2006/216/EC: Commission Decision of  16 March 2006  on the publication of the references of standard EN 143:2000  Respiratory Devices — Particle filters — Requirements, testing, marking  in accordance with Council Directive 89/686/EEC (personal protective equipment)  (notified under document number C(2006) 777)   (Text with EEA relevance)
Date: 2006-03-16
Institutions: European Commission
Subjects: European standard, defective product, product safety, protective equipment, technical regulations

L 80/76

EN

Official Journal of the European Union

17.3.2006

COMMISSION DECISION

of 16 March 2006
on the publication of the references of standard EN 143:2000 ‘Respiratory Devices — Particle
filters — Requirements,
in accordance with Council Directive 89/686/EEC

testing, marking’

(personal protective equipment)

(notified under document number C(2006) 777)

(Text with EEA relevance)

(2006/216/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

references of
harmonised standards.

the national

standards

transposing the

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Directive 89/686/EEC of 21
December 1989 on the approximation of
the
Member States relating to personal protective equipment (1),
and in particular Article 6(1) thereof,

the laws of

Having regard to the opinion of the Standing Committee set up
pursuant to Article 5 of Directive 98/34/EC of the European
Parliament and of the Council of 22 June 1998 laying down a
procedure for the provision of
information in the field of
technical standards and regulations (2),

Whereas:

(1)

(2)

Directive 89/686/EEC provides that personal protective
equipment may be placed on the market and brought
into service only if it preserves the health and ensures
the safety of users without prejudice to the health or
safety of other individuals, domestic animals or goods,
when properly maintained and used for its intended
purpose.

Pursuant to Article 5 of Directive 89/686/EEC, personal
protective equipment bearing the CE marking and with
respect to which the manufacturer is able to produce the
declaration of conformity and the EC type-examination
certificate issued by a notified body attesting to its
conformity to the relevant national standards transposing
the harmonised standards, the references of which have
been published in the Official
the European
Union by the Commission, is to be presumed to satisfy
the basic health and safety requirements referred to in
Article 3 of Directive 89/686/EEC and set out in Annex
II thereto. Member States are required to publish the

Journal of

(1) OJ L 399, 30.12.1989, p. 18. Directive as last amended by Regu-
lation (EC) No 1882/2003 of the European Parliament and of the
Council (OJ L 284, 31.10.2003, p. 1).

(2) OJ L 204, 21.7.1998, p. 37. Directive as last amended by the 2003

Act of Accession.

(3)

(4)

(5)

Pursuant to Article 6(1) of Directive 89/686/EEC, the
Commission and France have lodged a formal objection
that standard EN 143:2000 ‘Respiratory
to the effect
Devices — Particle filters — Requirements,
testing,
marking’, approved by the European Committee for Stan-
dardisation (CEN) on 7 January 2000 and the references
of which were first published in the Official Journal on
24 January 2001 (3), does not completely satisfy the basic
health and safety requirements referred to in Article 3 of
Directive 89/686/EEC with respect to particle filters, the
filtering efficiency of which is exclusively or partially
achieved by the use of materials based on non-woven
electrically-charged fibres, hereinafter referred to as ‘elec-
trostatic filters’.

the test procedure for

filter penetration as set out

On the basis of the results of tests on the filtering effi-
ciency of the various types of particle filters, there is
the
substantive evidence that
measuring of
in clauses
last sentence, of
8.7.2.4,
to which the
standard
taken three minutes
measurement of penetration is
to ensure
test,
the aerosol
after
compliance with basic health and safety requirement
3.10.1 (Respiratory protection) of Annex II to Directive
89/686/EEC with respect to electrostatic filters.

last sentence, and 8.7.3.4,
according

EN 143:2000,

the start of

fails

Specifically,
it has been observed that the filtering effi-
ciency of this type of filter can deteriorate rapidly during
use. The filtering efficiency as determined according to
the standardised test procedure — three minutes after the
the test — can become meaningless at any
start of
instance beyond these three minutes. The filtering effi-
ciency drop can be drastic and therefore compromise the
efficiency class allocated to an electrostatic filter and the
information related to it. When the allocation to an
efficiency class is deemed not correct during the period
of use,
the resulting potential exposure to dangerous
airborne particulates can seriously harm the health and
safety of the user. Test results point to a loss of filter
efficiency of electrostatic filters also when used intermit-
tently.

(3) OJ C 21, 24.1.2001, p. 2.

17.3.2006

EN

Official Journal of the European Union

L 80/77

(6)

(7)

(8)

In view of these findings, clauses 8.7.2.4, last sentence,
and 8.7.3.4, last sentence, of standard EN 143:2000 also
fail to ensure compliance with basic health and safety
requirements 1.1.1 (Ergonomics), 1.1.2.1 (Highest level
of protection possible) and 1.1.2.2 (Classes of protection
appropriate to different levels of risk) of Annex II to
Directive 89/686/EEC with respect
to electrostatic
In addition, clause 10 of the standard fails to
filters.
ensure
safety
compliance with basic health and
requirement 1.4(b) (Information supplied by the manu-
facturer), since no warning of the deterioration of the
filtering efficiency of electrostatic filters over time is
required.

Accordingly, other related harmonised standards, which
either provide that testing is to be done in accordance
with standard EN 143:2000 or provide for a test
measurement procedure identical
in
standard EN 143:2000, also fail to ensure compliance
with the basic health and safety requirements of
Directive 89/686/EEC referred to above with respect to
electrostatic filters.

to that set out

the

described

At the request of the Commission the European Standar-
disation Organisation — CEN, Technical Committee
CEN/TC 79 ‘Respiratory protective devices’, has started
to
the revision of standard EN 143:2000 in order
address
this
revision, in the interest of safety and legal certainty, the
publication of the references of standard EN 143:2000
should be accompanied by an appropriate warning which
should also be taken into account as regards the related
harmonised standards. Member States should add an
identical warning in their national standards transposing
that harmonised standard.

shortcomings.

Pending

(9)

The references of harmonised standard EN 143:2000
should therefore be republished accordingly,

HAS ADOPTED THIS DECISION:

Article 1

The references of harmonised standard EN 143:2000 are
replaced by the text set out in the Annex.

Article 2

States publish the

to Article 5(4) of Directive 89/686/EEC,
Where, pursuant
Member
the national
references of
standards transposing the harmonised standard referred to in
Article 1,
they shall add to that publication a warning
identical to that provided for in the text set out in the Annex
to this Decision.

Article 3

This Decision is addressed to the Member States.

Done at Brussels, 16 March 2006.

For the Commission

Günter VERHEUGEN
Vice-President

L 80/78

EN

Official Journal of the European Union

17.3.2006

Publication of references of European harmonised standards in accordance with Council Directive 89/686/EEC
of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective
equipment

ANNEX

ESO (*)

Reference and title of the harmonised standard (and reference
document)

First
publication
in OJ

Reference of
superseded
standard

Date of
cessation of
presumption of
conformity of
superseded
standard (**)

CEN

EN 143:2000
Respiratory protective devices — Particle
Requirements, testing, marking

filters —

24.1.2001

EN
143:1990

Date expired
(31.8.2000)

Warning: As regards particle filters the filtering efficiency of which is exclusively or partially achieved by the use of materials based on non-
woven electrically-charged fibres, this publication does not concern clauses 8.7.2.4, last sentence, 8.7.3.4, last sentence, and 10 of the
standard, in respect of which there shall be no presumption of conformity with the basic health and safety requirements of Directive
89/686/EEC. This warning shall also be taken into account in the application of the following harmonised standards: EN 149:2001;
EN 405:2001; EN 1827:1999; EN 12083:1998; EN 12941:1998; EN 12941:1998/A1:2003; EN 12942:1998; EN 12942:1998/A1:2002;
EN 13274-7:2002.

(*)

ESO: European Standardisation Organisation:
— CEN: rue de Stassart/Stassartstraat 36, B-1050 Brussels, Tel. (32-2) 550 08 11; fax (32-2) 550 08 19 (http://www.cenorm.be)
— CENELEC: rue de Stassart/Stassartstraat 35, B-1050 Brussels, Tel. (32-2) 519 68 71; fax (32-2) 519 69 19

(http://www.cenelec.org)

— ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel. (33) 492 94 42 00; fax (33) 493 65 47 16 (http://www.etsi.org)

(**) Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European Standardi-
sation Organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be
otherwise.

NOTE:
— Any information concerning the availability of the standards can be obtained either from the European Standardi-
sation Organisations or from the national standardisation bodies of which the list is annexed to the Directive
98/34/EC.

— Publication of the references in the Official Journal of the European Union does not imply that the standards are available

in all the Community languages.

— This list replaces all the previous lists published in the Official Journal of the European Union. The Commission ensures

the updating of this list.

More information about harmonised standards on the Internet at http://europa.eu.int/comm/enterprise/newapproach/
standardization/harmstds/