CELEX: 51993PC0155
Language: en
Date: 1993-05-14
Title: Proposal for a COUNCIL DIRECTIVE on the protection of the health and safety of workers from the risks related to chemical agents at work

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              COMMISSION OF THE EUROPEAN COMMUNITIES
                                                         C0M(93) 155 final - SYN 459
                                                         Brussels, 14 May 1993
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                                          Proposal for a
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                 on the protection of the health and safety of workers from the
                            risks related to chemical agents at work
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                                  (presented by the Commission)
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 ---pagebreak---                            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
 ---pagebreak--- 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.
 ---pagebreak--- 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
 ---pagebreak--- 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
 ---pagebreak--- 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
 ---pagebreak--- 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)     O J . N' L374 of 31.12.1990, p. 1
(7>     O J . N' L356 of 24.12.1988, p. 74
 ---pagebreak--- 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;
 ---pagebreak---     (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
 ---pagebreak---                                               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)
 ---pagebreak---                                          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
 ---pagebreak---                                      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.
 ---pagebreak---                                  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.
 ---pagebreak---                                    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.
 ---pagebreak---                                     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.
 ---pagebreak---                                   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.
 ---pagebreak---                                   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.
 ---pagebreak---                                      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)
 ---pagebreak---                                  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.
 ---pagebreak---                                   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.
 ---pagebreak---                                    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.
 ---pagebreak---                                        22
OPINION OF T H E 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 A S S E S S M E N T
       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.
 ---pagebreak---  ---pagebreak---                                         23
  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....
 ---pagebreak--- 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
 ---pagebreak---                                                 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>     O J . No. L196 of 16.08.1967, p. 1
    <10)    O J . No. L154 of 05.06.1992, p. 1
    UU      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)
 ---pagebreak--- 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
 ---pagebreak---                                          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 :
 ---pagebreak---                                       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.
 ---pagebreak---                              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).
 ---pagebreak---                                       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;
 ---pagebreak---                                          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;
 ---pagebreak---                                          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;
 ---pagebreak---                                        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
 ---pagebreak---                                        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.
 ---pagebreak---                                       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.
 ---pagebreak---                                       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.
 ---pagebreak---                                       Z€
    EINECS (1)             CAS (2)           Name of agent       Concentration
          No                  No                                   Limit for
                                                                   exemption
  ;  202-080-4              91-59-8         2-naphmylamine        0.1 % w/w
                                               and its salts
  ;   202-177-1             92-67-1         4-aminodiphenyl       0.1 % w/w
                                               and its salts
     202-199-1              92-87-5        Benzidme and its       0.1 % w/w
                                                   salts
   • 202-204-7              92-93-3         4-nitrodipheiiyl      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.
 ---pagebreak---                                       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.
 ---pagebreak---                                          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.
 ---pagebreak---                                               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,
 ---pagebreak---     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.
 ---pagebreak---                                     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 workersfromthe 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.
 ---pagebreak---                                           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 therisksrelated to exposure to asbestos at work;
             Article 12(2) of Directive 867188/EEC on the protection of workers
             from therisksrelated to exposure to noise at work;
      to the, procedure set outJn 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 therisksrelated 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.
 ---pagebreak---                                        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
    mefieldgoverned 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.
 ---pagebreak---                                      •\3
                                 Article 16
This Directive is addressed to the Member States.
Done at                                         For the Council
                                               The President
 ---pagebreak---                                            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
 ---pagebreak---     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'
 ---pagebreak---     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.
 ---pagebreak---                                             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
 ---pagebreak---                                            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 :
 ---pagebreak---                                        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;
 ---pagebreak---                                      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;
 ---pagebreak---                                         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.
 ---pagebreak---                                          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;
 ---pagebreak---                                        ^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;
 ---pagebreak---                                         ^
                                           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.
 ---pagebreak---                                                   ss
10.   Limit Values and Biological Limit Values
10.1    Limit Values (3) for occupational exposure
    EINECS                  CAS                Name of                       Limit Value (6)
      No.                    No.                Agent
       (1)                   (2)
                                                                mg/m3 (4)             ppm (5)
        -                      -            metallic Lead       0.15                           -
                                             and its ionic
                                             compounds
(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
             l i b ) , include measuring the blood-lead level (PbB); the biological limit
             value is:
 ---pagebreak---                                       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
 ---pagebreak---                                 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.
 ---pagebreak---                                                                            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.
 ---pagebreak---                                                          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
 ---pagebreak---                                           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.
 ---pagebreak---                                        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.
 ---pagebreak---                                         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.
 ---pagebreak---  ---pagebreak---                                                                      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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