No C 56/38 Official Journal of the European Communities 6. 3. 89 
Opinion on the proposal for a Council Directive on the protection of workers from the risks 
related to exposure to biological agents at work(1) 
(89/C 56/15) 
On 2 May 1988, the Council decided to consult the Economic and Social Committee 
under Article 118 A of the Treaty establishing the European Economic Community on the 
abovementioned proposal. 
The Section for Social, Family, Educational and Cultural Affairs which was responsible for 
preparing the Committee's work on the subject, drew up its Opinion on 10 November 1988. 
The Rapporteur was Mr Vidal. 
At its 261st plenary session (meeting of 14 December 1988), the Economic and Social 
Committee adopted the following Opinion by a substantial majority, with 2 abstentions. 
1. General comments 
1.1. The Committee welcomes the Commission pro­
posal, which complements previous proposals on which 
we have already issued Opinions in the wake of frame­
work Directive 80/1107/EEC. 
The recommendations made in these Opinions (2) must 
be reiterated since they have unfortunately not been 
taken into account by the Commission. The need for 
a ranking of the prevention and safety measures is 
emphasized as well as the need to standardize the 
definitions and terminology used in the various Direc­
tives which deal with biological agents and genetically 
modified organisms. We would also recommend that 
minimum limits be fixed as soon as possible in order 
to establish certain levels of protection and that the 
'standards' contained in the Directive must be binding 
in nature. 
Otherwise we would again draw attention to the gen­
eral issues (prevention policy, the role and responsibility 
of employers, the consultation and participation of 
workers, etc.) which were highlighted in the recent 
Opinion on the proposal for a (framework) Directive 
on improving workers' safety and health at the work­
place (3). 
1.2. The Committee recognizes the sensitivity of the 
subject and the difficulties involved. Apart from its 
intrinsic merit, the proposal represents an important 
initiative aimed at establishing first principles for regu­
lating this sensitive sector. In view of (a) the increasing 
number of jobs and industrial processes involving bio­
logical agents—in, for example, the agricultural and 
stock-farming and public health sectors—and (b) the 
discrepancies between, and frequent inadequacies of the 
relevant national legislation, we regard the proposal 
(!) OJ No C 150, 8. 6. 1988, p. 6. 
(2) See, for example, OJ No C 297, 28. 11. 1979 and OJ No 
C 208, 8. 8. 1988, p. 43. 
(3) OJ No C 175, 28. 4. 1988. as a very important first step towards tackling these 
complicated issues. It heralds the adoption at Com­
munity level of a set of measures designed to project 
workers more effectively against the risks related to 
exposure to biological agents at work and to promote 
a more comprehensive, deeper understanding of the 
problem as a basis for subsequent action. 
1.3. The Commission is currently preparing two 
further proposals for Directives relating to biological 
agents; we would recommend that the terminology used 
in all three should, as far as possible, be consistent, 
particularly where definitions are concerned. 
1.4. The Committee believes that the Directive 
should be geared to the establishment of criteria for 
standardization between the Member States. In this 
context, the adequacy of translations should be ensured 
and the technical expressions used in the proposal 
should be adjusted in line with the two proposals for 
Directives on the limited use of genetically-modified 
biological agents and on the deliberate release of genet­
ically-modified micro-organisms into the environment. 
Similarly, it must be stressed that there is a close interde­
pendence between public health sector projects or meas­
ures and action to protect workers who, by virtue of 
their specific jobs, are or could be exposed to contact 
with biological agents. 
1.5. The Directive should provide for the drafting of 
a list of biological agents (for indicative or orientation 
purposes) broken down into the groups 2, 3 and 4 
as proposed under Article 2. A priority task for the 
Technical Progress Committee—as referred to in pre­
vious ESC Opinions and in accordance with the pro-
6. 3. 89 Official Journal of the European Communities No C 56/39 
vision in Article 15—could be to draw up a list of this 
nature which will not be exhaustive but should be as 
complete as possible and periodically updated. 
1.6. The Directive should also provide for the pro­
motion of specialized and continuous training in tech­
niques for preventing and detecting risks and for rapid 
and effective intervention in the event of risks or symp­
toms of illness becoming apparent. Each Member State 
would have to be responsible for the latter. 
1.7. When a reasonable period of time has elapsed, 
the Commission should, in conjunction with the Advis­
ory Committee on safety, hygiene and health protection 
at work, compile a report on the implementation of the 
Directive indicating: 
— progress recorded in the different Member States, 
— information which has been compiled or which has 
recently become available, 
— progress made in drawing up or updating the list 
mentioned under 1.5. 
This periodical report should be referred to the Econ­
omic and Social Committee and to the European Parlia­
ment. 
2. Specific comments 
2.1. The Commission's explanatory memorandum 
could usefully include an overview of the special (separ­
ate) arrangements which have already been im­
plemented or mooted at Community level for protecting 
sea and air transport workers against the risks related 
to exposure to biological agents at work, since they are 
excluded [Article 1 (2)] from the current proposal. The 
case of these workers should preferably be studied in a 
separate Directive specifically promoting their protec­
tion against the said risks. 
2.2. The Committee would propose the following 
amendment to Article 1(1): 
'1. The purpose of this Directive is to establish 
measures preventing, or protecting workers against 
risks to health and safety arising or likely to arise 
from exposure to biological agents at work.' 
2.3. Article 2 
2.3.1. The criteria used in the draft Directive for 
grouping the biological agents are not very precise and allow for a kind of flexibility which might prove 
undesirable. 
The Committee consequently recommends that more 
stringent criteria be used and that particular care be 
taken in compiling the list of biological agents. 
2.3.2. The following amendment is proposed to the 
definition of a Group I biological agent in Article 2(b): 
'... that is normally unlikely to cause human dis­
ease ...' 
2.3.3. Definitions in Article 2(c), (d) and 
(e) 
In order to clarify the Directive's objectives, the concept 
of 'prophylaxis' should be defined in terms of either 
technical (collective and/or individual) or medical pre­
vention. 
2.3.4. Definitions in Article 2(a), (f) and 
(g) 
Since the definitions of 'biological agents', 'micro­
organisms' and 'genetically-modified biological agents' 
do not sound very scientific, we recommend that these 
concepts be redefined with reference, for example, to 
usage of the world health organization (WHO). 
2.3.5. In the Committee's view, the headings for the 
definitions do not correspond to their content and 
should be suitably revised. 
The Committee would also draw attention to the fact 
that the draft Directive places a special emphasis on 
activities related to biological agents involving a 'con­
scious decision' and accords less relevance and perhaps 
importance to activities involving 'merely' 'incidental 
exposure'. This could lead to a false sense of security 
as regards the latter which might prove all the more 
dangerous. 
2.4. Article 3 
2.4.1. The following amendment to the second sen­
tence of the first paragraph of Article 3(2) is proposed: 
'Member States shall fix the conditions of this 
assessment and of any further assessment if necess­
ary, and shall determine the institutions or bodies 
to be responsible for conducting the assessment; 
these must have the required technical and scientific 
capacity and shall base themselves on assessment 
criteria standardized throughout the Community.' 
2.4.2. Article 3(2), final paragraph, and 
Article 3 (5) 
The Committee takes this opportunity to recommend 
that the Commission seriously consider the possibility 
No C 56/40 Official Journal of the European Communities 6. 3. 89 
of linking up all Directives on this subject, especially 
as regards the definitions and terminology used. 
2.4.3. The first paragraph of Article 3(4) should be 
amended to read as follows: 
'Biological agents shall be assessed on the basis of 
the maximum degree of hazard until their real haz­
ard potential is known so they can be listed in the 
Annex for indicative and orientation purposes only.' 
2.4.4. Amendment to Article 3(7) 
The Committee believes that certain prevention and 
protection measures should be extended to apply for 
all workers regardless of whether they are exposed 
'incidentally' or as a result of a 'conscious decision'. 
Many of the measures provided for in Articles 6-14 
should thus apply to all workers subjected to the risk 
of exposure to biological agents. This will not be the 
case if Article 3(7) is maintained as it now stands. 
In line with the comments expressed under 2.3.5 above, 
the Committee would thus recommend that the Direc­
tive should be amended as regards this point without 
detracting from appropriate and practicable provisions 
and those laid down in Article 12(1) and (2) in par­
ticular. 
The difficulties smaller firms inevitably encounter as 
regards industrial medicine could be overcome by using 
services or bodies operating at an inter-company level. 
2.5. Article 4 
2.5.1. The first paragraph of Article 4 should relate 
the expression 'reasonably practicable' to technological 
feasibility. 
2.5.2. The Committee would propose adding the 
following to Article 4(a): 
'By marking off risk areas as far as possible, so that 
they can be isolated.' 
2.5.3. A further paragraph should be added to read 
as follows: 
'i) Special vaccination whenever available and in 
relation to the presumed risks.' 
2.6. Article 7 
2.6.1. The following amendment to Article 7(2) is 
proposed: 'The records referred to in paragraph 1 shall be 
kept for at least 10 years following the end of 
exposure and must be passed on to the health autho­
rities and institutions or bodies mentioned in 
Article 3(2).' (This assumes that the amendment 
proposed above under 2.4.1 is adopted). 
2.7. Article 9 
2.7.1. The Committee proposes amending 
Article 9(1) as follows in line with the amendment 
proposed under 2.6.1: 
'... shall make available to the responsible authori­
ties referred to under Article 3(2) ...' 
2.8. Article 10 
2.8.1. The Committee would raise the same objec­
tion to Article 10(1) as we have done above under 2.4.2. 
2.8.2. Regarding Article 10(3), we would propose: 
a) deleting the word 'severe' from the end of the para­
graph; 
b) adding the following: 'Business confidentiality must 
be preserved particularly as regards competitors.' 
2.9. Article 11 
The word 'serious' should be deleted from the first 
indent of point 1. 
2.10. Article 13 
The Committee suggests adding the following to the 
first indent of Article 13(2): 
'Uncertainties about the presence of biological 
agents which should initially, and in the absence of 
specific information to the contrary, be assumed to 
be present in the materials ...' 
2.11. Article 14 
2.11.1. The following addition is proposed for the 
second paragraph of Article 14(1): 
'... as classified in the list referred to under 
Article 3(4).' 
2.11.2. The Committee considers the principles out­
lined under Article 14(3) and (5) to be poorly coordi­
nated and also connected with the content of 
Article 3(4). 
The principle which should be adopted is that the 
physical containment level should be determined by 
6. 3. 89 Official Journal of the European Communities No C 56/41 
the biological agent representing the greatest hazard 
without infringing on the provisions of Article 3(4). 
Done at Brussels, 14 December 1988. 
1. Introduction 
1.1. The Commission's proposals are designed to 
further reform the sheepmeat (and goatmeat) regime. 
A major reform has already been introduced earlier in 
1988 through the application of agricultural stabilisers. 
1.2. The main philosophy underlying the proposals 
is to harmonize to the maximum extent possible the 
implementation of the regime and to reduce its cost. 
However, the Commission rightly recognizes that some 
differences exist between regions in the Community in 
production conditions and in the final product itself. 
1.3. Although not forming part of the Council Regu­
lation cited above, the Commission also proposes to 
renegotiate the import arrangements with third 
countries. 
2. General comments 
2.1. The Committee cannot offer a definitive 
Opinion on the Commission's proposal for changing 2.12. Article 17 
The word 'serious' should be deleted from Article 17(1). 
The Chairman 
of the Economic and Social Committee 
Alberto MASPRONE 
the internal aspects of the regime before the trade 
arrangements with third countries have been renego­
tiated. The Community still imports 20 % of its sheep-
meat requirements and with an increasing production 
trend it will be necessary for the import arrangements 
to allow the EC to become more self sufficient. In 
particular the Committee opposes any increase in the 
proportion of chilled meat imports. 
2.2. Nevertheless, the Committee wishes to outline 
its provisional views on the Commission's proposals. 
2.3. The Committee recognizes that with the 
achievement of the single market in 1992 it will be 
necessary for the sheepmeat regime to be harmonized. 
Some of the proposed changes are radical and they 
therefore welcome that they will be phased in over a 
transition period of four years. 
2.4. The financial implications of the proposals show 
large savings to the EC budget. Unless these are offset 
by significantly higher market prices, producers' Opinion on the proposal for a Council Regulation (EEC) on the common organization of 
the market in sheepmeat and goatmeat 
(89/C 56/16) 
On 3 November 1988 the Council decided to consult the Economic and Social Committee, 
under Article 198 of the Treaty establishing the European Economic Community, on the 
abovementioned proposal. 
The Section for Agriculture and Fisheries, which was responsible for preparing the Com­
mittee's work on the subject, adopted its Opinion on 1 December 1988. The Rapporteur was 
Mr. Straufi. 
The Economic and Social Committee adopted the following Opinion at its 261st plenary 
session (meeting of 14 December 1988) with no dissenting votes and 8 abstentions.