Post-Brexit, the Supply of Machinery (Safety) Regulations replaces the European Machinery Directive (2006/42/EC). To explain further, Lucinda Thorpe, Business Development Executive at Newgate shares her advice to its practicalities.
The regulations apply to manufacturers
As with the preceding EU directive, the regulations are aimed at manufacturers. There are, however, some instances where they may apply to installers. For example, if an installer converts a manual gate to a powered one, then they are considered to be the manufacturer of a powered gate. Powered gates are classed as machinery; hence the Supply of Machinery (Safety) Regulations would apply.
Failure to comply with the regulations can lead to prosecution under criminal law. Manufacturers also leave themselves open to civil lawsuits. For example, if an item of machinery causes someone an injury and it is determined that it is due to a manufacturing fault, then the manufacturer may be liable for civil damages.
The regulations apply to a wide range of items
The legal definition of machinery is very broad. In simple terms, however, if an item moves without needing a human or animal to touch it, then it’s probably classed as machinery. This means that common workplace equipment is very likely to come under the Supply of Machinery (Safety) Regulations. For example, powered gates, bollards and so forth definitely do.
It’s also important to note that the Supply of Machinery (Safety) Regulations are likely to apply to “partly completed machinery”. For example, kits to convert a manual gate into a powered gate would typically be considered “partly completed machinery”.
In this instance, however, the burden of compliance would fall on the installer rather than the manufacturer of the kit. This is because it’s the installer who brings everything together and hence, effectively, manufactures the powered gate.
The regulations require manufacturers to demonstrate compliance
As with a lot of modern legislation, particularly safety-related legislation, the onus is on the “responsible persons” to demonstrate compliance with the rules. There is a list of criteria you must meet in order to do this. These are as follows.
- Carry out a conformity assessment
- Issue a Declaration of Conformity
- Show that you have met the Essential Health and Safety Requirements in Annex 1 of the directive
- Provide the operator with instructions for use and maintenance (in an appropriate language)
- Ensure that the machinery is correctly CE marked
- Complete a technical file (and make it available to the authorities)
The practicalities of demonstrating compliance
In principle, demonstrating compliance with the Supply of Machinery (Safety) Regulations is largely a “tick box exercise”. It is, however, vital to ensure that all the relevant boxes are ticked in the right way. Here is some guidance.
Carrying out a conformity assessment
Conformity assessments basically check whether or not an item conforms to the relevant standards. This means that you need to know which standards apply. Then you need to know what to do to show compliance with them.
Keep in mind that standards can be, and often are, updated. The onus is on you to check for updates and then reflect those updates in your procedures.
Issuing a Declaration of Conformity
A Declaration of Conformity essentially identifies the manufacturer and gives details of the conformity assessment. The key point to note is that it needs to be issued and signed by the responsible person. This is the person who places the product on the UK market. Declarations of Conformity are never made by either a Notified Body or a test house.
Showing that you have met the Essential Health and Safety Requirements in Annex 1 of the directive
Essentially the same comments apply here. You need to know what the requirements are and clearly document how you are complying with them. Basically, think about what would happen if you were ever challenged on the issue. How would you be able to prove that you had complied with the requirements?
Providing the operator with instructions for use and maintenance (in English)
Out of all the steps involved in complying with the Supply of Machinery (Safety) Regulations, this one may be the most challenging. Manufacturers, by definition, will know every little detail of a product. They must, however, create documentation on the assumption that the reader will know absolutely nothing about it.
In fact, ideally, the use and maintenance documentation should assume that the reader has no technical knowledge whatsoever. This means that every point should be broken down into simple terms anyone can understand. Industry jargon must be avoided if possible. If it’s not possible, it must be clearly explained.
Creating effective user documentation can be a resource-intensive activity. On the plus side, the effort is usually more than justified. Not only can it satisfy relevant authorities, but it can also increase customer satisfaction and reduce support calls.
Ensuring that the machinery is correctly CE marked
This is literally just a matter of attaching the correct labelling to a product. It is, however, imperative that this step is completed, otherwise, you will be out of compliance with the Supply of Machinery (Safety) Regulations for a completely avoidable administrative reason.
Completing a technical file (and making it available to the authorities)
The contents of a technical file will depend on the actual item of machinery. As a rule of thumb, it will need to contain everything on the list of requirements given above. It may also need to contain further information, such as details of the methodology used to draw conclusions.
Technical files may be kept in digital form and may be stored outside the UK/EU. Manufacturers will, however, be expected to transmit them, promptly, in an agreed format upon any request by the authorities.
Prior to Brexit, this documentation could be made available in any one of the official community languages. Post-Brexit, however, it has been specified that the documentation must be provided in English.
As a reminder
All machinery must comply with the Supply of Machinery (Safety) Regulations. These regulations may, however, be a starting point rather than an endpoint. There will likely be many other laws with which you will need to comply. You will therefore need to inform yourself about what these are and what you need to do to demonstrate compliance with them.