Internal Market: Orgalim position on the proposal for a General Product Safety Regulation

Published: 3 December 2021

Policies & Issues: Internal Market - Product Safety Legislation

Orgalim supports the revision of the existing General Product Safety Directive (GPSD) and the decision to transform it into a Regulation (GPSR), which will improve uniform application across the European Union. We recognise the importance of ensuring the safety of all products, regardless of whether or not they fall under harmonised legislation. However, we are concerned by certain aspects of the new proposal which may create legal uncertainty and unnecessary burdens, with no or limited benefits to consumers. ​​​​​​​


Main messages:

  • Health and safety requirements for products should be proportionate to the risk of a product. We call on policymakers to refrain from introducing the precautionary principle in the GPSR. The application of the precautionary principle to non-harmonised products which present no to low risk for the health and safety of consumers might lead to disproportionate burdens for companies, with no concrete impact on the actual safety of consumers

  • The broadening of the definition of ‘product’ in Article 3 does not allow for a line to be drawn between consumer and professional products, thus increasing uncertainty. Moreover, it should be clarified in the text that stand-alone software is not covered by this Regulation

  • The current draft creates inconsistencies with other legislation that is currently being revised, reviewed, or newly proposed. Such inconsistencies exist in definitions (e.g. ‘substantial modification’) but also in requirements going beyond those set out in harmonised legislation. This will increase legal uncertainty and complexity and create the risk of diverging requirements for the same product

  • Cybersecurity products or cybersecurity aspects of products should not be regulated in the GPSR, but through the introduction of a horizontal legislation on cybersecurity for networkable products following NLF principles

  • With regard to the standardisation system, we encourage a close consultation with industry, the European Standardisation Organizations (ESOs) and other relevant stakeholders throughout the process and we stress the need to solve the well-known existing problems affecting the European standardisation system

  • Formal and administrative requirements (e.g. technical documentation, risk analysis, operating instructions, etc.) are excessive and should not be applied in case of no or low risk products

  • Penalties should be designed in such a way as to strike the right balance between effective deterrence and proportionality, as defined in Regulation 2019/1020

  • The envisaged 6 month transition period is too short and should be increased to at least 24 months


To read our recommendations in full, please download the document above.


Federica Boledi
Manager - Internal Market and Digital

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