Select Committee on European Communities Second Report - Written Evidence

Memorandum by the Spanish Embassy

  In Spain, the two directives regulating the possible risks for the environment (Directive 90/219/EEC and 90/220/EEC) have been incorporated into our domestic legislation by Law 15/94, of the 3 June, which lays down the regulations for contained use, deliberate release and placing on the market of genetically modified organisms, in order to prevent risks to human health and the environment.

  The fundamental basis for the procedures set down both in the directives and, logically, in Spanish law, is the Precautionary Principle. That is, bearing in mind that the risks to the environment involved in introducing and handling these organisms are unknown, each operation should be assessed case by case, and following a "step-by-step" procedure to introduce them into the environment.

  In Spain, internal negotiation for this programme has been drawn out due to our problems with the political distribution of competences with our regions, so we have been one of the last States to incorporate both directives which have been combined in one single legal instrument. Furthermore, the scope of Directive 90/219/EEC, which only regulated activities with genetically modified micro-organisms, has been extended, just as in most States.

  The incorporation of the two directives into the Spanish Law system by means of a regulation of legal status is due firstly to the fact that there exists no General Law on the Environment in our country, nor on Genetic Engineering, so there was no legal capacity which enabled the government to act by means of regulating. Secondly, the risks involved in these activities made it advisable to set down a system of penalties and, in accordance with the Constitution, this may only be done by Law.

  In addition to this, the basically regulatory character of both directives made it advisable to incorporate only the basic aspects by Law, leaving detailed questions to be developed by regulation, notwithstanding the possibility for the Autonomous Communities to lay down additional norms.

  Last 20 June, Royal Decree 951/1997 was finally passed, approving the general Regulations for the development and Implementation of Law 15/1994. As previously mentioned, these Regulations develop those aspects which are necessary for the effective application of the Law, such as:

  1. Requirements for carrying out the activities of contained use and voluntary release of genetically modified organisms.

  2. Obligations for the placing on the market of this kind of organism or of products which contain them.

  3. Regulations on information, surveillance and control of these activities.

  4. Responsibility, infractions and penalties.

  5. Creation and competencies of the official Competent Authority for granting state authorization and the National Advisory Body.

  The Royal Decree by which the General Regulations are approved for the development and implementation of Law 15/1994 incorporated into internal law not only the provisions of the Directives 90/219/EEC and 90/220/EEC, not included in the Law, but also subsequent Commission Directives passed to adapt their annexes to technical advances:

    —  Directive 94/51/EEC: criteria for the classification of GMMs in group 1.

    —  Directive 94/15/EEC: new annex II, differentiating between plants and other GMOs.

    —  Directive modification of annex III of Dir. 90/220/EEC, incorporating additional provisions on labelling of products which contain or consist of GMOs.

  Furthermore, different Commission Decisions are included, which have been passed with the favourable opinion of the Technical Committee, set up under section 21 of both directives:

    —  Decision 91/448/EEC, modified by 96/134/EC: criteria for determining the risk of GMOs.

    —  Decision 92/146/EC and 94/211/EC: models to conform to for the information on GMO releases which Member States must send to the Commission.

    —  Decision 94/730/EC: Simplified Procedures for genetically modified plants.


  The Law is arranged in the following chapters:

  1. General Provisions.

  2. Contained use of GMOs.

  3. Deliberate release of GMOs.

  4. Placing on the market of GMOs or products which contain them.

  5. Information and control.

  6. Infractions and penalties.

  7. Administrative competencies.

  One of the most important things is that we, as many other countries in Europe, decided to wide the scope and dealing with organisms for all the activities, and the definition given for an organism includes microorganisms, viruses, viroids; plants and animals; including ova, seeds, pollen, cell cultures and tissue cultures.


  The first of these activities, contained use, is regulated by chapter II, and is defined as "any activity by which an organism's genetic material is modified, or by which the modified organism is cultivated, stored, used, transported, destroyed or eliminated, whenever in carrying out these activities physical barriers are used, or a combination of these with chemical or biological barriers, in order to restrict their contact with the population or the environment".

  When the General Law came into force, a data base of institutions working with GMOs in contained facilities was elaborated, resulting that there are more than 200 departments, and around eight laboratories prepared for high risk activities.
Procedures for contained used

First installations Teaching, research and development operations Operations with industrial or commercial objectives

Low-risk GMOsCommunication 3 months Free of RegistryCommunication 2 months
High-risk GMOsCommunication Plus Authorization 3 months Communication 2 monthsCommunication plus authorization 3 months


  Chapter III, relative, as mentioned above, to the deliberate release of genetically modified organisms for research and development objectives or any other purpose than for placing on the market, first lays down the concept and scope of application. Thus, release is understood to mean "the deliberate introduction into the environment of an organism or a combination of genetically modified organisms without containment measures having been employed, such as physical barriers or a combination of these with chemical or biological barriers, in order to restrict their contact with the population or the environment".

  When a field release is requested, the competent authority must be presented with:

  1. A technical study with all the information and data shown in annex IV of the Regulations, parts A and B, in accordance with the recently-passed modification to this, which consists of laying down different requirements for higher plants (gymnosperms and angiosperms), since experience is much greater than with other organisms.

  2. An assessment of the possible effects of the release for human health and the environment.

  The application of norms on biosafety in Spain has been carried out in accordance with the indications and principles mentioned at the outset. That is, that these activities must be carried out step by step, from laboratory research to commercial plants, or from laboratory to field, and once their possible effects on human health and the environment have been tested and assessed, the products may be placed on the market.

  In addition, it is necessary to assess activities with genetically modified organisms case by case, since the characteristics of different crops and their effects on the environment may vary considerably. Thus, the assessment of new varieties is carried out in accordance with the following criteria:

    —  characteristics of the donor organism;

    —  characteristics of the receiving organism;

    —  sequences introduced;

    —  environment in which it is released.

  In Spain, as mentioned, this assessment is carried out by the Biosafety Commission, our Advisory Body which, since 1991 when the European Directives came into effect, has authorised over 130 field tests, in most cases each one in a variety of places. Prominent among the new varieties tested are those of maize with resistance to herbicides (27 per cent), resistance to insects (14 per cent) or both combined (7 per cent). Maize represents 33 per cent of field releases with respect to the total number of tests carried out. It is followed in second place by tomato (18 per cent), sugarbeet (11 per cent), tobacco (7 per cent) and others in lesser quantities.


  The next chapter regulates the placing on the market of genetically modified organisms or products which contain them, which is understood to mean "the delivery to third parties of these organisms or their products". This delivery is understood to be exclusively commercial. That is, it would not be considered to mean, for example, the delivery by the central office of a multinational company to one of their branches or the depositing of these organisms in order to patent them (article 17).

  As regards the report that petitioners must send to the competent authority, the following documentation:

    (a)  a technical study with the data and information set down in annex 5 of the Regulations;

    (b)  the assessment of risks to human health and the environment, of the product which is to be placed on the market; and

    (c)  the conditions for placing on the market as described in the Regulations.

  The Spanish authorities have presented three dossiers for placing in the market, that actually have received some objections from other Member States and will pass under the review of The Committee on Plants of the European Commission. The three crops evaluated are:

    —  Tomato expressing PG activity reduced from the British company Zeneca.

    —  Bt-Cotton expressing resistance to Heliothis from the American company Monsanto, and

    —  Roundup Ready cotton, expressing tolerance to glyphosate herbicide, from Monsanto as well.

  Maize is the most tested crop all over the European Union and in Spain too, it has been the first one (last 23 March, 1998) receiving the grant from the Ministry of Agriculture for the inscription of two varieties which contain the event 176, in the Register of Commercial Varieties.

  In view of the requirements of European consumers, after the modification of annex III of Directive 90/220/EEC which came into effect in July, 1997, products commercialized under this directive are obliged to conform to the following type of labelling:

    —  Mandatory labelling which reads "may contain genetically modified organisms" when it is thought that it may be a combination.

    —  Mandatory labelling which reads "contains genetically modified organisms" when it is known positively that it does.

  In this chapter, it is important to say that last 23 March two GM varieties of Bt-maize containing the event 176 from Novartis have been approved for inclusion in the Spanish Register of Varieties by the Ministry of Agriculture.


  Chapter V, "Information and control" sets down provisions of a general character which appears in both directives on three aspects of great importance: confidentiality, emergency situations, surveillance and control.

    1.  As regards confidentiality, article 23 of the Law grants holders the possibility to invoke the confidentiality of ceratin information and oblige the Administration to take the necessary steps to respect it. Nevertheless, this confidentiality can under no circumstances be applied to the following data:

        Description of the genetically modified organism.

        Identity of the holder.

        Objective and site of activity.

        Emergency and control measures.

        Assessment of effects on health and the environment.

    2.  If the activities regulated give rise to emergency situations, article 24 refers to the legislation on civil protection and special measures on public health issues.

    3.  As regards surveillance and control (article 25), this will, in all cases, be the responsibility of the Autonomous Communities, to whom holders must offer all their collaboration to achieve it.


  One of the aspects which most influenced the incorporation of the two directives by means of a Law was the need to establish possible infractions of the Law and their corresponding penalties, bearing in mind the risks involved in these activities. The Autonomous Communities shall be responsible for enforcing these penalties arising from infractions.

  The following, Chapter VI, Infractions and Penalties, lays down the list of infractions, classifying them under slight, serious and very serious. Penalties vary from a fine of 1,000,000 pesetas for slight infractions, up to 100,000,000 pesetas and definite closure of installations for very serious infractions (article 26 and 27). Compensation is also established for damages (article 28) so that, apart from the applicable penalty, those responsible for the infringing activity must return things to their original state and pay those compensations which the court may establish. Criteria laid down for assessing damages are:

    —  theoretical cost of restitution and replacement;

    —  value of damaged goods;

    —  cost of project or activity causing the damage, and

    —  profits obtained from the infringing activity.

  If the action furthermore constitutes an offence, it shall be transferred to the Attorney General's Office and the process of the penalty report shall be suspended.


  In Chapter VII, on Administrative Competencies, the Law lays down that both the contained use and the deliberate release of GMOs shall be the responsibility of Autonomous Communities, except in those cases which imply possible incorporation into medicines for human and/or veterinarian use, and in cases of basic state research (article 31) where the General Administration shall be responsible for granting such authorisation, in addition to cases of commercialisation, where the fifteen Member States give their consent for a product of this type to come onto the market.

  The Law lays down that an Official Organisation, under the Ministry of the Environment, in charge of granting those authorisations which correspond to Central Administration, made up from the Ministries of the Environmental Health and Consumption; Agriculture, Fisheries and Food; Industry and Energy and Education and Culture, in which greater significance shall be given to environmental authorities when the activities may imply a risk to the environment, requiring the conformity of Health when dealing with human medicines, and Agricultures when they are veterinarian.

  In the final part of the Law there are two additional provisions and seven final provisions, among which the third final provision is especially important, on the creation of the National Biosafety Commission, which shall act as a consultative body for the general Administration and the Autonomous Communities.

  Additionally, in the Single Additional Provision for this Royal Decree, the National Biosafety Commission is set up, composed of representatives from the ministries involved (Environment; Health and Consumption; Agriculture, Fisheries and Food; Industry and Energy; Education and Culture, and the Interior), by a representative from the Autonomous Communities that so request and by six experts in representation of institutions related to the issue, where NGO and Trade Unions can be incorporated.

  Finally, we should mention the seventh final provision which regulates the preparation, every three years, of a report on the situation in Spain regarding genetically modified organisms (GMOs).

4 June 1998

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