2-Biphenylol restriction amended in Annex V

2-Biphenylol (also known as o-Phenylphenol) is an antifungal agent and preservative – it is commonly used for post-harvest control of storage disease in fruits and also in cosmetics products as a preservative.

Due to the revised SCCS opinion on its safety, a new update regarding its usage in cosmetics was publish on the 26th of November 2018 by the European Commission.

The Regulation was amended to state that the use of the substance should be allowed with a maximum concentration of 0.15 % in leave-on and 0.2 % in rinse-off cosmetic products. In addition, the warning contact with eyes should be avoided will now need to be included in the label.

The use of the salts of 2-Biphenylol such as sodium o-phenylphenate, potassium o-phenylphenate and MEA o-phenylphenate as preservatives was also addressed in the amending regulation and their usage will no longer be permitted.

All changes to the regulation will apply from 17 June 2019 meaning that from this date, cosmetic products placed in the EU will need to comply with the above new restrictions. From 17 September 2019 cosmetic products containing Bi­phenyl-2-ol and that not comply with those conditions cannot be made available on the Union market.

If you wish to know more about restricted ingredients in the EU market, do not hesitate to contact us. Obelis Expert Consultants, with nearly 30 years of experience with EU regulatory affairs, will gladly answer your questions.

Guilherme Ferrugento

in News