No C 64/22 Official Journal of the European Communities 15. 3. 82 
Additional opinion on the draft Council recommendation concerning the registration of 
recombinant DNA (deoxyribonucleic acid) work (*) 
A. LEGAL BASIS FOR THE OPINION 
Pursuant to the third paragraph of Article 20 of its rules of procedure, the Committee 
delivered an additional opinion on the above matter, following its opinion of 
10 December 1980 on the aforementioned draft recommendation (2). 
B. OPINION OF THE ECONOMIC AND SOCIAL COMMITTEE 
The Economic and Social Committee prepared its opinion on the above matter at its 
193rd plenary session held in Brussels on 15 and 16 December 1981. 
The full text of the opinion is as follows: 
THE ECONOMIC AND SOCIAL COMMITTEE, 
Having regard to the Treaty establishing the 
European Economic Community, and in particular 
Article 198 thereof, 
Having regard to the request made by the Council of 
the European Communities on 25 September 1980 
for an opinion on the draft Council recommendation 
concerning the registration of recombinant DNA 
(desoxyribonucleic acid) work (l), 
Having regard to the study adopted by the section for 
protection of the environment, public health and 
consumer affairs on 25 November 1980 on safety 
measures against the conjectural risks associated with 
recombinant DNA workers, 
Having regard to its opinion of 10 December 1980 (2) 
on the aforementioned draft recommendation, 
Having regard to the proceeding of the colloquy 
which it organized in Brussels on 14 and 15 May 
1981, 
Having regard to its Decision of 29 October 1981, 
instructing the section for protection of the 
environment, public health and consumer affairs to 
prepare an additional opinion and report on the 
subject, 
Having regard to the opinion adopted by that Section 
at its meeting on 1 December 1981, 
Having regard to the oral report made by the 
rapporteur, Mrs Heuser, at this meeting, 
(i) OJ No C 214, 21. 8. 1980, p. 7. 
(2) OJ No C 353, 31. 12. 1980, p. 19. Having regard to the discussions at its meeting on 
15 December 1981 (193rd plenary session of 15 and 
16 December 1981), 
HAS ADOPTED THE FOLLOWING ADDITIONAL 
OPINION 
by 101 votes to 14, with 7 abstentions: 
1. On 10 December 1980, the Committee issued its 
opinion on the draft Council recommendation 
concerning the registration of recombinant DNA 
(desoxyribonucleic acid) work. One of the main 
questions was whether the Community should have a 
recommendation or a Directive. On that occasion the 
Committee, having regard to the current state of 
scientific knowledge, expressed its preference for a 
Directive, but at the same time stated that it wished to 
await the outcome of a hearing 'before adopting a 
final position'. 
2. The hearing was organized in the form of a 
colloquy. This took place in Brussels on 14 and 
15 May 1981. Six topics were examined: 
development potential, risks and risk assessment, 
safety, health protection, ethics and public 
information. The proceedings were published on 
23 October 1981. 
3. In its 1980 opinion, the Committee based its 
preference for a Directive on the following 
grounds: 
4—a recommendation is not an effective enough 
legal instrument for bringing about a genuine 
harmonization of national laws, 
15. 3. 82 Official Journal of the European Communities No C 64/23 
— although no short-term dangers have been 
detected in recombinant DNA work, serious 
consequences may still be discovered in the 
longer term, 
— as scientific knowledge stands at present, the 
conjectural risks associated with recombinant 
DNA work are low, but dangers may still occur, 
especially when using pathogens as a vector or 
host, 
— to ensure fair competition, it is necessary to 
harmonize both Member States' laws in this field 
and the voluntary supervisory and safety 
measures which are based on national 
recommendations'. 
4. It became clear at the colloquy that the risks 
associated with recombinant DNA work, per se, are 
now generally regarded as being small. Still, the 
Committee endorses the view that there is a need for 
continued emphasis on risk assessment studies, 
which should go hand-in-hand with the R&D work 
itself. 
5. It was also pointed out at the colloquy that as 
this technology progresses from a laboratory 
environment to industrial-scale applications, a much 
larger number of persons, who will not necessarily 
have appropriate training and experience in 'good 
microbiological practice' will become involved in 
recombinant DNA work. This is particularly 
important where pathogenic organisms are 
concerned. The Committee therefore believes that 
training in microbiological safety should be given 
high priority, and that it should accordingly be 
promoted by the public authorities. 
6. It also emerged clearly from the colloquy that 
both science and industry have achieved a high level 
of safety in their work to date. On the other hand, 
attention was drawn to the justified concern among 
the public about possible future developments and 
about whether such safety standards will be 
maintained in the face of increasing competitive 
pressures. Even where it might be technically 
possible to ensure safety through 'self-regulation', the 
Committee feels that public guidelines would 
probably be a more suitable way of ensuring an 
adequate level of safety. Such public guidelines 
should be defined in the form of laws. 
7. Whatever guidelines are introduced, and 
however these evolve over time, the Committee 
believes it is desirable that the Member States should agree on a uniform approach. As already pointed out 
in the 1980 opinion, harmonization of Member 
States' provisions is necessary to ensure both fair 
competition and equal safety in all the Member 
States. In practice, however, such harmonization can 
be achieved only by means of a Community 
instrument with sufficient legal force. 
8. Thus, while there has been a certain shift of 
emphasis on individual points, the general position 
adopted by the Committee in 1980 remains valid. For 
the reasons outlined in points 4, 5,6 and 7 above, the 
Committee believes that a Directive is still the 
appropriate instrument for dealing with this matter. 
This Directive should concentrate on the four aspects 
mentioned earlier: risk assessment studies, safety 
training, the maintenance of safety standards and 
harmonization. At the same time, the Committee 
reiterates the view expressed in the 1980 opinion that 
there should be a built-in flexibility in the Directive 
which would allow it to take account of 
developments in scientific knowledge. 
9. The Committee notes that the colloquy put the 
spotlight on an important area where a European 
initiative is required. The national experts are clearly 
agreed that there should be guidelines to cover work 
with known pathogens (micro-organisms which 
cause disease). At present, though, there are no such 
guidelines at European level or, in some instances, 
even at national level. However, the WHO has 
recently issued a series of recommendations to cover 
this area of research, and similar reports have been 
published in the United Kingdom (HOWIE) and in 
the Federal Republic of Germany (recommendations 
of the Federal Health Office). The Committee calls 
on the Commission to take the appropriate 
initiatives. For its part, the Committee reserves the 
right to revert to the issue in more detail at a later 
date. General guidelines for work with pathogens 
would, if adopted, also have the advantage of 
covering recombinant DNA work in the higher risk 
categories (i.e. where pathogenic organisms are 
involved). 
10. The Committee also notes that there are certain 
fears among the public that some activities in genetic 
research which go far beyond DNA recombination 
might one day jeopardize human freedom. In this 
area, there is a case for an international initiative that 
would guarantee appropriate ethical safeguards for 
all such activities. 
11. Finally, the Committee notes that the colloquy 
made an important contribution towards 
Community-level discussion of recombinant DNA 
No C 64/24 Official Journal of the European Communities 15. 3. 82 
work. The need for continued contact and exchange during the colloquy. The Committee therefore 
of information between scientists and those believes that such contacts should be fostered so that 
representing the public interest was also stressed future developments can be followed. 
Done at Brussels, 15 December 1981. 
The Chairman 
of the Economic and Social Committee 
Tomas ROSEINGRAVE 
APPENDIX 
to the opinion of the Economic and Social Committee 
The following proposals for amendments were rejected in the course of the proceedings: 
Point 3 
Delete the point. 
Reasons 
Repetition of the Committee's 1980 opinion is both unnecessary and illogical. Points 1 and 2 
provide an adequate introduction. An additional opinion should logically follow on from the 
original opinion and not overlap with it. 
Voting 
For: 13, against: 85, abstentions: 9. 
Points 5 and 6 
Replace the points by the following new paragraph: 
'It emerged clearly from the colloquy that industrial-scale applications using genetically-
manipulated organisms will not pose a safety problem. Unlike laboratory experiments which 
work with unknowns, industrial applications, by definition, involve bacteria whose genetic 
make-up has been fully defined. Since these bacteria have been artificially cultivated and 
altered to produce a specific product alien to their psychology, they would stand little chance 
of survival, in the natural environment. In vaccine production, it will become possible to use 
harmless bacteria in place of current methods which require the cultivation of large quantities 
of the pathogen itself. Thus, the industrial application of recombinant DNA technology will 
result in a substantial gain from a safety viewpoint, both to workers and the general 
public.' 
Reasons 
It is misleading to infer that industrial-scale applications using genetically-manipulated organisms 
will carry higher risks than experimental laboratory work, or that risks will be increased where 
pathogenic organisms are involved. In both instances, the direct opposite is true. 
Voting 
For: 15, against: 86, abstentions: 11. 
Point 7 
Delete the last sentence. 
Voting 
For: 11, against: 84, abstentions: 12. 
15. 3. 82 Official Journal of the European Communities No C 64/25 
Point 8 
Replace the point by the following text: 
"The evidence presented by the experts at the colloquy held in May 1981, indicates that the 
hazards associated with recombinant DNA are minimal, and that, in any case, these only arise 
to the extent that pathogenic organisms are involved. The Section therefore believes that a 
Directive covering recombinant DNA work, per se, is no longer the most appropriate 
measure. Accordingly, the Section can approve the draft Council recommendation 
concerning the registration of recombinant DNA work.' 
Reasons 
The submission and responses of the 'rapporteurs' and experts at the colloquy, as reported in Doc. 
CED — 81 — 014, support the above view. The above approach is therefore more consistent with 
the present state of scientific knowledge and the Community's future requirements in the field of 
micro-biological safety. 
Voting 
For: 17, against: 90, abstentions: 11. 
Point 10 
Delete the point. 
Reasons 
The paragraph, on its own admission, goes 'far beyond recombinant DNA', and hence the remit of 
the additional opinion. 
Voting 
For: 10, against: 90, abstentions: 15.