Adverse data notifications for pesticide products

Contents

• Why you need to be concerned with data showing adverse effects
• Potentially adverse effects
• How to notify HSE about adverse data
• Evaluation procedures and what happens once the data have been evaluated
• Annual reports of adverse effects relating to efficacy

When we use ‘pesticide product’ or ‘product’ in the following guidance, we are referring to a ‘plant protection product’.

Why you need to be concerned with data showing adverse effects

A condition of authorisation under Assimilated Regulation No 1107/2009 is that authorisation holders submit any new information on the potentially dangerous effects of the product (or active substance contained in the product) on human or animal health, ground water or the environment.

This requirement is based on the requirements of Article 56 of Assimilated Regulation No 1107/2009.

Failure to immediately submit any adverse information, or to knowingly give false information, is an offence and may result in prosecution and/or withdrawal of authorisations.

If you have any queries about the policy on adverse effects, email our Enforcement Team at [email protected].

Potentially adverse effects

Adverse effects can relate to your product as a whole or individual active substances, any metabolites, safener, synergist and/or individual co-formulants included in your product.

An adverse effect can be impacts on wildlife and the environment (including groundwater) in general, human or animal health and the safety of the crop.

Adverse effects are most likely to be identified from studies carried out by yourself, from published papers or reports of actual incidents involving your product.

In some cases, particularly incident reports, the information may be variable and lack sufficient details to be fully substantiated. However, if a number of incidents occur, this may indicate an adverse effect and should be reported as potentially adverse data.

Where there is a stewardship requirement for your product then any reports of adverse effects reported under those arrangements must be reported as potentially adverse data.

Your obligations only relate to data you generate yourself or that comes to your attention. This includes relevant information on decisions or assessments by international organisations which authorised your plant protection products (PPPs) or active substances in third countries.

You are not expected to acquire adverse data about your product from sources to which you would not be expected to have access.

If you become aware of potentially adverse effects whilst performing research and development or trials work on your product you only need to submit data on these effects if they relate to the authorised use(s) of your product.

How to notify HSE about adverse data

Once you are aware of potentially adverse data, it must be submitted immediately to HSE. Do not include it in any other application for your product.

Your notification must include:

• a covering letter detailing your concerns
• the data (or reports of adverse effects)
• an assessment of whether and how the new information affects the original risk assessment for your product or active substance
• a risk assessment for the area impacted by the new information and any mitigation measures you consider will reduce that risk of harm  

No application form, labels or letters of access are required.

HSE will take the final decision on the significance of the potentially adverse data and whether any withdrawal or amendments to your authorisation is required.

Submit your notification (clearly highlighted as potentially adverse data under Article 56 of Assimilated Regulation 1107/2009) by email to [email protected].

Or you can post your notification to:
PPP Applications Sift
Chemicals Regulation Division
Mallard House
Kings Pool
3 Peasholme Green
York
YO1 7PX

No fee will be charged for the evaluation of these data.

Evaluation procedures and what happens once the data have been evaluated

HSE will evaluate the data and/or information as a priority and we will keep you informed of the progress of this evaluation.

Where the adverse data/information just relates to the active substance, the assessment will consider whether the conditions of the approval of the active substance, safener or synergist contained in the plant protection product are no longer fulfilled, or whether in the case of a co-formulant it has been considered unacceptable and propose that the approval be withdrawn or the conditions amended.

Once your data have been evaluated, HSE will take the necessary regulatory action. This may mean that the conditions of authorisation (including label requirements) will change, or we may need to withdraw your product's authorisation. If the adverse data are considered sufficiently significant, we may widen the evaluation to a formal review of other products and uses.

Where it is clear that an active substance or plant protection product is likely to be of serious risk to human or animal health or the environment which cannot be contained by other measures then we may restrict or prohibit the use of the plant protection product.

If HSE intends to withdraw or amend your authorisation we will inform you and request comments and/or further information prior to acting on the decision.

Annual reports of adverse effects relating to efficacy

As an authorisation holder of a plant protection product, you must report annually if you have any information available relating to:

• the lack of expected efficacy
• the development of resistance
• any unexpected effect on plants, plant products or the environment

We will issue a request for this information annually, and nil returns will be required.

We will examine the information received to see if any regulatory action is required.