Transcript The Supply of Machinery (Safety) Regulations 2008

The Supply of Machinery
(Safety) Regulations 2008
Mike Lewis CMIOSH
November 2009
Regulations
 The new Regulations enact the Machinery Directive
2006/42/EC and replace the Supply of Machinery
(Safety) Regulations 1992 and subsequent
Amendments.
 The Regulations come into force on 29th December
2009.
 The Regulations can be viewed or downloaded at
www.opsi.gov.uk/si/si2008/uksi_20081597_en_1
Key Changes
The same basic principles apply but some
underlying detail has changed.
The Regulations provide clearer definitions.
Builders goods hoists and cartridge operated
tools are included in the scope.
Safety components, such as chains, ropes and
webbing, are required to be CE marked.
Some provisions apply to ‘partly completed
machinery’.
Key Changes (cont’d)
 Provides manufacturers with the option to use full
quality assurance in the conformity assessment process
for products regarded as particularly hazardous e.g.
 circular saws
 power presses
 plastic injection moulding machines etc.
 A full list is contained in (Annex IV of the Regulations).
 Provides an updated list of essential health and safety
requirements.
 Minor changes to the contents of the Declaration of
Conformity.
The Regulations apply to:
 Machinery described as:
 an assembly, fitted with or intended to be fitted with a drive system other
than directly applied human or animal effort, consisting of linked parts or
components, at least one of which moves, and which are joined together
for a specific application;
 an assembly as defined above, missing only the components to connect it
on site or to sources of energy and motion;
 an assembly as defined above, ready to be installed and able to function as
it stands only if mounted on a means of transport, or installed in a building
or structure;
 assemblies of machinery as referred to above, or partly completed
machinery, which, in order to achieve the same end, are arranged and
controlled so that they function as an integral whole;
 an assembly of linked parts or components, at least one of which moves
and which are joined together, intended for lifting loads and whose only
power source is directly applied human effort.
The Regulations apply to:
 Interchangeable Equipment described as:
 devices which, after the putting into service of
machinery or of a tractor, are assembled with that
machinery or tractor by operators themselves in order to
change its function or attribute a new function, in so far
as they are not tools.
The Regulations apply to:
 Safety Components described as components:
 which serve to fulfil a safety function;
 which are independently placed on the market;
 the failure or malfunction of which endangers the safety
of persons; and
 which are not necessary in order for the machinery to
function, or for which other components which do not
fall within previous sub paragraphs may be substituted
in order for the machinery to function.
 Full list of examples is provided in Annex V of the
Regulations.
The Regulations apply to:
 Lifting Accessories
 Chains, Ropes and Webbing.
 Removable Mechanical Transmission Devices.
 Drive Systems.
 Partly Completed Machinery.
Exceptions
The new Regulations do not apply to machinery
and safety components:
 Listed in Schedule 3 of the Regulations.
 In transit through the EU e.g. auctioned for use outside
the EU.
 Previously put on the market or in service prior to 29th
December i.e. second-hand machinery.
 That are in the supply chain prior to 29th December
2009, but unused.
 Exhibited at a trade fair or exhibition.
General Requirements
It is an offence for a ‘Responsible Person’ to
supply machinery, partly completed machinery
or safety components unless they comply with
the Regulations i.e.
 they have the requisite Technical File, Declaration of
Conformity, EC type Examination Certificate, Declaration
of Incorporation, as appropriate;
 the product is CE marked; and
 the product is safe!
Conformity Assessment
The responsibility for demonstrating that
machinery complies with the Directive rests with
the ‘Responsible Person’.
There are three methods of conformity
assessment.
Self Assessment
EC Type Examination
Full Quality Assurance
Self Assessment
This method is used for any machinery not
included in Annex IV of the Regulations.
The ‘Responsible Person’ required to:
Undertake a risk assessment against the
Essential Health and Safety Requirements (see
Schedule 2 Annex I of the Regulations);
Produce a Technical File;
Produce a Declaration of Conformity;
Affix CE mark to the product.
EC Type Examination
This method is used where the machinery is
included in Annex IV of the Regulations, but is
not manufactured wholly in accordance with
harmonised standards.
The machinery is required to be assessed by a
‘Notified Body’.
If compliant, the ‘Notified Body’ will issue an ECtype examination certificate.
Full Quality Assurance
This method is used for machinery included in
Annex IV of the Regulations and manufactured
using a full quality assurance system.
The ‘Responsible Person’ having manufactured a
product using a full quality control system, is
required to have their system assessed by a
‘Notified Body’, which has been accredited by
UKAS.
The ‘Notified Body’ will arrange the issue of any
necessary documentation and CE marking.
Further Guidance
The European Commission is scheduled to
publish comprehensive guidance on the
entire text of the revised Machinery
Directive in early December 2009.
The guidance will be web-based only.
Further Guidance
BIS, the Department for Business, Innovation
and Skills (previously known as BERR and the
DTI), has published guidance notes on the
Regulations.
The BIS guidance summarises and puts into
'plain English' the contents of the Machinery
Directive.
The guidance notes on the UK Regulations can
be viewed or downloaded at
http://www.berr.gov.uk/files/file52968.pdf