CLP Process for PPP Active Substances

CLP Process for PPP Active Substances

Dr Flavio Marchetto, Scientific Officer at the ECHA Classification and Labelling Unit, spoke at the recent Dublin Plant Protection Symposium, presented by Kerona Scientific Ltd. in November 2022 and explained the CLH process for plant protection product active substances.

The general CLH process starts with the submitters, manufacturers or member states, notifying a CLH intention and then submitting their dossier. The dossier is reviewed by ECHA to determine if all legal requirements are met, sending back the dossier for correction and resubmission until the requirements are satisfied. After that, the public consultation process is initiated with the concerned parties. The next step is that ECHA’s risk assessment committee (RAC) develops an opinion based on consultation with its members. After the RAC adopts an opinion it will be published and sent to the European Commission for the inclusion of the substance in the table of harmonized entries in Annex VI.

In the special case of CLH for plant protection products, the process is similar but will involve the inclusion of EFSA. After the submission of the dossier from the applicant, the RMS will send a CLH report to the ECHA following the normal CLH process and an assessment report (AR) to the EFSA initiating a parallel process.

Even if the two processes have a similar structure, EFSA will deal with a different legal basis under Regulation, 1107/2009 (PPP approval regulation) or Regulation 2020/1740 (for the renewal procedure for active substances). Considering this, the objective, the timelines and the legal and data requirements will be different.

To remove duplications of effort and facilitate the overall process there will be interactions between ECHA and EFSA. The most notable interactions are the substance identification (SID) check which is the same, the use of a common template for the process, the coordination of the public consultations, the coordination to invite the staff to the meetings and finally the dialogue and decision-making between ECHA and EFSA.

Finally, Dr Marchetto pointed out that the CLP regulation is currently under revision and preparing changes via two different acts. The first one is a change in the Ordinary Legislative Procedure (OLP) that includes a change in the body text like the COM right of initiative, changes in C&L inventory, labelling and poison centres. The other one is a modification of the Delegated Act (DA) that is focused on changes in Annex I with new hazard classes (ED, PBT/vPvB…) and new hazard statements.

If you missed the PPP Symposium, a copy of all the presentations is available on the publications section of the Kerona website at the link https://kerona.ie/product/dublin-ppp-symposium-2022-speakers-presentations/

Please don’t hesitate to contact our regulatory consultants if you have any queries on classification and labelling: info@kerona.ie