The Applicant Guide: Classification and labelling requirement on authorisations issued after 14 June 2011

Regulation (EC) No 1107/2009applies from 14 June 2011 and will replace the current plant protection product regulations in the UK (The Control of Pesticides Regulations (COPR) and The Plant Protection Product Regulations 2005 (PPPR 2005)). This new Regulation puts in place legal requirements relating to the content of authorisations and as such we are required to change our authorisation templates to include a classification of the plant protection product (Article 31(2) Para. 2). Therefore in addition to seeing changes to the legislative text and reference to authorisation (and not approval) after 14 June 2011 authorisations will also include a classification of the plant protection product. This information will appear in the ‘non-confidential section’ of the authorisation which is available via the CRD website thus also fulfilling our obligations under Article 57(1) (e) (Obligation to keep information available). This will not be applied retrospectively to existing product authorisations.

The classification will be based on the most up-to-date information we hold on our product files. Where we have not considered the classification of a product (e.g. prior to product re-registration) the classification on the agreed label will be specified. If this was pre-CHIP the information in the notification submitted circa. October 2003 in response to AAHL 16/2002 will be specified. In some instances it may be necessary to request the classification of your product and this will be done via the normal procedure of requesting further information. We will continue to check the classification of products only where it is relevant to the application e.g. if the application is for a formulation change, a new product or at re-registration.

Please note that the classification is based on the most up-to-date information we hold on our product files and if you do not agree with this classification then you are at liberty to make the necessary changes to the label without the need for an application. Ultimately it is your responsibility to ensure that the CHIP classification on the label is correct and up-to-date based on all of the information available. No amendment of the authorisation documentation is required for you to make changes to your label and ultimately you must be in a position to defend the classification. If you update your labels you are required under Article 31(3) Para 2 to immediately inform CRD and this information should be sent to applications@hse.gsi.gov.ukreferencing the product name and MAPP number. If the change in classification impacts on the risk assessment resulting in a more restrictive authorisation (e.g. an increase to the personal protective equipment (PPE) requirements) then this is considered to be ‘adverse’. As an approval holder you have an on-going obligation to submit immediately any new data and/or information on the potentially dangerous effects of an active substance and/or product. For further information on adverse data and procedures for submitting these data can be found in the Applicant Guide: Adverse Data.