Regulation (EC) No 1338/2008 of the European Parliament and of the Council of 16 December 2008 on Community statistics on public health and health and safety at work (Text with EEA relevance)
Date: 2008-12-16
Institutions: Council of the European Union, European Parliament
Subjects: EU programme, EU statistics, action programme, occupational health, occupational safety, public health

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REGULATION (EC) No 1338/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 16 December 2008

on Community statistics on public health and health and safety at work

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-
PEAN UNION,

Having regard to the Treaty establishing the European Commu-
nity, and in particular Article 285(1) thereof,

Having regard to the proposal from the Commission,

programmes. Building on this work, a list of European
Community Health Indicators (ECHI) has now emerged
providing an overview of health status, determinants of
health and health systems. In order to make available the
minimum statistical data set needed for the calculation of
ECHI, Community statistics on public health should be
consistent, when relevant and possible, with the develop-
ments and achievements resulting from Community action
in the field of public health.

Having regard to the opinion of the European Economic and
Social Committee (1),

(3)

Acting in accordance with the procedure laid down in Article 251
of the Treaty (2),

Whereas:

(1)

Decision No 1786/2002/EC of the European Parliament
and of the Council of 23 September 2002 adopting a pro-
gramme of Community action in the field of public health
(2003-2008) (3), stated that the statistical element of the
information system on public health was to be developed
in collaboration with Member States using, as necessary,
the Community Statistical Programme to promote synergy
and avoid duplication. Decision No 1350/2007/EC of the
European Parliament and of the Council of 23 October
2007 establishing a second programme of Community
action in the field of health (2008-2013) (4) indicated that
its objective of generating and disseminating health infor-
mation and knowledge would be pursued by actions to
develop further a sustainable health monitoring system
with mechanisms for collection of comparable data and
information, with appropriate indicators, and to develop,
with the Community Statistical Programme, the statistical
element of this system.

(2)

Community information on public health has been devel-
oped systematically through the Community public health

(4)

Council Resolution of 3 June 2002 on a new Community
strategy on health and safety at work (2002-2006) (5)
called on the Commission and the Member States to step
up work in hand on harmonisation of statistics on acci-
dents at work and occupational illnesses, so as to have
available comparable data from which to make an objec-
tive assessment of the impact and effectiveness of the mea-
sures taken under the new Community strategy, as well as
emphasised, in a specific section, the need to take into
account the increase in the proportion of women on the
labour market and to respond to their specific needs in
relation to policies on health and safety at work. In addi-
tion, in its Resolution of 25 June 2007 on a new Commu-
nity strategy on health and safety at work (2007-2012) (6)
the Council called on the Commission to cooperate with
the legislative authorities in establishing an appropriate
European statistical system in the area of occupational
safety and health, which takes account of the different
national systems and avoids imposing additional adminis-
trative burdens. Finally, in its Recommendation of 19 Sep-
tember 2003 concerning the European schedule of
occupational diseases (7), the Commission recommended
that the Member States progressively make their statistics
on occupational diseases compatible with the European
schedule, in accordance with the work being done on the
system of harmonising European statistics on occupational
diseases.

The Barcelona European Council of 15 and 16 March 2002
recognised three guiding principles for the reform of health
care systems: accessibility for all, high-quality care and
long-term financial sustainability. The Commission Com-
munication of 20 April 2004 entitled ‘Modernising social

(1) OJ C 44, 16.2.2008, p. 103.
(2) Opinion of

the European Parliament of 13 November 2007
(OJ C 282 E, 6.11.2008, p. 109), Council Common Position of 2 Octo-
ber 2008 (OJ C 280 E, 4.11.2008, p. 1) and Position of the European
Parliament of 19 November 2008 (not yet published in the Official
Journal).

(3) OJ L 271, 9.10.2002, p. 1.
(4) OJ L 301, 20.11.2007, p. 3.

(5) OJ C 161, 5.7.2002, p. 1.
(6) OJ C 145, 30.6.2007, p. 1.
(7) OJ L 238, 25.9.2003, p. 28.

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protection for the development of high-quality, accessible
and sustainable health care and long-term care: support for
the national strategies using the “open method of coordi-
nation”’, proposed starting work to identify possible indi-
cators for joint objectives for developing care systems on
the basis of activities undertaken in the context of the
Community action programme for health, of Eurostat’s
health statistics and of cooperation with international
organisations.
In establishing such indicators, specific
attention should be devoted to the use and comparability
of self-assessed health as reported in surveys.

Decision No 1600/2002/EC of the European Parliament
and of the Council of 22 July 2002 laying down the Sixth
Community Environment Action Programme (1) includes
an action on environment and health and quality of life as
a key environmental priority, calling for the definition and
development of indicators of health and environment. In
addition, the Council Conclusions on Structural Indicators
of 8 December 2003 requested that indicators on biodiver-
sity and health be included, under the title ‘environment’,
in the structural indicators database used for the annual
Spring Report to the European Council; health and safety
at work indicators are also included in this database, under
the title ‘employment’. The set of sustainable development
indicators adopted by the Commission in 2005 also con-
tains a theme on public health indicators.

The Environment and Health Action Plan 2004-2010 rec-
ognises the need to improve the quality, comparability and
accessibility of data on health status for diseases and dis-
orders linked to the environment, using the Community
Statistical Programme.

maximum use should be made of sources and structures of
the European Statistical System,
in particular through
development of harmonised survey modules, to acquire
the internationally comparable statistical
information
needed for monitoring progress.

(8)

(9)

In order to ensure relevance and comparability of the data
and avoid duplication of work, the statistical activities of
the Commission (Eurostat) in the area of public health and
health and safety at work should be carried out in coop-
eration with the United Nations and its special organisa-
tions, such as the World Health Organisation (WHO) and
the International Labour Organisation (ILO), as well as the
Organisation for Economic Cooperation and Development
(OECD), when relevant and possible.

The Commission (Eurostat) already collects on a regular
basis statistical data on public health and health and safety
at work from the Member States, which provide such data
on a voluntary basis. It also collects data on those areas
through other sources. Those activities are developed in
close collaboration with Member States. In the area of pub-
lic health statistics in particular, development and imple-
mentation are steered and organised according to a
partnership structure between the Commission (Eurostat)
and Member States. However, greater accuracy and reliabil-
ity, coherence and comparability, coverage, timeliness and
punctuality of the existing statistical data collections are
still needed and it is also necessary to ensure that further
collections agreed and developed with the Member States
are implemented in order to achieve the minimum statis-
tical data set necessary at Community level in the areas of
public health and health and safety at work.

(10)

The production of specific Community statistics is gov-
erned by the rules set out in Council Regulation (EC)
No 322/97 of 17 February 1997 on Community
Statistics (3).

Council Resolution of 15 July 2003 on promoting the
employment and social integration of people with disabili-
ties (2) called on the Member States and the Commission to
collect statistical material on the situation of people with
disabilities, including on the development of services and
benefits for this group. In addition, the Commission in its
Communication of 30 October 2003 entitled ‘Equal
opportunities for people with disabilities: A European
Action Plan’, decided to develop context indicators, which
are comparable across Member States, in order to assess
the effectiveness of disability policies. It indicated that

(11)

This Regulation ensures full respect for the right to the pro-
tection of personal data as provided for in Article 8 of the
Charter of Fundamental Rights of the European Union (4).

(12) Directive 95/46/EC of the European Parliament and of the
Council of 24 October 1995 on the protection of individu-
als with regard to the processing of personal data and on
the free movement of such data (5) and Regulation (EC)
No 45/2001 of the European Parliament and of the

(5)

(6)

(7)

(1) OJ L 242, 10.9.2002, p. 1.
(2) OJ C 175, 24.7.2003, p. 1.

(3) OJ L 52, 22.2.1997, p. 1.
(4) OJ C 303, 14.12.2007, p. 1.
(5) OJ L 281, 23.11.1995, p. 31.

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Council of 18 December 2000 on the protection of indi-
viduals with regard to the processing of personal data by
the Community institutions and bodies and on the free
movement of such data (1) apply in the context of this
Regulation. The statistical requirements to which Commu-
nity action in the field of public health, national strategies
for the development of high-quality, accessible and sustain-
able health care and Community strategy on health and
safety at work gives rise, as well as requirements arising in
connection with structural indicators, sustainable develop-
ment indicators and ECHI and other sets of indicators
which it is necessary to develop for the purpose of moni-
toring Community and national political actions and strat-
egies in the areas of public health and health and safety at
work, constitute a substantial public interest.

(13)

The transmission of data subject to statistical confidential-
ity is governed by the rules set out in Regulation (EC)
No 322/97 and in Council Regulation (Euratom, EEC)
No 1588/90 of 11 June 1990 on the transmission of data
subject to statistical confidentiality to the Statistical Office
of the European Communities (2). Measures which are
taken in accordance with those Regulations ensure the
physical and logical protection of confidential data and
ensure that no unlawful disclosure and non-statistical use
occur when Community statistics are produced and
disseminated.

(14)

In the production and dissemination of Community statis-
tics under this Regulation, the national and Community
statistical authorities should take account of the principles
set out in the European Statistics Code of Practice, which
was adopted by the Statistical Programme Committee on
24 February 2005.

(15)

Since the objective of this Regulation, namely the establish-
ment of a common framework for the systematic produc-
tion of Community statistics on public health and health
and safety at work, cannot be sufficiently achieved by the
Member States and can therefore be better achieved at
Community level, the Community may adopt measures, in
accordance with the principle of subsidiarity as set out in
Article 5 of the Treaty. In accordance with the principle of
proportionality, as set out in that Article, this Regulation
does not go beyond what is necessary in order to achieve
that objective.

(1) OJ L 8, 12.1.2001, p. 1.
(2) OJ L 151, 15.6.1990, p. 1.

(16)

Recognising that the organisation and management of
health care systems are matters of national competence
and that the implementation of Community legislation on
workplaces and labour conditions is primarily the respon-
sibility of Member States, this Regulation ensures full
respect for Member States’ competence for public health
and health and safety at work.

(17)

It is important that gender and age be included in the
breakdown variables as this allows the impact of gender
and age differences on health and safety at work to be
taken into account.

(18)

The measures necessary for the implementation of this
Regulation should be adopted in accordance with Council
Decision 1999/468/EC of 28 June 1999 laying down the
procedures for the exercise of implementing powers con-
ferred on the Commission (3).

(19)

(20)

In particular, the Commission should be empowered to
adopt the implementing measures covering characteristics
of certain subjects and their breakdown, the reference peri-
ods, intervals and time limits for data provision as well as
provision of metadata. Since those measures are of general
scope and are designed to amend non-essential elements of
this Regulation, inter alia by supplementing it with new
non-essential elements, they must be adopted in accor-
dance with the regulatory procedure with scrutiny pro-
vided for in Article 5a of Decision 1999/468/EC.

Complementary financing for the collection of data in the
fields of public health and health and safety at work are to
be provided respectively within the frameworks of the sec-
ond programme of Community action in the field of health
(2008-13) and of the Community Programme for Employ-
ment and Social Solidarity — Progress (4). Within those
frameworks, financial resources should be used to help
Member States in further building up national capacities to
implement improvements and new tools for statistical data
collection in the fields of public health and health and
safety at work.

(21)

The European Data Protection Supervisor has been
consulted.

(3) OJ L 184, 17.7.1999, p. 23.
(4) Decision No 1672/2006/EC of the European Parliament and of the
Council of 24 October 2006 establishing a Community Programme
for Employment and Social Solidarity — Progress (OJ L 315,
15.11.2006, p. 1).

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(22)

The Statistical Programme Committee has been consulted
in accordance with Article 3(1) of Decision 89/382/EEC,
Euratom (1),

Article 3

Definitions

HAVE ADOPTED THIS REGULATION:

For the purpose of this Regulation:

Article 1

Subject matter

(a)

‘Community statistics’ shall have the meaning assigned to it
by the first indent of Article 2 of Regulation (EC) No 322/97;

This Regulation establishes a common framework for the
1.
systematic production of Community statistics on public health
and health and safety at work. The statistics shall be produced in
compliance with standards on impartiality, reliability, objectivity,
cost-effectiveness and statistical confidentiality.

2.
The statistics shall include, in the form of a harmonised and
common data set, information required for Community action in
the field of public health, for supporting national strategies for the
development of high-quality, universally accessible and sustain-
able health care as well as for Community action in the field of
health and safety at work.

(b)

‘production of statistics’ shall have the meaning assigned to
it by the second indent of Article 2 of Regulation (EC)
No 322/97;

(c)

‘public health’ shall mean all elements related to health,
namely health status, including morbidity and disability, the
determinants having an effect on that health status, health
care needs, resources allocated to health care, the provision
of, and universal access to, health care as well as health care
expenditure and financing, and the causes of mortality;

The statistics shall provide data for structural indicators, sus-
3.
tainable development
indicators and European Community
Health Indicators (ECHI), as well as for the other sets of indicators
which it is necessary to develop for the purpose of monitoring
Community actions in the fields of public health and health and
safety at work.

(d)

‘health and safety at work’ shall mean all elements related to
the prevention and protection of the health and safety of
workers at work in their current or past activities, in particu-
lar accidents at work, occupational diseases and other work-
related health problems and illnesses;

Article 2

Scope

Member States shall supply to the Commission (Eurostat) statis-
tics on the following domains:

— health status and health determinants, as defined in Annex I,

— health care, as defined in Annex II,

— causes of death, as defined in Annex III,

— accidents at work, as defined in Annex IV,

(e)

‘microdata’ shall mean individual statistical records;

(f)

‘transmission of confidential data’ shall mean transmission
between national authorities and the Community authority
of confidential data which do not permit direct identification,
in accordance with Article 14 of Regulation (EC) No 322/97
and with Regulation (Euratom, EEC) No 1588/90;

(g)

‘personal data’ shall mean any information relating to an
identified or identifiable natural person, in accordance with
the Article 2(a) of Directive 95/46/EC.

Article 4

Sources

— occupational diseases and other work-related health prob-

lems and illnesses, as defined in Annex V.

(1) Council Decision 89/382/EEC, Euratom of 19 June 1989 establishing
a Committee on the Statistical Programmes of the European Commu-
nities (OJ L 181, 28.6.1989, p. 47).

Member States shall compile data concerning public health and
health and safety at work from sources which shall, depending on
the domains and subjects and on the characteristics of the national
systems, consist of either household or similar surveys or survey
modules, or national administrative or reporting sources.

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Article 5

Methodology

Article 7

Transmission, treatment and dissemination of data

1.
The methods used for the implementation of the data col-
lections shall take into consideration, including in the case of pre-
paratory activities, national experience and expertise, and national
specificities, capacities and existing data collections, in the frame-
work of the collaborative networks and other European Statisti-
cal System (ESS) structures with Member States set up by the
Commission (Eurostat). The methodologies for regular data col-
lections which result from projects with a statistical dimension
carried out under other Community programmes such as the
public health or the research programmes shall also be taken into
consideration.

1. When necessary for the production of Community statis-
tics, Member States shall transmit the confidential microdata or,
depending on the domain and subject concerned, the aggregated
data, in accordance with the provisions on transmission of data
subject to confidentiality set out in Regulation (EC) No 322/97
and in Regulation (Euratom, EEC) No 1588/90. Those provisions
shall apply to the treatment of the data by the Commission (Euro-
stat), in so far as the data are considered confidential within the
meaning of Article 13 of Regulation (EC) No 322/97. Member
States shall ensure that the transmitted data do not permit the
direct identification of the statistical units (individuals) and that
personal data are protected in compliance with the principles laid
down in Directive 95/46/EC.

2.
The statistical methodologies and data collections to be
developed for the compilation of statistics on public health and
health and safety at work at Community level shall take into con-
sideration the need for coordination, whenever relevant, with the
activities of international organisations in the field, with a view to
ensuring international comparability of statistics and consistency
of data collections as well as avoiding duplication of effort and of
deliveries of data by Member States.

2. Member States shall transmit the data and metadata required
by this Regulation in electronic form, in accordance with an inter-
change standard agreed between the Commission (Eurostat) and
the Member States. The data shall be provided in accordance with
the time limits set out, at the intervals provided for, and in respect
of the reference periods indicated in the Annexes or in the imple-
menting measures adopted in accordance with the regulatory pro-
cedure with scrutiny referred to in Article 10(2).

Article 6

Pilot studies and cost-benefit analyses

3.
The Commission (Eurostat) shall take the necessary steps to
improve the dissemination, accessibility and documentation of
the statistical information, in accordance with the principles of
comparability, reliability and statistical confidentiality laid down
in Regulation (EC) No 322/97 and with Regulation (EC)
No 45/2001.

1. Whenever data are required in addition to those already col-
lected and to those for which methodologies already exist, or
when insufficient quality of data is identified in the domains
referred to in Article 2, the Commission (Eurostat) shall institute
pilot studies to be completed on a voluntary basis by the Member
States. The purpose of such pilot studies shall be to test the con-
cepts and methods and to assess the feasibility of the related data
collections, including statistical quality, comparability and cost
effectiveness, in accordance with the principles set up by the
European Statistics Code of Practice.

2. Whenever preparation of an implementing measure is
envisaged in accordance with the regulatory procedure with scru-
tiny referred to in Article 10(2), a cost-benefit analysis, taking into
account the benefits of the availability of the data in relation to
the cost of the data collection and the burden on Member States,
shall be carried out.

Article 8

Quality assessment

1.
For the purpose of this Regulation, the following quality
assessment dimensions shall apply to the data to be transmitted:

(a)

‘relevance’ shall refer to the degree to which statistics meet
the current and potential needs of users;

(b)

‘accuracy’ shall refer to the closeness of estimates to the
unknown true values;

(c)

‘timeliness’ shall refer to the time lag between the availability
of the information and the event or phenomenon it describes;

3.
The Commission (Eurostat) shall prepare a report evaluat-
ing the findings of the pilot studies and/or cost benefit analysis,
including the effects and implications of national specificities, in
cooperation with Member States, in the framework of the col-
laborative networks and other ESS structures.

(d)

‘punctuality’ shall refer to the time lag between the date of the
release of the data and the target date when it should have
been delivered;

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(e)

(f)

‘accessibility’ and ‘clarity’ shall refer to the conditions and
modalities by which users can obtain, use and interpret data;

‘comparability’ shall refer to the measurement of the impact
of differences in applied statistical concepts and measure-
ment tools and procedures when statistics are compared
between geographical areas, sectoral domains or over time;

(g)

‘coherence’ shall refer to the adequacy of the data to be reli-
ably combined in different ways and for various uses.

2.
Every five years each Member State shall provide the Com-
mission (Eurostat) with a report on the quality of the data trans-
mitted. The Commission (Eurostat) shall assess the quality of data
transmitted and publish the reports.

Article 9

Implementing measures

The implementing measures shall cover:

1.

(a)

These measures designed to amend non-essential elements of this
Regulation, inter alia, by supplementing it, shall be adopted in
accordance with the regulatory procedure with scrutiny referred
to in Article 10(2).

2.
If necessary, derogations and transition periods for Member
States, both to be based upon objective grounds, shall be adopted
in accordance with the regulatory procedure referred to in
Article 10(3).

Article 10

Committee

The Commission shall be assisted by the Statistical Pro-

1.
gramme Committee set up by Decision 89/382/EEC, Euratom.

2. Where reference is made to this paragraph, Articles 5a(1)
to (4) and 7 of Decision 1999/468/EC shall apply, having regard
to the provisions of Article 8 thereof.

the characteristics, namely variables, definitions and classifi-
cations of the subjects, covered in Annexes I to V;

3. Where reference is made to this paragraph, Articles 5 and 7
of Decision 1999/468/EC shall apply, having regard to the pro-
visions of Article 8 thereof.

(b)

the breakdown of characteristics;

(c)

the reference periods,
provision;

intervals and time limits for data

(d)

the provision of metadata.

These measures shall take account of, in particular, the provisions
of Article 5, Article 6(2) and (3) and Article 7(1), as well as the
availability, suitability and the legal context of existing Commu-
nity data sources after examination of all sources related to the
respective domains and subjects.

The period laid down in Article 5(6) of Decision 1999/468/EC
shall be set at three months.

Article 11

Entry into force

This Regulation shall enter into force on the twentieth day fol-
lowing that of its publication in the Official Journal of the European
Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Strasbourg, 16 December 2008.

For the European Parliament
The President
H.-G. PÖTTERING

For the Council
The President
B. LE MAIRE

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ANNEX I

Domain: Health status and health determinants

(a) Aims

The aim of this domain is the provision of statistics on health status and determinants.

(b)

Scope

This domain covers the statistics on health status and health determinants that are based on self-assessment and com-
piled from population surveys such as the European Health Interview Survey (EHIS), as well as other statistics compiled
from administrative sources such as those on morbidity or accidents and injuries. Persons living in institutions as well
as children aged 0-14 years shall be included, when appropriate and at the relevant ad hoc intervals, subject to suc-
cessful prior pilot studies.

(c) Reference periods, intervals and time limits for data provision

Statistics shall be provided every five years from the EHIS; a different frequency may be needed for other data collec-
tions, such as those on morbidity or accidents and injuries, as well as for some specific survey modules; the measures
relating to the first reference year, the interval and the time limit for provision of the data shall be adopted in accor-
dance with the regulatory procedure with scrutiny referred to in Article 10(2).

(d)

Subjects covered

The harmonised and common data set to be provided shall cover the following list of subjects:

— health status, including health perceptions, physical and mental functioning, limitations and disability,

— diagnosis-specific morbidity,

— protection against possible pandemics and transmissible diseases,

— accidents and injuries, including those related to consumer safety, and, whenever possible, alcohol- and drug-

related harm,

— lifestyle, such as physical activity, diet, smoking, alcohol consumption and drug-use, and environmental, social

and occupational factors,

— access and use of preventive and curative health care facilities, as well as of long-term care services (population

survey),

— background demographic and socio-economic information on the individuals.

Not all subjects are necessarily to be covered at the time of each data provision. The measures relating to the charac-
teristics, namely variables, definitions and classifications of the subjects listed above, and the breakdown of character-
istics, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(2).

The implementation of Health Examination Surveys shall be optional in the framework of this Regulation. The average
length of the interview per household shall not exceed one hour for the EHIS and 20 minutes for the other survey
modules.

(e) Metadata

The measures relating to the provision of metadata, including metadata concerning characteristics of surveys and other
sources used, population covered and information about any national specificity essential for the interpretation and
compilation of comparable statistics and indicators, shall be adopted in accordance with the regulatory procedure with
scrutiny referred to in Article 10(2).

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ANNEX II

Domain: Health care

(a) Aims

The aim of this domain is the provision of statistics on health care.

(b)

Scope

This domain covers the sum of activities performed either by institutions or individuals pursuing, through the appli-
cation of medical, paramedical and nursing knowledge and technology, the goal of health, including long-term care, as
well as related administration and management activities.

The data shall be compiled mainly from administrative sources.

(c) Reference periods, intervals and time limits for data provision

Statistics shall be provided annually. The measures relating to the first reference year, the interval and the time limit for
provision of the data shall be adopted in accordance with the regulatory procedure with scrutiny referred to in
Article 10(2).

(d)

Subjects covered

The harmonised and common data set to be provided shall cover the following list of subjects:

— health care facilities,

— health care human resources,

— health care utilisation, individual and collective services,

— health care expenditure and financing.

Not all subjects are necessarily to be covered at the time of each data provision. The data set shall be established fol-
lowing the relevant international classifications and taking into consideration the circumstances and practices in Mem-
ber States.

The mobility of patients, namely their use of health care facilities in a country other than their country of residence,
and of health professionals, such as those practising their profession outside the country where they obtained their first
licence, shall be considered in the data collections. The quality of health care shall also be considered in the data
collection.

The measures relating to the characteristics, namely variables, definitions and classifications of the subjects listed above,
and the breakdown of characteristics, shall be adopted in accordance with the regulatory procedure with scrutiny
referred to in Article 10(2).

(e) Metadata

The measures relating to the provision of metadata, including metadata concerning characteristics of sources and com-
pilations used, population covered and information about any national specificity essential for the interpretation and
compilation of comparable statistics and indicators, shall be adopted in accordance with the regulatory procedure with
scrutiny referred to in Article 10(2).

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ANNEX III

Domain: Causes of death

(a) Aims

The aim of this domain is the provision of statistics on the causes of death.

(b)

Scope

This domain covers the causes of death statistics as derived from national medical death certificates taking into account
WHO recommendations. The statistics to be compiled refer to the underlying cause which is defined by WHO as ‘the
disease or injury which initiated the train of morbid events leading directly to death, or the circumstances of the acci-
dent or violence which produced the fatal injury’. The statistics shall be compiled for all deaths and stillbirths occurring
in each Member State, distinguishing residents and non-residents. Whenever possible, data on causes of death for resi-
dents dying abroad shall be included in the statistics of their country of residence.

(c) Reference periods, intervals and time limits for data provision

Statistics shall be provided annually. The measures relating to the first reference year shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in Article 10(2). The data shall be submitted no later than
24 months after the end of the reference year. Provisional or estimated data can be provided earlier. In the case of
public-health incidents, additional special data collections may be established, either for all deaths or for specific causes
of death.

(d)

Subjects covered

The harmonised and common data set to be provided shall cover the following list of subjects:

— characteristics of the deceased,

— region,

— characteristics of the death, including the underlying cause of death.

The causes of death data set shall be established in the framework of the WHO International Classification of Diseases
and shall follow the Eurostat rules and the UN and WHO recommendations for population statistics. The provision of
data relating to the characteristics of stillbirths shall be on a voluntary basis. Provision of data relating to neonatal deaths
(deaths up to the age of 28 days) shall recognise national differences in practice regarding the recording of multiple
causes of death.

The measures relating to the characteristics, namely variables, definitions and classifications of the subjects listed above,
and the breakdown of characteristics, shall be adopted in accordance with the regulatory procedure with scrutiny
referred to in Article 10(2).

(e) Metadata

The measures relating to the provision of metadata, including metadata concerning population covered and informa-
tion about any national specificity essential for the interpretation and compilation of comparable statistics and indi-
cators, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(2).

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Official Journal of the European Union

L 354/79

ANNEX IV

Domain: Accidents at work

(a) Aims

The aim of this domain is the provision of statistics on accidents at work.

(b)

Scope

An accident at work is defined as ‘a discrete occurrence in the course of work which leads to physical or mental harm’.
The data shall be collected, for the entire workforce, for fatal accidents at work and accidents at work resulting in more
than three days of absence from work, using administrative sources complemented with relevant additional sources
whenever necessary and feasible for specific groups of workers or specific national situations. A limited subset of basic
data on accidents with less than four days of absence may be collected, when available and on an optional basis, in the
framework of the collaboration with the ILO.

(c) Reference periods, intervals and time limits for data provision

Statistics shall be provided annually. The measures relating to the first reference year shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in Article 10(2). The data shall be submitted no later than
18 months after the end of the reference year.

(d)

Subjects covered

The harmonised and common microdata set to be provided shall cover the following list of subjects:

— characteristics of the injured person,

— characteristics of the injury, including severity (days lost),

— characteristics of the enterprise including economic activity,

— characteristics of the workplace,

— characteristics of the accident, including the sequence of events characterising the causes and circumstances of the

accident.

The accidents-at-work data set shall be established in the framework of the specifications laid down by the European
Statistics on Accidents at Work (ESAW) methodology, taking into consideration the circumstances and practices in
Member States.

The provision of data relating to the nationality of the injured person, the size of the enterprise and the time of the
accident shall be on a voluntary basis. Concerning the ESAW-methodology Phase III subjects, namely the workplace
and the sequence of events characterising the causes and circumstances of the accident, a minimum of three variables
shall be provided. Member States should also supply more data conforming to the ESAW Phase III specifications on a
voluntary basis.

The measures relating to the characteristics, namely variables, definitions and classifications of the subjects listed above,
and the breakdown of characteristics, shall be adopted in accordance with the regulatory procedure with scrutiny
referred to in Article 10(2).

(e) Metadata

The measures relating to the provision of metadata, including metadata concerning population covered, the declara-
tion rates for accidents at work and, when relevant, sampling characteristics, as well as information about any national
specificity essential for the interpretation and compilation of comparable statistics and indicators, shall be adopted in
accordance with the regulatory procedure with scrutiny referred to in Article 10(2).

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Official Journal of the European Union

31.12.2008

ANNEX V

Domain: Occupational diseases and other work-related health problems and illnesses

(a) Aims

The aim of this domain is the provision of statistics on recognised cases of occupational disease and other work-related
health problems and illnesses.

(b)

Scope

— A case of occupational disease is defined as a case recognised by the national authorities responsible for recogni-
tion of occupational diseases. The data shall be collected for incident occupational diseases and deaths due to occu-
pational disease.

— Work-related health problems and illnesses are those health problems and illnesses which can be caused, wors-
ened or jointly caused by working conditions. This includes physical and psychosocial health problems. A case of
work-related health problem and illness does not necessarily refer to recognition by an authority and the related
data shall be collected from existing population surveys such as the European Health Interview Survey (EHIS) or
other social surveys.

(c) Reference periods, intervals and time limits for data provision

For occupational diseases, statistics shall be provided annually and submitted no later than 15 months after the end of
the reference year. The measures relating to the reference periods, the intervals and the time limits for provision of the
other data collections shall be adopted in accordance with the regulatory procedure with scrutiny referred to in
Article 10(2).

(d)

Subjects covered

The harmonised and common data set to be provided for occupational diseases shall cover the following list of subjects:

— characteristics of the diseased person, including gender and age,

— characteristics of the disease, including severity,

— characteristics of the enterprise and workplace, including economic activity,

— characteristics of the causative agent or factor.

The occupational diseases data set shall be established in the framework of the specifications laid down by the Euro-
pean Occupational Diseases Statistics (EODS) methodology, taking into consideration the circumstances and practices
in Member States.

The harmonised and common data set to be provided for work-related health problems shall cover the following list of
subjects:

— characteristics of the person suffering the health problem, including gender, age and employment status,

— characteristics of the work-related health problem, including severity,

— characteristics of the enterprise and workplace, including size and economic activity,

— characteristics of the agent or factor that caused the health problem or made it worse.

Not all subjects are necessarily to be covered at the time of each data provision.

The measures relating to the characteristics, namely variables, definitions and classifications of the subjects listed above,
and the breakdown of characteristics, shall be adopted in accordance with the regulatory procedure with scrutiny
referred to in Article 10(2).

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L 354/81

(e) Metadata

The measures relating to the provision of metadata, including metadata concerning population covered and informa-
tion about any national specificity essential for the interpretation and compilation of comparable statistics and indi-
cators, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(2).