Proposals to accelerate procedures for low risk products

Eurofins Agroscience Regulatory experts comment on proposals to accelerate procedures for low risk products...

The registration process for the authorization of low risk plant protection products has come under intense scrutiny in recent years. As the number of crop protection products available on the market drastically reduces, we continue to look for more environmentally friendly, accessible alternatives. Many of these products are biological in nature, but are still subject to stringent testing and lengthy registration process. Here, a senior regulatory expert comments on proposals to accelerate procedures for these low risk products.

The Directors Contact Group (DCG) was established in 2010 to ‘monitor the overall preparedness of companies and to identify and resolve the priority issues of concern in meeting obligations relevant to the registration of chemical substances’. *

It recently asked for proposals from Member States (MS) on how to improve and accelerate the process for authorization of Biopesticides and low risk PPPs (REFIT Action Point). The conclusions were discussed at the last SMS SC (Southern Member States Steering Committee) meeting in November 2022.

The legal framework (Regulation 1107/2009, Art. 47: Placing on the market of low-risk plant protection products) and the procedures of zonal evaluation and mutual recognition remain the same, however the timeframe of the zonal evaluation will be improved by being reduced to 120 days, plus 6 months if additional data is requested.

A survey was conducted at the MS level. Currently, 61 active substances are approved as low risk. The survey leads to the conclusions that the state of the procedure for low risk PPP in the MS should be reviewed. Specific national assessment procedures and specific national administrative or legal provisions should be proposed. A fast-track procedure and low fees should be implemented. These proposals globally still remain the same as already previously announced.

Consequently, in order to take actions, the RATION project (Risk AssessmenT InnOvatioN) for Low Risk Pesticides), funded by the European Commission was launched last November 2022 and will run until October 2026.

The aim of this project is to develop a risk assessment scheme for low-risk pesticides, supported by new guidance documents and tools for its implementation, while considering the specific characteristics of the actual LRPs and emerging LRPs (ds-RNA). (Microbials, plant extracts, pheromones, semiochemicals).

A Stakeholders Forum is accessible to industry, academia, regulatory bodies, users and consumer representatives, creating a constant channel of communication for information, advice and support. The members will meet every six months online and through workshops. Thirteen countries and twenty-one partners are involved in the project: nine industrials, eleven academic, and one regulatory body (risk assessor). The RATION project is coordinated by the University of Thessaly (Greece).

Those interested in participation should be register by email

Contact Eurofins Agroscience Regulatory with any queries on this article.

*https://echa.europa.eu/fr/about-us/partners-and-networks/directors-contact-group