COMMISSION OF THE EUROPEAN COMMUNITIES 
C0MCÔ4) 230 final - SYN 459 
•Tiltttlt» 0«.0t.t9t4 
Amended proposal for a 
COUNCIL DIRECTIVE 
on the protection of the health and safety of workers 
from the risks related to chemical agents at work 
(presented by the Commission pursuant to Article 189 A (2) 
of the EC-Treaty) 
EXPLANATORY MEMORANDUM 
Amended proposal for a Council Directive 
on the protection of the health and safety of workers 
from the risks related to chemical agents at work 
Following receipt of the Opinion adopted by the European Parliament on the first reading on 
20 April 1994, the Commission submits to Council, pursuant to Article 189a(2) of the EC 
Treaty, an amended proposal for a Directive. 
There are two different types of proposed amendments: 
The first type of amendment adds precision to and makes useful clarification of the 
initial proposal; 
The second type of amendment is of a more general kind with the aim it strengthening 
the improvement of the health and safety of workers at work from risks related to 
chemical agents. 
The amended proposal of the Commission conserves the structure and objectives of the initial 
proposal but it clarifies and amplifies certain provisions. 
Of 38 amendments adopted by the European Parliament the Commission has not adopted 4 
in total and 1 in part 
The Commission has not accepted an enlargement of the scope to include the self-employed. 
The proposal is an individual Directive under the framework Directive 89/391/EEC where only 
workers and employers are covered. A lower biological limit value for lead for women 
workers was not accepted because it is justified only during pregnancy. The Directive 
concerning measures to protect pregnant workers already provides such protection. A 
graduation of the risk assessment depending on the undefined term "insignificant" was not 
accepted because Article 3 of the initial proposal already provides for proportionality between 
risk and control and prevention measures. 
The additional recital concerning the reference method retained from paragraphs B 3 and 4 
of Annex Ha of Directive 88/642/EEC is a consequence of the acceptance of the relevant 
amendments of the European Parliament. 
The addition of paragraph 8 of Article 8 is necessary in order to have consistency between 
biological limit values and limit values. The amendment of the European Parliament only 
contains the procedure to set biological limit values but not an obligation for Member States 
to implement such values. 
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
THE COUNCIL OF THE EUROPEAN 
COMMUNITIES 
Having regard to the Treaty 
establishing the European Economic 
Community, and in particular 
Article 118A thereof, 
Having regard to the proposal from 
the Commission, drawn up after 
consultation with the Advisory 
Committee on Safety, Hygiene and 
Health Protection at Work, 
In co-operation with the European 
Parliament), 
Having regard to the opinion of the 
Economic and Social Committee) 
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; 
Whereas, pursuant to that Article, 
such Directives must avoid imposing 
administrative, financial and legal 
constraints which would hold back 
the creation and development of 
small and medium-sized underta­
kings; 
Whereas the improvement of workers' 
safety, hygiene and health at work 
is an objective which should not be 
subordinated to purely economic 
cons iderat ions; 
Whereas the respect of minimum 
requirements on the protection of 
the health and safety of workers 
from the risks related to chemical 
agents ensures not only the pro­
tection 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 AMENDED TEXT 
THE COUNCIL OF THE EUROPEAN UNION 
Having regard to tho Treaty 
establishing th* European 
conmuhity, ana in particular 
Article USA thereof. 
-Page 1-ha^ 
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
competitiveness; 
Whereas a consistent level of 
protection from the risks related 
to chemical agents has to be estab­
lished 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 a work activity involving 
chemical agents is likely to expose 
workers to particularly high levels 
of risk; 
Whereas Council Directive 
80/1107/EEC of 22 November 1980 on 
the protection of workers from the 
risks related to exposure to 
chemical, physical and biological 
agents at work as last amended by 
Council Directive 88/642/EEC, 
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), and Council Directive 
88/364/EEC of 9 June 1988 on the 
protection of workers by the 
banning of certain agents and/or 
certain work activities (fourth 
individual Directive within the 
meaning of Article 8 of Directive 
80/1107/EEC) should, for the sake 
of consistency and clarity as well 
as for technical reasons, 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; 
Whereas this Directive is an individual Directive within the meaning of Article 16 of 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; 
Whereas, therefore the provisions of the said Directive, apply in full to workers exposed to chemical agents, without prejudice to more AMENDED TEXT 
Whereas a work activity involving 
chemical agents is likely to expose 
workers to risk; 
-Page 2-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
stringent and/or specific pro­
visions contained in this 
Directive; 
Whereas Council Directive 
67/548/EEC of 27 June 1967 on the 
approximation of the laws, regula­
tions and administrative provisions 
relating to the classification, 
packaging and labelling of danger­
ous substances, as last amended by 
Council Directive 92/32/EEC of 30 
April 1992, Council Directive of 26 
June 1978 on the approximation of 
the laws of the Member States 
relating to the classification, 
packaging and labelling of danger­
ous preparations (pesticides) and 
Council Directive 88/379/EEC of 7 
June 1988 on the approximation of 
the laws, regulations and admin­
istrative provisions of the Member 
States relating to the 
classification, packaging and 
labelling of dangerous prepara­
tions, as last amended by Council 
Directive 90/492/EEC, define and 
lay 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 
establishes a system for marking 
containers and pipes used for 
dangerous substances or 
preparations at work; 
Whereas Council Directive 
82/501/EEC of 24 July 1982, on the 
major-accident hazards of certain 
industrial activities has as its 
objective the limitation of the 
consequences of such accidents to 
man and the environment and to 
ensure high levels of protection 
against such accidents and their 
consequences throughout the 
Community; 
Whereas, in order to complete the 
information available to workers so 
as to ensure an improved level of 
protection, it is necessary that 
workers and their representatives 
be informed about the risks which 
chemical agents can pose for their AMENDED TEXT 
-Page 3-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
safety and health and about the 
measures necessary to reduce or 
eliminate those risks and that they 
should be in a position to check 
that the necessary protective 
measures are taken; 
Whereas employers must keep abreast 
of new developments in technology 
with a view to improving the 
protection of worker's safety and 
health, and assess on a regular 
basis the implications for the 
safety and health of workers; 
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 chemicals agents will none the 
less reduce these risks; 
Whereas Commission Directive 
91/322/EEC of 29 May 1991, 
establishes indicative limit values 
as provided for by Council 
Directive 80/1107/EEC on the 
protection of workers from the 
risks relating to chemical, 
physical and biological agents at 
work and whereas the former 
Directive should be maintained as 
part of the current framework; 
Whereas technical implementing 
measures for the application of 
this Directive should be entrusted 
to the Commission in close co­
operation with the Member States 
using the procedure provided in 
Article 13; AMENDED TEXT 
Whereas the requirements of 
Directive 88/642/EEC are repealed 
by the provisions of Article 14 of 
this Directive, and whereas the 
reference method in Annex lia of 
Directive 88/642/EEC and in 
particular paragraphs 3 and 4 
thereof, identifies a procedure for 
carrying out measurements of a 
concentration of a chemical agent 
in the air at the workplace the two 
above-mentioned paragraphs are to 
be retained in this Directive and 
whereas these methods shall be 
reviewed within 5 years taking 
account of modern standards for the 
general requirements for the 
performance of measuring procedures 
and devices for workplace 
measurements; 
-Page 4-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
Whereas this Directive is a 
practical contribution towards 
creating the social dimension of 
the internal market. 
HAS ADOPTED THIS DIRECTIVE : 
SECTION I 
GENERAL PROVISIONS 
Article 1 
Subject 
1. This Directive, which is the 
individual Directive within the 
meaning of Article 16 of 
Directive 89/391/EEC, lays down 
minimum requirements for the 
protection of workers against 
risks to their health and 
safety 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 to all chemical 
agents at work, without 
prejudice to other Community 
provisions under Directive 
82/501/EEC, as amended, on the 
major accident hazards of 
certain industrial activities 
and 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. 
For carcinogens at work the 
provisions of Directive 
90/394/EEC apply where these 
are more favourable to the 
safety and health of workers at 
work. 
4. The provisions of Directive 
89/391/EEC shall apply fully to AMENDED TEXT 
-Page 5-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
the whole area referred to in 
paragraph 1, without prejudice 
to more stringent and/or speci­
fic provisions contained in 
this Directive. 
5. The competent authorities shall 
regularly check if employers 
have taken the appropriate 
measures to protect the health 
and safety of workers at work 
and review the risk assessment 
pursuant to Article 3(2). 
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 by any work 
activity, whether or not pro­
duced intentionally and 
whether or not placed on the 
market; 
(b) "Activity involving chemical 
agents" means any work in 
which chemical agents are 
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. 
(c) "Occupational exposure level" 
means, unless otherwise 
specified , the concentration 
of a chemical agent at the 
workplace in the air within 
the breathing zone of a 
worker and includes "limit 
value" and " occupational 
guidance value"; 
(d) "Biological limit value" means 
the limit of concentration in 
the appropriate biological 
medium, of the relevant agent, 
its metabolite, or an 
indicator of effect; 
(e) "Hazard" means the intrinsic AMENDED TEXT 
(c) "Occupational exposure limit" 
means, unless otherwise 
specified in this Directive, 
the concentration of a 
chemical agent at the 
workplace in the air within 
the breathing zone of a worker 
and includes "limit value" and 
"occupational guidance value"; 
-Page 6-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
property of a chemical agent 
with the potential to cause 
harm; 
(f) "Risk" means the likelihood 
that the potential for harm 
will be attained under the 
conditions of use and/or 
exposure; 
(g) "Competent person" means any 
person who has the necessary 
knowledge, experience, 
practical ability and skills 
to perform the task in 
question; 
(h) "Waste" means any chemical 
agent remaining after a 
process, or any object or 
material contaminated by a 
chemical agent, which is 
intended for disposal; 
(i) "Health surveillance" means 
the assessment of an 
individual worker to determine 
the state of health of this 
individual. 
SECTION II 
PROVISIONS ADDRESSED TO EMPLOYERS 
Article 3 
General obligations 
1. To safeguard the safety and 
health of workers the employer 
shall take the necessary 
measures including the 
assignation of specific duties 
to a competent person to 
ensure that for activities 
involving chemical agents: 
a) workers can perform the 
work assigned to them 
without endangering their 
safety and health and/or 
those of other workers; 
b) the operation of 
workplaces when workers 
are present takes place 
under the responsibility 
of a person in charge; AMENDED TEXT 
ip safeguard .the safety :and 
health of workers the employer 
thai l talea tb« aeceaaary. ; 
prevent!?* measure» a«t ;oui la 
Article 0(11 and til) of: 
Directive 89/391/SEC to ensure 
that for activities involving 
çhemic&l.agents s 
-Page 7-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
c) work involving a special 
risk is entrusted only to 
competent staff and 
carried out in accordance 
with the instructions 
given; 
d) effective arrangements are 
made to deal with 
accidents and emergencies, 
including any relevant 
safety drills which are to 
be performed at regular 
intervals; 
e) all safety and health 
instructions are 
comprehensible to the 
workers concerned; 
f) appropriate first aid 
facilities are provided. 
The employer shall be in 
possession of an assessment of 
the risks concerning safety and 
health drawn up in a Document, 
hereinafter referred to as the 
"safety and health document", 
which shall be kept up-to-date. 
The safety and health document 
shall identify any risk at work 
and record in particular: 
- an assessment of the risks 
incurred by the workers in 
any activity involving 
chemical agents, and that 
a competent person has 
carried out this 
assessment; where a 
chemical agent has been 
subject to a specific 
evaluation concerning the 
risks for its users as 
part of a process of 
authorization for placing 
on the market, the risk 
assessment shall take into AMENDED TEXT 
c) work is entrusted only to 
competent staff and carried out 
in accordance with the 
instructions given; 
d) effective arrangements are 
made to deal with 
incidents,aceidents and 
emergencies, including any 
relevant safety drills 
which are to be performed 
at regular intervals; 
f) appropriate first aid 
facilities and appropria­
tely trained personnel are 
provided. 
The safety and health document 
shall identify any risk at work 
arising from the intrinsic 
properties of the agents, alone 
or in combination, the level of 
exposure and the circumstance 
of work involving chemical 
agents and record in 
particular: 
-Page 8-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
account the results of 
that evaluation; 
- that adequate measures 
will be taken to attain 
the aim of the Directive 
and in particular any 
precautionary measures to 
protect the health and 
safety of workers provided 
for in other Community 
legislation; 
- that the design, use and 
maintenance of the 
workplace and of the 
equipment involving 
chemical agents are safe; 
-that an up-to-date list 
has been made of the 
chemicals used, or 
intended to be used at 
work. 
The safety and health document 
must be drawn up prior to the 
commencement of work and shall 
be kept up-to-date in 
particular if there have been 
major changes which could 
render it out-of-date. 
The employer shall ensure that the workers are informed of the contents of the safety and health document whenever a major alteration at the workplace leads to a change in the document. 
The employer shall ensure that 
the risk from a chemical agent 
to the safety and health of 
workers at work is eliminated 
or reduced in particular by 
eliminating the risk at source 
or by seeking to achieve the 
maximum degree of reduction of 
risk by collective protection 
measures in particular cleaner 
technologies and the state of 
art and technology, in prefer­
ence to individual protection 
measures. AMENDED TEXT 
- which measures have been 
taken to attain the aim of 
this Directive. 
- that the work systems 
deployed the design and 
maintenance of the 
workplace and of the 
equipment involving 
chemical agents are safe; 
3. The employer shall ensure that 
the risk from a chemical agent 
to the safety and health of 
workers at work is eliminated 
or reduced in particular by 
eliminating the risk at source 
or by seeking to achieve the 
maximum degree of reduction of 
risk by collective protection 
measures in particular cleaner 
technologies and other 
organisational and technical 
measures as they become 
available, in preference to 
individual protection measures. 
-Page 9-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
4. For certain special activities 
within the undertaking or 
establishment, such as 
maintenance, in respect of 
which it is foreseeable that 
there is a potential for sig­
nificant exposure, or which may 
result in deleterious effects 
on safety and health for other 
reasons, even after all 
technical measures have been 
taken, the employer shall 
determine, after consultation 
of the workers or their 
representatives in the 
undertaking or establishment, 
the measures necessary to 
reduce the duration of workers' 
exposure to the minimum 
possible and to ensure 
protection of workers while 
they are engaged in such 
activities. 
The employer shall ensure that 
these activities take place 
only in areas that are clearly 
demarcated and indicated, or 
that persons not specifically 
authorised are prevented by 
other means from having access 
to such areas. 
The measures taken by the 
employer to meet the 
requirements of this Directive 
shall be consistent with the 
need to protect public health 
and the environment 
Article 4 
Specific protection and prevention 
measures 
The employer shall take measures 
appropriate to the nature of the 
risk : 
- to provide suitable and safe AMENDED TEXT 
The employer shall take measures 
appropriate to the nature of the 
risk in the workplace: 
to provide suitable protective 
equipment and facilities for 
use by workers; 
to provide training and safe working procedures; 
-Page 10-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
plant and process equipment; 
- to limit the quantity of a 
hazardous chemical agent at the 
workplace and to segregate 
incompatible chemical agents; 
to avoid, detect and combat the 
starting and spread of fires 
and explosions, and 
to prevent the occurrence of 
explosive and/or hazardous 
atmospheres. 
Article 5 
Communication, warning and alarm 
systems 
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 assistance, 
escape and rescue operations to be 
launched immediately if the need 
arises. 
Article 6 
Keeping workers informed 
1. Without prejudice to Article 10 
of Directive 89/391/EEC workers 
and/or their representatives 
shall be provided with: 
- information on chemical 
agents, as referred to in 
paragraph 9 of the Annex, 
in a comprehensible form 
and adapted to the needs 
of the individual worker; 
- information on appropriate 
Erecautions and actions to 
e taken in order to safe­
guard himself and other 
workers at the workplace; AMENDED TEXT 
to limit and confine the 
quantity of a hazardous 
chemical agent at the workplace 
to that essential to the nature 
of the process and to segregate 
incompatible chemical agents 
whose incompatibility presents 
a risk to health and safety; 
to avoid, detect and combat the 
starting and spread of fires 
and loss of containment, and 
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. 
information on appropriate 
precautions and actions to 
be taken in order to 
safeguard him/herself and 
other workers at the 
-Page 11-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
- written information where 
the assessment carried out 
pursuant to Article 3.2 
shows it to be necessary 
and which is kept up-to-
date. 
The employer shall ensure that 
containers used for chemical 
agents at work are provided 
with safety signs or are marked 
with the identity and the 
nature of the contents and 
their hazards. Where a safety 
data sheet has not been 
provided at the time of supply 
the employer shall obtain the 
relevant information from the 
supplier or other sources, and 
shall not use the chemical 
agent until such information 
has been obtained and made 
available to workers. 
SECTION III 
MISCELLANEOUS PROVISIONS 
Article 7 
Prohibitions 
The production, manufacture or 
use at work of chemical agents 
and work activities set out 
below are prohibited to the 
extent specified. 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. 
z.:nta No(') 
::2-080-4 
::z-i77-i CAS NoC) 
91-59-8 
92-67-1 
:::-199-! ! 92-87-5 
:::-204-7 92-93-3 Name of agent 
2-naphthylamine 
and its salts 
4-armnodi-
phenyl and iu 
salts 
Benzidine and 
iu salts Concentration 
limit (or 
exemption 
0,1 % w/w 
0,1 °/o w/w 
0,1 °/o w/w 
4-nitrodiphenvt 1 0,1 °/c w/w AMENDED TEXT 
workplace; 
written information where 
the assessment carried out 
pursuant to Article 3.2 
shows such information to 
be necessary and which is 
kept up-to-date. 
The employer shall ensure that 
containers used for chemical 
agents at work are provided 
with safety signs or are marked 
with the identity and the 
nature of the contents and 
their hazards or else are 
clearly identifiable with 
regard to their nature and 
hazards.Where a safety data 
sheet has not been provided at 
the time of supply the employer 
shall obtain the relevant 
information from the supplier 
or other sources, and shall not 
use the chemical agent until 
such information has been 
obtained and made available to 
workers. 
-Page 12-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
(1) EINECS : European Inventory of 
Existing Chemical Substances 
(2) CAS : Chemical Abstract Service 
2. An application from an employer 
Member States may grant 
specific derogations from the 
requirements of paragraph 1 in 
the following circumstances: 
for the sole purpose of 
scientific research and 
testing, including 
analysis; 
for work activities intended to eliminate the prohibited chemical agents; 
provided that the 
production or use is 
carried out in a closed 
system and that the 
chemical agent no longer 
remains at the end of the 
process. 
3. Amendments required with regard 
to the chemical agents and work 
activities already covered by 
this Article shall be 
determined and adopted, in 
accordance with the procedure 
referred to in Article 13. 
Article 8 
Occupational exposure levels AMENDED TEXT 
1. Occupational exposure levels 
shall be drawn up taking 
account of available informa­
tion, including scientific and 
technical data in accordance 
with the procedure referred to 
in Article 13. Occupational exposure limits and biological limit values 
1. Occupational exposure limits, 
drawn up at Community level 
after an evaluation of the 
latest available scientific 
data relevant to occupational 
health effects and on measuring 
aspects, shall be established 
or revised after consultation 
of the Advisory Committee on 
-Page 13-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
2. For any chemical agent for 
which a limit value is listed 
in the Anne (paragraph 10), 
Member States shall establish a 
corresponding occupational 
exposure level which shall not 
be exceeded. 
3. Occupational exposure levels 
established as indicative limit 
values by Directive 91/322/EEC 
shall be considered as 
occupational guidance values 
for the purpose of this 
Directive. 
4. Member States shall take into 
account occupational guidance 
values when setting 
occupational exposure levels on 
their own territories. AMENDED TEXT 
Safety, Hygiene and Health 
Protection at Work, in 
accordance with the procedure 
laid down in Article 13. For 
the purpose of this Directive 
these occupational exposure 
limits shall be referred to as 
"occupational guidance values". 
DELETED 
2. Occupational exposure limits 
established as indicative limit 
values by Directive 91/322/EEC 
shall be considered as 
occupational guidance values 
for the purpose of this 
Directive. 
3. Member States shall take into 
account occupational guidance 
values when setting national 
occupational exposure limits. 
They shall inform workers' and 
employers' organisations of 
occupational guidance values. 
In cooperation with these 
organisations Member States 
shall establish the time scale 
required to bring national 
occupational exposure limits 
into line with occupational 
guidance values. 
4. Occupational exposure limits, 
drawn up at Community level 
after an evaluation of the 
latest available scientific 
data relevant to occupational 
health effects and on measuring 
aspects and taking account of 
technical and feasibility 
factors whilst maintaining the 
aims of ensuring the health and 
safety of workers at work, 
shall be established or revised 
after consultation of the 
Advisory Committee on Safety, 
Hygiene and Health Protection 
at Work, in accordance with the 
procedure laid down in Article 
118A of the Treaty. For the 
purpose of this Directive, 
these occupational exposure 
limits shall be referred to as 
"limit values". 
-Page 14-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
5. When a Member State introduces 
or revises an occupational 
exposure level for a chemical 
agent, on the basis of new 
data, it shall inform the 
Commission and the other Member 
States thereof together with 
the relevant scientific and 
technical data. 
Article 9 
Health Surveillance 
Member States shall establish 
arrangements to ensure that workers 
receive health Surveillance 
appropriate to the safety and 
health risks they incur at work, in 
accordance with Article 14 of AMENDED TEXT 
5. For any chemical agent for 
which a limit value is 
established, Member States 
shall set up a corresponding 
national occupational exposure 
limit based on, but not 
exceeding, the Community 
minimum requirement. 
6. The Commission shall review 
each occupational guidance 
value within a period of 5 
years from the date of its 
adoption with à view either to 
proposing a limit value or to 
maintaining its status. 
7. Biological limit values shall 
take account of available 
information including 
scientific and technical data 
and shall be established after 
consultation of the Advisory 
Committee on Safety, Hygiene 
and Health Protection at Work, 
in accordance with the 
procedure laid down in Article 
118Â of the Treaty. 
8. For any chemical agent for 
which a biological limit value 
is established, Member States 
shall set up a corresponding 
national biological limit value 
based oh, but not exceeding, 
the Community minimum 
requirement. 
9. Where a Member State introduces 
or revises a national 
occupational exposure limit or 
a 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. 
-Page 15-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
Directive 89/391/EEC. 
Article 10 
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. In 
particular the employer shall make 
arrangements to facilitate the 
participation of workers and/or 
their representatives in appraising 
their workplace and in the 
establishment of the precautions to 
be adopted when it is found that an 
occupational exposure level or 
biological limit value is exceeded. 
Article 11 
Minimum requirements for health and 
safety 
1. A new activity involving 
chemical agents for the first 
time after the date on which 
this Directive is brought into 
effect as referred to in 
Article 15, must satisfy the 
minimum safety and health 
requirements laid down in the 
Annex. 
An activity involving chemical 
agents existing on the date on 
which this Directive is brought 
into effect as referred to in 
Article 15, must satisfy the 
minimum safety and health 
requirements laid down in the 
Anne as soon as possible and at 
the latest five years after 
that date. 
Article 12 
Adjustments to the Annex 
1. Technical adjustments to the AMENDED TEXT 
An existing activity involving 
chemical agents on the date on 
which this Directive is brought 
into effect as referred to in 
Article 15, must satisfy the 
minimum safety and health 
requirements laid down in the 
Anne as soon as possible and at 
the latest five years after 
that date. 
Adjustments to the Annex and 
practical implementation 
-Page 16-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
Anne in line with : 
- the adoption of Directives 
in the field of technical 
harmonisation and 
standardisation concerning 
chemical agents, 
and/or 
- technical progress, 
changes in international 
regulations or 
specifications and new 
findings concerning 
chemical agents, 
shall be adopted in accordance 
with the procedure laid down in 
Article 13. 
2. Detailed rules on technical 
guidance for the implementation 
of the provisions contained in 
this Directive shall be adopted 
in accordance with the 
procedure referred to in 
Article 13. 
Article 13 
Committee 
1. The Commission shall be assisted by the committee created in Article 17(1) of Directive 89/391/EEC. 
2. Where reference is made to the procedure laid down in this Article the matter shall be referred to the Committee by the chairman either on his own initiative or at the request of the representative of a Member State. 
The representative of the 
Commission shall submit to the AMENDED TEXT 
2. Detailed rules on technical 
guidance for practical aspects 
of the implementation of the 
provisions contained in this 
Directive shall be adopted, 
after consultation of the 
social partners, in accordance 
with the procedure referred to 
in Article 13. 
The provisions in point 12 of 
the Annex shall be reviewed in 
the light of technical progress 
within five years of adoption 
of this Directive. 
-Page 17-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
committee a draft of the 
measures to be taken. The 
committee shall deliver its 
opinion on the draft within a 
time limit which the chairman 
may lay down according to the 
urgency of the matter. The 
opinion shall be delivered by 
the majority laid down in 
Article 148(2) of the Treaty in 
the case of decisions which the 
Council is required to adopt on 
a proposal from the Commission. 
The votes of the repre­
sentatives of the Member States 
within the committee shall be 
weighted in the manner set out 
in that Article. The chairman 
shall not vote. 
The Commission shall adopt the 
measures envisaged if they are 
in accordance with the opinion 
of the committee. 
If the measures envisaged are 
not in accordance with the 
opinion of the committee, or if 
no opinion is delivered, the 
Commission shall, without 
delay, submit to the Council a 
proposal relating to the 
measures to be taken. The 
Council shall act by a 
qualified majority. 
If, on the expiry of three 
months from the date of the 
referral to the Council, the 
Council has not acted, the 
proposed measures shall be 
adopted by the Commission. 
Article 14 
Revocation 
The following Directives shall 
be repealed on the date this 
Directive comes into force : 
- Directive 80/1107/EEC, as 
amended by Directive 
88/642/EEC, on the protec­
tion of workers from the 
risks related to exposure 
to chemical, physical and 
biological agents at work; AMENDED TEXT 
-Page 18-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
Directive 82/605/EEC on 
the protection of workers 
from the risks related to 
exposure to metallic lead 
and its ionic compounds at 
work; 
Directive 88/364/EEC on 
the protection of workers 
by the banning of certain 
specified agents and/or 
certain work activities. 
2. The reference in : 
- Article 15(1) of Directive 
83/477/EEC and Article 
1(5) of Directive 
91/382/EEC amending 
Directive 83/477/EEC on 
the protection of workers 
from the risks related to 
exposure to asbestos at 
work; 
- Article 12(2) of Directive 
86/188/EEC on the 
protection of workers from 
the risks related to 
exposure to noise at work; 
to the procedure set out in 
Article 10 of Directive 
80/1107/EEC shall be construed 
as a reference to the procedure 
laid down in Article 13. 
3. Any other reference in 
- Directive 83/477/EEC, as 
amended by Directive 
91/382/EEC, on the protec­
tion of workers from the 
risks related to exposure 
to asbestos at work; 
Directive 86/188/EEC on the protection of workers from the risks related to exposure to noise at work; 
Directive 91/322/EEC on 
establishing indicative 
limit values by implement­
ing Council Directive AMENDED TEXT 
-Page 19-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
80/1107/EEC on the 
protection of workers from 
the risks related to expo­
sure to chemical, physical 
and biological agents at 
work; 
to Directive 80/1107/EEC, as 
amended by Directive 
88/642/EEC, is obsolete. 
Article 15 
Final provisions 
Member States shall bring into 
force the laws, regulations and 
administrative provisions 
necessary to comply with this 
Directive not later than 30th 
June 1996. They shall forth­
with inform the Commission 
thereof. 
2. When Member States adopt the 
provisions referred to in 
paragraph 1, these shall con­
tain 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 adopted 
by Member States. 
3. The 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. 
4. 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. AMENDED TEXT 
-Page 20-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
Article 16 
This Directive is addressed to the 
Member States. 
ANNEX 
Minimum Safety and Health 
Requirements as referred to in 
Article 11 of the Directive 
1. Preliminary note : 
The obligations laid down in 
this Annex apply whenever 
required by the features of 
the workplace, the activity, 
the circumstances or a 
specific risk. 
2. Supervisory obligations 
2.1 Person in charge 
A responsible and competent 
person who has been appointed 
by the employer in accordance 
with the national laws and/or 
practices must at all times 
be in charge of every 
workplace where chemical 
agents and workers are 
present. 
The employer may personally 
assume responsibility for the 
workplace referred to in the 
first paragraph, if he has 
the skills and competence 
required for the purpose in 
accordance with national laws 
and/or practices. 
2.2 Supervision 
To ensure workers' health and 
safety protection during all 
operations undertaken, the 
necessary supervision must be 
provided by competent persons 
having the necessary knowl­
edge, experience and skills 
for the purpose, in accord-AMENDED TEXT 
-Page 21-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
ance with national laws 
and/or practices, having been 
appointed by the employer and 
acting on his behalf. 
The employer may personally 
undertake the supervision 
referred to in the first 
paragraph if he has the 
skills and competence 
required for the purpose, in 
accordance with national laws 
and/or practices. 
3. Protective measures 
3.1 Measures must be taken for 
assessing the presence of 
harmful and/or potentially 
explosive substances in the 
atmosphere and for measuring 
the concentration of such 
substances. 
Where required by the safety 
and health document 
monitoring devices measuring 
gas concentrations at 
specified places automati­
cally and continuously, auto­
matic alarms and devices to 
cut off power automatically 
from electrical installations 
and internal combustion 
engines must be provided. 
Where automatic measurements 
are provided for, the values 
measured must be recorded and 
kept as stipulated in the 
health and safety document. 
3.2 The employer shall ensure 
that any chemical agent which 
meets the requirements to be 
classified, according to the 
criteria in Annex VI of 
Directive 67/548/EEC, as a 
category 1 or 2 carcinogen, 
mutagen or chemical agent 
toxic to reproduction, is as 
far as is technically 
possible, eliminated or 
replaced by a chemical agent 
or process which under its 
conditions of use is not 
dangerous, or is less 
dangerous, to workers' health 
and safety, as the case may AMENDED TEXT 
3.1 Measures must be taken for 
assessing the presence of 
harmful and/or potentially 
explosive substances in the 
atmosphere and for measuring 
and recording the concentra­
tion of such substances. 
Where required by the safety 
and health document 
appropriate monitoring and 
safety devices capable when 
necessary of shutting down 
production must be provided. 
-Page 22-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
be. Where it is not 
technically possible to 
replace the chemical agent by 
an agent or a process which 
is not dangerous or is less 
dangerous to workers' health 
and safety the employer shall 
reduce risk, giving prefer­
ence to the manufacture and 
use of the chemical agent in 
a closed system. 
3.3 The employer shall ensure 
that exposure of workers to < 
chemical agent at work does 
not exceed the limit value 
set for that chemical agent 
using the procedure referred 
to in Article 8. 
3.4 In cases where exposure 
occurs simultaneously to more 
than one chemical agent for 
which limit values have been 
set, the effects of exposure 
shall be considered as 
additive, unless a more 
precise evaluation of their 
combined effect is known. 
3.5 The employer shall carry out 
such periodic measurements of 
chemical agents at the 
workplace as are necessary in 
particular in relation to 
limit values, unless by other 
means the employer clearly 
demonstrates that adequate 
protection has been achieved. 
Any measurements shall be 
made by a competent person, 
using a valid technique. 
3.6 The measurements shall be 
carried out in such a way as 
to ensure that the result is 
representative of the 
exposure of the worker to the 
agent or agents in question. 
4. Protection from abnormal 
risks 
4.1 In order to protect the 
health and safety of workers 
from an incident, accident or 
emergency which is likely to 
result in abnormal conditions AMENDED TEXT 
3.4 In cases where exposure 
occurs simultaneously to more 
than one chemical agent for 
which occupational exposure 
limits have been set, the 
effects of exposure shall be 
considered as additive, 
unless a more precise 
evaluation of their combined 
effect is known. 
-Page 23-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
detrimental to the health and 
safety of workers, the 
employer shall establish 
procedures (action plans) 
which can be put into effect 
when any such event occurs, 
so that appropriate action is 
taken. 
4.2 In case of the occurrence of 
such an event the employer 
shall immediately inform the 
workers thereof. Until the 
situation has been restored 
to normal and the cause of 
the abnormal conditions have 
been eliminated: 
the employer shall identify 
the cause without delay and 
implement appropriate 
measures to remedy the 
situation as soon as 
possible; 
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. 
4.3 The workers who are permitted 
to work in the affected area 
shall be provided with 
appropriate protective 
clothing, personal protective 
equipment, specialised safety 
equipment and plant which 
they must use so long as the 
situation persists; that 
situation shall not be 
permanent. Unprotected per­
sons shall not be allowed to 
remain in the affected area. 
! 4.4.1 Where harmful substances 
accumulate or may 
accumulate in the atmos­
phere appropriate measures 
must be taken to ensure 
their collection at source 
and removal. 
Without prejudice to 
provisions for the 
protection of public health 
and the environment the 
system must be capable of AMENDED TEXT 
-Page 24-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
dispersing such hazardous 
atmospheres in such a way 
that workers are not at 
risk. 
4.4.2 Without prejudice to 
Directive 89/656/EEC, an 
appropriate and sufficient 
breathing and resuscitation 
equipment must be available 
in areas where workers may 
be exposed to atmospheres 
which are harmful to 
health. 
In such cases, a sufficient 
number of workers trained 
to use such equipment must 
be present at the 
workplace. 
The equipment must be 
suitably stored and 
maintained. 
4.4.3 Where toxic gases are or 
may be present in the 
atmosphere, a protection 
plan detailing the 
protective equipment 
available and the 
preventive measures taken 
must be kept and made 
available to the competent 
authorities. 
4.5 The employer shall ensure 
that information on emergency 
arrangements involving 
chemical agents is made 
available on request to the 
relevant internal and 
external accident and 
emergency services. It shall 
include the following: 
advance notice of relevant 
work hazards, hazard 
identification arrange­
ments, precautions, and 
procedures so that the 
emergency services can 
prepare their own response 
procedures and 
precautionary measures; and 
- any available information AMENDED TEXT 
4.4.3 Where toxic chemical agents 
are or may be present in 
the atmosphere and the risk 
assessment indicates it to 
be necessary a protection 
plan detailing the 
protective equipment 
available and the 
preventive measures taken 
must be kept and made 
available to the competent 
authorities. 
-Page 25-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
concerning specific hazards 
arising, or likely to 
arise, at the time of an 
accident or emergency, 
including information on 
procedures prepared 
pursuant to paragraph 4.1 
above. 
5. Derogation information 
5.1 When making an application 
for a derogation from a 
prohibition or restriction 
pursuant to Article 7(2), an 
employer shall submit the 
following information to the 
competent authority : 
the quantities to be used 
annually; 
the activities or reactions 
or processes to be carried 
out; 
the number of workers 
liable to be exposed; 
the precautions envisaged 
to protect the health and 
safety of workers con­
cerned. 
the technical and 
organisational measures to 
be taken to prevent the 
exposure of workers. 
6. Safety equipment maintenance 
Adequate safety equipment 
must be maintained ready for 
use and in good working order 
at all times. 
Maintenance must be 
undertaken with due regard to 
operations. AMENDED TEXT 
the reason for requesting 
the derogation. 
Staff required to use safety 
-Page 26-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
7. Special health surveillance 
measures 
The employer shall ensure 
that any worker exposed to 
a chemical known to cause 
sensitisation; 
the following chemical 
agents: 
Arsenic and its compounds; 
Beryllium; 
Cadmium and its compounds; 
Carbon disulphide; 
Chromâtes (Cr6+); 
Cobalt; 
Lead and its compounds; 
Mercury and its compounds; 
Organophosphoric esters; 
Tetrachloroethane; 
shall, if he so wishes, 
undergo health surveillance. 
Where biological monitoring 
is carried out it shall form 
part of health surveillance. 
Where indicated by the nature 
of the risk, biological moni­
toring shall be used to 
reveal pre-clinical effects 
on the health status of 
workers in order to permit 
intervention to prevent 
clinical deterioration. The 
result of biological 
monitoring shall not be used 
to discriminate against the 
worker. 
Biological limit values and 
related requirements are to 
be observed as part of health 
surveillance. AMENDED TEXT 
equipment must be trained and 
drilled in its use. 
Where the assessment carried 
out pursuant to Article 3.2. 
indicates a serious risk for 
the worker health 
surveillance shall be 
mandatory. Workers shall be 
informed of this requirement 
before being assigned to the 
task involving such a risk. 
-Page 27-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
Where, as a result of health 
surveillance, a worker is 
found to be suffering from an 
abnormality which is 
considered to be the result 
of exposure to a chemical 
agent, the employer shall: 
review the safety and 
health document, prepared 
pursuant to Article 3; 
take into account the 
advice of the doctor or 
medical authority and 
implement specific measures 
to eliminate or reduce 
exposure, including the 
possibility of assigning 
the worker to alternative 
work with a lesser risk of 
exposure; 
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 medical 
authority may propose that 
exposed persons undergo a 
medical examination. 
The doctor or medical 
authority shall inform the 
worker of the results of 
health surveillance which 
relate to him personally, 
including information and 
advice regarding any health 
surveillance which the worker 
should undergo following the 
end of exposure. 
8. Record keeping 
8.1 The employer shall ensure 
that the safety and health 
document prepared pursuant to 
Article 3 contains sufficient 
detail about the information 
on which it is based and the 
risk assessment methods used 
for the competent authority 
to evaluate the assessment 
and the measures taken to 
eliminate or reduce any risk. AMENDED TEXT 
-Page 28-
Proposal of tho Ootamiecion 
(OJTC 165 of 16.6.93) \ 
PREVIOUS TEXT. 
.ï The safety and health document 
chall bo kept for at loact E 
ears flow the «idle or* which it 
s made or revised ana shall ne 
marta avfi i 1 «hi « to wnrlmra or 
their represcntatiTCo and to 
Lhe vuupeLeuL authority uu 
recru est. 
8.2 Member states shall establish 
arrangements to ensure .that. 
for each worker who-undergoes 
health surveillance in, 
accordance with the 
requirement» of Article 9 an 
individual health record is 
made and.kept up-to-date. 
The health record shall .con- . 
tain a summary of the results • of health surveillance 
carried o.ufc and of any . 
monitoring data 
representative of the 
exposure of the individual. 
It shall be kept,, taking into 
account medical confidential­
ity/ in accordance with 
national laws and' practice. 
The health records shall be 
retained for at least.40 years 
from the date of the last 
entry. A copy shall be-' 
supplied to the competent ' 
medical authority on request. 
In accordance with national . 
laws and practice the individ­
ual worker shall, at his 
request, have access to the 
health record relating to him personally. 
in the' ease where an 
undertaking coaees to trade, 
the health records shall be 
made available to the competent 
authority, in accordance with 
national laws and practice. 
9. Information on chemical agents 
9.1 The information on chemical 
agents to bo provided to the 
worker shall vnelude.the 
following : 
DG V/F AMENDED TEXT 
.6.2 Member '. 3tates shall establish. 
arrangements to ensure that 
for each worker who undergoes, 
health surveillance in:: 
accordance with the 
requirements of Article 9 an 
individual;health and 
exposure record is made jnd 
kept up to date. The ;hcalth 
and exposure record shall. 
contain a summary of the 
recuite of.health ' 
surveillance, carried but: and 
of any monitoring data: 
• -representative or the •'. 
exposure of the individual. 
It shall be kept, taking:into 
. ..account medical confidential­
ity, in accordance with :-
national laws and practice 
The health and exposure 
records shall be retained for 
at least 40 years from the date 
bt the last entry. A copy; 
shall be supplied to the 
competent medical authority on 
request. In accordance with . national- lavs and practice'th<? 
individual worker shall,:at his 
request, have access to the 
health and exposure record: 
relating to him personally. 
In the case where an 
undertaking ceases to •'rid©, 
the health.and exposure records 
Shall be made available to: the 
competent authority, in r 
accordance with national: lavs 
and practice. 
lit. 
n 
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
the identity of the agent 
or agents to which exposure 
may occur; 
risks to health and safety 
arising from the work 
activity or process or 
arising from possible 
exposure at the workplace; 
the precautions which the 
employer has undertaken in 
order to reduce risks, 
including information on 
containment facilities, 
safe storage and handling, 
transport and waste 
disposal within the 
enterprise; 
the precautions which the 
worker must take in order 
to reduce exposure, 
including use of personal 
protective equipment; 
relevant occupational 
exposure levels; 
the consequence of any 
foreseeable abnormal 
situation including over­
exposure and action to be 
taken; 
- prepared action plans; 
- first aid measures; 
- fire fighting methods; 
action taken, or to be 
taken, in the case of a 
spillage or an incident, 
accident or emergency 
involving a chemical agent; 
any restrictions on use of 
agents or limitation of 
access to designated areas, 
including indications on 
how such areas may be 
recognised; 
up-to-date information 
giving the results of 
measurements of exposure. AMENDED TEXT 
-Page 30-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
9.2 The employer shall ensure 
'that containers and pipes for 
chemical agents at work are : 
in the case of chemical 
agents covered by the 
definition of dangerous 
substances or preparations 
in accordance with 
Directives 67/548/EEC and 
88/379/EEC as amended, 
provided with safety signs 
in accordance with Direc­
tive 92/58/EEC. 
Information shall also be 
frovided either by 
abelling on the container, 
or by other suitable means, 
on the contents and their 
hazards, the identity, and 
the risk and safety phrases 
in accordance with the 
criteria laid down in Annex 
VI of Directive 67/548/EEC 
and in Directive 
88/379/EEC; 
in the case of other 
chemical agents, marked or 
otherwise provided with an 
indication of the nature of 
the contents. 
9.3 The employer shall ensure 
that containers used for 
chemical agents which are 
labelled at the time of 
supply to the employer shall 
retain the label at the 
workplace while any hazard 
from the chemical agent 
remains. 
9.4 The employer shall make available to workers, or workers' representatives, on request, any safety data sheet provided by the supplier in accordance with AMENDED TEXT 
Where a chemical agent is 
sufficiently identifiable at 
the workplace under its 
generic or proprietary name, 
the use of this latter name 
shall be allowed. 
Smaller containers containing chemical agents transferred from a bulk supply also bear the necessary labels. 
-Page 31-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
Article 10 of Directive 
88/379/EEC and Article 27 of 
Directive 92/32/EEC or, where 
these Directives do not 
aPPly# with a data sheet of 
similar format and content 
containing relevant data. 
9.5 The competent authority shall 
ensure that employers may 
obtain information on 
chemical agents in order to 
protect the safety and health 
of workers at work. 
10. Limit Values and Biological 
Limit Values 
10.1 Limit Values (3) for 
occupational exposure 
. Metulic m ud i 
(1) 
(2) 
(3) EINECS: European Inventory of 
Existing Chemical Substances. 
CAS: Chemical Abstract 
Service Number. 
Measured or calculated in 
relation to a reference 
period of eight hours unless 
otherwise stated. 
(4) mg/m3 milligrams per cubic 
metre 
(5) ppm parts per million by 
volume in air (ml/m3) 
(6) at 20 C and 101,3 KPa (760 mm 
Mercury pressure) 
10.2 Biological Limit Values 
a) Lead 
Biological monitoring 
shall, apart from the 
exception mentioned in 
point 11 b), include 
measuring the blood-lead 
level (PbB); the biological 
limit value is: 
70 Mg Pb/100 ml blood AMENDED TEXT 
-Page 32-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
The method to be used for 
the analysis is atomic 
absorption spectroscopy. 
11. Special Measures for Lead 
a) The biological monitoring 
may also include one or more 
of the following biological 
indicators: 
delta aminolaevulinic acid 
in urine (ALAU); 
zinc protoporphyrin (ZPP); 
delta aminolaevulinic acid 
dehydratase in blood (ALAD). 
The related methods to be used 
for the analysis of samples 
are: 
ALAU: Davis or equivalent 
method 
ZPP: Haematofluorimetry or 
equivalent method 
ALAD: European standardised 
method or equivalent method 
b) The lead in blood (PbB) 
measurement may be replaced 
by that of ALAU when dealing 
with workers who have been 
subjected for a period of 
less than one month to risks 
of high exposure. In this 
case the following limit 
values shall be applied for 
ALAU: 
20 mg/g creatinine 
c) Biological monitoring shall 
be carried out at least 
every six months; this fre­
quency may be reduced to 
once a year where at the 
same time: 
- the results of the 
measurements for indivi­
duals or for groups of 
workers have shown, on 
the previous two con­
secutive occasions on 
which monitoring was 
carried out, a lead-in-
air concentration higher AMENDED TEXT 
-Page 33-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT 
than 0,075 mg/m3 and 
lower than 0,1 mg/m3. 
the PbB level of any 
individual worker does 
not exceed 50 ug Pb/100 
ml blood. AMENDED TEXT 
12. Requirements for measuring 
procedures 
(a) The measuring procedure 
must give results 
representative of 
worker exposure. 
(b) To ascertain the 
exposure of the worker 
at the workplace, where 
possible personal 
sampling devices should 
be used, attached to 
workers' bodies. 
Where a group of 
workers is performing 
identical or similar 
tasks at the same place 
and has similar 
exposure, sampling such 
as to be representative 
of the group may be 
carried out within that 
group. 
Fixed-point measuring 
systems may be used if 
the results make it 
possible to assess 
exposure of the worker 
at the workplace. 
Samples should as far 
as possible be taken at 
breathing height and in 
the immediate vicinity 
of workers. 
If in doubt, the point 
of greatest risk is to 
be taken as the 
measuring point. 
(c) The measuring procedure 
used must be 
appropriate to the 
agent to be measured, 
its limit value and the 
workplace atmosphere. 
The result must show 
the concentration of 
the agent exactly and 
in the same terms as 
the limit value. 
-Page 34-
Proposal of the Commission 
(OJ C 16S of 16.6.93) 
PREVIOUS TEXT AMENDED TEXT 
(d) If the measuring 
procedure is not 
specific to the agent 
to be measured, the 
full value recorded 
must be counted as 
applying to the agent 
to be measured. 
(e) The limits of 
detection, sensitivity 
and precision of the 
measuring procedure 
must be appropriate to 
the limit value. 
(f) The accuracy of the 
measuring procedure 
should be ensured. 
(g) The measuring procedure 
must have been tested 
under practical 
conditions of use. 
(h) If the European 
Committee for 
Standardization (CEN) 
publishes general 
requirements for the 
performance of 
measuring procedures 
and devices for 
workplace measurements 
together with 
provisions on testing, 
they should be referred 
to when selecting 
appropriate measuring 
procedures. 
Measurement specifications 
for detecting representative 
particle populations in the 
air at the workplace 
(a) Suspended matter 
concentration should be 
measured in relation to 
effect; therefore, when 
sampling, either the 
inspirable fraction or 
the respirable fraction 
should be measured. 
This requires particle 
separation according td 
aerodynamic diameter 
equivalent to the 
deposition occurring in 
breathing. 
Since, appropriate 
equipment for workplace 
sampling is not yet 
available, practical 
specifications for 
uniform measurement are 
needed. 
-Page 35-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT AMENDED TEXT 
(b) The fraction of 
suspended matter which 
can be breathed in by a 
worker through the 
mouth and/or the nose 
is deemed to be 
inspirable. 
By way of example, in 
measurement practice, 
devices with an 
inspiration rate of 
1,25 m/s +/- 10% or 
devices in conformity 
with ISO/TR 7708 1983 
(=e) are used for 
sampling. 
In the first of these 
two cases, cited by way 
of example: 
- with sampling devices 
attached to the 
person, the inlet 
should be directed 
parallel to the 
worker's face 
throughout sampling, 
- with fixed-point 
sampling, the 
position and shape of 
the inlet should 
enable samples 
representative of 
workers' exposure 
covering various 
directions of flow to 
be taken, 
- The position of the 
sampling device inlet 
is of little signi­
ficance where there 
are very low flow 
rates for the 
surrounding air, 
- with surrounding flow rates of lm/s and above, omnidirectio­nal sampling in the horizontal plane is recommended, 
(c) The respirable fraction of suspended matter comprises a population passed through a sepa­ration system equiva­lent in its effect to the theoretical separa­tion function of a sedimentation separa­tor giving 50% separa­tion of particles with 
-Page 36-
Proposal of the Commission 
(OJ C 165 of 16.6.93) 
PREVIOUS TEXT AMENDED TEXT 
an aerodynamic diameter 
of 5um (Johannesburg 
Convent ion, 1979). 
(d) If the CEN establishes 
specifications for the 
collection of suspended 
material at the work­
place, they should be 
applied, by way of 
preference. 
Other methods may be 
used provided that they 
yield the same conclu­
sions or a stricter 
conclusion in relation 
to compliance with the 
limit values'. 
-Page 37-
KSN 0254-1475 
COM(94) 230 final 
DOCUMENTS 
EN 04 
Catalogue number : CB-CO-94-243-EN-C 
ISBN 92-77-69576-5 
Office for Officiai Publications of the European Communities 
L-2985 Luxembourg