(Continuing my series on the efforts being made by UK Notified Bodies to establish operations in the EU27, to enable transfer of certificates and continued market access in the event of No Deal.)
I attempted in my last post through searches for Declarations of Performance and Certificates issued under the Construction Products Regulation 305/2011 (CPR) to identify prominent UK construction products Notified Bodies (NBs). First on the list was Element Warrington, which I examined in that post along with other UK NBs owned by Element Materials Technology Ltd. In this article I turn my attention to BSI Assurance UK Ltd, Notified Body 0086, which was the NB for three products out of twenty-four found in the searches. It is notified under fourteen Directives or Regulations, including the CPR:
In November 2018, as I described in an earlier post, BSI gained notified status in the Netherlands under the three medical device Directives. In December, it received accreditation from the Dutch Accreditation Council RvA for activities under the CPR as well as other legislation:
In February 2019, BSI announced that it had achieved notified status in the Netherlands for the CPR:
The Dutch scope of accreditation to EN ISO/IEC 17065:2012 (product certification) shows that three out of four of the locations where accredited activities are performed are in the UK, with the fourth being the address of the Head Office in Amsterdam:
BSI Assurance UK Ltd’s UKAS accreditation to ISO/IEC 17025:2005 (testing and calibration laboratories) shows that BSI Hemel Hempstead and Loughborough sites are laboratories, while the Milton Keynes site appears to be administrative:
Difference in scope
A BSI Q & A dated March 2019 reveals that not all CPR certificates were capable of being transferred to the Netherlands because of a difference in the range of standards covered. BSI Netherlands were said to be in the process of increasing the scope of its notification:
Moreover, its shorter length, at 9 pages long compared to BSI UK’s 14 pages, immediately suggests the possibility that gaps in coverage still remain.
Omission of System 3 Assessment
One major difference between the two NBs is that BSI Netherlands is not notified for any System 3 AVCP (Assessment and Verification of Constancy of Performance) tasks, whereas BSI Netherlands is notified for 23 such tasks, which are referred to as ‘Testing Laboratory’ tasks. For example, BSI UK is notified for assessment of road traffic noise reducing devices, employing System 3, to EN 14388:
and is also accredited ‘for the purpose of Notified Body Activity’:
to ISO/IEC 17065 (product certification):
for the same task:
To take another example, BSI UK is notified for both System 1 and System 3 assessment of ‘Curtain wall kits (as external walls subject to reaction to fire requirements)’ to EN 13830:2003:
whereas BSI Netherlands is notified for System 1 assessment of the same product family to the same standard, but not for System 3:
Likewise, BSI UK is accredited for both System 1 and System 3 assessments of this product family to this standard:
whereas BSI Netherlands has accreditation ‘suitable for notification’:
to ISO/IEC 17065 (product certification):
for System 1 only:
More limited range of standards
In other cases, the difference lies in the coverage of standards, rather than the mode of assessment. For example, BSI UK is notified for System 1 assessment of many types of thermal insulation product, including both factory-made products and products that are formed in-situ, although only for uses subject to regulations on reaction to fire:
BSI Netherlands is likewise notified for System 1 assessment of the same product, said to include both factory made and in-situ products, but the standards covered are a small sub-set of the standards covered by BSI UK:
but (despite what is stated in the notification scope shown above) to none of the standards for factory made products such as, for example, EN 13162:2012 for factory made mineral wool products:
The same difference in coverage for this product family exists also between the UKAS accreditation of BSI UK and the RvA accreditation of BSI Netherlands, with the latter being accredited to the same five standards only:
Tasks accredited but not notified
Not only is BSI Netherlands’ scope of accreditation narrower than that of BSI UK, but its scope of notification is narrower still. The following tasks are within the scope of accreditation but not the scope of notification:
1) In product area 28 ‘Pipes, tanks and ancillaries not in contact with water intended for human consumption’, System 1 assessment of pipes is both accredited and notified, but System 1 assessment of valves and taps is accredited only, and not notified.
2) In product area 3, ‘Membranes..’, System 1 assessment of roof underlays to EN 13859-1 is accredited only.
3) In product area 8, ‘Geotextiles..’, System 2+ assessment of geotextiles for use as a protective layer is accredited only.
4) In product area 10, ‘Fixed fire fighting equipment’, System 1 assessment of 27 types of product is both accredited and notified, but System 1 assessment of fire hose reel systems is accredited only.
5) In product area 13, ‘Structural timber products..’, System 1 assessment of structural glued laminated and other glued products are both accredited and notified, but System 2+ assessment of solid structural timber products is accredited only.
6) In the same product area, both System 2+ and System 1 assessment of wood-based panels is accredited only.
7) In product area 17, ‘Masonry and related products’, System 1 assessment of Category I masonry units is accredited only:
8) In product area 20, ‘Structural metallic products and ancillaries’, System 2+ assessment of welding materials is accredited only:
9) In product area 24, ‘Aggregates’, System 2+ assessment of two types of aggregate is both accredited and notified, while System 2+ assessment of the remaining four types of aggregate is accredited only.
In all cases except no. 8, welding materials, BSI UK is both accredited and notified for the task. Like BSI Netherlands it is accredited for welding materials but not notified. In other respects, its scope of accreditation is closely, although not perfectly, aligned with its scope of notification. Likewise, by way of comparison, Element Netherland’s Dutch scope of accreditation is closely aligned with its Dutch scope of notification. Why is the same not true of BSI Netherlands?
Relationship of notification to accreditation
In accordance with Article R14 of the ‘common framework for the marketing of products’ laid down in Decision 768/2008/EC, Article 40(1) of the CPR makes a ‘notifying authority’ responsible for the assessment and notification of the conformity assessment bodies (CABs) who are in turn to assess the compliance of products with the legislation:
A Member State may decide that the monitoring and assessment of the CABs should be carried out by their national accreditation body:
The notifying authority may even delegate notification itself to another body:
Article 42(1) of the CPR provides that each Member State is to inform the Commission of its assessment and notification procedures, and the Commission in turn has to make them publicly available. The notifying authority is usually a government department. For the CPR in the UK, for example, it is the MHCLG. Unusually, the Dutch Accreditation Council is listed on NANDO alongside the relevant government department as a Notifying Authority:
The page for both authorities carries a link (here and here), each to the same Notification Procedures which state that, in accordance with Article 40(2) of the CPR, the Netherlands has decided that the RvA (Dutch Accreditation Council) should carry out the assessment and monitoring of CABs:
A body which is seeking notification should apply to the RvA for ‘accreditation for the purpose of notification’:
The scope of the accreditation is to be aligned with the scope of the notification:
Moreover, the RvA is to communicate with the applicant CAB to ensure that the scope of accreditation is aligned with the required scope of the notification:
The Ministry for Housing and Building appears to retain a responsibility to conduct a check on the ‘integrity’ of the applicant, but there is no indication that it is involved in any assessment of its technical capability:
In accordance I think with Article 40(3) CPR, it appears to be the RvA which notifies the Commission and Member States of the decision to designate the CAB as a Notified Body (or Technical Assessment Body):
Since first, every effort is made to ensure that the scope of accreditation is aligned with the scope of notification and second, the accreditation body appears to itself issue the notification, a significant departure from alignment would seem to call for an explanation.
Objections by member states
One possible reason why a scope of notification could be more restricted than the scope of accreditation would be an objection to the notification raised by a Member State, as provided for in Article 48(5) of the CPR:
Lloyds Register, for example, received accreditation for product certification by the Dutch Accreditation Council earlier this year but have not yet achieved notified status because of just such an objection raised by a member state to the notification issued by the Dutch notifying authority:
While the nature of the objection is not stated, it seems to have concerned some aspect of Lloyds Register’s mode of operation, since the company is making changes to the way it works in order to comply with new requirements apparently imposed by the European Commission:
Is there perhaps something about the nine tasks listed above, that are accredited but not notified, that could have prompted an objection from a member state? If there is, it is by no means readily apparent, at least to this observer.
Likely reason for BSI Netherlands not being accredited for System 3 assessment
While the reason for the divergence of BSI Netherlands’ scope of notification from its scope of accreditation remains so far unidentified, a possible explanation is apparent for the absence of System 3 tasks from its scope of accreditation.
The Dutch Notification Procedure, discussed above (link here) states that System 3 tasks are accredited to ISO/IEC 17025 (testing and calibration laboratories), not to ISO/IEC 17065:
BSI Netherlands is accredited against ISO/IEC 17065 and EN ISO/IEC 17021-1 (management systems) only:
and its notification shows only accreditation to EN ISO/IEC 17065:
and so cannot be notified in the Netherlands for System 3 tasks.
BSI UK is accredited by UKAS to six standards including ISO/IEC 17020:2012 (Inspection Body), ISO/IEC 17021-1:2015 (management systems), ISO/IEC 17025:2005 (testing and calibration laboratories), and ISO/IEC 17065 (product certification).
Nevertheless, BSI UK’s notification, which includes System 3 tasks, shows only accreditation to EN ISO/IEC 17065:
but nevertheless its accreditation to ISO/IEC 17065:2012 does include System 3 tasks, as shown earlier in this article.
The UK construction products Notifying Authority is the MHCLG:
Its notification procedures (link on the above page), unlike those of the Netherlands authorities, do not directly specify the accreditation standard to be used for each conformity assessment System. It does seem to claim, however, that the accreditation standards will be employed in accordance with EA 2/17, a guidance document issued by European Accreditation: 2
it does not specify which standard is to be used for which form of conformity assessment (the term ‘module’ being used in standard New Approach product safety legislation, ‘system’ being peculiar to the CPR):
EA 2/17 lays down the ‘preferred standard’ against which Conformity Assessment Bodies are to be accredited for each conformity assessment procedure. Under the CPR, ISO/IEC 17025 is to be employed for System 3 assessment:
UKAS seems therefore to have departed from the EA’s Preferred Standard in accrediting BSI to ISO/IEC 17065 for System 3 tasks under the CPR. EA 2/17 makes allowance for such departures but states that they should be justified when they occur:
It can be seen therefore that the RvA has kept to normal practice by not including any System 3 tasks in BSI Netherlands’ EN ISO/IEC 17065 accreditation schedule. The question that then arises is whether BSI Netherlands will be accredited by RvA to EN ISO/IEC 17025 so that System 3 tasks can be added to the scope of its notification.
The Dutch Notified Body Kiwa Nederland B.V. is shown in its notification as accredited by RvA to both EN ISO/IEC 17065 and EN ISO/IEC 17025:
It is notified for two System 3 tasks including, for example, assessment of doors and gates to EN 13241:
Its scope of accreditation by RvA to EN ISO/IEC 17025:
includes accreditation suitable for notification for System 3 assessment of doors and gates to EN 13241, corresponding to its scope of notification:
If Kiwa Nederlands B.V. has achieved notification for System 3 tasks, why has BSI Netherlands B.V. apparently not been able to do so to date?
BSI has successfully achieved notified status in the Netherlands under the Construction Products Regulation, enabling the transfer of certificates from BSI UK to BSI Netherlands in order to allow continued access to the EU27 market in the event of a No Deal Brexit. The scope of notification of the new body, however, is considerably less than that of BSI UK, in three respects:
- System 3 assessment is omitted, as it is also in the scope of accreditation.
- For the other types of assessment, the range of standards covered is more limited, generally corresponding to equivalent limitation in the scope of accreditation.
- Although the Dutch notification procedures provide for the scope of notification to be aligned with the scope of accreditation, there are nine tasks for which BSI Netherlands is accredited but not notified.
The immediate reason for the omission of System 3 assessment seems very likely to be the new body’s lack of accreditation to EN ISO/IEC 17025, which is the accreditation standard employed in the Netherlands for System 3 tasks. No reason has been identified, however, for the lack of accreditation to this standard. Neither has any cause been established for the other two ways in which the scope of notification is restricted.
In my next post, I intend to gauge the magnitude of the problem by identifying products, currently certified by BSI UK, whose conformity assessment procedures fall outside the scope of BSI Netherlands, resulting in potential difficulties in EU27 market access for their manufacturers.