Pursuant to Article 12, paragraph 1 of the Health and Safety at Work Act (Official Gazette
59/96, 94/96, 114/03 and 100/04), the Minister of the Economy, Labour and
Entrepreneurship, upon approval of the Minister of Health and Social Welfare, hereby issues
the
ORDINANCE
ON THE PROTECTION OF WORKERS FROM RISKS
RELATED TO EXPOSURE TO CARCINOGENS AND/OR
MUTAGENS
CHAPTER I
I GENERAL PROVISIONS
Article 1
This Ordinance regulates the obligations of employers in terms of the protection of the safety
and health of workers from risks related to occupational exposure to carcinogens and/or
mutagens and the prevention of such risks. The provisions of this Ordinance relating to
carcinogens and/or mutagens are also applicable, mutatis mutandis, to preparations containing
carcinogens and/or mutagens.
This Ordinance lays down the minimum requirements for protection, including limit values.
The provisions of this Ordinance shall not apply to cases of exposure of workers to ionising or
non-ionising radiation.
The provisions of the Health and Safety at Work Act shall fully apply to the entire area
referred to in paragraph 1, without prejudice to more stringent and/or specific provisions of
this Ordinance.
This Ordinance shall not apply to work activities involving asbestos or asbestos-containing
products, unless the provisions of this Ordinance prescribe a higher level of safety and health
at work.
Definitions
Article 2
For the purposes of this Ordinance, the following terms have the following meanings:
Carcinogens shall be defined as:
- those substances which, pursuant to special regulations, meet the criteria for the
classification into such substances and which are marked with standard risk-phrases R 45
and/or R 49;
- substances that workers are exposed to during work activities involving procedures listed in
Annex I;
- substances marked CA-1 in accordance with the Ordinance on maximum permissible
concentrations of harmful substances in the atmosphere of work premises and areas and on
biological limit values;
2
- preparations containing carcinogens determined as carcinogenic pursuant to special
regulations.
Mutagens shall be defined as:
- those substances which, pursuant to special regulations, meet the criteria for the
classification into such substances and labelled with a warning sign R 46, and their
preparations determined as mutagenic pursuant to special regulations.
Work shall be defined as all activities during which workers are exposed or could be exposed
to carcinogens and/or mutagens, and in particular during their use, production, storage,
treatment, processing, decanting, blending, disposal, destruction and similar activities. These
activities shall also include those which involve procedures resulting in release or generation
of carcinogens and/or mutagens.
The working environment is the environment in which the worker may come into contact with
carcinogens and/or mutagens during the work process.
Limit value shall be defined as a time-weighted average concentration of airborne carcinogen
or mutagen within a worker's breathing zone over an eight-hour working day exposure.
The competent authorities, each within its field of competence, are: the ministry responsible
for labour, the ministry responsible for health, the Croatian Institute for Occupational
Medicine, the Croatian National Institute of Public Health and the body responsible for labour
inspection.
Scope - determination and assessment of risks
Article 3
1. The provisions of this Ordinance shall apply to activities during the performance of which
workers are or may be exposed to carcinogens or mutagens.
2. In the performance of activities where workers come or may come into contact with
carcinogens and/or mutagens, the employer shall, pursuant to the provisions of the Ordinance
on risk assessment, determine the nature, degree and duration of workers’ exposure in order to
assess any risk to the safety and health of workers performing these activities. On the basis of
such assessment, the employer must undertake the necessary protective measures.
3. The employer must renew regularly the assessment referred to in the previous paragraph,
especially in the event of any change in the conditions which may affect workers’ exposure to
carcinogens and/or mutagens.
4. The assessment of risk shall be drawn in a written form by the employer and at the request
of the competent authority, the employer shall supply the competent authority with the
information used in making the assessment.
5. The risk assessment referred to in item 2 of this Article shall also include all cases of
maximum permissible exposure of workers and cases where absorption of carcinogens and/or
mutagens into the skin and/or through the skin may occur.
6. The employer shall take particular care when carrying out risk assessment for jobs where
young people or pregnant women or nursing mothers may come into contact with carcinogens
and/or mutagens, and shall take particular care not to assign to such jobs workers below 18
years of age, and pregnant women and nursing mothers.
3
CHAPTER II
EMPLOYER’S OBLIGATIONS
Restriction of use and replacement
Article 4
1. The employer shall replace carcinogens and/or mutagens at the place of work with harmless
or less harmful substances or preparations. If this is not possible, the employer shall restrict
the use of carcinogens and/or mutagens at the place of work to the lowest possible extent.
2. The employer shall take such organisational measures in order to ensure that the number of
workers exposed during regular work operations is kept at the lowest possible level.
3. At the request of competent authorities, the employer shall supply the results of the
examinations performed by authorised entities, the risk assessment made in accordance with
the Ordinance on risk assessment, and other documentation related to workers’ exposure to
carcinogens and/or mutagens.
Prevention and restriction of exposure
Article 5
1. Where the results of the assessment reveal a risk to the health or safety of workers, the
exposure of workers shall be prevented.
2. Where it is not technically possible to replace carcinogens or mutagens by substances,
preparations or procedures which, when respecting the conditions for their use, are not
dangerous or are less dangerous to health or safety, the employer shall ensure that the
carcinogens or mutagens are, in so far as is technically possible, manufactured and used in a
closed system.
3. Where a closed system is not technically possible, the employer shall prevent the release of
carcinogens and/or mutagens into the working environment by maintaining appropriate
subpressure in such a system.
The employer shall regularly monitor the subpressure, which shall be at least 20 Pa, with a
measuring device.
4. The exposure of workers shall not exceed the limit values for carcinogens set out in Annex
III.
5. With every use of carcinogens or mutagens, the employer shall apply all the following
measures:
(a) limit to the smallest possible level the quantity of carcinogens or mutagens at the place of
work;
(b) keep as small as possible the number of workers exposed or likely to be exposed;
(c) design work processes and engineer control measures so as to avoid or minimise the
release of carcinogens or mutagens into the working environment;
(d) remove carcinogens or mutagens at their source, by the local exhaust system or general
ventilation; all such methods must be appropriate and compatible with the requirements for
protection of public health and the environment;
4
(e) use the existing appropriate procedures for measurement of carcinogens or mutagens, in
particular for early detection of unusual exposures resulting from an unforeseeable event or
accident;
(f) apply suitable working procedures and methods;
(g) apply collective protection measures and/or, where exposure cannot be avoided by other
means, individual protection measures;
(h) apply hygiene measures, in particular regular cleaning of floors, walls and other surfaces;
(i) provide information to workers;
(j) demarcate risk areas and use appropriate warning and safety signs including “no smoking”
and “do not eat or drink or keep food” in areas where workers are exposed or likely to be
exposed to carcinogens and/or mutagens;
(k) draw up plans to deal with emergencies likely to result in unusually high exposure;
(l) apply means for safe storage, handling and transportation, in particular by using sealed and
clearly and visibly labelled containers;
(m) apply means for safe collection, storage and disposal of waste by workers, including the
use of sealed and clearly and visibly labelled containers.
Article 5.a
If technical measures referred to in the previous Article cannot prevent the release of
carcinogens and/or mutagens into the working environment, the employer shall provide for a
spatial separation of such work processes from other work processes and ensure safe
separation of carcinogens and/or mutagens.
The exhausted air may be re-introduced into the working environment provided it has been
purified from all carcinogens and/or mutagens.
The exhausted air containing group I carcinogens set out in Annex III, shall not be reintroduced into the working environment.
The employer shall ensure monitoring of the efficacy of the exhaust systems, to be performed
within the time limits set by the exhaust system producer or within the time limits set in the
main design of the building where the relevant premises are located, which shall in no case
exceed twelve months.
Release into the environment shall be done in accordance with the regulations governing the
environmental protection.
Article 5b
The employer shall provide reaction vessels so constructed that their interior does not need
frequent cleaning.
It shall be possible for the cleaning apparatus to be inserted into the vessel by means of
technical equipment in such a way that cleaning is possible with the vessel lid closed.
The employer shall ensure that the working areas in which carcinogens and/or mutagens are
used in the work process are cleaned regularly. Sweeping and airing these areas is forbidden.
Notification of the competent authority
5
Article 6
1. The employer shall notify the authority competent for labour inspection and the Croatian
Institute for Occupational Medicine in writing 30 days before each use of carcinogens and/or
mutagens.
2. The notification supplied by the employer shall comprise the data on:
(a) the activities and procedures carried out, including the reasons why carcinogens and/or
mutagens are used;
(b) identification of carcinogens and/or mutagens;
(c) the quantities of carcinogens and/or mutagens manufactured or used;
(d) the number of workers exposed to carcinogens and/or mutagens;
(e) the preventive technical and health measures taken;
(f) the type of personal protective equipment used;
(g) the nature, degree and duration of exposure;
(h) the cases of replacement of substances.
3. The obligation referred to in item 1 of this Article shall not apply to laboratories in which
carcinogens and/or mutagens are used only occasionally and in small quantities.
4. The employer shall update the notification supplied to the competent authorities in the case
of any change in the data referred to in the previous Article.
Unforeseeable exposure
Article 7
1. The employer shall immediately inform the workers of each case where in the course of
work a dangerous situation emerges or an accident occurs which may result in an
unforeseeable exposure of workers to carcinogens and/or mutagens.
2. Until the status is restored to normal and causes of the unforeseen exposures removed, the
employer shall:
- ensure that no other workers are present in the endangered zone except those informed about
the dangers and the harms, trained to work in a safe manner and essential for the carrying out
repairs and other necessary work;
- ensure protective clothing and appropriate personal respiratory protection equipment and
make sure that the workers use them;
- ensure that the exposure of an individual worker to carcinogens and/or mutagens is not
permanent and ensure that such exposure is kept to the shortest possible period of time;
- ensure that unprotected workers are not allowed to work in the affected area.
Foreseeable exposure
Article 8
1. For certain activities such as maintenance, rehabilitation, demolition, control, repair of
machines, equipment, apparatuses and buildings, in respect of which the employer foresees
6
that a significant increase in exposure of workers may occur, and in respect of which all
technical preventive measures for limiting workers’ exposure have already been undertaken,
the employer shall determine, after consultation with the workers or their representatives and
the competent work protection service or expert, the protective measures necessary to reduce
workers’ exposure and ensure the protection of the health and safety of workers while they are
engaged in such activities.
2. In accordance with the provision of the previous paragraph, the employer shall provide for
all the exposed workers the necessary personal protective equipment which they must use as
long as the foreseen exposure persists.
3. The employer shall reduce the exposure of each individual worker to the shortest possible
period of time.
The employer shall take appropriate measures to ensure that the areas in which the activities
referred to in item 1 of the first paragraph take place are clearly demarcated and indicated or
that unauthorised persons are prevented by other means from having access to such areas.
Access to risk areas
Article 9
The employer shall take appropriate measures to ensure that access to areas in which the
activities posing a risk for the health or safety of workers due to exposure to carcinogens and
or/mutagens are conducted, is authorised solely to workers who, for reasons of their work or
duties are required to enter them. Such areas shall be clearly demarcated and indicated.
Hygiene and individual protection
Article 10
1. The employer shall be obliged, in the case of all activities posing a risk of contamination
with carcinogens or mutagens, to take appropriate measures to ensure that:
(a) workers do not eat, drink or smoke in the areas where there is a risk of contamination with
carcinogens or mutagens;
(b) workers are provided with appropriate protective clothing or other appropriate special
clothing;
(c) separate storage places are provided for working clothing or protective clothing and for
ordinary clothes;
(d) workers are provided with appropriate and adequate washing and toilet facilities;
(e) protective personal equipment is properly stored in a well-designated place and that it is
checked and cleaned if possible before, and in any case, after each use;
(f) defective personal protective equipment is repaired or replaced before further use.
2. Workers may not be charged for the costs of the measures set out in item 1.
Informing and training of workers
Article 11
7
1. The employer shall ensure that the workers working with carcinogens and/or mutagens
receive training for such activities beforehand, in particular as regards:
(a) potential risks to health, including the additional risks related to smoking;
(b) precautions to be taken to prevent exposure;
(c) hygiene requirements;
(d) wearing and use of protective equipment and clothing;
(e) steps to be taken by workers, including rescue workers, in case of accidents and in order to
prevent accidents.
2. The training shall be designed to take account of new or changed risks and, if necessary,
the obligation of periodic checks of the training received shall be imposed.
3. The employer, in co-operation with the specialist in occupational medicine, shall provide
training for workers on health protection during work with carcinogens and/or mutagens
before they begin work, according to the established programme of the Croatian Institute for
Occupational Medicine.
4. The employer shall acquaint the workers in detail, before they begin work, with the
equipment used for processing, re-processing, treatment, blending, transportation etc. of
carcinogens and/or mutagens. The employer shall also acquaint the workers with the
containers, vessels and installations in any way connected to this equipment.
5. The employer shall ensure that the equipment and installations are labelled clearly and
legibly and display prominent warning and hazard indications.
Information for workers
Article 12
Appropriate measures shall be taken to ensure that:
(a) workers and/or any workers’ representatives responsible for health and safety at work may
check whether this Ordinance is applied and whether they can be involved in its application,
in particular with regard to:
- the consequences for workers’ safety and health of the selection, wearing and use of
protective clothing and equipment, without prejudice to the employer’s responsibility for
determining the effectiveness of protective clothing and equipment;
- the measures determined by the employer referred to in item 1 of the first paragraph of
Article 8, without prejudice to the employer’s responsibility for determining such measures;
(b) workers and/or any workers’ representatives responsible for health and safety at work are
informed as quickly as possible of unusual exposures, including those referred to in Article 8,
of the causes thereof and of the measures taken or to be taken to rectify the state;
(c) the employer keeps an updated list of the workers engaged in the activities in respect of
which the results of the assessment reveal a risk to workers’ health or safety, indicating, if
information is available, the exposure to which they have been subjected;
(d) specialists in occupational medicine and/or inspection bodies and other persons
responsible for health and safety at work have access to the list referred to in subparagraph
(c);
(e) each worker has access to the information on the list which relates to him personally;
8
(f) workers and/or any workers’ representatives responsible for health and safety at work have
access to anonymous collective information.
Consultation and participation of workers
Article 13
The employer must ensure consultation of workers and/or their representatives and their
participation in all issues regulated by this Ordinance and its Annexes, within the scope and in
the manner established by law and subordinate regulations.
CHAPTER III
MISCELLANEOUS PROVISIONS
Article 14
Health surveillance
The employer shall ensure preventive health checks for workers working with carcinogens
and/or mutagens before beginning and during their work at such jobs.
The employers shall ensure initial health checks for workers before they begin work.
Employers shall provide specific periodical or targeted preventive health checks for workers
exposed to carcinogens and/or mutagens in the course of their work.
The health of workers shall be monitored in accordance with the principles and practice of
occupational medicine.
Specific periodic health checks shall be conducted at maximum 12-month intervals.
In case of a suspected accident, the worker shall be referred for an extraordinary health check.
Based on an expert evaluation by a specialist in occupational medicine, the employer shall
refer the worker for a specific periodic or targeted health check ahead of the prescribed time
limit.
Workers shall have the right to a health check ahead of the prescribed time limit if it may be
justifiably presumed that their health problems are related to the work they do.
These measures ought to ensure health protection of workers and improved health and safety
at work in jobs where workers are exposed to carcinogens and mutagens.
At the request of a specialist in occupational medicine, labour inspection, or the Croatian
Institute for Occupational Medicine, the employer shall make available the information
relating to workers working with carcinogens and/or mutagens, the results of measurements of
concentrations of carcinogens and mutagens and the results of other measurements of load
levels and work place hazards.
The employer shall allow a labour inspector, a specialist in occupational medicine or a
specialist in occupational medicine from the Croatian Institute for Occupational Medicine to
examine the places of work where workers use carcinogens and/or mutagens.
If the specialist in occupational medicine establishes that there is an imminent risk to health or
that damage to health has already occurred, he or she shall:
- recommend to the employer in writing to reassess the risk, if he/she believes a worker’s
health is at risk because of the conditions at his or her work place,
9
- give medical advice to the worker in a written form,
- inform in writing the authority competent for labour inspection.
In the case of a deviation from normal values of the established concentrations of specific
substances or metabolites or some of the biological indicators in the body of a worker, the
specialist in occupational medicine shall inform the worker, but not the employer, in writing
of the results of the tests.
If changes of a worker’s health status are found which might result from exposure to
carcinogens and/or mutagens, the specialist in occupational medicine or the authority
competent for labour inspection may require the employer to conduct health checks of other
workers who have been similarly exposed.
In cases where health surveillance is carried out, an individual medical record shall be kept
and the doctor or the authority competent for health surveillance shall propose any protective
or preventive measures to be taken in respect of any individual worker.
Information and advice shall be given to workers regarding any health surveillance which
they may undergo following the cessation of exposure.
Workers shall have access to the results of the health surveillance which concern them and
shall have the right to request a review of the results of the health surveillance.
Employers shall have the right to request a review of the results of the health surveillance.
Practical recommendations for the health surveillance of workers are given in Annex II.
A specialist in occupational medicine shall notify all cases of cancer which might be related to
occupational exposure to carcinogens and/or mutagens to the authority competent for labour
inspection, the Croatian Institute for Occupational Medicine and the Croatian National
Institute of Public Health.
Record-keeping
Article 15
1. The employer shall keep a list of the workers engaged in the activities in respect of which
the results of the assessment reveal a risk to workers’ health and safety, indicating the
exposure to which they have been subjected and shall regularly update such a list in
accordance with any change in the data referred to in Article 5.
2. The employer shall keep the results of the measurements of concentrations of carcinogens
and/or mutagens at the workplace for at least forty years following the cessation of use of
carcinogens and/or mutagens.
3. The employer which has been using carcinogens and/or mutagens which terminates his
business activity, shall be obliged to submit to the Croatian Institute for Occupational
Medicine and the Croatian National Institute of Public Health the results of the measurements
of concentrations of carcinogens and/or mutagens at the workplace and the list of workers
referred to in item 1 of this Article.
4. As regards the conduct of health surveillance, individual records shall be kept of medical
check-ups in accordance with the law and subordinate legislation consisting of the following
data:
- name and surname,
- date and place of birth,
10
- address,
- date of employment and date of termination of employment,
- type of hazard at the workplace (risks, measured load levels , and harms),
- type of work, information on the beginning and end of each individual task,
- information on the time spent at the previous workplace where where there was a risk of
some form of harm or load,
- dates of preventive health checks and results of the initial examination, accompanied by a
professional assessment,
- date of the next preventive health check,
- information on the person who keeps the records.
5. Individual records of medical check-ups shall be kept for at least 40 years following the
cessation of exposure.
6. If the employer which has used carcinogens and/or mutagens terminates his business
activity, authorised institutions and specialists in occupational medicine pursuing a private
practice in occupational medicine which carried out health surveillance of this employer’s
workers, in accordance with the regulations governing occupational medicine, shall submit
the records on individual medical check-ups to the Croatian Institute for Occupational
Medicine and the Croatian National Institute of Public Health.
Limit Values
Article 16
1. The employer shall ensure the measurement, at maximum 1 year intervals, of
concentrations of carcinogens and/or mutagens at the workplace which:
- are marked with standard risk phrases R 45 and/or R 49;
- workers are exposed to while carrying out procedures set out in Annex I;
- are substances set out in Annex III;
- are marked with standard risk phrases R 45 and/or R 49;
- are marked CA-1 in accordance with the Ordinance on maximum permissible concentrations
of harmful substances in the atmosphere of work premises and areas and on biological limit
values;
- are preparations containing carcinogen substances determined as carcinogenic pursuant to
special regulations;
- are mutagens labelled with a warning sign R 46 and their preparations established as
mutagenic pursuant to special regulations.
.2. The employer shall notify the authority competent for labour inspection within 24 hours
about each case where limit values of carcinogens and/or mutagens listed in the Annex have
been exceeded. Depending on the extent to which the limit values have been exceeded, the
competent authority shall issue a decision on discontinuation of work activities or on the
conditions which have to be met if the work process is to be continued. Where the work
process may be continued, the employer shall, within three months from the date when it was
established that the limits have been exceeded, determine and eliminate the causes and make
11
control measurements, and notify thereof the authority competent for labour inspection. In
exceptional cases when the causes cannot be eliminated, the work process may be continued
exclusively subject to an approval from the authority competent for labour inspection and the
Croatian Institute for Occupational Medicine.
3. In case of a worker’s exposure to limit values of carcinogens and/or mutagens set out in
Annex III or in the Ordinance on maximum permissible concentrations of harmful substances
in the atmosphere of work premises and areas and on biological limit values, the employer
shall ensure that such work is not against a quota and that the worker does not work more than
full time and not more than forty hours a week.
4. The limit values and other directly related provisions are set out in Annex III and in the
Ordinance on maximum permissible concentrations of harmful substances in the atmosphere
of work premises and areas and on biological limit values.
Article 17
As regards the maximum permissible concentrations of benzene in the working environment,
instead of the values set out in Annex III to this Ordinance, the provisions of the Ordinance on
maximum permissible concentrations of harmful substances in the atmosphere of work
premises and areas and on biological limit values (Official Gazette 92/93) shall apply until 1
January 2009.
Article 18
This Ordinance shall enter into force on the eighth day after the day of its publication in the
Official Gazette.
Class: 115-01/06-01/09
Reg. No.: 526-08-03/3-07-2
Zagreb, 10 April 2007
The Minister
Branko Vukelić, m.p.
12
ANNEX I
List of substances, preparations and procedures
1. Manufacture of auramine.
2. Work involving exposure to aromatic polycyclic hydrocarbons present in soot, tar and coal
pitch.
3. Work involving exposure to dusts, fumes and sprays produced during roasting and
electrorefining of cupro-nickel mattes.
4. Strong acid processes in the manufacture of isopropyl alcohol.
5. Work involving exposure to hardwood dust 1 .
ANNEX II
Practical recommendations for the health surveillance of workers
(Article 14 paragraph 7)
1. The doctor and/or the authority competent for the health surveillance of workers exposed to
carcinogens or mutagens must be familiar with the conditions or circumstances of the
exposure of each worker.
2. Health surveillance of workers must be carried out in accordance with the principles and
practices of occupational medicine; it must include at least the following measures:
- keeping records of a worker’s medical and occupational history,
- personal interview,
- where appropriate, biological monitoring, and detection of early and reversible effects.
Further tests may be decided upon for each worker when he/she is the subject of health
surveillance, in the light of the most recent knowledge available in the field of occupational
medicine.
ANNEX III
Limit values for work exposure
Agent
Benzene
Vinyl chloride
monomer
1
EINECS
(1)
CAS
(2)
200-753-7
71-43-2
200-831
75-01-4
Limit value
Note
Transitional
measures
mg/m3
(3)
3.25
(5)
ppm
(4)
1 (5)
skin (6)
7.77
(5)
3(5)
-
Limit value:
3 ppm (=9.75
mg/m3)
-
For a list of some hardwood see Monographs on the Evaluation of Carcinogenic Risks to Humans, Vol. 62 –
“Wood Dust and Formaldehyde”, issued by the International Agency for Research on Cancer, Lyon, 1995.
13
Hardwood
dust
-
-
5.0(5)
(7)
(1) EINECS: European Inventory of Existing Chemical Substances.
(2) CAS: CAS number (Chemical Abstract Service Number).
(3) mg/m3 = milligram per cubic meter of air at 20°C and 101.3 kPa (760 mm Hg).
(4) ppm = parts per million by volume (ml/m3)
(5) Measured or calculated for an eight hour reference period.
(6) Considerable contribution to total skin load possible through skin exposure.
(7) A fraction that may be inhaled; in case of hardwood dust mixed with other types of wood
dust, this limit value refers to all types of wood dust found in the mixture.