Replacing insoles in safety footwear

Work and safety footwear and (semi-) orthopaedic insoles are Personal Protective Equipment (PPE). The current associated standard EN-ISO 20345 stipulates which essential health and safety requirements a safety shoe must meet.

Safety shoes are certified in combination with an interchangeable insole or non-interchangeable insole.In case the original interchangeable insole in a safety shoe is replaced by an alternative insole, the new combination (safety shoe + alternative insole) must be re-tested by an accredited body (‘Notified Body’) based on the current standard EN-ISO 20345:2022. The current standard EN-ISO 20345:2022 stipulates that the manufacturer of an alternative insole may also replace the insole in the original safety shoe. This manufacturer of an alternative insole can therefore be a different manufacturer from the manufacturer of the original safety shoe! 

Product liability and warranty

The manufacturer of (the protocol for) the alternative insole is product liable for the alternative insole in combination with the safety shoe. It should be noted that the person who manufactured the alternative insole based on a protocol must have followed the instruction from this protocol exactly. Including the mandatory registration of the alternative insole in combination with the original safety shoe. The purpose of this is to check whether the relevant combination (original safety shoe + alternative insole) has been tested and approved in accordance with standard EN-ISO 20345.

In case the protocol for the alternative insole is not fully followed, the person who manufactured the alternative insole becomes the manufacturer of the new combination (original safety shoe + alternative insole). For this manufacturer of the new combination, all legal obligations apply to the safety shoe in accordance with PPE legislation, including product liability.

The manufacturer of the original safety shoe always remains product liable for this safety shoe. The manufacturer of the safety shoe cannot withdraw its product liability and warranty on the safety shoe, after the installation of an alternative insole by a third party, by operation of law.

Manufacturers who nevertheless withdraw their product liability and warranty on the original safety shoe, in case the original insole has been replaced by an alternative insole from a insole manufacturer, deliberately mislead their customers, employers and employees. These manufacturers ultimately disadvantage the users for whom the orthopaedic insoles are medically necessary.

Supervisor

Regulation EU/2016/425 for Personal Protective Equipment (PPE) with associated standard EN-ISO 20345:2022 for safety footwear is harmonised European legislation applicable in all European countries. Each EU country has appointed a supervisor who monitors the application of European legislation Regulation (EU) 2016/425 and associated standard EN-ISO 20345:2022. For example, in the Netherlands, the supervisor is the Dutch Labour Inspectorate. National supervisors are coordinated and instructed on European legislation at European level, so that there is always a unified European enforcement policy.

Based on PPE legislation, the supervisor therefore checks whether products placed on the market comply with this legislation. In case of an accident, the supervisor will assess the cause: the alternative insole in the safety shoe and/or the original safety shoe.

Conclusion

The current standard EN-ISO 20345:2022 stipulates that the manufacturer of an alternative insole may also replace the insole in the original safety shoe. This manufacturer of an alternative insole can therefore be a different manufacturer from the manufacturer of the original safety shoe!

The manufacturer of the alternative insole may therefore replace the insole with its own alternative insole without the permission of the footwear manufacturer, provided that the safety shoe and alternative insole combination has been tested and approved in accordance with the current standard EN-ISO 202345:2022.

Based on European legislation, the supervisor has confirmed in writing that the safety shoe manufacturer always remains product liable for the original safety shoe. The manufacturer of (the protocol for) the alternative insole is product liable for this combination (original safety shoe + alternative insole).

Thus, the manufacturer of the original safety shoe cannot, by operation of law, revoke its product liability and warranty after third-party installation of an alternative insole. Manufacturers and their industry associations that make such (threatening) statements deliberately mislead their customers, employers and employees with this misinformation. Clients for whom orthopaedic insoles are medically necessary are severely disadvantaged in this way.