CE Marking 25 Years on… 1995-2020

The Machinery Directive 89/392/EEC became law in the EU on January 1st, 1995. This was a New Approach Directive, where before being able to apply the CE Marking, the supplier should ensure that the Essential Health and Safety Requirements (EHSR’s) have been addressed, and the machinery is safe. The requirement for carrying out Risk Assessment was part of this, and the EHSR’s were supported by Harmonised Standards, or European Normative Standards which provided a Presumption of Conformity to the EHSR’s, if followed. The Directive has been updated a number of times and is currently 2006/42/EC. The use of standards is voluntary, however complying with them is a good way to show compliance to the Directive. EN Standards can be bought from any EU Standards Agency and currently Estonia is one of the cheapest places to buy them from.

At the start of January 2020, this article intends to reflect on the last quarter of a century, and changes within the UK and EU.

In mid-1995 I was made redundant when the company I worked for went into liquidation. I was asked by an Italian company that I had worked with previously to help them with the CE Marking of their main product, a refuse truck, as they hadn’t addressed CE marking up to that point.

In 1992, Paul Laidler had been working as a lecturer in Electrical Engineering at Longlands College, Middlesbrough. He had attended a seminar by the Department of Trade and Industry on the approaching Directives in 1992, and as part of the colleges intent to assist local industry, reviewed how the college could help.

Longlands Advisory and Consulting Service (LACS) was born, and Paul started helping small to medium enterprises in the North-East of England to meet the Machinery Directive Essential Requirements, initially in a small way, however, Paul was in the right place at the right time and very soon was working all over the world, assisting Blue Chip companies with CE Marking.

The work became more than one person could handle, and a team was set up within the college. A software package was developed in conjunction with Pilz to assist with risk assessment. Sadly, I don’t have any reports or screen shots from those days, but I remember the greater the hazard, the ‘smiley face’ became a red unhappy face. An early use of emoji.

I asked for help from LACS, and Dave Kirton assessed the machine, identified non-compliances and advised how to meet the requirements. He arranged for a Notified Body (Peter Hanmore of Plant Safety) to review the machine and Technical File, and in December of 1995 the machine was issued with a certificate from Plant Safety, the company applied the CE Marking and issued Declarations of Conformity for each unit supplied.

Dave had told me how busy LACS were, so early in 1996, I met with Paul and started working for LACS, initially carrying out risk assessments at a local crisp factory. Very soon I became part of the team and a growing organisation. The lack of knowledge within manufacturers of machinery and end-users at the time, provided a large potential customer base all over the world.

The original Use of Work Equipment Directive was published in 1989. Each country adopted this in different ways. In the UK, it came into law as the Provision and Use of Work Equipment Regulations (PUWER) and has been updated a couple of times over the years. Regulation 10 of PUWER puts the onus of ensuring compliance with any EHSR of any Directive on the end user.

In 1998, the college decided that education was its primary focus and a consulting organisation was not part of its future. Laidler Associates Consulting Service Ltd was formed and went from strength to strength, Laidler Certification was created as a Notified Body 0870 in 2000, to show that we had some competence. EMC testing equipment was acquired, and the company grew, being involved with many well-known companies, and many projects. We CE marked the cranes that built the Storeb?lt Bridge, at the time the longest in the world. We CE marked the world’s largest postal sorting facility, HWDC near Heathrow. We CE marked machinery that made items including face masks, car components, armaments, cars, pharmaceuticals and food. We worked with many good machinery manufacturers and are proud that we made a difference and improved machinery safety in many industries.

Laidler provided advice and assistance in getting machinery safe. All too often though, the brief was to visit a company and CE mark a machine that had already been built. (which still happens to this day). This usually resulted in a lot of rework for the manufacturer. It’s much more effective to do a design review before the machinery is built and try to eliminate the hazards at the start of the project.

Training was a large part of the services offered, with CE marking qualifications being developed in conjunction with Teesside University. A long relationship with the Processing & Packaging Machinery Association, (PPMA) developed, with training still being provided to PPMA members to this day.

Software was developed to provide consistency in production of Technical Files; the first version replacing the emoji’s with triangular purple buttons; later versions became less colourful and were known as Risk Management Software or RMS. In 2010 the ‘new’ Machinery Directive was introduced, so a new software package, mCom was introduced. When TUV-SUD took over, they stopped supporting this (later rewriting it), so COMPLIANCE Risk Software was developed to continue to assist compilation of Technical Files, record Risk Assessments, CE Audits and PUWER assessments.

In the early 2000’s, Safety Systems Technology became part of the Laidler Group. SST carried out upgrades to machinery guarding and safety related control systems, in accordance with the Directives and UK Regulations. SST is still providing this service as an independent company now, with Mark Smailes, one of the original Laidler directors, still at the helm.

In early 2010, Paul Laidler decided it was time to retire and the company became the Machinery Division of TUV-SUD Product Services, growing from around 35 people to around 17,000. A number of companies have been set up by people who left in the years following the takeover, including Astute, Kay IT, Laicon Inc in the USA, MSCS, Spiers and Safe Machine. Some former Laidler staff moved to companies such as Dematic, Pilz, Rockwell and ST&L. Other associates such as Bob Mackrell (Promark) and Jack Carver helped when there was too much work to cope with. Apologies if I’ve missed anyone!

In 1998 when Laidler Associates started, the Directors were concerned that the company had a limited life, as surely all manufacturers of machinery would soon start to do CE marking properly, and every machinery end user would ensure that their machines met the requirements of PUWER, and the work would dry up. Clearly, given the number of machinery safety consultants and companies around today, this was an unfounded concern!

One of the main issues in the early days was that there was a lot of non-compliant machinery being supplied from UK and EU manufacturers. Training has helped, but the authorities who police the legislation tend to prosecute end users under PUWER rather than prosecuting the machinery manufacturers. It is very rare to see a prosecution for not complying with CE marking, whereas there are many under PUWER. Similarly, in the rest of the EU, there don’t seem to be many prosecutions. Manufacturers of machinery have little incentive to ensure their machines comply. There have been some cases of equipment being stopped from entering the EU, however it has not been well publicised, and there is little deterrent.

Market surveillance is a requirement within the Directives, and governments are starting to recover from the austerity years following the financial crash in 2008, there does seem to be more resources going into market surveillance, which may mean that inspection will improve in the next ten years or so.

There is still a lot of machinery coming into the EU from other parts of the world - some better than others. Some manufacturers make the effort, however there is a lot of incorrectly CE marked equipment still arriving, and still some with no CE marking at all.

Machinery has generally got safer over the years, there are more safety devices available and more technology has been introduced. Standards have become more difficult to meet, especially regarding safety related control systems, and many companies don’t bother, believing that if it has a safety relay and dual channel it must be OK. Many don’t consider Common Cause Failure or Automatic Disconnection of Supply (ADS).

Validating Safety Related Control Systems (SRCS) to EN 13849 can be difficult and expensive. There are tools available to help, but often companies rely on spreadsheets. Errors creep in and are difficult to check. End users often don’t ask for the proof of validation, and if they modify the SRCS later, should redo the validation. ?If the original validation is provided to the end user, at least changes can be made without having to redo it from scratch.

Assemblies of machinery still tend to cause issues with lack of understanding as to where responsibility lies for the CE Marking. Ultimately the responsibility for the safety will be with the end user, so it is important that the end user ensures the supplier has dealt with all the hazards adequately before putting the machinery into service. CE Audits and design reviews can ease this process and ensure common issues are addressed in the early stages of the project.

As the UK is leaving the EU, the Machinery Directive is likely to be one of the legislative changes. Initially UK CA marking is proposed, which is an additional requirement, however the UK EHSR’s are virtually identical, with only a few minor changes in language of documentation proposed. Given the political changes of 2019, we will have to see what sort of regulations we are left with. As the UK has had the Health and Safety at Work Act since 1974, it is unlikely that safety requirements will be lowered in the UK.

There is a new Machinery Directive (MD) in the process of being developed within the EU, changes are expected to focus on connectivity of machinery and security. The rise of the internet means that hacking is now a serious concern, also many machines are now routinely controlled over the internet, many wind turbines for example rely on the internet. It is expected that whilst the UK will not be subject to the new MD, that many of the changes are likely to be implemented into any new UK legislation. Of course, any UK manufacturers supplying into the EU must still apply CE Marking to their machines. Non-UK suppliers will have to apply UK CA Marking to equipment entering the UK.

In conclusion, I’d like to provide a list of things for manufacturers and end users to check have been done before putting machinery into service. This is not an exhaustive list, these are items which are often missing in my experience.

Manufacturers:

• Ensure there is a Technical File that not only contains drawings and calculations, but an Essential Health and Safety Requirement report explaining how the EHSR’s have been met;
• Ensure that risk assessments are in place that demonstrate non-compliances have been addressed.
• Ensure that any standards and Directive listed on the Declaration are current, use the Europa Machinery pages to assist. There is a Guide to CE marking, plus a list of current Harmonised Standards.
• Ensure there is a Safety Related Control System validation report done on a proprietary software such as SISTEMA or PASCal. Provide the report and files to the end user.
• Common electrical issues continue to include incorrect installation of inverter drives, not in accordance with manufacturers instructions, meaning that they will not meet the EMC Directive; Earth cables should be on separate terminals, wiring and components should be clearly identified. Components should be CE marked, especially if being imported from outside of the EU. Spare wiring should be terminated correctly and identified. A plate should identify all information as required by EN 60204-1; If there is no isolator the location of the isolator should be identified, not just ‘isolate elsewhere’.
• Other common issues are lack of identification of fluid power connections, leading to errors of fitting, and poorly located hydraulic power packs which are difficult to drain without spillage.

End Users:

• Ensure specifications and contracts determine where responsibility for CE Marking lies. If it is a stand-alone machine, clearly the manufacturer; if a new line with different suppliers, who is responsible for the overall CE Marking?
• Ensure that any specifications provided explain issues like colour of controls required (Machinery should have White Start, Black Stop, Blue Reset, (See EN 60204-1) however, if going into a site where controls are Green Start, Red Stop etc., then consistency is preferred).
• Ensure a CE Audit is carried out before accepting the equipment, (there is a free to download checklist on the Safe Machine website), make sure a Technical File exists. The supplier does not have to provide a copy to the end user, (and should not), but should allow access to his site and show relevant reports EHSR, Risk Assessments, Drawings, Calculations etc. (Machinery Directive 2006/42/EC explains what should be in a Technical File in Annex VII).
• Carry out a PUWER assessment before putting the machinery into service.

Derek Coulson is a Technical Advisor with Safe Machine Ltd., who assist companies with machinery safety inspections for CE Marking or PUWER; a Director of DD ITS Ltd who provide COMPLIANCE Risk Software and a Director of Hold Tech Files Ltd. who store and review Technical Files in the Republic of Ireland for companies outside of the EU.

Derek also acts as a moderator for the 2006/42/EC Machinery Directive Group on LinkedIn.

I’d like to thank all those who I’ve worked with over the years. I’d also like to remember Arthur Armstrong, John McGee, Lynne Boucher and Patricia Thornton who all passed away too soon. I'd also like to remember Paul Skyrme, probably the best electrical engineer I have ever worked with, who sadly passed away in 2023.