Facilitating the alignment of the Classification & Labelling process of plant protection product (PPP) active substances under Regulation (EC) 1272/2008 [Classification, Labelling and Packaging of substances and mixtures] and their evaluation for approval/non-approval purposes under Regulation (EC) 1107/2009
Regulatory Update: 21/2015
Issued: 18 December 2015
This E-bulletin is to invite applicants seeking approval (under Regulation 1107/2009) of a new active substance or renewal of approval of an existing active substance to submit together with the relevant (pesticide) dossier a first draft of a Harmonised Classification and Labelling (CLH) report under Regulation 1272/2008 for the same substance.
The concomitant submission of the pesticide dossier and the CLH report at the outset will facilitate the alignment of the Classification & Labelling (C&L) process of PPP active substances under Regulation 1272/2008 and their evaluation for approval/non-approval purposes under Regulation 1107/2009. This is important in view of the growing importance of classification for the potential use of the active substance as a pesticide. The alignment of the two processes will ensure that a formal ECHA (European Chemicals Agency) RAC (Risk Assessment Committee) Opinion on the C&L of the substance is available before the EFSA (European Food Standards Authority) Conclusion on the hazard, classification proposal and risk assessment of the substance under Regulation 1107/2009 is finalised.
In the absence of a formal RAC Opinion on the C&L of the substance, the classification proposal from the EFSA Conclusion is considered legally valid for the purpose of approval/non-approval of the substance.
Approval under Regulation 1107/2009 is heavily dependent on C&L. In particular there are C&L-dependent criteria that, when satisfied, lead to non-approval of the active substance as follows:
- C (carcinogen) M (mutagen) R (reprotoxicant) 1A/B – exclusion criteria;
- C2 and R2 – exclusion criteria (1st interim criterion for Endocrine Disrupters);
- R2 and toxicity to endocrine organs - exclusion criteria (2nd interim criterion for Endocrine Disrupters);
- C2 or M2 or R2 – potential for non-approval if groundwater metabolites present at levels > 0.1 µg/l.
There is now stronger awareness of the consequences of hazard classification for pesticide approval and there is growing concern from industry about the disconnect in timings and procedures between the pesticide approval process and the classification process (http://echa.europa.eu/addressing-chemicals-of-concern/harmonised-classification-and-labelling).
It is in everyone's best interest to align both processes to achieve clarity and certainty. To facilitate this, given the applicant's primary knowledge of the hazard characteristics of their substances at the point of submission of a dossier when seeking approval, HSE is inviting applicants to also complete and submit, at the outset, the first draft of a CLH proposal. If this is done, when HSE is completing the pesticide DAR (Draft Assessment Report) or RAR (Renewal Assessment Report), it will use the applicant's draft CLH document to finalise the UK CLH report simultaneously.
A template for a CLH report (also available at http://echa.europa.eu/web/guest/support/guidance-on-reach-and-clp-implementation/formats) and an example of how it should be completed can be obtained from HSE. Discussions about the potential hazard classification of the active substance will also be held during the standard pre-submission meetings between applicants and HSE.
When does this apply?
HSE will apply these voluntary arrangements from 1 April 2016.