Machinery

Safety requirements and standards

The statutory safety requirements are mandatory. The machinery must meet the requirements under the Machinery Decree that concern the machine in question. The harmonised standards have been drawn up so that by complying with them, the product is deemed to comply with the essential requirements of EU legislation. However, compliance with the standards is voluntary.

Essential health and safety requirements for the machinery

The machine must be safe for persons, domestic animals and property when properly installed, used and maintained in accordance with the instructions. However, the machinery must not present any danger, even if it is used in a foreseeable manner that is contrary to the manufacturer’s instructions. The manufacturer must therefore also take account of any reasonably foreseeable misuse of the machinery in its design and manufacture.

The machinery must be designed and constructed in accordance with the essential health and safety requirements provided for in annex I of the Machinery Decree. The requirements of the Machinery Decree are quite general in nature. The harmonised standards describe more specific technical solutions to meet these requirements. The manufacturer can also use technical solutions in the machine that differ from the harmonised standards, but the manufacturer is then obliged to prove that the machine meets the requirements of the Machinery Decree in another way. It is also worth noting that the harmonised standards provide a good indication of the state of the art to be considered when applying the safety requirements of the Machinery Decree.

Risk assessment

In order to determine the health and safety requirements to be applied to the machinery, the manufacturer must carry out a risk assessment of the machinery. After this, the machinery must be designed and constructed taking the results of the risk assessment into account.

Risk means a combination of the probability and degree of an injury or damage to health that can arise in a hazardous situation caused by the machinery.

Machinery’s risk assessment and risk reduction is an iterative process. During the process, the manufacturer must:

• determine the limits of the machinery, including both the use intended by the manufacturer and reasonably foreseeable misuse
• identify the hazards that the machine may present, and the dangerous situations associated with them
• estimate the risks associated with those hazards
•  evaluate the risks to determine whether risk reduction is necessary
• eliminate hazards or reduce the risks associated with the hazards

Measures to eliminate or reduce the risks associated with the machinery must be taken and followed in this order:

1.      The risks are eliminated or reduced as far as possible by the safe design or construction of the machine itself.

•  Example: The machinery is designed so that it does not have open gaps through which a limb could be extended to moving parts.

2.      Appropriate protective measures will be taken for the risks which cannot be eliminated.

• Example: A guard is installed around the splitting wedge of the splitting machine.

3.      Inform users of the residual risks, i.e. the risks that remain after the two primary steps. These are therefore risks which cannot be eliminated by design or by protective measures. Residual risks are mentioned in the machinery’s instructions and markings.

• Example: Inform chainsaw users of the need for personal protective equipment.

More examples:

• If the hot parts of the machine can be positioned so that the user cannot reach them even accidentally, this must be done instead of protecting the parts with separate guards. If this is impossible, the hot parts must be insulated with guards, rather than only having a warning in the instructions.
• For example, if the machine can be designed and manufactured so that its rotating parts do not have any protruding bolts on which the user’s glove might get caught, this must also be done instead of protecting the bolts with a separate guard or having a warning in the user instructions.
• If the machine has moving parts that can be reached with a limb, and these parts can be protected by installing a guard in front of them, this should also be done instead of leaving the parts unprotected and only including a warning in the user instructions.

Harmonised standards

The product legislation of the EU sets essential requirements related to safety, health and the environment on certain product groups. To make the manufacturing of compliant products easier, and to ensure that the requirements of the EU legislation are fulfilled, European or harmonised standards are drawn up, by order of the EU.

A harmonised standard is a standard drawn up by a European standardisation organisation that has been confirmed upon the request of the European Commission in order to apply the EU product legislation. The references of harmonised standards are published in the Official Journal of the European Union. 

Official Journal of the European Union OJEU 

The Official Journal of the European Union (OJEU) is the main content source for EUR-Lex. It is published every day in the official languages of the EU (regularly from Monday to Friday; only in urgent cases on Saturdays, Sundays and public holidays). 

The journal has two series: 

• L (legislation) 

• C (communications and notices) 

The subseries CA (e.g. C019A), which is published on the same day and the same number as the C-series, contains calls for expressions of interest and vacancy notices. The CA series journals can appear in one, several, or all of the official languages. 

The new subseries LI and CI were introduced on 1 January 2016. They give flexibility to situations where the planned content of the Official Journal changes. Since 1 July 2013, the electronic version of the Official Journal has been the authentic version of the Official Journal with legal effects.  

Official Journal of the European Union 

What does presumption of conformity mean, and how does it relate to standards?

When a machine is designed and manufactured in accordance with the harmonised standards, it enjoys a “presumption of conformity”, meaning that it is considered to comply with the relevant essential requirements of EU law if 

• the manufacturer has designed, manufactured, examined and tested the product in accordance with the harmonised standards  
• and the product complies fully with all the relevant harmonised standards. 

The manufacturer has no obligation to manufacture the device in accordance with the standards, as the standards are recommendations in nature, and their use is voluntary. The requirements provided for in acts and decrees are mandatory, meaning that they must be followed. 

Harmonised machinery safety standards

The manufacturer of the machinery can use the harmonised standards to meet the legal requirements for the machinery. Harmonised standards are drawn up so that the machinery is deemed to comply with the essential safety requirements if the harmonised standards are complied with in full when designing and constructing the machinery.

The harmonised standards relating to the safety of machinery fall into three basic categories:

• A-type standards: fundamental safety standards that can be applied to all machinery.
• Example: Standard EN ISO 12100:2010 Safety of machinery – General principles for design – Risk assessment and risk reduction
• B-type standards: deal with specific aspect of safety or protective device
• Example: Standard EN ISO 13851:2019 Safety of machinery - Twohand control devices – Principles for design and selection
• C-type standards: standards specific to a machine type
• Example: Standard EN 1494:2000+A1:2008 Mobile or movable jacks and associated lifting equipment

Compliance with standards is not mandatory. If the manufacturer designs and manufactures the machinery in a way that differs from harmonised standards, the manufacturer is obliged to prove that the machine meets the requirements of the Machinery Decree in another way. The harmonised standards also provide a good indication of the state of the art to be considered when applying the safety requirements of the Machinery Decree. This leaves room for the development of new and perhaps better technical solutions, while ensuring an adequate level of safety.

However, in the case of machinery covered by annex IV of the Machinery Decree, you should remember that if the machine is not manufactured in accordance with the harmonised standards, there will be an obligation to use a third party (notified body) for conformity assessment. Read more about conformity assessment procedures.

You can find the harmonised standards in accordance with the Machinery Directive on the European Commission website: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/machinery-md_en

Watch a recording of Tukes’ I Know My Product webinar, Deep scan for machinery safety: reviewing the machinery and its technical safety: 

Watch a recording of Tukes’ I Know My Product webinar, Safety of lifting machines and accessories: