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
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
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
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
||Teaching, research and development operations
||Operations with industrial or commercial objectives
|Low-risk GMOs||Communication 3 months
||Free of Registry||Communication 2 months
|High-risk GMOs||Communication Plus Authorization 3 months
||Communication 2 months||Communication 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
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;
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
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.
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
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,
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