O-phenylphenol restriction and ban of sodium o-phenylphenate, potassium o-phenylphenate and MEA o-phenylphenate

Due to concerns raised by several Member States and potential risks to human health, the European Commission has decided to amend Annex V of the EU cosmetics regulation on 26 November 2018 in order to restrict the use of preservative o-phenylphenol and ban the use of preservatives sodium o-phenylphenate, potassium o-phenylphenate and MEA o-phenylphenate in cosmetics:

  • The use of o-phenylphenol as a preservative should be allowed with a maximum concentration of 0,15 % in leave-on and 0,2 % in rinse-off cosmetic products. There should also be an indication that the contact with eyes should be avoided.
  • The use of sodium o-phenylphenate, potassium o-phenylphenate and MEA o-phenylphenate as preservatives should not be allowed.

In February 2018, the SCCS has adopted its opinion on the use of o-phenylphenol as a preservative. In an addendum, the SCCS indicated that preservatives sodium o-phenylphenate, potassium o-phenylphenate and MEA o-phenylphenate have greater skin penetration and consequently may exhibit more potent toxic effects than o-phenlyphenol and therefore the same use levels cannot be applied.

Timelines for the use of Biphenyl-2-ol as a preservative:

  • From 17 June 2019 cosmetics products that are not in compliance with these new restrictions shall not be placed on the EU Market
  • From 17 September 2019 cosmetic products that are not in compliance with these new restrictions shall not be made available to the EU market

Timelines for the use of Sodium 2-biphenylate, Potassium 2-biphenylate or 2-aminoethan-1-ol; 2-phenylphenol as preservatives:

  • From 17 June 2019 cosmetics products with mentioned banned preservatives shall not be placed on the EU market.
  • From 17 September 2019 cosmetic products with mentioned banned preservatives shall not be made available on the EU market.