paragraph 2, in the case of including information on the Distributor and in case of parallel imports, a sobreetiquetado complies with the regulatory requirements by another person other than the holder of the authorization, may be provided that the plant protection product in its original packaging, with the seals intact and visible parts of the label where listed the identification data for the product and the holder of the authorization or , where appropriate, of the manufacturer. Also, the additional label should include the details of who made the sobreetiquetado, which will be responsible for the compliance with provisions in paragraph 1.d).

4 distributors, vendors and other commercial operators of plant protection products shall be: to) be in possession of the enabling university degree for exercise as a competent technician in the field of plant health, or have staff who possess it, fulfilling the requirements established by law for professional practice in both cases.

(b) meet the requirements for the storage and marketing.

(c) provide plant protection products only to persons or entities that meet the conditions and legal requirements for its possession or use in its condition of users.

(5. them manufacturers of products plant protection and who are holders of the authorization of these products, as well as them distributors, sellers and others operators that intervene in its marketing, are forced a: to) meet them requirements established with regard to record and control of their establishments and activities.

(b) provide to the competent bodies information on production, marketing and use of plant protection products and other aspects related to them, for statistical purposes and the terms established legislation on this matter.

(c) report immediately to the competent authority any new information which occurs on the potentially dangerous effects of its products on animal or human health, or the environment, as well as its phytotoxic effects.

Article 41. Use of phytosanitary products.

1 users and those who handled pesticides must be: to) be informed of indications or warnings that appear on labels and instructions for use or, where applicable, by means of appropriate advice, on all aspects relating to the custody, handling and correct use of these products.

((b) apply phytosanitary practices, according the indications or warnings referred to in paragraph a).

(c) comply with the training requirements laid down by legislation, according to the categories or classes of danger of plant protection products.

(d) observe, where applicable, the principles of the integrated fight that applicable.

(e) comply with the provisions concerning the disposal of empty containers in accordance with the conditions laid down and, in any case, with those listed 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 paragraph 5 of article 40, must: a) staff with the levels of training required.

(b) have adequate means of implementation and maintaining a system of periodic reviews of the operation of the same.

(c) a contract which should include, at least, the data of the application to perform and the further conditions which, where appropriate, appropriate to comply with the user of the service performed in each case.

Article 42. Maximum residue limits.

1. the plants, plant products and their processed, intended for human food or animal not may contain, from the time of its first marketing after harvest, or out of the warehouse in the case of post harvest treatment, residues of pesticides at levels higher than the maximum limits established by regulations, report of the Joint Commission of residues of plant protection products.

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

3. in fixing the maximum residue limits will ensure that they represent no risk to the health of consumers. However, notwithstanding that the maximum levels that correspond to safeguard people's health may be higher, the MRLs shall be established according to the resulting levels of tests carried out in the conditions of phytosanitary practices, in order to ensure that the contents in residues are the possible minimum. You can also set by extrapolation of test results comparable, in terms of the affinity of the crop, the phytosanitary practices or environmental conditions, particularly in the case of minor applications, understanding as such those whose field of use is restricted to crops, or small areas of crops, which have little significance for the whole of the agricultural surface or whose productions have a significant share in food diets.

4 as provided for in paragraph 1 in relation to the maximum limits is applicable to products intended for export to third countries, unless: a) the third country of destination requires a particular treatment to prevent the introduction of pests in its territory, or b) the treatment is necessary to protect the vegetable products during transport to the third country of destination and storage in the same , in accordance with international standards in the field of phytosanitary quarantine or the laws in force in that country.

Article 43. Special system of authorization of trials.

The use of plant protection products in trials of field, for the purpose of research and development, will require the corresponding prior official authorization checking that, under the proposed conditions, not may be risks to human health, animal or the environment, unless shall be carried out by entities authorized on a generic basis for this activity. These authorizations, as well as the official recognition of the tests and analysis of plant protection products for the purposes of paragraph 2 of article 30, shall be subject to a special regime established by regulation.

Chapter IV biological media and other means of phytosanitary defense article 44. Biological media.

1. the introduction into the national territory, distribution and release of exotic biological control organisms will require the prior authorization of the Ministry of agriculture, fisheries and food, following a report from the Ministry of environment on the possible environmental impact and condition to biodiversity, both when its purpose is conducting field trials for research and development, such as when is the release for biological control or use as biological plant protection product , in accordance with the regulations established by law.

2. the breeding or production and distribution, marketing and release of no exotic biological control organisms will require advance notice to the Ministry of agriculture, fisheries and food, in accordance with rules to be established by regulation.

3. the authorizations to that referred to in paragraph 1 and communications previous to that referred to in paragraph 2 shall be entered in the official register of products and plant Material.

Article 45. Other means of plant defense.

1 means of Defense plant other than pesticides and biological control organisms referred to in the preceding articles, including models or prototypes of the means of application of plant protection products, must meet the requirements according to the rules established to ensure its adequate behaviour in conditions of good plant protection practice and prevent which, by its nature or operation they can pose risks to the health of persons or animals, the environment or crops or productions.

2. the marketing of the means referred to in the preceding paragraph will require advance notice to the competent body of the autonomous community, giving transfer the same to the Ministry of agriculture, fisheries and food for your registration in the official register of products and plant Material, unless it is implementing the requirement of prior authorization.

Such communications and authorizations shall be made in accordance with the regulations referred to in the preceding paragraph.

Title IV inspections, violations and sanctions chapter I inspection and control article 46. Competencies.

It corresponds to the different public administrations, in the field of their respective competencies, carrying out controls and inspections necessary to ensure the observance of this law.

Article 47. Controls.


1. by the competent bodies of public administrations official controls shall be established to ensure compliance with the provisions of the present law. Such controls may be systematic in border inspection points and dependencies which are grown, produced, stored or marketed plants, plant products and other objects, and occasional, at any time and place where moving or where those products are.

2. inspections and systematic programs of surveillance in manufacturing, marketing and use of means of phytosanitary defense, particularly the fulfilment of the good plant protection practice as well as the monitoring of the levels of residues present in the plants, plant products and their processed, and prepared food from them, corresponding to the competent bodies of the autonomous communities they will be coordinated by the General Administration of the State, to that effect, setting out plans or national control programmes.

3 as instruments of support to the checks to be carried out by the public administrations, the competent bodies thereof shall appoint: to) at least one plant protection laboratory in its territory for the realization of diagnostics and identification of pests and biological control organisms.

(b) laboratories official u officially recognized, that are appropriate for: 1 make them analysis and trials of the samples taken in the execution of them programs of surveillance to is concerns the paragraph 2 of this article.

2. make, where appropriate, trials and analysis referred to in paragraph 2 of article 30.

3rd participate in coordinated programs of harmonisation of techniques and methods that are to be used.

((c) centres of technical inspection of the means of implementation, official or officially recognized, that are appropriate for periodic inspection referred to in paragraph b) of paragraph 2 of article 41.

(d) centres or stations of test media application and other items or equipment, official or officially recognized, that are appropriate for testing and tests necessary for the purposes specified in this law.

4. the Ministry of agriculture, fisheries and food will have reference laboratories, appointed between the previous ones or others of recognized prestige, with the functions of harmonizing methods and techniques that have been used, participate in national programmes of prospection of pests, issuing mandatorily report prior to the Declaration of the existence of a pest of quarantine appeared for the first time in the national territory the activities related to the implementation of programmes for the application of good laboratory practice that are of its competence, participate in coordinated programs and perform analyses or tests that, for arbitration purposes or other purposes, requested him.

(5. the Ministry of agriculture, fisheries and food will keep up-to-date, available to interested parties, a relationship of official or officially recognised laboratories and centres of technical inspection referred to in paragraph 3, paragraph b)) and (c), of this article. For this purpose, the autonomous communities shall refer to this Department the relevant information about those laboratories and centers or testing stations that exist in their respective territorial areas.

Article 48. Precautionary measures.

The precautionary measures that they can be taken are the following: to) destruction of goods or, where appropriate, burial.

(b) forwarding of goods introduced.

(c) forwarding of goods from some areas to others.

(d) detention and, in his case, containment of goods.

(e) sealed or closing time of equipment, facilities, local or establishments.

(f) temporary suspension of authorizations and registrations in official records.

(g) change or restrictions of the use or destination of those goods, with or without transformation.

(h) disinfection or fumigation.

(i) seizure of documents.

Article 49. Precautionary measures.

1 bodies competent and, where appropriate, the accredited inspectors may take in a motivated way measures precautionary that they are specified in the following cases: to) in the case of goods from third countries, the introduction of which is prohibited or with respect to which there is suspicion of being affected by pests that may have economic importance or containing residues exceeding the permitted maximum limits ((((((, referred to in paragraphs to), b), d) and, where appropriate, g), h) e i) of the preceding article, giving to the party concerned, whenever possible, the option to choose between any of these measures.

((b) for other goods, if there is evidence or suspicion of risk of adverse consequences for crops or productions, to the health of persons or animals or for the environment, or without proper authorization, any of the measures established in the previous, except paragraphs b article) and f).

(((c) in the case of establishments, equipment, facilities or premises that fail to comply with the requirements established with risk to crops or their products, for the health of persons or animals or the environment, or that do not meet the proper auto approval, those provided for in paragraphs e), h) e i) of the preceding article.

d) when the effectiveness of the measures taken may be diminished by the existence of an authorisation or official registration, is may propose to the competent authority the measure provided for in paragraph (f)) of the preceding article.

2. when the precautionary measures to be taken by inspectors, will be notified with immediate to the competent organ for the initiation of the disciplinary procedure, which will proceed in the period of fifteen days, by a reasoned ruling, to ratify them, modify them or lift them and, where appropriate, complement them with others from those laid down in the previous article that it deems appropriate.

3. them measures precautionary is adjusted in intensity, proportionality and requirements technical to them objectives that is intended to ensure in each so-called concrete, and its duration not exceed to it of the situation of risk or lack of authorization that them has motivated.

Article 50. Powers of inspectors.

Staff at the service of the public administrations which exercises the functions of inspection provided for in this law shall have the nature of authority and may: to) access to any location, installation, or dependency, public or private ownership. The prior consent of the owner or court order will be required in the case of household inputs.

(b) obtain the necessary minimum samples for examination or more detailed analysis in specialized centers.

(c) require the information and submission of documents attesting that regulations be established.

d) measures injunctions of article 48.

Article 51. Inspection report.

1. the inspector will raise record which shall include particulars of the inspected company, the person before whom performs inspection, the measures which had ordered and all the relevant facts of the same, in particular, which may have impact on a possible sanctioning procedure.

2. the Act of inspection will have value probative of them made collected in the same, without prejudice of any other means admitted in right that can provide is.

3. the minutes shall be sent to the competent authority to initiate the sanctioning procedure.

Article 52. Obligations of inspected persons.

The natural or legal persons to whom an inspection is carried out shall be obliged a: to) supply all sorts of information about facilities, products or services, allowing verification by inspectors.

(b) provide to obtain copy or reproduction of documentation.

(c) permit the timely test is practiced or taking of samples free of products or goods in the quantities strictly necessary.

(d) and, in general, allow the completion of the inspection.

Chapter II infringements article 53. Qualification of offences.

The offences contained in this chapter are classified in minor, serious and very serious.

Article 54. Infractions minor.

(Is considered mild them following violations administrative: to) the exercise of activities of production, marketing or of services, subject to the requirement of authorization official, after expiring the same without having requested in term and form its update or renewal, whenever said breach not is find typified as lack serious or very serious.

(b) the breach of them requirements established for the manufacturing or production and marketing, included the storage, packaging and labeling, of vegetable, products plant and means of Defense plant, whenever said breach not is find typified as lack serious or very serious.

(c) the production, packaging or marketing of vegetable, products vegetable or its processed, whose content of waste exceed them limits maximum established, provided their levels lack of significance toxicological.

(d) failure to comply with the requirements laid down with regard to books, invoices, accompanying documents and other documents required, provided that such failure is not typified as serious or very serious lack.


(e) the neglect of the phytosanitary care of crops, forests and natural environment.

(f) the use and manipulation of media of Defense plant without observe the conditions of use u others requirements required when this not put in danger the health human, it of them animals or the environment.

(g) the breach of the obligation of communicate to it administration public competent the appearance of organisms harmful for them vegetable or of symptoms of disease for them vegetable and its products, when not are known in the area, whenever said breach not is typified as serious.

(h) hinder the Inspector work through any act or omission that disrupt or delay it.

(i) the breach of them requirements in matter of degree or qualification of the personal, when thus is established for the production, marketing and the management or use of them means of Defense plant, whenever said breach not is typified as serious.

Article 55. Offences serious.

They shall be regarded as serious offences: to) activities of production, manufacturing and marketing of phytosanitary products without the corresponding administrative authorization.

(b) the provision of documents or false or inaccurate data, so misleading public administrations to grant authorisations of activities, establishments or phytosanitary defence without that to meet the requirements or conditions established for this purpose.

(c) the manufacture and marketing of phytosanitary defence whose nature, composition or quality, or that of their packaging, differ significantly from the conditions for its approval.

(d) the marketing of phytosanitary defence with labelling, information or advertising that may lead to confusion to the user about the uses and conditions for which were authorized, on requirements for the disposal of containers or that do not allow to identify the person responsible for marketing.

(e) the marketing of plant protection products in containers that present leaks or breaks, major losses in the text of labelling or mandatory information, closures or broken seals or that they have been transferred.

(f) the production, packaging or marketing of plants, plant products or their processed, containing residues of pesticides at levels that exceed the established maximum limits and excess have significance to toxicological level.

(g) do not possess the necessary documents that verify the existence or not of serious or very serious offences, or carry it in such a way that it prevents to carry out this check.

(h) the failure to comply with the requirement of the Government report on the phytosanitary status of crops or provide false information.

(i) the handling or use of means of phytosanitary defense unauthorized, or the authorized without respecting the requirements established for this purpose, including those relating to the management of packaging, when it represents a risk to human health, animal health or the environment.

(j) the failure to comply with the requirements for certification or qualification of staff, when he is thus established for production, marketing and the management or use of means of plant defense, when it represents a risk to animal or human health or the environment.

(k) breach of the obligation to notify the competent public administration the appearance of a quarantine pest.

(l) preventing the performance of duly accredited inspectors.

(m) failure to comply with the phytosanitary measures established to combat a plague, or prevent or hinder its fulfilment.

(n) the introduction, circulation, possession and manipulation in the national territory of plants, plant products, organisms and related material where it is prohibited, or without permission as it is mandatory.

(o) the introduction into the national territory of plants, plant products, organisms and materiel through points of entry other than those authorized.

p) break measures precautionary established, provided that such breach is not typified as very serious.

(q) the obtaining of subsidies, and, in general, any type of aid provided for in this law, based on false information, as well as allocated to purposes other than those provided.

(r) does not declare the presence, in a consignment contract of foreign trade or transit within the national territory, of those plants, plant products and materiel which need to be inspected, as well as do not indicate, hide or distort the true origin of the same.

Article 56. Very serious offences.

The following infringements shall be considered very serious: to) the concealment to the administration of the information concerning the danger of pesticides by those who manufacture them or placed on the market.

(b) the manufacture or marketing of unauthorised plant protection products or with labelling, information or advertising that conceals its danger.

(c) non-compliance with the measures laid down by the competent administration to combat pests of extremely grave nature, or to mitigate its effects.

d) break measures precautionary putting into circulation products or frozen goods.

(e) handling and use, or use means of phytosanitary defense unauthorized, or the authorized without respecting the requirements established therefor, including, where appropriate, those relating to the Elimination of containers, when it represents a serious risk to human health, animal health or the environment.

Article 57. Liability for violations.

1. are responsible for of them made constituent of them offences classified in the present law them people physical or legal that them commit, even to title of simple negligence.

2 However, when the object of the violation is a product or other merchandise, responsible shall be presume: to) violations in products packaged and properly sealed, the natural or legal person whose name or company name appears on the label, unless proven forgery or poor maintenance by the holder, provided that they may be known or specified in the container for storage conditions.

(b) of violations in products in bulk or without the seals of origin, the holder thereof, except when this can be demonstrated the responsibility of a previous holder.

(c) in any case, if the suspect proves that the infringement has occurred by misinformation or lack of information regulations required, and is another person responsible for the information, identified the offence be liable to the latter.

3. the administrative responsibility for the infringements referred to in this law shall be independent civil, criminal liability or other order which, if necessary, may be required, under the terms established by law.

Chapter III sanctions article 58. Types of sanctions.

1 the offences covered by this law will be sanctioned with fines within the following limits: to) minor offences, from 300 to 3,000 euros.

(b) serious offences, from 3.001 to 120,000 euros.

(c) offences very serious, from 120.001 to 3,000,000 of euros.

2. it authorizes the Government to update the amount of previous sanctions according to the indices of prices to the consumer of the National Institute of statistics.

3. in all case, the limit superior of them sanctions provided for in this article may overcome is until the duplo of the benefit retrieved by the infringing when this benefit is top to said limit.

Article 59. Graduation of the sanction.

1. the sanction will graduate according to the following criteria: recidivism, the intention of the offender, breaching the previous warnings, damage and damages incurred, benefits and social alteration that may occur.

2. when violations endanger human health, of animals or the environment, the sanctions will increase 50 per 100.

3. when a single fact is establishing two or more offences, shall be punished only by which is more serious.

Article 60. Accessory penalties.

1. the competent authority may agree, as accessory penalties, confiscation of goods that may involve serious risk to plant health or animal, or the environment, or any type of risk to human health.

Such goods shall be destroyed if its use or consumption would constitute a danger to public health. In other cases, the final destination of the seized goods shall be determined.

Costs that originate intervention, deposit, seizure, transportation and destruction operations shall be borne by the offender.

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

2. in the case of offences committed by persons who develop an activity subject to administrative authorization or communication, the competent authority may agree as accessory sanction cessation or interruption of activity production, marketing or service of the infringer or, where appropriate, propose to the competent authority the review, Declaration of extinction, suspension, withdrawal or non-renewal of the corresponding records or administrative authorisations.


3. in the case of infringements classified as very serious, you will remember the temporary closure of the company, exploitation or local, for a maximum period of five years, and complementary measures to the full effectiveness of the decision may be adopted.

(4. in the event of infringement referred to in article 55.q), is set as accessory punishment the disqualification to obtain grants or public subsidies for a maximum period of five years.

Article 61. Advertising of the sanctions.

Whenever any of the circumstances of the risk to public health, accredited intentionality in the infringement or recidivism offences of a similar nature, organ which meets the record may agree publication of penalties imposed as a result of the provisions of this law when they have acquired firmness.

Article 62. Sanction powers.

When the competence of the General Administration of the State, the initiation of the record shall be made by the competent Directorate-General in the field of plant health and resolution shall be responsible to the Director general for the minor offences, the Secretary General of agriculture for the serious and the Minister of agriculture, fisheries and food for the very serious up to the maximum of 600,000 euros amount , corresponding to the Government the imposition of them superior to that amount.

The authority that start the procedure sanctioning may agree accordingly the adoption of them measures precautionary that consider necessary for ensure the efficiency of the resolution that could fall.

Chapter IV means of execution and other measures article 63. Fines enforcement.

1. in the event that the interested not run them obligations established in the present law or that the authority competent decides to apply them measures established in the article 18 or the adoption of them measures precautionary planned in the article 48, may require to them affected so in a term enough come to the compliance of those, with warning of that , in case contrary, is imposed a fine coercive, with pointing of its claims in each case and to a maximum of 3,000 euros, without prejudice of them sanctions applicable, in your case.

2. the competent authority, in the event of non-compliance, shall be requirements successive, increasing the periodic penalty payment at 20 per 100 of the agreed on the previous requirement.

3. the granted deadlines shall be sufficient to carry out the measure in question and the damage that can occur from not run so far in due time.

4. regardless of which can correspond in concept of sanction, the sanctioning body may agree the imposition of periodic penalty payments pursuant to the provisions of article 99 of the law 30/1992, of 26 November, legal regime of public administrations and common administrative procedure, once after the deadlines specified in the corresponding request. The amount of each of these fines shall not exceed 20 per 100 of the fine fixed by the corresponding violation.

Article 64. Subsidiary execution.

In the case that those affected do not execute in due time and form measures or obligations to come obliged by virtue of this Act, or when the Administration considers it necessary to act immediately, the competent authority shall execute them, with their own or using services outside, at the expense of the obligor, whose amount will be required by way of enforcement , regardless of the penalties or periodic penalty payments that would place.

Article 65. Other measures.

The competent authority may apply the following measures, which will not have a sanctioning character: to) the closure or closure of businesses, facilities, holdings, premises or means of transport, which do not have the authorizations or mandatory registries, or the suspension of its operation until such is rectify defects or met the requirements for approval.

(b) the returned of them aid or subsidies unduly received.

Title V fees phytosanitary article 66. Legal regime.

The fees provided for in this title shall be governed by this law and other normative sources that for rates set out in article 9 of the law 8/1989, of 13 April, rates and prices public.

Article 67. Taxable and amounts.

The taxable and the sum of the charges will be, in each case, that are contained in the following sections: 1. to) by the phytosanitary inspection referred to in article 12(1) for the export of plants, plant products and objects related to third countries where phytosanitary certificate is not callable: three euros per tonne, with a minimum of 30 euros per each phytosanitary certificate.

(b) for each issue of copy of the phytosanitary certificate or proceedings in the same: without consultation of the record, 10 euros, and with consultation of the record, 20 euros.

(c) for testing and prior to export official controls laid down in article 12(2). Processing of applications and completion of the first control: 1 crops, trees or shrubs: 150 euros/hectare/variety.

2nd not tree crops outdoor: 75 Euro/hectare/variety.

3rd forced crops: 100 EUR/hectare/variety.

4th forced crop plants: 100 euro / hectare.

(d) for tests and prior to export official controls laid down in article 12(2). Realization of the set of tests and inspections needed, other than those set forth in paragraph (c)): 1 crops, trees or shrubs: 100 EUR/hectare/variety.

2nd not tree crops outdoors: 100 euro / hectare/variety.

3rd forced crops: 300 euros/hectare/variety.

4th forced crop plants: 100 euro / hectare.

2 for the processing of applications relating to active substances: a) Inclusion in the Community list: 2,400 euros.

(b) equal to others included in the Community list: 1.080 euros.

(c) modification of Community specifications: 900 euros.

(d) national authorization: 1.440 euros.

(e) equal to other national authorization: 960 euros.

(f) modification of national specifications: 480 euros.

(g) fixing of MRLs: 540 euros.

3 for the processing of applications of first authorisation of plant protection products subject to harmonised Community legislation: to) provisional authorization: 3.300 euros.

(b) new preparations: 1,800 euros.

(c) recognition of authorisation: 1,200 euros.

(d) comparable to other authorized: 1,200 euros.

(e) equal to other authorized generics: 720 euros.

(f) exceptional authorizations: 1,200 euros.

4 by processing applications of first authorisation or registration of means of phytosanitary defense subject to the requirements of the national legislation: to) new preparations: 1,500 euros.

(b) preparations equivalent to other authorized: 900 euros.

(c) equal to other authorized generics: 600 euros.

(d) exotic biological control organisms: 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 amendment of authorisations for plant protection products subject to harmonised Community legislation: to) enlargement to new uses: 720 euros.

(b) extension to secondary uses in crop or already authorized applications: 240 euros.

(c) extension to minor uses: 300 euros; with public interest: 120 euros.

(d) conditions of use: 300 euros.

(e) content in active substances: 480 euros.

(f) content or replacement of coformulantes: 360 euros.

(g) other types of modifications: 240 euros.

6 for the processing of applications for amendment of authorisations of plant defense media subject to the requirements of the national legislation: to) new uses of preparations: 480 euros.

(b) secondary uses of preparations: 180 euros.

(c) applications under prepared: 240 euros; with public interest: 120 euros.

(d) conditions of use of preparations: 180 euros.

(e) active substances content: 240 euros.

(f) content or replacement of coformulantes: 180 euros.

(g) other amendments relating to phytosanitary defence: 180 euros.

7 for the processing of applications concerning the authorization to perform tests with means of phytosanitary defense: to) for a single trial or trials plan: 180 euros.

(b) to one or more types of generic tests: 600 euros; officially recognized: 900 euros; with good laboratory practice: 900 euros.

(c) modification of authorization conditioning: 120 euros.

8 for the processing of requests for modification of the name of the holder or of phytosanitary defence manufacturer: to) change of name or social denomination: 120 euros.

(b) by a transfer between two parts of a means of phytosanitary defence rights: 180 euros; by transfer of two or more means of phytosanitary defense: 300 euros.

(c) by transfer between more than two parties of the rights of a means of phytosanitary defense: 300 euros; by transfer of two or more means of phytosanitary defense: 480 euros.

9 for the processing of requests for renewal and provisional extension of authorisations, records and communications, referred to in the previous paragraphs, in cases that do not require other acts specifically defined as taxable transactions: to) plant protection products: 480 euros.

(b) to carry out tests: 360 euros.

(c) for other means of phytosanitary defense: 180 euros.


(d) extensions provisional of authorization: 120 euros.

10 by the issuance of certifications or simple notes on authorizations, texts for labelling and other supporting or informational documents of facts or actions on which there is evidence for registration records of plant defence: a) certifications of official recognition or good laboratory practice in trials with phytosanitary defence: 180 euros.

(b) certifications or texts for labelling relating to an authorization or registration: 90 euros.

(c) certifications relating to the authorisations granted to a holder: 120 euros.

(d) other certifications that require consult two or more records: 180 euros.

(e) regarding authorization or registration simple notes: 30 euros.

(f) notes relating to authorisations granted to a holder single: 60 euros.

(g) other simple notes that require consult two or more records: 90 euros.

11 by regulatory inspection, including the corresponding Act and drafting of report: a) fulfillment of requirements: 180 euros.

(b) in compliance with requirements and procedures: 240 euros.

Article 68. Payers of the fees.

They will be payers of the fees provided for in this title the physical or legal persons who affect or benefit, personally or in their goods, services or public activities that constitute taxable.

Article 69. Accrual, payment and management.

1. rates are shall accrue when the application that initiates the action or the record is submitted. He payment of them rates will be condition required for the home of it performance administrative, except for them renewals of authorization that require it realization of others acts established as made taxable, in whose case the applicant must make initially the payment of the rate corresponding to the renewal and subsequently the payment of it another rate, when you is notified the Act additional that appropriate.

2. the payment will be in cash, enter the amount in deposit institution authorized by the Ministry of finance.

3. to the Ministry of agriculture, fisheries and food deserves the Administration and collection of rates from the previous article, without prejudice to the powers which, in his case, correspond to the Ministry of public administration.

4. the rates shall be autoliquidación by the taxable person.

Sole additional provision. Records.

The official registration of products and plant Material and the national registry of producers and traders of vegetables that reference this law will be treated with the personal media and materials in the General Administration of the State, while his run suppose any spending increase.

First transitional provision. Import and release of exotic biological control agents.

While not set forth rules concerning import, distribution and liberalization of exotic organisms of biological control, Ministry of agriculture, fisheries and food will exercise its functions, taking into account the principles established in the code of conduct for the import and release of exotic agents of Biological Control of the world Organization for agriculture and food (FAO).

Second transitional provision. Procedure of inspections and sanctions.

Until they are established specific procedures for inspections and sanctions, applies the provisions of the Royal Decree 1945 / 1983, of 22 June, which regulates infractions and sanctions in defense of the consumer and of the agro-food production, except what is contrary to the provisions of law 30/1992, of 26 November Legal regime of public administrations and common administrative procedure, without prejudice to the powers of the autonomous communities.

Third transitional provision. Regulatory standards in the field of plant health.

1 insofar as not they handed down, in accordance with this law, new provisions on the respective subjects, are in force all declared compulsory the fight against certain pests; which regulate the import, export, transit and movement of plants and plant products; which regulate the manufacture, sale and use of products and material phytosanitary, and which set them tolerances or limits maximum for the presence of waste of products plant protection in vegetable and products plant.

2. in particular, the following provisions remain in force: articles 1 to 4 of the Decree of September 19, 1942, on manufacture and trade of plant protection products, and its implementing regulations.

Real Decree 3349/1983, of 30 November, which passes the reglamentación for the manufacture, marketing and use of pesticides, and its implementing regulations.

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

Royal Decree 280/1994, of 18 February, which establishes the maximum limits of pesticide residues and their control on certain products of plant origin, and its implementing regulations.

Royal Decree 2163 / 1994 of 4 November, whereby the Community harmonized system of authorization to market and use of plant protection products, and its implementing regulations is implanted.

Royal Decree 401/1996 of March 1, is establishing the conditions for the introduction into the national territory of certain agencies noci vos, plants, plant products and other objects, for trial purposes, scientific and for the activity of selection of varieties, and its implementing regulations.

Royal Decree 1190 / 1998, 12 June, which regulates the national programmes of eradication or control of harmful organisms of plants not yet established in the national territory, and its implementing regulations.

Royal Decree 1201 / 1999, of 9 July, which establishes the national programme of eradication and control of the fire blight fireblight, and its implementing regulations.

Royal Decree 1644 / 1999, of 22 October, on the control of the harmful organism called "Ralstonia solanacearum (Smith) Yabuuchi et to the", and its implementing regulations.

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

Order of January 31, 1973, on the supplementary classification of plant protection products in terms of their dangerousness for the annual wildlife (amended by order of 9 December 1975).

Order of October 8, 1973 which regulates the use of hormonal herbicides.

Order of 12 of August of 1976 by which is classified those products agrochemicals for the purposes of registration.

Order of 7 October 1976 on protective treatments of wood.

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

Order of 28 February 1986 relating to the ban on the marketing and use of plant protection products containing certain active substances.

Order of 28 February 1986 relating to the prevention and fight against nematode cyst of the potato, in application of Directive 69/465/EEC of the Council of the European communities.

Order of 28 February 1986 relating to the fight against warty scab of potato, in application of Directive 69/464/EEC of the Council of the European communities.

Order of 12 March 1987 by which establish phytosanitary rules concerning the import, export and transit of plants and plant products for the Canary Islands.

Order of 17 November 1989 by which establishes a program for the promotion of the fight integrated pest of various crops through groupings for integrated agriculture (ATRIAS) treatments.

Order of 17 May 1993 which establishes the normalization of phytosanitary passports for the movement of certain plants, plant products and other objects within the community, and that procedures are established to issue such passports and the conditions and procedures for replacement.

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

Order of 4 August 1993 to establish the requirements for applications for authorisations of plant protection products.

Order of 31 January 1994 that establishing modalities for studies to be carried out within the framework of the recognition by the EU of the protected areas in Spain, exposed to specific phytosanitary risks.

Order of 15 February 1994 which establishes standards for the movement of certain plants, plant products and other objects through a protected zone and the circulation of such plants, plant products and other objects from such protected within the same area.

Order of 22 March 1994 concerning the fight against bacterial necrosis of the potato, in application of Directive 93/85/EEC of the Council of the European communities.


Order of 16 December 1994 that establish provisional SPS measures for the fight against outbreaks of citrus Leafminer "Phyllocnistis citrella Stainton" within the scope of the Spanish territory.

Order of 1 March 1995 which establishes the procedure for notification of interception of consignments or organisms from third countries presenting an imminent phytosanitary danger.

Order of 29 November 1995 which establishes the uniform principles for evaluation and authorisation of products.

Order of 11 December 1995 which lays down provisions relating to authorisations for trials and experiences with plant protection products.

Order of 28 March 1996 by which establish standards for the evaluation 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 which regulates the authorization and the development of phytosanitary inspections in stores of packaging for export and re-export to third countries of plants and plant products.

Order of 31 March 1997 which establishes the prohibition of importation of fresh fruits of kiwis "Actinidia chinensis", originating in New Zealand in the Canary Islands.

Order of 12 November 1997 which establish aid for the renovation of the citrus plantations affected by the virus of sadness.

Order of 14 April 1999 establishes that annex I of Royal Decree 2163 / 1994.

Order of 28 February 2000 that establish provisional measures of protection against the Ferruginous curculionido of Palm trees ["Rhynchophorus ferrugineus" ("Olivier")].

Only degoratoria available. Repeal legislation.

Many provisions are opposed to provisions of this law and, specifically, the following are repealed: Act of May 21, 1908, of pests of field and defense against them.

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

The law of 20 of December of 1952, of Defense of the mountains against the pest forest.

Chapter II of title IV of the law of Montes, of June 8, 1957.

The Decree 496 / 1960, of 17 of March, by which is validated rates by management tecnico-facultativa of the services agronomic.

He Real Decree 699 / 1995, of 28 of April, by which is updated them rates relating to the registration of products and material plant, expedition of certifications and granting of authorizations.

First final provision. Basic character.

The provisions of the present law has the character of basic legislation, under cover of the provisions of article 149.1.13. a, 16th and 23.ª of the Constitution, which attributes to the State the exclusive jurisdiction on bases and coordination of the general planning of economic activity, bases and general coordination of the health and basic legislation on protection of the environment respectively. Is exceptional from the character of basic legislation the regulation contained in articles 10, 11 and 12 of this law, which are issued under cover of the provisions of article 149.1.10. 2nd and 16th, first subparagraph, of the Constitution, that the State given the exclusive competence in the field of foreign trade and foreign health, respectively.

Second final provision. Faculty of development.

The Government will adopt, in the scope of their powers, rules of application and development of the present law.

Therefore, command to all Spaniards, private individuals and authorities, which have and will keep this law.

Madrid, November 20, 2002.

JUAN CARLOS R.

The Prime Minister, JOSÉ MARÍA AZNAR LÓPEZ

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