Annual notification by the authorisation holder

According to Article 56 of Regulation 1107/2009, the authorisation holder of a plant protection product has a legal obligation to notify the Ctgb once annually about information which indicates that the efficacy of the product is below expectations, about development of resistance and about any unexpected effect on plants, plant products or the environment.

The annual notification can be submitted by using the ‘Annual Notification’ form. This form can be e-mailed to Ctgb. The Ctgb reviews the notification and, if necessary, conducts an assessment based on the applicable criteria. Depending on the outcome of the assessment, it will be determined whether measures are necessary and whether the authorisation needs to be amended.

If the authorisation holder has a proposal for amending the authorisation, they simultaneously submit a request for amendment.

Examples of situations reported in the annual notification

• Reduced efficacy – situations that indicate reduced efficacy and cannot be explained by a clear cause (such as weather conditions), even though the plant protection product is used as authorised and according to the instructions on the label.
• Unexpected effects on plants – situations in which unexpected and obvious damage is caused to the crop even though the plant protection product is used as authorised and according to the instructions on the label.
• Development of resistance – situations in which there is a suspicion or evidence of the target organism developing resistance, that are published in annual reports of international resistance management organisations: IRAC (www.irac-online.org), FRAC (www.frac.info) and HRAC (www.hracglobal.com)], industry resistance monitoring programmes or any other source that has brought this to the attention of the authorisation holder.