What the new EU endocrine disruptor assessment means for renewal of your active ingredients

Introduction

The new EU requirements for endocrine disruptor identification will impact any active ingredient (AI) renewals with expected decisions from November 2018 onwards. Learn more about these requirements and key strategies to meet them, below[CS1] [CS2].

The European Commission has adopted new criteria for identifying endocrine disruptors (EDs) – these criteria apply to new active ingredients (AIs) and those going through renewal (). So, if the AIs in your plant protection products (PPPs) are due for renewal you need to understand the new requirements and how you can meet them.

What is an endocrine disrupter and how is it assessed?

New guidance on identification of EDs was published in June of 2018 and took effect on November 10[RH3] , 2018 for PPPs. There are three criteria that an AI must fulfill to be classified as an ED.

1. It must produce an adverse effect in an intact organism, subpopulation or progeny.
2. It must have endocrine activity that could alter the function of the endocrine system.
3. There must be a plausible, causal link between 1 and 2.

New guidance on identification of EDs was published in June of 2018 and took effect from on November 10, 2018 for PPPs.

What does the new regulation mean for your AI renewals?

Any planned AI renewal, or any renewal in progress that has not yet reached the stage of a regulatory vote on a draft decision, needs to comply with the new guidelines. This means either providing evidence that the AI is not an ED or, if it is or suspected of being an ED, applying for derogation on the basis that there is no alternative available.

Registrants can apply for extra time to compile the necessary data, asking for anything from 3 to 30 months.

1. Data requirements

The data required for the renewal process is determined by the stage of the renewal on November 10^,, 2018.

• Just starting the renewal process: ED data needs must be established by the registrant and included in the renewal submission as a supplementary summary dossier.
• Prior to rapporteur draft renewal assessment report (DRAR) submission: The rapporteur should provide a detailed outline of the data needed to enable ED assessment.
• At European Food Safety Authority (EFSA) review stage: EFSA will use existing data to rule on ED status or request new data; if EFSA believes ED criteria have been met it will inform the registrant who has three months to apply for derogation.
• Prior to Commission vote: The Commission may still ask for new data to allow ED assessment.

Once a supplementary summary dossier is submitted, the rapporteur has 90 days to evaluate new data before creating a DRAR, which it sends to EFSA, who then has 120 days to finalize its opinion.

2. How to qualify for derogation

You can request derogation of your AI if there is no alternative crop protection approach available. Key to successful derogation arguments is a good understanding of your AI’s mode of action and its use in an agricultural context. For example, your AI might qualify for derogation when:

• It is the only AI that offers either a contact or systemic action for controlling the pest and that mode of action is critical for controlling the pest.
• It is important for use in a resistant management program to prevent further development of resistant strains or resistance to another AI.
• It is the only compatible AI for use within an integrated pest management program.

This is not an exhaustive list of examples but illustrates how to think about derogation arguments.

According to Regulation 1109/2009, national authorities can grant derogations under Article 53 for emergency use in special circumstances and when a danger cannot be contained by any other reasonable means. This emergency derogation is time limited but has been open to abuse in the past.

3. What should you do now?

• Understand where your AIs are in the renewal program and start planning.
• Establish which of your AIs could qualify for derogation: think about this from a scientific viewpoint and its importance in agricultural pest control.
• Apply for a 30-month extension for all AIs for which you think not enough information was submitted to meet the revised guidelines, and those that qualify for derogation: use this time to compile the data needed. Get your data gap analysis completed quickly and book studies as soon as possible, as CRO capacity may be limited due to high demand.

Conclusions

The identification of which AIs going through renewal are EDs has started – it is important to act swiftly to request time to create a supplementary dossier and identify the AIs that may qualify for derogation.

Any AI that is classified as an ED will no longer be approved and cannot be marketed in Europe.

We have been keeping abreast of guideline discussions to anticipate requirements and we’re building capacity to enable us to support client needs now and in the future.

For more information about our regulatory services for crop protection, click here.