On 29 December 2009, Machinery Directive 98/37/EC will end and be replaced by the new Directive 2006/42/EC. And, with the sole exception of portable cartridge-operated fixing and other impact machinery, there is to be no transition period to ease the switch. As a result, 20 years on from the original European Machinery Directive – itself amended and consolidated in 1998 to yield the current version – the regulation of machines within the European Economic Area (EEA) is set to undergo an abrupt transformation.

While the general intention is largely to simplify and clarify existing legislation as part of the EU’s ‘New Approach’ regulatory model, which aims to harmonise laws and create more coordinated European market, the overhaul will also usher in some significant changes. Incorporated within this new directive will be alterations to its scope, the treatment and definition of machines and partly-completed machinery, health and safety requirements, necessary documentation, certification, conformity assessment and enforcement provisions.

For machine manufacturers, or companies involved in importing, assembling or modifying machinery within the EEA, adequate preparation for the changeover –especially in terms of the key areas of difference between the old and new – is an obvious high priority. Moreover, with so wide a product base falling within the directive’s coverage, the EU’s drive towards harmonising national safety standards and removing non-tariff barriers to trade are likely to have major ramifications for industry as a whole.

What is a machine?

“The EU’s drive towards harmonising national safety standards and removing non-tariff barriers to trade are likely to have major ramifications for industry.”

One major departure lies in the broader definition of what constitutes a ‘machine’. The old directive’s largely intuitive interpretation of the word has been replaced with a more detailed and comprehensive approach. Accordingly, from December, a machine is anything listed in Article 1.1 (a–f), including machines, safety components, removable transmission systems, robes, webbings and chains, lifting accessories and interchangeable equipment.

While this will lead to many more products falling within its scope than is currently the case, the directive also establishes a range of exemptions, most notably replacement safety components, machinery constructed and used temporarily for laboratory research, ordinary office and domestic equipment, switch and control gear, IT equipment, transformers and electric engines.

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It also introduces – in Article 2 (g) – a new concept, namely that of ‘partly completed machinery’, effectively extending and expanding on the former Annex IIB provision. This covers the various assemblies, including drive systems, which cannot themselves perform specific applications and are exclusively intended to be assembled with other machines or partly completed machines to form ‘machinery’ as defined, and now brings them firmly within the purview of the directive’s safety standards. Unsurprisingly, the difficulties inherent in such definitions have originated much debate – not least during the UK’s Department for Business, Enterprise and Regulatory Reform (BERR) consultation exercise on implementation.

Practical implications

The lengthy discussions that led up to the birth of this new directive in 2006 were something that machinery manufacturers followed closely and for them, falling into step with the new regime when it arrives will simply be a matter of course. Measures to meet the revamped health and safety requirements, their newly explicit obligation to perform risk assessment and the changes to documentation and declarations of conformity are already well in hand. Likewise, importers of machinery manufactured outside of the EEA will have taken steps to address the ‘authorised representative’ issue – the need for a company or individual within one of the EEA states who holds the written mandate from the manufacturer to meet the directive obligations on the manufacturer’s behalf.

“The directive also established the authority for the EC to prohibit or restrict the sale of machines if their technical characteristics are deemed to pose a risk.”

Although some commentators have chosen to see this as a contentious move towards European protectionism, the criticism is unfair. It has not always been a simple matter to allocate responsibility for CE-marked machines from outside the EEA, which have been imported by multiple importers into different countries. This provision in the new directive should remove any such confusion in the future – which ultimately has to be in everyone’s best interest.

However, on a practical level for companies directly involved in packaging, there are one or two scenarios which may provide a few headaches – at least in the early stages of the changeover. A firm looking to upgrade an existing packaging or production line in 2010, for instance, will be faced with existing machinery, new machines and new parts and assemblages – which in all likelihood themselves constitute ‘partly completed machines’. Since ‘the safety-related parts of the control system must apply in a coherent way to the whole of an assembly of machinery and/or partly completed machinery’, even though each individual component holds the appropriate certification, in integrating the upgraded line, the machine owner has become responsible for meeting the risk assessment provisions. As daunting a prospect as this may seem, the good news is that there are more than enough solutions providers in the automation and machinery field ready to help.

Enforcing the new directive

The embedded measures for policing the regulations have also had some new provisions added to help ensure the underlying aim of uniform compliance across the EEA. The obligations of individual member states to organise collaborative ‘market surveillance’ to encourage cooperative working form part of the duties that have been explicitly drafted into the directive but the scales are balanced with a clear requirement for transparency and a respect for commercial confidentiality.

“It has left the manufacturer responsible for making users aware of the shortcomings and any counter-measures that should be employed.”

The directive also established the authority for the EC to prohibit or restrict the sale of machines if their technical characteristics are deemed to pose a risk.

Aims and objectives

The directive’s gestation was a protracted – and at times stormy – one, the renegotiation process being firmly aimed at providing a thorough overhaul and update of the original regulations while leaving the fundamental features and principles essentially unchanged. Few would disagree that the legal instrument that has emerged has achieved that, while also making considerable in-roads into establishing a harmonised European market by removing many of the potential pitfalls inherent in multiple national sovereignties.

At its heart, the directive is, of course, a common safety measure and as such specifies the first duty of machinery manufacturers – and this includes packagers modifying existing lines, as discussed earlier – as being the reduction of risk through safe design and construction approaches. Where it scores particularly well in a practical sense is in recognising that this will not always be possible; it has left the manufacturer responsible for making users aware of the
shortcomings and any counter-measures that should be employed.

Whenever new packaging machinery requires integration into a pre-existing line, the interface between old and new will always demand attention. There is, of course, nothing new in that but December’s incoming machinery directive does introduce a slightly different slant on the issue and getting up to speed ahead of the change may call for some careful thought.