§3.4.4 Substantial modification

It is essential that products remain safe throughout their lifespan. Modification of a product, by physical or digital means, might affect the nature and characteristics of the product in a way which was not foreseen in the initial risk assessment of the product, and which might jeopardise its safety. Such modification by any natural or legal person should therefore be considered as a substantial modification and, when not done by the consumer or on his behalf, should lead to the product being considered as a new product from a different manufacturer. In order to ensure compliance with the general safety requirement laid down in this Regulation, the person that carries out that substantial modification is considered as the manufacturer and subject to the same obligations. That requirement should only apply in respect to the modified part of the product, provided that the modification does not affect the product as a whole. In order to avoid an unnecessary and disproportionate burden, the person carrying out the substantial modification should not be required to repeat tests and produce new documentation in relation to aspects of the product that are not affected by the modification. It should be up to the person that carries out the substantial modification to demonstrate that the modification does not affect the product as a whole. Please also be aware that if you rebrand products and place them on the market under your name, you are considered to be the manufacturer of that product, and you must bear all the responsibilities of a manufacturer.

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Source: EUR-Lex (Cellar) · retrieved 2026-09-07