Internal Market and industry, public health
Any interested parties, including authorities of the Member States, manufacturers of cosmetic products, producers of the substances concerned and relevant industry and consumer associations.
Period of consultation: 11 November 2016 - 15 February 2017
Salts of o-Phenylphenol, namely Sodium o-Phenylphenate (CAS 132-27-4), Potassium o‑Phenylphenate (CAS 13707-65-8) and MEA o-Phenylphenate (CAS 84145-04-0) are listed in Annex V, entry 7, of Regulation (EC) No 1223/2009 on cosmetic products as preservatives, together with o‑Phenylphenol, authorised up to a maximum concentration of 0.2% (as phenol) in the finished cosmetic product. MEA o-Phenylphenate is also regulated under Annex III, entry 61, on 'Monoalkylamines, monoalkanolamines and their salts'.
In 2013, the Commission published a call for data on o‑Phenylphenol to collect available data for risk assessment by the Scientific Committee on Consumer Safety (SCCS) following concerns expressed by French authorities over the safety of the substance at the current maximum authorised concentration of 0.2% for its use as a preservative in cosmetic products.
This additional call for data is aimed at retrieving existing data for the safety assessment of the other 3 substances covered by entry 7 of Annex V used as preservatives. Due to the possible uses of salts of o-Phenylphenol in cosmetic products other than as preservative, this call also covers safety information regarding these additional uses.
Action proposed by the Commission
In order to prepare requests for scientific opinions to the SCCS, interested parties are invited to submit any relevant scientific information on the safety of Sodium o-Phenylphenate (CAS 132-27-4), Potassium o-Phenylphenate, (CAS 13707-65-8) and MEA o-Phenylphenate (CAS 84145-04-0) as preservative and non-preservative ingredients in cosmetic products and, in particular, data regarding all toxicological end-points and an indication on the suggested concentration safe limits for these ingredients. The dossiers shall be in line with the SCCS's Notes of Guidance (9th revision).
In view of the above, the Commission would like to invite any interested parties, including authorities of Member States, manufacturers of cosmetic products, producers of the substances Sodium o-Phenylphenate (CAS 132-27-4), Potassium o-Phenylphenate, (CAS 13707-65-8) and MEA o-Phenylphenate (CAS 84145-04-0) and relevant industry and consumers associations, to submit their contributions.
How to submit your contribution
Any information should be delivered with the reference: 'Salts of o-Phenylphenol' by post or email by 15 February 2017 at the latest to:
Directorate General Internal Market, Industry, Entrepreneurship and SMEs
Unit D/4, Health Technology and Cosmetics,
Av. d’Auderghem 45, BREY 12/10