European Commission requests SCCS Opinion on Biphenyl-2-ol and Sodium 2-biphenylolate 
Ingredients: BIPHENYL-2-OL AND SODIUM 2-BIPHENYLOLATE

Date of publication: 28/02/2024

The European Commission has requested the Scientific Committee on Consumer Safety (SCCS) to assess the safety of Biphenyl-2-ol and Sodium 2-biphenylolate. The SCCS approved this mandate on February 28 2024, and the Committee has now six months to deliver its Opinion.

BACKGROUND

Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27- 4/205-055-6) 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 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. In this opinion the SCCS was unable to draw a conclusion regarding the safe use of 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-Phenylphenate (OPP) and its three compounds cannot be made’. The conclusions of this opinion resulted in amending entry 7 of Annex V to the Cosmetics Regulation, removing from the list the previously authorised OPP salts. 

It should be noted that o-Phenylphenol, Sodium and Potassium o-Phenylphenate are active ingredients in broad-spectrum fungicides surface biocides. Under EU biocidal Regulation (EU) 528/2012, o-Phenylphenol has been evaluated for the different product types (PTs) such as PT 1, PT 2, PT4, PT 6 as a preservative ranging from 0.1 to 0.5 % w/w. 

The European Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) issued in December 2022 an opinion recommending among others a classification for o-Phenylphenol as ‘Carcinogen of Category 2’.

Questions to be addressed by the SCCS

Following the RAC opinion, the European Commission may propose a classification for o-Phenylphenol as a ‘Carc.2’ (CLP Regulation Annex VI entry). According to Article 15(1) of the Cosmetics Regulation ‘the use in cosmetic products of substances classified as CMR substances, of category 2, under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall be prohibited. However, a substance classified in category 2 may be used in cosmetic products where the substance has been evaluated by the SCCS and found safe for use in cosmetic products’. 

In December 2023, the Commission services received a dossier to defend the safe use of o-Phenylphenol, as well as its sodium salt (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205- 055-6) as preservatives in cosmetic products according to Article 15(1) of the Cosmetics Regulation 1223/2009. 

The Commission requests the SCCS to carry out a safety assessment on these ingredients in view of the information provided. 

  1. In light of the data provided and taking under consideration the classification as ‘Carcinogen Cat. 2’, does the SCCS consider o-Phenylphenol safe when used as preservative up to a maximum concentration of 0.2 % in rinse-off and 0.15 % in leave-on cosmetic products? 
  1. Alternatively, what is according to the SCCS, the maximum concentration considered safe for use of o-Phenylphenol in cosmetic products? 
  1. In light of the data provided and taking under consideration the classification as ‘Carcinogen Cat. 2’ of o-Phenylphenol, does the SCCS consider Sodium o-Phenylphenate safe when used as preservative up to a maximum concentration of 0.2 % in rinse-off and 0.15 % in leave-on cosmetic products? 
  1. Alternatively, what is according to the SCCS, the maximum concentration considered safe for use of Sodium o-Phenylphenate in cosmetic products? 
  1. Does the SCCS have any further scientific concerns with regard to the use of o-Phenylphenol and Sodium o-Phenylphenate in cosmetic products? 

REFERENCES

Scientific Committee on Consumer Safety (SCCS) – Request for a scientific opinion on Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6).

other REGULATORY UPDATES

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Date of publication: 15/09/2022

Date of application: 17/12/2022

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Regulation (EU) 2022/1531 – OMNIBUS ACT V – applicable as of 17 December 2022

Ingredients: METHYL SALICYLATE, SODIUM HYDROXYMETHYLGLYCINATE, DBMC, MIBK

Date of publication: 15/09/2022

Date of application: 17/12/2022

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