Following the opinion of the ECHA (European Chemicals Agency) Risk Assessment Committee (RAC) recommending a harmonised classification of Carc. 2 (category 2 carcinogen), the industry submitted a dossier in defence of the substance to avoid a ban. The European Commission has just asked the SCCS to assess it. The Scientific Committee accepted this mandate on 28 February 2024.
Background
“Biphenyl-2-ol” and “Sodium 2-biphenylolate” (CAS/EC No.90-43-7/201-993-5 and 132-274/205-055-6) are known with the INCI names “o-Phenylphenol” and “Sodium o-Phenylphenate”, respectively, as cosmetic ingredients.
The use of o-Phenylphenol as a preservative is currently authorised in entry 7 of Annex V to the Cosmetics Regulation (EC) No.1223/2009, with a maximum concentration of 0.15% (as phenol) in leave-on and 0.2% (as phenol) in rinse-off cosmetic products.
The Scientific Committee on Consumer Safety (SCCS) adopted an Opinion on o-Phenylphenol (OPP), Sodium o-Phenylphenate (SOPP), and Potassium o-Phenylphenate (POPP) (SCCS/1555/15) in June 2015, later revised on 15 December 2015, with the following conclusion: “Based on the information provided, no conclusions of safe use can be drawn for Sodium o-Phenylphenate and Potassium o-Phenylphenate”.
In 2018, the SCCS released an addendum to the above scientific Opinion, specifically addressing Sodium o-Phenylphenate, Potassium o-Phenylphenate, and MEA o-Phenylphenate. The SCCS concluded that “Due to the lack of relevant information, the SCCS is unable to answer the question regarding the safe use level of sodium-OPP, potassium-OPP, and MEA-OPP. In the SCCS’s view, a direct comparison between the safety of o-Phenylphate (OPP) and its three compounds cannot be made.” The conclusions of this Opinion resulted in amending entry 7 of Annex …
