PM Group’s senior engineers Pat Swords and Margaret Doran presented a poster and associated technical paper at the Institution of Chemical Engineers ‘Hazards 26’ conference in Edinburgh, which took place last month. The subject matter, ‘CE Marking; ATEX, Machinery Directive, etc – How to Get it Right’, arose out of a recognition that in the process industry sector in general, there was a failure to identify where the EU’s CE marking compliance requirements arose and to develop a practical strategy to implement the legally required ‘essential health and safety requirements’. The full 12-page technical paper is available on the PM Group’s website, so it is not intended to replicate the content here, but instead introduce the subject matter and its relevance. For starters, what is CE marking and how is it relevant to implementing an engineering project? The EU’s ‘New Approach’ to standardisation, associated conformity assessment and CE marking now runs to some 28 directives and five regulations. These ‘New Approach’ directives define essential requirements related to health, safety and environmental issues. Products must meet these requirements in order to be placed on the European market. As such, then, the traditional process plant now has additional compliance requirements, primarily associated with the Machinery Directive, the Pressure Equipment Directive and the ATEX (Explosive Atmospheres) ‘equipment’ Directive. These ‘essential health and safety requirements’ are supported by a comprehensive set of international and European standards, which define the state of the art with regard to machinery safety, equipment for potentially explosive atmospheres, etc. In Europe, the manufacturer or its authorised representative is required to undergo a specific conformity procedure and CE mark the equipment. Outside of the European Economic Area, no such CE marking is required, but under the general duty of care, compliance with the same recognised standards and state of the art would be expected. Indeed, as part of World Trade Organisation (WTO) agreements, there is an increasing harmonisation of technical standards, although the manner in which they are implemented depends on the legal jurisdiction. For instance, in Russia and the associated Eurasian Customs Union, there is a product conformity system, previously called GOST, but now being replaced by the EAC mark, i.e. ‘Eurasian Conformity’: Different marking to our familiar CE, but same technical standards supporting the necessary compliance!

Regulatory compliance

[caption id="attachment_30467" align="alignright" width="163"]Machinery Directive CLICK TO ENLARGE: Fig 1: Decision steps - substantial modification to machinery[/caption]

In Germany, if we consider the accident statistics for 2013, there were 78 fatalities and 2,252 new pensions, the latter resulting from circumstances where it was not possible to rehabilitate injuries with respect to a full return to employment. The message is clear: deficiencies in machinery safety, even in a country which would be considered ‘best in class’, are having a significant impact. Therefore, CE compliance is an integral part of PM Group’s general duty of care, as an international engineering design and construction management company.

However, were we approaching it right? In practice in the process industry sector, a wide variety of approaches was occurring, from doing nothing to attempting to CE marking complete process plants. The latter made no sense at all, as the EU’s ‘New Approach’ legislation and associated CE marking only applied to certain specific product types. An industrial process plant may contain some of those products, but it would not necessarily require CE marking. Not least, an industrial plant is not a ‘product’ recognised by that legislation. In many respects, one has to recognise that the EU’s safety legislation has two different, but interconnecting, strands, namely that of product safety and that of occupational safety. Process plants have been designed for many decades to tried-and-trusted standards and guidelines related to occupational and process safety; CE marking is not intended to replace this. However, the ‘Work Equipment’ Directive, now codified as 2009/104/EC, is clear. ‘Work equipment’ is defined as “any machine, apparatus, tool or installation used at work” and: • Work equipment which, if provided to workers in the undertaking or establishment for the first time after 31 December 1992, complies with … the provisions of any relevant Community directive which is applicable. Therefore, if ‘New Approach’ legislation relating to CE marking was applicable to a product, such as machinery, from that date, then compliance should be ensured. As the PM Group technical paper presented at Hazards 26 documented, the key step in any engineering project is to identify at the initial phase, where the relevant ‘New Approach’ legislation applies - in particular to the circumstances where machines are being assembled together or significantly modified, such that legal obligations then arise with regard to ‘manufacturing for own use’. Note: While in layman’s English there is a tendency to interchange the words ‘equipment’ and ‘machinery’, for the purpose of the relevant EU legislation they have very defined meanings, in particular as can be seen from Directive 2009/104/EC above, machinery is a ‘subset’ of ‘equipment’. Therefore, while the Machinery Directive may not apply to certain equipment, other ‘New Approach’ Directives, such as the Pressure Equipment Directive (2014/68/EC) or the ATEX ‘equipment’ Directive (2014/34/EC) may be applicable.

Sourcing compliant equipment

Ideally, equipment requiring CE marking should be as much as possible sourced fully compliant from the relevant vendors. Even for what one would consider straightforward equipment items, such as a pump or an electrical motor, this may appear straightforward, but it does require a focused and structured approach incorporated into the project delivery system. Leaving it to the end of the project does not cut the mustard, for a number of reasons. Naturally ,the ability to leverage a supplier for correct documentation does not really work well, when payments have already been essentially completed. More importantly though, equipment modules are often built up as layers, comprising individual CE marked products from multiple vendors. Once the relevant CE marking and Declaration of Conformity are provided, and there are no obvious or known defects, then the user at the next level is entitled to presume that the product is in compliance with the applicable ‘essential health and safety requirements’. However, the safe instructions for use need to be incorporated into the subsequent installation and how can one successfully design and implement that requirement, when the relevant documentation does not arrive until the end of the project? Indeed, for more complex equipment, such as bespoke machinery with a significant hazard potential, the issue is even more complex, as a series of risk assessments need to be completed, to EN ISO 12100:2010 ‘Safety of machinery -- General principles for design -- Risk assessment and risk reduction’, before the machinery design can be finalised. For instance, the ‘hazard zone’ or ‘danger zone’ is “any space within and/or around machinery in which a person can be exposed to a hazard”. Identification of the ‘hazard zone’ is absolutely critical when it comes to designing the correct guarding, but the ‘hazard zone’ for complex machinery is inherently related to how and where the machinery is installed and as to what other hazards are in the vicinity from adjacent equipment and processes. Expecting a vendor to turn up at the factory gate with the correctly certified design solution, when the project team have not been previously actively engaged, is really leaving it to chance. Early identification of these requirements with the necessary active engagement is essential. However, by far the most complex issue that occurs with the Machinery Directive is where machinery is modified or alternatively joined together with other machinery in what is called an ‘assembly of machinery’. Depending on the significance of the safety issues, Sourcing which then arise, a new CE compliance procedure can be engaged for the modified machinery or assembly of machinery respectively. The project team is then responsible for implement the necessary measures to ensure compliance with the relevant ‘essential health and safety requirements’ and the applicable conformity procedure. This is what is called ‘manufacturing for own use’. Practical examples of a modification to machinery, which could engage the requirement to complete a new CE conformity process is where there is a new hazard, or an increase in an existing risk, and the existing protective measures are not sufficient or suitable. This is not solely related to mechanical modifications, but could also occur where the automation is modified. (See decision flow sheet from the German Federal Ministry of Labour - Figure 1, above right.) Similarly, when individual machinery items are connected, such as on a production line, and there is both a production technical and safety technical connection, then a new CE Conformity procedure is engaged for the resulting assembly of machinery. image004Pat Swords BE CEng PPSE FIChemE CEnv MIEA, principal process and environment, health and safety consultant, PM Group and Margaret Doran BE Chemeng M Eng MIChemE, environment, health and safety manager, PM Group