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Expert opinion

Addendum to the scientific opinion on Zinc pyrithione (P81) ref. SCCS/1512/13

Final Opinion

Details

Publication date
22 February 2018
Author
Scientific Committee on Consumer Safety (SCCS)

Description

WG on Cosmetic Ingredients
SCCS members: U. Bernauer (Rapporteur), L. Bodin, Q. Chaudhry (SCCS Chair), P. Coenraads (SCCS Vice-Chair and Chairperson of the WG), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum, E. Panteri, V. Rogiers (SCCS Vice-Chair), C. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
SCCS members: A. Simonnard, A. Koutsodimou
Contact:SANTE-C2-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1593/18
Adopted on: 21-22 February 2018

Conclusion of the opinion:

1. In light of the new evidence available, does the SCCS still consider that zinc pyrithione, when used in a concentration up to 2.0% as an anti-dandruff agent in rinse-off hair care products, is safe for the consumer as concluded in SCCS/1512/13?

The newly provided studies on fertility and developmental toxicity did not lead to changes of point of departure for risk assessment compared to SCCS/1512/13. Further additional studies mentioned in the Swedish CLH proposal confirm neurotoxicity as a sensitive endpoint of ZPT toxicity. In view of the additional studies SCCS confirms the LOAEL of 0.5 mg/kg bw/d that was derived in SCCS/1512/13 as a conservative value for risk assessment of ZPT.

Therefore ZPT is considered safe when used at a concentration up to 2.0% as an anti-dandruff agent in rinse-off hair care products.

2. Does the SCCS have any further scientific concerns regarding the use of zinc pyrithione in cosmetic products?

The conclusion from SCCS/1512/13 was specifically targeted to risk assessment for the particular use of ZPT in a concentration up to 2.0% as an anti-dandruff agent in rinse-off hair care products. Aggregate exposure from non-cosmetic sources has not been considered.

In view of apparent further (non-cosmetic) uses and in view of the fact that classification as Repr 1B is currently proposed, the SCCS recommends risk assessment taking into consideration all possible sources of exposure in line with Art 15 of Cosmetics Regulation (EU 1223/2009).

Not all relevant toxicological studies performed with ZPT have been made available to the SCCS (see section 3.1. Introduction of SCCS/1512/13).

Keywords:

SCCS, scientific opinion, addendum, preservative, P81, Zinc pyrithione, Regulation 1223/2009, CAS 13463-41-7

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), addendum to the Opinion on preservative Zinc pyrithione (P81) ref. SCCS/1512/13, 21-22 February 2018, SCCS/1593/18.

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