(b)

where relevant Union or national rules on product safety lay down no threshold on what is to be considered a substantial modification, that: changes the product’s original performance, purpose or type, without that change having been foreseen in the manufacturer’s initial risk assessment; and changes the nature of the hazard, creates a new hazard or increases the level of risk.

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Source: EUR-Lex CELLAR · retrieved 2026-08-26 · Text as adopted (Official Journal); later amendments are not incorporated in this text.