COMMISSION OF THE EUROPEAN COMMUNITIES 
Brussels, 10.03.1998 
COM(1998) 162 final - SYN 459 
Re-examined proposal for a 
COUNCIL DIRECTIVE 
on the protection of the health and safety of workers from the risks related to chemical 
agents at work (fourteenth individual Directive within the meaning of Article 16(1) of 
Directive 89/391/EEC) 
(presented by the Commission pursuant to Article 189 c (d) 
of the EC Treaty) 

1 
EXPLANATORY MEMORANDUM 
The initial proposal was adopted hy the Commission on 14 May 1993 and forwarded 
lo Council on 17 May I993(l). 
The aim of.the proposal is to lay down minimum requirements for the protection of 
workers from risk to their safety and health arising from the effects of chemical agents 
that are present at the workplace or as a result of any work activity involving chemical 
agents. 
Further to the first reading at the European Parliament, the Commission forwarded an 
amended proposal to the Council on 9 June 1994(2). 
On account of significant divergences in delegations' positions, work on the amended 
proposal was suspended in 1994 and only resumed on the basis of a compromise text 
put forward by the Irish Presidency in October 1996. 
On 7 October 1997 a common position'1' was adopted by the Council laying down 
general principles covering all chemical agents. The common position reflected most 
of (he principles proposed by the Commission and was therefore supported. In 
particular the common position accepted the existence of two kinds of occupational 
limit values (indicative and binding). It confirmed the Commission's proposal that in 
conformity with Directive 89/391/EEC, the employer shall assess any risk to the 
safety and health of workers, but additionally it defined the type of risk assessment to 
be undertaken for the hazardous chemical agents at work. It also provided more details 
relating lo health surveillance for workers exposed to hazardous chemical agents by 
introducing in the text requirements mentioned in the Annex of the amended proposal. 
On the other hand the common position did not include some technical requirements 
which were included in the Annex of the Commission's amended proposal, e.g. 
requirements in respect of measuring procedures, and in respect of specific protective 
measures. 
The European Parliament at its second reading proposed 12 amendments lo the 
common position adopted by the Council. 
OJC 165,16.6.1993, p. 4 
O.IC 191, 14.7.1994, p.7 
OJC375, 10.12.1997, p. 1 
tflL 
The Commission has agreed on 9 amendments (plus one part amendment), which it 
considers improve the text of the common position. The amendments draw particular 
attention to the training of and information to workers, to the need to make cross 
reference to particular Directives such as Directive 89/654/EEC0 concerning the 
minimum safety and health requirements for the workplace, directive 89/656/EEC(,) on 
the minimum health and safety requirements for the use by workers of personal 
protective equipment at the workplace, Directive 92/85/EEC(6) on the introduction of 
measures to encourage improvements in the safety and health at work of pregnant 
workers and workers who have recently given birth or are breastfeeding and Directive 
94/33/1 ;MC{1) on (he protection of young people at work and to appropriate actions to 
be taken by the Commission for closer harmonization in the field of occupational 
exposure limits. 
The legal consistency under Article 8 the Commission has also inserted reference to 
Article 12 of Directive 89/39 l/EEC to align the text with the title of the Article. 
This re-examined proposal contains the amendments accepted by the Commission and 
is presented by the Commission under the terms of article 189 C(d) of the Treaty. 
(4) OJ No L 393, 30.12.1989, p. 1 
(5) OJ No L 393, 30.12.1989, p. 18 
(6) OJ No L 348, 28.11.1992, p. 1 
(7) OJ No L 216, 20.8.1994, p. 12 
It. 
Re-examined proposal for a 
COUNCIL DIRECTIVE 
on the protection of the health and safety of workers from the risks related to chemical agents 
at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 
89/391/EEC) 
(Text with EEA relevance) 
PREVIOUS TEXT AMENDED TEXT 
THE COUNCIL OF THE EUROPEAN 
UNION, 
Having regard to the Treaty establishing the 
European Community, and in particular 
Article 118a thereof, 
Having regard to the proposal from the 
Commission0', drawn up after consultation 
with the Advisory Committee on Safety, 
Hygiene and Health Protection at Work, 
Having regard to the Opinion of the 
Economic and Social Committee(2), 
Acting in accordance with the procedure 
laid down in Article 189c of the Treaty(3), 
(i) 
(2) 
(3) OJNoC 165, 16.6.1993, p. 4. 
OJNoC 34, 2.2.1994, p. 42. 
Opinion of the European Parliament of 20 April 1994 (OJ NoC 128, 9.5.1994, p. 167), Council 
common position or 7 October 1997 (O.J. C 375, 10.12.1997, p. 1) and Decision of the European 
Parliament of (not yet published in the Official Journal). 
(1) 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 guarantee a 
better level of protection of the safety and 
health of workers; 
(2) Whereas, pursuant to that Article, 
such Directives shall avoid imposing 
administrative, financial and legal 
constraints in a way which would hold back 
the creation and development of small and 
medium-sized undertakings; 
(3) Whereas the improvement of 
workers' safety, hygiene and health at work 
is an objective which should not be 
subordinated to purely economic 
considerations; 
(4) Whereas the respect of minimum 
requirements on the protection of the health 
and safety of workers from the risks related 
to chemical agents aims to ensure not only 
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 
competition; 
(5) Whereas a consistent level of 
protection from the risks related to 
chemical agents has to be established for 
the Community as a whole; 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; 
(6) Whereas a work activity involving 
chemical agents is likely to expose workers 
to risk; 
(7) Whereas Council Directive 
80/1107/EEC of 27 November 1980 on the 
protection of workers from the risks related 
to exposure to chemical, physical and 
biological agents at work(4), Council 
Directive 82/605/EEC of 28 July 1982 on 
the protection of workers from the risks 
related to exposure to metallic lead and its 
ionic compounds at work (first individual 
Directive within the meaning of Article 8 of 
Directive 80/1107/EEC)(5) and Council 
Directive 88/364/EEC of 9 June 1988 on 
the protection of workers by the banning of 
certain specific agents and/or certain work 
activities (fourth individual Directive within 
the meaning of Article 8 of Directive 
80/1107/EEC)(r,), for the sake of 
consistency and clarity as well as for 
technical reasons, should be revised and 
included in a single Directive laying down 
minimum requirements for the protection of 
the health and safety of workers in work 
activities involving chemical agents; 
whereas these Directives can be repealed; 
(8) Whereas this Directive is an 
individual Directive within the meaning of 
Article 16(1) of Council Directive 
89/391/EEC of 12 June 1989 on the 
introduction of measures to encourage 
improvements in the safety and health of 
workers at work<7) ; 
(9) Whereas therefore the provisions of 
the said Directive apply in full to the 
exposure of workers to chemical agents, 
without prejudice to more stringent and/or 
specific provisions contained in this 
Directive; 
14) 
(5) 
(6) 
17) OJ No L 327, 3.12.1980, p. 8. Directive as last amended by DirecUve 88/642/EEC (OJ No L 356, 
24.12.1988, p. 74). 
OJ No L 247, 23.8.1982, p. 12. 
OJ No L 179, 9.7.1988, p. 44. 
OJ No L 183, 29.6.1989, p. 1. 
(10) Whereas more stringent and/or 
specific provisions relating to the transport 
of hazardous chemical agents are contained 
in binding international agreements and 
conventions incorporated into Community 
provisions on transport of dangerous goods 
by road, rail, water and air; 
(11) Whereas in Directive 67/548/EEC(8) 
and Directive 88/379/EEC(9) on the 
approximation of the laws, regulations and 
administrative provisions relating to the 
classification, packaging and labelling of, 
respectively, dangerous substances and 
preparations, the Council laid down a 
system of criteria for the classification of 
dangerous substances and preparations, 
(12) Whereas the definition of hazardous 
chemical agent should include any chemical 
substance which meets these criteria and 
also any chemical substance which whilst 
not meeting these criteria may because of 
its physico-chemical, chemical or 
toxicological properties, and the way it is 
used or is present in the workplace, present 
a risk to the safety and health of workers; 
(13) Whereas in Directive 90/492/EEC(,(,) 
the Commission defined and laid down a 
system of specific information on 
dangerous substances and preparations, in 
the form of safety data sheets principally 
intended for industrial users to enable them 
to take the measures necessary to ensure 
the protection of the safety and health of 
workers; whereas Council Directive 
92/58/EEC of 24 June 1992 on the 
minimum requirements for the provision of 
safety and/or health signs at work (ninth 
(8) 
(3) 
(10) OJ No 196, 16.8.1967, p. 1. Directive as last amended by Directive 96/56/EC (OJ No L 236, 
IH.9.1996, p. 35). 
OJ No L 187, 16.7.1988, p. 14. Directive as last amended by Commission Directive %/65^EC 
(OJ No L 265, 18.10.1996, p. 15). 
OJNoL275, 5.10.1990, p. 35. 
individual Directive within the meaning of 
Article 16(1) of Directive 89/391/EEC)(,,) 
establishes a system for marking containers 
and pipes used for dangerous substances or 
preparations at work; 
(14) Whereas the employer should assess 
any risk to the safety and health of workers 
arising from the presence of hazardous 
chemical agents at the workplace, in order 
to take the necessary preventive and 
protective measures set out in this 
Directive; 
(15) Whereas the preventive measures 
identified by the assessment of risk and 
taken by the employer should be consistent 
with the need to protect public health and 
the environment; 
(16) Whereas, to supplement the 
information available to workers so as to 
ensure an improved level of protection, it is 
necessary for workers and their 
representatives to be informed about the 
risks which chemical agents can pose for 
their safety and health and about the 
measures necessary to reduce or eliminate 
those risks, and for them to be in a position 
to check that the necessary protective 
measures are taken; 
(17) Whereas the health surveillance of 
workers for whom the results of the 
aforementioned assessment reveal a risk to 
health, can contribute to the prevention and 
protection measures to be undertaken by 
the employer; 
(18) Whereas the employer must on a 
regular basis carry out evaluation and 
measurements and be aware of new 
developments in technology with a view to 
improving the protection of workers' safety 
and health; 
1111 OJ No L 245, 26.8.1992, p. 23. 
(19) Whereas the latest scientific data 
should be evaluated by independent 
scientists to assist the Commission in 
setting occupational exposure limit values; 
(20) Whereas, although in some cases 
scientific knowledge may not be such that a 
level of exposure to a chemical agent can 
be established below which risks to health 
cease to exist, a reduction in exposure to 
these chemical agents will nonetheless 
reduce these risks; 
(21) Whereas in Directive 91/322/EEC(,2) 
and Directive 96/94/EC<l3) the Commission 
laid down indicative limit values as 
provided for by Directive 80/1107/EEC; 
whereas the former Directives should be 
maintained as part of the current 
framework ; 
(22) Whereas necessary technical 
adjustments to this Directive should be 
drawn up by the Commission in 
cooperation with the Committee set up by 
Directive 89/391/EEC to assist the 
Commission in making technical 
adaptations to individual Directives 
adopted under the framework of that 
Directive; whereas the Commission, after 
first seeking the advice of the Advisory 
Committee on Safety, Hygiene and Health 
Protection at Work in accordance with 
Decision 74/325/EEC<N), should also draw 
up practical guidelines for the application of 
this Directive; 
(23) Whereas the repeal of Directive 
80/1107/EEC must not give rise to the 
lowering of the present standards of worker 
protection from chemical, physical and 
biological agents; whereas standards 
resulting from the existing Directives on 
,12) OJNoL 177, 5. 7.1991, p. 22 
'13) OJ No L 338, 28.12.1996, p. 86 
(14) OJ No L 185, 9.7.1974, p. 15 Decision as last amended by the 1994 Act of Accession. 
biological agents, the proposed Directive 
on physical agents, this Directive and any 
amendments to these texts should rellect 
and at least maintain the standards laid 
down in the said Directive; 
(24) Whereas this Directive is a practical 
contribution towards creating the social 
dimension of the internal market 
HAS ADOPTED TINS DIRECTIVE: 
SECTION I 
GENERAL PROVISIONS 
Article I 
Objective and scope 
I. This Directive, which is the fourteenth 
individual Directive within the meaning of 
Article 16( I) of Directive 89/391/EEC, lays 
down minimum requirements for the 
protection of workers from risks to their 
safety and health arising, or likely to arise, 
from the effects of chemical agents that are 
present at the workplace or as a result of 
any work activity involving chemical 
agents. 
2. The requirements of this Directive apply 
where hazardous chemical agents are 
present or may be present at the workplace, 
without prejudice to the provisions for 
chemical agents to which measures for 
radiation protection apply pursuant to 
Directives adopted under the Treaty 
establishing the European Atomic Energy 
Community. 
3 For carcinogens at work the provisions 
of this Directive shall apply without 
prejudice to more stringent and/or specific 
provisions contained in Council Directive 
90/394/EEC of 28 June 1990 on the 
protection of workers from the risks related 
to exposure to carcinogens (sixth individual 
Directive within the meaning of Article 
16(1) of Directive 89/39l/EEC)(,5). 
4. The provisions of Directive 89/391/EEC 
shall apply fully to the whole field referred 
to in this Article, without prejudice to more 
stringent and/or specific provisions 
contained in this Directive. 4 The provisions of Directive 89/391/EEC 
and subsequent individual directives, in 
particular Directive 89/654/EEO"0 
concerning the minimum safety and health 
requirements for the workplace. Directive 
89/656/EEC(17> on the minimum health and 
safety requirements for the use by workers 
of personal protective equipment at the 
workplace. Directive 92/85/EEC(18) on the 
introduction of measures to encourage 
improvements in the safety and health at 
work of pregnant workers and workers 
who have recently given birth or are 
breastfeeding and Directive 94/33/EEC(>9) 
on. the protection of young people at work. 
shall apply fully to the whole field referred 
to in this Article, without prejudice to more 
stringent and/or specific provisions 
contained in this Directive. 
5. As far as the transport of hazardous 
chemical agents is concerned, the 
provisions of this Directive shall apply 
without prejudice to more stringent and/or 
specific provisions contained in Directive 
94/55/EC (20), in Directive 96/49/EC (21), in 
(15) 
(17) 
(IX) 
(20) OJNoL 196, 26.7.1990, p. I. 
OJ No I. 393, 30.12.1989. p. I 
OJ No I-393, 30.12.1989, p. 18 
OJ No L 348, 28.11.1992, p. I 
OJ No L 216, 20.8.1994, p. 12 
Council Directive 94/55/EC of 21 November 1994 on the approximation of ihc laws of the Member 
Stales with regard to the transport of dangerous goods by road 
(OJ No L 319, 12.12.1994, p. 7). Directive as amended by Commission Directive 96/86/EC (OJ No L 
335, 24.12.1996, p. 43). 
the provisions of the IMDG Code, 
IBCCode and 1GC Code as defined in 
Article 2 of Directive 93/75/EEC (22), in the 
provisions of the European Agreement 
concerning the International Carriage of 
Dangerous Goods by Inland Waterway and 
of the Regulation for the Carriage of 
Dangerous Substances on the Rhine as 
incorporated in Community law and in the 
technical instructions for the safe transport 
of dangerous goods issued, at the date of 
entry into force of this Directive, by the 
International Civil Aviation Organization. 
Article 2 
Definitions 
For the purpose of this Directive, the terms 
used shall have the following meanings: 
(a) "Chemical agent" means any chemical 
element or compound, on its own or 
admixed, as it occurs in the natural 
state or as produced, used or released, 
including release as waste, by any work 
activity, whether or not produced 
intentionally and whether or not placed 
on the market; 
(b) "Hazardous chemical agent" means: 
(i) any chemical agent which meets 
the criteria for classification as a 
dangerous substance according to 
the criteria in Annex VI to 
Directive 67/548/EEC, whether or 
not that substance is classified 
under that Directive, other than 
(21) Council Directive 96/49/EC of 23 July 1996 on the approximation of the laws of the Member States 
with regard to the transport of dangerous goods by rail (OJ L No 235, 17.9.1996, p. 25). Directive as 
amended by Commission Directive 96/87/EC 
(OJ No L 335, 24.12 1996, p. 45). 
Council Directive 93/75/HEC of 13 September 1993 concerning minimum requirements for vessels 
bound for or leaving Community ports and carrying dangerous or polluting goods (OJ No L 247, 
5.10.1993, p. 19). Directive as last amended by Commission Directive 97/34/EC (OJ No L 158, 
17.6.1997, p. 40). 
those substances which only meet 
the criteria for classification as 
dangerous for the environment; 
(ii) any chemical agent which meets 
the criteria for classification as a 
dangerous preparation within the 
meaning of Directive 88/379/EEC, 
whether or not that preparation is 
classified under that Directive, 
other than those preparations 
which only meet the criteria for 
classification as dangerous for the 
environment; 
(iii) any chemical agent which, whilst 
not meeting the criteria for 
classification as dangerous in 
accordance with (i) and (ii), may, 
because of its physico-chemical, 
chemical or toxicological 
properties and the way it is used or 
is present in the workplace, 
present a risk to the safety and 
health of workers, including any 
chemical agent assigned an 
occupational exposure limit value 
under Article 3. 
(c) "Activity involving chemical agents" 
means any work in which chemical 
agents arc used, or are intended to be 
used, in any process, including 
production, handling, storage, 
transport or disposal and treatment, or 
which result from such work; 
(d) "Occupational exposure limit value" 
means, unless otherwise specified, the 
limit of the time-weighted average of 
the concentration of a chemical agent 
in the air within the breathing zone of a 
worker in relation to a specified 
reference period; 
11 
(e) "Biological limit value" means the limit 
of the concentration in the appropriate 
biological medium of the relevant 
agent, its metabolite, or an indicator of 
effect; 
(f) "Health surveillance" means the 
assessment of an individual worker to 
determine the state of health of that 
individual, as related to exposure to 
specific chemical agents at work; 
(g) "Hazard" means the intrinsic property 
of a chemical agent with the potential 
to cause harm; 
(h) "Risk" means the likelihood that the 
potential for harm will be attained 
under the conditions of use and/or 
exposure. 
Article 3 
Occupational exposure limit values and 
biological limit values 
1. The Commission shall evaluate the 
relationship between the health effects of 
hazardous chemical agents and the level of 
occupational exposure by means of an 
independent scientific assessment of the 
latest available scientific data. 
2. On the basis of the evaluation described 
in paragraph 1, the Commission, after first 
consulting the Advisory Committee on 
Safety, Hygiene and Health Protection at 
Work, shall propose European objectives in 
the form of indicative occupational 
exposure limit values for the protection of 
workers from chemical risks, to be set at 
Community level. 
12 
These limit values shall be established or 
revised, taking into account the availability 
of measurement techniques, in accordance 
with the procedure laid down in Article 17 
of Directive 89/391/EEC. Member States 
shall keep workers' and employers' 
organizations informed of occupational 
exposure limit values set at Community 
level. These limit values shall be established or 
revised, taking into account the availability 
of validated measurement techniques, in 
accordance with the procedure laid down in 
Article 17 of Directive 89/391/EEC. 
Member States shall keep workers' and 
employers' organizations informed of 
indicative occupational exposure limit 
values set at Community level. 
3. For any chemical agent for which an 
indicative occupational exposure limit value 
is established at Community level, Member 
States shall establish a national 
occupational exposure limit value, taking 
into account the Community limit value, 
determining its nature in accordance with 
national legislation and practice. 
4. Binding occupational exposure limit 
values may be drawn up at Community 
level and, in addition to the factors 
considered when establishing indicative 
occupational exposure limit values, shall 
reflect feasibility factors while maintaining 
the aim of ensuring the health of workers at 
work. Such limit values shall be established 
in accordance with Article 118a of the 
Treaty and laid down in Annex I to this 
Directive. 
5 For any chemical agent for which a 
binding occupational exposure limit value is 
established, Member States shall establish a 
corresponding national binding 
occupational exposure limit value based on, 
but not exceeding, the Community limit 
value. 
6. Binding biological limit values may be 
drawn up at Community level on the basis 
of the evaluation described in paragraph 1 
and of the availability of measurement 
techniques, and shall reflect feasibility 
factors while maintaining the aim of 
ensuring the health of workers at work. 
13 
Such limit values shall be established in 
accordance with the procedure laid down in 
Article 118a of the Treaty and laid down in 
Annex II to this Directive, together with 
other relevant health surveillance 
information. 
7. For any chemical agent for which a 
binding biological limit value is established, 
Member States shall establish a 
corresponding national binding biological 
limit value based on, but not exceeding, the 
Community limit value. 
8. Where a Member State introduces or 
revises a national occupational exposure 
limit value or a national biological limit 
value for a chemical agent on the basis of 
new data, it shall inform the Commission 
and other Member States thereof together 
with the relevant scientific and technical 
data. The Commission shall undertake the 
appropriate action. 8. Where a Member State introduces or, on 
the basis of new data, revises a national 
occupational exposure limit value or a 
national biological limit value for a 
chemical agent, it shall inform the 
Commission and other Member States 
thereof together with the relevant scientific 
and technical data. The Commission shall 
undertake the appropriate action. 
8a. On the basis of the reports provided 
by the Member States under Article 15 the 
Commission shall carry out an assessment 
of the way in which Member States have 
taken account of Community indicative 
lim i t_ values when establishing the 
corresponding national occupational 
exposure limit values. If this assessment 
reveals wide differences in standards the 
Commission shall undertake appropriate 
action with a view to closer harmonization 
in this area. 
9. Standardized methods for the 
measurement and evaluation of workplace 
air concentrations in relation to 
occupational exposure limit values shall be 
developed in accordance with Article 12(2). 
14 
SECTION II 
EMPLOYERS' OBLIGATIONS 
A Hide 4 
Determination and assessment of risk of 
hazardous chemical agents 
I. En carrying out the obligations laid down 
in Articles 6(3) and 9(1) of Directive 
89/391/EEC, the employer shall first 
determine whether any hazardous chemical 
agents are present at the workplace. If so, 
he shall then assess any risk to the safety 
and health of workers arising from the 
presence of those chemical agents, taking 
into consideration the following: 
- their hazardous properties; 
- information on safety and health that 
shall be provided by the supplier, (e.g. 
the relevant safety data sheet in 
accordance with the provisions of 
Directive 67/548/EEC or 
Directive 88/379/EEC); 
- the level, type and duration of exposure; 
- the circumstances of work involving 
such agents, including their amount; 
- any occupational exposure limit values 
or biological limit values established on 
the territory of the Member State in 
question; 
- the effect of preventive measures taken 
or to be taken; 
- where available, the conclusions to be 
drawn from any health surveillance 
already undertaken. 
I.s 
The employer shall obtain additional 
information which is needed for the risk 
assessment from the supplier or from other 
readily available sources. Where 
appropriate, this information shall comprise 
the specific assessment concerning the risk 
to users established on the basis of 
Community legislation on chemical agents. 
2. The employer must be in possession of 
an assessment of the risk in accordance 
with Article 9 of Directive 89/391/EEC, 
and shall identify which measures have been 
taken in accordance with Articles 5 and 6 
of this Directive. The risk assessment shall 
be documented in a suitable form according 
to national law and practice, and may 
include a justification by the employer that 
the nature and extent of the risks related to 
chemical agents make a further detailed risk 
assessment unnecessary. The risk 
assessment shall be kept up-to-date, 
particularly if there have been significant 
changes which could render it out-of-date, 
or when the results of health surveillance 
show it to be necessary. 2. The employer must be in possession of 
an assessment of the risk in accordance 
with Article 9 of Directive 89/391/EEC, 
and shall identify which measures have been 
taken in accordance with Articles 5 and 6 
of this Directive. The risk assessment shall 
be recorded in a suitable form according to 
national law and practice, and may include 
a justification by the employer that the 
nature and extent of the risks related to 
chemical agents make a further detailed risk 
assessment unnecessary. The risk 
assessment shall be kept up-to-date, 
particularly if there have been significant 
changes which could render it out-of-date, 
or when the results of health surveillance 
show it to be necessary. 
3. Certain activities within the undertaking 
or establishment, such as maintenance, in 
respect of which it is foreseeable that there 
is a potential for significant exposure, or 
which may result in deleterious effects to 
safety and health for other reasons, even 
after all technical measures have been 
taken, shall be included in the risk 
assessment. 
4. In the case of activities involving 
exposure to several hazardous chemical 
agents, the risk shall be assessed on the 
basis of the risk presented by all such 
chemical agents in combination. 
16 
5. In the case of a new activity involving 
hazardous chemical agents, work shall only 
commence after an assessment of the risk 
of that activity has been made and any 
preventive measures identified have been 
implemented. 
6. Practical guidelines for the determination 
and assessment of risk, and for their review 
and, if necessary, adjustment, shall be 
developed in accordance with Article 12(2). 
Article 5 
General principles for prevention of 
risks associated with hazardous chemical 
agents and application of this Directive 
in relation to assessment of risks 
1. In carrying out his obligation to ensure 
the health and safety of workers in any 
activity involving hazardous chemical 
agents the employer shall take the 
necessary preventive measures set out in 
Article 6(1) and (2) of 
Directive 89/391/EEC and include the 
measures set out in this Directive. 
2. Risks to the health and safety of workers 
at work involving hazardous chemical 
agents shall be eliminated or reduced to a 
minimum by: 
- the design and organization of systems 
of work at the workplace; 
- the provision of suitable equipment for 
work with chemical agents and 
maintenance procedures which ensure 
the health and safety of workers at 
work; 
17 
- reducing to a minimum the number of 
workers exposed or likely to be 
exposed; 
- reducing to a minimum the duration and 
intensity of exposure; 
- appropriate hygiene measures; 
- reducing the quantity of chemical agents 
present at the workplace to the minimum 
required for the type of work concerned; 
suitable working procedures including 
arrangements for the safe handling, 
storage and transport within the 
workplace of hazardous chemical agents 
and waste containing such chemical 
agents. 
Practical guidelines for preventive measures 
to control risk shall be developed in 
accordance with Article 12(2). 
3. Where the results of the assessment 
referred to in Article 4(1) reveal a risk to 
the safety and health of workers, the 
specific protection, prevention, monitoring 
and information measures laid down in 
Articles 6, 7, 8 and 10 shall be applied. 3. Where the results of the assessment 
referred to in Article 4(1) reveal a risk to 
the safety and health of workers, the 
specific protection, prevention and 
monitoring measures laid down in 
Articles 6, 7 and 10 shall be applied. 
4. Where the results of the risk assessment 
referred to in Article 4(1) show that, 
because of the quantities of a hazardous 
chemical agent present in the workplace, 
there is only a slight risk to the safety and 
health of workers, and the measures taken 
in accordance with paragraphs 1 and 2 of 
this Article are sufficient to reduce that 
risk, the provisions of Articles 6, 7 and 10 
shall not apply. 
18 
Article 6 
Specific protection and prevention 
measures 
1. The employer shall ensure that the risk 
from a hazardous chemical agent to the 
safety and health of workers at work is 
eliminated or reduced to a minimum. 
2. In applying paragraph 1, substitution 
shall by preference be undertaken, whereby 
the employer shall avoid the use of a 
hazardous chemical agent by replacing it 
with a chemical agent or process which, 
under its condition of use, is not hazardous 
or is less hazardous to workers' safety and 
health, as the case may be 
Where the nature of the activity does not 
permit risk to be eliminated by substitution, 
having regard to the activity and risk 
assessment referred to in Article 4, the 
employer shall ensure that the risk is 
reduced to a minimum by application of 
protection and prevention measures, 
consistent with the assessment of the risk 
made pursuant to Article 4. These will 
include, in order of priority: 
(a) design of appropriate work processes 
and engineering controls and use of 
adequate equipment and materials, so 
as to avoid or minimize the release of 
hazardous chemical agents which may 
present a risk to workers' safety and 
health at the place of work; 
(b) application of collective protection 
measures at the source of the risk, such 
as adequate ventilation and appropriate 
organizational measures; 
(c) where exposure cannot be prevented 
by other means, application of 
individual protection measures 
including personal protective 
equipment. 
Practical guidelines for protection and 
prevention measures to control risk shall be 
developed in accordance with Article 12(2). 
3. The measures referred to in paragraph 2 
of this Article shall be accompanied by 
health surveillance in accordance with 
Article 10 if it is appropriate to the nature 
of the risk. 
4. Unless the employer clearly 
demonstrates by other means of evaluation 
that, in accordance with paragraph 2, 
adequate prevention and protection have 
been achieved, the employer shall carry out 
on a regular basis, and when any change 
occurs in the conditions which may affect 
workers' exposure to chemical agents, such 
measurements of chemical agents which 
may present a risk to workers' health at the 
workplace as are necessary, in particular in 
relation to the occupational exposure limit 
values. 
5. The employer shall take into account the 
results of the procedures referred to in 
paragraph 4 of this Article in carrying out 
the obligations laid down in or resulting as 
a consequence of Article 4. 
In any event, where an occupational 
exposure limit value ellectively established 
on the territory of a Member State has been 
exceeded, the employer shall immediately 
take steps, taking into account the nature of 
that limit, to remedy the situation by 
carrying out preventive and protective 
measures. 
20 
6. On the basis of the overall assessment of 
and general principles for the prevention of 
risks in Articles 4 and 5, the employer shall 
take technical and/or organizational 
measures appropriate to the nature of the 
operation, including storage and handling, 
providing protection of workers against 
hazards arising from the physico-chemical 
properties of chemical agents. In particular 
he shall take measures, in order of priority, 
to 6. On the basis of the overall assessment of 
and general principles for the prevention of 
risks in Articles 4 and 5, the employer shall 
take technical and/or organizational 
measures appropriate to the nature of the 
operation, including storage, handling and 
segregation of incompatible chemical 
agents, providing protection of workers 
against hazards arising from the physico-
chemical properties of chemical agents. In 
particular he shall take measures, in order 
of priority, to: 
(a) prevent the presence at the workplace 
of hazardous concentrations of 
inflammable substances or hazardous 
quantities of chemically unstable 
substances or, where the nature of the 
work does not allow that, 
(b) avoid the presence of ignition sources 
which could give rise to fires and 
explosions, or adverse conditions 
which could cause chemically unstable 
substances or mixtures of substances to 
give rise to harmful physical effects, 
and 
(c) mitigate the detrimental effects to the 
health and safety of workers in the 
event of fire or explosion due to the 
ignition of inflammable substances, or 
harmful physical effects arising from 
chemically unstable substances or 
mixtures of substances. 
Work equipment and protective systems 
provided by the employer for the protection 
of workers shall comply with the relevant 
Community provisions on design, 
manufacture and supply with respect to 
health and safety. Technical and/or 
organizational measures taken by the 
employer shall take account of and be 
consistent with the equipment group 
21 
categorization in Annex I to Directive 
94/9/EC of the European Parliament and of 
the Council of 23 March 1994 on the 
approximation of the laws of the Member 
States concerning equipment and protective 
systems intended for use in potentially 
explosive atmospheres (23). 
The employer shall take measures to 
provide sufficient control of plant, 
equipment and machinery or provision of 
explosion suppression equipment or 
explosion pressure relief arrangements. 
Article 7 
Arrangements to deal with accidents, 
incidents and emergencies 
I. Without prejudice to the obligations laid 
down in Article 8 of Directive 89/391/EEC, 
the employer shall, in order to protect the 
safety and health of workers from an 
accident, incident or emergency related to 
the presence of hazardous chemical agents 
at the workplace, establish procedures 
(action plans) which can be put into effect 
when any such event occurs, so that 
appropriate action is taken. These 
arrangements shall include any relevant 
safety drills which are to be performed at 
regular intervals, and the provision of 
appropriate first aid facilities. 
2. In the case of the occurrence of an event 
such as is mentioned in paragraph 1, the 
employer shall immediately take steps to 
mitigate the effects of the event and to 
inform the workers concerned thereof. 
In order to restore the situation to normal: 
- the employer shall implement 
appropriate measures to remedy the 
situation as soon as possible; 
)i No !, 100, 19.4. i 994, p. 1. 
22 
only those workers who are essential to 
the carrying out of repairs and other 
necessary work shall be permitted to 
work in the affected area. 
3. The workers who are permitted to work 
in the affected area shall be provided with 
appropriate protective clothing, personal 
protective equipment, specialized safety 
equipment and plant which they must use as 
long as the situation persists; that situation 
shall not be permanent. 
Unprotected persons shall not be permitted 
to remain in the aflectcd area 
4. Without prejudice to Article 8 of 
Directive 89/391/EEC the employer shall 
take the measures necessary to provide the 
warning and other communication systems 
required to signal an increased risk to safety 
and health, to enable an appropriate 
response and to launch remedial actions, 
assistance, escape and rescue operations 
immediately if the need arises. 
5. The employer shall ensure that 
information on emergency arrangements 
involving hazardous chemical agents is 
available. The relevant internal and 
external accident and emergency services 
shall have access to this information. It 
shall include the following: 
- advance notice of relevant work hazards, 
hazard identification arrangements, 
precautions and procedures, so that the 
emergency services can prepare their 
own response procedures and 
precautionary measures; and 
23 
any available information concerning 
specific hazards arising, or likely to 
arise, al the time of an accident or 
emergency, including information on 
procedures prepared pursuant to this 
Article. 
Article 8 
Information for workers 
3. Without prejudice to Article 30 of 
Directive 89/391/EEC the employer shall 
ensure thai workers and/or their 
representatives are provided with: 
- the data obtained pursuant to Article 4 
of this Directive, and further informed 
whenever a major alteration at the 
workplace leads to a change in these 
data; 
information on hazardous chemical 
agents, such as the identity of such 
agents, the risks to safety and health, 
relevant occupational exposure limit 
values and other legislative provisions; 
- information on appropriate precautions 
and actions to be taken in order to 
safeguard themselves and other workers 
at the workplace; 
access to any safely dala sheet provided 
by the supplier in accordance with 
Article 10 of Directive 88/379/EEC and 
Article 27 of Directive 92/32/EEC "',); 
And that the information is: Information and training for workers 
3. Without prejudice to Articles 10 and 12 
of Directive 89/391/EEC the employer 
shall ensure that workers and/or their 
representatives are provided with: 
information on the hazardous chemical 
agents in the workplace and hazardous 
chemical agents identified in the risk 
assessment made pursuant to Article 
4( 1 ) such as the identity of these agents, 
the risks to safety and health, relevant 
occupational exposure limit values and 
other legislative provisions; 
training and information on appropriate 
precautions and actions to be taken in 
order to safeguard themselves and other 
workers at the workplace; 
OJNoI, 154, 5.6.1992, p. 1. 
24 
provided in a manner appropriate to the 
outcome of the risk assessment pursuant 
to Article 4 of this Directive. This may 
vary from oral communication to 
individual instruction and training 
supported by information in writing, 
depending on the nature and degree of 
the risk revealed by the assessment 
required by the said Article; 
- updated to take account of changing 
circumstances. 
2. Where containers and pipes for 
hazardous chemical agents used at work are 
not marked in accordance with the relevant 
Community legislation on the labelling of 
chemical agents and on safety signs at the 
workplace, the employer shall, without 
prejudice to the derogations provided for in 
the above mentioned legislation, ensure that 
the contents of the containers and pipes, 
together with the nature of those contents 
and any associated hazards, are clearly 
identifiable. 
3. Member States may take measures 
necessary to ensure that employers may, 
preferably from the producer or supplier, 
obtain on request all information on 
hazardous chemical agents needed to apply 
Article 4(1) of this Directive, insofar as 
Directives 67/548/EEC and 88/379/EEC do 
not include any obligation to provide 
information. 
2.S 
SECTION m 
MISCELLANEOUS PROVISIONS 
Article 9 
Prohibitions 
1. To prevent the exposure of workers to 
health risks from certain chemical agents 
and/or certain activities involving chemical 
agents, the production, manufacture or use 
at work of the chemical agents and the 
activities set out in Annex III shall be 
prohibited to the extent specified therein. 
2. Member States may permit derogations 
from the requirements of paragraph 1 in the 
following circumstances: 
- for the sole purpose of scientific 
research and testing, including analysis; 
- for activities intended to eliminate 
chemical agents that are present in the 
form of by-products or waste products; 
for the production of the chemical 
agents referred to in paragraph 1 for use 
as intermediates, and for such use. 
The exposure of workers to chemical 
agents referred to in paragraph 1 must be 
prevented, in particular by providing that 
the production and earliest possible use of 
such chemical agents as intermediates must 
take place in a single closed system, from 
which the aforesaid chemical agents may be 
removed only to the extent necessary to 
monitor the process or service the system. 
Member States may provide for systems of 
individual authorizations. 
26 
3. When derogations are permitted 
pursuant to paragraph 2, the competent 
authority shall request the employer to 
submit the following information: 
- the reason for requesting the derogation; 
- the quantity of the chemical agent to be 
used annually; 
the activities and/or reactions or 
processes involved; 
- the number of workers liable to be 
involved; 
- the precautions envisaged to protect the 
safety and health of workers concerned; 
- the technical and organizational 
measures taken to prevent the exposure 
of workers. 
4. The Council, in accordance with the 
procedure laid down in Article 118a of the 
Treaty, may amend the list of prohibitions 
under paragraph I of this Article, to include 
further chemical agents or activities. 
27 
A Hide 10 
Health Surveillance 
I. Without prejudice to Article 14 of 
Directive 89/391 /EEC, Member States shall 
introduce arrangements for carrying out 
appropriate health surveillance of workers 
for whom the results of the assessment 
referred to in Article 4 of this Directive 
reveal a risk to health. These 
arrangements, including the requirements 
specified for health and exposure records 
and their availability, shall be introduced in 
accordance with national laws and/or 
practice 
Health surveillance, the results of which 
shall be taken into account in applying 
preventive measures in the specific 
workplace, shall be appropriate where: 
- the exposure of the worker to a 
hazardous chemical agent is such that an 
identifiable disease or adverse health 
effect may be related to the exposure; 
and 
- there is a likelihood that the disease or 
effect may occur under the particular 
conditions of the worker's work, and 
the technique of investigation is of low 
risk to workers. 
Furthermore, there shall be valid techniques 
for detecting indications of the disease or 
effect. Health surveillance procedures shall be 
agreed with the worker concerned. 
28 
Where a binding biological limit value has 
been set as indicated in Annex II, health 
surveillance shall be a compulsory 
requirement for work with the hazardous 
chemical agent in question, in accordance 
with the procedures in that Annex. 
Workers shall be informed of this 
requirement before being assigned to the 
task involving risk of exposure to the 
hazardous chemical agent indicated. 
2. Member States shall establish 
arrangements to ensure that for each 
worker who undergoes health surveillance 
in accordance with the requirements of 
paragraph I, individual health and exposure 
records are made and kept up-to-date. 
3. Health and exposure records shall 
contain a summary of the results of health 
surveillance carried out and of any 
monitoring data representative of the 
exposure of the individual. Biological 
monitoring and related requirements may 
form part of health surveillance. 
Health and exposure records shall be kept 
in a suitable form so as to permit 
consultation at a later date, taking into 
account any confidentiality. 
Copies of the appropriate records shall be 
supplied to the competent authority on 
request. The individual worker shall, at his 
request, have access to the health and 
exposure records relating to him personally. 
Where an undertaking ceases to trade, the 
health and exposure records shall be made 
available to the competent authority. 
4. Where, as a result of health surveillance. 
29 
a worker is found to have an identifiable 
disease or adverse health effect which is 
considered by a doctor or occupational 
health-care professional to be the result 
of exposure at work to a hazardous 
chemical agent; or 
a binding biological limit value is found 
to have been exceeded, 
the worker shall be informed of the result 
which relates to him personally, including 
information and advice regarding any health 
surveillance which he should undergo 
following the end of the exposure, and the worker shall be informed by the doctor 
or other suitably qualified person of the 
result which relates to him personally, 
including information and advice regarding 
any health surveillance which he should 
undergo following the end of the exposure, 
and 
the employer shall: 
- review the risk assessment made 
pursuant to Article 4( I ); 
review the measures provided to 
eliminate or reduce risks pursuant to 
Articles 5 and 6; 
take into account the advice of the 
occupational health-care professional or 
other suitably qualified person or the 
competent authority in implementing any 
measures required to eliminate or reduce 
risk in accordance with Article 6, 
including the possibility of assigning the 
worker to alternative work where there 
is no risk of further exposure, and 
30 
arrange continued health surveillance 
and provide for a review of the health 
status of any other worker who has been 
similarly exposed. In such cases the 
competent doctor or occupational 
health-care professional or the 
competent authority may propose that 
exposed persons undergo a medical 
examination 
Article 11 
Consultation and participation of 
workers 
Consultation and participation of workers 
and/or their representatives shall take place 
in accordance with Article 11 of Directive 
89/391/EEC on the matters covered by this 
Directive, including the Annexes hereto. Consultation and participation of workers 
and/or their representatives shall take place 
in accordance with Article 11 of Directive 
89/39l/EEC on the matters covered by this 
Directive, including the Annexes hereto. 
Workcrs and/or their representatives shall 
in particular_bje_consulted in relation to the 
outcome of the risk assessment ..referred to 
in Article 4(1) and the protection and 
prevention measures referred to in Articles 
5 and 6. 
Article 12 
Adaptation of the Annexes, preparation 
and adoption of technical guidance 
I. Adjustments of a strictly technical nature 
to the Annexes in line with: 
the adoption of Directives in the field of 
technical harmonization and 
standardisation concerning chemical 
agents, and/or 
technical progress, changes in 
international standards or specifications 
and new findings concerning chemical 
agents, 
31 
shall be adopted in accordance with the 
procedure laid down in Article 17 of 
Directive 89/391/EEC. 
2. The Commission shall draw up practical 
guidelines of a non-binding nature. These 
guidelines shall address the topics referred 
to in Articles 3, 4, 5 and 6, and Annex II, 
section I. 
The Commission shall first consult the 
Advisory Committee on Safely, Hygiene 
and Health Protection at Work in 
accordance with Decision 74/325/EEC. 
In the context of the application of this 
Directive, Member States shall take 
account as far as possible of these 
guidelines in drawing up their national 
policies for the protection of the health and 
safety of workers. 
Article 13 
Repeal and amendment of earlier 
Directives 
1. Directives 80/1107/EEC, 82/605/EEC 
and 88/364/EEC shall be repealed on the 
date referred to in Article 14(1). 
2. Council Directive 83/477/EEC of 19 
September 1983 on the protection of 
workers from the risks related to exposure 
to asbestos at work (second individual 
Directive within the meaning of Article X 
of Directive SO/I 107/EEC) ('S), is amended 
as follows: 
OJ No L 263, 24.9.1983, p. 25. Directive as amended by Directive 91/382/EEC (OJ No I, 206, 
29.7.1991, p. 16). 
32 
(a) in the first sentence of Article 1(1), the 
following words shall be deleted: 
"which is the second individual 
Directive within the meaning of 
Article X of Directive 80/1 107/EEC"; 
(b) Article 9(2) shall be replaced by the 
following: 
"2. The amendments necessary to 
adapt the Annexes to this Directive to 
technical progress shall be adopted in 
accordance with the procedure laid 
down in Article 17 of Council 
Directive 89/391/EEC of 12 June 1989 
on the introduction of measures to 
encourage improvements in the safety 
and health of workers at the 
workplace. 
(c) in the second subparagraph of 
Article 15(1) the words "in accordance 
with the procedure set out in Article 10 
of Directive 80/1 107/EEC" shall be 
replaced by "in accordance with the 
procedure laid down in Article 17 of 
Directive 89/39l/EEC". 
3. Council Directive 86/188/EEC of 
12 May 1986 on the protection of workers 
from the risks related to exposure to noise 
at work (2f,) is amended as follows: 
(a) in Article 1(1), the following words 
shall be deleted: "which is the third 
individual Directive within the 
meaning of Directive 80/1107/EEC"; 
(b) in Article 12(2), the second 
subparagraph shall be replaced by the 
following: 
(26) OJNoL 137, 24.5.1986, p. 28. 
33 
"Annexes I and II shall be adapted to 
technical progress in accordance with 
the procedure laid down in Article 17 
of Council Directive 89/391/EEC of 12 
June 1989 on the introduction of 
measures to encourage improvements 
in the safety and health of workers at 
the workplace. 
4. Any other reference in Directive 
83/477/EEC and Directive 86/188/EEC to 
Directive 80/1107/EEC shall be obsolete 
from the date of repeal of the said 
Directive 
5. Directives 91/322/EEC and 96/94/EC 
remain in force. 
SECTION IV 
Final provisions 
Article 14 
1. Member States shall bring into force the 
laws, regulations and administrative 
provisions necessary to comply with this 
Directive not later than [ ]( '. They 
shall forthwith inform the Commission 
thereof. 
When Member States adopt these 
measures, they shall contain a reference to 
this Directive or shall be accompanied by 
such reference on the occasion of their 
official publication. The methods for 
making such reference shall be laid down by 
Member States. 
2. Member States shall communicate to the 
Commission the texts of the provisions of 
national law which they have already 
adopted or which they adopt in the field 
governed by this Directive. 
Three years aller publication of this Directive in the Official Journal of the European Communities. 
34 
Article 15 
Member States shall report to the 
Commission every five years on the 
practical implementation of this Directive, 
indicating the views of employers and 
workers. 
The Commission shall inform the European 
Parliament, the Council and the Economic 
and Social Committee thereof. 
Article 16 
This Directive shall enter into force on the 
twentieth day following that of its 
publication in the Official Journal of the 
European Communities. 
Article 17 
This Directive is addressed to the Member 
States. 
Done a I 
For the Council 
The President 
35 
ANNEX 1 
List of binding occupational exposure limit values 
Name ol" 
agent 
Inorganic 
lead and its 
compounds KINKCS 
(')No CAS 
(2) No ()ccu pat i ona 1 exposu re 
limit value 8 h (') 
mg/m' 
0,15 pom 
O Occupational 
exposure limit value 
Short-term f/) 
mg/m* ppm 
(') EÎNECS: European Inventory of Existing Commercial Chemical Substances 
(2) CAS: Chemical Abstracts Service 
C) Measured or calculated in relation to a reference period of 8 hours, 
limc-wcightcd average 
C1) A limit value above which exposure should not occur, and which is related to 
a 15 minute period uniess otherwise specified 
C) jiig/ni"* = milligrams per cubic metre of air at 20° C and 101,3 KPa 
(6) ppm = parts per million by volume in air (ml/m3) 
36 
ANNEX H 
Binding biological limit values and health surveillance 
measures 
I. Lead and its ionic compounds 
1.1. Biological monitoring must include measuring the 
blood-lead level (PbB) using absorption 
spectrometry or a method giving equivalent 
results. The binding biological limit value is: 
70ugPb/100mlblood 
1.2. Medical surveillance is carried out if: 
exposure to a concentration of lead in air is 
greater than 0,075 mg/m3, calculated as a 
time-weighted average over 40 hours per 
week, or 
a blood-lead level greater than 
40 pg Pb/100 ml blood is measured in 
individual workers. 
1.3. Practical guidelines for biological monitoring and 
medical surveillance must be developed in 
accordance with Article 12(2). These must 
include recommendations of biological indicators 
(e.g. ALAU, ZPP, ALAD) and biological 
monitoring strategies. 
37 
ANNEX 111 
Prohibitions 
The production, manufacture or use at work of the 
chemical agents and activities involving chemical agents 
set out below are prohibited. The prohibition does not 
apply if the chemical agent is present in another chemical 
agent, or as a constituent of waste, provided that its 
individual concentration therein is less than the limit 
specified. 
(a) Chemical Agents 
EINECS (') No 
202-080-4 
201-177-1 
202-199-1 
202-204-7 CAS (2) No 
91-59-8 
92-67-1 
92-87-5 
92-93-3 Name of agent 
2-naphthylaminc 
and its salts 
4- aminodiphenyl 
and its salts 
Benzidine and its 
salts 
4-nitrodiphenyl Concentration 
Limit for 
exemption 
0,l%w/w 
0.1%w/w 
0,l%w/w 
0.1%w/w 
(') EINECS: European Inventory of Existing Commercial Chemical 
Substances 
(2) CAS: Chemical Abstracts Service 
(b) Work Activities 
None. 
28 
The Commission is unable to accept the following amendments proposed bv the 
European Parliament 
1. part of Amendment N° 5 (concerning Article 4.2) 
This part of the amendment requires employers to record the risk assessment in a 
suitable form taking into account national law and practice. This would certainly 
weaken the common position which requires the records to be made according to 
national law and practice, that is with full respect of the national law. 
2. Amendment N° 8 (concerning Article 6.5) 
The amendment requires the employers always to adhere to the occupational 
exposure limit value, irrespective of the nature of the national provision. The 
Commission considers that this amendment would undermine the distinction 
between indicative and binding limit value. 
3. Amendment N° 14 (concerning Article 12, 1, second indent) 
This amendment requires deletion of "new findings" among situations requiring 
technical adjustments of Annexes. The Commission believes that "new findings" 
are indeed one of the main reasons behind a need for technical changes. The 
procedure presented in the common position gives the Community the possibility 
to react rapidly with technical solutions to "new findings"; the use of this 
procedure is limited to strictly technical adjustments. 

3.1 
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COM(98) 162 final 
DOCUMENTS 
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ISBN 92-78-32043-9 
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