A biocidal product shall not be authorised for placing on the market for use by the general public if: a. it meets the criteria of the CLP Regulation1in order to be classified as follows:2 1. acute oral toxicity category 1, 2 or 3, 2. acute dermal toxicity category 1, 2 or 3, 3. acute inhalation toxicity (gases and dust/mist) category 1, 2 or 3, 4. acute inhalation toxicity (vapours) category 1 or 2, 5. specific target organ toxicity by single or repeated exposure category 1, 6. a category 1A or 1B carcinogen, 7. a category 1A or 1B mutagen, or 8. toxic for reproduction category 1A or 1B; b. it consists of, contains or generates a substance with properties meeting the criteria for being PBT or vPvB in accordance with Annex XIII to the REACH Regulation3; c.4 it has endocrine-disrupting properties meeting the criteria specified in Delegated Regulation (EU) 2017/21005; or d. it has developmental neurotoxic or immunotoxic effects.
See footnote to Art. 2 para. 2 let. a No 2. ↩
Amended by No I of the O of 15 Nov. 2023, in force since 1 Jan. 2024 (AS 2023 709). ↩
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, OJ L 396 of 30 December 2006, p. 1; last amended by Regulation (EU) No 2015/830, OJ L 132 of 29 May 2015, p. 8. ↩
Amended by No I of the O of 15 Nov. 2023, in force since 1 Jan. 2024 (AS 2023 709). ↩
Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council, amended by OJ L 301 of 17.11.2017, p. 1. ↩
0 commentaries