JOHN CARLOS I

KING OF SPAIN

To all who present it and understand it.

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

EXPLANATORY STATEMENT

Law 15/1994 of 3 June establishing the legal regime for the contained use, voluntary release and placing on the market of genetically modified organisms, in order to prevent health risks On 23 April 1990, the Commission adopted a proposal for a Council Directive on the approximation of the laws of the Member States relating to the approximation of the laws of the Member States relating to: April 1990, on the deliberate release into the environment of modified organisms genetically.

Subsequently, the general regulation for the development and implementation of the aforementioned law, approved by Royal Decree 951/1997 of 20 June 1997, not only incorporated into the legal system those rules of the aforementioned directives which, by its more contingent or adjective character was not necessary to include by law of legal status, but also transposed Directives 94 /51/EC and 94 /15/EC, both of 7 November 1994, which adapted to technical progress, respectively, the Annexes of Directives 90 /219/EEC and 90 /220/EEC.

With the publication of the aforementioned state rules, not only were obligations derived from Community law complied with, but an existing regulatory vacuum was filled in Spain, when the legal instruments were introduced. necessary to be able to assess the potential negative effects on human health and the environment arising from genetic manipulations.

However, the steady progress of scientific knowledge and the experience gained in biotechnology has led to the fact that regulatory standards in this field are subject to frequent changes. This has been the case with Directive 90 /219/EEC, which has been amended by Council Directive 98 /81/EC of 26 October 1998 and Directive 90 /220/EEC, which has been repealed by Directive 2001 /18/EC of the European Parliament and of the Council, of March 12, 2001, on the deliberate release into the environment of genetically modified organisms.

These new directives, although they do not substantially alter the current regime, affect many of the articles of Law 15/1994 of 3 June, which is why it has been deemed necessary to repeal them. Consequently, this law is intended to bring our legal order into line with the new Community legislation, and also to incorporate certain precepts in order to meet the new demands in relation to the management and control of the activities of confined use and voluntary release, including placing on the market, of genetically modified organisms. The law incorporates the substantive rules of the aforementioned Directives 98 /81/EC and 2001 /18/EC, that is, those that for Spanish law must be covered by the principle of reserve of law, leaving for a later regulatory development those other technical content or those which, due to their cyclical or seasonal nature, may be subject to frequent and unexpected changes and variations.

The principles that inspire the law, which are identical to those existing at Community and international level, are the prevention and precautionary principle, which involves taking appropriate measures to avoid potential adverse effects on the environment. human health and the environment derived from these activities; the "case by case", that is, the assessment of the risks associated with the genetically modified organisms for each one of them; the "step by step", which means that only proceed to the release of genetically modified organisms when the assessment of the stages The information and public participation may be passed on to the next without any risk; the information and public participation, ensuring consultation of the public before the authorisation of certain contained use activities, as well as all the release activities voluntary and the placing on the market of genetically modified organisms or products containing them, and the access of citizens to information on authorised releases or marketing.

The law is structured in four titles, respectively, dedicated to the general provisions; to the contained use, voluntary release for purposes other than the marketing and marketing of organisms genetically modified; to the regulation of tax obligations, and to surveillance, control and sanctioning regime.

In Title I, the object and scope of the law, similar to that of the law that is repealed, is specified and a list of concepts that define for their correct application is collected; among them, the meaning of genetically modified organism is defined in accordance with the ethical principles ratified by the international community, excluding human beings from such a concept.

In this title, the competencies that correspond to the General Administration of the State and the Administrations of the Autonomous Communities are regulated to grant the authorizations of the activities included in the the scope of the law, as well as to monitor, monitor and sanction non-compliance with the obligations which for the holders of those activities are established.

The law aims to prevent possible risks or to reduce the potential harm to human health and the environment could be derived from such activities. Consequently, in accordance with the powers conferred on the autonomous communities on these matters by the various Autonomy Statutes, it is for those communities to grant the authorisations for the activities of the contained use and voluntary release, excluding those for marketing, as well as exercising the remaining management functions.

However, on the basis of other state competence titles, which must be considered to be prevalent by virtue of their specificity, on medicinal products and pharmaceuticals, on scientific and technical research and on intellectual property, the General Administration of the State shall grant such authorisations in certain cases, and in some cases also reserve oversight and sanction functions.

Finally, given its immediate effect on the supra-regional and even supranational level, it is also up to the State to grant authorization for the placing on the market, import and export of modified organisms. or products containing them.

Title II establishes the legal status of the various activities under the law, dedicating a specific chapter to each of them and completing the regulation with a general chapter on which the common rules are laid down. confined uses, voluntary releases and marketing.

The risk assessment, both for human health and for the various elements that make up the environment, is the key to granting authorization to allow the subsequent execution of the various operations to the that the law applies, being one of the most novel aspects of the law, that the risk of the confined uses is determined according to the activities to be carried out with the agencies, forgetting the criterion existing in the legislation that repeals that it established the risk on the basis of the genetically modified organism itself, taking, in some cases, consideration of the purpose of the operations.

However, the existence of specific containment measures to avoid contact with the population and the environment in the contained use activities has led to the requirement that only, in general, be required. express authorisation of the competent authority for those who are qualified as moderate or high risk.

The activities of voluntary release in the environment of genetically modified organisms are always subject to prior administrative authorisation. The content of the application for authorisation is mainly reinforced by including the methodology used to carry out the risk assessment.

With regard to the placing on the market of genetically modified organisms or of products containing them, the law more accurately delimits the concept of marketing and submits the corresponding authorisations to a period of time. The period of validity, after which they shall be renewed. It also lays down the obligation to monitor and monitor the genetically modified organisms or the products containing them, in order to identify, where they are already authorised, any adverse effects they may have. to produce in human health or the environment; it is also required to label them appropriately to ensure not only their control and monitoring by the competent authorities, but also adequate information from consumers.

Since the directives that have been incorporated establish deadlines for submitting the communications and applications, for processing the files and for the resolution authorizing or denying the different operations; that in the procedure The European Commission and the other Member States are also involved in the authorisation of voluntary and marketing releases, and the time limits laid down in Community rules are likely to be met. of frequent changes, it has been deemed necessary to determine these deadlines in the Regulation of the development and enforcement of the law.

Also, given the consequences for human health and the environment could be derived if requests for authorisation by silence are estimated, in accordance with the provisions of paragraph 2 of the amended Article 43 of Law 30/1992, of November 26, of the Legal Regime of Public Administrations and of the Common Administrative Procedure, the desestimatorium effect of the administrative silence is determined.

Title III, dedicated to tax obligations, creates a tax that will tax the provision of services and the actions to be performed by the General Administration of the State related to the activities in which Genetically modified organisms and regulates their constituent essential elements. Since the procedures for the provision of such services and activities are similar in all the countries of the European Union, the quotas to be met by the various taxable events have been determined taking into account the established in other Member States.

In turn, Title IV regulates the surveillance and control regime, imposing the obligation on the holders of the activities to collaborate with the inspectors, to which it grants the character of agents of the authority, and establishes the sanctioning regime, making new infringements not included in Law 15/1994, updating pecuniary fines and regulating precautionary measures prior to the initiation of the sanctioning procedure and subsequent interim measures that did not exist in the law.

Finally, two collegiate bodies are regulated in law: the Inter-Ministerial Council of Genetically Modified Organisms, which will perform functions similar to those which it was necessary to develop to the collegiate body created in the Article 30 (3) of Law 15/1994, and the National Biosafety Commission, which in addition to the functions currently entrusted to it by the third final provision of the law to be repealed and the general regulation for its development and implementation, shall inform the requests for authorization which it is appropriate to grant to the Administration of the Autonomous Communities.

TITLE I

General provisions

CHAPTER I

Object and Scope of the Law

Article 1. Object and scope of application.

1. The purpose of this law is to establish the legal regime applicable to the activities of confined use, the voluntary release of genetically modified organisms and the placing on the market of such organisms or products containing them, in order to avoid any risks or to reduce the potential damage to human health or the environment from these activities.

2. The activities referred to in the preceding paragraph shall be excluded from the scope of this law where the genetic modification of the organisms is obtained by means of mutagenesis or fusion (including protoplast) techniques of plant cells, in which the resulting organisms may also be produced by traditional methods of multiplication or cultivation, provided that such techniques do not involve the use of recombinant nucleic acid molecules or modified organisms genetically.

Likewise, the use of in vitro fertilization, conjugation, transduction, transformation or any other natural process and polyploid induction techniques are excluded from this law, provided they do not involve use of recombinant nucleic acid molecules or genetically modified organisms obtained by means of techniques or methods other than those excluded under the previous paragraph.

Article 2. Definitions.

For the purposes of this law, it is understood by:

a) Body: any biological entity capable of reproducing or transferring genetic material, including within this concept the microbiological entities, whether or not they are cellular.

(b) genetically modified organism: any organism, with the exception of humans, whose genetic material has been modified in a way that does not occur naturally in mating or recombination natural, provided that the techniques are used which are regulated.

(c) Accidents: any incident involving a significant and involuntary release of genetically modified organisms during their contained use and which may pose an immediate or delayed danger to human health or for the environment.

CHAPTER II

Administrative competencies

Article 3. Powers of the General Administration of the State.

1. The General Administration of the State shall be competent to:

(a) Grant authorisations for the placing on the market of genetically modified organisms or of products containing them.

(b) Authorise the trials of supplementary voluntary releases which, if appropriate, are required under the marketing authorisation procedure. In the latter case, a previous report will be requested from the Autonomous Community where the release will be performed.

(c) Grant authorisations related to the import and export of genetically modified organisms and the products containing them, including surveillance, control and sanction.

2. It is also for the General Administration of the State to authorise the contained use and voluntary release for any other purpose other than placing on the market in the following cases:

(a) Where their object is the possible incorporation into medicinal products for human and veterinary use, as well as to other medical devices and articles and to those which, by affecting the human being, may pose a risk to health In accordance with Articles 40.5 of Law 14/1986, of 25 April, General of Health, and 2 of Law 25/1990 of 20 December of the Medication.

b) In the cases arising from Law 13/1986, of 14 April, of the Promotion and General Coordination of Scientific and Technical Research. In this case, the General Administration of the State shall also be competent for the surveillance and control of the activities of contained use and release in the environment when the research programmes are carried out by organs or bodies dependent on it.

c) In the cases related to the technical examination for the registration of commercial varieties, which are derived from Law 3/2000, of January 7, of the legal regime of the protection of plant varieties, and of the Law 11/1971, of seeds and nursery plants. In this case, the General Administration of the State shall also be competent for surveillance, control and sanction.

3. The authorisations referred to in the preceding paragraphs shall be granted by the Interministerial Council of Genetically Modified Organisms provided for in the second provision of this Law, but the adoption of the resolution The relevant administrative authority shall be subject to the conformity of the representation of the competent ministry in each case.

Interministerial Council resolutions of Genetically Modified Organisms that grant or deny authorizations will end the administrative route.

4. In cases of serious and urgent need, the General Administration of the State may, by way of exception, promote, coordinate or take all measures necessary to protect human health or to prevent irreparable damage to the environment. environment, with the collaboration of the autonomous communities and in accordance with their respective competences.

Article 4. Competencies of the Autonomous Communities.

1. It is for the Autonomous Communities, except in the cases provided for in the previous Article, to exercise the functions governed by this law in relation to the activities of the contained use of genetically modified organisms and to grant the authorisations for the voluntary release of such organisms for any other purpose other than that of their placing on the market.

2. It is also for the autonomous communities to monitor, control and impose penalties for infringements committed in the performance of the activities referred to in this law, with the exception of the provisions of paragraph c). in paragraph 1 and in paragraphs (b) and (c) of paragraph 2 of the previous Article.

TITLE II

Legal regime for contained use, voluntary release for purposes other than the placing on the market and marketing of genetically modified organisms

CHAPTER I

Confined use of genetically modified organisms

Article 5. Concept and delimitation.

1. Any activity in which the genetic material of an organism is modified or by which it is, thus modified, cultured, stored, used, transported, destroyed or removed is understood to be confined to any activity, provided that in the performance of such activities are used for confinement, in order to limit their contact with the population and the environment.

2. The genetic modifications obtained by means of self-cloning and cellular fusion techniques, including protoplasts, of both prokaryotic species and the exchange of genetic material, are excluded from the obligations laid down in this chapter. known physiological processes, such as cells of any eukaryotic species, including the production of hybridomas, provided that such techniques or methods do not involve the use of recombinant nucleic acid molecules or organisms genetically modified by means of techniques or methods other than those are excluded pursuant to the first subparagraph of Article 1 (2).

3. The provisions of this Chapter shall not apply to the storage, cultivation, transport, destruction, disposal or use of genetically modified organisms which have already been placed on the market in accordance with Chapter III of this Title or other standard requiring an environmental risk assessment equivalent to that set out in this Chapter, provided that the contained use is adjusted, if any, to the conditions of the placing on the market authorisation.

Article 6. Classification of activities.

1. The contained use activities shall be classified, in the light of the prior assessment of risks to human health and the environment, in risk activities that are zero or negligible, low risk, moderate risk and high risk.

2. Each of these activities shall apply to them a sufficient degree of confinement to protect human health and the environment.

Article 7. Requirements for the realization of contained use activities.

1. Any natural or legal person intending to carry out a contained use of genetically modified organisms shall be obliged to:

a) Make a prior assessment of possible risks to human health and the environment.

b) Take a record of the assessment.

c) Meet the specific standards of safety and professional hygiene and apply the correct principles and practices of microbiology.

d) Apply the general principles and containment measures appropriate to the risk of the contained use activity.

e) Develop emergency and facility surveillance plans, when provided for.

f) Regularly review the applied containment and protection measures.

2. The requirements set out in the previous paragraph shall be met in accordance with the specifications to be determined.

3. Transport by any means of genetically modified organisms will require a prior assessment of possible risks to human health and the environment and that the specific safety and hygiene standards are met. professional.

Article 8. Prior communication to the Administration.

1. Natural or legal persons who intend to use for the first time specific facilities for confined uses of genetically modified organisms shall be required to communicate it in advance to the competent authority.

Such communication shall also be required of natural or legal persons intending to carry out any activity of the contained use of genetically modified organisms, except in the case of activities of null or negligible risk.

2. The activities notified may be carried out by the parties concerned after the time limits which are determined. However, the competent authority may expressly authorise them before the end of these periods, limit the period in which they are allowed to be carried out or make them subject to compliance with certain conditions.

Article 9. Activities subject to authorisation.

1. The contained use activities of genetically modified organisms classified as moderate or high risk are subject to administrative authorisation.

2. Low-risk, contained use activities shall also be subject to express authorisation where the competent authority requests the data subject to provide more information than that provided by its communication or to modify the conditions of the proposed contained use.

Article 10. Check by the Administration.

In the contained use activities, the competent authority shall verify the documentation provided, compliance with the requirements laid down in Article 7 and that the measures relating to the management of waste, security and response in case of emergency are the right ones.

The competent authority may also request additional information, consult persons and institutions, submit to the public the draft contained use, require the modification of the conditions of the proposed contained use and classification of the risk assigned to the activity, or prevent the start of the activity, suspend or terminate it.

CHAPTER II

Voluntary release of genetically modified organisms for purposes other than their marketing

Article 11. Concept and scope of application.

1. Voluntary release means the deliberate introduction into the environment of a body or combination of genetically modified organisms without specific containment measures having been adopted, in order to limit their contact with the population and the environment and provide them with a high level of safety.

2. The provisions of this Chapter shall not apply to the transport by any means of genetically modified organisms or to medicinal substances and compounds of human use consisting of genetically modified organisms or in combinations of these or containing such organisms, provided that their voluntary release, for purposes other than their placing on the market, is authorised by other Community rules or by the Spanish legislation given for their compliance, the requirements laid down in this law and in its implementing regulation are laid down; and execution.

However, where these special provisions exist for medicinal substances and medicinal products for human use, the competent bodies for their authorisation shall apply in advance to the Inter-Ministerial Council of Bodies. Genetically Modified a report on the specific environmental risk assessment.

Article 12. Authorisation regime.

1. Natural or legal persons who intend to carry out a voluntary release of genetically modified organisms shall apply for authorisation from the competent authority.

To this effect, together with the corresponding application for authorization, they must submit:

(a) A technical study, comprising the information and data that are to be determined.

b) An assessment of the risks to human health and the environment, which should include the methodology used and the conclusions on its potential impact on the environment.

2. Once the documents and data provided, the results of the public information and, where appropriate, the results of the consultations and additional information carried out and the observations made by others have been analysed, the competent authority shall Member States or other public administrations shall decide on the release requested, authorise or refuse it, and, where appropriate, impose the conditions necessary for its implementation.

CHAPTER III

Marketing of genetically modified organisms or products containing them

Article 13. Concept and scope of application.

1. Marketing means any act involving a supply to third parties, whether for consideration or free of charge, of genetically modified organisms or of products containing them.

2. The supply of genetically modified organisms for the following activities is not considered to be on the market:

a) The contained use, including crop collections.

b) Voluntary release for purposes other than marketing.

3. The provisions of this Chapter shall not apply:

a) To transport by any means of genetically modified organisms.

(b) to genetically modified organisms which are products or components of products, or to medicinal products for human or veterinary use which consist of genetically modified organisms or combinations thereof; or contain such bodies, which are governed by Community rules other than those incorporated by this law or by the Spanish legislation issued for compliance, provided that they require a specific assessment of the risks to the environment equivalent to that regulated in this law and its implementing rules. In the case of products or components of products, these specific rules shall also contain requirements for risk management, labelling, monitoring, where appropriate, information to the public and safeguard clause, equivalent to those provided for in this law and in its implementing rules.

During the assessment of the applications for the placing on the market of genetically modified organisms referred to in the preceding paragraph, the competent bodies for granting the authorisation shall first apply to the Council. Interministerial of Genetically Modified Organisms a report on the specific environmental risk assessment.

Article 14. Requests.

1. Natural or legal persons intending to place on the market, for the first time, genetically modified organisms or a combination of genetically modified organisms as products or components of products, shall request authorisation from the Competent administration, referring to the effect:

(a) A technical study, comprising the information and data that are to be determined.

b) An assessment of the risk to human health and the environment, which should include the methodology used and the conclusions on the potential impact on the environment.

c) The conditions for the marketing of the product, including those for use and handling.

d) A follow-up plan, with a proposal of its validity.

e) A proposal for labeling and packaging.

f) The proposal for the duration of the authorisation, which may not exceed 10 years.

(g) The information available to them, where appropriate, on data or results of other releases of the same genetically modified organism in the process of authorisation or already carried out, both by the person concerned and by third parties, provided that they have given their written agreement.

h) A summary of the file, which will be made available to the public.

2. A new authorisation should be sought for the placing on the market of products which, while containing the same genetically modified organisms as those in other products already authorised, are intended for different use.

Article 15. Assessment report.

1. The General Administration of the State shall make an assessment report indicating whether or not genetically modified organisms should be placed on the market and under what conditions.

2. The assessment report, together with the summary of the dossier, shall be forwarded to the European Commission and, by the Commission, to the other Member States, and may request additional information, make comments or submit reasoned objections to the report. placing on the market of the genetically modified organism concerned.

3. The General Administration of the State shall give a decision to reject the application where, being the assessment report contrary to the marketing, it decided, after the completion of the relevant procedure, that the must be marketed.

Article 16. Authorisation regime.

1. The marketing authorisation may be granted only where a voluntary release has previously been authorised for the non-commercial purposes of those bodies, or a risk assessment has been carried out in accordance with the provisions of this Regulation. law or with its implementing rules.

2. If objections are raised by the Member States or the European Commission and no agreement is reached, the General Administration of the State may not grant the corresponding authorisation without the prior approval of the European Union.

3. The authorization shall specify:

a) Their scope, with the identification of the genetically modified organisms to be marketed and their unique identifier.

(b) Its term of validity, which shall be for a maximum duration of 10 years.

c) The product marketing conditions.

d) The control samples that must be in the repository.

e) Labelling and packaging requirements.

f) The product tracking requirements.

4. The authorisations granted shall be renewed in the form and in accordance with the procedure to be determined.

Article 17. Free movement and safeguard clause.

1. The placing on the market of genetically modified organisms, or products containing them, which have been authorised by other Member States, may not be prohibited, restricted or prevented, provided that these authorisations have been granted with the provisions transposing into national law the European Communities ' rules on this subject and strictly respecting the conditions laid down in the respective authorisations.

2. However, the General Administration of the State may restrict or suspend the use and sale of a duly authorised product where, after authorisation, it has new information to which the product is to be deducted poses a risk to human health or the environment, and should in this case inform the public.

Article 18. Traceability.

The natural or legal persons who place genetically modified organisms or products containing them, shall retain and transmit the data and information which they regulate in order to facilitate their control and possible withdrawal from the market, at all stages of marketing, in order to obtain the retroactive location of their movements at all stages of production, processing and distribution.

CHAPTER IV

Common rules

Article 19. Additional information.

1. Where, after the submission of the communication, the application for authorization or the granting of such authorization, new information is available in respect of the risks which the activity may entail for human health or the environment, the holder the activity is obliged to inform the competent authority immediately, to review the information and the requirements specified in the communication, application or authorization and to take the necessary measures to protect the health human and the environment.

These same obligations, as well as those laid down in regulation, shall be payable to the holders of the contained use activity in the event of an accident.

2. Where the competent authority has information which indicates that the activity may pose a higher risk than those provided for, it shall require the holder to amend the conditions of execution, suspension or termination of the activity. the activity, and inform the public.

Article 20. Confidentiality and information to the public.

1. The holders of the activities covered by this law providing information to the Administration may invoke the confidential nature of certain information and information provided, providing the appropriate justification.

The Administration shall decide on the confidentiality invoked and shall refrain from providing the information to third parties on the data and information to which it recognizes that character.

2. Information and data relating to the description of genetically modified organisms, the identification of the holder, the purpose and place of the activity, the classification of the risk of the activity of the undertaking, and the identification of the risk of contained use and containment measures, emergency and control systems and measures and the assessment of the effects on human health and the environment.

3. The information concerning voluntary releases, the marketing authorisations granted, the relationship of the genetically modified organisms to which they are intended shall not be kept confidential and shall be made available to the public. the marketing has been authorised or rejected as products or components of products, the assessment reports, the results of the marketing controls and the opinions of the scientific committees consulted, specifying for each product the genetically modified organisms it contains and its uses.

Article 21. Emergency situations.

The activities covered by this law may give rise to emergency situations, for the purposes set out in the civil protection legislation.

Likewise, these activities may give rise to situations of risk, or negative health consequences that determine the application of Articles 24, 26 and 28 of Law 14/1986, of 25 April, General of Health, as well as of the measures provided for in the Organic Law 3/1986 of 14 April of Special Measures in the field of Public Health.

Article 22. Tagged.

The genetically modified organisms to be supplied for the activities referred to in Article 13.2 of this Law, and the products or components of products placed on the market containing modified organisms genetically modified organisms or a combination of genetically modified organisms, shall be subject to the labelling requirements to be determined by regulation.

TITLE III

Tax Obligations

CHAPTER I

Rate Elements

Article 23. Concept.

1. The levy on the provision of services and the implementation of actions by the General Administration of the State for the implementation of the activities in which genetically modified organisms are involved is hereby established.

2. This fee shall be governed by this law and by the other regulatory sources which are established for the fees laid down in Article 9 of Law 8/1989 of 13 April of Fees and Public Prices.

Article 24. Taxable fact.

It constitutes the taxable fact of the fee for the provision by the General Administration of the State of the services and activities related to the processing, evaluation, studies, trials or similar derivatives of the communications or applications for authorisation, of which it is competent pursuant to Article 3 of this Law, for the execution of the following activities:

(a) The first use of specific facilities involving the contained use of genetically modified organisms whatever the risk assigned to the activity.

(b) The contained use of genetically modified organisms in low-risk, moderate-risk and high-risk activities.

c) The voluntary release of genetically modified organisms.

d) The placing on the market of genetically modified organisms or products containing them.

Article 25. Accrual.

The accrual of the fee will occur when the application or communication initiating the action or the file is filed, which will not be made or processed without the payment being made.

Article 26. Taxable person.

The fee shall be payable by natural or legal persons who request or are provided with any of the services and actions of the General Administration of the State that constitute their taxable fact.

Article 27. Tax base.

The tax base will be determined according to the direct or indirect costs that contribute to the formation of the total cost of the provision by the General Administration of the State of the services and the activities that constitute the taxable fact of the levy.

Article 28. Rates.

1. The fees payable in the cases referred to in paragraph (a) of Article 24 shall be as follows:

(a) First use of facilities for limited or negligible risk contained use activities: EUR 1,130.

b) First use of facilities for low-risk, contained use activities: EUR 2,380.

c) First use of facilities for activities of limited use at moderate risk: EUR 2,980.

(d) First use of facilities for high-risk confined use activities: EUR 3,960.

2. The fees payable in the cases referred to in paragraph (b) of Article 24 shall be as follows:

(a) Confined use of genetically modified organisms in low-risk activities, in previously reported facilities, for activities of contained use of the same or higher risk: 1,235 euro.

(b) Confined use of genetically modified organisms in moderate risk activities, in previously reported facilities, for activities of contained use of that risk or higher: EUR 1,535.

(c) Confined use of genetically modified organisms in high-risk activities, in previously reported facilities, for contained use activities of the same risk: EUR 1,985.

3. The fee payable in the case referred to in paragraph (c) of Article 24 shall be as follows: EUR 4,525.

4. The quota to be met in the case referred to in paragraph (d) of Article 24 shall be as follows: EUR 12,040.

Article 29. Bonuses and exemptions.

1. The quotas laid down for the communications and authorizations of the activities referred to in paragraph 1 (b), (c) and (d) of the preceding Article shall be subsidised by 30% in the case of installations notified in advance. contained use activities from the previous category.

2. The quota established for voluntary release activities of genetically modified organisms as referred to in paragraph 3 of the previous Article shall be subsidised by 30% in the case of test extensions and repeated applications of the the same genetic modification as part of multi-annual research and development projects.

3. The bonuses regulated in this article may be accumulated.

4. They shall be exempt from the payment of the quotas provided for in the preceding Article, the assumptions arising from Law 13/1986 of 14 April of the promotion and coordination of scientific and technical research, where the projects or activities of Research and development are carried out by institutions, entities or public bodies.

CHAPTER II

Management and Settlement

Article 30. Self-validation.

The rate will be the subject of self-validation by the taxable persons, according to the models approved by the Joint Order of the Ministries of Finance and the Environment, making their payment in cash by means of income in the the deposit institution authorised by the Ministry of Finance.

Article 31. Rate management.

The management of the rate set out in this chapter corresponds to the Ministry of the Environment, who will also hold the competition to agree to the deferral and fractionation of the voluntary payment.

TITLE IV

Surveillance and control. Sanctioning regime

CHAPTER I

Surveillance and control

Article 32. Obligation of collaboration.

The holders of the activities referred to in this law are obliged to provide all the cooperation to the competent authorities in order to enable them to carry out the examinations, checks, sampling and collection of information required for the performance of your mission.

Article 33. Agents of the authority.

Officials who perform inspection duties on the activities regulated in this law shall have the status of officers of the authority.

CHAPTER II

Sanctioning Regime

Article 34. Violations.

1. Violations of this law are classified as minor, serious and very serious.

2. They are minor infractions:

(a) Simple irregularities in observing the rules established in this law without direct relevance to human health or the environment.

b) Failure to comply with the obligation to keep the register of risk assessment updated in the contained use activities.

c) The implementation of activities of the contained use of genetically modified organisms with non-compliance with the correct principles and practices of microbiology.

3. These are serious violations:

(a) the conduct of the contained use of genetically modified organisms and the first use of facilities for such activities without prior notification to the competent authority; where such communication is required.

(b) The conduct of contained use activities subject to communication without respecting the conditions imposed or the time limits determined by the competent authority.

(c) The implementation, without due administrative authorisation, of contained use activities carried out with genetically modified organisms where such authorisation is required.

d) Failure to comply with the conditions imposed in the authorisation of the contained use activities.

e) Failure to comply with the obligation to report to the Administration in cases where this is so provided, provided that there is no serious risk.

f) The lack of implementation of the confinement and safety and hygiene measures at work.

g) The lack of collaboration in the inspection and surveillance work of the Competent Administration.

h) The concealment or distortion of data, as well as the refusal to supply the information requested by the competent authority or the intentional delay in the provision of such information.

i) Failure to comply with any other requirements, conditions or prohibitions that are established for each activity, or the omission of the acts to which it requires.

(j) Non-compliance with the labelling requirements of the genetically modified organisms and the products containing them.

k) Failure to comply with traceability requirements to be established in a regulated manner.

(l) The import, export and transit of genetically modified organisms in breach of the requirements laid down in Community or international standards in force.

4. These are very serious violations:

a) The implementation of voluntary release and marketing activities without due administrative authorisation.

(b) Failure to comply with the conditions imposed in the authorisation of voluntary release and marketing activities.

(c) Failure to report immediately to the competent authority for the existence of a serious risk or damage, as well as for any type of accident or incident.

(d) Failure to comply with the measures provided for in the emergency plan in the cases referred to in paragraph (c).

e) The import and export of genetically modified organisms without the corresponding authorisation of the country of destination, in accordance with the Community or international standards in force.

Article 35. Penalties.

1. The infringements shall result in the imposition of some or some of the following penalties:

a) Mild infractions:

1. Mull up to 6,000 euros.

2. A partial closure on a temporary basis of the facilities where the infringement was committed.

b) Serious infractions:

1. Mull from 6,001 euros to 300,000 euros.

2. The temporary Cese of the activities.

3. A temporary, total or partial closure of the installations in which the infringement was committed.

4. Disregard Genetically modified organisms or products containing them.

5. A Product Marketing Ban.

6. Inablement for the exercise of any of the activities provided for in this law for a period of time not exceeding one year.

7. ª revocation of the authorization or suspension thereof for a time not exceeding one year.

c) Very severe infractions:

1. Mull from EUR 300,001 to EUR 1,200,000.

2. th definitive or temporary cessation of activities.

3. Final definitive closure or temporary closure, in whole or in part, of the facilities where the offence has been committed.

4. Disregard Genetically modified organisms or products containing them.

5. A Product Marketing Ban.

6. Inablement for the exercise of any of the activities provided for in this law for a period of not less than one year and no more than 10.

7. ª Revocation of the authorization or suspension of the authorization for a period of not less than one year and no more than 10.

8. Publication, by means of the means deemed appropriate, of the penalties imposed, once they have acquired firmness in administrative or, in their case, jurisdictional way, as well as the names, surnames or names or social reason for the responsible natural or legal persons and the nature and nature of the infringements.

2. Penalties shall be imposed in the light of the circumstances of the person responsible, his degree of guilt, reiteration, participation and benefit, and degree of incidence or risk of serious harm to human health, the environment or resources. natural.

3. Where the amount of the fine is less than the benefit obtained by the commission of the infringement, the penalty shall be increased to at least twice the amount in which the infringer has benefited.

4. The body to which the sanction procedure is to be resolved shall determine the final destination to be given to the genetically modified organisms or to the products containing them which have been seized. The costs arising from the destruction operations of those shall account for the infringer.

Article 36. Precautionary measures.

When, before a sanctioning procedure is initiated, the competent authority finds that the activity is carried out without the appropriate authorization or without having communicated or when it can cause serious harm to the health (a) the seal or closure of the installation or part of the installation where the activity is carried out and, where appropriate, the freezing or confiscation of the genetically modified organisms or the products containing them, the competent authority having to start the corresponding the procedure for sanctioning or the instructor of the file shall decide on its continuity or its lifting within a period of 15 days from the date on which the measures were agreed.

Article 37. Measures of a provisional nature.

When a sanctioning procedure has been initiated, the competent authority may adopt some or some of the following provisional measures:

a) Temporary, partial or total closure, suspension or cessation of installations.

b) Temporary suspension of the authorization for the exercise of the activity.

(c) Mobilization of the genetically modified organisms or the products containing them.

d) Any other corrective, security or control measures that impede the continuity of the damage production.

Article 38. Obligation to replenish, periodic penalty payments and subsidiary execution.

1. Without prejudice to the penalties provided for, those responsible for infringing activities shall be obliged to replace the state they had before the infringement and to pay the corresponding compensation for damages. (a) the amount shall be fixed by the Administration which, in each case, is competent, without prejudice to the jurisdiction of judges and courts.

When the damage is difficult to assess, the following criteria will apply, either jointly or separately: the theoretical cost of restitution and replacement, the value of the damaged goods, the cost of the project or the activity causing the damage and profit obtained with the infringing activity.

2. If, after the completion of the sanctioning procedure and after the time limits laid down in the relevant requirement, the infringer does not proceed to the replacement or restoration provided for in the preceding paragraph, the competent authority may agree to the imposition of periodic penalty payments, the amount of which shall not exceed one third of the fine for the type of infringement committed.

3. The competent authority may also carry out subsidiary implementation on behalf of the infringer and its coast.

Additional disposition first. Antibiotic resistance markers.

The elimination of antibiotic resistance marker genes in genetically modified organisms that may have negative effects on human health and the environment will be performed progressively, with be disposed of before 31 December 2008, in the case of voluntary release activities for purposes other than placing on the market, and before 31 December 2004, in the case of the placing on the market of such organisms.

Additional provision second. Collegiate bodies.

1. The powers which this law confers on the General Administration of the State in relation to the activities within it shall be exercised by the following bodies:

(a) The Inter-Ministerial Council of Genetically Modified Organisms, to which it is appropriate to grant authorizations for the activities of contained use, voluntary release and marketing of modified organisms It will be composed of representatives of the ministerial departments with powers related to this law.

(b) The National Biosafety Commission, a consultative body of the General Administration of the State and the Autonomous Communities, which shall inform the relevant applications for authorisation, shall be composed of: representatives of the ministerial departments, of the autonomous communities that request it, as well as of persons and institutions which are experts or have competence in matters covered by this law.

2. The National Biosafety Commission shall also inform, in addition, the requests for authorisation to be granted to the Autonomous Communities.

3. These collegiate bodies will be attached to the Ministry of the Environment, which will provide the necessary resources for its proper functioning. Its composition and functions shall be established regulatively.

Additional provision third. Records.

The competent authorities shall establish public records in which the location of the genetically modified organisms released for purposes other than the placing on the market, as well as the location of which they are located, shall be recorded. cultivates in accordance with the provisions of this law for marketing.

Under the Ministry of Environment there will be a central register that will be nourished by the data available to the department itself and from those provided by the autonomous communities.

Additional provision fourth. Administrative silence.

The lack of resolution expressed by the competent Administration of the authorization requests regulated in this law will produce disestimatory effects.

Additional provision fifth. Processing and procedure.

1. The communications, applications and authorisations referred to in Title II of this Act shall be submitted, processed and resolved by means of the procedures and within the time limits to be determined.

2. The time limits for the implementation of the acts before the Commission of the European Communities and the other Member States which are governed by this law shall be counted from the dates which for such cases shall be determined.

First transient disposition. Authorization requests pending resolution.

Applications for authorisation for the contained use and voluntary release of genetically modified organisms, which have not been resolved at the entry into force of this law, will continue to be processed in accordance with the procedure provided for in Law 15/1994 and in the General Regulation for its development and implementation.

Second transient disposition. Renewal of previously granted marketing authorizations.

The marketing authorisations for genetically modified organisms obtained in accordance with the legislation to be repealed by this law shall be renewed, where appropriate, in accordance with the procedure laid down in this Regulation.

regulation (EU) No 176/2014 of the European Parliament and of the Council

Transitional provision third. Transitional regime of the General Regulation for the development and implementation of Law 15/1994 and the temporary validity of collegiate bodies.

1. The general regulation for the development and implementation of Law 15/1994 of 3 June establishing the legal system for the contained use, voluntary release and placing on the market of genetically modified organisms, to prevent risks to human health and the environment, approved by Royal Decree 951/1997 of 20 June, will be applicable in so far as it does not object to the provisions of this law during the six months from its entry into force, during which the Government must lay down the rules that replace it.

2. Likewise, the collegiate bodies provided for in Law 15/1994 and the General Regulation for their development and implementation shall continue and carry out the tasks assigned to them until the new collegiate bodies provided for therein are established. law.

Single repeal provision. Regulatory repeal.

Law 15/1994 of 3 June, establishing the legal regime for the contained use, voluntary release and placing on the market of genetically modified organisms, is hereby repealed in order to prevent risks for human health and for the environment, as well as how many provisions of equal or lower rank are opposed to what is established in this law.

Final disposition first. Constitutional foundation.

This law is issued in accordance with the provisions of Article 149.1.16. and 23. of the Constitution, which reserves the State competence in the field of basic and general health care and legislation on the protection of the environment, respectively. However, Title III of the Constitution is dictated by the provisions of Article 149.1.14. of the Constitution, which reserves the State exclusive competence in matters of general hacienda.

Final disposition second. Reporting obligation.

1. The Autonomous Communities shall provide the Ministry of the Environment with the data necessary to comply with the reporting obligations to the European Commission. The Ministry of the Environment will also make available to the Autonomous Communities the information available to them.

2. Applications for the authorisation of voluntary releases to be addressed to the Autonomous Communities will be brought to the attention of the Ministry of the Environment, so that the Inter-Ministerial Council of Genetically Modified Organisms may make comments, and for the department to submit the relevant documentation to the European Commission. The Ministry of the Environment will bring them to the attention of the other autonomous communities to issue the comments or suggestions they deem appropriate.

Likewise, applications for authorization of voluntary and marketing releases to be addressed to the Interministerial Council of Genetically Modified Organisms will be made available to the communities. (a) to make their comments.

Final disposition third. Updating rates and penalties.

The government, by means of a royal decree, may update the amount of the fees and penalties provided for in this law, taking into account the variation in the consumer price index.

Final disposition fourth. Situation reports.

Every three years a report will be produced, which will be made public, on the situation in Spain in the field of genetically modified organisms, in the terms that are regulated.

Final disposition fifth. Development enablement.

The Government is empowered to make, within the scope of its powers, the necessary provisions for the development and implementation of this law and to amend its provisions when such amendments result from a change in the law. Community rules and affect the techniques or methods excluded from the field of application of the law, both general and those of each activity; to the definitions; to the classification of the risk of the activities of contained use, and to the requirements to be able to perform the activities regulated in this law.

Therefore,

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

Madrid, 25 April 2003.

JOHN CARLOS R.

The President of the Government,

JOSÉ MARÍA AZNAR LÓPEZ