Omnibus Regulation 2019

Regulation of o-Phenylphenol and its derivatives

o-Phenylphenol (also called Biphenyl-2-oln CAS 90-43-7) and its derivatives (MEA o-Phenylphenate, Potassium o-Phenylphenate and Sodium
o-Phenylphenate) are official preservativesreported under Entry 7 of Annex V to the European Cosmetics Regulation EC No 1223/2009.
As of today, these preservatives can be used at up to 0.2% (as phenol) in all cosmetic products. In practice, it appears that the use of his preservative by the cosmetic industry is very rare.

The European Regulators have decided to regulate further this ingredient and its derivatives:

  • The maximum use level in rinse-off products remain 0.2% (as phenol).
  • The new maximum use level in leave-on products is 0.15% (as phenol).
  • The special warning “Avoid contact with eyes” is required for all products containing these ingredients.
  • The use of Sodium o-Phenylphenate, Potassium o- Phenylphenate, MEA o-Phenylphenate in cosmetic products becomes prohibited.

This new amendment (EU No 2018/1847) will enter into force on Monday, December 17th, 2018. However, transition periods are granted:

  • From June 17th, 2019 (> 6 months from now) only cosmetic products that comply with this Regulation shall be placed on the Union market (namely, no further placing on the market of non-compliant products after this date).
  • From September 17th, 2019 (> 9 monthsfrom now) only cosmetic productsthat comply with this Regulation shall be made available on the Union market (namely, non-compliant products are withdrawn from the market by this date).

Any questions?

Author

  • Christophe Brault-Chevalier

    Christophe Brault-Chevalier is the Scientific & Regulatory Affairs Director at Biorius, bringing over 20 years of experience in the cosmetics industry. He has previously held positions at International Flavors & Fragrances Inc. (IFF) and LVMH, further enhancing his expertise in the field.

    View all posts Scientific & Regulatory Affairs Director @ BIORIUS