1. 10. 79 Official Journal of the European Communities No C 247/3 
ANNEX 
to the opinion of the Economic and Social Committee 
The following text of the Section's opinion was deleted following the adoption of an amendment 
proposed during the debate: 
Point 5, second paragraph 
'The Section for its part would point out that long-term studies are not completed within one year so 
that Karaya gum should be prohibited, in accordance with the opinion of the Scientific Committee for 
Food, and not lumped together with additives classified by the Scientific Committee for Food under 
another category, namely additives acceptable on a temporary basis.' 
Voting 
For: 38; against: 32; abstentions: 3. 
Opinion on the proposal for a Council Directive establishing safety measures against the 
conjectural risks associated with recombinant DNA work 
The text referred to the Committee has been published in Official Journal of the European 
Communites No C 301 of 15 December 1978, page 5. 
A. LEGAL BASIS FOR THE OPINION 
On 2 April 1979 the Council referred the abovementioned proposal to the Economic and 
Social Committee in accordance with Article 198 of the Treaty establishing the European 
Economic Community. 
B. OPINION OF THE ECONOMIC AND SOCIAL COMMITTEE 
The Economic and Social Committee prepared its opinion on the above matter at its 170th 
plenary session held in Brussels on 17 and 18 July 1979. 
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 2 April 1979 for an opinion, 
Having regard to the decision taken by its Bureau on 18 
December 1978, in anticipation of the Council's official 
request, instructing the Section for Protection of the 
Environment, Public Health and Consumer Affairs to 
draw up an opinion on the matter, 
Having regard to the opinion issued by the Section for Protection of the Environment, Public Health and 
Consumer Affairs at its meeting held on 3 July 1979, 
Having regard to the oral report submitted by the 
rapporteur, Mrs Heuser, 
Having regard to the discussions at its 170th plenary 
session held on 17 and 18 July 1979 (meeting of 17 July 
1979), 
HAS ADOPTED THE FOLLOWING OPINION 
unanimously: 
1. Introduction 
1.1. The Committee has tried to answer the following 
questions: 
No C 247/4 Official Journal of the European Communities 1. 10. 79 
(a) What is the present situation as regards work on 
recombinant nucleic acids? 
(b) Is there a pressing need for a Council Directive to be 
adopted establishing safety measures against the 
conjectural risks associated with recombinant DNA 
work? 
(c) Will the present proposal straighten out the 
problems to be solved? 
1.2. Since 1973, when scientists agreed at the 
Asilomar Conference to comply with strict safety 
measures when working on the recombination of nucleic 
acids and to carry out such work using only carefully 
selected donor and host organisms, the risks and 
usefulness of recombinant DNA work has been 
constantly reassessed in line with the progress made in 
this field of science. The initial judgements made, which 
were very speculative like those in the explanatory 
statement to the Commission's proposal, have 
increasingly been modified or superseded by established 
knowledge. 
1.3. The Committee notes that since 1973 many 
genetic engineering experiments have been carried out 
and in none of them has there been any indication that 
particular dangers are involved in such work. 
1.4. The results of experiments conducted with the 
specific aim of assessing risks are now available. It has 
been shown that a large quantity of experimental 
equipment is necessary before foreign genetic 
information that has been introduced into a donor 
organism can be expressed; it is therefore highly 
improbable that a potentially dangerous organism will 
be created unintentionally. This has partly been 
explained by genetic engineering experiments which have 
shown that genes in the higher organisms do not exhibit 
continual DNA sequences but have genetic 'gaps'. 
Attempts to turn non-pathogenic germs (E. coli K12) 
into potentially pathogenic agents by genetic engineering 
experiments have proved unsuccessful. 
1.5. After a very thorough series of investigations it 
has been shown that the polyoma virus, which causes 
disease in mice, is not released in the body as an 
infectious agent when introduced into intestinal bacteria 
using genetic engineering methods. 
1.6. However, isolated nucleic acid from bacterial 
viruses into which two complete polyoma genomes have 
been introduced as a tandem molecule has proved to be 
infectious for the natural host of the polyoma virus, the 
mouse. But gene combinations of this kind usually only 
occur as a result of specific experiments to produce them; 
they do not occur unintentionally or by chance. 1.7. Although the results of attempts to assess risk 
should not be assumed to be generally applicable, the 
fact that such results support each other must be taken as 
a decisive indication that the risk element in genetic 
engineering work is generally small. 
1.8. The Committee cannot agree with the argument' 
that the introduction of expensive protective measures is 
in itself already sufficient proof that a real risk exists. 
Such measures are either part of the voluntary restraint 
system or are laid down a priori by the appropriate 
authorities. 
1.9. Thanks to this technology, essential new 
discoveries have already been made concerning the 
structure and function of hereditary material. Further, 
important progress is surely to be expected given the 
speed at which biological knowledge is expanding. 
1.10. The possibilities of using this technology to 
produce important biological substances for curing 
disease are being actively explored by scientists and the 
research industries. Here too the first successes have been 
marked up. 
1.11. Another possibly important field where genetic 
engineering methods could be applied in the future 
should be agriculture, as put forward in the 
Commission's explanatory statement. 
1.12. When analyzing the present situation it should 
be stressed that the scientists involved have voluntarily 
complied with restraints imposed by themselves. There is 
no reason why this voluntary restraint system should be 
abandoned. Industry too has adopted a voluntary 
restraint system. 
1.13. In addition to the voluntary restraint system put 
forward by the scientists themselves and followed by 
them there are national directives, which are either 
incorporated in existing laws (as in Great Britain) or are 
binding on all projects financed by the State (as in West 
Germany). 
1.14. These directives classify experiments according 
to their suspected hypothetical danger and lay down a 
procedure for reporting planned experiments to a 
supervisory authority and obtaining permission from 
that authority. The Committee notes that these 
procedures have proved their worth. 
1.15. If these directives are constantly updated in the 
light of scientific knowledge it will be possible to achieve 
a high degree of harmonization as regards the important 
classification criteria. This means that there will be no 
basic serious differences in risk assessment in the 
Member States. 
1. 10. 79 Official Journal of the European Communities No C 247/5 
1.16. In some countries it is feared in industrial circles 
that if the obligation to publish research findings is very 
wide-ranging this will conflict with the natural interest of 
industry in maintaining secrecy. 
2. General comments 
2.1. Bearing in mind what has been said above, the 
question of whether it is absolutely necessary to have a 
Council Directive on the establishment of safety 
measures against the conjectural risks associated with 
recombinant DNA work should be approached with 
great caution, if one is to consider only the suspected 
hypothetical dangers. However, the Committee is aware 
that some scientists and many concerned ordinary people 
do not entirely agree with the experts' highly optimistic 
assessment of the risks involved in this new technology. 
2.2. It is also aware that the introduction of a Council 
Directive may not only involve a curtailment of scientific 
work; it would also mean that the important of this field 
of research was recognized and that science would have a 
certain amount of room for manoeuvre. 
2.3. It must be pointed out too that such an optimistic 
assessment presupposes continuing compliance with the 
voluntary restraint rules. Although there are no signs 
that voluntary restraint is to be abandoned, the circles 
concerned want the scheme to be made legally binding. 
This call is supported by some scientists (in the 
Netherlands for example) in order to allay the underlying 
mistrust felt by the general public, who are not always 
adequately and properly informed. 
2.4. Some scientists fear that legally binding directives 
cannot be adapted quickly enough to scientific and 
technical progress. They suggest instead that the 
voluntary moratorium be kept going until sufficient 
knowledge is available to enable the drawing-up of rules 
which would be valid for longer periods. If, as the 
Commission wants, legislation on recombining nucleic 
acids is to serve as an example for other areas, such a 
consideration should not be dismissed lightly. These 
misgivings could partly be removed if the Council 
directives were to oblige the Member States to examine, 
and possibly adapt, pending national directives at regular 
and frequent intervals. 
2.5. In view of the above considerations the 
Committee is in favour of a Directive being enacted. The 
main objectives of the Directive should be to ensure 
harmonization of safety requirements in all Member States of the Community, the need for which is stated in 
paragraphs 2.9 and 2.10, and to provide the basis for 
harmonization on a wider international scale. The 
Committee therefore feels, unlike the Commission, that 
an obligation to give notice of experiments will generally 
be sufficient. 
2.6. The appropriate authorities should have the right 
to veto experiments that have to be notified, i.e. they 
should be able within a specified period to issue an 
injunction or impose a ban. Such action should be 
properly justified in each case. 
2.7. Only experiments within a closely defined area of 
research should have to seek prior authorization, such as 
those involving more than probable risks for the 
environment and staff conducting tests. Examples of this 
are work with highly pathogenic micro-organisms, such 
as the smallpox virus, or work involving the transfer of 
genetic information on highly dangerous toxins, such as 
snake venom. 
2.8. Regulations such as those on radiological 
protection or the control of epidemics, under which 
certain areas of research and industry are subject to 
something more than an obligation to notify the 
authorities, would not be affected by the proposed 
Directive. 
2.9. Finally the Committee would like to point out 
that it was not able in the short time at its disposal to 
determine whether the specific physical and biological 
safety measures (eg- the special rules governing 
laboratories or the selection of vectors and hosts) are 
adequate for dealing with the suspected risks, especially 
as scientific knowledge in the field of genetic engineering 
is progressing so1 rapidly. The Committee believes that it 
is more important for the Member States to follow a 
common line on such matters, especially as far as 
industrial uses of this new technology are concerned. 
2.10. In addition to the proposed Council Directive 
there is a need for national measures and the voluntary 
safety codes on genetic engineering in the Member States 
to be harmonized. This is all the more important if, as is 
the case at present, the legal status and content of the 
rules in force varies from one Member State to another. 
The industrial application of this new technology can be 
particularly affected by such anomalies. 
2.11. The Committee thinks that these questions 
should be gone into thoroughly. As views differ, 
especially on the nature and extent of the risks involved, 
the Committee (with the help of experts) should draw vp 
No C 247/6 Official Journal of the European Communities 1. 10. 79 
a study on its own initiative on the points covered in 
paragraphs 2.9 and 2.10. On the basis of this study, 
hearings should be organized in conjunction with the 
Commission to collect the opinions of experts from the 
world of science, the unions, industry and public interest 
groups. 
3. Specific comments 
3.1. The definitions given in Article 1, paragraphs 1.2 
(a) and 1.2 (b), must be changed so that there is no doubt 
as to their meaning and all potentially dangerous work is 
covered. 
3.2. The potential danger lies not in isolated 
recombined nucleic acid but in host organisms 
containing recombined nucleic acids. 
3.3. As a rule, the recombining of nucleic acids and 
their introduction into suitable host organisms will be 
part of one experiment carried out in one place. But it 
cannot be ruled out that host organisms containing 
recombined nucleic acids may be reproduced in another 
place, particularly as part of an industrial process. 
The Committee assumes that both these possibilities are 
to be covered by the definitions in paragraphs 1.2 (a) and 
1.2 (b). 
3.4. The definitions proposed by the Commission do 
not cover the work described as 'self-cloning', whereby 
the arrangement of genes or the number of a particular 
gene in an organism is altered. Such manipulation may 
lead to the creation of pathogenic organisms or 
strengthen the potency of organisms that are already 
pathogenic. The Committee therefore suggests the 
following new definitions: 
Done at Brussels, 17 July 1979. 3.5. Article 1, paragraph 1.2 (a) 
Recombination of nucleic acids 
The coupling of nucleic acid molecules outside a living 
organism to form a new molecule not occurring in nature 
and the introduction of this new molecule into a host 
organism where it is propagated and passed on to future 
generations of the host organism. 
3.6. The Committee regrets that the Commission has 
neglected to lay down criteria for assessing risks in 
Article 2.2. It is convinced that such action will advance 
the cause of harmonization. A standard classification 
system is of great importance to scientific and industrial 
cooperation between the Member States. 
3.7. The estimates of the suspected hypothetical 
dangers in the different countries have become closer to 
each other. The physical safety measures considered to 
be necessary should now be implemented without 
difficulty in all the Member States. So there is no 
compelling reason to do without a generally acceptable 
classification of safety measures. 
3.8. Article 3 
Article 3 must be amended in line with the conclusions of 
the general comments in paragraph 2.2 et seq. 
3.9. The Committee thinks that the period of 90 days 
given to the national authorities to reach a decision is too 
long and suggests that six weeks at the most is sufficient. 
The national authority concerned should have the right 
of extending this period for a further six weeks at the 
most through issuing an explicit notice to this effect to 
those giving notice of an experiment. 
3.10. Articles 
Article 5 lays down that the Council Directive is to be 
constantly checked and updated. This provision should 
also apply to the directives to be issued by the national 
authorities. 
The Chairman 
of the Economic and Social Committee 
Raffaele VANNI 
1. 10. 79 Official Journal of the European Communities No C 247/7 
ANNEX 
to the opinion of the Economic and Social Committee 
The following passage was amended following the adoption of an amendment at the plenary session: 
Paragraph 2.11, second and third sentences 
'As views differ, especially on the nature and extent of the risks involved, the Section suggests that 
hearings should be organized in conjunction with the Commission on the points covered in 
paragraphs 2.9 and 2.10 to sound out the opinions of experts from the world of science, the unions, 
industry and public interest groups. Afterwards, a paper should be prepared which would serve as a 
basis for aligning safety rules within the Member States.' 
Voting 
The amendment was adopted with no votes against and one abstention. 
Opinion on the: 
— proposal for a Council Directive on the approximation of the laws, regulations and 
administrative provisions of the Member States relating to construction products 
— proposal for a Council resolution laying down a list of priority products to be covered by 
Directives implementing Council Directive /EEC/ on the approximation of the 
laws, regulations and administrative provisions of the Member States relating to 
construction products 
The text referred to the Committee has been published in Official Journal of the European 
Communities No C 308 of 23 December 1978, page 3. 
A. LEGAL BASIS FOR THE OPINION 
On 11 December 1978 the Council referred the abovementioned proposal to the Economic 
and Social Committee in accordance with Article 100 of the Treaty establishing the European 
Economic Community. 
B. OPINION OF THE ECONOMIC AND SOCIAL COMMITTEE 
The Economic and Social Committee prepared its opinion on the above matter at its 170th 
plenary session held in Brussels on 17 and 18 July 1979. 
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 100 
thereof, 
Having regard to the request made by the Council of the 
European Communities on 11 December 1978 for an 
opinion, 
Having regard to the decision taken by its Bureau on 18 
December 1978 instructing the Section for Industry, 
Commerce, Crafts and Services to draw up an opinion 
and a report on the matter, 
Having regard to the opinion issued by the Section for 
Industry, Commerce, Crafts and Services at its meeting 
held on 4 July 1979, Having regard to the report submitted by the rapporteur, 
Mr. Masprone, 
Having regard to the discussions at the 170th plenary 
session held on 17 and 18 July 1979 (meeting of 18 July 
1979), 
HAS ADOPTED THE FOLLOWING OPINION 
unanimously, with one vote against and one abstention: 
1. The Committee's approval is contingent upon the 
procedure for adopting implementing Directives being 
amended to provide for: