1982L0605 — EN — 12.08.1982 — 000.001 — 1
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►B COUNCIL DIRECTIVE
of 28July 198 2
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 8of Directive
80/1107/EEC)
(82/605/EEC)
(OJ L 247, 23.8.1982, p. 12)
Corrected by:
►C1Corrigendum, OJ L 283, 6.10.1982, p. 24 (82/605)
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COUNCIL DIRECTIVE
of 28July 198 2
on the protection of workers from the risks related to exposure to
metallic lead and its ionic compounds at work (first individualDirective within the meaning of Article 8of Directive 8 0/1107/EEC)
(82/605/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Havingreg ard to the Treaty establishingthe European Economic
Community, and in particular Article 100 thereof,
Havingreg ard to the proposal from the Commission(1),
Havingreg ard to the opinion of the European Parliament(2),
Havingreg ard 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 establishment of specific harmonized proced-
ures regarding the protection of workers with respect to lead;
Whereas Council Directive 80/1107/EEC of 27 November 1980 on the
protection of workers from the risks related to exposure to chemical,physical and biological agents at work (
5), lays down certain provisions
which have to be taken into account for this protection; whereas thatDirective provides for the layingdown in individual Directives of limitvalues and specific requirements for those agents listed in Annex I,which include lead;
Whereas metallic lead and its ionic compounds are toxic agents found
in a large number of circumstances at work; whereas many workers aretherefore exposed to a potential health risk;
Whereas, therefore, preventive measures for the protection of the health
of workers exposed to lead and the commitment envisaged for MemberStates with regard to the surveillance of their health are important;
Whereas workers exposed to lead in the extractive industries must enjoy
a level of health protection similar to that laid down in this Directive;whereas, given the specific nature of such activities, the implementationof such protection will need to be covered by special provisionsembodied in a subsequent Directive;
Whereas this Directive includes minimum requirements which will be
reviewed on the basis of experience acquired and of developments intechnology and medical knowledge in this area, the objective being toattain greater protection of workers,
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. This Directive, which is the first individual Directive within the
meaningof Article 8 of Directive 80/1107/EEC has as its aim theprotection of workers against risks to their health, including the preven-tion of such risks, arisingor likely to arise at work from exposure tometallic lead and its ionic compounds; it shall not apply to alkylatedlead compounds. It shall lay down limit values and other specificrequirements.
(1) OJ No C 324, 28. 12. 1979, p. 3.
(2) OJ No C 101, 4. 5. 1981, p. 14.
(3) OJ No C 300, 18. 11. 1980, p. 22.
(4) OJ No C 165, 11. 7. 1978, p. 1.
(5) OJ No L 327, 3. 12. 1980, p. 8.
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2. This Directive shall not apply to:
— sea transport,
— air transport,— miningand quarryingof lead-containingores and the preparation of
lead-ore concentrate at the site of the mine or quarry.
3. This Directive shall not prejudice the right of Member States to
apply or introduce laws, regulations or administrative provisionsensuring greater protection for workers or for a particular category ofworkers.
Article 2
1. Any work likely to involve a risk of absorbinglead shall be
assessed in such a way as to determine the nature and degree of theexposure to lead of the workers.
Annex I contains an indicative, non-exhaustive list of activities where
there is reason to consider that there may be a risk of absorbinglead.
2. If the assessment provided for in paragraph 1 reveals the presence
of at least one of the followingconditions:
— exposure to a concentration of lead in air greater that 40 µg/m
3,
calculated as a time-weighted average over 40 hours per week,
— a blood-lead level greater than 40 µgPb/100 ml blood in individual
workers,
the provisions regarding information set out in Article 11 (1) shall apply
and appropriate measures shall be taken to minimize the risk ofabsorbing lead which arises through smoking, eating and drinking at theplace of work.
3. If the assessment provided for in paragraph 1 reveals that the
blood-lead level of workers due to lead absorption is between 40 µgand
50µgPb/100 ml blood, Member States shall endeavour to carry out
biological monitoring of the workers concerned in accordance with theprocedures laid down by the Member States.
4. If the assessment provided for in paragraph 1 reveals the presence
of at least one of the followingconditions:
— exposure to a concentration of lead in air greater than 75 µg/m
3,
calculated as a time-weighted average over 40 hours per week,
— a blood-lead level greater than 50 µgPb/100 ml blood in individual
workers,
the protection provided for in this Directive, in particular the lead-in-air
monitoringand the medical surveillance set out in Articles 3 and 4, is tobe given to the workers concerned.
5. The assessment provided for in paragraph 1 shall be the subject of
consultation with the workers and/or their representatives within theundertakingor establishment and shall be revised where there is reasonto believe that it is incorrect or there is a material change in the work.
Article 3
1. All lead-in-air measurements shall be representative of worker
exposure to particles containinglead.
Particles containinglead within the meaningof this Directive shall be
those particles captured by equipment havingthe samplingcharacteris-tics specified in Annex II, point 1, and analyzed in accordance with themethods indicated in Annex II, point 2.
2. Monitoringof the concentration of lead in air shall take place at
least every three months.
This frequency may, however, be reduced in the cases listed in para-
graph 3.
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3. Frequency of monitoringmay be reduced to once a year, providedthat there is no material change in the work and conditions of exposure,where:
(i) the results of the measurements for individual workers or for groups
of workers have shown that on the previous two consecutive occa-sions on which monitoringwas carried out:
— the lead-in-air concentration did not exceed 100 µg/m
3,o r
— the conditions or exposure did not fluctuate appreciably, or
(ii) the blood-lead level of any worker does not exceed 60 µgPb/100
ml blood.
4. The monitoringfor a worker or g roup of workers, as stipulated in
paragraph 2, shall entail taking one or more air samples.
Without prejudice to the second indent of Article 7 (b), samplingshall
be carried out in such a way as to permit assessment of the probablemaximum risk to which the individual worker or workers are exposed,account beingtaken of the work done, the workingconditions and thelength of exposure during the course of the work. The workersconcerned and/or their representatives within the undertakingor estab-lishment shall be consulted to this end.
For the initial monitoring, after it has been established that the values
laid down in Article 2 (4) have been exceeded, the duration of thesamplingperiod shall not be less than four hours.
Subsequently this duration shall not be less than four hours if the results
obtained on the occasion of the precedingmonitoringhave shownhigher lead-in-air concentration values than those obtained before thatmonitoring.
Where groups of workers are performing identical or similar tasks in the
same location and are thus beingexposed to the same health risk,samplingmay be carried out on a g roup basis. In such a case, samplingshall be carried out for at least one worker out of 10.
5. The specifications referred to in paragraph 1 and Annex II, with
the exception of the specification concerningthe air intake velocitygiven at point 1 (a) of the Annex, and the technical aspects of thisArticle shall be adapted in the light of technical progress in accordancewith the procedure set out in Article 10 of Directive 80/1107/EEC,within the limits laid down in Annex III to that Directive.
Article 4
1. Workers shall be subject to medical (clinical and biological)
surveillance. This surveillance must start prior to or at the beginning ofthe exposure. The frequency of clinical assessment shall be at least oncea year duringthe period of employment. Biolog ical monitoringshall becarried out, in accordance with paragraph 2, at least every six months.
This surveillance shall take account not only of the magnitude of the
exposure but also of the individual worker’s susceptibility to lead.
2. The biological monitoring shall, apart from the exception
mentioned in paragraph 3, include measuring the blood-lead level(PbB).
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This monitoringmay also include measuringone or more of the
followingbiolog ical indicators:
▼C1
— delta aminolaevulinic acid in urine (ALAU),
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— zinc protoporphyrin (ZPP),
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— delta aminolaevulinic acid dehydratase in blood (ALAD).
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The methods of measuringthe biolog ical indicators referred to above
are listed in Annex III and may be adapted in accordance with theprocedure specified in Article 10 of Directive 80/1107/EEC.
3. The PbB measurement referred to in paragraph 2 may be replaced
by that of ALAU when dealingwith workers who have been subjectedfor a period of less than one month to risks of high exposure.
4. The frequency of biological monitoring 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 onwhich monitoringwas carried out, a lead-in-air concentration hig herthan the value laid down in the first indent of Article 2 (4) andlower than 100 µg/m
3,
— the PbB level of any individual worker does not exceed the value
laid down in the second indent of Article 2 (4).
5. Practical recommendations to which Member States may refer for
clinical assessment are set out in Annex IV and may be adapted inaccordance with the procedure set out in Article 10 of Directive 80/1107/EEC.
Article 5
1. Where the biological monitoring carried out in accordance with
Article 4 (2) reveals an individual PbB level higher than 60 µgPb/100
ml blood but lower than the limit value set out in Article 6 (1) (b), aclinical examination shall be carried out as soon as possible. However,this clinical examination may be deferred until a repeat determination ofthe PbB level, undertaken within one month, shows that the value of 60µgPb/100 ml blood continues to be exceeded.
Thereafter, biological monitoring and clinical assessment shall be
carried out at shorter intervals than those laid down in Article 4 (1) atleast until the PbB level is below 60 µgPb/100 ml blood.
2. Followingthe clinical examination referred to in parag raph 1, the
doctor or authority responsible for the medical surveillance of theworkers should advise on any protective or preventive measures to betaken on an individual basis; these may include, where appropriate, thewithdrawal of the worker concerned from exposure to lead or a reduc-tion in the period of his exposure.
Article 6
1. The followinglimit values shall be applied:
(a) lead-in-air concentration:
150 µg/m
3, calculated as a time-weighted average over 40 hours per
week;
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(b) value of the biological parameters:
PbB level in individual workers: 70 µg/Pb/100 ml blood (1).
However, a PbB level of between 70 and 80 µgPb/100 ml blood
shall be allowed if the ALAU level remains lower than 20 mg/gcreatinine or the ZPP level remains lower than 20 µg/g haemo-
globin or the ALAD level remains greater than six European units.
2. Where biological monitoring is based solely on ALAU measure-
ment in accordance with Article 4 (3), the followinglimit value shall beapplied for ALAU: 20 mg/g creatinine.
3. The Council, actingon a proposal from the Commission, and
taking into account in particular progress made in scientific knowledgeand technology as well as experience gained in the application of thisDirective, shall re-examine the limit values for the biological parameterswithin five years of adoption of this Directive, with a view to settingamaximum blood-lead limit value of 70 µgPb/100 ml blood.
Article 7
For the purpose of establishingwhether or not the lead-in-air limit value
fixed in Article 6 (1) (a) has been exceeded, it is appropriate to proceedas follows:
(a) If the total samplingperiod is of 40 hours in one week then the
lead-in-air concentrations obtained can be compared directly withthe limit value laid down in Article 6 (1) (a);
(b) If the total samplingperiod is less than 40 hours in one week then:
— the limit value laid down in Article 6 (1) (a) shall not be
considered as havingbeen exceeded if the concentrationobtained by samplingin accordance with Article 3 (4) is belowthe numerical level of the limit value,
— if the concentration referred to in the first indent exceeds the
numerical level of the limit value then at least three additionallead-in-air samples shall be taken which are representative ofaverage exposure to lead; the total period over which each ofthese three samples is taken shall be at least four hours.
If, from four samples taken over a period of one week, it is found
that three levels of concentration are below the numerical level ofthe limit value, then it shall be deemed that this limit value has notbeen exceeded.
Article 8
1. Where the lead-in-air limit value laid down in Article 6 (1) (a) is
exceeded the reasons for the limit beingexceeded shall be identifiedand appropriate measures to remedy the situation shall be taken as soonas possible.
The doctor or authority responsible for the medical surveillance of the
workers shall judge whether an immediate determination of the biolog-ical parameters of the workers concerned should be carried out.
In order to check the effectiveness of the measures mentioned in the
first subparagraph, a further determination of the lead-in-air concentra-tions on the basis of the procedures laid down in Articles 3 and 7 shallbe carried out.
2. Where the measures referred to in the first subparagraph of para-
graph 1 cannot, owing to their nature or magnitude, be taken within onemonth and a further determination of lead-in-air concentrations showsthat the lead-in-air limit values continue to be exceeded, work may notbe continued in the affected area until adequate measures have beentaken for the protection of the workers concerned, in the light of theopinion of the doctor or authority responsible for medical surveillance.
(1) Corresponds in SI units to 3 ·4µmol lead per litre blood.
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Where the exposure cannot reasonably be reduced by other means andwhere the wearingof individual respiratory protective equipment provesnecessary, this may not be permanent and shall be kept to the strictminimum necessary for each worker.
3. In the case of incidents likely to lead to significant increases in
exposure to lead, workers shall be immediately evacuated from theaffected area. Only workers whose presence is required to carry out thenecessary repairs may enter the affected area on condition that they usesuitable protective apparatus.
4. In the case of certain operations in respect of which it is foreseen
that the limit value set out in paragraph 1 will be exceeded and inrespect of which technical preventive measures for limitingconcentra-tions in the air are not reasonably practicable, the employer shall definethe measures intended to ensure protection of the workers duringopera-tions of this kind. The workers and/or their representatives in theundertakingor establishment shall be consulted on these measuresbefore such operations are effected.
Article 9
1. Where the biological limit value laid down in Article 6 (1) (b) has
been exceeded:
— the necessary steps shall be taken immediately to ascertain the
reasons for this excess and to remedy the situation. Such measuresmay, dependingon the mag nitude of the excess, and where it isconsidered desirable by the doctor or authority responsible for themedical surveillance of the workers include the immediate with-drawal of the worker concerned from all exposure to lead,
— a further determination of the PbB level shall be made within three
months. Followingthis determination, the worker concerned mustnot continue at his work or at any other work involvingan equal orgreater risk of exposure to lead if the biological limit valuecontinues to be exceeded. The worker concerned may be assigned,followingan opinion from the doctor or authority responsible formedical surveillance, to other work involvinga lesser risk ofexposure. In this case, he shall be subject to more frequent medicalassessments.
However, Member States may take different measures for workers who,
havingbeen exposed to lead over a number of years, have a very hig hbody burden of lead when this Directive becomes applicable.
2. The worker concerned or the employer may ask for a review of
the assessments referred to in paragraph 1.
Article 10
1. For all work carried out under the conditions set out in Article 2
(4), appropriate measures shall be taken to ensure that:
(a) (i) the risk of absorbing lead through smoking, eating or drinking
is avoided,
(ii) areas are set aside where workers can eat and drink without
riskingcontamination by lead,
(iii) in very hot workplaces where workers should be encouraged to
drink, workers are provided with drinkingwater or other drinksnot contaminated by the lead present in the workplace;
(b) (i) workers are provided with appropriate workingor protective
clothing, taking into account the physico-chemical propertiesof the lead compounds to which they are exposed.
(ii) this workingor protective clothingremains within the under-
taking. It may, however, be laundered in establishmentsoutside the undertakingwhich are equipped for this sort ofwork, if the undertakingitself does not carry out cleaning ;where this is the case, the clothingshall be transported inclosed containers,
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(iii) workingor protective clothingand street clothes are stored
separately,
(iv) workers are provided with adequate and appropriate washing
facilities, includingshowers in the case of dusty operations.
2. The cost of the measures taken pursuant to paragraph 1 shall not
be borne by the workers.
Article 11
1. For all work carried out under the conditions set out in Article 2
(2), appropriate measures shall be taken so that workers and theirrepresentatives in the undertakingor establishment are provided withadequate information on:
— the potential risks to health from lead exposure, includingthe poten-
tial risks for the foetus and infants beingbreast-fed,
— the existence of statutory limit values and the need for biological
and atmospheric monitoring,
— hygiene requirements, including the need to refrain from smoking,
eatingor drinkingat the workplace,
— the precautions to be taken as regards the wearing and use of
protective equipment and clothing,
— the special precautions to be taken to minimize exposure to lead.
2. In addition to the measures referred to in paragraph 1, for all work
carried out under the conditions set out in Article 2 (4), appropriatemeasures shall be taken so that;
(a) workers and/or their representatives within the undertakingor estab-
lishment have access to:
— the results of lead-in-air measurements,
— the statistical (non-personalized) results of biological
monitoring,
and explanations of the significance of these results are available to
them;
(b) if the results exceed the lead-in-air limit value laid down in Article
6 (1) (a) the workers concerned and their representatives in theundertakingor establishment are informed as quickly as possible ofthe excess and the reason for it and the workers and/or theirrepresentatives in the undertakingor establishment are consulted onthe measures to be taken or, in an emergency, are informed of themeasures which have been taken;
(c) each time PbB tests, ALAU tests or any other biological measure-
ments for assessinglead exposure are carried out, the workersconcerned are informed, on the authority of the doctor responsible,of the results of those measurements and the interpretation placedon the results.
Article 12
The doctor or authority responsible for medical surveillance of the
workers shall have access to all information necessary for determiningthe extent of workers’ exposure to lead, includingthe results of thelead-in-air monitoring.
Article 13
Steps shall be taken to ensure that individual data relatingto the
exposure of workers and their clinical and biological examinations arerecorded and stored in an appropriate form, in accordance with nationallaws and practices.
Article 14
1. Member States shall bringinto force the laws, reg ulations and
administrative provisions necessary to comply with this Directive by 1January 1986 at the latest and shall forthwith inform the Commissionthereof.
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2. Member States shall communicate to the Commission the texts ofthe provisions of national law which they adopt in the field covered bythis Directive.
Article 15
This Directive is addressed to the Member States.
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ANNEX I
List of activities referred to in the second subparagraph of Article 2 (1)
1. Handlingof lead concentrate.
2. Lead and zinc smeltingand refining(primary and secondary).3. Lead arsenate spray manufacture and handling.4. Manufacture of lead oxides.5. Production of other lead compounds (includingthat part of the production of
alkyl lead compounds, where it includes exposure to metallic lead and itsionic compounds).
6. Manufacture of paints, enamels, mastics and colours containinglead.7. Battery manufacture and recycling(
1).
8. Craftwork in tin and lead.9. Manufacture of lead solder.
10. Lead ammunition manufacture.11. Manufacture of lead-based or lead-alloy objects.12. Use of paints, enamels, mastics and colours containinglead.13. Ceramic and craft pottery industries (
1).
14. Crystal glass industries.15. Plastic industries usinglead additives.16. Frequent use of lead solder in an enclosed space.17. Printingwork involvingthe use of lead.18. Demolition work, especially the processes of scrapingoff, burningoff and
flame-cuttingexecuted on materials coated with paint containinglead, aswell as the breakingup of plant (e.g . lead furnaces) (
1).
19. Use of lead ammunition in an enclosed space.20. Automobile construction and repair work (
1).
21. Manufacture of leaded steel.22. Lead temperingof steel.23. Lead coating.24. Recovery of lead and metallic residues containinglead.
(1) Inasmuch as lead is used or is present.
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ANNEX II
Technical specifications referred to in the second subparagraph of Article 3
(1)
1. The equipment is that which complies with the technical specifications listed
below:
(a)Air intake velocity at the orifice: 1·2 5m / s±1 0% ;
(b)Air flow rate: at least 1 l/min.;
(c)Sampling head characteristics: a closed face samplinghead should be
used, to avoid filter contamination;
(d)Intake orifice diameter: at least 4 mm diameter in order to avoid wall
effects;
(e)Filter or intake orifice position: as far as possible kept parallel to the face
of the worker duringthe whole samplingperiod;
(f)Filter efficiency: a minimum of 95 % efficiency for all particles sampled
down to an aerodynamic diameter of 0 ·3µm;
(g)Filter homogeneity: maximum homogeneity of the lead content in the
filter to allow for comparison between two halves of the same filter.
2. The lead-in-air sample collected in accordance with the procedures in point 1
is to be analyzed by atomic absorption spectroscopy or any other methodwhich gives equivalent results.
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ANNEX III
Methods of measuring biological indicators referred to in Article 4 (2)
PbB: Atomic absorption spectroscopy,
ALAU: Davis (1) or equivalent method,
ZPP: Haematofluorimetry (2)or equivalent method,
ALAD: European standardized method (3)or equivalent method.
Appropriate quality control programmes will be established by the Commission.
(1) Davis J. R., and Andelman S. L. ‘Urinary delta-aminolevulinic acid levels in lead
poisoning. A modified method for the rapid determination of urinary delta-aminolevu-linic acid using disposable ion-exchange chromatographic columns'. Arch. Environ.Health 15, 53-9 (1967).
(
2) BlumbergW. E., Eising er J., Lamola A. A., and Zuckerman D. M. ‘Zinc protopor-
phyrin level in blood determination by a portable haematofluometer. A screeningdevice for lead poisoning'. J. Lab. Clin. Med. 89, 712-723 (1977).
(
3) (a) Council Directive 77/312/EEC of 29 March 1977 on biological screening of the
population for lead. OJ No L 105, 28. 4. 1977, p. 10 (Annex III).
(b) A. Berlin and K. H. Schaller ‘European standardized method for the determina-
tion ofdelta-aminolevulinic acid dehydratase activity in blood'. 3. Klin. Chem.Klin. Biochem. 12, 389-390 (1974).
1982L0605 — EN — 12.08.1982 — 000.001 — 13
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ANNEX IV
Practical recommendations for the clinical assessment of workers referred
to in Article 4 (5)
1. Current knowledge indicates that large-scale absorption may produce adverse
effects in the followingsystems:
— hematopoietic,
— gastro-intestinal,— central and peripheral nervous,— renal.
2. The doctor in charge of the medical surveillance of the worker exposed to
lead should be familiar with the exposure conditions or circumstances of eachworker.
3. Clinical assessment of the workers should be carried out in accordance with
sound practice; it should include the followingmeasures:
— records of the worker’s medical and occupational history,
— physical examination and a personal interview with special attention to the
associated symptoms of early lead poisoning,
— evaluation of the pulonary status (for possible use of respiratory protective
equipment).
Blood analyses (and, in particular, establishment of the hematocrit level) and
urine analysis should be carried out duringthe first medical examination andthen regularly according to the doctor’s judgement.
4. In addition to the decisions based on the results of biological monitoring, the
examiningdoctor will establish the cases where exposure or continuedexposure to lead is contra-indicated. The most important of these contra-indi-cations are:
(i) — congenital abnormalities:
— thalassemia,
—G—6—P D deficiency;
(ii) — acquired conditions:
— anaemia,
— renal deficiencies,— hepatic deficiencies.
5. Use of chelatingag ents:
The prohphylactic use of chelatingag ents, sometimes called ‘preventive ther-
apy'is medically and ethically unacceptable. Many chelatingag ents may beconsidered nephrotoxic when administered for longperiods.
6. Intoxication therapy:
To be carried out by specialists.