Activities Involving A UK Appointed Notified Body
Activities Involving A UK Appointed Notified Body
Activities Involving A UK Appointed Notified Body
The RCD ADCO of 5 & 6th November 2009 has a number of tabled papers
relating to PCA activities (Agenda item 5) and related to concerns raised at
the activities of a UK appointed Notified Body (NB).
It is clear that there is some confusion with those raising these papers as to
the actual situation. There are two. One relates to second-hand craft seeking
to use the PCA route to gain entry into the EU – some for use by their owners
and some being brought in for placing on the market. The other relates to new
craft which are being modified by a person with Legal identity, badged under
their name and placed on the market.
These are quite different processes and need to be dealt with separately.
New Products being placed on the market re-badged
The notified body has been contacted by a legal entity in the US who is
modifying and re-badging products with the intent of placing them on the
market taking responsibility as manufacturer presumably taking notice of the
definition in the RCD as well as described in the Blue Guide.
The party in the US proposes to use module Aa and has had the notified body
carry out the assessment with regard to “Stability & buoyancy”, “exhaust
emission” and “noise emission”.
Issue: A number of concerns have been raised with regard to the actions of a
UK appointed Notified Body with regard to PCA.
Complaint that the new 2009 guidelines had not been followed.
Response: NB said that they had not followed the 2009 version of the RSG Guidelines
because the assessment was done before the new version of the guidelines had been
published.
Complaint states that the PWCs are not inline with the directive..
Response: While some minor administrative aspects have been highlighted no
evidence has been provided of any non-compliances of the craft with the essential
safety requirements (ESR) of the Directive.
Discussions with the Notified body has identified that they have carried out the
following for each PCA:
A full inspection of each product was made to determine whether or not it was
damaged. Assessment against the ISO Standard for design and construction
i.e. a full inspection against the standard for each craft.
Reference to “Technical File” has proved misleading; this will be clarified that
it is a report by a subcontractor into the aspects of the design which address
the ESRs.
In the view of the UK Authorities the NB is complying with the spirit, intent and
requirements of the Directive. However, they need to consider how references
to supporting documents will be seen by others not participating in their
activities, particularly when English is not their first language.
Additional Comments
The purpose of the RCD is to ensure that only safe products i.e. compliant
with annex I A, and compliant with the environmental requirements of annex I
B are placed on the Community market, it is not the intent of the RCD to act
as a trade barrier or to protect markets other than from non-compliant
products.
For the assessment of the engines under PCA the wording of the Directive is
important – “engines shall be designed, constructed and assembled” so noise
emissions shall not exceed those in the RCD, there is no requirement to test.
Such evidence can be furnished by compliance with California Air Resources
Board which has limits compatible with the RCD requirement. Neither the
RCD nor any other Community law addresses aging only that “engines shall
be designed, constructed and assembled”. Given that the RCD places a life
on PWC engines of 350 hours or 5 years whichever is the shorter this is not
unreasonable as these engines will need to either be refurbished or replaced
to ensure the limits for emissions continue to be met – or continue to be
operated with no guarantee the RCD limits are met.
The NB has advised that all of the measurements they have made have been
well within the limits specified in the Directive, meeting them is not considered
onerous.
It is clear that the intent of the Directive is that Article 8.1 is to be used
independent of articles 8.2, 8.3 and 8.4. If articles 8.3 and 8.4 were
additionally applied with article 8.1 it would effectively frustrate an important
provision of the RCD as there is no specific provision which duels 8.1
applicable to them. Additionally to argue Articles 8.3 & 8.4 continue to apply
when 8.1 is used would imply that article 8.2 was also still applicable which
would completely frustrate the purpose of article 8.1.
Comment has been made on the RSG Guidelines. RSG were specifically
asked to develop guidance. The guidance has been circulated for discussion
amongst MS and the Commission; RSG have been included in these
discussions. While it is guidance, it is not binding on NBs, but the principles
behind it are that there is an understanding that products, including will be
assessed by an NB on the basis of informed assessment based on the
available information, such non-destructive test as can be reasonably be
performed, the NBs skills and experience etc, ultimately it will be for the NB to
satisfy themselves that the product is indeed compliant.
With regard to the specific tabled documents the UK makes the following
comments:
Document 5A.
I would disagree that the requirements have been made easier. The objective
has remained the same, however experience with the process has allowed
NBs carrying out PCA to develop their experience and to better come to terms
with what is needed to satisfy themselves as to whether a product does or
does not comply with the RCD.
My understanding is that the work of RSG has been fully supported by the MS
in the past and should continue to be in the future.
It must be remembered that all products placed new on the market are on the
basis of a single type approval with product quality assurance to ensure
similar products are the same. No MS has a scheme to test on a continuing
basis that these products are in compliance with the RCD requirements, if
they do this is not an issue – if they do not then the position with craft
assessed under PCA will be no different to those placed on the market by
alternative means. However if the baseline for emission or noise has changed
since the engine was manufactured then an assessment will be required.
NBs are credible by virtue of the fact that they are appointed, monitored and
operate in accordance with the requirements of the Directive and under the
supervision of the appointing MS. PCA procedures for NBs would have been
introduced after the amending Directive. Clearly where a product has had the
emission configuration changed it is no longer as originally designed and if
being placed on the market for the first time it will need an individual
assessment, but it will be for the NB to determine the impact and what if any
additional tests are required. Similarly products already in use the community
would need to be assessed to determine whether the craft had been altered to
the extent that the original assessment was invalid in which case a new
assessment would be required, the only option available being a PCA.
I would disagree that a PCA is simpler than either, module A self declaration,
or module B type approval plus production surveillance (Quality system) or
unit verification. PCA does require each and every model to be assessed. The
others do not require anything like the level of assessment PCA would require
particularly as for PCA there will be little, if any, documents to form a technical
file.
Document 5B
The UK must question the legality of stopping the products. They have a PCA
which demonstrates compliance with the RCD; no evidence has been tabled
to indicate the products do not meet the RCD.
The fact the Commission are looking to lower the acceptable emission levels
is irrelevant, the RCD sets the levels that are required now, that is the legal
requirement.
Document 5C
For the current Directive relevant Commission guidance is the Blue Guide
which indicates that any party can be the manufacturer, specifically any party
whose brand appears on the goods.
If these products are the ones of which we have been informed then the US
Dealer is not proposing PCA but module Aa.
The PCA process is not limited in application by the RCD so yes it can be
used for multiple craft – however such an application is both time consuming
and uneconomic compared with other approaches.
Therefore with the proposed position we would disagree with the first and
second proposals.