Accurate efficiency

40 MACHINERY UPDATE JANUARY/FEBRUARY 2015 www.machineryupdate.co.uk
Regulations
How to avoid the pitfalls
around CE marking
Paul Laidler
BUSINESS DIRECTOR FOR MACHINERY SAFTEY AT TÜV SÜD PRODUCT SERVICE
Misconceptions about CE marking mean that it is one of the most misunderstood requirements of
all the applicable EU Directives. Here’s a guide to ensuring machinery compliance
By applying the CE
marking and providing
the associated EU
Declaration of Conformity
(DoC), a manufacturer or
importer is confirming
that a machine meets the
requirements of all applicable
EU Directives.
The DoC is a formal
statement that a machine
complies with applicable
Directives and standards.
It must be signed by the
responsible person within
the organisation and that
signatory may be subject to
prosecution if the equipment
is found not to comply.
The DoC must include:
• Name and address of
the manufacturer
(or their authorised
representative)
• Description of the product
- including type, model
and any other information
that clearly relates
the equipment to the
Declaration
• Reference to the standards
applied
• Identification of the
signatory.
An essential element
in demonstrating that CE
marking requirements have
been met is the production of
a technical construction file
(TCF), which must conform to
the provisions set out in the
Machinery Directive.
DOCUMENTATION ON
RISK ASSESSMENT
Annex VII of the Machinery
Directive states, in paragraph
1(a), that the TCF must now
include “documentation
on risk assessment”
demonstrating the procedure
followed, including:
i a list of the essential health
and safety requirements
(EHSRs) which apply to the
machinery,
ii the description of the
protective measures
implemented to eliminate
identified hazards or
to reduce risks and,
when appropriate, the
indication of the residual
risks associated with the
machinery.
In addition, EHSR 1.1.2
states “machinery must be
designed and constructed
so that it is fitted for its
function, taking into account
foreseeable misuse” and
“the aim of measures taken
must be to eliminate any risk
throughout the foreseeable
lifetime of the machinery”.
USE ONLY THE LATEST
SOFTWARE VERSIONS
Software has been designed
for machinery compliance risk
management, taking much
of this headache away, but it
is essential that it is the latest
version that reflects current
legislation. Any substantial
changes to machinery, such as
upgrades or if it is interlinked
with other equipment as part
of an assembly, may make
the existing DoC invalid. This
could therefore necessitate a
new conformity assessment,
even if the machinery was
originally compliant with
CE marking when it was first
purchased and where it was
put into service.
There are two key areas of
guidance to help machinery
end users identify if the
modifications they have made
will be considered substantial
by the regulatory authorities.
The first is the Health &
Safety Executive, which
outlines the different situations
involving modifications
to machinery where the
requirements of the Machinery
Directive are likely to apply and
action must be taken:
Any substantial changes made to
machinery, such as upgrades may
make the existing DoC invalid
• Machinery is modified
so much that it should
be considered as ‘new’
machinery
• Machinery refurbishment
with a different safety
package
• An existing assembly of
machines is modified
• Machinery modified before
it is first put into service.
A second reference guide
is the CEOC International
document ‘Modification
of Machinery in Service
– Guide for Inspection’,
which gives clear guidance
on what constitutes a ‘non
substantial’ and a ‘substantial’
modification.
In order to carry the CE
marking and comply with
the Machinery Directive,
any machine that has
EMC sensitive electrical or
electronic components must
meet the requirements of the
EMC Directive (2004/108/EC).
The only machines
that are not subject to
conformity assessment with
the essential requirements
of the EMC Directive are
fixed installations. Often
the presumption is that if
machinery is screwed to the
floor it can be considered a
fixed installation. However,
if such a machine, or assembly
of machines into a production
line, is moved and modified at
any time, it ceases to become
a fixed installation.
It is therefore very rare that
something that is presumed to
be a fixed installation actually
is and we regularly see this
misunderstanding when we
make site visits. A best practice
approach would be to err on
the side of caution and conduct
onsite pre-compliance EMC
tests for machinery, even if it
could possibly fall within the
fixed installation definition.
The CE marking is a visible
sign that a machine complies
with all the relevant standards
and Directives. It is therefore
essential that manufacturers
understand how to apply the
vast range of possible relevant
standards and Directives
to machinery, in order to
ensure both compliance and
the saleability of equipment
destined for the European
market.
i For more information
contact W www.tuvps.com
TÜV SÜD Product Service
is the PPMA’s technical and
legislative partner