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Vol. 1983/0 141 
  
 
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COMMISSION OF THE EUROPEAN COMMUNITIES
C0M<83> 356 final  
Brussels, 13 June 1983
Proposal for a  
COUNCIL DECISION
adopting the second stage (January 1984-March 1986) of the  
multiannual research and training programme for the  
European Economic Community in the field of  
biomolecular engineering
(submitted to the Council by the Commission)
C0M(83) 356 final

REASONS FOR PROPOSAL
1. INTRODUCTION
1.1. Background information
Council adopted on 7 December 1981 (1) a multi-annual research  
and training programme for the European Economic Community in the  
field of biomolecular engineering (indirect action April 1982 to  
March 1986). In its decision, Council specified that the  
programme was to be revised before its third year of  
implementation and executed in two stages, the first stage  
running from 1 April 1982 until the revision and the second from  
this revision until 31 March 1986.
Council defined, in its decision, the scientific content of the  
programme and established the amount of the appropriations and  
the staff required for the execution of the programme already  
agreed. In the statements attached to the Council minutes,  
specifications were made which provided the list of priorities  
for research actions during the first stage :  they focused on
agriculture and on the area of agro-food production. As for the  
training actions, implemented by means of training contracts and  
grants for short training periods, they covered the entire  
content of the programme outlined in the decision of Council.  
When the programme was adopted, the financial means allocated  
amounted to 8 million ECU (including expenditure on a staff of  
three) but article 3 of the Council decision stated that the  
amount of the appropriations and the staff required to execute  
the programme were to be re-evaluated when the programme was  
revised.
(1) OJ No L 375, 30.12.1980, p. 1-3.
1

1.2. Implementation_of_the_£irst_phase
Implementation started on 1 April 1982.
As far as research by means of cost-shared contracts is concerned  
a total number of 169 applications, representing a proposed  
research effort of 550 man/year and a total budget of 68 million  
ECU (with a request for Community funds of 31 million ECU), were  
received before the deadline of July 15, 1982. From these, after  
consultation with the ACPM for Biomolecular Engineering,  
51 proposals were selected for the negotiation of contracts  
starting at the beginning of 1983 and involving, as support from  
the Commission, the totality (5,66 million ECU) of the funds  
foreseen for research actions in the budget of the programme.  
Among the 118 remaining proposals, many applications of excellent  
quality had to be rejected for lack of funding possibilities. The  
proposals accepted were selected on the basis of their scientific  
merits and in view of the necessity to constitute the initial  
nuclei of Community R&D for each of the priorities of the  
programme. The research sectors covered by these nuclei, which  
are often of sub-critical size and obviously need to be rapidly  
expanded, are the following :
- technology of second generation reactors for production of  
agro-food
- production of vaccines for farm animals
- degradation of ligno-cellulose
- identification and transfer of genes in plant cells
- nitrogen fixation
- regeneration of isolated cells of cereals and legumes.
With regard to training,  48 applications for training contracts  
were received at the closing date of June 15, 1982. Among these,  
15 proposals were selected for an effective start on the 1st of  
January 1983. The areas covered by the training contracts is  
broad and concerns all sectors of biomolecular engineering. The  
laboratories participating as host-institutions in the training  
contracts have been chosen on the basis of their present  
leadership in European R&D. The deadline of July 15, 1983 has
been established for the selection of training contracts foreseen  
to start in 1984.
2

L.3. Relations with the R&D Framework Programme and the "Biotechnology
R&D Action Programme"
1.3.1. As regards the Framework Programme, the present  
Biomolecular Engineering Programme is directly related to  
the following goals and objectives :
- Promotion of agricultural competitivity
- Promotion of industrial competitivity (new technologies)  
as well as to
- Improvement of raw materials management
- Development of renewable energies
- Improvement of safety and protection of health.
1.3.2. The Commission has announced its intention to present in  
the near future to Council a plan for "Action Programmes"  
related to the various objectives of the Framework  
Programme (2).
In this respect a "R&D Action Programme for Bio­
technology" is envisaged by the Commission. Its aim would  
be to pool and strengthen Community R&D in areas of key  
importance for agriculture and industries. The programme  
proposal would consist of horizontal actions from which  
all sectors of biotechnology should benefit, and vertical  
actions focused upon the solution of certain specific  
problems.
This programme, if implemented, will include the present  
Biomolecular Engineering Programme and will foresee its  
extension beyond April 1986.
(2) C0M(82) 865 of 21 December 1982.
3

2. PROGRAMME PROPOSAL FOR THE SECOND STAGE
In order to allow for the revision of the programme and the  
implementation of its second stage, the Commission asks that the  
project of Council decision (annex 1) be adopted.
The Commission considers, in this respect, that several reasons  
militate in favour of a rapid adoption and implementation of the  
revised programme. Most of these reasons have been outlined in  
the initial proposal (3) of the Commission and concern the need,  
now .  widely recognized, to promote in the Community, through  
oriented research and training actions, the exploitation of basic  
discoveries in modern biology which are likely to increase the  
capacity of the Member States to compete with the outside world  
in key areas dealing with the elaboration of improved  
agricultural and bio-industrial products.
As in the first phase, the programme is to consist of research  
actions by means of cost-shared contracts and of training  
actions.
2.1. Research actions
The constitution and consolidation at Community level, of action  
groups composed of some of the best laboratories in Europe and  
involved in a joint research effort for the elimination of  
specific bottlenecks to biotechnological developments, is one of  
the means through which the Community may hope to bridge part of  
the present gap with countries, like Japan and the United States,  
of advanced technology.
(3) COM(79) 793 final

The research programme for the second stage, described in  
annex 1, focuses, with only few modifications, on those very same  
objectives which were considered as priorities for Community R&D  
during the first stage of implementation. This choice, which  
takes into account the necessity, underlined by the European  
Parliament, for clearly specified objectives, was made after  
detailed discussions with scientists and national representatives  
of R&D in the Member States (see in annex 2 the opinion of the  
ACPM Biomolecular Engineering).  It is based upon an assessment of  
Community needs and of the achievements which are likely to be  
fulfilled through a programme with limited budgetary resources.  
The conclusion that the actions presently in progress in the  
first phase should be reinforced stem from :
- the massive response of laboratories in the Member States  
to the call for tenders issued for implementing the first phase  
of the programme. This response demonstrated the interest and  
need of European laboratories for support in the R&D areas  
covered by the programme; the quality of the numerous proposals  
which had to be rejected clearly showed, moreover, that it is  
possible, in order to give full significance to the programme, to  
increase the size, often sub-critical, of the nuclei of Community  
R&D constituted for each sector of the first phase.
- the confirmation that plant cells, a basic material in  
the first phase of the programme, are indeed amenable to  
modifications through genetic engineering and to exploitation by  
fermentation (see, for instance, the recent involvement of  
organizations such as IPRI, Monsanto, Nestle, Unilever or the  
Wolfson Institute of Biotechnology in plant cell research).
Only one change is introduced to the scientific programme, namely  
the extension to pharmaceutical and fine chemicals industries of  
the second generation bioreactor technology which, in the first  
phase, was restricted to the production of agro-food. This change  
results from the fact that recent and expected technical  
developments make it possible to catalyse reactions of increased  
complexity which lead to products of higher added value in many  
biotechnology-based industries.
5

The research proposed is fully compatible with some of the main  
orientations defined for biotechnology R&D in the Framework  
Programme of the Commission, and with specific recommendations  
presented in the report "Forecasting and assessment in the field  
of science and technology" of the Commission services. While it  
is not possible to outline here in details all the relations  
between the present proposal and the scientific orientations and  
recommendations mentioned above, it can nevertheless be stated  
that the objectives retained for the second phase (production of  
substances with high added value for the industries, preparation  
of animal vaccines, transformation of ligno-cellulose,  creation  
of plant cell-lines meeting the requirements of European  
agriculture and agro-industry, improvement of symbiotic relations  
between plants and microorganisms) are among those which are  
considered as essential priorities for Community R&D.
2.2 Training actions
The Commission, in full agreement with the ACPM Biomolecular  
Engineering, is of the opinion that the training actions serve! an  
essential purpose for the proper retraining of scientists, their  
mobility, the acquisition of skills necessary for  
multidisciplinary research and the transfer of information  
between public and private enterprises. It is therefore  
considered that the effort accomplished during the first phase  
must be continued and the advertisement of funding possibilities  
intensified. The scientific field to be covered by the trailing  
actions is not to be modified and should consist of the six areas  
defined in the Council decision of 7 December 1981.
6

Financial means:  the appropriations estimated as necessary for  
the execution of the second stage of the programme should be  
7 million ECU, including expenditure for an additional staff of  
two (1 A post and 1 C post).
The financial means for the execution of the training action  
shall not exceed 20% of the total budget to be allocated to the  
second stage of the programme. The financial means for the  
contribution of the Commission to research actions by means of  
cost-shared contracts with laboratories in the Member States  
shall not be lower than 80% of the total budget to be allocated  
to the second stage of the programme.
Taking into account the appropriations already decided upon by  
Council for the first stage of the programme, these estimations  
bring to a total of 15 million ECU, including expenditure on a  
staff of five, the total appropriations allocated to the  
programme.
This proposal is in line with the following statements entered in  
the minutes of the Council of 7.12.1981, which mentioned that :
"The Commission considered that a staff complement of five  
(2 A's, 1 B, 2 C’s) was needed to carry out this programme. If  
the Council agrees to this complement, the Commission undertakes  
to reduce the staff complement of the programme "Biology - Health  
Protection" by two persons compared with the ceiling decided by  
the Council. The Commission further considered that three  
officials (1 A, 1 B, 1 C) would suffice to carry out the first  
phase of the programme".
"The Council specified that when taking the revision decision  
which will re-evaluate the amount and the staff allocated to the  
programme, due account must be taken of the draft compromise  
worked out at CREST providing for an overall amount of  
15 million ECU for a four-year programme running from 1981 to  
1984".
7

Annex 1
Proposal for a  
COUNCIL DECISION
adopting the second stage (January 1984-March 1986) of the  
multi-annual research and training programme for the  
European Economic Community in the field of  
biomoLecular engineering
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic  
Community, and in particular Article 235 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Parliament (1),
Having regard to the opinion of the Economic and Social Committee (2),
Whereas Article 2 of the Treaty assigns to the Community, inter alia,  
the task of promoting throughout the Community a harmonious development  
of economic activities, a continuous and balanced expansion and an  
accelerated raising of the standard of living;
Whereas by Decision 81/1032/EEC the Council adopted a research and training  
programme in the field of biomolecular engineering (3); whereas the programme is to  
be implemented in two stages, the first stage running from 1 April 1982  
until the revision of the programme in 1983 and the second stage from this  
revision until 31 March 1986;
Whereas the Council decided that the amount of the appropriations and  
the staff required to execute the programme is to be re-evaluated when  
the programme is revised;
Whereas the implementation of the first stage of the programme through  
research and training contracts has clearly confirmed the need for the  
strengthening of the programme during the second stage;
Whereas the importance of research and training at Community level in  
the area of biomolecular engineering is fully recognized in the framer  
work programme (1984-1987) prepared by the Commission (4);
Whereas the Treaty has not provided the necessary specific powers; '·'·*
(1)
(2)
(3) OJ No L 375, 3Q.J2.1981, p. 1.
(4) COM(82) 865, 21.12.1982.
1

Whereas account should be taken of the opinion of the Scientific and  
Technical Research Committee (CREST) on the Commission proposal;
Whereas account should be taken of the opinion of the Advisory Committee  
(ACPM) for the Management of the Biomolecular Engineering Programme,
HAS DECIDED AS FOLLOWS:
Article 1
The second stage of the multi-annual research and training programme  
hereinafter called "the programme", for the European Economic Community  
is hereby adopted, in the form set out in the Annex for the period  
starting on 1 January 1984 and ending on 31 March 1986.
Article 2
The appropriations necessary for the execution of the second stage  
of the programme, which are to be added to those already allocated for  
the first stage/· are estimated at 7 million ECU, including expenditure  
related to an additional staff of two. These appropriations shall be  
entered in the general budget of the European Communities.
2

Annex to annex 1
ANNEX
1. Research actions
1.1. Development of second generation bioreactors (multienzymatic,  
multiphasic or co-factor requiring) for detoxification and for  
industrial applications including agro-food applications. Are also  
included in this sector research activities focusing upon:
- the study of the physiology and the stability of cell
populations, including genetically manipulated cells, in  
relation with whole cell immobilization.
- the analysis and prevention of enzyme inactivation in
immobilized systems (particularly under non physiological
conditions specific of high salinity, non-aqueous, high
temperature and extreme pH environments).
1.2. Improved production, by means of biomolecular engineering methods,  
of substances for:
- animal husbandry (particularly vaccines, hormones, ...),
- agro-food industries.
1.3. Upgrading of plant products, particularly ligno-cellulose,  by means 
of biomolecular engineering methods.
1.4. Improvement, by means of genetic engineering, of plants and  
microorganisms which play on important role in agriculture.  
Research activities in this sector are to include:
- the characterization of the structure and the expression of  
microbial and plant genomes, including their organelles and  
plasmid DNA,
- the study of the molecular mechanisms of interactions between  
plants and symbiotic microorganisms and the improvement by  
genetic engineering of these symbiotic relations,
- the development of methods for the identification, transfer and  
expression of new genetic information in cultivated plant  
species,
- the control of regeneration and differentiation of plant cells  
and plant protoplasts into mature organisms,
- the use of biomolecular engineering for the early detection of  
genetic or pathogenic changes in plants.
1

1.5. Development of methods for detecting contamination and for the  
assessment of possible risks associated with applications of  
biomolecular engineering in agriculture and industry.
The financial means for the execution of research actions shall not be  
lower than 80% of the total budget allocated to the 2nd stage of the  
programme.
2. Training
2.1. Development of new reactors using immobilized multi-enzyme systems,  
including those requiring multi-phase environment and co-factor  
regeneration;
2.2. Development of bio-reactors for human detoxification;
2.3. The transfer of genes from diverse sources to the bacterium  
Escherichia coli, the yeast Saccharomyces cerevisiae and other  
suitable organisms;
2.4. Development of cloning systems;
2.5. Gene transfer in micro-organisms and in plants important to  
agriculture;
2.6. Improvement of methods for detecting contamination and for the  
assessment of possible risks associated with applications in  
agriculture and industry of biomolecular engineering.
The financial means for the execution of this training action shall not  
exceed 20% of the total budget allocated to the second stage of the  
programme.
2

Annex 2
OPINION OF THE ACPM "BIOMOLECULAR ENGINEERING'It
During its meeting of October 28-29 in Brussels the ACPM "Biomolecular  
Engineering", in accordance with article 5 of the decision of Council  
adopting a two stages multi-annual research and training programme for  
the European Economic Community in the field of biomolecular engineering  
(0J No L375, 30.12.1981), examined in detail the scientific programme to  
be executed during its second stage.
The ACPM is unanimously of opinion that it is the interest of the  
Community to supplement and broaden knowledge and expertise in  
biomolecular engineering with the view of rendering possible new  
developments in biotechnology.
The ACPM stated unanimously that the programme for the 2nd stage is  
based on a valid assessment of Community needs in the area of bio­
engineering, that the research and training actions foreseen will allow  
a stimulation of efforts which are essential for European industry and  
European agriculture, and that the revised programme is sufficiently  
flexible to permit its continuous adaptation to the progress of science  
and technology.
The ACPM stated unanimously that adequate budgetary means and staff  
expenditures must be foreseen in order to create a proper basis for a  
meaningful Community Biomolecular Engineering programme.
The ACPM emphasized unanimously that the decision adopting the second  
stage of the Biomolecular Engineering programme should be taken as early  
as possible in 1983 in order to allow for the publication of a call for  
tenders and a proper timing for the selection and negotiation of  
contracts.
VAN DER PLAS
(Chairman of the  
Biomolecular Engineering ACPM)
Brussels, November 1982

FINANCIAL RECORD
BUDGET CHAPTER :
- Post :  line 7370
- Title :  Biomolecular Engineering
JURIDICAL BASIS
Article 235 of EEC Treaty  
Council Decision
DESCRIPTION OF ACTION AND OBJECTIVES
Second stage (January 1984 - March 1986) of the multiannual  
research and training programme for the European Economic  
Community in the field of biomolecular engineering.
Programme carried out, by means of cost-sharing contracts with 
research organizations in the Member States and by means of  
training contracts, along the following projects :
1. Development of new reactors using immobilized multienzyme 
systems including those requiring multiphase environment and  
cofactor regeneration.
2. Development of bioreactors for human detoxification.
3. The transfer of genes from diverse sources to the bacterium  
Escherichia coli,  the yeast Saccharomyces cerevisiae and other  
suitable organisms.
4. Development of cloning systems.
5. Gene transfer in micro-organisms and in plants important to  
agriculture.
6. Improvement of methods for detecting contamination and for the  
assessment of possible risks associated with applications in  
agriculture and industry of biomolecular engineering.
The objective of these actions are to accelerate the production  
of data, biological materials and methods in bio-engineering  
which are necessary for the domestication and the transformation 
of the basic properties of living organisms useful to man and to  
place such data, materials and methods at the disposal of  
industries and agricultural research centres.

JUSTIFICATION OF ACTION
There is a need to promote in the Community, through oriented  
research and through training, the exploitation of basic  
discoveries in modem biology and to increase in this manner, by 
an integrated effort, the capacity of the Member States to  
compete with the outside world in areas dealing with the  
elaboration of improved agricultural and bio-industrial products.  
The proposed activities are not only intended to contribute to  
the reduction of deficits in trade and in patents but should also  
lead to the establishment of new methods for the estimation of  
bio-hazards possibly associated to modern biotechnology and, in  
the long run, to the decrease of energy consumption and the  
diminuation of waste products. Finally, it should allow the  
uniform and harmonious development throughout the Community of  
the regulations and protection devices which should always be  
associated, from the start, with new and economically important  
exploitation methods. Considering the present gap which separates  
the Community of Member States from countries with advanced  
technology and the partition which too often isolate in Europe 
basic research from industrial research, these results can only  
be obtained through a global and continuously renewed analysis of  
the Community needs and through the stimulation of Community  
activities which allow the pooling together of competences and of  
research tools.
FINANCIAL INCIDENCE OF ACTION ON INTERVENING SUPPLIES
(including costs for staff and expenses for administrative and  
technical management).
1 Total cost during the entire term envisaged ........  12.6 MioECU
2 
Participation to funding
- on Community budget ...............
- 
by national administrations )
- by other sectors at national level )
.3 Multiannual schedule7.0 MioECU  
5.6 MioECU

5.3.1.1 Commitment in MioECU
Expenditures 1984 1985 1986 Total
Staff 0.12 0.14 0.04 0.30
Administ. and  
Technical Manag. 0.20 0.25 0.05 0.50
Contracts 6.20— — 6.20
TOTAL 6.52 0.39 0.09 7.00
5.3.1.2 Payment in MioECU
Expenditures 1984 1985 1986 Total
Staff 0.12 0.14 0.04 0.30
Administ.  and  
Technical Manag. 0.20 0.25 0.05 0.50
Contracts 2.95 2.95 0.30 6.20
TOTAL 3.27 3.34 0.39 7.00
3

5.3.2 Methods of calculation
a) Personnel expenditures
Taking into account the appropriations already decided upon  
by Council (1 A post, 1 B post, and 1 C post), the minimal  
needs for the implementation of the 2nd phase of the  
programme are assessed to an additional staff of :
1 A post  
1 C post.
These needs take into account the necessity to carry out  
the administrative and scientific management of  
approximately 50 new research contracts and 60 new training  
contracts.
The calculations are based upon annual figures estimated 
for 1983 at 75.100 ECU for an A post and 29.800 ECU for a  
C post and upon a rate of salary increase amounting to 8%  
per year.
b) Expenditure for administrative and technical operations
They cover travel, mission and meeting expenses as well as  
the cost of scientific and technical assistance whenever it  
proves necessary for the implementation of the programme.
c) Expenditure in respect of contracts
Since the nature of the work and the qualifications of the  
contracting parties vary, it is impossible to introduce a  
standard method of calculation. The average cost of  
90.000 ECU in 1982 per scientist/year with an annual 
increase of 8% of the cost of the research and a  
contribution from the Commission of 50% to the cost of this  
research were used as a basis for estimation. However, the  
Advisory Committee on Programme Management (ACPM) will  
always be consulted on the allocation of funds.
6. FINANCIAL INCIDENCE ON RUNNING SUPPLIES FOR PERSONNEL AND  
MANAGEMENT :
(see point 5 above)
7. FINANCING OF EXPENDITURES
Funds to be included in future budgets
4

8.FINANCIAL IMPLICATIONS IN RESPECT OF REVENUE :
- Community tax on income of officials
- Contribution of officials to pension scheme
9. TYPE OF CONTROL FORESEEN :
- Scientific controls :  ACPM
Officials appointed by DG XII
- Administrative controls :
.  Budget implementation :  Directorate-General for Financial
Control
.  Regularity of expenditure :  Directorate-General for
Financial Control and Contract  
Department of DG XII.
5