RFU-PLG-013 Conformity to other regulations - CIRCA - Europa

RECOMMENDATION FOR USE RFU-PLG-013
CO-ORDINATION BETWEEN NOTIFIED BODIES
DIRECTIVES 96/48/EC AND 2001/16/EC ON THE
INTEROPERABILITY OF THE TRANS-EUROPEAN HIGH-SPEED
AND CONVENTIONAL RAILWAY SYSTEMS
TITLE
RECOMMENDATION FOR USE
Issue 05
Date: 20/07/2010
Page 1 of 3
OBLIGATION TO "CHECK CONFORMITY" TO "OTHER REGULATIONS ARISING FROM THE
TREATY".
ORIGINATOR SUBJECT RELATED TO
AEA TECHNOLOGY RAIL NOTIFIED BODY LTD
1127
DESCRIPTION AND BACKGROUND EXPLANATION
DIRECTIVE EC96/48 ANNEX VI AND TSI
SUBSYSTEM ASSESSMENT MODULES
This was previously discussed under QC 1127-01-02. Strategy Group 24/9/04 agreed
to make this an RFU.
Annex VI of the Directive (and by consequence TSI Subsystem Modules) require
Notified Bodies under this Directive to check and certify compliance with other
regulations deriving from the Treaty. This gives rise to two issues:
1. The term "other regulations" is unclear, since there are over 2,000 items listed in the
EU website relating to "legislation" including Council Decisions and other matters. It is
understood that the intention of this clause was to cover other Directives.
2. The obligation to meet other Directives and in turn to check/verify conformity and
issue certification falls to Contracting Entities and Notified Bodies under those other
Directives. For Notified Bodies under EC96/48 to be responsible for assuring all
relevant Directive certifications are present would latently require levels of knowledge
and competency against those other Directives. RFU 4 sought to have the obligation
removed, but was unsuccessful and the Schedule remains worded as it is. In order to
honour the wording of the Annex, yet not institute a seemingly unintended "policing"
role against Notified Bodies under EC96/48, the following interpretation is suggested.
RFU PROPOSAL
The interpretation of the text of Annex VI (1) second bullet point is:
1. The meaning of the term "other regulations" means, "other Directives of technical
harmonisation based on the principles of "New Approach" or "Global Approach".
2. During the course of subsystem verifications, the Notified Body under EC96/48 will
request evidence of conformity to all "other regulations" (as defined above) from the
Contracting Entity. The Contracting Entity will provide such conformity evidence as is
relevant and the Notified Body will include this without further consideration into the
Technical File. In order to consider any omissions from the evidence submitted and
raise queries with the Contracting Entity, the Notified Body will utilise a list of Directives
of credible relevance to the rail industry. The list will be derived from the appropriate
EU website. Directives of credible relevance to rail applications will be identified by NB
Rail and the list updated and agreed at each plenary meeting. The current list will be
made available on the CIRCA website. An example listing is given below.
The origin of the listing of Directives in Section A to D is taken from the EU website
"List of references of harmonised standards"

RECOMMENDATION FOR USE RFU-PLG-013
CO-ORDINATION BETWEEN NOTIFIED BODIES
DIRECTIVES 96/48/EC AND 2001/16/EC ON THE
INTEROPERABILITY OF THE TRANS-EUROPEAN HIGH-SPEED
AND CONVENTIONAL RAILWAY SYSTEMS
RECOMMENDATION FOR USE
Issue 05
Date: 20/07/2010
Page 2 of 3
(http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist.html).
An overview of the references of Directives based on the principles of “New Approach”
or “Global Approach” and harmonised standards can be found on this EU website.
Although it is updated regularly, it may not be complete and only publication in the
Official Journal produces legal effect.
Information provided on the above mentioned website ("List of references of
harmonised standards") is split into three columns
Text of Directive and Amendments (column 1)
The links provide access to the texts of the corresponding directives which are
accessible in all official Union languages on the EUR-Lex website.
The EUR-Lex site hosts the electronic version of the legal acts in force set out in the
Official Journal of the European Union, along with the Directory of Union legislation in
force which provides access to the texts of such legal acts and to information on their
dates of adoption, entry in force, application, end of validity and relationship with other
documents (amendments, corrections, legal basis, consolidated versions, etc).
The texts provided in the directory are intended for use as documentation tools and the
Institutions do not assume any liability for their content. For legal purposes please refer
to the texts published in the 'Official Journal of the European Union'.
Consolidated version of directive (column 2)
The links provide access to the consolidated texts of the Directives which are
accessible in all official Union languages on the EUR-Lex website.
Through consolidation, the basic instruments of European Union legislation, their
amendments and corrections at the moment of the release of the consolidated version
are integrated into a single, non-official document. Newer directives are not
implemented into the consolidated version before some time after publication and thus
have to be read in addition to the consolidated version.
These texts have no legal value and they are intended only for use as documentation
tools. The Institutions do not assume any liability for their content.
Subject (short title of directive). Lists of references of harmonised standards
and general information (column 3)
The links provide access to general information about the directive, to the publications
of the references of harmonised standards in the Official Journal and to the summary
lists of titles and references to harmonised standards of the corresponding directive.
The information contained in the summary lists is a compilation of the references of
standards which have been published in the Official Journal of the European Union.
Although the lists are updated regularly, they may not be complete and they do not

RECOMMENDATION FOR USE RFU-PLG-013
CO-ORDINATION BETWEEN NOTIFIED BODIES
DIRECTIVES 96/48/EC AND 2001/16/EC ON THE
INTEROPERABILITY OF THE TRANS-EUROPEAN HIGH-SPEED
AND CONVENTIONAL RAILWAY SYSTEMS
RECOMMENDATION FOR USE
Issue 05
Date: 20/07/2010
Page 3 of 3
have any legal validity; only publication in the Official Journal produces legal effect.
Information about references of harmonised standards which were recently published
in the Official Journal is available on the following website:
http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/whatsnew.html
(Grey-shaded Directives are perceived to have no relevance to Rail applications)
(Yellow shaded items are new since last issue)
PM 15 October 19th 2005 (Issue 03)
PM 26 June 17 th 2009 (Issue 04)
PM 29 June 16 th 2010 (Issue 05)
DATE OF AGREEMENT AT NB RAIL PLENARY MEETING
For a list of applicable Directives please refer to document “WKD-STR-004
Directives Listing - Annex to RFU-PLG-013” available on the NB Rail public
website in the RFU-section:
http://circa.europa.eu/irc/nbg/nbrail/info/data/en/information/nbrail/WKD/WKD-
STR-004%20Directives%20Listing.pdf