HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 90/22
EN
Official Journal of the European Union
6.4.2011
COMMISSION REGULATION (EU) No 328/2011
of 5 April 2011
implementing Regulation (EC) No 1338/2008 of the European Parliament and of the Council on
Community statistics on public health and health and safety at work, as regards statistics on causes
of death
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
HAS ADOPTED THIS REGULATION:
Having regard to the Treaty on the Functioning of the European
Article 1
Union,
Scope
European statistics in the domain of ‘causes of death’ shall
Having regard to Regulation (EC) No 1338/2008 of the
concern all registered deaths and stillbirths occurring in each
European Parliament and of the Council of 16 December
Member State, distinguishing residents and non-residents.
2008 on Community statistics on public health and health
and safety at work ( 1 ), and in particular Article 9(1) thereof,
Article 2
Whereas:
Definitions
For the purpose of this Regulation, the following definitions
shall apply:
(1) Regulation
(EC)
No
1338/2008
establishes
a
common
framework for the systematic production of European
statistics on public health and health and safety at work.
(a) ‘death’ means the permanent disappearance of all evidence
of life at any time after live birth has taken place (post-natal
(2) Pursuant
to
Article
9(1)
of
Regulation
(EC)
No
cessation of vital functions without capability of resusci
1338/2008, implementing measures are needed to
tation). This definition excludes stillbirths;
specify the data and metadata to be provided on causes
of death covered by Annex III to that Regulation and to
set the reference periods and intervals for providing this
(b) ‘stillbirth’ means foetal death, namely death prior to the
data.
complete expulsion or extraction from its mother of a
product of conception, irrespective of the duration of
pregnancy. Death is indicated by the fact that after such
(3) Confidential
data
sent
by
Member
States
to
the
separation from its mother the foetus does not breathe or
Commission (Eurostat) should be handled in accordance
show any other evidence of life, such as beating of the
with the principle of statistical confidentiality as laid
heart, pulsation of the umbilical cord, or definite
down in Regulation (EC) No 223/2009 of the
movement of voluntary muscles;
European Parliament and of the Council of 11 March
2009 on European statistics ( 2 ) and with Regulation
(EC) No 45/2001 of the European Parliament and of
the Council of 18 December 2000 on the protection
(c) ‘gestational age’ means the duration of gestation, measured
of individuals with regard to the processing of personal
from the first day of the last normal menstrual period.
data by the Community institutions and bodies and on
Gestational age is expressed in completed days or
the free movement of such data (
completed weeks;

3 ).
(4) A
cost-benefit
analysis
has
been
carried
out
and
evaluated (d) ‘neonatal death’ means the death occurring among live
in accordance with Article 6 of Regulation (EC) No
births during the first 28 completed days of life (days 0-27);
1338/2008.
(e) ‘parity’ means the number of previous live births or
(5) The
measures
provided
for
in
this
Regulation
are
in
stillbirths (0, 1, 2, 3 or more previous live births or
accordance with the opinion of the European Statistical
stillbirths);
System Committee,
( 1 ) OJ L 354, 31.12.2008, p. 70.
( 2 ) OJ L 87, 31.3.2009, p. 164.
(f) ‘other deaths’ means the deaths occurring after the neonatal
( 3 ) OJ L 8, 12.1.2001, p. 1.
death period from the 28th completed day of life onwards;

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EN
6.4.2011 Official
Journal
of
the
European
Union L
90/23
(g) ‘underlying cause of death’ means the disease or injury
(b) birth weight of 1 000 g and more or when birth weight
which initiated the train of morbid events leading directly
does not apply gestational age after 27 completed weeks or
to death, or the circumstances of the accident or violence
when neither of the two applies crown-heel length of 35 cm
which produced the fatal injury;
or more (Variable 10).
(h) ‘resident’ means ‘usual resident’ in the place where a person
Article 4
normally spends the daily period of rest, regardless of
temporary absences for purposes of recreation, holidays,
Reference period
visits to friends and relatives, business, medical treatment
or religious pilgrimage.
The reference period shall be the calendar year.
The following persons alone shall be considered to be usual
Member States shall provide the data specified in this Regulation
residents of the geographical area in question:
to the Commission (Eurostat) within 24 months after the end of
the reference year.
(i) those who have lived in their place of usual residence for a
continuous period of at least 12 months before the
The first reference year shall be 2011.
reference date; or
(ii) those who arrived in their place of usual residence during
Article 5
the 12 months before the reference date with the intention
Metadata
of staying there for at least 1 year.
Relevant information, including information on national
differences regarding definitions, coverage of data, the Inter
Where the circumstances described in point (i) or (ii) cannot be
national Classification of Diseases (ICD) revision and updates
established, ‘usual residence’ shall mean the place of legal or
used and the automated coding systems, as well as information
registered residence.
about the selection and modification of the underlying cause of
death, shall be transmitted by Member States to the
Commission (Eurostat).
Article 3
Data required
Article 6
Member States shall transmit to the Commission (Eurostat) the
list of variables set out in the Annex. Whenever possible,
Provision of data and metadata to the Commission
statistics concerning deaths of residents dying abroad shall be
(Eurostat)
included.
Member States shall provide aggregated or micro data (finalised,
validated and accepted) and metadata required by this Regu
For stillbirths at least one of three reporting criteria shall be
lation in accordance with an exchange standard specified by
applied in the following order: (1) birth weight; (2) gestational
the Commission (Eurostat). Data and metadata shall be
age; and (3) crown-heel length. Data collection shall be limited
provided to Eurostat through the single entry point.
to the following groups:
Article 7
(a) birth weight from 500 g to 999 g or when birth weight
Entry into force
does not apply gestational age from 22 to 27 completed
weeks, or when neither of the two applies crown-heel
This Regulation shall enter into force on the 20th day following
length from 25 to 34 cm (Variable 9); and
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 Brussels, 5 April 2011.
For the Commission
The President
José Manuel BARROSO

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L 90/24
ANNEX
List of variables to send to the Commission (Eurostat)
Residents Non-residents
who
died
in
the
reporting
country
Variables
Stillbirths Neonatal
deaths Other
deaths Stillbirths Neonatal
deaths Other
deaths
EN

1) Year of death (date of occurrence)
C
C
C
C
C
C
2) Sex
V
C
C
V
C
C
3) Underlying cause of death ICD (4 digits)
V
C
C
V
C
C
4) Age (0 days, 1, 2, 3, 4, 5, 6 days, 7-27 days, 28-365 days, 1 year, 2, 3, 4,
X
C
C
X
C
C
5-9, … 85-89, … 105+)
5) Country of occurrence
V
C
C
V
C
C
Off
6) Region of occurrence (NUTS 2)
V C
(*) C
(*)
V
C
C
icial
7) Region of residence (NUTS 2)/Region of residence of the mother (NUTS 2)
V
C
C
V
V
V
Jour
8) Country of residence/Country of residence of the mother
X
X
X
V
C
C
nal
of
9) First group of stillbirth
V
X
X
V
X
X
the
— birth weight from 500 g to 999 g or when birth weight does not apply
European
— gestational age from 22 to 27 completed weeks or when neither of the two
applies
— crown-heel length from 25 to 34 cm
Union
10) Second group of stillbirth
V
X
X
V
X
X
— birth weight of 1 000 g and more or when birth weight does not apply
— gestational age after 27 completed weeks or when neither of the two applies
— crown-heel length of 35 cm or more
11) Age of mother by age group (less than 15 years of age, 5 years age groups
V
V
X
V
V
X
thereafter up to 49 years of age and 50 years of age or more)
12) Parity
V
V
X
V
V
X
N.B.: C - Compulsory; V - Voluntary; X - Not applicable.
(*) Voluntary for residents dying abroad.
6.4.2011

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