1980L1107 — EN — 01.01.1995 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCIL DIRECTIVE
of 27November 1980
on the protection of workers from the risks related to exposure to chemical, physical and biological
agents at work
(80/1107/EEC)
(OJ L 327, 3.12.1980, p. 8)
Amended by:
Official Journal
Nopage date
►M1Council Directive 88/642/EEC of 16 December 1988 L 356 74 24.12.1988
Amended by:
►A1Act of Accession of Spain and Portugal L 302 23 15.11.1985
►A2Act of Accession of Austria, Sweden and Finland C 241 21 29.8.1994
(adapted by Council Decision 95/1/EC, Euratom, ECSC) L 1 1 1.1.1995
1980L1107 — EN — 01.01.1995 — 001.001 — 2
▼B
COUNCIL DIRECTIVE
of 27November 1980
on the protection of workers from the risks related to exposure to
chemical, physical and biological agents at work
(80/1107/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community, and in particular Article 100 thereof,
Having regard to the proposal from the Commission(1), drafted
following consultation with the Advisory Committee on Safety,Hygiene and Health Protection at work,
Having regard to the opinion of the European Parliament(
2),
Having regard to the opinion of the Economic and Social Committee(3),
Whereas the Council resolution of 29 June 1978 on an action
programme of the European Communities on safety and health atwork (
4), provides for the harmonization of provisions and measures
regarding the protection of workers with respect to chemical, physicaland biological agents; whereas efforts must therefore be made towardsapproximation, while the improvement is being maintained, of the laws,regulations and administrative provisions of the Member States inaccordance with Article 117 of the Treaty;
Whereas certain differences are revealed by an examination of the
measures taken by Member States to protect workers from the risksrelated to exposure to chemical, physical and biological agents at work;whereas, therefore, in the interests of balanced development, thesemeasures, which directly affect the functioning of the common market,should be approximated and improved; whereas this approximation andimprovement should be based on common principles;
Whereas the said protection should as far as possible be ensured by
measures to prevent exposure or keep it at as low a level as is reason-ably practicable;
Whereas to this end it is appropriate that the Member States should,
when they adopt provisions in this field, comply with a set of require-ments, including in particular the laying down of limit values; whereasan initial list of agents may be adopted in this Directive for the applica-tion of further more specific requirements; whereas the Member Stateswill determine whether and towhat extent each o f these requirements isapplicable tothe agent co ncerned;
Whereas provision should be made, within the time limits set by this
Directive, for the implementation, in respect of a limited number ofagents, of provisions to ensure, for the workers concerned, appropriatesurveillance of their state of health during exposure and the provision ofappropriate information;
Whereas the Council will lay down the limit values and other specific
requirements for certain agents in individual Directives;
Whereas certain technical aspects concerning the specific requirements
established in the individual directives can be reviewed in the light ofexperience and progress made in the technical and scientific fields;
Whereas representatives of employers and workers have a role to play
in the protection of workers;
(1) OJ NoC 89, 5. 4. 1979, p. 6.
(2) OJ NoC 59, 10. 3. 1980, p. 73.
(3) OJ NoC 297, 28. 11. 1979, p. 5.
(4) OJ NoC 165, 11. 7. 1978, p. 1.
1980L1107 — EN — 01.01.1995 — 001.001 — 3
▼B
Whereas, since the Hellenic Republic is to become a member of theEuropean Economic Community on the 1 January 1981 in accordancewith the 1979 Act of Accession, it should be granted a longer period inwhich toimplement this Directive soas toenable it toset up thenecessary legislative, social and technical structures, in particular thoseconcerning consultation of both sides of industry, the setting up of asystem for monitoring the health of workers as well as the supervisionof such implementation,
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. The aim of this Directive is the protection of workers against risks
to their health and safety, including the prevention of such risks, arisingor likely to arise at work from exposure to chemical, physical andbiological agents considered harmful.
2. This Directive shall not apply to:
— workers exposed to radiation covered by the Treaty establishing the
European Atomic Energy Community,
— sea transport,— air transport.
Article 2
For the purposes of this Directive:
(a) ‘agent'means any chemical, physical or biological agent present at
wo rk and likely tobe harmful tohealth;
(b) ‘worker' means any employed person exposed or likely to be
exposed to such agents at work;
(c) ‘limit value'means the exposure limit or biological indicator limit
in the appropriate medium, depending on the agent.
Article 3
1. In order that the exposure of workers to agents be avoided or kept
at as low a level as is reasonably practicable, Member States shall,when they adopt provisions for the protection of workers, concerning anagent, take:
— the measures set out in Article 4,— the additional measures set out in Article 5, where the agent appears
in the initial list in Annex I.
▼
M1
The Council, in accordance with the procedure laid down in Article118a of the Treaty, may amend Annex I with a view, inter alia, to
inserting in it agents in respect of which a binding limit value orbinding limit values and/or other specific requirements appear neces-sary.
▼
B
2. For the purposes of paragraph 1, the Member States shall deter-mine the extent, if any, to which each of the measures provided for inArticles 4 and 5 is toapply, taking intoacco unt the nature o f the agent,the extent and duration of the exposure, the gravity of the risk and theavailable knowledge concerning it, together with the degree of urgencyof the measures to be adopted.
3. Member States shall adopt the measures necessary to ensure:
— in the case of the agents listed in Annex II, Part A, appropriate
surveillance of the state of health of workers during the period ofexposure,
— in the case of the agents listed in Annex II, Part B, access for
workers and/or their representatives at the place of work to appro-priate information on the dangers which these agents present.
1980L1107 — EN — 01.01.1995 — 001.001 — 4
▼B
4. The adoption of the measures referred to in paragraph 3 by theMember States shall not oblige them to apply paragraphs 1 and 2.
Article 4
The measures referred toin the first indent o f Article 3 (1) shall be:
1. limitation of the use of the agent at the place of work;2. limitation of the number of workers exposed or likely to be
exposed;
3. prevention by engineering control;
▼
M1
4. (a) in the case of any activity likely to involve a risk of exposure
of workers, determination of the nature and degree of theworkers’ exposure so that any risk to their safety or health canbe assessed and the measures tobe taken can be defined;
(b) establishment of limit values and of sampling procedures,
measuring procedures and procedures for evaluating results; inthe case of chemical agents, the establishment of samplingprocedures, measuring procedures and procedures for evalu-ating results, in accordance with the reference methoddescribed in Annex II a or a method yielding equivalent results;
(c) when a limit value is exceeded, identification without delay of
the reasons for the limit being exceeded and implementation assoon as possible of appropriate measures to remedy the situa-tion;
▼
B
5. protection measures involving the application of suitable working
procedures and methods;
6. collective protection measures;7. individual protection measures, where exposure cannot reasonably
be avoided by other means;
8. hygiene measures;
▼
M1
9. appropriate measures shall be taken by the employer to ensure that
workers and/or their representatives in undertakings or establish-ments receive full information on, and instruction in:
(a) the potential risks connected with their exposure, the technical
preventive measures to be observed by workers and the precau-tions taken by the employer and to be taken by workers;
(b) the risk assessment methods used, the existence of a limit value
as referred toin po int 4 (b) and the need tocarry o ut measure-ments, and the action to be taken, as laid down in point 4 (c), inthe event of a limit value being exceeded;
▼
B
10. use of warning and safety signs;11. surveillance of the health of workers;12. keeping updated records of exposure levels, lists of workers
exposed and medical records;
13. emergency measures for abnormal exposures;14. if necessary, general or limited ban on the agent, in cases where use
of the other means available does not make it possible to ensureadequate protection.
Article 5
The additional measures referred to in the second indent of Article 3 (1)
shall be:
1. providing medical surveillance of workers prior to exposure and
thereafter at regular intervals. In special cases, it shall be ensuredthat a suitable form of health surveillance is available to workerswhohave been expo sed tothe agent, after expo sure has ceased;
1980L1107 — EN — 01.01.1995 — 001.001 — 5
▼B
2. access by workers and/or their representatives at the place of work to
the results of exposure measurements and to the anonymous collec-tive results of the biological tests indicating exposure when suchtests are provided for;
3. access by each worker concerned to the results of his own biological
tests indicating exposure;
4. informing workers and/or their representatives at the place of work
where the limit values referred toin Article 4 are exceeded, o f thecauses thereof and of the measures taken or to be taken in order torectify the situation;
5. access by workers and/or their representatives at the place of work to
appropriate information to improve their knowledge of the dangers towhich they are exposed.
Article 6
Member States shall see toit that:
— workers’ and employers’ organizations are consulted before the
provisions for the implementation of the measures referred to inArticle 3 are adopted and that workers’ representatives in the under-takings or establishments, where they exist, can check that suchprovisions are applied or can be involved in their application,
— any worker temporarily suspended on medical grounds in accord-
ance with national laws or practices from exposure to the action ofan agent is, where possible, provided with another job,
— the measures adopted in implementation of this Directive are consis-
tent with the need to protect public health and the environment.
Article 7
This Directive and the individual Directives referred toin Article 8 shall
not prejudice the right of Member States to apply or introduce laws,regulations or administrative provisions ensuring greater protection forworkers.
Article 8
▼
M1
1. The Council shall, in accordance with the procedure laid down inArticle 118a of the Treaty, fix in the individual directives that it adoptswith regard tothe agents listed in Anne x I a binding limit value or
binding limit values and/or other specific requirements.
▼
B
2. The titles of the individual Directives shall include serial numbers.
3. Adaptation to technical progress in accordance with the procedure
in Article 10 shall be restricted tothe technical aspects listed in AnnexIII under the conditions laid down in the individual Directives.
▼
M1
4. Without prejudice to paragraph 1, for agents other than thoselisted in Annex I, indicative limit values shall be drawn up in accord-ance with the procedure laid down in Article 10.
The Member States shall take account, inter alia, of those indicative
limit values when establishing the limit values referred toin Article 4(4) (b).
Indicative limit values shall reflect expert evaluations based on
scientific data.
1980L1107 — EN — 01.01.1995 — 001.001 — 6
▼B
Article 9
▼M1
1. With a view tothe adaptatio n totechnical pro gress referred toinArticle 8 (3) and tothe establishment o f indicative limit values asreferred to in Article 8 (4), a committee is hereby established consistingof representatives of the Member States and chaired by a representativeof the Commission.
▼
B
2. The Committee shall draw up its own rules of procedure.
Article 10
1. Where the procedure laid down in this Article is invoked, matters
shall be referred to the Committee by the chairman, either on his owninitiative or at the request of the representative of a Member State.
2. The representative of the Commission shall submit to the
Committee a draft of the measures to be taken. The Committee shalldeliver its opinion on this draft within a time limit which the chairmanmay set according to the urgency of the matter. Decisions shall be takenby a majority of ►
A262◄votes, the votes of Member States being
weighted as provided for in Article 148 (2) of the treaty. The chairmanshall not vote.
3. (a) The Commission shall take the proposed measures where they
are in accordance with the opinion of the Committee.
(b) Where the proposed measures are not in accordance with the
opinion of the Committee, or if no opinion is delivered theCommission shall without delay propose to the Council themeasures tobe taken. The Co uncil shall act by a qualifiedmajority.
(c) If the Council has not acted within three months of receiving the
proposal, the proposed measures shall be adopted by theCommission.
Article 11
1. Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this Directive withina period of three years of its notification and shall forthwith inform theCommission thereof.
However, in the case of Article 3 (3), first indent, this period shall be
four years.
In derogation from the above provisions, the time limits laid down in
the first and second subparagraphs shall be four and five years respec-tively in the case of the Hellenic Republic.
2. Member States shall communicate to the Commission the provi-
sions of the national law which they adopt in the field governed by thisDirective.
Article 12
This Directive is addressed tothe Member States.
1980L1107 — EN — 01.01.1995 — 001.001 — 7
▼B
ANNEX I
List of agents referred to in Article 3 (1), second indent, and Article 8 (1)
Acrylonitrile
AsbestosArsenic and compoundsBenzeneCadmium and compoundsMercury and compoundsNickel and compoundsLead and compounds
Chlorinated hydrocarbons: — chloroform
— paradichlorobenzene— carbon tetrachloride
1980L1107 — EN — 01.01.1995 — 001.001 — 8
▼B
ANNEX II
A.List of agents referred to in Article 3 (3), first indent
1. Asbestos
2. Lead and compounds
B.List of agents referred to in Article 3 (3), second indent
1. Asbestos
2. Arsenic and compounds3. Cadmium and compounds4. Mercury and compounds5. Lead and compounds
1980L1107 — EN — 01.01.1995 — 001.001 — 9
▼M1
ANNEX II a
REFERENCE METHOD REFERRED TO IN ARTICLE 4 (4) (b)
A. DEFINITIONS
I.Suspended matter
1.Physico-chemical definitions
(a) ‘Dust'means a disperse distribution of solids in air, brought about
by mechanical processes or stirred up.
(b) ‘Fume' means a disperse distribution of solids in air, brought
about by thermal and/or chemical processes.
(c) ‘Mist' means a disperse distribution of liquids in air, brought
about by condensation or dispersion.
2.Occupational medicine and toxicological definitions of particle popu-
lations
(a) Dusts, like fumes and mists, fall into the category of suspended
matter.
In assessing the health risks of suspended matter, account must be
taken of particle size as well as specific dangerous effect, concen-tration and exposure time.
(b) Only part of the total suspended matter within a worker’s
breathing area is inhaled. This is termed the inspirable fraction.
Important factors here are the inspiration rate around the nose and
mouth and flow conditions about the head.
(c) Depending on its size, the inspirable fraction may be deposited in
various areas of the respiratory tract.
Deposition has, inter alia, a considerable effect on the point and
nature of noxious effect.
The fraction of the inspirable fraction reaching the alveoli is
called the respirable fraction.
The respirable fraction is of particular interest in occupational
medicine.
II.Limit value
(a) The limit value is stated as the eight-hour time-weighted average
concentration of exposure of a substance in gaseous, vaporous orsuspended form in the air at the workplace.
Exposure means the presence of a chemical agent in the air within the
breathing area of a worker.
It is described in terms of concentration over a reference period.This section does not concern limit values for biological indicators.
(b) In addition it may be necessary to limit, for certain substances,
permissible upward excursions from the average eight-hour time-weighted exposure to substances for shorter terms.
Monitoring then relates to the average concentration of the substance
for the shorter term in question.
(c) The limit value for gases and vapours is stated in terms independent
of temperature and air pressure variables in ml/m
3(ppm) and in terms
dependent on those variables in mg/m3for a temperature of 20 °C
and a pressure of 101,3 kPa.
The limit value for suspended matter is given in mg/m3for operating
conditions at the workplace.
B. ASSESSMENT OF EXPOSURE AND MEASURING STRATEGY
1.Basics
(a) If the presence of one or more agents in gaseous, vaporous or
suspended form in the air at the workplace cannot for certain be ruledout, an assessment must be made to see whether the limit values arecomplied with.
1980L1107 — EN — 01.01.1995 — 001.001 — 10
▼M1
(b) In this assessment, all points which might be relevant to exposure
must be carefully looked into, for example:
— agents used or produced,— operations, technical installations and processes,— temporal and spatial distribution of concentrations of agents.
(c) A limit value is complied with if the assessment shows that exposure
does not exceed it.
If the information obtained is insufficient to establish reliably whether
the limit values are complied with, it must be supplemented byworkplace measurements.
(d) If the assessment shows that a limit value is not complied with:
— the reasons for the limit being exceeded must be identified and
appropriate measures to remedy the situation must be imple-mented as soon as possible,
— the assessment must be repeated.
(e) If the assessment shows that the limit values are complied with,
subsequent measurements at appropriate intervals must, if necessary,be taken to ensure that the situation continues to prevail.
The nearer the concentration recorded comes to the limit value, the
more frequently measurements must be taken.
(f) If the assessment shows that, on a long-term basis, owing to the
arrangement of the work process, the limit values are complied withand there is no substantial change in conditions at the workplacelikely to lead to a change of workers’ exposure, the frequency ofchecks on compliance through measurements may be curtailed.
In such cases, however, it must regularly be checked whether the
assessment leading to that conclusion is still applicable.
(g) If workers are exposed simultaneously or consecutively to more than
one agent, this fact must be taken into consideration in evaluating thehealth risk towhich they are expo sed.
2.Requirements for persons who carry out measurements
Those carrying out measurements must possess the necessary expertise
and facilities.
3.Requirements for measuring procedures
(a) The measuring procedure must give results represesentative of worker
exposure.
(b) To ascertain the exposure of the worker at the workplace, where
possible personal sampling devices should be used, attached to work-ers’ bodies.
Where a group of workers is performing identical or similar tasks at
the same place and has similar exposure, sampling such as to berepresentative of the group may be carried out within that group.
Fixed-point measuring systems may be used if the results make it
possible to assess exposure of the worker at the workplace.
Samples should as far as possible be taken at breathing height and in
the immediate vicinity of workers.
If in doubt, the point of greatest risk is to be taken as the measuring
point.
(c) The measuring procedure used must be appropriate to the agent to be
measured, its limit value and the workplace atmosphere.
The result must show the concentration of the agent exactly and in the
same terms as the limit value.
(d) If the measuring procedure is not specific to the agent to be meas-
ured, the full value recorded must be counted as applying to the agenttobe measured.
(e) The limits of detection, sensitivity and precision of the measuring
procedure must be appropriate to the limit value.
(f) The accuracy of the measuring procedure should be ensured.
(g) The measuring procedure must have been tested under practical
conditions of use.
(h) If the European Committee for Standardization (CEN) publishes
general requirements for the performance of measuring proceduresand devices for workplace measurements together with provisions on
1980L1107 — EN — 01.01.1995 — 001.001 — 11
▼M1
testing, they should be referred to when selecting appropriate meas-
uring procedures.
4.Measurement specifications for detecting representative particle
populations in the air at the workplace
(a) Suspended matter concentration should be measured in relation to
effect; therefore, when sampling, either the inspirable fraction or therespirable fraction should be measured.
This requires particle separation according to aerodynamic diameter
equivalent to the deposition occurring in breathing.
Since appropriate equipment for workplace sampling is not yet avail-
able, practical specifications for uniform measurement are needed.
(b) The fraction of suspended matter which can be breathed in by a
worker through the mouth and/or the nose is deemed to be inspirable.
By way of example, in measurement practice, devices with an inspira-
tion rate of 1,25 m/s +/- 10 % or devices in conformity with ISO/TR7708 1983 (E) are used for sampling.
In the first of these two cases, cited by way of example:
— with sampling devices attached to the person, the inlet should be
directed parallel to the worker’s face throughout sampling,
— with fixed-point sampling, the position and shape of the inlet
should enable samples representative of workers’ exposurecovering various directions of flow to be taken,
— the position of the sampling device inlet is of little significance
where there are very low flow rates for the surrounding air,
— with surrounding flow rates of 1 m/s and above, omnidirectional
sampling in the horizontal plane is recommended.
(c) The respirable fraction of suspended matter comprises a population
passed through a separation system equivalent in its effect to thetheoretical separation function of a sedimentation separator giving50 % separation of particles with an aerodynamic diameter of 5 µm
(Johannesburg Convention, 1979).
(d) If the CEN establishes specifications for the collection of suspended
material at the workplace, they should be applied, by way of prefer-ence.
Other methods may be used provided that they yield the same conclu-
sion or a stricter conclusion in relation to compliance with the limitvalues.
1980L1107 — EN — 01.01.1995 — 001.001 — 12
▼B
ANNEX III
Technical aspects referred to in Article 8 (3)
1. Sampling procedures and measuring methods (including quality control) with
respect tothe limit values in sofar as such pro cedures and metho ds have noeffect on the quantitative significance of those limit values.
2. Practical recommendations on medical surveillance before and during
exposure and after such exposure has ceased and keeping of records on theresults of such medical surveillance.
3. Practical procedures regarding the establishment and keeping of records
concerning ambient measurement results and lists of exposed workers.
4. Practical recommendations for alarm systems to be installed at workplaces
where abnormal exposures are likely to occur.
5. Practical recommendations for emergency measures to be taken in the event
of abnormal emissions.
6. Collective and individual protection measures for certain operations (e.g.
servicing and repairs) during which it cannot be guaranteed that concentra-tions or intensities of the agents will be kept below the limit values.
7. Procedures regarding general hygiene requirements, and means of ensuring
personal hygiene.
8. Signs toidentify areas where significant expo sure is likely too ccur and to
indicate the precautions which have to be taken.