Addendum to the scientific opinion on Zinc pyrithione (P81) ref SCCS/1512/13 - Latest edition SCCS/1593/2018 – Final Opinion - Archive ouverte HAL Accéder directement au contenu
Ouvrages Année : 2019

Addendum to the scientific opinion on Zinc pyrithione (P81) ref SCCS/1512/13 - Latest edition SCCS/1593/2018 – Final Opinion

U. Bernauer
  • Fonction : Auteur
L. Bodin
  • Fonction : Auteur
Q. Chaudhry
  • Fonction : Auteur
P.J. Coenraads
  • Fonction : Auteur
M. Dusinska
  • Fonction : Auteur
J. Ezendam
  • Fonction : Auteur
C. L. Galli
  • Fonction : Auteur
B. Granum
  • Fonction : Auteur
E. Panteri
  • Fonction : Auteur
V. Rogiers
  • Fonction : Auteur
M. Stepnik
  • Fonction : Auteur
T. Vanhaecke
  • Fonction : Auteur
S. Wijnhoven
  • Fonction : Auteur
A. Simonnard
  • Fonction : Auteur
A. Koutsodimou
  • Fonction : Auteur

Résumé

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 antidandruff 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).
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Dates et versions

hal-02054805 , version 1 (02-03-2019)

Identifiants

Citer

U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, et al.. Addendum to the scientific opinion on Zinc pyrithione (P81) ref SCCS/1512/13 - Latest edition SCCS/1593/2018 – Final Opinion. Publications Office of the European Union, 2019, 978-92-76-00238-3. ⟨10.2875/34622⟩. ⟨hal-02054805⟩
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