Law 9/2003 of 25 April establishing the legal regime for the contained use, voluntary release and placing on the market of genetically modified organisms, incorporated into Spanish law the substantive rules of Council Directive 98 /81/EC of 26 October 1998 amending Directive 90 /219/EEC on the contained use of genetically modified micro-organisms and Directive 2001 /18/EC of the European Parliament and of the Council Proposal for a European Parliament and Council Directive of 12 March 2001 on the deliberate release in the medium the environment of genetically modified organisms and repealing Council Directive 90 /220/EEC.

However, as evidenced in its explanatory memorandum, Law 9/2003 of 25 April 2003 makes a partial incorporation into the Spanish law which is limited to the collection and adaptation of those rules of the abovementioned Directives. which, by reason of their legal nature and their full effectiveness in the internal system, are subject to the principle of the reserve of law, while the incorporation of those other rules of the directives of technical or Cyclical nature, not subject to the above mentioned principle, has been deferred to the regulatory field.

On the other hand, since the date of its entry into force, the rules which have been the subject of the abovementioned directives have been affected by the European Union's order from two different perspectives.

First, by the publication of various Commission and Council decisions which complement the content of both directives, including the Commission Decision 2000 /608/EC of 27 September 2000, which is the subject of the Commission's Decision 2000 /608/EC of 27 September 2000. 2000, concerning the guidance notes for the risk assessment described in Annex II to Directive 90 /219/EEC; Council Decision 2001 /204/EC of 8 March 2001 supplementing Directive 90 /219/EEC in respect of the criteria for establishing the safety of genetically modified micro-organisms for the purposes of human health and the environment; Commission Decision 2002/623/EC of 24 July 2002 laying down guidance notes in addition to Annex II to Directive 2001 /18/EC; Council Decision 2002/811/EC of 3 December 2002 on the October 2002 laying down additional guidance notes to Annex VII to Directive 2001 /18/EC; Council Decision 2002/812/EC of 3 October 2002 laying down, in accordance with Directive 2001 /18/EC, the the summary of the notification of the placing on the market of genetically modified organisms as a product or product component; Council Decision 2002/813/EC of 3 October 2002 establishing, in accordance with Directive 2001 /18/EC, the model of the summary of the notification of deliberate release in the medium the environment of genetically modified organisms for purposes other than their placing on the market; Commission Decision 2003 /701/EC of 29 September 2003 establishing a model for the presentation of the results of the release intended for the environment of higher plants for a purpose other than that of their placing on the market in accordance with Directive 2001 /18/EC of the European Parliament and of the Council and the Commission Decision laying down detailed rules for the operation of registers established under the Directive 2001 /18/EC of the European Parliament and of the Council for the recording of information relating to genetic modifications in genetically modified organisms.

The provisions contained in Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on the cross-border movement of modified organisms should be considered. genetically, which supplements the content of the said Directives, in Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 on the traceability and labelling of genetically modified organisms and the traceability of the food and feed produced from the food and feed from which the Directive 2001 /18/EC and Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed, which requires the collection of these modifications in a standard of range regulatory.

In addition, the effective implementation of Law 9/2003, of 25 April, involves developing regulations, among others, on various aspects of its articles related to the structure, composition and functions of the Council. inter-ministerial meeting of genetically modified organisms and the National Biosafety Commission, with the requirements for the implementation of contained use activities, voluntary release for purposes other than their marketing and the placing on the market of genetically modified organisms, with the rules on information, monitoring and control of these activities, as well as on the subject of sanctions.

According to the above, it is necessary to proceed to the approval and publication of a rule that allows the Government to develop the content of Law 9/2003, of April 25, and to finalize, at the same time, the process of incorporation into the (a) the Spanish legislation of the directives and other Community rules mentioned above; a rule which, by virtue of its legal nature and in accordance with the enabling provision which is the subject of the fifth final provision of that law, must cover the range and form of a royal decree.

In the elaboration of this royal decree, the autonomous communities have been heard, as well as the sectors affected.

In its virtue, on the proposal of the Ministers of the Environment, Agriculture, Fisheries and Food, of Health and Consumer Affairs and of Science and Technology, with the prior approval of the Minister of Public Administrations, according to the Council of State and after deliberation by the Council of Ministers at its meeting on 30 January 2004,

DISPONGO:

Single item. Adoption of the Regulation.

The General Regulation for the Development and Implementation of Law 9/2003 of 25 April, establishing the legal regime for the contained use, voluntary release and placing on the market of organisms, is hereby approved. genetically modified, which is inserted after this royal decree.

Additional disposition first. Central record.

In accordance with the provisions of the additional provision of Law 9/2003 of 25 April 2003 establishing the legal regime for the contained use, voluntary release and placing on the market of organisms Genetically modified, the Central Register of genetically modified organisms is created, attached to the Ministry of the Environment, whose management corresponds to the General Directorate of Quality and Environmental Assessment.

The Central Register is unique throughout the national territory and is based in Madrid.

The Inter-Ministerial Council of Genetically Modified Organisms, the National Biosafety Commission, the ministerial departments responsible for the matter and the competent bodies of the Autonomous Communities forward to the Central Register how much data they have on account of their competence, and which result from the processing of communications and applications for authorisation for contained use, voluntary release, and placing on the market of bodies genetically modified as referred to in the Regulation which is adopted.

The register will also be fed by information from the European Commission and the other Member States through the appropriate links.

The registration should reflect the location of the genetically modified organisms subject to voluntary release for purposes other than placing on the market, as well as those that are grown in accordance with the provisions of the Law 9/2003 of 25 April 2003 and in the regulation adopted by this royal decree for the marketing of such organisms, in order that the possible effects of such organisms on the environment may be monitored, in accordance with the provisions of the Article 37 (f) and Article 42 of the Regulation. The information on the location of crops of genetically modified plant varieties shall be that corresponding to their distribution by autonomous communities and provinces.

The data will be contained in an appropriate file to receive, store and retain all the information that has to be recorded in the register, and to be able to retrieve it and make it available to the public.

The provision of data may be carried out by telematic means, provided that the support used ensures the authenticity of the communication and its content, and that the full remission and receipt of the data are recorded and which were made.

Public access to the information collected in the register shall be made taking into account the provisions of Law 38/1995 of 12 December 1995 on the right of access to information in the field of the environment, and in accordance with the provisions relating to trade and industrial secrecy, the secrecy of procurement and the protection of personal data.

Additional provision second. Economic impact.

The functioning of the Inter-Ministerial Council of Genetically Modified Organisms, the National Biosafety Commission and the Central Register Regulated in the Additional Provision of this Royal Decree will not increase of public expenditure, and its functioning will be met with the human and material resources of the Ministry of the Environment.

Single repeal provision. Regulatory repeal.

Royal Decree 951/1997 of 20 June 1997 is hereby repealed. The General Regulation for the Development and Implementation of Law 15/1994 of 3 June 1994 establishing the legal system for the use of the contained use is hereby repealed. voluntary release and placing on the market of genetically modified organisms, in order to prevent risks to human health and the environment, and how many provisions of equal or lower rank are opposed to the provisions of this royal decree.

Final disposition first. Implementation of the Cartagena Protocol on Biosafety.

as National Focal Point and National Competent Authority, according to the Instrument of Ratification of the Protocol of Cartagena, of December 10, 2002, the Directorate General of Quality and Environmental Assessment of the Ministry of the Environment Environment shall assume the functions laid down in Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on the transboundary movement of genetically modified organisms

Final disposition second. Basic character.

This royal decree and the precepts of the regulation adopted, except for Articles 1, 5, 6, 7, 8, 9, second paragraph, 24.2 and 3, 25.5 and 6, are of a nature of basic legislation on the protection of the environment and the health, and they are issued under the terms of Article 149.1 16. and 23. of the Constitution.

Final disposition third. Development enablement.

Ministers of the Interior, Education, Culture and Sport, Agriculture, Fisheries and Food, Health and Consumer Affairs, Environment, Economy and Science and Science and Technology are empowered to dictate, in the field of their respective powers, how many provisions are necessary for the implementation and development of what is established in this royal decree.

Final disposition fourth. Entry into force

This royal decree will enter into force on the day following its publication in the "Official State Gazette".

Given in Madrid, 30 January 2004.

JOHN CARLOS R.

The Second Vice President of the Government

and Minister of the Presidency,

JAVIER ARENAS BOCANEGRA

GENERAL REGULATION FOR THE DEVELOPMENT AND IMPLEMENTATION OF LAW 9/2003 OF 25 APRIL ESTABLISHING THE LEGAL REGIME FOR THE CONTAINED USE, VOLUNTARY RELEASE AND PLACING ON THE MARKET OF MODIFIED ORGANISMS GENETICALLY

TITLE I

General Provisions

CHAPTER I

Object and Scope

Article 1. Object.

This regulation is intended to lay down the rules necessary for the development and implementation of Law 9/2003 of 25 April establishing the legal regime for the contained use, voluntary release and placing on the market of genetically modified organisms.

Article 2. Scope.

1. This Regulation shall apply to activities of contained use, voluntary release for purposes other than the placing on the market and placing on the market of genetically modified organisms or of products containing them.

2. The activities referred to in the preceding paragraph shall be excluded from the scope of this Regulation where the genetic modification of the organisms is obtained by means of mutagenesis or fusion (including protoplast) techniques plants, 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 organisms genetically modified.

Also excluded from this regulation are the use of "in vitro" fertilization, conjugation, transduction, transformation or any other natural process and polyploid induction, provided they do not involve the 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 3. Techniques that result in a genetic modification.

For the purposes of Article 2 (b) of Law 9/2003, of 25 April, the following are considered to be techniques which give rise to a genetic modification:

(a) nucleic acid recombination techniques, including the formation of new combinations of genetic material by the insertion of nucleic acid molecules-obtained by any means outside an organism-into a virus, bacterial plasmid or other vector system and its incorporation into a host organism in which they are not naturally found but may continue to be reproduced.

(b) Techniques involving direct incorporation into a body of hereditary material prepared outside the body, including microinjection, macroinjection and microencapsulation.

c) Cell fusion techniques (including protoplast fusion) or hybridization in which live cells are formed with new combinations of hereditary genetic material by merging two or more cells using methods that do not occur naturally.

Article 4. Definitions.

For the purposes of Law 9/2003 of 25 April, and in this Regulation, in addition to the definitions set out in Article 2 of that Law, it is understood by:

a) Risk assessment: assessment of risks to human health and the environment, whether direct or indirect, immediate or deferred, which may involve activities with genetically modified organisms regulated in Law 9/2003 of 25 April, and in this regulation.

(b) Product: preparation consisting of a genetically modified organism or a combination of or containing the genetically modified organisms and placed on the market.

c) Traceability: the ability to trace the genetically modified organisms and products produced from genetically modified organisms along the production and distribution chains in all the stages of their marketing.

(d) Unique identifier: single numeric or alphanumeric code whose purpose is to identify each genetically modified organism according to the authorised genetic transformation from which it is derived, and to make it easier to collect specific information for those.

(e) Operator: any natural or legal person who places a product on the market or receives a product marketed in the European Union, both in a Member State and in a third country, at any stage of its production or distribution, except for the final consumer.

f) End Consumer: The last consumer who is not going to use the product as part of a business operation.

g) Prepackaged product: condition of a unit item for sale, consisting of a product and the packaging in which it has been placed before it is put up for sale and which covers it in whole or in part, provided that the content does not may be modified without opening or altering the package.

h) Self-cloning techniques: the extraction of nucleic acid sequences from a cell of an organism, which may or may not be followed by the total or partial reinsertion of said nucleic acid (or a synthetic equivalent), with or without prior enzymatic or mechanical phases, in cells of the same species or of a species with very similar phylogenetic characteristics, which may exchange genetic material for natural physiological processes, provided that it is unlikely that the resulting organism is pathogenic to humans, animals or plants. Self-cloning may include the use of recombinant vectors in relation to which a long history of safe use is available in the relevant organisms.

CHAPTER II

Competencies of public administrations and organs of the General Administration of the State

Article 5. Powers of the public administrations.

1. The powers conferred on the General Administration of the State in the field of authorisations and report paragraphs 1 to 3 of Article 3 and the second provision of Law 9/2003 of 25 April establishing the The legal basis for the contained use, voluntary release and placing on the market of genetically modified organisms, will be carried out by the inter-ministerial Council of genetically modified organisms and by the National Biosafety Commission, attached to the Ministry of the Environment.

2. The inter-ministerial Council of genetically modified organisms and the National Biosafety Commission shall adjust their actions and function to the provisions of Chapter II of Title II of Law No 30/1992 of 26 November 1992. Legal of Public Administrations and of the Common Administrative Procedure.

3. It is for the autonomous communities to exercise the functions provided for in Article 4 of Law 9/2003 of 25 April establishing the legal system for the contained use, voluntary release and marketing of genetically modified organisms.

Likewise, in accordance with the second final provision of the abovementioned law, it is for the autonomous communities to make observations on applications for authorization of releases. (a) voluntary and marketing measures to be adopted by the Inter-Ministerial Council of genetically modified organisms.

Section 1 of the Interministerial Council of Genetically Modified Organisms

Article 6. Composition of the Council.

1. The inter-ministerial Council of genetically modified organisms shall be composed of the following members:

a) President: the Director General of Environmental Quality and Evaluation at the Ministry of the Environment.

b) Eleven vowels that will correspond to:

A representative of the Ministry of the Interior.

A representative of the Ministry of Education, Culture and Sport.

Two representatives from the Ministry of Agriculture, Fisheries and Food.

A representative of the Ministry of Health and Consumer Affairs.

A representative of the Ministry of the Environment.

A representative of the Ministry of Economy.

Two representatives from the Ministry of Science and Technology.

A representative of the Spanish Food Safety Agency.

A representative of the Spanish Agency for Medicines and Health Products.

2. The vowels, with the rank of director general, will be proposed by the corresponding ministers and appointed by the Minister of the Environment.

Subject to the procedure laid down in the preceding paragraph, the competent ministries may appoint alternates to replace the vowels in the cases of vacancy, absence or sickness of such persons, provided that the (a) a designation of level 30 officials engaged in activities in the field of biotechnology.

The Council may also appoint from among its members a vice-president who shall replace the president in the absence, vacancy or illness of the president.

3. He will act as secretary, with voice but no vote, a group A official from the Directorate General of Quality and Environmental Assessment who performs functions in biotechnology-related areas.

4. Without prejudice to the above paragraphs, where the nature or the importance of the cases to be dealt with so requires, they may attend meetings of the inter-ministerial Council of genetically modified organisms, with a voice but without a vote, the holders of other management bodies of the departments mentioned, whose scope of management is related to the subject matter to be dealt with.

5. The Council shall meet as many times as necessary for the performance of its tasks and, in any event, at least twice a year.

Article 7. Duties of the Council.

1. It is for the inter-ministerial Council of genetically modified organisms to grant the authorisations referred to in Article 3 of Law 9/2003 of 25 April, as well as the other functions assigned to it in this Regulation.

2. Where the authorisations for the use of the contained use and voluntary release for purposes other than the placing on the market are intended to cover one of the activities referred to in Article 3.2.a) of the law referred to above, the authorisation shall be conditional on the agreement of the representative of the Ministry of Health and Consumer Affairs, except in the case of medicinal products for veterinary use which shall require the approval of the representatives of the Ministries of Health and Consumption and Agriculture, Fisheries and Food.

3. If the authorisations were intended to carry out activities for the contained use and voluntary release of genetically modified organisms, in the cases referred to in Law 13/1986 of 14 April of promotion and coordination In the context of scientific and technical research, and in the framework of research programmes carried out by bodies or bodies dependent on the General Administration of the State, the granting of authorization is subject to the representation of the Ministry of Science and Technology.

4. For authorizations relating to the technical examination for the registration of commercial varieties referred to in Article 3.2.c of Law 9/2003 of 25 April, the conformity of the representation of the Ministry of Agriculture shall be required, Fishing and Food.

5. Decisions of the inter-ministerial Council of genetically modified organisms which grant or refuse authorisations shall terminate the administrative route.

Section 2 of the National Biosafety Commission

Article 8. Nature and composition of the National Biosafety Commission.

1. The National Biosafety Commission, provided for in the second provision of Law 9/2003 of 25 April, is a collegiate body of consultative status of the General Administration of the State and the Autonomous Communities.

2. The National Biosafety Commission shall be composed of the following members:

(a) President: an official of the Environmental Quality and Assessment Directorate, appointed by the Secretary-General of the Environment.

(b) A vice-president, appointed from among the vowels representing the General Administration of the State by agreement of the plenary of the Commission, to be appointed by the Secretary-General of the Environment.

c) The following vowels representing the General Administration of the State:

1. A representative of the Directorate General of Civil Protection, Ministry of the Interior.

2. A representative of the Ministry of Education, Culture and Sport.

3. Four officials representing the Ministry of Agriculture, Fisheries and Food, experts in food technology, agriculture and livestock.

4. Four officials representing the Ministry of Health and Consumer Affairs, food safety experts, medicines for human and veterinary use, public health and analytical techniques.

5. Two officials from the Ministry of the Environment, biosafety and biodiversity experts.

6. An official representing the Ministry of Economy, an expert in foreign trade.

7. Four officials from the Ministry of Science and Technology, with expertise in technology policy, research programs and agri-food technology.

The vowels will be appointed by the respective ministries and appointed by the Secretary-General of the Environment.

d) One voice for each of the autonomous communities that so request the Secretary General of the Environment.

e) Up to a maximum of six members representing scientific institutions, experts in matters covered by Law 9/2003 of 25 April, appointed by the Secretary-General for the Environment on a proposal from the Council inter-ministerial of genetically modified organisms.

The advice of scientists or experts for specific topics may also be sought.

f) He will act as secretary, with voice but no vote, an official from the Environmental Quality and Evaluation Directorate.

Article 9. Functions.

The National Biosafety Commission will inform preceptively about applications for authorization to be granted to the General Administration of the State and to the Autonomous Communities.

In addition, perform the following functions:

(a) Report on the classification of the most appropriate type for the contained use of genetically modified organisms, in the case referred to in Article 12.3.

b) Report on whether the data and documents provided are complete and accurate, whether the measures relating to the management of waste, security and response in the event of an emergency are appropriate and whether the activity of which it is carried out intends to comply with the provisions of Law 9/2003 of 25 April and of this Regulation, as set out in Article 16.1 of the latter.

(c) Report on whether projects for the contained use of genetically modified organisms are to be submitted to public information, as set out in Article 16.2.d).

(d) To report on the basis of prior adoption of the relevant decision by the competent bodies, in the cases provided for in Articles 15, 17.3, 19.4, 24, 25.5 and 6, 33.2, 35.1, 40.2, 42.1, 44.2, 46.2 and 50.

e) Report on the proposals, development and implementation of the monitoring plans in the cases referred to in Articles 32.2, 37 and 42.

(f) Report on the other issues to be submitted for consideration by the Inter-Ministerial Council of genetically modified organisms or by the competent body of the Autonomous Communities

Article 10. Operation of the Commission.

1. The National Biosafety Commission may act in plenary or through working groups, and shall meet as many times as necessary to report applications for authorisation for activities carried out with genetically modified organisms and for the performance of the other functions referred to in the previous Article.

2. Under the Commission's dependence, it may be possible to establish how many expert groups are deemed necessary for carrying out the necessary scientific and technical support activities for the performance of their duties.

The agreement to set up such groups, which will not be permanent, will be carried out by the plenary of the Commission and will establish its composition, objectives and deadlines for action, corresponding to the coordination of the groups which the President of the Commission is believed.

3. The members of the National Biosafety Commission and the expert groups shall channel any institutional relationship arising from their membership through their president, and shall refrain from carrying out any communication activities. risks, as well as any form of statements or statements in relation to their reporting, study or evaluation activities, without prejudice to the duty of information of the representatives of public administrations to their departments.

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 11. 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. They are excluded from the obligations set out in this Chapter:

(a) The genetic modifications obtained by means of self-cloning and cell fusion techniques, including protoplasts, of both prokaryotic species and the exchange of genetic material by known physiological processes, of 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 genetically modified organisms obtained by techniques or methods other than those excluded under Article 2.2, First paragraph.

(b) Confined uses which include only types of genetically modified organisms of an innocuous nature determined in accordance with Council Decision 2001 /204/EC of 8 March 2001 and other provisions Community that modify or supplement it.

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 to another standard requiring an assessment of the risk to human health and the environment equivalent to that laid down in this Chapter, provided that the contained use is adjusted, if any, to the conditions of the authorisation. of placing on the market.

Article 12. Classification.

1. The contained use activities of genetically modified organisms shall be classified according to the prior assessment of risks to human health and the environment in the following types:

a) Type 1. Zero or negligible risk activities: those in which the level 1 of confinement is sufficient to protect human health and the environment.

b) Type 2. Low-risk activities: those in which the degree 2 of confinement is sufficient to protect human health and the environment.

c) Type 3. Moderate risk activities: those in which the level 3 of confinement is sufficient to protect human health and the environment.

d) Type 4. High-risk activities: those in which the level 4 of confinement is sufficient to protect human health and the environment.

2. The risk assessment for human health and the environment shall be carried out in accordance with the provisions set out in Annex I.

3. Where there are reasonable doubts as to the classification of a given activity, the measures corresponding to the highest risk rate shall apply. However, the competent authority may authorise the activity to be carried out using less stringent measures, provided that the person responsible for the operation has notified it in advance, providing evidence to justify it.

4. For the purposes of the above paragraph, where the competence corresponds to the General Administration of the State, the communication shall be addressed to the Director-General of Quality and Environmental Assessment of the Ministry of the Environment, in its quality of president of the inter-ministerial Council of genetically modified organisms.

The Director General of Quality and Environmental Assessment, through the secretary of the inter-ministerial council of genetically modified organisms, will bring to the attention of its members and of the National Commission of Biosafety communication. The Inter-Ministerial Council shall, within one month, decide on the authorisation requested, subject to a report from the Commission.

Article 13. 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 the risk to human health and the environment, as set out in the previous article.

(b) To record the risk assessment for human health and the environment to be submitted to the competent body as part of the communications referred to in Article 14, as well as when requested. The register shall contain at least the following information:

1. The date of submission of the communication referred to in Article 14.1.

2. The name of the owner of the activity and the persons responsible for the supervision and security.

3. The activity description: objective and duration of the activity.

4. Identification of the characteristics of the genetically modified organism that may cause adverse effects on human health or the environment.

5. The final classification of the activity.

6. º Dates of the periodic reviews of the facilities referred to in paragraph (f) of this paragraph that the holder of the activity performs.

(c) Meet the specific safety and professional hygiene standards and apply the principles of good microbiology practice, as set out in Annex II.

(d) Apply the general principles and the containment and protective measures corresponding to the type of contained use, as provided for in Annex II, in such a way that the exposure of the workplace and the environment to the Genetically modified organisms are as minor as possible and a high degree of safety is ensured.

(e) Develop the emergency plans and the monitoring of installations, in the cases provided for in Article 20.

f) Review regularly the containment and protective measures applied, as well as the risk assessment carried out. Such a review shall be carried out whenever the confinement measures applied are no longer appropriate or the type assigned to the contained uses is no longer correct, or where there is reason to assume that, in the light of new knowledge scientists or technicians, the risk assessment is no longer adequate.

2. Transport by any means of genetically modified organisms will only require an assessment of the risk to human health and the environment and that the specific safety and professional hygiene standards are met.

Article 14. Prior communication to the Administration.

1. Natural or legal persons who intend to use for the first time specific installations for the use of confined uses of genetically modified organisms shall be obliged to inform the competent authority thereof, without prejudice to the other authorisations or licences which are due in accordance with the legislation in force.

This communication shall contain the information set out in Part A of Annex III

2. For the first or subsequent confined uses of type 2, following the communication referred to in paragraph 1, a communication containing the information set out in Part B of Annex III shall be submitted.

3. For the first or successive uses confined to types 3 and 4, following the communication referred to in paragraph 1, a communication containing the information set out in Part C of Annex III shall be submitted.

Article 15. Presentation of the communications.

1. Where the competence corresponds to the General Administration of the State, the communications regulated in this Chapter shall be addressed to the Director General of Quality and Environmental Assessment, as chairman of the Inter-Ministerial Council of genetically modified organisms.

The Director General of Quality and Environmental Assessment, through the secretary of the inter-ministerial council of genetically modified organisms, will bring to the attention of its members and those of the National Commission of Biosecurity such communication.

2. Where the competition concerns the autonomous communities, the holder of the activity shall submit to the competent authority of that authority the relevant communication.

The competent body, once the appropriate documentary evidence has been carried out, will immediately send a copy of the aforementioned communication to the Director General of Quality and Environmental Assessment who, through the secretary of the Inter-Ministerial Council of genetically modified organisms, shall make known to the National Biosafety Commission a copy of the communication for the purpose of issuing the mandatory report in accordance with Article 9.

Article 16. Verification by the competent body.

1. The competent authority shall verify that the information, data and documents provided are complete and accurate, that the risk assessment for human health and the environment and the type of contained use of genetically modified organisms they are correct and that, where appropriate, the measures relating to the containment, the other protective measures, the management of the waste, the emergency and monitoring plans are the appropriate ones, and all of this, as well as the activity to be carried out, complies with the provisions of Law 9/2003 of 25 April and of this Regulation.

2. Where appropriate, the competent authority may:

(a) Require those responsible for the contained use of genetically modified organisms to provide additional information, to modify the conditions or the type assigned to the proposed contained use. In this case, the competent authority may require that the proposed contained use is not initiated and, if it has already been initiated, suspended or terminated until the competent authority has given its consent in accordance with the information provided for in this Article. additional obtained or the modification of the conditions for the contained use.

b) Limit the period in which the contained use is permitted, or subject it to certain specific conditions.

(c) Consult experts, institutions or public administrations when the characteristics or nature of the activity to be developed are deemed to be appropriate.

d) Submit communication to public information, with this being required if it is a transaction of types 3 and 4, for a period of 30 days.

Article 17. Execution of the activities communicated to the Administration.

1. The contained use activities of type 1 may be carried out by the holders of the activities:

(a) Immediately after the submission of the first use communication of a facility for contained use activities of type 1 referred to in Article 14.1.

(b) If the installation has already been the subject of a communication in accordance with Article 14.1, the successive contained use activities of type 1 shall not require any other communication.

The natural and legal persons intending to carry out these operations shall be required to keep a record of the risk assessments for human health and the environment of such operations, which they shall provide to the competent body where it so requests. The register shall contain at least the information referred to in Article 13.1.b

2. The confined uses of type 2 may be carried out by the holders of the activities:

(a) If the facilities have not been the subject of prior communication relating to the contained use activities of types 2 or below, the contained use of type 2 may be initiated unless otherwise specified in the the competent authority, 45 days after the submission of the communication referred to in Article 14.2, or earlier if the competent authority so authorises.

(b) If the facilities have been subject to prior communication relating to the contained use activities of types 2 or below and the requirements of the authorisation are met, the contained use of type 2 may be start immediately after the new communication.

3. For the purposes of the above paragraphs and in accordance with Article 9, the competent body shall adopt the relevant resolution, after a report from the National Biosafety Commission.

Article 18. Activities subject to express authorisation.

1. The contained use activities of types 3 and 4 shall be expressly authorised by the competent body.

2. The contained use activities of type 2 shall also be subject to express authorisation in the following cases:

(a) Where the competent authority requests the holder more information than that provided in its communication, or when the conditions or the type assigned to the proposed contained use are modified.

(b) At the request of the person concerned to make a contained use of type 2 in installations which have been the subject of any of the communications referred to in Article 14 (2) and (3

.

Article 19. Resolution and notification of authorizations.

1. The competent body shall issue a decision on the authorisation of the contained use activities provided for in Article 18.2 within 45 days of the communication referred to in Article 14.2.

2. The competent authority shall issue a decision on the authorisation of the contained use activities of types 3 and 4, as provided for in Article 18.1

(a) Within 45 days of the submission of the communication referred to in Article 14.3, if the facilities have been previously authorised to carry out confined uses of types 3 and 4, and requirements for the authorisation for the same type of contained use or a higher type than the contained use that is intended to be made.

(b) Within 90 days of the submission of the communication referred to in Article 14.3, if the facilities have not been subject to prior authorisation to carry out confined uses of types 3 and 4.

3. However, the competent authority may expressly authorise the performance of the activities before the time limits set out in the preceding paragraphs.

4. For the purposes of this Article, and in accordance with the provisions of Article 9, the competent body shall adopt the relevant resolution, subject to the report of the National Biosafety Commission.

5. Resolutions shall be notified within the time limit for the adoption of the authorisations provided for in this Article.

Article 20. Emergency plans.

1. Where necessary, in the opinion of the competent authority, and in any event before the start of a contained use operation of genetically modified organisms of types 3 and 4, and in any case where a failure of the measures of (a) a health emergency plan and an epidemiological and environmental surveillance plan must be drawn up, except in cases where a plan of emergency has been drawn up; This is an emergency of these characteristics under the existing sectoral legislation applicable to the installation. These plans shall include the actions to be taken for the protection of human health and the environment in the event of an accident outside the premises where the activity is radiating.

2. These health emergency and epidemiological and environmental surveillance plans shall be drawn up by the body designated by the autonomous community where the facilities are located and shall be referred to the competent body. The plans shall be drawn up taking into account the data provided by the holders of the contained use activities, as set out in Annex III, and shall have at least the following content:

a) Analysis of the risks that different accident scenarios may pose to human health and the environment outside the facility.

(b) Health, epidemiological and environmental actions to be followed in the event of an accident.

c) Organization of the services, resources and resources necessary for the performance of the planned actions.

(d) Identification of the person or body to whom the information on safety measures and the behaviour to be observed should be provided, in the event of an accident, outside the premises, of in accordance with paragraph 5 of this Article.

(e) Identification of the person or body to which the holder of the activity must report, in the event of an accident, the information referred to in Article 21.

(f) Identification of the person or body to whom the functions of management and coordination of the actions to be followed in the event of an accident are attributed, in accordance with Article 21.

3. Where the inter-ministerial Council of genetically modified organisms, in the cases referred to in Article 3.2 of Law 9/2003 of 25 April, considers that a health emergency and epidemiological and environmental surveillance plan should be drawn up, send the information provided by the holders of the contained use activities, in accordance with Annex III, to the body designated by the autonomous community concerned, in order to produce such information. plan.

4. The holders of the activities shall draw up emergency and internal surveillance plans which provide for appropriate risk prevention measures and actions in the event of emergency, alarm or relief, and evacuation within the internal borders. of the facilities.

5. Where this is required by the rules applicable in the field of civil protection, the body to which the approval of the emergency plans falls, prior to the approval of the emergency plans, shall forward the plans to the competent body in question. civil protection matters, for the purpose of obtaining their approval or of establishing the coordination of actions and resources as appropriate.

6. The competent authority shall ensure that, prior to the start of a contained use, persons, bodies and authorities which may be affected in the event of an accident are adequately informed of the plans of the accident. the emergency and surveillance provided for in the previous paragraphs. This information shall be repeated and updated at the appropriate intervals. In any case, such information shall be public and free of access to the citizen.

7. Information on safety measures and behaviour which, in the event of an accident, must be observed inside the facility shall be provided by the operators of the activities.

The information on safety measures and behaviour to be observed on the outside of the facility shall be provided by the person or body who, in each case, is established in the relevant emergency plan. health and epidemiological and environmental surveillance.

8. The information referred to in paragraph 2 shall be communicated to the Directorate-General for Quality and Environmental Assessment in order to inform the other Member States of the European Union concerned of the safety measures adopted in accordance with this Directive. with this article. The Directorate-General for Quality and Environmental Assessment shall also consult on the implementation of health emergency plans and epidemiological surveillance on Member States that may be affected in the event of an accident.

Article 21. Information and actions in the event of an accident.

1. In the event of an accident, the holder of the activity shall immediately inform the competent authority, as well as the person or body, which has been established in the health emergency and epidemiological surveillance plan and environmental of the Autonomous Community, providing the following information:

a) The circumstances of the accident.

(b) The identity and quantity of the genetically modified organisms concerned.

c) Any information necessary to assess the effects of the accident on the health of the population and on the environment.

d) Emergency measures that have been taken after the accident.

For the purposes of this paragraph, when the competition to receive the communication corresponds to the General Administration of the State, the communication will be directed to the Director General of Quality and Environmental Assessment, in its quality of President of the Interministerial Council of genetically modified organisms, and may be present in any of the places referred to in Article 38 (4) of Law 30/1992 of 26 November.

The Director General of Quality and Environmental Assessment, through the secretary of the inter-ministerial council of genetically modified organisms, will bring to the attention of its members and those of the National Commission of Biosecurity such communication.

2. Where, in accordance with the provisions of the previous paragraph, an accident is reported, the person or body assigned to the health emergency plan and the epidemiological and environmental surveillance plan shall be informed of the functions of management and coordination. the action to be taken in the event of an accident, shall have its implementation and the mobilisation of the services, resources and resources provided for in the event necessary for:

(a) Adopt all emergency measures necessary for the protection of human health and the environment.

b) Collect the information necessary to carry out a thorough analysis of the accident and, where appropriate, make recommendations to avoid similar accidents in the future and to limit their consequences.

3. For the purposes of their communication to the European Commission, the persons or bodies assigned the functions of management and coordination of health emergency plans and of epidemiological and environmental surveillance shall refer to the Directorate-General for General Quality and Environmental Assessment the information they have received, in accordance with paragraph 1, and provide detailed data on the circumstances of the accident, the identity and the quantity of the organisms (a) genetically modified which would have been released, the emergency measures applied and their effectiveness, as well as an analysis of the accident with recommendations to limit its effects and avoid similar accidents in the future.

The Directorate-General for Quality and Environmental Assessment shall inform the European Commission as soon as possible and immediately to the Member States of the information referred to in the preceding paragraph.

4. Without prejudice to the provisions of the above paragraphs, the operators shall report any accident to the competent authority in the field of civil protection, providing the information and taking the necessary emergency measures. (a) to be required, in accordance with the provisions of this matter.

CHAPTER II

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

Article 22. 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. Pursuant to Article 11 (2) of Law 9/2003 of 25 April 2003, this Chapter shall not apply to the transport by any means of genetically modified organisms or to medicinal substances and compounds of human use which consist of genetically modified organisms or combinations thereof, or containing such organisms, provided that their voluntary release, for purposes other than placing on the market, is authorised by other Community rules or by the Spanish legislation issued for compliance, provided that such legislation provides:

(a) An assessment of the risk to human health and the environment, carried out in accordance with Annex IV, without prejudice to any other additional requirements laid down in the legislation referred to in paragraph 1. This section.

b) A pre-release express authorization.

(c) A monitoring plan as set out in Annex V with a view to detecting the effects of genetically modified organisms on human health or the environment.

d) The appropriate requirements for the processing of new data, information to the public, data on the results of the release and exchange of equivalent information, at least as provided for in Law 9/2003 of 25 April, and in this regulation.

However, where these special provisions exist for medicinal substances and compounds for human use, the body responsible for their authorisation shall first request the Inter-Ministerial Council of genetically modified a report on the risk assessment for human health and the environment.

3. The rules referred to in the preceding paragraph shall provide for procedures to ensure the conformity of the health and environmental risk assessment and its equivalence with the provisions of Law 9/2003 of 25 April 2003. of this regulation, and must refer to them.

4. The authorisation of voluntary release in cases relating to the technical examination of genetically modified varieties shall not be required where the genetic modifications which they contain have previously obtained the authorisation of the on the market as provided for in Law 9/2003 of 25 April and in this Regulation.

5. No material derived from genetically modified organisms which have been released on a voluntary basis in the terms of this Chapter shall be placed on the market unless it is carried out in accordance with the provisions of Chapter III of this Chapter. title.

Article 23. Request for authorization.

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

2. The authorization request must contain:

(a) A technical study, providing the information specified in Annex V that is necessary to carry out the risk assessment for human health and the environment of voluntary release and at least:

1. General Information that includes the personnel and their training.

2. Information on genetically modified organisms.

3. Information about release conditions and the possible receiving environment.

4. Information on the interaction of genetically modified organisms and the environment.

5. A follow-up plan to determine the effects of genetically modified organisms on human health and the environment.

6. Information on control, methods of repair, waste treatment and action plans in case of emergency.

7. A summary of the dossier, which shall be in accordance with the model set out in the Annex to Council Decision 2002/813/EC of 3 October 2002.

(b) An assessment of the risk to human health and the environment and the conclusions required in Section D of Annex IV, together with the bibliographic references and indicators relating to the methods used to arrive at those conclusions. The risk assessment shall be carried out in accordance with the principles laid down in Annex IV to this Regulation, the additional guidance notes set out in the Annex to Commission Decision 2002/623/EC of 24 July 2002, and taking into account the information provided in accordance with Annex V to this Regulation.

In such a risk assessment, due account should be taken of genetically modified organisms containing genes expressing resistance to antibiotics used in medical or veterinary treatments, in order to to identify and progressively eliminate, in genetically modified organisms, markers of resistance to antibiotics which may have adverse effects on human health and the environment, as provided for in the first provision of Law 9/2003 of 25 April 2003 laying down the legal system for the Contained use, voluntary release and placing on the market of genetically modified organisms.

In each case, the risk assessment shall take into account the potential adverse effects that genetic transfers of modified organisms may have directly or indirectly on human health or the environment. genetically to other organisms.

Any genetic transfer of genetically modified organisms to other organisms should be subject, on a case by case basis, to an assessment of potential adverse effects that may be directly or indirectly related to health. human and the environment.

3. The holder of the activity may refer to data or results of releases previously made by other operators, provided that such information is not confidential or that the preceding holders have given their written consent. The holder of the activity may also present the supplementary information which it considers relevant.

4. The competent authority may accept that a single application for authorisation shall be submitted when the holder of the activity intends to make releases from the same genetically modified organism or a combination of modified organisms. genetically in the same place or in different places for the same purpose and within a defined period.

Article 24. Submission of the authorization request.

1. Applications for the authorisation of voluntary releases of genetically modified organisms shall be addressed to the competent body in each case, which shall acknowledge receipt of them.

2. Where the competence corresponds to the General Administration of the State, the application for authorization shall be addressed to the Director-General of Quality and Environmental Assessment, as chairman of the Inter-Ministerial Council of modified organisms. and may be present in any of the places referred to in Article 38.4 of Law No 30/1992 of 26 November of the Legal Regime of Public Administrations and of the Common Administrative Procedure.

The Director General of Quality and Environmental Assessment, through the secretary of the inter-ministerial council of genetically modified organisms, will bring to the attention of its members and those of the National Commission of Biosecurity that application for the purposes of paragraph 1 of the second provision of Law 9/2003 of 25 April 2003.

3. Where the competition concerns the autonomous communities, the holder of the activity shall submit to the competent authority of that authority the corresponding application for authorization.

The competent body, once the appropriate documentary evidence has been carried out, shall immediately forward a copy of the application for authorization to the Directorate-General for Quality and Environmental Assessment for the compliance with this obligation of information with the European Commission and with the other Member States.

The Director General of Quality and Environmental Assessment, through the secretary of the inter-ministerial council of genetically modified organisms, will bring to the attention of the National Biosafety Commission a copy of the the application for the provision of the mandatory report in accordance with paragraph 2 of the second provision of Law 9/2003 of 25 April 2003 and Article 9 of this Regulation.

Article 25. Procedure.

1. Upon receipt of the request and the receipt of the receipt of the receipt, the competent authority shall examine that the information, data and documents contained in the application are complete and accurate, shall assess the risks posed by the release and It will verify that all this, as well as the activity to be carried out, complies with the provisions of Law 9/2003, of 25 April, and of this regulation.

The Directorate-General for Quality and Environmental Assessment, within 30 days of receipt of the application for authorization, shall send the summary of the file referred to in Article 23.2 for information and transfer to the European Commission and subsequent referral by the Commission to the other Member States. Following the receipt, where appropriate, of the observations of the European Commission or other Member States, the Directorate-General for Quality and Environmental Assessment shall transmit these to the competent bodies of the autonomous communities and to the National Commission. In the case of Biosafety, in the cases in which they have the competence to grant the authorisation for the voluntary release of genetically modified organisms in accordance with the provisions of Law 9/2003 of 25 April, and in this Regulation.

2. For the purposes of the resolution of the authorisation, the competent authority may require the person responsible for the voluntary release of genetically modified organisms to provide any additional information or to carry out any tests appropriate, justifying such a requirement.

3. The competent body may consult experts, institutions or public administrations when the characteristics or nature of the activity to be developed considers it appropriate.

4. The competent body shall submit to the public for 30 days the draft voluntary release. Without prejudice to Article 48, information to the public shall include the summary of the dossier referred to in Article 23.2, in particular the name and address of the holder of the activity, the general description of the body genetically modified to be released, the place and purpose of the release and, finally, the intended period of the release.

5. Where the competition concerns the General Administration of the State, the inter-ministerial Council of genetically modified organisms shall, prior to the adoption of the resolution, request a report to the National Commission of Biosecurity and, at the same time, shall transmit a copy of the application to the Autonomous Communities to make the observations they deem relevant within 10 days.

6. Where the competence corresponds to the autonomous communities, the competent authority concerned shall, prior to the adoption of the resolution, request a report from the National Biosafety Commission.

Article 26. Resolution.

1. The competent body, after the analysis of the documents and data provided, the results of the public information and, where appropriate, the results of the consultations, the additional information, the comments made by other Member States and the report of the National Biosafety Commission, shall decide on the voluntary release of genetically modified organisms, authorising or denying it, as or not according to the requirements laid down in Law 9/2003, of 25 April, and in this regulation. The decision authorising the voluntary release shall impose the conditions necessary for its implementation, shall be expressed and notified in writing to the holder of the activity within three months of receipt of the request for a authorization.

In order to calculate the period of the three months mentioned above, the time periods in which the competent body is waiting to receive the additional information requested from the holder or the latter shall not be taken into account. making public information, which in no case shall extend the period of the three months referred to in more than 30 days.

2. The Directorate-General for Quality and Environmental Assessment shall inform the European Commission of the decisions taken in accordance with the provisions of this Article, including, where appropriate, the grounds for refusing authorisation. Where the competent authority is the autonomous community, it shall provide the Directorate-General for Quality and Environmental Assessment with the information necessary to comply with this obligation, in accordance with the provisions of the final provision of the Law 9/2003 of 25 April.

Article 27. Obligation to report on releases.

1. The holder of the release activity is obliged to inform the competent body of the result of the voluntary release of genetically modified organisms in relation to the risks to human health and the environment, and shall state, where appropriate, the intention to proceed to the future placing on the market of the released body or of a product containing it. Such information shall be provided at the intervals established in the authorisation in the light of the results of the risk assessment for human health and the environment and, in the case of genetically modified higher plants, as the model in Annex XI.

2. The Directorate-General for Quality and Environmental Assessment shall inform the European Commission of the results of the releases received pursuant to the previous paragraph under the provisions of the second paragraph of Law 9/2003, 25 of April.

Article 28. Differentiated procedures.

1. Where sufficient experience has been gained in the release of certain genetically modified organisms into specific ecosystems and those organisms fulfil the criteria set out in Annex VI, the General Directorate for Quality and Environmental assessment may submit to the European Commission a reasoned proposal to apply to such types of genetically modified organisms differentiated procedures for the purpose of making a decision by the European Commission.

2. The Directorate-General for Quality and Environmental Assessment shall inform the European Commission of its decision whether or not to apply a differentiated procedure laid down in any Community decision.

Article 29. Simplified procedures.

1. By way of derogation from the above Articles, a single application for authorisation may be submitted for several voluntary releases of genetically modified plants which have been generated from the same plants. The recipients are cultured but may differ in any of the inserted or deleted sequences or have the same inserted or deleted sequences but differ in the phenotype.

Also, a single application for authorization may be submitted for a development program for a previously specified complete job, with a single receiving plant species and a specified range of inserts and deletions over several years in different places.

2. In accordance with Commission Decision 94 /730/EEC of 4 November 1994, the authorisations provided for in the previous paragraph shall be granted by means of the simplified procedure set out in Annex VII, provided that the following conditions are met: conditions:

a) That the taxonomy and biology of the receiving plants are well known.

(b) The information on the interactions of the recipient plant species in the ecosystems in which an agricultural or experimental release is programmed.

(c) Data on safety for human health and for the environment of experimental releases in which genetically modified plants of the same recipient plant species are present.

d) That the inserted sequences and the products of their expression be safe for human health and the environment in the conditions of experimental release.

e) That the inserted sequences have been correctly characterized.

f) That all inserted sequences are integrated into the nuclear genome of the plant.

g) That all releases belong to the same a priori established work program.

h) That all releases are performed in a limited and previously fixed period.

CHAPTER III

Marketing of genetically modified organisms as products or product components

Article 30. Concept.

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 following operations are not considered to be placed on the market:

(a) The supply of genetically modified organisms for activities covered by Chapter I of this Title, including crop collections.

(b) The supply of genetically modified organisms to be used exclusively for voluntary releases that meet the requirements set out in Chapter II of this Title.

Article 31. Scope of application.

1. The provisions of this Chapter shall not apply:

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

(b) to genetically modified organisms, such as genetically modified plant varieties and medicinal products for human or veterinary use consisting of genetically modified organisms or combinations of these, or containing such organisms, regulated by Community rules other than those incorporated in Law 9/2003 of 25 April, and this Regulation, provided that they require a specific assessment of the risks to the environment. The environment is equivalent to that regulated in the law and in this regulation. In the case of products or components of products, such as genetically modified plant varieties, 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 Law 9/2003 of 25 April, and in this Regulation.

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 request the Council inter-ministerial of genetically modified organisms a report on the specific environmental risk assessment.

2. Until the necessary legislation is adopted to ensure that the requirements referred to in paragraph 1 (b) are equivalent to those laid down in Law 9/2003 of 25 April, and this Regulation, only the bodies may be placed on the market genetically modified products or components of products covered by Community rules other than those incorporated in Law 9/2003 of 25 April, or by this Regulation, once their placing on the market has been authorised by the competent body of the General Administration of the State in accordance with this Chapter, without prejudice to obtain other authorizations that apply to them.

Article 32. Request for authorization.

1. Natural or legal persons intending to place on the market, for the first time, genetically modified organisms, or a combination thereof as products or components of products, shall request authorisation from the Inter-Ministerial Council of genetically modified and may only be placed on the market where they have received such authorisation and fulfil the conditions laid down by it.

2. The authorization request will include:

(a) A technical study, comprising the information and data contained in Annexes V and VIII, and which shall take into account the diversity of places of use of the genetically modified organisms which are products or components of a product and include data and results obtained from voluntary releases for research and development purposes, on the consequences of release for human health and the environment.

(b) An assessment of the risk to human health and the environment and the conclusions required in Section D of Annex IV. The risk assessment shall be carried out in accordance with the principles laid down in Annex IV to this Regulation, the additional guidance notes set out in the Annex to Commission Decision 2002/623/EC of 24 July 2002, and on the basis of the information provided in accordance with Annexes V and VIII to this Regulation.

In such a risk assessment, due account should be taken of genetically modified organisms containing genes expressing resistance to antibiotics used in medical or veterinary treatments, in order to to identify and progressively eliminate, in genetically modified organisms, markers of resistance to antibiotics which may have adverse effects on human health and the environment, as provided for in the first provision of Law 9/2003 of 25 April.

In each case, the risk assessment shall take into account the potential adverse effects that genetic transfers of modified organisms may have directly or indirectly on human health or the environment. genetically to other organisms.

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

d) A monitoring plan, in accordance with Annex X, with a proposal for the implementation of the plan, which may be different from the duration of the authorisation.

e) A proposal for labelling and packaging, which must meet the requirements set out in Annex VIII. The labelling will clearly indicate the presence of genetically modified organisms. The words 'This product contains genetically modified organisms' shall be shown on the label or in the accompanying documentation.

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

g) The information available, 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 data subject and by third parties persons, provided that they have given their written agreement.

(h) A summary of the dossier, to be submitted in accordance with the model set out in the Annex to Council Decision 2002/812/EC of 3 October 2002.

3. 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.

4. If, on the basis of the results of releases authorised in accordance with Chapter II of this Title, or on the basis of other substantiated and substantiated scientific arguments, the applicant for the authorisation considers that the placing on the market and the use of a genetically modified organism, either as a product or as a component of a product, presents no risk to human health or the environment, may propose to the inter-ministerial Council of modified organisms not to submit all or part of the information required under paragraph B of Annex VIII.

5. The Directorate-General for Quality and Environmental Assessment or the European Commission may propose criteria and information requirements to be met by applications for the marketing of certain types of genetically modified organisms, such as: products or components of products. Those criteria and requirements shall be adopted in accordance with the Community procedure laid down for that purpose and shall replace the provisions laid down in paragraph 2 of this Article, without prejudice to the application of the other provisions of this Chapter. (a) to be required to obtain marketing authorisations for genetically modified organisms.

Article 33. Submission of the authorization request.

1. Applications for authorisation under this Chapter shall be addressed to the Director-General for Quality and Environmental Assessment, as Chair of the Inter-Ministerial Council of Genetically Modified Organisms, who shall acknowledge receipt of the those. Applications for authorisation may be submitted in any of the places referred to in Article 38.3 of Law 30/1992 of 26 November.

2. The Director-General of Quality and Environmental Assessment, through the Secretary of the Inter-Ministerial Council of Genetically Modified Organisms, will bring to the attention of its members and those of the National Biosafety Commission applications, for the purpose of which the collegiate body, after having been informed by the Commission, adopts the relevant decision.

3. The Inter-Ministerial Council of genetically modified organisms simultaneously with the implementation of the report procedure provided for in the previous paragraph, will transfer the requests to the autonomous communities to formulate the comments that you consider relevant within 10 days.

Article 34. Procedure.

1. Upon receipt of the application for authorisation and on receipt of receipt, the inter-ministerial Council of genetically modified organisms shall immediately forward the summary of the dossier referred to in Article 32.2.h) to the authorities. the competent authorities of the other Member States and the European Commission.

2. The inter-ministerial Council of genetically modified organisms shall, without delay, verify whether the information provided meets the requirements of Article 32.2 and may, where appropriate, request the holder of the application for authorization to provide the additional information that you consider necessary.

Once you have found that the application for authorisation meets the requirements of Article 32.2, it shall, at the latest when it sends the assessment report provided for in Article 15 of Law 9/2003 of 25 April, send a copy of the request to the European Commission, which shall forward it to the competent authorities of the other Member States and make it available to the public on the terms laid down in Community legislation.

3. Within three months of receipt of the request, the inter-ministerial Council of modified organisms shall prepare a risk assessment report, in accordance with the guidelines set out in Annex IX, and forward it to the holder. of the application for authorisation. The assessment report shall indicate whether or not the genetically modified organisms concerned should be placed on the market and under what conditions.

Upon receipt of the assessment report, the holder of the application may withdraw the file. This does not preclude a subsequent application for authorisation from a competent authority in another Member State.

4. If the assessment report indicates that the genetically modified organisms in question may be placed on the market, the inter-ministerial Council of genetically modified organisms shall forward that assessment report to the European Commission together with the with the additional information submitted by the holder of the application for authorisation and any other information which has been used as a basis for his report.

Once the documentation referred to in the previous paragraph has been received, the European Commission shall forward it to the competent authorities of the other Member States within 30 days of the date of its receipt. receipt of the above documentation.

5. If the assessment report indicates that the genetically modified organisms concerned should not be placed on the market, the inter-ministerial Council of genetically modified organisms shall forward that assessment report to the European Commission together with the with the additional information submitted by the holder of the application and any other information that has been used as a basis for its report.

This referral shall be carried out at least 15 days after the submission of the assessment report to the holder of the application for authorisation provided for in paragraph 3, and not more than 105 days after the submission of the application for authorisation by the holder to the inter-ministerial Council of genetically modified organisms.

Upon receipt of the documentation referred to in the preceding paragraphs, the European Commission shall forward it to the competent authorities of the other Member States within 30 days of the date of its receipt. receipt.

6. When calculating the three-month period referred to in paragraph 3, the time periods in which the inter-ministerial Council of genetically modified organisms has been waiting for the additional information shall not be taken into account. which would have justified the holder of the application for authorisation.

Article 35. Intervention by the Inter-ministerial Council of genetically modified organisms in the Community authorisation procedure.

1. After receipt of the assessment report and the documentation corresponding to a marketing application submitted in another Member State by the European Commission, the Inter-Ministerial Council of genetically modified organisms it shall have a period of 60 days to request a reasoned request for further information, to make comments or to raise reasoned objections to the placing on the market of the genetically modified organisms concerned, and of a period of 105 days, from the date of receiving the report, to study together with the European Commission and the other Member States. I would like to make the following points. In order to carry out these activities, the Inter-Ministerial Council of Genetically Modified Organisms will seek a report from the National Biosafety Commission.

2. The replies to requests for information, the comments or objections referred to in the previous paragraph shall be sent to the European Commission, which shall immediately transmit them to the other Member States.

3. Periods in which you have been waiting to receive further information from the data subject shall not be counted for the purposes of the calculation of the day in which the deadline for reaching an agreement expires.

Article 36. Authorisation regime.

1. The authorisation to place genetically modified organisms on the market may be granted only where the voluntary release of the genetically modified organisms has been previously authorised, or the risk assessment has been carried out for the human health and the environment referred to in Article 4 (a), in accordance with the provisions of Law 9/2003 of 25 April, and in this Regulation. In any case, the products must comply with the existing rules on the marketing of products.

2. The inter-ministerial Council of genetically modified organisms shall grant the authorization in writing, transmit it to the holder of the application and inform thereof the other Member States and the European Commission within 30 days if a After the expiry of the 60-day period referred to in Article 34, no justified objections have been received from a Member State or from the European Commission or if any pending cases have been resolved within 105 days.

3. If, on the other hand, objections have been raised and no agreement is reached between the Member States, the authorization shall be subject to the procedure laid down in Community legislation and such authorization may not be granted without the prior approval by the European Commission. Where a favourable decision has been taken in that procedure, the inter-ministerial Council of genetically modified organisms shall grant the authorization in writing and transmit it to the holder of the application and inform the other States. Member States and the European Commission within 30 days of the publication or notification of that decision.

4. Authorisations granted by any Member State shall enable the genetically modified organism or the product containing it to be marketed in Spain, provided that such authorisations have been granted in accordance with the provisions incorporating Community rules on this subject into national law and strictly respecting the conditions laid down in the respective authorisations and, in particular, the conditions relating to the environment and to geographic areas.

5. As set out in the first provision of the royal decree approving this regulation, the marketing authorisations shall be included in the Central Register and shall be accessible to the public.

Article 37. Content of the authorization.

The resolution of the marketing authorisation of genetically modified organisms shall contain:

(a) The scope of the authorisation, including the identity of the genetically modified organisms to be marketed as products or components of products, and their unique identifier.

(b) The period of validity of the authorisation, which may not exceed 10 years from the date of authorisation.

(c) The conditions for the placing on the market of the product, including the specific conditions for the use, handling and packaging of genetically modified organisms as products or components of products and the requirements for protection of particular ecosystems, environments or geographical areas.

(d) The obligation of the person concerned to provide control samples to the inter-ministerial Council of genetically modified organisms when requested.

e) The labelling requirements as set out in Annex VIII. The labelling will clearly indicate the presence of genetically modified organisms. The mention: 'This product contains genetically modified organisms' shall appear on the label or in a document accompanying products containing genetically modified organisms.

(f) The requirements and the monitoring plan provided for in Article 42, carried out in accordance with Annex X, including the reporting obligations to the European Commission and the other Member States and the time limit for the plan monitoring. Where appropriate, the obligations of persons placing the product or its users on the market, as well as information deemed appropriate on the location of the genetically modified organisms, shall be identified.

The authorization resolution will specify case-by-case requirements, procedures, and obligations for the tracking plan.

Any similar measure established by other specific Community rules or by the Spanish legislation dictated for compliance must take into account the monitoring plans referred to in Law 9/2003 of 25 April, and in this regulation. For this purpose, such measures shall be brought to the attention of the National Biosafety Commission in good time before their approval.

Article 38. Term of validity.

1. The authorisation shall be granted for a maximum period of 10 years from the date of the authorisation.

2. For the approval of a genetically modified organism or its progeny for the purposes of marketing its seed only in accordance with the applicable Community provisions, the period of the first authorisation shall be terminated. no later than 10 years from the date of the first registration in the Register of commercial varieties provided for in Law 11/1971 of 30 March of seed and nursery plants of the first plant variety containing modified organisms genetically.

In the case of forest reproductive material, the period of the first authorisation shall end no later than 10 years from the date of the first registration of the basic material with a genetically modified organism in the National catalogue of basic materials, regulated in accordance with Council Directive 1999 /105/EC of 22 December 1999 on the marketing of forest reproductive material.

Article 39. Renewal of the authorization.

1. In accordance with the provisions of Article 16.4 and the second transitional provision of Law 9/2003 of 25 April 2003, the authorisations granted in accordance with this Chapter and those granted before 17 October 2002 shall be renew.

2. Natural and legal persons intending to renew their marketing authorisation shall submit an application for renewal within a maximum period of nine months before the expiry of the authorisation obtained in accordance with this Chapter or before of 17 October 2006 if they were granted before 17 October 2002.

3. The refresh request will include the following:

(a) A copy of the marketing authorisation of the genetically modified organisms.

(b) A report of the results of the monitoring carried out in accordance with Article 42. In the case of authorisations obtained before 17 October 2002, that report shall be submitted when the monitoring has been carried out.

(c) Any new information that is available in relation to the risks that the product poses to human health or the environment.

(d) Where appropriate, a proposal to amend or supplement the conditions of the initial authorisation, i.e. those relating to the future monitoring and the time of the authorisation.

4. After submitting the application for renewal of the authorisation, the holder of the application may continue to market the genetically modified organisms in accordance with the conditions laid down in that authorisation until it is resolved. definitely their renewal.

Article 40. Submission of the request for renewal of the authorization.

1. Applications for renewal of the authorisations provided for in this Chapter shall be addressed to the Director-General of Quality and Environmental Assessment, as Chair of the Inter-Ministerial Council of Genetically Modified Organisms, who acknowledge receipt of the requests. Applications for renewal of authorisations may be submitted in any of the places referred to in Article 38.4 of Law 30/1992 of 26 November.

2. The Director-General of Quality and Environmental Assessment, through the Secretary of the Inter-Ministerial Council of the genetically modified organisms, will bring to the attention of its members and those of the National Biosafety Commission requests, for the adoption of the relevant resolution by the Inter-Ministerial Council of the genetically modified organisms, following the report of the said Commission.

Article 41. Procedure for renewal of the authorization.

1. Following receipt of the request for renewal of the authorisation and receipt of the authorisation, the Inter-Ministerial Council of genetically modified organisms, after a report from the National Biosafety Commission, shall verify that the application for renewal of authorisation is in accordance with Article 39.3 and shall carry out an assessment report in accordance with the guidelines set out in Annex IX. This assessment report shall indicate whether or not the genetically modified organism should remain on the market and under what conditions.

The inter-ministerial Council of genetically modified organisms will immediately proceed to forward a copy of the renewal application, as well as its assessment report, to the European Commission, which, within 30 days of from the date of receipt, it shall forward them to the competent authorities of the other Member States. The assessment report shall also be forwarded to the holder of the application.

2. Once the assessment report has been received, the Member States and the European Commission have a period of 60 days to request further information, to make comments, or to submit reasoned objections to the placing on the market of the modified organisms. in question. The replies to requests for information, comments or objections shall be sent to the European Commission, which shall immediately communicate them to the other Member States. The Member States and the European Commission will be able to discuss the outstanding issues with a view to reaching an agreement, with an additional deadline of 15 days.

3. The interministerial Council of genetically modified organisms shall grant the renewal of the authorization in writing and transmit it to the person concerned and shall inform the other Member States and the European Commission within 30 days of the After the expiry of the 60-day period since the assessment report was provided, no justified objections have been received from a Member State or from the European Commission, or if any pending cases have been resolved within 75 days. from the date of receipt of the assessment report.

4. The validity of the renewed authorisation should not exceed 10 years. However, this period may be reduced or extended as appropriate for specific reasons, where no justified objections have been received from a Member State or from the European Commission.

Article 42. Monitoring.

1. After the placing on the market of genetically modified organisms as products or components of products, the natural or legal person authorised to place the product on the market, in accordance with Article 32, shall ensure that the product is monitoring and reporting on those carried out in accordance with the conditions specified in the authorisation. On the basis of those reports, in accordance with the terms of the authorisation and within the framework of the monitoring plan specified therein, the Inter-Ministerial Council of genetically modified organisms may, after reporting by the National Commission, of Biosafety, adapt the monitoring plan at the end of the first monitoring period, in accordance with Annex X.

2. The inter-ministerial Council of genetically modified organisms shall send reports of such monitoring to the European Commission and the competent authorities of the other Member States.

Article 43. Free movement and safeguard clause.

1. It shall not be possible to prohibit, restrict or impede the placing on the market of genetically modified organisms which have been authorised by other Member States provided that these authorisations have been granted in accordance with the incorporate into the respective national rights the rules of the European Communities on this subject and strictly respect the conditions laid down in the respective authorisations.

2. However, the inter-ministerial Council of genetically modified organisms may temporarily restrict or suspend the use and sale on its territory of a genetically modified organism which is a product or a product component duly authorised by another Member State, where new information is available to the other Member State after authorisation has been given that it represents a risk to human health and the environment. Such information should affect the assessment of the risk to human health and the environment or be a new assessment of existing information on the basis of new or additional scientific knowledge.

In the event that, on the basis of the information provided for in the preceding paragraph, the existence of serious risk was known, emergency measures, such as suspension or cessation of marketing, shall apply.

In the cases referred to in the preceding paragraphs of this paragraph, the public shall be informed.

3. In the cases provided for in the preceding paragraph, the inter-ministerial Council of genetically modified organisms shall immediately inform the European Commission and the other Member States of the actions taken, stating the reasons for its action. (a) decision making and facilitating the reassessment of the risk assessment for human health and the environment, indicating whether and in what form the conditions of the authorisation should be amended or whether the latter should be terminated and, where appropriate, the new or additional information on which your decision is based.

Article 44. Modification of the conditions of the marketing in case of new information.

1. Without prejudice to Article 46.2, if the inter-ministerial Council of genetically modified organisms is granted prior authorisation, information which may have an impact on the risk of the placing on the market of the organisms genetically modified for human health or the environment, it shall immediately forward the information to the European Commission and the competent authorities of the other Member States. In this case, the time limits laid down for the resolution of cases pending in Articles 35.1 and 41.3 may be applied, in the case of an application for authorisation or a renewal of that application.

2. Where the information referred to in the previous paragraph has been accessed after the authorisation has been granted, the inter-ministerial Council of genetically modified organisms, following a report from the National Biosafety Commission, shall send the European Commission its assessment report within 60 days from the date of receipt of the new information, indicating whether the conditions of the authorisation should be modified and how, or whether the authorisation should be revoked. The European Commission shall forward this report to the other Member States within 30 days of its receipt.

3. If, within 60 days of the date of referral of the new information, no objection is raised by any Member State or by the European Commission, or if the pending cases are resolved within 75 days, the Council shall decide whether the inter-ministerial of genetically modified organisms which drafted the report shall amend the authorisation in the proposed sense, send the amended authorisation to the marketing holder and inform the other Member States and the the European Commission within 30 days.

Article 45. Traceability.

1. Operators, as defined in Article 4 (e), who place on the market products containing or consisting of genetically modified organisms at any stage of their production or distribution shall keep and transmit in writing to the operator who Receive the product the following information:

(a) The indication that the product contains or is composed of genetically modified organisms.

(b) The unique identifier or identifiers assigned to those genetically modified organisms in accordance with the Community procedure to be established in this respect.

2. In the case of products consisting of mixtures of genetically modified organisms or containing them, intended to be used solely and directly as food or feed, or to be processed, the information referred to in paragraph 1 (b) may be replaced by a declaration of use by the operator, together with a list of the unique identifiers of all genetically modified organisms that have been used to constitute the mixture.

3. Operators shall keep the information specified in paragraph 1 for the five years after each commercial transaction in order to know which operator they come from and to which operator the products have been supplied.

4. For the products referred to in paragraphs 1 and 2 above, operators shall ensure that:

(a) In the case of pre-packaged products the label shall contain the following indication: "This product contains genetically modified organisms" or: " This product contains (name of the organisms) modified genetically ".

(b) In the case of non-prepackaged products offered to the final consumer, the indication: "This product contains genetically modified organisms" or: " This product contains (name of the organisms) modified ", shall consist of the presentation of the product or the documentation accompanying the product.

5. The preceding paragraphs shall not apply to traces of genetically modified organisms which are present in a proportion not exceeding the thresholds laid down in Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003, or other specific rules of the European Union, provided that such traces are either accidental or technically unavoidable.

CHAPTER IV

Common Provisions

Article 46. Additional information.

1. Where, after the submission of communications, applications for authorization or the granting of such applications are provided for in Chapters I, II and III of this Title, new information is available in respect of the risks which the activity may entail. represent for human health and the environment, its holder is obliged to inform the competent body immediately, to review the information and requirements specified in the communication, application or authorization and to take the measures necessary to protect human health and the environment.

For the purposes of this paragraph, when the competence to receive the information corresponds to the General Administration of the State, the communication will be directed to the Director General of Quality and Environmental Assessment, in its quality of President of the Inter-Ministerial Council of genetically modified organisms, and may be present in any of the places referred to in Article 38.4 of Law 30/1992 of 26 November.

The Director General of Quality and Environmental Assessment, through the secretary of the inter-ministerial council of genetically modified organisms, will bring to the attention of its members and those of the National Commission of Biosecurity such communication.

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

For such purposes, where the competition concerns the General Administration of the State, the inter-ministerial Council of genetically modified organisms shall adopt the relevant resolution, subject to a report from the Commission. National of Biosafety.

Article 47. Modifications to the activity.

1. The obligations laid down in the previous Article shall also apply if a change in the contained use or voluntary release may have consequences for the risks to human health or the environment. In this case, the competent body should be informed before the modification takes place or when the unintended change is known.

2. For the purposes of the placing on the market of genetically modified organisms, the provisions of the preceding Article and Article 44 shall be provided.

Article 48. Confidentiality.

1. In the exercise of the powers conferred by Law 9/2003 of 25 April, and in this Regulation, the competent authorities shall ensure that intellectual property rights are respected, as well as the rules on freedom of access to information on the environment.

2. The holders of the activities covered by Articles 13, 23 and 32 of Law 9/2003 of 25 April and in this Regulation providing information to the competent body may invoke the confidential nature of certain information and information. provided, providing the appropriate justification.

The competent body shall, after consulting the holder, decide on the confidentiality invoked, inform it of its decision and refrain, where appropriate, from providing the information to third parties.

3. The information and particulars relating to the description of the genetically modified organisms, the identification of the holder of the activity concerned, the purpose and the place of the activity shall not be confidential. classification of the risk of the contained use activity, the containment measures, the emergency and control systems and measures and the assessment of the effects on human health and the environment.

4. If, for any reason, the holder of the activity, after the communication, notifies the intention not to carry out the activity, or to withdraw the application for authorization, the competent body must respect the confidential nature of the information provided.

Article 49. Information to the public.

In accordance with the provisions of the single additional provision of the royal decree approving this regulation and without prejudice to the provisions of the previous article, the information relating to them shall be made available to the public. authorisations for contained use, voluntary releases for purposes other than their placing on the market and the placing on the market of genetically modified organisms. The relationship of the genetically modified organisms whose marketing has been authorised or rejected as products or components of products, the assessment reports, the results of the tests shall also be made available to the public. controls on the placing on the market and the reports of the National Biosafety Commission. The genetically modified organisms containing and their uses shall be specified for each product.

Article 50. Tagged.

1. Without prejudice to Article 45, the competent bodies of public administrations shall ensure that, at any stage of the placing on the market of genetically modified organisms, the conditions for labelling and packaging set in the authorization.

2. The abovementioned bodies will also ensure that operators apply the minimum thresholds laid down by the European Commission, below which they will not need to label products for which traces cannot be excluded. accidental or technically unavoidable of genetically modified organisms.

3. The genetically modified organisms to be provided for the operations provided for in Article 30.2 shall be subject to the appropriate labelling requirements in accordance with Annex VIII in order to provide for the clear information on a label or accompanying document on the presence of genetically modified organisms. To do so, they will be on a label or accompanying document the words "This product contains genetically modified organisms".

Article 51. Reporting obligation.

1. At the end of each calendar year, the Directorate-General for Quality and Environmental Assessment shall forward to the European Commission:

(a) A synthetic report on the confined uses of types 3 and 4, authorised during that year, in accordance with Article 18 et seq., including the description, purpose and risks of use contained in question.

(b) A list of the genetically modified organisms released on their territory and a list of the rejected applications for authorisation.

2. According to the fourth final provision of Law 9/2003, of 25 April, every three years the Directorate-General for Quality and Environmental Assessment will draft a report, which will be sent to the European Commission and made public, on the situation in Spain and the experience gained in the field of genetically modified organisms.

3. The General Directorate of Quality and Environmental Assessment, in the terms established in Law 9/2003, of 25 April, in this regulation and in the current Community regulations, will exchange information with the European Commission about the experience acquired in the field of the prevention of risks associated with the contained use, voluntary release and placing on the market of genetically modified organisms. Such exchange of information shall also include the application of Article 30.2 of this Regulation, the assessment of the risk to human health and the environment, monitoring and consultation and information to the public.

4. The Directorate-General for Quality and Environmental Assessment shall inform the European Commission and the other Member States of the actions, sanctions and measures implemented to put an end to the contained uses, voluntary releases and marketing of genetically modified organisms, which have been carried out without the required authorisation.

5. In order to complete the provisions of the above paragraphs, the Autonomous Communities shall provide the Ministry of the Environment with the data necessary to fulfil the reporting obligations to the European Commission.

6. The information referred to in paragraphs 1 to 4 shall also be brought to the attention of the Ministries of Health and Consumer Affairs, Agriculture, Fisheries and Food and Science and Technology, as well as any other ministerial or bodies of the General Administration of the State with competence in this field.

7. In accordance with the provisions of the second final provision of Law 9/2003 of 25 April, the Ministry of the Environment shall make available to the autonomous communities the information referred to in paragraphs 1 to 4 above.

Likewise, the Ministry's Directorate-General for Quality and Environmental Assessment will report, on a quarterly basis, to the competent authority of the Autonomous Communities on the authorizations granted by the Inter-Ministerial Council of genetically modified organisms in respect of activities that are developed within the geographical scope of each Autonomous Community.

Article 52. Interruption of deadlines.

For the computation of the periods referred to in Articles 16, 19, 26.1, 34.3 and 35.1, the periods during which the competent body is awaiting the additional information it may be required shall not be taken into account. have requested, or are, where appropriate, a period of public information in accordance with Articles 16.2 and 25.4.

Article 53. Administrative silence.

The lack of resolution expressed by the competent authority to grant the authorizations regulated in Law 9/2003 of April 25, and in this regulation will produce disestimatory effects.

TITLE III

Surveillance and control. Administrative responsibility and sanctioning regime

CHAPTER I

Surveillance and control

Article 54. Obligation of collaboration.

The holders of the activities referred to in Law 9/2003 of 25 April, and this regulation will be obliged to provide all the collaboration to the competent authorities in order to enable them to carry out the examinations, controls, sampling and collection of information necessary for the performance of their mission.

Article 55. Agents of the authority.

Officials and public employees performing inspection duties on activities regulated in Law 9/2003 of April 25, and in this regulation will have the status of agents of the authority.

For such purposes, officials carrying out inspection and control tasks shall be empowered to require all information and documentation to be required for the exercise of their functions and for access to the areas, means and facilities in which activities are regulated in Law 9/2003 of 25 April, and in this Regulation, unless they have the legal status of domicile, in which case the inspector must comply with the rules that guarantee their inviolability.

In any case, the inspection and control activities carried out and the results of these inspections must be recorded in the corresponding minutes extended by the officials who will carry out these actions.

The minutes shall be of evidentiary value in respect of the facts reflected in them, without prejudice to the evidence which may be provided by the parties in defence of their rights.

Article 56. Obligations of the inspectors.

1. These are the obligations of the inspectors:

(a) Carry out the necessary inspection and control measures to ensure that the activities, installations and other elements which are the subject of those activities comply with the requirements laid down by European legislation; and national.

b) Draw up the corresponding inspection minutes.

(c) Exorder the certificates that correspond to the rules in force, provided that the object of the inspection is a creditor of the certificate, and, in any case, whenever the person concerned requests it.

2. The inspectors shall, in the performance of their duties, carry a personal supporting document, issued by the competent authority, which shall be submitted for the purpose of carrying out their duties.

3. In the exercise of their duties, the duty of respect and consideration must be observed because of the persons concerned, and all the necessary measures shall be taken to ensure the protection of the privacy of the persons and the necessary to ensure that beyond what is essential to the normal functioning of the activities under control and inspection.

The inspectors are, likewise, obliged to keep professional secrecy about the activities carried out and to respect the rules regarding incompatibilities.

CHAPTER II

Violations and Liability

Article 57. Violations.

They will have the consideration of breaches of this regulation as set out in Article 34 of Law 9/2003 of April 25, without prejudice, if any, of the possible civil and criminal liability arising from the the violations committed.

Article 58. Responsibility.

1. The following natural or legal persons shall be liable for the infringements:

(a) In the event that activities are carried out for which authorisation is required under Title II of this Regulation, without the corresponding authorisation, the natural or legal persons who perform them.

(b) In the event of non-compliance with the conditions of the authorisation of activities provided for in Title II of this Regulation, the holders of such authorisations.

(c) In the event that activities of the contained use of genetically modified organisms are carried out that do not require administrative authorisation, the natural or legal persons who intend to carry out or perform such activities.

(d) In the case of the placing on the market of products containing or consisting of genetically modified organisms, operators.

2. Where damage to the environment or to the health of persons is caused by the accumulation of activities due to different persons, the competent authority may individually impute this responsibility and its economic effects.

CHAPTER III

Sanctions and other measures

Article 59. Penalties.

The violations of the provisions of Law 9/2003, of April 25, and in this regulation will be sanctioned in accordance with the provisions of article 35.1 of the aforementioned law.

Article 60. Sanctioning powers.

1. It is for the competent bodies of the autonomous communities to impose penalties for the commission of infringements committed in the implementation of the activities covered by Law 9/2003 of 25 April and in this Regulation, with the Exceptions governed by the following paragraphs.

2. The General Administration of the State shall be competent to impose penalties for the commission of infringements relating to the performance of the activities referred to in paragraph 1 (c) and paragraphs (a), (b) and (c) of paragraph 1. Article 3 of Law 9/2003 of 25 April, subject to the provisions of the following paragraphs.

3. The imposition of the penalties by the commission of infringements related to the activities covered by Article 3 (2) (a) of Law 9/2003 of 25 April, as well as those related to the importation and export of organisms genetically modified and the products containing them, where the commission of the offences involves risk to human health or to the health control of the environment, shall be:

(a) To the Director General of Public Health, in the case of minor infractions.

(b) To the Secretary-General of Health, in the case of serious infringements.

c) To the Minister of Health and Consumer Affairs, in the case of very serious infringements.

4. The jurisdiction for the imposition of penalties by the commission of infringements related to the conduct of the research programmes referred to in Article 3.2.b of Law 9/2003 of 25 April shall be:

(a) To the Director-General of Investigation, in respect of minor infractions.

b) To the Secretary of State for Scientific and Technological Policy, in respect of serious infringements.

c) To the Minister of Science and Technology, regarding very serious infractions.

5. The imposition of the penalties for the conduct of infringements committed in the case of technical examination referred to in Article 3.2.c of the abovementioned law, as well as those carried out in respect of imports and exports of Non-forest seed and nursery plants incorporating or containing genetically modified organisms, without prejudice to the provisions of paragraph 3 of this Article, shall be:

(a) To the Director General of Agriculture, by the commission of minor infractions.

(b) to the Secretary-General for Agriculture and Food, in respect of serious infringements.

c) To the Minister of Agriculture, Fisheries and Food, the sanction of very serious infractions.

6. Infringements committed in connection with the import and export of genetically modified organisms and the products containing them for use in bioremediation or other activities other than those referred to in the paragraphs 3, 4 and 5 of this Article, provided that they do not pose a risk to human health or to the health control of the environment, shall be sanctioned by:

(a) The Director General of Conservation of Nature, in the case of minor infractions.

(b) The Secretary-General for the Environment, in the case of serious infringements.

c) The Minister of the Environment, in very serious infractions.

7. The sanctioning bodies referred to in this Article shall take into account in their resolutions the provisions laid down in Article 35 (4) of Law 9/2003 of 25 April.

Article 61. Graduation criteria.

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

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

Article 62. 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 body responsible for initiating the appropriate sanctioning procedure or the instructor of the file shall decide on its continuity or its lifting within 15 days from the date on which the said procedures have been agreed. measures.

Article 63. Measures of a provisional nature.

When a sanctioning procedure has been initiated, the competent body 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 genetically modified organisms or products containing them

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

Article 64. 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 order, the infringer does not proceed to the repair or refund required in the preceding paragraph, the competent authority may agree to the imposition of periodic penalty payments. The amount of each of the fines shall not exceed one third of the fine fixed for the offence committed.

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

Article 65. Rules of procedure and prescription.

1. The power of sanction in the field of application of Law 9/2003, of 25 April, and of this regulation, as well as the limitation of the infringements and penalties, will be governed by the provisions of Law 30/1992, of 26 November, of Legal Regime of the Public Administrations and the Common Administrative Procedure, and Royal Decree 1398/1993 of 4 August, approving the Rules of Procedure for the exercise of sanctioning powers.

2. Following a sanctioning procedure, the resolution shall be brought to the attention of other bodies of the same or of the various public administrations with competence in the field of genetically modified organisms.

ANNEX I

PRINCIPLES TO BE FOLLOWED FOR THE ASSESSMENT OF THE RISK TO HUMAN HEALTH AND THE ENVIRONMENT NECESSARY FOR THE CONDUCT OF THE CONTAINED USE OF GENETICALLY MODIFIED ORGANISMS

This annex describes in general terms the elements to be taken into account and the procedure to be followed for the assessment of the risk to human health and the environment to which it refers. Article 12 of this Regulation. As a supplement to this Annex, the guidance notes laid down in Commission Decision 2000 /608/EC of 27 September 2000 should be used and any other Community provisions to be adopted in this area should be complied with. whether they are directly applicable or once they are incorporated into the internal order.

A. ASSESSMENT ELEMENTS

1. The following effects should be considered potentially harmful:

Diseases that affect people, including allergic or allergic effects.

Diseases that affect animals or plants.

Delethereal effects due to the inability to treat a disease or to perform effective prophylaxis.

Delethereal effects due to the establishment or dissemination in the environment.

Delethereal effects due to the natural transfer of inserted genetic material to other organisms.

2. The assessment referred to in Article 12 shall be based on

following:

a) Identification of any potentially harmful effects, and in particular those related to:

The receiving organism.

The genetic material inserted from the donor organism.

The vector.

The donor organism (if used during the operation).

The resulting genetically modified organism.

b) Characteristics of the activity.

c) Severity of potentially harmful effects.

d) Probability of potentially harmful effects.

B. PROCEDURE

1. The first step in the evaluation process should be to identify the harmful properties of the receiving organism and, where appropriate, the donor, as well as any harmful properties related to the vector or to the material introduced, including alterations to the initial properties of the receiver.

2. In general, they shall be considered appropriate for inclusion in type 1, as defined in Article 12, only genetically modified organisms which have the following characteristics:

(a) It is unlikely that the recipient or body of origin causes disease in humans, animals or plants (only animals and plants belonging to the environment that could be exposed).

(b) The nature of the vector and the incorporated material are such that they do not transmit to the genetically modified organism a phenotype that may cause disease in humans, animals or plants (only animals and plants) (a) the environment which could be exposed), nor any deleterious effects on the environment.

c) It is unlikely that the genetically modified organism will cause disease in humans, animals or plants (only animals and plants belonging to the environment that could be exposed) and that it is unlikely which has harmful effects on the environment.

3. In order to take cognizance of the information necessary for the implementation of this process, the person concerned may first take account of existing Community legislation, in particular Council Directive 90 /679/EEC of 26 June 1990. In November 1990, as well as the legislation incorporating it into the Spanish legal order, in particular Royal Decree 664/1997 of 12 March on the protection of workers against risks related to exposure to biological agents during the job. They may also take into consideration national or international classification systems and their updated versions in accordance with new scientific knowledge and technical progress.

These systems refer to natural organisms and are therefore normally based on the ability of organisms to cause disease in humans, animals or plants and in the severity and transmissibility of the disease. disease that they can cause. Royal Decree 664/1997, of 12 March, classifies organisms as biological agents in four types of risk according to their potential effects on a healthy adult. These types of risk may serve as guidance for the classification of the activities of the contained use in the four types of risk referred to in Article 12 (1). The data subject may also take into account classification systems for plant and animal pathogens. The classification systems mentioned above provide only a provisional indication of the type of risk of the activity and of the necessary containment and control measures.

4. The risk identification process, carried out in accordance with the preceding paragraphs of this Annex, should lead to the determination of the level of risk associated with the genetically modified organisms.

5. The selection of control measures and other protective measures, according to the level of risk associated with the genetically modified organisms, should then be carried out, also taking into account:

(a) The characteristics of the environment which may be exposed to genetically modified organisms (e.g. the presence of known fauna and flora which may be adversely affected by the use of genetically modified organisms). micro-organisms used in the contained use activity).

b) The characteristics of the activity (nature, magnitude, etc.).

c) Non-normalized operations (e.g., inoculation of animals with genetically modified organisms, equipment that can generate aerosols).

The consideration of paragraphs (a) to (c) for the activity concerned may increase, reduce or maintain constant the level of risk associated with the genetically modified organisms as set out in the 6.

6. The analysis carried out in accordance with the preceding paragraphs shall ultimately lead to the allocation of the activity to one of the rates described in Article 12 (1

.

7. The final classification of the contained use shall be confirmed by reviewing the assessment referred to in Article 12.

ANNEX II

PRINCIPLES, CONFINEMENT MEASURES AND OTHER PROTECTIVE MEASURES

General principles

1. The tables set out the minimum standard requirements as well as the measures necessary for each degree of confinement.

Confinement can also be ensured through the use of good working practices, training, confinement equipment and particular design of facilities. In all activities involving genetically modified organisms, the principles of good microbiological practice and the following basic principles of safety and hygiene in the workplace shall apply:

(a) Maintain the exposure of the workplace and the environment to any genetically modified organism at the lowest possible level in practice.

b) Apply industrial control measures at the source and, if necessary, complete these with appropriate personal protective clothing and equipment.

c) Check and properly maintain control measures and equipment.

d) Verify, where appropriate, the presence of viable process organisms outside the primary physical confinement.

e) Providing staff with appropriate training.

f) Create biological safety committees and subcommittees, if necessary.

g) Formulate and apply local codes of practice for the security of personnel, as required.

h) If applicable, have signs of biological risk.

i) Establish cleaning and decontamination facilities for staff.

j) Bring the corresponding records.

k) Prohibited that you eat, drink, smoke, use cosmetics, or store food for human consumption in the work area.

l) Ban pipette with your mouth.

m) Set, if applicable, written work protocols in order to ensure security.

n) Make available disinfectants and specific disinfection procedures in case genetically modified organisms have been spread.

n) Dispose of a storage place of total safety for contaminated equipment and laboratory materials if necessary.

2. The titles of the tables are indicative.

Table 1 A lists the minimum requirements for laboratory activities.

Table I B collects the additions and modifications of Table I A for activities in greenhouses or hotbeds with genetically modified organisms.

Table I C contains the additions and modifications of Table I A for activities with animals in which genetically modified organisms are used.

In Table II, the minimum requirements for activities other than those in the laboratory are set out.

In some particular cases it may be necessary to apply a combination of measures, from Tables 1 A and II, corresponding to the same degree.

In some cases users may, after agreement of the competent authority, not apply a specification in a particular degree of confinement or combine specifications of two different degrees.

In these tables the term "optional" means that the user may apply these measures in each individual case, depending on the risk assessment referred to in Article 12 (1).

3. In the interests of clarity of requirements, the general principles of paragraphs 1 and 2 may also be incorporated in the following tables in the application of this Annex.

Table 1 A

Confinement measures and other protective measures for laboratory activities

Equipment

12

18

Waste

Specifications		Degree of confinement
		1	2	3	4
1	Dependencies of the	Unrequired		Unrequired	Required
Not Required
2	Lab: Hermetic to perform a fumigation	Not Required	No required	Required	Required
3	Existence of a separate entry and exit	Not Required	Required
	4	Surfaces resistant to acids, alkalis, solvents, disinfectants and decontamination and easy cleaning agents	Required (table)	Required (table)	5
5	5	5	5	Table_table_izq"> Lab Access through an Exclude2	Not required	Not Required	Optional
6	Negative Pressure on Immediate Environment Pressure	Not Required	Unrequired	Required with Exception of3
7	7	7	7		Unrequired	Not Required	Required: (HEPA)4: outbound air with exception of3	Required: (HEPA)5: input and output
8	Enclosure or Microbiological Security Campaign	Not Required	Optional	Required
9	Autokey	In situ	In the building	In the6	In the lab = with two ends
Work
10	Restricted access	Not required	Required	Required
11	Senalizing a biological hazard at the door			Required		Required
Required
Required
Required
Required
Required
Required
Specific measures for training control and aerosol diffusion	Not required	Required: minimize	Required: avoid	Required: avoid
13	Ducha	Not Required	Not Required	Optional	Optional
14	14	appropriate protection	Appropriate protection clothing	Appropriate protective clothing and footwear	Full clothing and footwear change before entering and
15	Unrequired		Optional	Optional
18	Effective vector control (for example, rodents and insects)	Optional		Required			Required
19	Inactivation of genetically modified organisms in the effluents of sinks, drains and similar showers or effluents	Unrequired	Unrequired	Unrequired		Optional
20	Inactivation of modified organisms genetically in contaminated material and waste	Optional	Required	Required
21
	21	measures	21		Unrequired	Not Required	Optional
Required
23	A watch window or similar to view the occupants	Optional	Optional	Optional	Required

¹ Isolation: The lab is separated from other areas of the same edificiate or in a separate building.

² Exclude: The entry must be made through an isolated lab lock. The clean side of the lock must be separated from the restricted side by means of facilities with changing rooms or showers and preferably with doors with dependent locks.

³ The activities in which the transmission is not performed by air.

⁴ HEPA:High Efficiency Particulate Air.

⁵ On premises where viruses that are not retained by the HEPA filters are manipulated, other requirements for the exit air are required.

⁶ The safe transport of material to the autoclave that is outside the laboratory is permitted by validated procedures and with an equivalent level of protection.

Table 1 B

Confinement measures and other protective measures for activities in greenhouses and hotbeds

The terms "greenhouse" and "hotbed" refer to structures with walls, ceiling and floor designed and used primarily to grow plants in a protected and controlled environment.

All the rules set out in Table 1 A shall apply with the following additions or modifications:

Specifications		Degree of confinement
		1	2	3	4
Building
1	Greenhouse: permanent structure1	Not Required	Required	Required
3
Entry through a lock with two doors with a dependent lock	Not required	Optional	Optional
	4	Optional	Optional	Minimize the runoff	Avoid runoff	Avoid runoff
6	Measures to control unwanted species (insects and other arthropods, rodents, etc.)	Required	Required	Required
7	7 The_table_table_izq"> Procedures to prevent the dissemination of genetically modified organisms during the transport of live material between the greenhouse or the seedbed, the protective structure and the laboratory		Minimize the dissemination	Avoid dissemination	Avoid Dissemination

¹ The greenhouse will be a permanent structure with continuous and impermeable cover, located in a place whose slope allows to prevent the entry of surface water runoff and provided with automatic closing.

² When there can be transmission by the floor.

Table 1 C

Confinement measures and other protective measures for activities in animal units

All the rules listed in Table I A shall apply with the following additions or modifications

Specifications		Degree of confinement
		1	2	3	4
1
	1
of the1	Optional	Required	Required	2
2 animal premisesby lockable	Optional	Required
	3 3	decontamination material (cages, etc.), waterproof and easy to wash	Optional	Optional	Required
4	Soil and easy to wash walls	Optional	Required (soil)	Required (dirty and walls)	Required (dirty and walls)
5	Containment of animals in suitable receptacles such as cages, pens, or boxes	Optional	Optional	Optional	Optional	Optional
6	Filters in isolation boxes or isolated rooms3	Not required	Optional	Required	Zant_table_izq">

¹ Animal unit: building or separate area of a building that has premises and other areas such as changing rooms, showers, autoclaves, food storage. etc.

² Local animals: premises that are usually used to house reserve, breeding, or experimentation animals or to perform small surgical interventions.

³ Isolation boxes: transparent boxes in which animals can be introduced, inside or outside the cage; for large animals it would be more appropriate to use isolated rooms.

Table II

Confinement measures and other protective measures for other activities

2

Specifications		Degree of confinement
		1	2	3	4
general
1	The viable organisms must be maintained on a system that separates the process from the environment (closed system)	Optional	Required
	2	Control of System Escape Gas closed	Not Required	Required, minimizing release	Requiring, avoiding release	Requiring, avoiding release
3	Control of aerosols during sampling, the introduction of material into a closed system, or the transfer of material to another closed system	Optional	Required, Minimizing Release	Required, preventing release	Required. Avoiding release
4	Inactivating the mass-growing liquid before removing it from the closed system	Optional	Required, with validated media	Required, with validated media	Required, with validated media
5	Close Systems designed to minimize or prevent release	No specific requirement	Minimize the release	Avoid Release	Avoid
6	Zone capable to contain the spill of all the contents of the closed system.	Optional	Optional	Required
7	Unrequired controlled zone for fumigation	Optional	Optional	Optional	Require
8	Entrance through lock	No required	Not Required	Optional
9	Surfaces resistant to water and acids, alkalis, solvents, disinfectants and decontamination agents, and easy to clean	Required (table, if any)	Required (table, if any)	10
		10	10	10	10	10	10	10	Table_table_izq"> Specific measures to properly ventilate the controlled zone and thus minimize contamination atmospheric	Optional	Optional	Optional	Required
11	Controlled zone with negative pressure on surrounding pressure	Not required	Not Required	Optional	Require
12	Processing the filtered zone's output and input air with HEPA filters	Not Required	Not Required	Required (output air; optional for input air)
						13
13
13	13	13	Optional		Optional
Required
14	Restricted access exclusively to authorized personnel	Unrequired	Required	Required
15	Obligation to indicate biological hazard	Not required		Required	Required
17	Staff must shower before leaving the controlled zone	Not required	Not Required	Optional
18	Require protection for staff	(work indumentaria)	Required (work indumentaria)	Required	Total change of indumentaria before to enter and
Waste
22	Inactivation of the organisms genetically modified in the effluents of sinks and showers or similar effluents	Unrequired	Not Required	Optional
Required
23	Inactivation of genetically modified organisms in contaminated material and residues, including genetically modified organisms present in the effluent before end spill	Optional	Required, with validated means	Required, with validated means	Required, with validated

ANNEX III

INFORMATION REQUIRED FOR THE COMMUNICATION REFERRED TO IN ARTICLE 14

PART A

Information required for the communication referred to in Article 14.1:

1. The name of the user or users, including those responsible for monitoring and security.

2. Information on the professional training and qualifications of persons responsible for supervision and security.

3. Data on all biological committees or subcommittees.

4. ° Address and general description of the premises.

5. ° Description of the nature of the job to be performed.

6. ° Type of confined use.

7. Only for confined uses of type 1, summary of the risk assessment referred to in Article 12 and information on waste management.

PART B

Information required for the communication referred to in Article 14.2:

1. ° Date of presentation of the communication referred to in Article 14.1.

2. Name of persons responsible for supervision and safety, and information on their professional training and qualifications.

3. ° recipient, donor and/or parental agencies and, if applicable, host-vector systems used.

4. ° Provenance and projected functions of the genetic materials used in the modifications.

5. Identity and characteristics of genetically modified organisms.

6. ° Finality of the contained use, including expected results.

7. ° Approximate quantities of crops to be used.

8. Description of the containment and protection measures to be applied, including information relating to the management of waste, including waste produced, its treatment and its final form and destination.

9. Summary of the risk assessment referred to in Article 12.

10. Information necessary for the competent body to be able to assess health emergency and epidemiological and environmental surveillance plans drawn up in accordance with Article 20.

PART C

Information required for the communication referred to in Article 14.3:

a)

Date of submission of the communication referred to in Article 14.1,

Name of those responsible for supervision and security and information on vocational training and qualifications.

b)

Receiving or parental agencies to be used.

Host-vector systems to be used (if applicable).

Provenance and projected functions of the genetic materials used in the modifications.

Identity and characteristics of the genetically modified organism.

Quantities of crops to be used.

c)

Description of the containment measures and other protective measures to be applied, including information relating to the management of the waste including the type and form of the waste to be produced, its treatment and its final form and destination.

The purpose of the contained use, including expected results.

Description of the parts of the installation.

(d) Information on accident prevention and health and epidemiological surveillance and environmental surveillance plans, if applicable:

Specific risks due to the installation site.

Preventive measures applied, such as safety equipment, alarm systems, and confinement methods.

Procedures and plans for checking the permanent effectiveness of confinement measures.

Description of information provided to workers.

Information necessary for the competent body to be able to assess health emergency and epidemiological and environmental surveillance plans, drawn up in accordance with Article 20.

e) A copy of the risk assessment referred to in Article 12.

ANNEX IV

PRINCIPLES TO BE FOLLOWED FOR THE ASSESSMENT OF THE RISK TO HUMAN HEALTH AND THE ENVIRONMENT NECESSARY FOR THE IMPLEMENTATION OF VOLUNTARY RELEASE AND MARKETING ACTIVITIES OF GENETICALLY MODIFIED ORGANISMS

This Annex describes in general terms the objective to be achieved, the elements to be considered and the general principles and methodology to be followed in order to carry out the risk assessment for human health and the environment which is required to carry out voluntary release and marketing activities for genetically modified organisms. As a supplement to this Annex, the guidance notes laid down in Commission Decision 2002/623/EC of 24 July 2002 should be used and any other Community provisions to be adopted in this area should be complied with. direct application or once its incorporation into the internal order.

In order to contribute to a common understanding of the terms "direct, indirect, immediate and deferred" in applying this Annex, without prejudice to further guidance in this respect and in particular as regards the Scope in which indirect effects can and should be taken into account, these terms are described as follows:

(a) The "direct effects" refer to the main effects on human health or the environment which are the result of the genetically modified organism itself and not a causal chain of events.

(b) The "indirect effects" refer to the effects on human health or the environment resulting from a chain of causal events, through mechanisms such as interactions with other organisms, transfer of genetic material or changes in use or management.

The observations of indirect effects are likely to be observed.

(c) The "immediate effects" refer to the effects on human health or the environment observed during the period of the release of the genetically modified organisms. Immediate effects may be direct or indirect.

d) The "deferred effects" refer to the effects on human health or the environment which are not observed during the period of the release of the genetically modified organisms but which manifest as effects either directly or indirectly at a later stage, either after the release in question has been completed.

A general principle for the assessment of the risk to human health and the environment should also consist of the need to carry out an analysis of the "long-term cumulative effects" of the release and the marketing. 'Long-term cumulative effects' means the cumulative effects that authorisations may have on human health and the environment, including, inter alia, flora and fauna, soil fertility, soil capacity, soil capacity, soil capacity, soil capacity, soil capacity, to degrade organic matter, the food chain for both animals and humans, biological diversity, animal health and antibiotic resistance problems.

A. Objective

The objective of a risk assessment is, on a case by case basis, to identify and assess potential adverse effects of the genetically modified organism, whether direct or indirect, immediate or deferred, on human health and the the environment that the voluntary release or the placing on the market of genetically modified organisms may have.

The risk assessment should be carried out in order to identify whether there is a need for risk management and, if so, the most appropriate methods to be used.

B. General principles

In accordance with the precautionary principle, when carrying out the risk assessment, the following general principles should be followed:

1. The identified characteristics of the genetically modified organism and its use having a potential for adverse effects shall be compared to those of the unmodified organism from which it is derived and its use in similar situations.

2. The risk assessment shall be carried out in a scientific and transparent manner on the basis of the available scientific and technical data.

3. The risk assessment shall be carried out on a case-by-case basis, so that the information required may vary according to the type of the genetically modified organisms concerned, their intended use and the environment. potential reception environment, taking into account, among other things, genetically modified organisms already in the environment.

4. In case of new information on the genetically modified organism and its effects on human health or the environment, a new risk assessment may be necessary to:

Determine if the risk has changed.

Determine if risk management needs to be modified accordingly.

C. Methodology

C. 1. Characteristics of the genetically modified organisms and releases

Depending on the case, the risk assessment should take into account the relevant technical and scientific details that relate to the characteristics:

a) From the recipient (s) or parental (s) body (s).

b) From the genetic modification (s), by inclusion or deletion of genetic material, and relevant information about the vector and the donor.

(c) The genetically modified organism.

d) Of intentional release or use, including its scale.

e) The potential reception environment, and

f) The interaction between these features.

Information regarding the releases of similar organisms and similar traits and their interaction with similar environments may be useful for risk assessment.

C. 2. Phases of the risk assessment

When drawing conclusions as regards the risk assessment, the following points should be taken into account:

1. Determining characteristics that may cause adverse effects

Any characteristic of genetically modified organisms linked to genetic modification which may have adverse effects on human health or the environment shall be identified. A comparison of the characteristics of the genetically modified organisms or organisms with which the unmodified organism presents, under similar conditions of release or use, shall facilitate the determination of potential harmful effects. specific to the fact that the genetic modification has been revealed. It is important that no potential adverse effect is ruled out on the grounds that it is unlikely to occur.

The potential adverse effects of genetically modified organisms will vary dramatically in each case, and may be manifested:

a) Diseases in humans, including allergenic or toxic effects [see, p. for example, Section A. 11 and Section C. 2.i. of Chapter II of Annex V A, and Section B. 7 of Annex V B].

b) Diseases in animals and plants, including toxic effects, and, where appropriate, allergenic [see, p. for example, Section A. 11 and Section C. 2.i. of Chapter II of Annex V A, and Section B. 7 and Section D. 8 of Annex V B].

c) Effects on the dynamics of species populations in the receiving environment and the genetic diversity of each of these populations [see, p. for example, Section B. 8, 9 and 12 of Chapter IV of Annex V A].

d) Altered susceptibility to pathogens that facilitate the spread of infectious diseases and/or create new reservoirs or vectors.

(e) Decrease in the effectiveness of medical, veterinary or phytosanitary protection, prophylactic or therapeutic treatments, for example by transferring genes that confer resistance to antibiotics used in the human or veterinary medicine [see, p. for example, Section A. 11.e) and Section C. 2.i), Chapter II (4) of Annex V A).

f) Effects on biogeochemistry (biogeochemical cycles), in particular the recycling of coal and nitrogen by changes in the decomposition of organic soil material [see, p. for example, Section A. 11.f. of Chapter II and Section B. 15 of Chapter IV of Annex V A, and Section D11 of Annex V B].

Adverse effects may occur directly or indirectly through mechanisms that may include:

1. The spread of the organism or genetically modified organisms in the environment.

2. The transfer of the inserted genetic material to other organisms, or to the same organism, whether genetically modified or not.

3. Phenotypic and Genetic Instability.

4. ° Interactions with other organisms.

5. Changes in management and also, where appropriate, in agricultural practices.

2. Assessment of the potential consequences of each adverse effect, in case of occurrence

The magnitude of the consequences of each potential adverse effect should be assessed. Such an assessment shall presuppose that this adverse effect is to be produced. The magnitude of the consequences will presumably be influenced by the environment in which the genetically modified organism or organisms must in principle be released and the manner in which the release is carried out.

3. Assessment of the probability of occurrence of each identified adverse effect

An important factor in assessing the presumption or likelihood of harmful effects is the characteristics of the environment in which the modified organism or organisms should be released in principle. genetically, and the way the release is performed.

4. Estimation of the risk posed by each identified characteristic of the genetically modified organism (s)

To the extent possible, an estimate of the risk to human health or the environment should be made that raises each identified characteristic of the genetically modified organism with the potential for adverse effects, in accordance with the current state of knowledge, combining the presumption of the adverse effect and the magnitude of its consequences, in the event of occurrence.

5. Application of management strategies to the risks of voluntary release or the placing on the market of the genetically modified organism (s)

Risk determination can identify the risks that require management, how to manage them better, and define a risk management strategy.

6. Determination of the overall risk of the genetically modified organism (s)

An assessment of the overall risk of the genetically modified organism (s) should be carried out taking into account any proposed risk management strategy.

D. Conclusions on the potential impact on the environment of the voluntary release or placing on the market of genetically modified organisms

On the basis of risk assessments carried out in accordance with the principles and methodology set out in Sections B and C of this Annex, applications for authorisation should be included in order to facilitate the extraction of conclusions on the potential impact on the environment of the voluntary release or placing on the market of genetically modified organisms, where appropriate, information on the points contained in the subsections D1 or D2 below:

D. 1. In the case of genetically modified organisms other than higher plants

1. The likelihood of the genetically modified organism becoming persistent and invasive in natural habitats under the proposed conditions of release (s).

2. Any selective advantage or disadvantage acquired by the genetically modified organism and the likelihood of it becoming a reality in the proposed release (s) conditions.

3. Potential transfer of genes to other species in the proposed release conditions of the genetically modified organism and any selective advantage or disadvantage that such species acquire.

4. Potential impact on the immediate and/or deferred environment of direct and indirect interactions between the genetically modified organism and the bodies covered by the investigation if appropriate.

5. Potential impact on the immediate and/or deferred environment of direct and indirect interactions between the genetically modified organism and non-research bodies, including the impact on the population levels of the competitors, dams, hosts, symbionts, predators, parasites and pathogenic organisms.

6. Possible immediate and/or deferred effects on human health as a result of direct and indirect potential interactions between the genetically modified organisms and the persons working with them, are in contact with them or near the release (s) of genetically modified organisms.

7. Possible immediate and/or deferred effects on animal health and consequences on the human or animal food chain resulting from the consumption of the genetically modified organism and any derived products from which it is intended to be used as animal feed.

8. Possible immediate and/or deferred effects on the biogeochemical processes resulting from potential direct and indirect interactions between the genetically modified organism and organisms subject to or outside the investigation near the or of the release (s) of genetically modified organisms.

9. Possible direct and indirect impact on the immediate and/or deferred environment of the specific techniques used for the management of the genetically modified organism where they are different from those used for organisms that have not been genetically modified.

D. 2. In the case of genetically modified higher plants (PSMG)

1. Likelihood that PSMG will become more persistent than the recipient or parental plants in agricultural or more invasive habitat in natural habitats.

2. Any advantage or disadvantage that the PSMG has acquired.

3. Potential for gene transfer to the same or other sexually compatible plant species in the planting conditions of the PSMG and any selective advantage or disadvantage to be acquired by such plant species.

4. Potential impact on the immediate and/or delayed environment resulting from direct and indirect interactions between PSMG and research organisms such as predators, parasitoids and pathogens (if any).

5. Possible impact on the immediate and/or delayed environment resulting from direct and indirect interactions between PSMG and non-research bodies (also taking into account the bodies that interact with the bodies involved in the investigation). constitute the objective), including the impact on the population levels of the competitors, herbivores, symbiontes (if any), parasites and pathogens.

6. Possible immediate and/or deferred effects on human health resulting from potential direct and indirect interactions between the PSGM and the persons working with them, are in contact with them or close to the release or the releases from PSMG.

7. Possible immediate and/or deferred effects on animal health and consequences for the human and animal feed chain of the consumption of the genetically modified organism and any product derived from it which is intended to be used in the animal feed.

8. Possible direct and indirect impact on the immediate and/or deferred environment of the specific cultivation, management and harvesting techniques used for PSGM when they are different from those used for higher plants that have not been genetically modified.

9. Possible immediate and/or deferred effects on the biogeochemical processes resulting from direct and indirect potential interactions between the genetically modified organism and the research or other bodies involved in the investigation find near the releases of genetically modified organisms.

ANNEX V

INFORMATION REQUIRED IN THE APPLICATION FOR VOLUNTARY RELEASE AND MARKETING AUTHORISATION

The applications for authorisation referred to in Chapters II and III of Title II of this Regulation shall provide, where appropriate, the information set out in Annexes V A and V B.

Not all points included will apply in each case. It is to be expected that each particular request will take into account only the subset of considerations that are appropriate to its specific situation.

The level of accuracy required of the response to each subset of considerations may vary according to the nature and extent of the proposed voluntary release.

Future developments in the field of genetic manipulation may make it necessary to adapt this annex to technical progress or to develop guidance notes from this annex. Once sufficient experience has been gained on applications for voluntary release of genetically modified organisms, it may be appropriate to differentiate the necessary information requirements for different types of organisms. genetically modified; for example, single-celled organisms, fish or insects, or for a particular use of genetically modified organisms such as vaccine development.

The file must also include the description of the methods used or a reference to internationally recognized or two-standard methods, together with the name of the entity or entities responsible for carrying out the studies.

Annex V A shall apply to the release of any type of genetically modified organism which is different from higher plants. Annex V B shall apply to the release of genetically modified higher plants.

The expression "higher plants" refers to the plants belonging to the taxonomic groups of the spermatophytes (gymnospenas and angiosperms).

ANNEX V A

INFORMATION REQUIRED FOR APPLICATIONS FOR THE VOLUNTARY RELEASE OF GENETICALLY MODIFIED ORGANISMS OTHER THAN HIGHER PLANTS

I. GENERAL INFORMATION

A. Name and address of the data subject (company or institution).

B. Name, degree and experience of the responsible scientist or scientists.

C. Project title.

II. INFORMATION ON GENETICALLY MODIFIED ORGANISMS

A. Characteristics of the body or bodies: (a) donors; (b) recipients, or (c) (where applicable) parental:

1. Scientific name.

2. Taxonomy.

3. Other names (common name, strain name, etc.).

4. Phenotypic and genetic characteristics.

5. Degree of kinship between donor and recipient organisms or between parental organisms.

6. Description of identification and detection techniques.

7. Sensitivity, reliability (in quantitative terms) and specificity of detection and identification techniques.

8. Description of the geographical distribution and natural habitat of the organism, including information on natural predators, prey, parasites, competitors, symbionts and guests.

9. Organisms with which the transfer of genetic material is known to occur in natural conditions.

10. Verification of the genetic stability of the organisms and factors that influence it.

11. Pathological, ecological and physiological traits of organisms:

(a) Classification of risks in accordance with existing Community rules on the protection of human health and/or the environment.

b) Period of generation in natural ecosystems, sexual and asexual reproductive cycle.

c) Information about survival, including seasonality and ability to form survival structures.

d) Pathogenicity: infectivity, toxigenicity, virulence, allergenicity, carrier (vector) of pathogen, possible vectors, range of hosts including organisms that are not the subject of the investigation.

Possible activation of latent viruses (provirus). Ability to colonize other organisms.

e) Resistance to antibiotics and the potential use of such antibiotics in humans and domestic organisms for prophylactic and therapeutic purposes.

f) Participation in environmental processes: primary production, nutrient cycles, decomposition of organic matter, respiration, etc.

12. Nature of indigenous vectors:

a) Sequence.

b) Frequency of mobilization.

c) Specificity.

d) Presence of genes that confer resistance.

13. History of previous genetic modifications.

B. Characteristics of the vector:

1. Nature and provenance of the vector.

2. Sequence of transposons, vectors and other non-coding genetic fragments used to produce the genetically modified organisms and to make the introduced vector and insertion fragment work on them.

3. Frequency of mobilization of the inserted vector and/or genetic transmission capacity, as well as methods for its determination.

4. Information on the extent to which the vector is limited to the DNA required to perform the desired function.

C. Characteristics of the modified organism:

1. Genetic modification information:

a) Employee modification methods.

b) Methods used to prepare and perform insertion or insertions at the receiver or to delete a sequence.

c) Description of the preparation of the insert and/or vector fragment.

d) Absence from the insertion fragment of any unknown sequence, and information about the extent to which the inserted sequence is limited to the DNA required to perform the desired function.

e) Methods and criteria used in the selection.

f) Sequence, functional identity and location of the altered, inserted or deleted segment or segments of the nucleic acid, with particular reference to any known harmful sequence.

2. Information on the genetically modified organism:

a) Description of genetic traits or phenotypic characteristics and in particular of all those traits and new features that may be expressed or those that can no longer be expressed.

b) Structure and quantity of any vector and/or donor nucleic acid remaining in the final composition of the modified organism.

c) Stability of the organism from the point of view of genetic traits.

d) Coefficient and level of expression of the new genetic material. Measurement methods and sensitivity.

e) Activity of the protein or protein expressed.

f) Description of the identification and detection techniques, including the techniques for identification and detection of the inserted sequence and vector.

g) Sensitivity, reliability (in quantitative terms) and specificity of identification and detection techniques.

h) History of previous releases or uses of the genetically modified organism.

i) Aspects relating to human health and animal health, as well as phytosanitary aspects:

1. ° allergenic or toxic effects of genetically modified organisms and/or their metabolic products.

2. ° Comparison of the pathogenicity of the modified organism with that of the donor, recipient or (if applicable) parental organism.

3. ° Colonization capacity.

4. ° In case the organism is pathogenic to immunocompetent persons: diseases caused and pathogenic mechanisms, including the ability to invade and virulence,

communication gapacity,

infectious dose,

range of guests, possibility of alteration,

possibility of survival outside the human host,

presence of vectors or means of dissemination,

biological stability,

antibiotic resistance patterns,

allergenicity,

existence of appropriate therapies.

5. ° Other hazards resulting from the product.

III. INFORMATION ON THE CONDITIONS OF VOLUNTARY RELEASE AND THE RECEIVING ENVIRONMENT

A. Information on voluntary release:

1. Description of the proposed voluntary release, including the purpose or the intended purpose and products.

2. Expected dates of the release and timing of the experiment, with the frequency and duration of the releases.

3. Preparation of the site prior to release.

4. Extent of the place.

5. Methods to be used for release.

6. Quantities of genetically modified organisms to be released.

7. Changes caused at the site (type and method of cultivation, mining, irrigation or other activities).

8. Measures for the protection of operators during the release.

9. Treatment of the place after the release.

10. Techniques for the disposal or deactivation of the genetically modified organisms after the experiment.

11. Information and results of previous releases of the genetically modified organisms, especially at different scales and in different ecosystems.

B. Information on the environment (both in situ and in a wider environment):

1. Geographical location and reference coordinates of the place (s) (in the case of applications under Chapter III, the areas where the use of the product is intended to be released).

2. Physical or biological proximity to important human and flora and fauna.

3. Proximity of biotopes, protected areas or important drinking water supplies.

4. Climatic characteristics of the region or regions that could be affected.

5. Geographical, geological and edaphological characteristics.

6. Flora and fauna, including crops, livestock and migratory species.

7. Description of the ecosystems that could be affected, whether they are the subject of the investigation or not.

8. Comparison of the natural habitat of the receiving organism with the place or sites proposed for the release.

9. Any urban project or land use modification project that may have an influence on the environmental effect of the release.

IV. INFORMATION ON THE INTERACTION BETWEEN GENETICALLY MODIFIED ORGANISMS AND THE ENVIRONMENT

A. Characteristics that affect survival, multiplication and dissemination:

1. Biological characteristics that affect survival, multiplication and dispersion.

2. Known or anticipated environmental conditions that may affect survival, multiplication and dissemination (wind, water, soil, temperature, pH, etc.).

3. Sensitivity to specific agents.

B. Interactions with the environment:

1. The intended habitat of the genetically modified organisms.

2. Studies on the behavior and characteristics of genetically modified organisms and on their ecological impact, carried out in simulated natural environments, such as microcosm, growth chambers, greenhouses, etc.

3. Genetic transmission capacity:

a) Transmission of genetic material from genetically modified organisms to affected ecosystem organisms, after release.

b) Transmission of genetic material from the ecosystem's own organisms to genetically modified organisms, after release.

4. Probability that after the release a selection is produced that manifests in the expression of unexpected and/or undesirable traits in the modified organism.

5. Measures used to ensure and verify genetic stability. Description of genetic traits that may prevent or minimize the dispersion of genetic material. Methods of verifying genetic stability.

6. Biological dispersion routes, known or possible models of interaction with the dissemination agent: among them inhalation, ingestion, superficial contact, penetration through the skin, etc.

7. Description of the ecosystems in which genetically modified organisms could be disseminated.

8. Possibility of excessive population increase in the environment.

9. Competitive advantage of the genetically modified organisms in relation to the non-modified receiving or parental organism (s).

10. Identification and description of the bodies covered by the investigation, where appropriate.

11. The mechanism provided for and the outcome of the interaction between the genetically modified organisms released and the body or bodies covered by the investigation, where appropriate.

12. Identification and description of the bodies which are not the subject of the investigation and may be adversely affected by the release of the genetically modified organisms and the intended mechanisms of the negative interaction identify.

13. Possibilities for post-release changes in biological interactions or in the range of guests.

14. Known or anticipated interactions with environmental organisms that are not the subject of research, such as competitors, dams, hosts, symbionts, predators, parasites and pathogens.

15. Known or anticipated implications for biogeochemical processes.

16. Other possible interactions with the environment.

V. INFORMATION ON MONITORING, CONTROL, TREATMENT OF WASTE AND EMERGENCY ACTION PLANS

A. Control techniques:

1. Methods of tracing genetically modified organisms and monitoring their effects.

2. Specificity (to identify genetically modified organisms and to distinguish them from the donor, recipient or, if appropriate, parental organism), sensitivity and reliability of control techniques.

3. Transmission detection techniques to other organisms of the donated genetic material.

4. Duration and frequency of control.

B. Release Control:

1. Methods and procedures to prevent and/or minimise the spread of genetically modified organisms outside the site of the release or the intended area for use.

2. Methods and procedures for protecting the place mentioned against the entry of unauthorized persons.

3. Methods and procedures to prevent other organisms from entering the site.

C. Waste treatment:

1. Type of waste produced.

2. Estimated volume of waste.

3. Description of the proposed treatment.

D. Action plans in case of emergency:

1. Methods and procedures for the control of genetically modified organisms in the event of unexpected dissemination.

2. Methods of decontamination of the affected areas, e.g. eradication of genetically modified organisms.

3. Methods of disposal or sanitation of plants, animals, soils, etc., exposed to the organism during or after the dissemination.

4. Methods of isolation of the area affected by the spread.

5. Plans for the protection of human health and the environment in the event of an undesirable effect.

ANNEX V B

INFORMATION REQUIRED FOR APPLICATIONS FOR THE RELEASE OF GENETICALLY MODIFIED HIGHER PLANTS (PSMG) (GYMNOSPERMS AND ANGIOSPERMS)

A. GENERAL INFORMATION

1. Name and address of the data subject (company or institution).

2. Name, degree and experience of the responsible scientist or scientists.

3. Project title.

B. INFORMATION CONCERNING PLANT A) RECEIVING OR (WHERE APPROPRIATE) B) PARENTAL

1. Full name:

a) family;

b) gender;

c) species;

d) subspecies;

e) cultivar/playline;

f) vulgar name.

2.

a) Replay Information:

1. Mode or modes of playback.

2. ° Specific factors, if any, affecting reproduction.

3. Generation Period.

b) Sexual compatibility with other cultivated or wild plant species, indicating the distribution of compatible species in Europe.

3. Ability to survive:

a) Ability to form survival or latency structures.

b) Specific factors, if any, affecting survival.

4. Dissemination:

a) Forms and amplitude (for example, an estimate of how much the possible pollen and/or seeds decrease with the distance) of the spread.

b) Specific factors, if any, affecting dissemination.

5. Geographical distribution of the plant.

6. In case of plant species not normally present in the Member State or Member States, description of the natural habitat of the plant, including information on natural predators, parasites, competitors and symbionts.

7. Other possible plant interactions, relevant to the genetically modified organism, to other organisms in the ecosystem in which it normally grows or from any other place, including information relating to toxic effects on humans humans, animals and other organisms.

C. GENETIC MODIFICATION INFORMATION

1. Description of the methods used for genetic modification.

2. Nature and origin of the vector used.

3. The size, origin (name) of the donor organism (s), and the intended function of each component fragment of the region that is inserted.

D. INFORMATION RELATING TO THE GENETICALLY MODIFIED PLANT

1. Description of the features and features that have been introduced or modified.

2. Information about the inserted/deleted sequences actually:

a) The size and structure of the insertion fragment and methods used for its characterization, including information on the parts of the vector that are introduced into the PSMG or any foreign carrier or DNA that is left in the PSMG.

b) In case of deletion, size, and function of the deleted region or regions.

c) Number of copies of the insert fragment.

d) Localization of the fragment or fragments of insertion into the plant cells (integrated into the chromosome, chloroplasts, mitochondria, or maintained in non-integrated form) and methods of determination.

3. Information about the insertion fragment expression:

a) Information about the expression of the development of the insertion fragment during the biological cycle of the plant and methods used for its characterization.

b) Parts of the plant in which the insertion fragment is expressed (e.g. roots, stem, pollen, etc.).

4. Information on how genetically modified plants vary with respect to the receiving plant as to:

a) Mode and rate of playback.

b) Dissemination.

c) Survival capacity.

5. Genetic stability of the insertion fragment and phenotypic stability of the PSMG.

6. Any change in the ability of the PSMG to transfer genetic material to other organisms.

7. Information on any potential toxic or allergenic effects or other harmful effects on human health due to genetic modification.

8. Information on the safety of the PSMG for animal health, in particular as regards its potential toxic or allergenic effects or other harmful effects due to genetic modification, when the PSMG is intended for food animal.

9. Mechanism of the interaction between the genetically modified plant and the organisms that are the subject of the investigation (if applicable).

10. Possible variations in the interactions of the PSMG with organisms that are not the subject of the research due to genetic modification.

11. Possible interactions with the abiotic environment.

12. Description of the techniques for the detection and identification of the genetically modified plant.

13. Information on previous releases of the genetically modified plant, if any.

E. INFORMATION RELATING TO THE PLACE OF RELEASE (ONLY IN THE CASE OF AN APPLICATION SUBMITTED IN ACCORDANCE WITH ARTICLES 23 to 25, 28 and 29)

1. Location and extent of the place or places of release.

2. Description of the ecosystem of the place of release, including data on climate, flora and fauna.

3. Presence of sexually compatible plant species, both cultivated and wild, that are relatives.

4. Proximity of officially recognised biotopes or protected areas that may be affected.

F. INFORMATION RELATING TO THE RELEASE (ONLY IN THE CASE OF A NOTIFICATION SUBMITTED IN ACCORDANCE WITH ARTICLES 23 to 25, 28 and 29)

1. Objective of the release.

2. Date or dates and expected duration of the release.

3. Method for the release of genetically modified plants.

4. Method of preparation and management of the place of release, with prior, simultaneous or post-release character, including cultivation practices and methods of collection.

5. Approximate number of plants (or plants per square meter).

G. INFORMATION ON THE PLANS FOR THE CONTROL, MONITORING AND TREATMENT OF WASTE AFTER THE RELEASE (ONLY IN CASE OF NOTIFICATION SUBMITTED UNDER ARTICLES 23 to 25, 28 and 29)

1. Precautions taken:

a) Distance or distances of sexually compatible plant species, both related and cultivated wild varieties.

b) Measures to reduce or prevent the dispersal of any reproductive organ of PSMG (e.g. pollen, seeds, tubers).

2. Description of the methods of treatment of the place after the release.

3. Description of the methods of treatment after the release as regards the collection and residues of the genetically modified plant.

4. Description of the monitoring plans and techniques.

5. Description of the emergency plans.

6. Methods and procedures for the protection of the place of release.

ANNEX VI

CRITERIA FOR APPLYING DIFFERENTIATED PROCEDURES

(Article 28)

The criteria referred to in Article 28 are listed below.

1. Taxonomy and biology (mode of reproduction and pollination, ability to cross with like-minded species, pathogenesis) of the unmodified organism (receptor) should be well known.

2. Safety for human health and the environment of parental organisms, where appropriate, and the recipient in the release environment shall be known to a sufficient extent.

3. Information shall be available on any particular interaction relevant to the risk assessment involving the parent, where appropriate, and the recipient and other organisms in the experimental release ecosystem.

4. There should be available information demonstrating that all genetic material introduced is well characterized, as well as information on the construction of vector systems or sequences of genetic material used with the carrier DNA. Where a genetic modification includes the deletion of genetic material, the extent of the deletion must be known. Sufficient information on genetic modification shall also be provided to allow the identification of the genetically modified organism and its progeny during a release.

5. The genetically modified organism must not present greater or more numerous risks to human health or the environment under the conditions of experimental release than those present in the releases of the parental organisms, where applicable, and corresponding recipients. No capacity for propagation in the environment, invasion of non-related ecosystems and transfer of genetic material to other organisms in the environment shall have adverse effects.

ANNEX VII

SIMPLIFIED PROCEDURE FOR THE VOLUNTARY RELEASE OF GENETICALLY MODIFIED PLANTS AS LAID DOWN IN ARTICLE 29

1. Applications for authorisation and, in particular, the information to be provided shall be governed by the provisions of Chapter II.

2. In order to obtain a single authorisation which includes several releases, all necessary information on each of them, including the various release sites and the experimental design, as well as the information required, must be provided in the application. an indication of any risk management condition for each particular release. A clear reference should be made to each release included in the application and attach the appropriate information to be able to complete the summary application and information model.

3. In the cases referred to in Article 29, it shall not be necessary to provide, in the application, detailed indications or descriptions of the places of release, subsequent intra-specific sexual crossings, or the conditions of release. However, sufficient data must be provided in the application for a comprehensive risk assessment and a detailed assessment, which will be made at least for the first release included in the work programme. Where applicable as set out in the previous paragraph, the applicant shall, where appropriate, submit to the competent authority additional information together with a statement indicating whether the original risk assessment remains valid. and, if it is not, will facilitate a further evaluation. This information shall be submitted prior to the specific release referred to in the form of a simple additional notification for information purposes only.

In such cases, the competent body shall immediately send to the European Commission any additional information on the risk assessment received in accordance with the provisions of the preceding paragraph.

If the additional information submitted shows that the original authorisation by simplified procedure has ceased to be applicable, the competent authority shall indicate to the applicant within 15 days of receipt of the information. of the notification, which may only proceed to the proposed release if it obtains an authorisation for the normal procedure laid down in this Regulation. After this period has not been adopted by the competent authority, the applicant may continue with the specific release concerned.

4. Where the single authorisation is granted in the terms of the simplified procedure, conditions may be attached to each of the releases to which it relates. These conditions may be amended by the competent body in accordance with Articles 46.2 and 47.1.

5. Once one or more of the releases approved under the simplified procedure have been carried out, the applicant shall submit to the competent body a report containing the results of one or more releases within the time limit specified in the authorisation. Such reports may be presented separately or as clearly identifiable part of a subsequent release notification.

6. The competent authority may alter the conditions of the first authorisation or intervene to alter the conditions of subsequent specific releases, based on the results of the reports or on the information obtained in the course of the inspections.

ANNEX VIII

SUPPLEMENTARY INFORMATION

This annex describes in general terms the additional information to be provided in the case of a marketing authorisation application as well as the information required for the labelling of the modified organism genetically as a product or component of the product being marketed and of the genetically modified organism used in operations which are not considered to be placed on the market pursuant to Article 30.2. It shall be supplemented by guidance notes as regards, for example, the description of the intended use for the product, which are approved in Community legislation. The labelling of the exempted bodies referred to in Article 50 (3) shall be established by the formulation of appropriate recommendations and restrictions on their use. As a supplement to this Annex, the requirements laid down in Community legislation relating to the information on genetic modifications to be included in the register referred to in paragraph A 7 shall apply.

A.

In the application for the marketing authorisation of a genetically modified organism as a product or component of a product, the following information shall, in addition to that required in Annex V, be provided:

1. Proposals for trade names for products, the names of the genetically modified organisms they contain, as well as any specific identification, name or code used by the person concerned to identify the organism genetically modified. Once the authorisation has been granted, all new trade names must be provided to the inter-ministerial Council of genetically modified organisms.

2. The name and full address of the person domiciled in the European Community responsible for the marketing, whether the manufacturer, the importer or the distributor.

3. The name and full address of the supplier or suppliers of the control samples.

4. The description of how the product and the genetically modified organism are intended to be used as a product or component of the product. Differences in the use or management of the genetically modified organism in comparison with similar non-genetically modified products should be highlighted.

5. The description of the area or geographical areas and the types of environment in which the use of the product is envisaged within the European Community, including, where possible, an estimate of the scale of its use in each area.

6. The categories of user intended for the product, such as industry, agriculture, or craft or consumption by the general public.

7. Information on the genetic modification carried out in order to record in one or more records modifications made to organisms, which may be used to detect and identify products with genetically modified organisms in order to facilitate post-marketing control and inspection. This information shall include, where appropriate, the deposit of samples of the genetically modified organism or its genetic material to the competent body, as well as details of the nucleotide sequences or other information necessary for the purposes of the identify the product with genetically modified organisms and their progeny, for example the methodology for detecting and identifying the product with genetically modified organisms, including experimental data demonstrating specificity of the methodology. Information not to be included, for reasons of confidentiality, shall be identified in the part of the register accessible to the public.

8. The proposal for labelling, on a label or in an attached document, which must include, at least in the form of a summary, a trade name for the product, the words 'this product contains genetically modified organisms', the name of the genetically modified organism and the information referred to in paragraph A 2. The labelling shall indicate how to access the information collected in the part of the register accessible to the public.

B.

In addition to the provisions of paragraph A, the following information shall be provided in accordance with Article 30:

1. The measures to be taken in the event of inadvertent release or incorrect use of the product.

2. Specific instructions or recommendations for storage and handling.

3. The specific instructions for the control and information to the data subject and, where appropriate, the competent body, in such a way that the competent authorities are effectively informed of any adverse effects.

These instructions must be compatible with paragraph C of Annex X.

4. Proposals for restrictions on the approved use of the genetically modified organism, for example, where the product can be used and for what purpose.

5. The proposed packaging.

6. An estimate of the domestic production and/or import to the European Community.

7. A proposal for supplementary labelling, which may include, at least in the form of a summary, the information referred to in paragraph A 4 and 5 and paragraph B 1, 2, 3 and 4.

ANNEX IX

GUIDELINES FOR ASSESSMENT REPORTS

The assessment report provided for in Articles 34. 3, 41.1 and 44 2, shall include in particular the following:

1. Identification of the characteristics of the receiving organism relevant for the assessment of the genetically modified organism (s) in question. The identification of any known risk to human health and the environment resulting from the release of the unmodified receiving organism into the environment.

2. The description of the result of the genetic modification in the modified organism.

3. An assessment of whether the identification of the genetic modification characteristics is sufficient to assess the risks to human health and the environment.

4. The identification of any new risk to human health and the environment which may be produced from the release of the genetically modified organism or organisms in question as compared with the release of the organism or the relevant non-modified organisms based on the assessment of the risk to human health of the environment carried out in accordance with the provisions of Annex IV.

5. A conclusion on whether the genetically modified organisms or organisms in question should be placed on the market as a product (s) or component (s) of a product (s) and under which conditions, if the genetically modified organism (s) concerned do not may be placed on the market or if it is necessary to appear from other competent authorities and the European Commission on specific issues of risk assessment for human health and the environment. These aspects should be specified. The conclusion should clearly refer to the proposed use, risk management and the proposed monitoring plan. In the event of the conclusion that the genetically modified organism (s) in question should not be placed on the market, the inter-ministerial Council of genetically modified organisms shall state its conclusion.

ANNEX X

TRACKING PLAN

This annex describes in general terms the objective to be achieved and the general principles to be followed for the design of the monitoring plan referred to in Article 32.2, Article 37 and Article 42. As a supplement to this Annex, the guidance notes set out in the Annex to Council Decision 2002/811/EC of 3 October 2002 should be used and any other Community provisions to be adopted in this area should be complied with, either directly applicable, or after incorporation into the internal order.

A. Objective

The goal of a tracking plan is:

1. ° Confirm that any assumptions regarding the occurrence and consequences of potential adverse effects of the genetically modified organism or its use in the assessment of the risk to human health and the environment environment are correct, and

2. Identify adverse effects of the genetically modified organism or its use on human health or the environment that have not been contemplated in the assessment of the risk to human health and the environment environment.

B. General principles

The monitoring, as provided for in Articles 32.2, 37 and 42, is taking place as a result of the authorisation to place a genetically modified organism on the market.

The interpretation of data collected by monitoring should be considered in light of other existing environmental conditions and activities. Where changes in the environment are observed, a new assessment should be considered which establishes whether they are a consequence of the genetically modified organism or its use, since such changes may be the result of factors the environmental impact of the genetically modified organism.

Experience and data acquired through the monitoring of experimental releases of genetically modified organisms may help to design the follow-up regime after the required market research for the placing on the market of genetically modified organisms as products or as components of products.

C. Design of the tracking plan

The layout of the tracking plan should:

1. Detailed in each case taking into account the risk assessment for human health and the environment.

2. Take into account the characteristics of the genetically modified organism, the characteristics and scale of its intended use and the range of relevant environmental conditions where the genetically modified organism is expected to be released.

3. Include general surveillance for the detection of unforeseen adverse effects, as well as, where necessary, specific control (for certain cases) focusing on the adverse effects identified in the risk assessment for human health and the environment:

3.1 Whereas the specific monitoring of each case should be carried out for a sufficient period of time to detect immediate and direct effects, as well as, where appropriate, any deferred or indirect effects identified in the risk assessment for human health and the environment.

3.2 Whereas surveillance may, where appropriate, make use of routine surveillance practices already in place, such as the supervision of agricultural crops, plant health protection, or veterinary and medical products. The authorisation holder shall be provided with the manner in which the relevant information collected through routine surveillance practices already established shall be made available to the holder.

4. To facilitate the systematic observation of the release of a genetically modified organism in the receiving environment and the interpretation of those observations with regard to the safety of human health or the environment.

5. Determine who will carry out the various tasks required by the monitoring plan and who is responsible for ensuring that the monitoring plan is properly addressed and implemented, and to ensure that there is a channel to allow the monitoring plan to be implemented. the authorisation and the inter-ministerial Council of genetically modified organisms are informed of any adverse effects observed in human health and the environment. (The dates and time intervals for reports on the results of the monitoring will be indicated.)

6. Consider the mechanisms for identifying and confirming any adverse effects observed in human health and the environment and allowing the holder of the authorisation or the competent authority, where appropriate, to take the necessary measures to protect human health and the environment.

ANNEX XI

Model for the presentation of the results of the intentional release trials in the environment of genetically modified higher plants according to Article 27

The holder of the activity shall use the "report model" below for the presentation to the competent body of the results of the deliberate release into the environment of modified higher plants genetically.

Each form will correspond to an authorization granted and will be identified by its notification number.

For each notification number, the holder shall submit a final report and, where appropriate, one or more post-release follow-up interim reports. Both reports will conform to the report model.

The final report must be delivered after the last harvest. This will be the only report in case the release does not require further follow-up.

The competent body shall specify in its authorisation, where appropriate, the duration of post-release monitoring, as well as the frequency of the submission of interim follow-up reports to the competent body. release.