(b)

a simplified risk-based assessment procedure based on scientific principles, taking particular account of: evidence regarding the intrinsic hazard of the substance concerned, and in particular its aquatic ecotoxicity and human toxicity via aquatic exposure routes, evidence from monitoring of widespread environmental contamination, including monitoring data reported by the Member States to the Commission in accordance with Article 8b(4) of Directive 2008/105/EC, and other proven factors which could indicate the possibility of widespread environmental contamination, such as production or use volume of the substance concerned, and use patterns.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-08 · Text as adopted (Official Journal); later amendments are not incorporated in this text.