Before any item of machinery can be legally placed on the market in the EU, it must bear the CE marking. This cannot be applied unless the machine has been proven to meet the requirements of the Machinery Directive and any other applicable directives.
The CE marking involves a four-step process:
1) Essential Health & Safety Requirements (EHSRs)
2) Technical Construction File
3) Declaration of Conformity
4) Affix the CE Marking
All machines supplied in the European Economic Area (EEA) from 1 January 1995, must comply with the Machinery Directive and be safe. The Essential Health and Safety Requirements (EHSR) lay down the minimum compliance criteria. The preferred way to comply with EHSRs is by Risk Assessment and the application of harmonized EN standards, which are replacing the national standards of member states.
The EHSR requirements are wide ranging, taking into account potential dangers to operators and other persons who may be at risk. A typical example of an EHSR is the requirement to provide adequate warning labels where there are moving parts that might trap parts of the body of personnel using the machine. Another would be the requirement to provide safety guards to machine tools.
However, taking into account the state-of-the-art, it may not be possible to meet all the objectives set by EHSRs, as technologies often move more quickly than the standards trying to catch up with them. With this in mind, the machinery must be designed and constructed with the purpose of approaching these objectives. Within the Supply of Machinery (Safety) Regulations, the Essential Health and Safety Requirements are divided into six sections:
- EHSRs applicable to all machinery<
- EHSRs for certain categories of machinery, including foodstuffs machinery; machinery for cosmetics or pharmaceutical products; hand-held and/or hand-guided machinery; portable fixing and other impact machinery; machinery for working wood and material with similar physical characteristics
- EHSRs to offset hazards due to the mobility of machinery
- EHSRs to offset hazards due to a lifting operation
- EHSRs for machinery intended for underground work
- EHSRs to offset hazards due to the lifting of moving of persons
The Machinery Directive’s more notable EHSRs include:
- EHSR 1.1.7 The operating position must be designed to avoid any risk due to exhaust gases/ lack of oxygen<
- EHSR 1.1.8 work stations that are an integral part of the machine must be designed for the installation of seating
- EHSR 1.2.2 Manual controls must be clearly visible and identifiable; the use of pictograms is recommended
- EHSR 220.127.116.11 Fixed guards. Fixing systems must remain attached to the guards when removed
- EHSR 1.1.2 requires risk assessment to be carried out
When considering EHSRs, risk assessment is a vital step in ensuring compliance and therefore the fundamental starting point for designers of machinery under the Machinery (Safety) Regulations. Some useful references include the standard EN ISO 12100 ‘Safety of Machinery – Risk Assessment’, which defines risk assessment as ‘a series of logical steps to enable, in a systematic way, the analysis and evaluation of the risks associated with machinery.’
EN ISO 12100 goes on; ‘Risk assessment is followed, whenever necessary, by risk reduction. Iteration of this process can be necessary to eliminate hazards as far as practicable and to adequately reduce risks by the implementation of protective measures.’
Technical construction file
A technical construction file will prove due diligence and provide the evidence of compliance. It must also conform to the provisions set out in Annex VII of the Machinery Directive and remain available for inspection by a competent national authority for a period of ten years. However, it does not have to include detailed information such as the sub-assemblies of the machine, unless a knowledge of them is essential for verification and compliance with the EHSRs.
As the documentation within the technical file must enable enforcement authorities to assess the conformity of the product, it is best to remember that they may not be highly skilled machinery engineers, so plain language must be used and explanations given. They are also entitled to demand the technical file is provided in any official EU language, so be prepared to translate it.
The technical file can be a traditional paper file, or stored electronically, with hyperlinks to documents, and it must be updated as the product is adapted.
Declaration of Conformity
The Declaration of Conformity must accompany every machine placed on the market. This is the manufacturer’s assurance to the customer that the product complies with the applicable directives. It must carry relevant product information and be signed by a responsible person on behalf of the manufacturer or importer.
The alternative to a Declaration of Conformity is a Declaration of Incorporation. This applies to partly completed machinery that is intended to be part of an assembly but cannot itself perform a specific application. This declaration and assembly instructions for the partly completed machinery will then form part of the technical file for the final machinery assembly.
The final step to prove compliance of machinery is to affix the CE marking to machines being sold in the European Union and UKCA mark for those being placed on the UK market (post Brexit).
Regardless of what happens with the Brexit deal, the actual process for manufacturing compliant machinery for the UK market will have little effect from a legal perspective. As EU Directives are already transposed into National Law, the UK already has a legal system in place that applies. There will of course be text amendments to reflect UK legislative requirements, including the UKCA mark and removal of references to EU directives and the CE marking. While references to ‘harmonized standards’ will change to ‘designated standards’, the actual standards will remain the same as EU harmonized standards, and will be carried across as UK designated standards to maintain a single standards model.
As a machinery end-user, before accepting any new machines check that they meet the requirements of the order and also conform to the Machinery Directive. A pre-purchase audit is a useful system that can help machinery buyers ensure that equipment is both safe and correct.
Paul Taylor is Head of Industrial Products (UK) at TÜV SÜD, one of the world’s leading experts in product testing and certification, with 150,000 product certificates in circulation globally. Its Product Service division analyses over 20,000 products each year in Europe, Asia-Pacific and the Americas, using its technical expertise to help customers optimize market access.