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Status under Reg. (EC) No 1107/2009 (repealing Directive 91/414/EEC )
Legislation Reg. (EU) 2017/1114 ,
Reg. (EU) No 540/2011
Old Legislation 03/31/EC ,
Reg. (EU) 2016/950 ,
Reg. (EU) 2017/841 ,
Reg. (EU) No 823/2012
Date of approval 01/09/2017 Expiration of approval 31/08/2024
RMS

Co-RMS
NL

ES
Risk Assessment EFSA
Category HB Review Report   Renewal Report 2017
  List of studies 2016
  Inclusion 2003
Remarks Renewal of approval Reg. (EU) 2017/1114
The original RMS was Spain.

Type Candidate for Substitution (CfS) CfS - criteria two PBT criteria
Authorisation at national level
Authorised in In progress for
AT, BE, BG, CY, CZ, DE, DK, EE, EL, ES, FI, FR, HR, HU, IE, IT, LT, LU, LV, MT, NL, PL, PT, RO, SI, SK, UK
Classification Reg. 1272/2008
Skin Sens. 1 - H317 Aquatic Acute 1 - H400
Aquatic Chronic 1 - H410  
Toxicological information
Reference values Source Remark
ADI 0.125 Reg. (EU) 2017/1114  
ARfD 0.3 Reg. (EU) 2017/1114  
AOEL 0.17 Reg. (EU) 2017/1114  
Other
ARfD 0.1 AUS 1987 
Legend
  • RMS:Rapporteur Member State
  • Co-RMS:Co-Rapporteur Member State
  • ADI:Acceptable daily intake
  • ARfD:Acute reference dose
  • AOEL:Acceptable operator exposure level