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C0M(93)86 final - SYN 421 
Brussels, 4 March 1993 
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BriW" r a*. Amended proposal for a 
COUNCIL DIRECTIVE 
amending Directive 90/679/EEC 
on the protection of workers from risks related 
to exposure to biological agents at work 
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of the EEC-Treaty) 
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Amended proposal for a 
Council Directive 
amending Directive 90/679/EEC 
on the protection of workers from risks 
related to exposure to biological agents 
at work 
EXPLANATORY MEMORANDUM 
At its plenary sitting on 10 February 1993, the European Parliament adopted a series of 
amendments introducing a Recommended Code of Practice on Vaccination oi workers, 
clarifying future methods for classifying genetically modified biological agents, and 
modifying the application ol the containment levels required under Directive 
90/679/EEC' for certain non-airborne biological agents. 
The Commission has accepted all the amendments proposed by the Parliament with the 
exception of those whose purpose is to upgrade the classifications of the three 
biological agents, as the proposed Directive lays down only minimum requirements, 
leaving Member States free to apply stricter national requirements if they wish. 
Amended proposal for a 
COUNCIL DIRECTIVE 
amending Directive 90/679/EEC 
on the protection of workers from risks related to 
exposure to biological agents at work 
CQM(93) .final 
(forwarded by the Commission pursuant to Article 149(3) 
of the EEC Treaty on 1993) 
(l)OJ C 217 of 24.8.1992, p. 32 
PREVIOUS TEXT AMENDED TEXT 
Citations and recitals unchanged 
Recital 5 a (new) 
Whereas the first list does not contain 
genetically modified biological agents; 
whereas the inclusion of such agents in a 
future list will be achieved by a new 
amendment to this Directive; 
Recital 5 b (new) 
Whereas it is appropriate to include in this 
Directive a Recommended Code of Practice 
on Vaccination of workers exposed to 
biological agents for which effective 
vaccines exist; 
Article 1 
Directive 90/679/EEC shall be amended as Directive 90/679/EEC shall be amended as 
follows: follows: 
1. The following point is added at the 
end of the second paragraph of 
Article 14(3): 
"In making vaccines available 
employers shall take account of the 
Recommended Code of Practice on 
Vaccination set out in Annex VII." 
Annex III shall be supplemented by a first 
list of Groups 2, 3 and 4 biological agents 
as given in the Annex to this Directive. Annex III shall be supplemented by a 
first list of Groups 2, 3 and 4 
biological agents as given in the 
Annex to this Directive. 
An Annex VII shall be attached to 
this Directive after Annex VI. 
Articles 2 and 3 unchanged 
ANNEX 
Annex III 
INTRODUCTORY NOTES 
Points 1-8 unchanged 
Point 9 
This list also gives a special indication 
in cases where the biological 
agents are likely to cause toxic or 
allergic reactions, where preventive 
vaccination is available, or where it is 
advisable to keep a list of exposed 
workers for more than ten years. 9. This list also gives a special indication 
in cases where the biological agents 
are likely to cause toxic or allergic 
reactions, where preventive 
vaccination is available, or where it is 
advisable to keep a list of exposed 
workers for more than ten years. The 
application of preventive vaccination 
shall take account of the 
Recommended Code of Practice in 
Annex VII. 
Annex III (list of biological agents) 
The provisions of Annex III other than those listed below are unchanged 
BACTERIA and similar BACTERIA and similar 
Mycobacterium africanum 
Mycobacterium bovis 
(excluding BCG strain) 
Mycobacterium microti 
Mycobacterium ulcerans 
Rickettsia akari Mycobacterium africanum 3(1) 
Mycobacterium bovis 
(excluding BCG strain) 3(1) 
Mycobacterium microti 3(1) 
Mycobacterium ulcerans 3(1) 
Rickettsia akari 3(1) 
Lj. 
Rickettsia canada 3 
Rickettsia montana 3 
Salmonella Typhi 3 
Shigella dysenteriae (Type 1) 3 
VIRUSES 
Central European tick-borne 
encephalitis virus 3 
Louping ill 3 
Wesselsbron virus 3 
Hepatitis B virus 3 
Rabies virus 3 Rickettsia canada 
Rickettsia montana 
Salmonella Typhi 3(1) 
3(1) 
3(1) 
Sigella dysenteriae (Type 1) 3(1) 
VIRUSES 
Central European tick-borne 
ecephalitis virus 3(1) 
Louping ill 3(1) 
Wesselsbron virus 3(1) 
Hepatitis B virus 3(1) 
Rabies virus 3(1) 
Hepatitis A virus 
(human enterovirus type 72) 
White pox virus 
(Variola virus) Hepatitis A virus 2 V 
(human enterovirus type 72) 
White pox virus 
(Variola virus) 4 V 
(1) Application of measures laid down as part of the containment levels for airborne 
transmission, to be evaluated by the Member States. 
s. 
ANNEX VII 
RECOMMENDED CODE OF PRACTICE 
ON VACCINATION 
(Article 14 (3)) 
1. Vaccination of workers shall be 
considered following the assessment 
of the risk of exposure of workers to 
biological agents. 
2. Where a risk assessment demonstrates 
exposure to biological agents for 
which effective vaccines exist 
employers shall offer vaccination to 
those workers. Vaccination shall also 
be offered before workers begin work 
which exposes them to a risk of 
contamination. Vaccination shall be 
offered at appropriate intervals after 
that. 
3. Vaccination shall not be obligatory 
but employers shall inform workers of 
the benefits and drawbacks of 
vaccination and non-vaccination. 
4. Workers who refuse vaccination shall 
be warned that this could jeopardise 
their work or career prospects. 
However, where risk assessments 
show that other preventive measures 
give adequate protection against 
contamination, such workers shall be 
allowed to continue work with the 
biological agents in question. 
5. Employers shall not require prior 
vaccination as a condition for 
employment. 
6. Vaccinated workers shall be 
monitored at regular intervals to 
ensure that vaccination remains 
effective. Workers shall also be 
monitored for any side effects of 
vaccination. Workers who do not 
respond to the vaccine shall be 
informed accordingly. They shall be 
allowed to continue work with the 
relevant biological agents if risk 
assessments show that other 
L 
preventive measures give adequate 
protection against contamination. If 
adequate protection cannot be given, 
workers who do not respond to the 
vaccine should be offered alternative 
work which does not expose them to 
the relevant biological agents. 
7. Employers shall offer vaccination at 
no cost to workers. This shall include 
paid leave, travel expenses and 
doctors' fees where relevant. 
8. A record of vaccination shall be kept 
for each worker. This record shall be 
made available to the individual 
concerned and to competent 
authorities. Collected results shall be 
made available to workers' 
representatives. 

f. 
ISSN 0254-1475 
COM(93) 86 final 
DOCUMENTS 
EN 04 
Catalogue number : CB-CO-93-107-EN-C 
ISBN 92-77-53512-1 
Office for Official Publications of the European Communities 
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