Annex ZZ to harmonised standards Assessment by Consultant

1
Annex ZZ to harmonised standardsAssessment by
Consultant
Ingrid SoetaertHarmonised Standards Manager
2
GENERAL INFO

• Links between New Approach Directives and
  Standardisation
• Annex ZZ
• New Approach Consultants
• New CS procedures

3
GENERAL INFO

• Principles of the New Approach
• Harmonisation is limited to essential
  requirements (ERs)
• Only products fulfilling the ERs may be placed on
  the market and put into service
• Harmonised standards, the reference numbers of
  which have been published in the Official Journal
  and which have been transposed into national
  standards, are presumed to conform to the
  corresponding ERs
• Application of harmonised standards or other
  technical specifications remains voluntary, and
  the manufacturers are free to choose any
  technical solution that provides compliance with
  the ERs
• Manufacturers may choose between different
  conformity assessment procedures provided for in
  the applicable directive

4
THE PRINCIPLE
Law (mandatory)
Standard (voluntary)
New Approach Directives (ERs)
European Standard
MANDATE
5
ANNEX ZZ THE PRINCIPLE

• Presumption of conformity
• to what?
• which ERs?

C L A R I T Y ! ! !
A N N E X Z Z
6
ANNEX ZZ THE DETAIL
Agreement between the Commission and CENELEC

• all new harmonised standards offered after 01
  October 2004 are to contain an (informative)
  Annex ZZ.

• there is no retroactive action for those
  standards which have already been listed in the
  OJ unless new editions are offered.

7
ANNEX ZZ THE DETAIL
For amendments

• No Annex ZZ
• Unless the amendment alters the coverage of the
  ERs

• Example
• EN 504162005 contains an Annex ZZ indicating
  that noise requirements are not covered
• A future amendment will introduce noise
  requirements, which will be indicated in its
  Annex ZZ

8
ANNEX ZZ THE DETAIL

• LVD harmonized standards are for the moment
  being exempted (no specific mandate, no
  detailed ERs, listing in OJ for information)

9
ANNEX ZZ THE DETAIL

• CENELEC BT has laid down the wording of
• the foreword of the EN
• the Annex ZZ

10
ANNEX ZZ THE DETAIL
The foreword of the EN shall include the
following paragraph "This European Standard has
been prepared under a mandate given to CENELEC by
the European Commission and the European Free
Trade Association and covers essential
requirements of EC Directive(s). See Annex ZZ."
11
ANNEX ZZ THE DETAIL
An informative Annex ZZ shall indicate the
coverage by the EN of the ERs of the relevant
Directive(s). Depending on whether all, some or
most ERs are covered, the text of Annex ZZ shall
use one of the three options given - completed
with the information provided by the Technical
Body / SR - and shall read as follows
12
ANNEX ZZ THE DETAIL
Annex ZZ (informative) Coverage of Essential
Requirements of EC Directives This European
Standard has been prepared under a mandate given
to CENELEC by the European Commission and the
European Free Trade Association and within it
scope the standard covers - all relevant ERs as
given in ... of the EC Directive ../../EC. -
only the following ERs out of those given in ...
of the EC Directive ../../EC - ER 1 - ER
7 - all relevant ERs as given in ... of the EC
Directive ../../EC, except the following -
ER 2 - ER 5
13
ANNEX ZZ THE DETAIL
(Informative Annex ZZ, continued) Compliance with
this standard provides one means of conformity
with the specified essential requirements of the
Directive(s) concerned. WARNING Other
requirements and other EC Directives may be
applicable to the products falling within the
scope of this standard.
14
ANNEX ZZ THE DETAIL
Derogation from the wording in the Annex ZZ?

• No

• However, for specific needs and on a justified
  basis, BT approval could be sought

15
ANNEX ZZ THE PROCEEDING
Q During the standardisation process, when is a
good time to start thinking about the Annex ZZ?
A As soon as possible!
New Work Item proposal sheet
16
ANNEX ZZ THE PROCEEDING

• Main steps
• enquiry
• vote
• ratification

17
ANNEX ZZ THE PROCEEDING
ENQUIRY

• CLC home-grown standard preferably Annex ZZ
  included

• IEC based standard no Annex ZZ needed yet

18
ANNEX ZZ THE PROCEEDING
VOTE

• CLC home-grown standard obligation to have Annex
  ZZ

• IEC based standard no Annex ZZ needed yet

19
ANNEX ZZ THE PROCEEDING
RATIFICATION

• CLC home-grown standard contains always Annex ZZ

• IEC based standard obligation to have Annex ZZ

20
NEW APPROACH CONSULTANTS
New Approach Consultants

• check the correct interpretation of the ERs in
  the standard.

• assessment of all projects that go to enquiry or
  vote and before they are offered to the
  Commission for listing in the OJ

• no distinction between CLC home-grown standards
  and IEC based standards or between EN and
  amendment

• assistance to technical bodies during drafting of
  documents

21
NEW APPROACH CONSULTANTS THE PROCEEDING

• ENQUIRY
• Consultant is requested to assess the document
• Consultant sends assessment to CS technical
  body a few weeks before end of enquiry period
• CS forwards Consultant's assessment to Reporting
  Secretariat

22
NEW APPROACH CONSULTANTS THE PROCEEDING

• VOTE
• Consultant is requested to assess the document
• Consultant sends assessment to CS technical
  body a few weeks before end of voting period
• Assessment positive well done! no problem
• Assessment negative no ratification! solve the
  problem first!

If needed, ask BT.
23
NEW APPROACH CONSULTANTS THE PROCEEDING
Database negative advice from Consultant during
voting period the project is put in "Pending"
"Pen" "P"
24
CONCLUSIONS

• A document is sent to enquiry
• For projects where Annex ZZ is needed
• CLC home-grown standard preferably contains Annex
  ZZ
• IEC based standard no Annex ZZ needed yet
• Consultant is asked for assessment

25
CONCLUSIONS

• A document is sent to vote
• For projects where Annex ZZ is needed
• CLC home-grown standard Annex ZZ obligatory
• IEC based standard no Annex ZZ needed yet
• Consultant is asked for assessment

26
CONCLUSIONS

• A document is proposed for ratification
• Voting results are to be positive
• For projects where Annex ZZ is needed
• CLC home-grown standard always contain Annex ZZ
• IEC based standard Annex ZZ obligatory
• Consultant's assessment is to be available

27
Thank you for your attention