Internal Market, Industry, Entrepreneurship and SMEs

Call for data on ingredients: Salts of O-Phenylphenol (Sodium O-Phenylphenate, Potassium O Phenylphenate and MEA O-Phenylphenate)

Call for data on ingredients: Salts of O-Phenylphenol (Sodium O-Phenylphenate, Potassium O Phenylphenate and MEA O-Phenylphenate)
Published on: 11/11/2016
This is a call for data on the ingredients: Salts of O-Phenylphenol (Sodium O-Phenylphenate, Potassium O Phenylphenate and MEA O-Phenylphenate) in the framework of Regulation (EC) 1223/2009 of the European Parliament and of the Council on cosmetic products.

Policy fields

Internal Market and industry, public health

Target

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

Background

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).

Request

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:

European Commission
Directorate General Internal Market, Industry, Entrepreneurship and SMEs
Unit D/4, Health Technology and Cosmetics,
Av. d’Auderghem 45, BREY 12/10
1040 Brussels
Belgium

Email: GROW-D4@ec.europa.eu

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