Commission Implementing Decision (EU) 2016/109 of 27 January 2016 not to approve PHMB (1600; 1.8) as an existing active substance for use in biocidal products for product-types 1, 6 and 9 (Text with EEA relevance)

What Commission Implementing Decision (EU) 2016/109 of 27 January 2016 not to approve PHMB (1600; 1.8) as an existing active substance for use in biocidal products for product-types 1, 6 and 9 (Text with EEA relevance) requires

Commission Implementing Decision (EU) 2016/109, adopted at Brussels on 27 January 2016 by the European Commission under authority of Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, formally declines to approve PHMB (1600; 1.8) (EC No: n.a., CAS No 27083-27-8 and 32289-58-0) as an existing active substance for use in biocidal products for product-type 1 (human hygiene), product-type 6 (preservatives for products during storage), and product-type 9 (fibre, leather, rubber and polymerised materials preservatives), as defined in Annex V to Regulation (EU) No 528/2012. The Decision follows evaluation by France as the designated evaluating competent authority, which submitted assessment reports on 5 September 2013, 8 October 2013, and 14 February 2014. The European Chemicals Agency's Biocidal Products Committee formulated its opinions on 16 and 17 June 2015, concluding that biocidal products containing PHMB (1600; 1.8) for product-types 1, 6 and 9 may not be expected to satisfy the requirements laid down in Article 19(1)(b) of Regulation (EU) No 528/2012, as the scenarios evaluated in the human health risk assessments and the environmental risk assessments identified unacceptable risks. The Decision entered into force on the twentieth day following its publication in the Official Journal of the European Union.

Pillar: Legal & IP Sovereignty · Authority: European Commission · Version: 1.0.0 · Last updated: 2016-01-27

Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32016D0109

SHA-256 integrity: 4f93abcb36b1d67a86dc12cfdf37119d897567dc3db04262d7444e7726ce18e7

Primary Citations — 9 traced to source

• Article 1: 'PHMB (1600; 1.8) (EC No: n.a., CAS No 27083-27-8 and 32289-58-0) is not approved as an active substance for use in biocidal products for product-types 1, 6 and 9.'
• Article 2: 'This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.'

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