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HomeAddendum to the scientific opinion on o-Phenylphenol, Sodium ophenylphenate and Potassium o-phenylphenate (SCCS/1555/15)
Here: the use as preservative of Sodium o-phenylphenate, Potassium o-phenylphenate, MEA o-Phenylphenate (CAS n. 132-27-4, 13707-65-8, 84145-04-0)
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Biphenyl-2-ol and its salts, covering o-Phenylphenol (OPP), Sodium o-phenylphenate, Potassium o-phenylphenate, MEA o-phenylphenate (CAS n. 90-43-7, 132-27-4, 13707-65- 8, 84145-04-0) as preservatives are regulated in Annex V, entry 7 of the Cosmetics Regulation (EC) n. 1223/2009 at a maximum concentration of 0.2 % (as phenol). The substance MEA o-phenylphenate is also regulated through entry 61 of Annex III on Monoalkylamines, monoalkanolamines and their salts which are restricted for use in cosmetic products to a maximum secondary amine content of 0,5% in ready for use preparation. The SCCS Committee adopted an opinion on o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate (SCCS/1555/15) in June 2015, later revised on 15 December 2015, with the following conclusion: "o-Phenylphenol as preservative with a maximum concentration of 0.2 % in leave-on cosmetic products is not safe. Also, in view of further exposures including non-cosmetic uses, the maximum concentration of o-Phenylphenol in leave-on cosmetic products should be lowered. However, the proposed maximum use concentration of up to 0.15% by the applicant can be considered safe. The use of o-Phenylphenol as preservative with a maximum concentration of 0.2 % in rinseoff cosmetic products is considered safe. Based on the information provided, no conclusions of safe use can be drawn for Sodium ophenylphenate and Potassium o-phenylphenate." Following this SCCS opinion, several Member States raised specific concerns as regards the potential risk to human health of Sodium o-phenylphenate, Potassium o-phenylphenate and MEA o-phenylphenate. In December 2017, the German Federal Institute for Risk Assessment submitted a document providing information on the safety of Sodium o-phenylphenate, Potassium ophenylphenate and MEA o-phenylphenate when compared to OPP.
- Publicatiedatum:
- Thema's Medisch en biologisch onderzoek , Farmaceutische en cosmetische industrie , Gezondheid van de consument
- Onderwerp: bescherming van de consument , chemische verbinding , cosmetisch product , giftige stof , kankerverwekkende stof , organisch chemisch product , verordening (EU) , volksgezondheid , wetenschappelijk onderzoek
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| ISSN 1831-4767 | ISBN 978-92-76-00237-6 | DOI 10.2875/753010 | Catalogusnummer EW-AQ-19-004-EN-N |
- Released on EU publications website:
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