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S71, ~~* COMMISSION OF THE EUROPEAN COMMUNITIES 
C0M(93) 155 final - SYN 459 
Brussels, 14 May 1993 
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) 
&+«*™r^^ 
EXPLANATORY MEMORANDUM 
Legal base 
1. This proposal is based on Article 118A of the EEC Treaty and is presented 
in the form of an individual Directive under Article 16 of Council Directive 
89/391/EEC "on the introduction of measures to encourage improvements in the 
health and safety at work" 0). 
Justification for this proposal 
a) Reason for Community action 
2. Exposure to chemical agents occurs in every aspect of daily life. Over 
100,000 chemicals are included in the European Inventory of Existing Chemical 
Substances (EINECS). Many of these chemicals have dangerous properties which 
can adversely affect the health and safety of workers at work. It has been estimated 
that accidents and ill health at work account for approximately 7% of all social 
security expenditure within the EC, affecting 10 million workers every year at an 
overall cost of 20 billion ECU. It is clear from information in Member States that a 
significant proportion of the ill-health that is caused by work activities is due to 
(0 O J. N' L183 of 29.06.1989, p. 1 
exposure to chemical agents. It is therefore important that suitable precautions 
should be taken at the workplace to prevent these problems. 
3. In Member States the legal provisions concerning protection of workers 
against the risks related to chemical agents are divergent. In some cases they are 
rudimentary and in others they are comprehensive; some are more stringent than the 
present proposal which is designed to ensure that all Member States come up to at 
least the minimum level considered necessary. In line with Article 118A of the 
EEC Treaty the proposal is couched in general terms with general principles 
covering all chemical agents. This is because it is the most cost-effective way of 
providing a general framework, which will avoid the need for specific Community 
provisions for many individual chemicals on a case-by-case basis. 
b) Subsidiarity. 
4. The proposal does not breach the principle of subsidiarity, because it is only 
by Community action that a minimum level of protection for workers from the risks 
related to exposure to chemical agents can be assured in all Member States. Such 
action will also avoid any distortion in the area of competitiveness by preventing the 
unequal application of minimum standards for worker protection in one or other 
Member States. 
5. Moreover this proposal will encourage more flexibility in cross border 
employment because workers can be reassured that they will find at least the 
minimum level of protection of their health and safety in all Member States. 
Employers will also be reassured that the costs of production will not be unduely 
distorted as a result of differences in the levels of protection of health and safety at 
work. 
6. The current proposal responds to the above needs. It is also one of the 
actions aimed at achieving the social dimension of the internal market. The text 
includes measures relating to information on dangerous chemical agents as 
specifically referred to in the programme on the Community Charter of Basic Social 
Rights for workers. Information is one of the pillars on which effective health and 
safety practices are built; it forms an integral part of this text and aligns 
requirements for the labelling of containers for chemicals at work with the existing 
labelling requirements that apply for the purpose of placing chemical agents on the 
market. 
7. The objectives outlined above involve a number of different areas of 
Community policy. It is unlikely that they can be achieved by Member States 
acting individually therefore it is necessary that a co-ordinated action is taken at 
Community level. 
c) Proportionality 
8. Community provisions have to be framed in such a way that they meet the 
requirements for acceptable minimum standards of health and safety without 
imposing an undue burden on employers; in particular they must avoid constraints 
which would hold back the creation and development of small and medium-sized 
enterprises. The present proposal is believed to achieve those two requirements. 
9. In the first place the proposal is an amplification of the requirements of the 
Framework Directive 89/391/EEC on the introduction of measures to encourage 
improvements in the safety and health of workers at work rather than a set of new 
and unrelated measures. Requirements on employers under this proposal are 
therefore based on an assessment of risks made by the employer in accordance with 
Article 6 (3) of Directive 89/391/EEC. The measures to be taken are therefore in 
proportion to the risks incurred from the chemical agents being used at work. In 
the same sense that the text is an amplification of Directive 89/391/EEC the more 
specific requirements of this text in fact render the framework of Directive 
89/391/EEC less onerous, by the provision of guidance on its application. 
10. The proposal as it stands covers all chemical agents without prejudging 
whether or not they are hazardous. This is important because even chemical agents 
that are nominally harmless may interact with others to create or enhance a risk. 
Chemical agents not normally considered hazardous in daily life may also be 
hazardous when used in larger quantities at the workplace. For example sand is not 
hazardous unless it is ground to a fine powder when it can cause lung disease such 
as has occured in foundries and potteries. Also hazardous interaction may occur 
involving chemicals that are nominally harmless on their own. For example water 
may react violently with other chemicals such as strong acids or metals; it is only 
when the combination of the water and the other chemical occurs together that a risk 
exists. 
Therefore it is only by taking into account the combined action of all chemical 
agents that a proper assessment can be made and the correct measures taken to 
protect workers. 
If it can be shown that for any particular chemical there are no foreseeable risks 
from the chemical or its interaction then no further action is required once the 
assessment has been completed. 
11. In amplifying the requirements of Directive 89/391/EEC care has been taken 
to cast the proposals in terms of objectives to be achieved, rather than as detailed 
and prescriptive requirements. The employer is given maximum flexibility in 
deciding how best to achieve the objectives for any of the 100,000 or more 
industrial chemical agents that may be relevant in his particular circumstances. It is 
only in cases of particularly dangerous chemical agents e.g. for materials that may 
be carcinogenic, mutagenic or toxic to reproduction, that this freedom is limited by 
prescribing which measures shall have priority. Other specific measures should be 
established e.g. limit values, only when this is shown to be necessary. 
12. As further evidence that the measures required by this proposal are 
reasonable in proportion to the risks from chemical agents it should be noted that 
they follow closely the Convention on Chemicals adopted by ILO in 1990 and 
therefore already have a substantial measure of acceptance world-wide. 
d) The case for consolidation of existing provisions. 
13. The Council Resolution of 21.12.1987 (2) on the Commission's programme 
concerning safety, hygiene and health at work (3) welcomed the intention to bring 
forward further proposals concerning dangerous agents. Moreover, at the time of 
the adoption of the Framework Directive 89/391/EEC the Council, in a 
Declaration, invited the Commission to examine coherence between the new 
Directive and Directive 80/1107/EEC on chemical, physical and biological agents 
(4). This is indispensable in order to bring the existing related individual Directives 
on specific chemical agents into conformity with Directive 89/391/EEC and in 
particular to remove ambiguities in existing requirements. 
14. The further need for consolidation of the requirements relating to chemical 
agents and to ensure harmony of content and approach in relation to the new 
Framework Directive 89/391/EEC was emphasised by the Council at the time of the 
(2> OJ. N* C28 of 03.02.1988, p. 1 
<3> O.J. N' C28 of 03.02.1988, p. 4 
<4> OJ. N* L327 of 03.12.1980, p. 8 
adoption of Council Directive 90/394/EEC "on the protection of workers from the 
risks related to exposure to carcinogens at work" (5), 
15. The current proposal responds to these various invitations. However, it is 
proposed that carcinogens should continue to be covered by a separate text. This 
exception also covers asbestos and vinyl chloride monomer both of which are 
already classified as human carcinogens (R 45) and which are, therefore, already 
within the scope of Directive 90/394/EEC on carcinogens. In the case of asbestos 
and vinyl chloride monomer, the detailed requirements contained in Directives 
83/477/EEC as amended by Directive 91/382/EEC and Directive 78/610/EEC will 
be reviewed separately taking account of the more recent Directive on carcinogens 
covering all classified R 45 substances. 
16. It should also be noted that biological agents, which are included in the 
coverage of Directive 80/1107/EEC which covers physical, chemical and biological 
agents are now subject to a specific Directive 90/679/EEC for the protection of 
workers from the risks related to exposure to biological agents at work (6). 
Furthermore, a separate proposal is in preparation to deal with physical agents. 
Thus the adoption of Directives on biological agents and physical agents will render 
Directive 80/1107/EEC obsolete for these agents. Therefore the present proposal 
deals only with chemical agents. At the same time as the Directive on chemical 
agents comes into force, the outdated Directives will be repealed. 
17. When Directive 80/1107/EEC was modified in 1988 by Directive 
88/642/EEC(7) one of the amendments was to introduce a detailed Annex relating to 
technical aspects concerning the measurement of exposure to chemical agents. This 
Annex made reference to the use of CEN standards. Since that time several draft 
(5> OJ. N' L196 of 26.07.1990, p. 1 
<6) OJ. N' L374 of 31.12.1990, p. 1 
(7> OJ. N' L356 of 24.12.1988, p. 74 
CEN standards have been developed as part of the standardisation policy of the 
European Community. Such standards will be of particular relevance to chemical 
agents. Three standards are in the process of adoption namely: 
1. CEN standard on "Guidelines for the assessment of exposure to chemical agents 
in the air at the workplace for comparison with Limit Values". (Pr EN 689) 
2. CEN standard on "General requirements for the performance of procedures for 
workplace measurements". (Pr EN 482) 
3. CEN standard on "Specifications for conventions for measurement of suspended 
matter in workplace atmospheres". (Pr EN 481) 
18. The above-mentioned draft CEN standards will, after their adoption, provide 
comprehensive guidance on carrying out measurements of exposure. For this 
reason detailed guidance on measurement methods is not included in the Annex of 
the current text and some of the detailed requirements from Directive 82/605/EEC 
on lead are being omitted without reducing the level of protection provided. 
Objectives of the Current Proposal 
19. This proposal has the following objectives : 
(a) to establish minimum requirements for the protection of workers against 
risks to their health and safety arising from all chemical agents at work; 
(b) to consolidate, update and adapt existing provisions in relation to 
chemical agents in the light of current knowledge and to align them with 
the measures established in Directive 89/391/EEC; 
(c) to encorporate into the new text the individual Directive 82/605/EEC 
relating to exposure to metallic lead and its compounds and the Directive 
88/364/EEC relating to the banning of certain agents and certain work 
activities; 
(d) to establish additional requirements with respect to improving the 
protection of workers against the risks arising from activities involving 
chemical agents; 
(e) to remove ambiguities in the requirements of existing Directives and 
uncertainty in the extent of their application; 
(f) to clarify the Community provisions relating to the health and safety of 
workers exposed to chemical agents, and to provide an improved basis 
for the provision of information to workers; 
(g) to ensure that all precautionary measures at work are based on a proper 
assessment of risks arising from the way chemical agents are used and 
that measures to afford protection take account of the features of the 
workplace, the activity, the circumstances and any specific risk. In this 
way, the measures taken can properly reflect the scale of risk, the 
appropriate precautions and the size of the undertaking without 
unnecessarily imposing burdens on employers; 
(h) to render more explicit the existing alignment of Community provisions 
with the ILO Convention No. 170 (8) and its associated 
Recommendation No. 177 on Chemical Agents at work; 
(8) Convention No 170 concerning safety in the use of chemicals at work, adopted by the 
International Labour Conference at its 77th session, Geneva, 25 June 1990 
10 
(i) to ensure that the Directive on Carcinogens (90/394/EEC) remains in 
force, and is excluded from this text, as it contains specific additional 
requirements for carcinogenic chemical agents. 
Description of this proposal 
20. This proposal comprises a preamble, three parts and an Annex which sets 
out minimum health and safety requirements: 
a) Contents of the proposal 
Proposal for a Council Directive on the protection of the health and safety of 
workers from the risks related to chemical agents at work 
Preamble 
Section I : General provisions 
Article 1 Subject 
Article 2 Definitions 
Section II : Provisions addressed to employers 
Article 3 General obligations 
Article 4 Specific protection and prevention measures 
Article 5 Communication, warning and alarm systems 
3) 
11 
Article 6 Keeping workers informed 
Section III : Miscellaneous provisions 
Article 7 Prohibitions 
Article 8 Occupational exposure levels 
Article 9 Health surveillance 
Article 10 Consultation and participation of workers 
Article 11 Minimum requirements for health and safety 
Article 12 Adjustments to the Annex 
Article 13 Committee 
Article 14 Revocation 
Article 15 Final Provisions 
Article 16 Address 
Annex 
Minimum Safety and Health requirements as referred to in Article 11 of the 
Directive. 
b) Characteristics of this proposal 
12 
1. Preamble 
2. Section I : General Provisions 
Article 1 
This Article establishes the Directive as an individual Directive under 
the Framework Directive 89/391/EEC, its requirements therefore being 
minimum requirements under Article 118A of the Treaty. 
Article 2 
The definition of 'chemical agent' in this text is very broad, with the 
aim of bringing within its scope all chemical agents, while ensuring in 
the text that the requirements imposed are commensurate with the risk. 
It covers all forms of chemical agents, such as fumes, contaminants and 
wastes that may arise in the course of work activities as well as chemical 
agents that are produced or used intentionally. 
3. Section II : Provisions addressed to employers 
Article 3 
This Article places an obligation on the employer to ensure that workers 
can carry out their work without endangering themselves or others at 
work. 
13 
Because an assessment of workplace hazards and risks is an important 
practical contribution to the actions which an employer must take to 
protect health and safety, this Directive adapts the requirements laid 
down in Directive 89/391/EEC so that assessments are made of the risks 
incurred by the workers in any activity involving chemical agents. The 
assessment has to cover all the chemical agents that are used or likely to 
be used. 
For chemical agents which have been the subject of specific evaluation 
within the Community as part of the process of authorisation for placing 
on the market, e.g. for plant protection products, this evaluation and any 
related labelling or safety instructions will often provide the basis for a 
major part of the work assessment under this Directive. What has to be 
done, in addition, is an assessment of the way in which the hazards of 
the chemical agents interact with other aspects of the workplace and the 
methods of use. 
The employer is also required to ensure supervision of the workplace, 
that competent staff are employed for important tasks such as the 
assessments and work involving special risks, that arrangements, 
including first-aid facilities, are made to deal with emergencies, and that 
clear instructions are given to workers. 
The Article also establishes the principle that priority is given to 
collective protection measures in preference to individual protection 
measures. 
14 
Article 4 
This Article sets out general requirements for the arrangements of plant 
and equipment so as to reduce risks to the health and safety of workers 
at work. 
Article 5 
This Article places an obligation on the employer to make arrangements 
to provide warning if there is an increased risk to health and safety. 
Article 6 
This Article is concerned with making information available to workers 
about the chemical agents and precautions to be taken. 
Section III : Miscellaneous provisions 
Article 7 
The prohibitions at present contained in Directive 88/364/EEC on the 
banning of certain specific agents and/or work activities are included in 
this Article without material change. Provision is made for new bans to 
be added by Council based on Article 118 A of the Treaty, whereas 
technical amendments to existing provisions are to be carried out by the 
Commission in accordance with the procedure referred to in Article 13. 
15 
Article 8 
Co-operation already exists between Member States in the scientific 
process leading to the establishment of occupational exposure levels. 
The text lays down a Community framework so that in the future this 
co-operation can be developed in a systematic way at Community level. 
The concept of having two different types of occupational exposure 
levels, of different status, is retained. 
'Limit values' under this proposal incorporate the 'binding limit values' 
under Directive 88/642/EEC and the existing limit value for lead under 
Directive 82/605/EEC. Member States will be required to set a national 
occupational exposure level once a Community limit value has been 
established which shall not be exceeded. 
For 'occupational guidance values', Member States are to be required to 
take them into account if they set or revise a national limit for a 
particular chemical agent. 
During the five year period before an occupational guidance value is 
reviewed, all interested parties will have the opportunity to submit 
information arising from experience gained in its practical application. 
16 
Article 9 
This Article sets out general arrangements for the provision of health 
surveillance, with particular reference to activities involving chemical 
agents. 
Article 10 
This Article adapts the general arrangements for consultation and 
participation of workers set out in Article 11 of Directive 89/391/EEC 
to activities involving chemical agents. 
Employers are obliged to involve workers in appraising the workplace 
and on the precautions to be adopted when it is found that an 
occupational exposure level or biological limit value is exceeded. 
Article 11 
This Article establishes the time scale in which employers shall meet the 
minimum requirements for health and safety which are set out in the 
Annex. For new activities, the employer shall comply at the time this 
Directive comes into force; for existing activities there is a transition 
period of five years. 
Article 12 
This Article sets out arrangements for technical adjustments to be made 
to the Annex and provides for the establishment of technical guidance. 
17 
Article 14 
The Directives listed will become redundant on the adoption of this 
Directive and are therefore to be repealed. It is to be noted that 
Directive 80/1107/EEC covers chemical, physical and biological agents. 
Of these, biological agents are already covered by Directive 
90/679/EEC and physical agents are the subject of a separate proposal 
already under discussion. 
The three individual Directives under Directive 80/1107/EEC can, in 
principle, stand alone even if 80/1107/EEC is repealed. However the 
first individual Directive on lead (82/605/EEC) is already assimilated 
into the present proposal and can be repealed also. The second, on 
asbestos (83/477/EEC as amended by 91/382/EEC) will be the subject 
of a separate review to be carried out by 31 December 1995 persuant to 
Article 9(1) of Directive 83/477/EEC as amended. The third, on noise 
(86/188/EEC) will be consolidated into the proposal relating to physical 
agents referred to above. The fourth on banning certain specified agents 
and/or work activities (88/364/EEC) is already assimilated into the 
current proposal and can therefore be repeated. 
18 
ANNEX 
1. Preliminary note 
The Annex sets out minimum safety and health requirements which 
apply whenever appropriate taking account of the features at the 
workplace, the activity, the circumstances or a specific risk. 
2. Supervisory obligations 
The text sets out the requirements for competence of the person in 
charge of the workplace and those supervising workers. It explains that 
the employer may personally fill these roles so long as he meets the 
requirements for competence. 
3. Protective measures 
This paragraph is concerned with the concentration in air of chemical 
agents which might present a risk to the health and safety of workers. 
The employer is obliged to ensure that the exposure of workers to a 
chemical agent for which a limit value has been set does not exceed the 
occupational exposure limit. Arrangements are summarised for 
assessing and measuring the exposure of workers. 
4) 
19 
4. Protection from abnormal risks 
This paragraph requires the employer to give special consideration to 
activities, such as maintenance, where the risks may be increased 
because the normal process controls cannot be applied. It also covers 
situations such as an emergency and where remedial action has to be 
taken after an accident or incident and requires the employer to make 
arrangements as to how to deal with such events, if they occur. 
5. Derogation information 
This paragraph states the information to be provided to competent 
authorities where derogations is sought from the prohibitions. 
6. Safety equipment maintenance 
General requirements are set out. 
7. Health surveillance measures 
For some chemical agents the Commission believes that specific 
provisions on health surveillance are necessary. These agents fall into 
two categories: 
- sensitisers; 
- other specified dangerous chemicals as referred to in this paragraph of 
the Annex. 
20 
For these agents, health surveillance is to be provided. 
Biological limit values and related requirements are to be observed as 
part of health surveillance. 
8. Record keeping 
The paragraph sets out arrangements to be made by an employer to 
maintain a record of the safety and health document. It also provides 
for Member States to arrange for individual health records. 
9. Information on chemical agents 
This paragraph requires the employer to provide the worker with the 
information that is necessary to ensure safe working practices. Where 
appropriate and in line with other Community Directives, the 
information is to be provided by signs, labels and safety sheets. 
An obligation is placed on the employer to ensure that containers and 
pipes used for chemical agents at the workplace are labelled or marked 
in line with Directive 92/58/EEC. In many cases the products bought 
by the employer will already be clearly marked with their identity and 
hazards according to other legislation. Where the original labelling is 
not available e.g. when the chemical is transferred in-plant to another 
container, the employer must make other arrangements. At the time of 
the adoption of the 7th amendment to Directive 67/548/EEC the Council 
specifically invited the Commission to make proposals in this matter 
with respect to intermediates. 
21 
There are also obligations to make available to workers the Safety Data 
Sheets from the supplier and where these are not available to prepare an 
equivalent data sheet. 
10. limit Values and Biological Limit Values 
This paragraph sets out the limit values and biological limit values that 
have been established. At present there are the limit value for lead in air 
at the workplace, and the biological limit value (which indicates 
absorption of lead by the worker). The list of values may be extended 
in due course. 
When Directive 82/605/EEC on risks related to exposure to lead was 
adopted there was a requirement to review the exposure limit value for 
lead and the biological limit values with a view to reducing them. The 
current proposal confirms the biological limit value in blood of 
70fig/100 ml as a minimum requirement; however it removes the 
latitude set out in Directive 82/605/EEC which permitted a lead in blood 
level of between 70 and 80/ig Pb/100 ml under certain circumstances. 
11. Special measures for lead. 
This paragraph sets out other means of biological monitoring for lead. 
22 
OPINION OF THE ADVISORY COMMITTEE 
The opinion of the Advisory Committee on Safety, Hygiene, and Health 
Protection at Work has been obtained on the proposal. The Commission 
has taken due note of the Committee's opinion in preparing the text now 
submitted to the Council, in particular in relation to the procedure for 
setting limit values, the requirements for the assessment and for record 
keeping, the strengthening of the provisions relating to safety, and the 
limit value for lead in air, which remains unchanged from the limit 
valuein Directive 82/605/EEC on lead. 
IMPACT ASSESSMENT 
An impact study has been carried out and a copy of the summary 
assessment is attached as Annex A to this explanatory note. It should be 
noted that as a result of this impact study the list of chemical agents for 
which health surveillance is required, under Article 9, has been reduced 
by more than half from the draft on which the study was based. 

2 3 
PROPOSAL FOR A COUNCIL DIRECTIVE ON THE PROTECTION OF 
THE HEALTH AND SAFETY OF WORKERS FROM THE RISKS 
RELATED TO CHEMICAL AGENTS AT WORK 
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 CommitteeC3) 
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 undertakings; 
œ O.J. No.... 
(2) OJ. No.... 
0) OJ. No.... 
Whereas the improvement of workers' safety, hygiene and health at work is an 
objective which should not be subordinated to purely economic considerations; 
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 
protection of the health and safety of each individual worker but also provides a 
level of minimum protection of all workers in the Community which avoids any 
possible distortion in the area of competitiveness; 
Whereas a consistent level of protection from the risks related to chemical agents 
has to be established for the Community as a whole and whereas that level of 
protection has to be set not by detailed prescriptive requirements but by a 
framework of general principles to enable Member States to apply the minimum 
requirements consistently; 
Whereas 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(4 ) as last amended by Council Directive 88/642/EEC (5), 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)(6), 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 
<4> OJ. No. L327 of 03.12.1980, p. 8 
<5> OJ. No. L356 of 24.12.1988, p. 74 
<6> O J. No. L247 of 23.08.1982, p. 12 
zs 
within the meaning of Article 8 of Directive 80/1107/EEC)(7) 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(1) 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 (8) ; 
Whereas, therefore the provisions of the said Directive, apply in full to workers 
exposed to chemical agents, without prejudice to more stringent and/or specific 
provisions contained in this Directive; 
Whereas Council Directive 67/548/EEC of 27 June 1967 on the approximation of 
the laws, regulations and administrative provisions relating to the classification, 
packaging and labelling of dangerous substances(9), as last amended by Council 
Directive 92/32/EEC of 30 April 1992(10),Council Directive of 26 June 1978 on the 
approximation of hte laws of the Member States relating to the classification, 
packaging and labelling of dangerous preparations (pesticides) (n) and Council 
Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations 
and administrative provisions of the Member States relating to the classification, 
packaging and labelling of dangerous preparations^2), as last amended by Council 
Directive 90/492/EEC(13), define and lay down a system of specific information on 
dangerous substances and preparations, in the form of safety data sheets, principally 
C7) OJ. No. L179 of 09.07.1988, p. 44 
<*> O J. No. L183 of 26.09.1989, p. 1 
<9> OJ. No. L196 of 16.08.1967, p. 1 
<10) O J. No. L154 of 05.06.1992, p. 1 
U U O. J. No. L206 of 29.07.1978, P. 13 
<12> OJ. No. L187 of 16.07J988, p. 14 
<13) OJ. No. L275 of 05 J0.1990, p. 35 
(5) 
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(14) 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(15) 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 
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 
<14) O J. No. L245 of 26.08.1992, p. 23 
<15> OJ No L 230 of 05.08.1982, p.l 
29 
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 tor 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: 
Whereas this Directive is a practical contribution towards creating the social 
dimension of the internal market. 
HAS ADOPTED THIS DIRECTIVE : 
zt 
SECTION I 
GENERAL PROVISIONS 
Article 1 
Subject 
1. This Directive, which is the [ ] individual Directive within the meaning of 
Article 16(1) 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. 
3. 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 the whole area 
referred to in paragraph 1, without prejudice to more stringent and/or specific 
provisions contained in this Directive. 
g ^rvo 
5 • The competent authorities shall regularly check if employers have taken the 
appropriate measures to protecdt the health and safety of workers at work and 
review the risk assessment pursuant to Article 3(2). 
29 
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 produced 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 property of a chemical agent with the potential to 
cause harm; 
3o 
(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; 
31 
b) the operation of workplaces when workers are present takes place under 
the responsibility of a person in charge; 
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. 
2. 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 
authorisation for placing on the market, the risk assessment shall take 
into account the results of that evaluation; 
3^ 
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. 
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 the state of art and technology, in preference to individual 
protection measures. 
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 
significant exposure, or which may result in deleterious effects on safety and 
health for other reasons, even after all technical measures have been taken, the 
33 
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. 
5. 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 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. 
3 if 
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 precautions and actions to be taken in order 
to safeguard himself and other workers at the workplace; 
written information where the assessment carried out pursuant to Article 
3.2 shows it to be necessary and which is kept up-to-date. 
3-T 
2. 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 
1. 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€ 
EINECS (1) 
No 
; 202-080-4 
; 202-177-1 
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-naphmylamine 
and its salts 
4-aminodiphenyl 
and its salts 
Benzidme and its 
salts 
4-nitrodipheiiyl Concentration 
Limit for 
exemption 
0.1 % w/w 
0.1 % w/w 
0.1 % w/w 
0.1 % w/w 
(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 earned 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. 
3=? 
Article 8 
Occupational exposure levels 
1. Occupational exposure levels shall be drawn up taking account of available 
information, including scientific and technical data in accordance with the 
procedure referred to in Article 13. 
2. Eor any chemical agent for which a limit value is listed in the Annex 
(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. 
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. 
3% 
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 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. 
33 
Article 11 
Miriinmm 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 14, must 
satisfy the minimum safety and health requirements laid down in the-Annex. 
2. An activity involving chemical agents existing on the date on which this 
Directive is brought into effect as referred to in Article 14, must satisfy the 
: minimum safety and health requirements laid down in the Annex as soon as 
possible and at the latest five years after that date. 
Article 12 
Adjustments to the Annex 
1- Technical adjustments to the Annex 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. 
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 Hie chairman either on his own initiative 
or at the request of the representative of a Member State. 
The representative of the Cornmission shall submit to the 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 
! representatives of the Member States within the committee shall be weighted in 
the manner set out in that Article. The chairman shall not vote. 
40 eu 
The tanirnission 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 
1. 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 
protection of workers from the risks related to exposure to chemical, physical 
and biological agents at work; 
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. 
H4 
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 867188/EEC on the protection of workers 
from the risks related to exposure to noise at work; 
to the, procedure set out Jn 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 
protection 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 
implementing Council Directive 80/1107/EEC on the protection, of 
workers from the risks related to exposure to chemical, physical and 
biological agents at work; 
to Directive 80/1107/EEC, as amended by Directive 88/642/EEC, is obsolete. 
Article 15 
Knal provisions 
1. Member States shall bring into fbrce the laws, regulations and adrnimstrative 
provisions necessary to comply with this Directive not later man 30th June 1996. 
They shall forthwith inform the Cornrnission thereof. 
2. When Member States adopt the provisions referred to in paragraph 1, these shall 
ccmtam-a_rfifecence to this Directive or shall be accompanied by such icfeBCfltc 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 Qnnrmssion the texts of the 
provisions of national law which they have already adopted or which they adopt in 
me 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. 
•\3 
Article 16 
This Directive is addressed to the Member States. 
Done at For the Council 
The President 
MM 
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 
2.2 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. 
2.3 Supervision 
To ensure workers' health and safety protection during all operations 
undertaken, the necessary supervision must be provided by competent persons 
having the necessary knowledge, experience and skills for the purpose, in 
accordance 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 automatically and 
continuously, automatic 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 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 preference to the 
manufacture and use of the chemical agent in a closed system. 
3.3 The employer shall ensure that exposure of workers to a 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 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. 
M> 
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 persons 
shall not be allowed to remain in the affected area. 
4.4.1 Where harmful substances accumulate or may accumulate in the atmosphere 
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 dispersing such hazardous 
atmospheres in such a way that workers are not at risk. 
4.4.2 Without prejudice to Directive 89/656/EEC (16), 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. 
(16) OJ No. L393, 30.12.1989, p. 18 
ws 
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 
arrangements, precautions, and procedures so that the emergency 
services can prepare their own response procedures and precautionary 
measures; and 
any available information 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 : 
V3 
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 
concerned. 
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. 
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; 
Sa 
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 monitoring 
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. 
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; 
S1 
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. 
The safety and health document shall be kept for at least 5 years from the date 
on which it is made or revised and shall be made available to workers or their 
representatives and to the competent authority on request. 
8.2 Member States shall establish arrangements to ensure that for each worker 
who undergoes health surveillance in accordance with the requirements of 
Article 9 an individual health record is made and kept up-to-date. The health 
record shall contain a summary of the results of health surveillance carried out 
and of any monitoring data representative of the exposure of the individual. It 
shall be kept, taking into account medical confidentiality, in accordance with 
national laws and practice. 
sz 
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 individual worker 
shall, at his request, have access to the health record relating to him 
personally. 
In the case where an undertaking ceases 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 be provided to the worker shall include 
the following : 
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; 
^3 
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. 
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 Directive 92/58/EEC. Information shall also be provided either by 
labelling 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; 
^ 7 
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 
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. 
ss 
10. Limit Values and Biological Limit Values 
10.1 Limit Values (3) for occupational exposure 
EINECS 
No. 
(1) 
-CAS 
No. 
(2) 
-Name of 
Agent 
metallic Lead 
and its ionic 
compounds Limit Value (6) 
mg/m3 (4) 
0.15 ppm (5) 
-
(1) EINECS: European Inventory of Existing Chemical Substances. 
(2) CAS: Chemical Abstract Service Number. 
(3) Measured or calculated in relation to a reference period of eight hours unless 
otherwise stated. 
(4) mg/tar milligrams per cubic metre 
(5) ppm parts per million by volume in air (ml/m^) 
(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 
lib), include measuring the blood-lead level (PbB); the biological limit 
value is: 
SQ 
70 f*g Pb/100 ml blood 
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 aminolevulinic 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 
s ? 
c) Biological monitoring shall be carried out at least every six months; this 
frequency may be reduced to once a year where at the same time: 
- the results of the measurements for individuals or for groups of 
workers have shown, on the previous two consecutive occasions on 
which monitoring was carried out, a lead-in-air concentration higher 
than 0,075 mg/m^ and lower than 0,1 mg/vn?. 
- the PbB level of any «individual worker does not exceed 50 fig Pb/100 
ml blood. 
ANNEXA 
IMPACT ASSESSMENT 
THE IMPACT OF THE PROPOSAL ON BUSINESS 
with special reference to small and medium sized 
enterprises (SMEs) 
Title of proposal: Proposal for a Council Directive on the protection 
of the health and safety of workers from the risks 
related to chemical agents at work 
Document reference number: HK/seh/consoli/100.6 
The proposal 
1. Taking account of the principle of subsidiarity, why is Community legislation 
necessary in this area and what are its main aims? 
a) Reason for Community action 
Exposure to chemical agents occurs in every aspect of daily life. Over 
100,00&hemicals are included in the European Inventory of Existing Chemical 
Substances (EINECS). Many of these chemicals have dangerous properties 
which can adversely affect the health and safety of workers at work. It has 
been estimated that accidents and ill health at work account for approximately 
7% of all social security expenditure within the EC, affecting 10 million 
workers every year at an overall cost of 20 billion ECU. It is clear from 
information in Member States that a significant proportion of the ill-health that 
is caused by work activities is due to exposure to chemical agents. It is 
therefore important that suitable precautions should be taken at the workplace 
to prevent these problems. 
The proposal does not breach the principle of subsidiarity, because it is 
only by Community action pursuant to Article 118A of the Treaty that a 
minimum level of protection for workers from the risks related to exposure to 
chemical agents can be assured in all Member States. Such action will also 
avoid any distortion in the area of competitiveness by preventing the unequal 
application of minimum standards for worker protection in one or other 
Member States. 
se 
Moreover this proposal will encourage more flexibility in cross border 
employment because workers can be reassured that they will find at least the 
minimum level of protection of their health and safety in all Member States. 
Employers will also be reassured that the costs of production will not be 
unduely distorted as a result of differences in the levels of protection of health 
and safety at work. 
b) Objectives of the proposal 
(a) to establish minimum requirements for the protection of workers 
against risks to their health and safety arising from all chemical 
agents at work; 
(b) to consolidate, update and adapt existing provisions in relation to 
chemical agents in the light of current knowledge and to align them 
with the measures established in Directive 89/391/EEC; 
(c) to incorporate into the new text the individual Directive 82/605/EEC 
relating to exposure to metallic lead and its compounds and the 
Directive 88/364/EEC relating to the banning of certain agents and 
certain work activities; 
(d) to establish additional requirements with respect to improving the 
protection of workers against the risks arising from activities 
involving chemical agents; 
(e) to remove ambiguities in the requirements of existing Directives and 
uncertainty in the extent of their application; 
(f) to clarify the Community provisions relating to the health and safety 
of workers exposed to chemical agents, and to provide an improved 
basis for the provision of information to workers; 
(g) to ensure that all precautionary measures at work are based on a 
proper assessment of risks arising from the way chemical agents are 
used and that measures to afford protection take account of the 
features of the workplace, the activity, the circumstances and any 
specific risk. In this way, the measures taken can properly reflect 
the scale of risk, the appropriate precautions and the size of the 
undertaking without unnecessarily imposing burdens on employers; 
(h) to render more explicit the existing alignment of Community 
provisions with the ILO Convention No. 170 (*) and its associated 
Recommendation No. 177 on Chemical Agents at work; 
(1) Convention No 170 concerning safety in the use of chemicals at work, adopted by the 
International Labour Conference at its 77th session, Geneva, 25 June 1990 
go 
(i) to ensure that the Directive on Carcinogens (90/394/EEC) remains in 
force, and is excluded from this text, as it contains specific 
additional requirements for carcinogenic chemical agents. 
The impact on business 
2, Who will be affected by the proposal? 
• which sectors of business 
• which sizes of business (what is the concentration of small and medium 
sized firms) 
• are there particular geographical areas of the Community where these 
businesses are found 
The proposal covers all enterprises that manufacture or use chemicals. It will 
apply to enterprises in manufacturing, construction, agriculture and to some 
degree in services, including public services. 
The impact on businesses will depend on the number of chemicals used and the 
number of exposed workers. 
Of the enterprises within the scope of the Directive approximately 40-60% are 
expected to be SME's (less than about 75 employees). It is not possible to 
precise about the number and proportion of SME's because the data on their 
use of chemicals do not exist. Consequently it is not possible to say whether 
the impact will be greater on SME's in general as opposed to larger firms. 
3. What will business have to do to comply with the proposal? 
There are few additional obligations on employers because most of the 
requirements have already been established by previous Directives for the 
protection of the health and safety of workers at work. This text amplifies 
these existing general provisions as they apply to chemical agents. 
Examples of this amplification of the framework Directive 89/391/EEC are to 
be found in these parts of the proposal dealing with the assessment of risk, 
protection and prevention measures, control of exposure, plan of action in the 
case of an emergency and information to and consultation and participation of 
workers. 
The provisions on Health surveillance too which specify those chemical agents 
where health surveillance is considered to be necessary are an amplification of 
the framework Directive 89/391/EEC in this case Article 14. 
el 
The text also consolidates some specific requirements again already in 
existence, e.g. prohibition of use of certain chemical agents or work activities, 
requirements concering lead and record keeping. 
The obligation to draw up an inventory of chemical agents used at work can be 
seen as an amplification of the requirement in the framework Directive 
89/391/EEC for making a risk assessment at work. It is a logical extension of 
this requirement which enables the Community to carry forward the 
requirements of ILO convention 170 and its associated recommendation 177 on 
chemicals at work. 
4. What economic effects is the proposal likely to have? 
• on employment 
• on investment and the creation of new businesses 
• on the competitive position of businesses 
The provisions concerning health surveillance (Art. 9 and Annex paragraph 7) 
are in addition to current requirements and will have some impact in all 
Member States, with the possible exception of France. The most significant 
impact is expected for enterprises in Denmark, Greece, Ireland, Netherlands 
and United Kingdom, where few such provisions exists today. 
Financial calculations have been possible for Article 9 only (Health 
surveillance). A partial estimate, based on current costs for between 8-30 
chemical agents in each Member State have been made, covering 31 percent of 
the Community's employed workers (Denmark, Ireland, Netherlands, United 
Kingdom). This showed additional costs of at least 100-120 million ECU per 
year for 22 originally listed agents on the basis of data from these five Member 
States. With the reduction in the size of the list from 22 to 10, for those 
chemical agents requiring health surveillance, the overall cost for the 
implementation of Article 9 can be reduced to approximately 50 million ECU 
on a pro rata basis. 
The cost per health examination varies widely, both according to the agent in 
question and according to the cost level in Member States. The lowest 
minimum cost reported is 20 ECU per examination the highest cost 130 ECU 
(both including biological monitoring). 
The cost per worker is likely to be a little higher in small enterprises because 
larger enterprises may be able to get discounts on laboratory tests, etc. The 
variation relative to the size of the enterprise is expected to be much narrower 
than the variation between Member State price levels. The aggregate costs are 
unlikely to have any measurable impact on employment, investment or the 
creation of new businesses. 
G Z, 
The requirement in Article 3(2) for employers to keep a list of chemical agents 
used is expected to have only a minor economic impact. 
5. Does the proposal contain measures to take account of the specific situation 
of small and medium sized firms (reduced or different requirements etc.)? 
The intention behind the proposal is to create acceptable minimum level of 
protection for all workers, irrespective of the size of the employers 
undertaking. 
For chemical agents which have been the subject of specific evaluation within 
the Community as part of the process of authorisation for placing on the 
market, e.g. for plant protection products, this evaluation and any related 
labelling or safety instructions will often provide the basis for a major part of 
the work assessment under this Directive. What has to be done, in addition, is 
an assessment of the way in which the hazards of the chemical agents interact 
with other aspects of the workplace and the methods of use. 
Only one Article (health surveillance) obliges the employer to use a specific 
method. The remaining Articles define the goals to achieve, but the employer 
can choose between various methods to reach this goal. This gives him the 
maximum possibility to choose the methods suited to the workplace, the 
technology or the size of the undertaking. 
Consultation 
6. List the organisations which have been consulted about the proposal and 
outline their main views. 
The opinion of the Advisory Committee on Safety, Hygiene and Health 
Protection at Work has been obtained on the proposal. The Commission has 
taken due note of the Committee's opinion in preparing the text now submitted 
to the Council, in particular in relation to the procedure for setting limit 
values, the requirements for the assessment and for record keeping, the 
strengthening of the provisions relating to safety, and the limit value for lead 
in air, which remains unchanged from the limit value in Directive 82/605/EEC 
on lead. 

ISSN 0254-1475 
COM (93) 155 final 
DOCUMENTS 
EN 
Catalogue number : CB-CO-93-179-EN-C 
ISBN 92-77-54601-8 
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