By Carla N. Hutton

The European Food Safety Authority (EFSA) announced on March 15, 2021, that it has begun a public consultation on a draft updated Guidance on the assessment of exposure of operators, workers, residents, and bystanders in risk assessment for plant protection products (PPP).  According to EFSA, the Guidance is designed to assist risk assessors and applicants when quantifying potential non-dietary, systemic exposures as part of the regulatory risk assessment for PPPs.  The Guidance is based on the Scientific Opinion on “Preparation of a Guidance Document on Pesticide Exposure Assessment for Workers, Operators, Residents and Bystanders” developed by the EFSA Panel on Plant Protection Products and their Residues (PPR) in 2010.  EFSA states that highlighting some inconsistencies between the approaches adopted by regulatory authorities, the PPR Panel proposed a number of changes to the practices in use (i.e., use of deterministic methods for individual PPPs; need to perform an acute risk assessment for PPPs that are acutely toxic; use of appropriate percentile for acute or longer term risk assessments).  In the first version of the Guidance, issued in 2014, EFSA included several scenarios for outdoor uses, with an annexed calculator, as well as recommendations for further research.  EFSA has updated the Guidance in 2021 to include additional scenarios and revise default values on the basis of the evaluation of additional evidence.  To support users in performing the assessment of exposure and risk, EFSA further developed an online calculator that reflects the Guidance content.  Comments on the draft updated Guidance are due May 9, 2021.  EFSA will assess all comments submitted in line with the specified criteria.  The relevant EFSA Panel will further consider the comments and take them into consideration if found to be relevant.

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By Lisa R. Burchi

The European Commission (EC) Standing Committee on Plants, Animals, Food and Feed has issued a guidance document entitled Draft Guidance Document on the Interpretation of the Transitional Measures for the Data Requirements for Chemical Active Substances and Plant Protection Products according to Regulation (EU) No. 283/2013 and Regulation (EU) No. 284/2013. Following the adoption in 2009 of Regulation (EC) No. 1107/2009 concerning the placing of plant protection products (PPP), additional regulations were adopted to establish the necessary data requirements for active substances and PPPs. In 2013, Regulation (EU) No. 283/2013 (amended by Regulation (EU) No. 1136/2014) updated the data requirements for active substances, while Regulation (EU) No. 284/2013 updated data requirements for products. These Regulations include transitional measures to explain when certain applications can rely upon former data requirements and when the updated data requirements must be satisfied.

The Guidance provides two charts describing the transitional measures for: (1) applications for approval, renewal, or approval or amendment of approval of Active Substances; and (2) applications for authorization, renewal of authorization, or amendment of authorization of Plant Protection Products. Each chart describes the type of application at issue and the resulting data requirements. For authorization applications, the Guidance divides the types of applications and resulting data requirements into four active substances categories: (1) AIR-2 active substances; (2) AIR-3 active substances/substances not yet renewed; (3) new active substances; and (4) mixtures.

The Guidance was developed to assist EU Member States in consistently applying and interpreting these transitional measures. Many of the data requirement decisions depend on the type of active substances and whether an application is submitted before or after December 31, 2015, so companies considering or planning to submit applications should review the Guidance carefully to determine what data requirements may be applicable.
 

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By Lisa R. Burchi

On January 27, 2015, the European Union (EU) Standing Committee on Plants, Animals, Food and Feed agreed to a proposed list of 77 pesticide active substances to be classified as Candidates for Substitution (CFS). The draft list of CFS is available online.  A Question and Answer (Q&A) document regarding the CFS list is available online. Additional information regarding the proposed list is also available online.

This list is an important and long-awaited development under the Plant Protection Product (PPP) Regulation (EC) No. 1107/2009. The Standing Committee clarifies that the CFS active substances are not banned and that approved CFS active substances will remain on the EU market, although there are potentially significant consequences for those listed active substances. Most challenging is the requirement that Member States do the following for new applications for authorization of PPPs containing CFS active substances that are submitted after August 1, 2015: (1) conduct a comparative assessment when evaluating an application for authorization for a PPP containing an active substance approved as a CFS; and (2) not authorize or restrict the use of a PPP containing a CFS for use on a particular crop where the comparative assessment weighing up the risks and benefits demonstrates that safer alternatives exist. In addition, substances not evaluated by the Standing Committee (e.g., substances approved after January 1, 2013) can be identified as a CFS under Article 24 of the PPP Regulation. In those cases, any approval will be limited to a maximum of seven years, compared to 10 or 15 years for other active substances.

The next step will be review and adoption of the CFS list by the European Commission, and then publication of the list as a Commission Regulation in the Official Journal.
 

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