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The European Commission has published Regulation (EU) 2018/1847 to restrict the use of o-phenylphenol, MEA o-phenylphenate, potassium o-phenylphenate and sodium o-phenylphenate in cosmetic products.

SAFEGUARDS | Cosmetics, Personal Care & Household NO. 001/19

SafeGuardS orig high angle view of makeup products

The European Commission published Regulation (EU) 2018/1847 on November 27, 2018 to restrict the use of o-phenylphenol and its salts in cosmetic products. The regulation shall enter into force on twentieth day following that of its publication in the Official Journal of the European Union.

Biphenyl-2-ol and its salts, namely o-phenylphenol, MEA o-phenylphenate, potassium o-phenylphenate and sodium o-phenylphenate have been listed in Annex V as preservatives of EC 1223/2009, with a maximum concentration of 0.2% (as phenol).

However, following consideration of the Scientific Committee on Consumer Safety (SCCS) opinion SCCS/1555/15 which advised the presence of potential risk to vision system with the use of o-phenylphenol in cosmetic products, another SCCS opinion SCCS/1597/18 also indicated that sodium o-phenylphenate, potassium o-phenylphenate and MEA o-phenylphenate may have potentially more potent toxic effects than o-phenylphenol, due to greater skin penetration. These substances have been prohibited by the European Commission.

Based on SCCS opinions on o-phenylphenol and its salts, the European Commission decided to restrict the use of o-phenylphenol at a maximum concentration of 0.15% (as phenol) in leave-on cosmetic products and 0.2% (as phenol) in rinse-off cosmetic products with warning ‘Avoid contact with eyes’. Sodium o-phenylphenate, potassium o-phenylphenate and MEA o-phenylphenate are not allowed for use as preservatives any more.

Chemical name/ INN/ XAN Biphenyl-2-ol
Name of Common Ingredients Glossary o-Phenylphenol
CAS number 90-43-7
EC number 201-993-5
Maximum concentration in ready for use preparation (a) 0.2% (as phenol) in rinse-off products
(b) 0.15% (as phenol) in leave-on products
Wording of conditions of use and warnings Avoid contact with eyes

Timeline for compliance:

  • From June 17, 2019, cosmetic products containing Biphenyl-2-ol and not complying with those conditions shall not be placed on the Union market
  • From September 17, 2019, cosmetic products containing Bi­phenyl-2-ol and not complying with those conditions shall not be made available on the Union market

Reference Source:

  1. Commission Regulation (EU) 2018/1847 of 26 November 2018 amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products [1]

The industry is advised to check and confirm if existing leave-on cosmetic products which are already on market contain more than 0.15% (as phenol) in their formulation. For cosmetic products containing o-phenylphenol, MEA o-phenylphenate, potassium o-phenylphenate and sodium o-phenylphenate shall be phased out in the above-mentioned period or shall be replaced by other ingredients which provide similar function.

SGS is committed to providing information about development in regulations for consumer products as complimentary services. Through a global network of laboratories, SGS provides a wide range of services including physical/mechanical testing, analytical testing and consultancy work for technical and non-technical parameters applicable to a comprehensive range of consumer products. Please do not hesitate to contact us for further information.

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Denny Li
Technical Support
t: +86 020 2909 3881

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