CE certification service for ‘grey area’ installations

Sumitomo (SHI) Demag has launched a new CE certification service for robotic injection moulding machines, relieving its customers of the burden of self-certification – a time-consuming process that requires specific legal and technical knowledge. The new service has been created specifically to enable injection moulders to achieve compliance with European health, safety and environmental directives governing machines that have been modified to incorporate a robot and peripheral equipment.

Since 1995, injection moulding equipment manufactured outside of the EU or imported from non-EU countries has been subject to the CE marking process when put into service in the European market. When the injection moulder incorporated a robot, it was sufficient for the robot to be accompanied by a Declaration of Incorporation, as the robot was considered to be partly completed machinery. There was no requirement, by law, for the cell in its entirety to be CE marked.

With the Supply of Machinery (Safety) Regulations 2008 and amendment in 2011, it became mandatory for the complete robotic cell to carry the CE marking. The directive also stated that whoever created the final installation – whether integrator or end-user – was responsible for obtaining this certification. The regulation is enforced in Great Britain by the HSE (Health and Safety Executive) and any non-compliant installation can result in a fine of £5000 or up to two years in prison.

However, according to Nigel Flowers, managing director of Sumitomo, many companies are unaware that the onus for CE marking their robotic injection moulders has shifted, and may be breaching the law. “Whilst most of the larger moulding shops are well aware of their legal responsibilities, a lot of smaller injection moulders aren’t. There are many instances of companies who have added a robot and guarding to their injection moulding machine and think that makes it perfectly safe and legal.”

Even companies who are aware of the need to obtain CE certification for installations are struggling to find someone to certify their equipment – and for a fair, not extortionate, fee, according to Nigel. “It’s straightforward enough when buying a robot and an injection moulding machine together from the same supplier, as they will usually CE certify the cell before it leaves the factory. Complications arise when, for example, the injection moulder and the robot are from different manufacturers, or a company is buying a robot to incorporate into an existing moulder. We’ve heard of companies being quoted £10,000 just to get one cell CE certified.”

He said the issue has become more apparent as take-up of robots by the injection moulding industry has grown. “More and more injection moulders are investing in robotics, and a lot of companies run the risk of not having all their safety paperwork in place when trying not to  hold up an automation project,” he explained.

There is the option of self-certification. To achieve compliance the company must nominate a ‘Responsible Person’ to undertake the conformity assessment process. This includes meeting all relevant essential health and safety requirements (EHSRs) for the product, producing comprehensive user instructions, and showing how compliance has been achieved in the technical file.  However, even if companies have someone in-house with the necessary competence to undertake this responsibility, it will probably take them several days to carry out the inspections and compile the supporting documentation. Furthermore, injection moulding machines have to meet the higher safety requirements set out in the European Standard BS EN 201:1997.

With this in mind, Sumitomo has come to the rescue with a full CE compliance service for a fraction of the cost of many other CE consultancy offerings.  Available exclusively to Sumitomo customers from a £3,000 fee, this comprehensive service gives customers peace of mind, as well as a full technical file containing all relevant information to support the CE marking of their cells. This usually includes technical drawings, bill of materials, test reports and assessments, instructions and other documents required by the directive to support the conformity of the product.

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