Chemistry Reference
In-Depth Information
Report of the Workshop on Harmonized
Classification and Labelling (CLH) of Active
Substances in Plant Protection Products Held
in Berlin on 12 and 13 April 2011
Roland Solecki, Abdelkarim Abdellaue, Teresa Borges, Kaija Kallio-Mannila,
Herbert Köpp, Thierry Mercier, Vera Ritz, Gabriele Schöning and José Tarazona
Additional information is available at the end of the chapter
http://dx.doi.org/10.5772/55603
1. Introduction
For approval of active substances Regulation (EC) No 1107/2009 (here referred to as PPP
Regulation) provides in Annex II “Procedure and criteria for the approval of active
substances, safeners and synergists pursuant to Chapter II” that, amongst other things,
active substances, safeners and synergists (here referred to as active substances) cannot be
approved if they are classified or have to be classified for carcinogenicity, mutagenicity or
reproductive toxicity (CMR), category 1A or 1B hazard classes in accordance with the
Classification Labelling and Packaging (CLP) Regulation, unless exposure is negligible (for
C and R, 1A or 1B). The PPP Regulation specifies in the approval procedures that the applicant
shall submit a dossier to the Rapporteur Member State (RMS), who shall assess the dossier and
present the results of that assessment in the draft assessment report (DAR). The RMS shall
submit its DAR to the Commission and the European Food Safety Authority (EFSA). EFSA is
required to make the DAR available within 30 days to the other Member States for a 60-day
commenting period. In parallel, the DAR is also made publicly available by EFSA. EFSA have
to adopt a conclusion within 120-150 days of the end of the commenting period on whether the
active substance can be expected to meet the approval criteria and send this to the Commission
and Member States. The Commission then has to present a review report and a draft
regulation (proposed decision) to the Standing Committee on the Food Chain and Animal
Health within 6 months of receipt of the conclusion.
For classification of active substances Regulation (EC) No 1272/2008 (here referred to as CLP
Regulation), requires that proposals for Harmonized Classification and Labelling (C&L) of
