1. A natural or legal person shall be deemed to be a manufacturer for the purposes of this Regulation and shall be subject to the obligations of the manufacturer set out in Article 9 where that natural or legal person places a product on the market under the natural or legal person’s name or trademark.
2. A natural or legal person, other than the manufacturer, that substantially modifies the product, shall be deemed to be a manufacturer for the purposes of this Regulation and shall be subject to the obligations of the manufacturer set out in Article 9 for the part of the product affected by the modification or for the entire product if the substantial modification has an impact on its safety.
3. A modification of a product, by physical or digital means, shall be deemed to be substantial where it has an impact on the safety of the product and the following criteria are met:
(a) the modification changes the product in a manner which was not foreseen in the initial risk assessment of the product;
(b) the nature of the hazard has changed, a new hazard has been created or the level of risk has increased because of the modification; and
(c) the modifications have not been made by the consumers themselves or on their behalf for their own use.