The Applicant Guide: Adverse data
Why do I need to be concerned with data showing adverse effects?
A condition of an authorisation under EC Regulation 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 EC Regulation 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 revocation of authorisations.
Any queries about the policy on adverse effects should be addressed to our Compliance Branch.
What are adverse effects?
Adverse effects can relate to your product as a whole or individual active substances and/or individual co-formulants included in the formulation of your product.
- An adverse effect can occur on wildlife and the environment 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 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 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 adverse effects whilst performing experimental 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 do I submit adverse data?
Once you are aware of adverse data, it should be submitted immediately to CRD and should not be included in any other application for your product. You should include the data (or reports of adverse effects) and a covering letter detailing your concerns. No application form, labels or letters of access are required. You must provide an assessment of whether and how the new information affects the original risk assessment for your product or active substance, but we will take the final decision on the significance of the adverse data and if any revocations or amendments to your authorisation is required.
Your application (clearly highlighted as adverse data) should be submitted to:
Pesticides Branch / Applications Sift, Chemicals Regulation Division, Mallard House, Kings Pool, 3 Peasholme Green, York, YO1 7PX or to [email protected] You are also required to inform other regulatory authorities and the European Commission.
No fee will be charged for the evaluation of these data.
What are the procedures for evaluation and what happens once the data have been evaluated?
The Member State (MS) which first granted an authorisation within the central zone will evaluate the information received and inform the other MSs belonging to the same zone, where it decides to withdraw or amend the authorisation.
CRD will reserve the right to evaluate the data and/or information as a priority where it is considered necessary to conduct a national assessment, and you will be kept informed of the progress of this evaluation.
Where the adverse data/information just relates to the active substance the Rapporteur Member State (RMS) will assess these data/information. That Member State shall inform the other Member States and the Commission where it considers that 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,CRD will take the necessary regulatory action. This may mean that the conditions of authorisation (including label requirements) will change or we may need to revoke 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 and cannot be contained by other measures then we may restrict or prohibit the use of the plant protection product. The European Commission may also restrict or prohibit the use of the plant protection product.
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 and 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.