COMVIISSION OF THE EUROPEAN COMMUNITIES 
COM(91)386 final- SYN 265 
Brussels, isOctober 1991 
Amended proposal for a 
COUNCIL PEC)?IQN 
adopting a specific research and technological development 
programme in the field of Biotechnology 
(1990-1994) 
(presented by the Commission pursuant to Article 149(3) 
of the EEC-Treaty) 

A-
Justification 
On 28th May 1990, the Commission presented its proposal for a specific programme of 
research and technological development in the field of biotechnology (COM(90)160 final -
SYN 265). The Economic and Social Committee gave an opinion on the proposal on 18th 
October 1990. The European Parliament examined it in first reading on 9 October 1991, and 
voted 62 amendments. 
Amendments 2 and 3, as well as 12 and 14 in their latter parts, are compatible with the 
measures adopted for other specific programmes and can be accepted by the Commission in 
an appropriate form. The other amendments of horizontal character fall outside the agreement 
of the three Presidents of 17 April or the decisions relating to preceding programmes, and have 
not been taken up : this concerns numbers 13, 14 (2 first parts), 15, 16, 40 to 50, 53 and 55. 
Certain amendments did not respect the limits of the areas of competence attributed to this 
programme, by excess or deficiency : these are numbers 9,12 (first part), 17, 26, 28, 37, 51, 54, 
58, 60 to 64, 66 and 67. Others, on the contrary, constituted useful additions to the technical 
description of the objectives and are taken up, as they are or subject to reformulation, in the 
modified proposal of the Commission : numbers 1, 4, 6 to 8, 11,18, 22 to 25, 27, 29 to 36, 38, 
52, 69 and 72. 
So far as concerns Community regulation on genetically modified organisms, the Commission 
will conform to the content of the directives adopted by Council, as expressed in its version of 
amendments 5 and 19. Ethical concerns will be taken into account by including in the modified 
proposal amendments numbers 8, 11, 29 and 38, and by substituting for amendment 20 the 
"recital" on social and economic impact received from the trilogue, but enlarged to include the 
concept of ethics. Amendment number 8 completes the references which the Commission 
intends to make to the ethical impact of the research work. Amendment number 10 will not 
be taken up. The part of amendment 59 relating to the protection of animals against 
unnecessary suffering inflicted in laboratories is taken up in a formulation referring to the 
Community Directive in force. 
Amendment 38 is added, in a modified version, to the indicative breakdown of expenses, and 
includes certain elements of amendment 39 which in its other parts is not acceptable. 
The modifications to the original proposal, underlined, appear hereafter in the order in which 
they should appear in the text. 
The proposal thus modified is presented by the Commission in accordance with paragraph 3 
of Article 149 of the EEC Treaty. 
-I' 
Amended Proposal for a 
COUNCIL DECISION | 
adopting a specific research and technological development * 
pmgranune in the field of Biotechnology \ 
(1990-1994) \ 
\ 
^ 
The proposal for a Council Decision adopting a specific research and technological j 
development programme in the field of Biotechnology (COM/90/160 final - SYN 265) is j 
amended as follows : I 
Recital 2 a (new) 
Whereas research and technological development 
in this field should be linked to various relevant 
Community policies and objectives; 
Recital 3 a (new) 
Whereas basic research in the field of 
biotechnology must be encouraged throughout 
the Community; 
Recital 3 b (new) 
Whereas, in addition to the specific programme 
concerning human resources and mobility, it is 
necessary to encourage the training of research 
workers in the context of this programme; 
Recital 3 c (new) 
Whereas, in the context of this programme, an 
assessment should be made of the ethical, 
economic and social impact as well as of any 
eventual technological risks; 
-3-
Recital 6 a (new) 
Whereas biological research. in 
particular that which uses the 
methods of recombinant DNA. is often 
subject to national laws with which 
the contractors must comply; 
Recital 6 b (new) 
Whereas the Community issued two directives on 
23 April 1990 (Directive 90/219/EEC on the 
contained use of genetically modified micro­
organisms and Directive 90/220/EEC on the 
deliberate release into the environment of 
genetically modified organisms^ on recombinant 
DNA technologies, which the Member States 
undertook to bring into force through laws, 
regulations and administrative provisions no later 
than 23 October 1991; 
Recital 7 a (new) 
Whereas research in biotechnology may lead to 
improvements of agricultural and industrial 
efficiency and viability, of preservation of 
environment and health, and of quality products 
for the consumer; 
li-
Recital 9 a (new) 
Whereas actions should be 
undertaken to ensure that the 
necessary consideration is given to 
the ethical and social effects of 
these projects, and their 
applications in agriculture, 
industry, health care and the 
environment; whereas such actions 
will ensure that information is made 
available to the public concerning 
the content of the programme; 
Recital 9 b (new) 
Whereas the contextual conditions 
for the beneficial development of 
biotechnology in Europe can be 
improved through concertation 
activities; 
Recital 10 a (new) 
Whereas the results which may be 
achieved by genetic research make it 
necessary to adopt an integrated 
approach which takes account of the 
scientific, ethical and legal 
aspects of possible applications and 
of the need to ensure that the 
results are not used in an improper 
manner or subject to 
misrepresentation; 
Recital 10 b (new) 
Whereas the Commission has announced its 
intention to establish an appropriate advisory 
structure to examine the ethical implications of 
biotechnology; 
9 
Article 1 
A specific research and technological 
development programme for the European 
Economic Community in the field of 
biotechnology, as defined in Annex I, is hereby 
adopted for a period beginning on ... and ending 
on 31 December 1994. 
Article 6, 3rd paragraph 
A work programme shall be drawn up at 
the start of the programme and shall be 
regularly revised. It shall set out the 
detailed objectives and types of projects 
to be undertaken, and the financial 
arrangements to be made for them. The 
Commission shall make calls for 
proposals for projects on the basis of the 
work programme. 
-6 
Annex I, 4th paragraph, third sentence 
Deleted. 
Annex I, 4th paragraph, fourth sentence 
For all projects conducted in this framework, 
contractors will always be requested to provide, 
using a suitable form, information necessary for 
the detailed evaluation of the social, ethical and 
ecological impact of their studies and, where 
necessary, approval from the responsible 
authorities. The provisions of relevant 
Community directives must be applied as regards 
the ecological impact. 
Annex I, Area 1, 1st paragraph 
Research under this theme is aimed at two goals. 
First, to understand and control biological 
functions carried out by proteins (enzymes, 
hormones, antibodies, receptors, body structures, 
etc.). Second, to produce potentially useful 
proteins (new drugs, industrial enzymes, etc.). 
Annex I, Area I, 2nd paragraph 
Target areas will include enzymes 
and proteins associated with 
biological membranes. 
f-
Annex I, Area 1, 4th paragraph, 
first sentence 
The goal is to arrive at a greater 
understanding of biological and 
genetic mechanisms. 
Annex I, Area 1, 5th paragraph 
Efforts will be undertaken to 
contribute to the sequencing work 
on the entire genome of yeast, which 
displays a genetic structure and 
organization (genome) comparable to 
that of plants and animals, and to 
initiate a Community effort for 
sequencing genes in suitable 
microorganism, plant and animal 
species. 
Annex I, Area 1, 8th paragraph 
In order to make full use of the 
above information on gene structure, 
the processes through which the 
information stored as DNA in the 
genes is expressed in the form of 
active proteins will be studied in 
some models of practical importance 
- transcription factors, factors 
affecting transcription, RNA-
polymerases, their interactions 
with signals, ligands, DNA and 
posttranscriptional processes. A 
specific objective is the analysis 
of a number of DNA polymerases and 
transcription factors in yeast, 
plants and mammalian cells. 
-? 
Annex I, Area 2, 1st paragraph, 2nd sentence 
Research will be 
centred on the control of 
development, cell commitment and 
cell totipotency in higher organisms 
starting with the simplest levels of 
organization, namely gametes, eggs, 
proliferating lines and their 
reorganization into organs and 
embryos. Research projects on human 
embryos are not included in the 
programme. 
Annex I, Area 2, 3rd paragraph 
The goal is to provide to industrial and 
agricultural undertakings the basic knowledge 
necessary for a more rational utilisation of 
resources at the levels of production, 
transformation and animal-rearing. 
The analysis of biological material with a view to 
studying and safeguarding human health will 
make use of new animal models including, as 
necessary, transgenic animals. All unnecessary 
suffering will be strictly avoided, and the 
G anm . , t i iùjx ). iLions ' on the protection of 
animals ased for experimental purposes will be 
applied. 
\anex I, Area 2, 4th paragraph 
Research will concern the regulatory mechanisms 
governing some of the biological functions or 
metabolic activities in species which are 
important to man (e.g. as specific objectives, 
production and secretion in microorganisms, 
extremopirilcinicroorganisms,metabolicpathways 
under extreme environments, nitrate assimilation 
in plants, food utilization and metabolic control 
in animals, etc). 
; Council Directive 86/609/EEC of 24/11/1986 
-5-
Annex I, Area 2, 6th paragraph 
Research will be focused on the 
immune and the nervous systems. 
Immunological studies will concern 
the complex interaction between the 
three main types of cells (antigen 
presenting cells, T-lymphocytes and 
B-lymphocytes) responsible for the 
reaction of the animal body to 
foreign substances (antigens). 
Concerning pre-normative objectives, 
pharmacological and toxicological 
test systems for use in the 
assessment of biotechnologically 
produced compounds will be 
developed, with special attention to 
immune reactions in 'drug targeting' 
and immunotoxicology as such. 
Synergism with protein engineering 
will be assured. 
Annex I, Area 2, 7th paragraph 
In neurobiology, attention will be 
given to the basic unit of the 
brain, the neurons and their 
i nteractions. The biochemical, 
pharmacological and genetic 
characterization of newly discovered 
neuroreceptors systems will 
constitute a specific objective of 
the programme. 
-</o-
Annex I, Area 3, 2nd paragraph 
Particularly in the case of micro-organisms, the 
systematic analysis of possible risks will be carried 
out taking into consideration the need for a 
comprehensive understanding of the relevant 
characteristics of the ecosystems involved, such as 
the soil. Research will include the analysis of 
representative examples of interactions between 
microbial populations and other organisms in the 
ecosystems; the study of the impact of the 
introduction of genetically modified or 
genetically marked micro-organisms on the 
rhizosphere or leaf surface; the determination of 
the behaviour and effects upon ecosystems of 
organisms, including those modified by genetic 
engineering (including as a complement to 
ongoing research in BRIDGE, fishes and 
insects). 
Annex I, Area 3, heading 
between 2nd and 3rd paragraphs 
Biological diversity 
Annex I, Area 3, 4th paragraph, 
first sentence 
Taxonomy will be revitalized with inputs from 
molecular biology, providing specific and target 
support to decentralized collections of biotic 
materials; this support will be restricted to 
research and will exclude the maintenance or 
expansion of existing collections; a systematic 
assessment of the residual genetic variability of 
agricultural and industrial species of regional and 
traditional importance will be initiated. 
-u-
Annex I, Area 3, 4th paragraph, 
second sentence 
A systematic assessment of the residual genetic 
variability of microbial, plant and animal species, 
with particular emphasis on species and varieties 
which have played a major role in traditional 
European agriculture and food. 
Annex I, Area 3, 6th paragraph 
Work in this area will link into Community 
research programmes dealing with environmental 
issues and international cooperation. 
Annex H, last sentence 
The breakdown between different areas does not 
exclude the possibility that projects could cover 
several areas. 
Tent percent of the amount will be allocated to 
basic research. Between 5 and 7% of the amount 
will be allocated to training of researchers. 
Three percent of the amount will be allocated to 
the assessment of ethical and socio-economic 
effects and technological risks. 
ISSN 0254-1475 
COM(91) 386 final 
DOCUMENTS 
EN 15 
Catalogue number : CB-CO-91-444-EN-C 
ISBN 92-77-76473-2 
Office for Official Publications of the European Communities 
L-2985 Luxembourg