COMMISSION OF THE EUROPEAN COMMUNITIES 
Brussels, 24.07 1996 
COM(96) 414 final 
95/0229 (SYN) 
OPINION OF THE COMMISSION 
on the amendments proposed by the European Parliament 
to the Council's common position on the 
proposal for a 
COUNCIL DIRECTIVE 
on the protection of workers from the risks related to 
exposure to carcinogens at work 
(presented by the Commission pursuant to Article 189 c (d) of the EC Treaty) 

EXPLANATORY MEMORANDUM 
The initial proposal for this amendment to the Directive was presented by the 
Commission to the Council on 14 September 19951. 
The main aims are the removal of the existing exclusion in Directive 90/394/EEC of a 
whole series of preparations containing carcinogens and the laying down of a limit value 
for occupational exposure to benzene, a well-known carcinogen. 
The European Parliament and the Economic and Social Committee gave their opinion 
on 20 June 19962 and 31 January 19963 respectively. 
In drawing up this amended proposal, the Commission took into account for the most 
part the amendments from the European Parliament and suggestions put forward by the 
Economic and Social Committee, and in particular: 
a) the role of biological monitoring in health surveillance for exposed workers; 
b) the need for coherence with other Community acts on the same subject; 
c) the advisability of having a uniform method for measuring benzene 
concentrations in air and for analysis; 
d) the advisability of including the derogation concerning primary synthesis in the 
production of materials for perfumes among the temporary derogations relating 
to limit values for benzene. 
This amendment is presented by the Commission under the terms of Article 189a(2) of 
the Treaty. 
1 OJ C 317, 28.11.1995, p.16. 
OJ 
OJ C 97, 1.04.1996, p.25. 
A 
Amended Proposal for a Council Directive 
amending for the first time Directive 90/394/EEC 
on the protection of workers from the 
risks related to exposure to carcinogens at work 
(Text with EEA relevance) 
COMMISSION PROPOSAL AMENDED COMMISSION 
PROPOSAL 
THE COUNCIL OF THE EUROPEAN 
UNION, THE COUNCIL OF THE EUROPEAN 
UNION, 
Having regard to the Treaty establishing 
the European Union, and in particular 
Article 118a thereof, 
Having regard to Council Directive 
90/394/EEC of 28 June 1990 on the 
protection of workers from the risks related 
to exposure to carcinogens at work(1), and 
in particular Article 16, 
Having regard to the proposal from the 
Commission^), drawn up following 
consultation with the Advisory Committee 
on Safety, Hygiene and Health Protection 
at Work, 
In cooperation with the European 
Parliament(3), 
1 
Having regard to the opinion of the 
Economic and Social Committee(4), 
Whereas Article 118a of the Treaty 
provides that the Council shall adopt, by 
means of directives, minimum 
requirements for encouraging 
improvements, especially in the working 
environment, to ensure a better level of 
protection of the safety and health of 
workers; 
Whereas, under the terms of that Article, 
such directives are to avoid imposing 
administrative, financial and legal 
constraints in a way which would hold 
back the creation and development of 
small and medium-sized undertakings, 
Whereas the Commission's communication 
on its programme in the field of safety, 
hygiene and health at the workplace (1996-
2000)(5) provides in particular for the 
continuation of work on setting limit 
values for exposure at the workplace; 
Whereas Commission Directive 
91/325/EEC(6) of 1 March 1991 adapting 
to technical progress for the twelfth time 
Council Directive 67/548/EECO on the 
approximation of the laws, regulations and 
administrative provisions relating to the 
classification, packaging and labelling of 
dangerous substances introduces in Annex 
in new risk phrases to indicate the health 
hazards resulting from prolonged exposure 
and the risk of cancer through inhalation; 
Whereas in all work situations workers 
must be protected in respect of 
preparations containing one or more 
carcinogens; Whereas in all work situations workers 
must be protected in respect of 
preparations containing one or more 
carcinogens and from carcinogenic 
compounds arising at work; 
Whereas, for some agents it is necessary to 
consider all absorption pathways, including 
the possibility of penetration through the 
skin, in order to ensure the best possible 
level of protection; 
Whereas the wording of point 2 of Annex 
I to Directive 90/394/EEC relating to 
polycyclic aromatic hydrocarbons has 
posed problems of interpretation in many 
Member States; whereas, therefore, a new, 
more precise wording is called for; 
Whereas Article 16 of the aforementioned 
Council Directive 90/394/EEC makes 
provision for the establishment of exposure 
limit values on the basis of the available 
information, including scientific and 
technical data, in respect of all those 
carcinogens for which this is possible; 
Whereas occupational exposure limit 
values must be regarded as an important 
component of the general arrangements for 
the protection of workers; whereas such 
limit values must be revised whenever this 
becomes necessary in the light of more 
recent scientific data; 
Whereas benzene is a carcinogen which is 
present in many work situations whereas, 
therefore, a large number of workers are 
exposed to a potential health risk; whereas, 
although current scientific knowledge is 
not such that a level can be established 
below which risks to health cease to exist, 
a reduction in exposure to benzene will 
nonetheless reduce these risks; Whereas benzene is a carcinogen which is 
present in many work situations; whereas, 
therefore, a large number of workers are 
exposed to a potential health risk; whereas, 
although current scientific knowledge 
classifies benzene among the substances 
for which a level cannot be established 
below which risks to health cease to exist, 
a reduction in exposure to benzene will 
nonetheless reduce these risks; 
Whereas it is important to set biological 
limit values to carcinogens in order to 
estimate the level of absorption of other 
routes than the breath. Because bio-
monitoring is an important procedure for 
assessing benzene exposure, the 
Commission should propose a biological 
limit value for benzene without delay; 
Whereas the respect of the minimum 
requirements on the protection of health 
and safety of workers from the specific 
risks related to carcinogens ensures not 
only the protection of the health and safety 
of each individual worker but also provides 
a level of minimum protection of all 
workers in the Community which avoids 
any possible distortion in the area of 
competitiveness; Whereas the respect of the minimum 
requirements on the protection of health 
and safety of workers from the specific 
risks related to carcinogens aims not only 
to ensure the protection of the health and 
safety of each individual worker but also 
to provide a level of minimum protection 
of all workers in the Community which 
avoids any possible distortion in the area 
of competitiveness; 
Whereas provision should be made to 
ensure the protection of the health and 
safety of workers concerned, in the case of 
derogations provided for specified 
activities or sector of activity where the 
implementation of the limit value proposed 
for benzene may be difficult to meet 
within the date proposed; Whereas all the directives concerning 
protection of the health of workers at the 
place of work and the directives 
concerning protection of public health and 
of the general environment must reflect a 
single overall vision of socio-economic 
development in the European Community 
whereas the measures taken concerning 
benzene under the present Directive must 
therefore be consistent with the aims and 
provisions of Directive 94/63/EC(*) on the 
control of volatile organic compound 
emissions (and thus of benzene emissions) 
resulting from the storage of petrol and its 
distribution from terminals to service 
stations; 
Whereas in most small and medium sized 
enterprises where the main use of benzene 
might be as a solvent, provisions to lower 
exposure will not be required as legal 
provisions already exist in nearly all the 
member States to restrict or prohibit its 
use. 
Whereas a consistent level of protection 
from the risks related to carcinogens has to 
be established for the Community as a 
whole and whereas that level of protection 
has to be set not by detailed prescriptive 
requirements but by a framework of 
general principles to enable Member States 
to apply the minimum requirements 
consistently; 
Whereas this amendment constitutes a 
practical aspect of the realisation of the 
social dimension of the internal market; 
Whereas, pursuant to Decision 
74/325/EECO, as last amended by the 
1985 Act of Accession, the Advisory 
Committee on Safety, Hygiene and Health 
Protection at Work is to be consulted by 
the Commission with a view to drawing up 
proposals in this field, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 Article 1 
Directive 90/394/EEC is hereby amended 
as follows: 
1. Article 2 shall be replaced by the 
following: 
"For the purposes of this Directive, 
(a) "carcinogen" means: 
i) a substance which meets the 
requirements for classification as 
category 1 or 2 carcinogen 
according to the criteria of 
Annex VI of Directive 
67/548/EEC(7). 
ii) a preparation composed of one 
or more substances referred to in 
point (a)i) where the 
concentration of one or more of 
the individual substances meets 
the requirements for 
concentration limits for the 
classification of a preparation as 
a category 1 or 2 carcinogens set 
out either: 
in Annex I to Directive 
67/548/EEC 
or 
in Annex I of Directive 
88/379/EEC(10) where the 
substance or substances do 
not appear in Annex I to 
Directive 67/548/EEC or 
appear in it without 
concentration limits. 
iii) a substance, preparation or 
process referred to in Annex I as 
well as a substance or 
preparation released by a process 
referred to in Annex I. 
(b) "limit value" means, unless otherwise 
specified, the limit of concentration 
for a "carcinogen" in the air within 
the breathing zone of a worker." (b) "limit value" means, unless otherwise 
specified, the limit of concentration 
for a "carcinogen" within the 
breathing zone of a worker in 
relation to an appropriate reference 
period. Breathing zone is the space 
from where he takes his breath. It 
shall be forbidden to exceed this 
value. 
(c) "biological limit value" means the 
limit of concentration in the 
appropriate biological medium, of the 
relevant agent, its metabolite, or an 
indicator of effect. It shall be 
forbidden to exceed this value. 
2. Article 3(3) shall be replaced by the 
following: 
"Furthermore, when assessing the 
risk, account shall be taken of all 
other routes of exposure, such 
absorption into and/or through the 
skin". 
3. In Article 16, the following 
paragraph shall be added: 
"3. In the case of derogations provided 
for in Annex m, the Member States 
shall be obliged to ensure that 
employers comply with procedures 
and measures in order to take adequate 
precautions to protect the health and 
safety of the workers concerned." 
4. Item 2 of Annex I shall be replaced by 
the following: 
"Work involving exposure to 
polycyclic aromatic hydrocarbons 
present in coal soot, coal tar or coal 
pitch". 
5. Part A of Annex III shall be replaced 
by the following: 
10 
"A. LIMIT VALUES FOR 
OCCUPATIONAL EXPOSURE 
Nome Elnecs CAS 
of agent (1) (2) 
Benzene 200-753-7 71-43-2 Limit values 
nag/m1 (3) ppm (4) 
3.25(5) 1(5) Notation 
Skin (6) Derogations 
Limit value: 3 ppm 
(-9.75 mg/m') until 31 
December 2000 for the 
following activities or 
sector of activity: 
Selected sites in coke 
plants (primary coolers, 
benzol/suiphatehouses, 
benzol storage and 
loading) 
- cleaning and 
maintenance of tanks 
loading and unloading 
of tanker 
vessels and lorries 
• marine transport 
• motor vehicle repair 
shops 
- service station with 
filling 
- attendant 
Nome Elnecs CAS 
of agent (1) (2) 
Benzene 200-753-7 71-43-2 Limit values 
mg/m1 (3) ppm (4) 
3.25 (5) 1 (5) Notation 
Skin (6) Derogations 
Limit value: 3 ppm 
(-9.75 mg/m1) until 31 
December 2000 for the 
following activities or sector 
of activity: 
• Selected sites in coke 
plants (primary coolers, 
benzol/sulphate houses, 
benzol storage and 
loading) 
• cleaning and maintenance 
of tanks 
• loading and unloading of 
tanker 
- vessels and lorries 
- marine transport 
- motor vehicle repair 
shops 
• service station with 
filling 
attendant 
- primary synthesis in 
fragance material 
production Biological 
limit 
value<s) 
p.m. 
(1) EINECS: European Inventory of Existing Chemical Substances 
(2) CAS: Chemical Abstract Service Number 
(3) mg/m* - milligrams per cubic metre of air at 20 C and 101J KPa (760 mm mercury pressure) 
(4) ppm - parts per million by volume in air (ml/m*). 
(5) Measured or calculated in relation to a reference period of eight hours. 
(6) Substantial contribution to the total body burden via dermal exposure possible." 
11 
Article 2 
1. Member States shall bring into force 
the laws, regulations and administrative 
provisions necessary to comply with 
this Directive not later than 31 
December 1998. They shall forthwith 
inform the Commission thereof. Part B of Annex III shall be replaced by 
the following: 
"B. OTHER DIRECTLY RELATED 
PROVISIONS 
Benzene 
For the measuring procedure, CEN 
689:1995 should be used preferentially. 
In the absence of a uniform analytical 
method, at Community level, Member 
States shall provide the method to be used. 
2. When Member States adopt these 
provisions, these shall contain a 
reference to this Directive or shall be 
accompanied by such reference at the 
time of their official publication. The 
procedure for such reference shall be 
laid down by the Member States. 
Member States shall communicate to 
the Commission the texts of the 
provisions of national law which they 
adopt in the field covered by this 
Directive 
12 
Article 3 
This Directive is addressed to the Member 
States. 
1. OJNoL 196, 26.7.1990, p. 1 
2. OJC317, 28.11.1995, p. 16 
3. OJ 
4. OJ C 97, 01.04.1996, p. 25 
5. COM(95) 282 final 
6. OJNoL 180, 8.7.1991, p. 1 
7. OJNoL 196, 16.8.1967, p. 1 
8. OJ No L 365, 31.12.1994, p. 24 
9. OJ No L 185, 9.7.1974, p. 15 
10. OJ No L 187, 16.7.1988, p. 14 
U ISSN 0254-1475 
COM(96) 414 final 
DOCUMENTS 
EN 04 05 06 
Catalogue number : CB-CO-96-398-EN-C 
ISBN 92-78-07688-0 
Office for Officiai Publications of the European Communities 
L-2985 Luxembourg