4.
‘substance of concern’ means any substance which has an inherent capacity to cause an adverse effect on humans, animals or the environment and is present or is produced in a plant protection product in sufficient concentration to present risks of such an effect. Such substances include, but are not limited to, substances meeting the criteria to be classified as hazardous in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures OJ L 353, 31.12.2008, p. 1. , and present in the plant protection product at a concentration leading the product to be regarded as dangerous within the meaning of Article 3 of Directive 1999/45/EC;
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Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.