Regulatory Update: 32/2011
Issued: 13 September 2011
Regulatory Update 15/2011 announced the changes we considered necessary to our revocation procedures in order to comply with Regulation (EC) No 1107/2009. However, since the publication of this Regulatory Update further amendments have been made in order to comply with Regulation (EC) No 1107/2009. Furthermore, it has also been necessary to update the product authorisation and permit templates. An explanation and summary of the main changes are provided below.
What are the main changes to plant protection product authorisation and permit templates?
- The legislative text for applications submitted after 14 June 2011 has been updated throughout the templates to include reference to Regulation (EC) No 1107/2009 and Regulation (EU) No 540/2011 as required.
- There are now 4 main authorisation/permit templates which reflect the Articles and terminology in Regulation (EC) No 1107/2009 and these are as follows:
We have also taken this opportunity to bring the format of the Extension of authorisation template in line with the other template formats
- Authorisation for a plant protection product (standard plant protection product authorisation [formally approval and consent for a plant protection product])
- Extension of authorisation for a minor use of a plant protection product (formally off-label approval (COPR) or extension of use [PPPR])
- Parallel trade permit for a plant protection product (formally approval and consent for a plant protection product)
- Permit for trial purposes of a plant protection product (formally approval and consent for a plant protection product [experimental approval])
- The ‘authorisation end’/’permit end’ dates have been amended to reflect the maximum duration and grace period specified in Regulation (EC) No 1107/2009 and the terminology has been updated. With the exception of provisional authorisations which cannot exceed 3 years (Article 30), permits for trial purposes (Article 54) and where changes/amendments have been made to existing authorisations ahead of the full Annex III assessment (see Regulatory Update 24/2010 for details) the ‘authorisation end’/’permit end’ dates are as follows:
- [1 year from expiry date of earliest active] except as set out in (b) and below:
- [Date (a) plus 6 months] for sale and distribution of existing stocks
- [Date (b) plus 12 months] for the disposal, storage and use of existing stocks
The (a) date comes from Article 32 (Duration) which states that the duration of an authorisation shall be set for a period not exceeding 1 year from the date of the expiry of the approval of the active substance. The (b) and (c) dates then come from the Grace Period (Article 46) which states that where a MS withdraws or amends an authorisation or does not renew it, it may grant a grace period which shall not exceed 6 months for the sale and distribution and an additional maximum of 1 year for the disposal, storage and use of existing stocks.
Applications submitted before 14 June 2011 will be issued on the ‘old’ approval templates (COPR or PPPR 2005 as required) and will automatically and immediately be deemed authorised under Regulation (EC) No 1107/2009. Applications issued under old PPPR will be given the new expiry dates as outlined above. Applications under old COPR will still be given the COPR backstop dates of 31 December 2020 for sale and distribution and 31 December 2021 for disposal storage and use of existing stocks. Further details on the transitional arrangements for product authorisations can be found in the Applicant Guide.
Withdrawal of authorisations and permits
Previously when an approval was withdrawn a revocation notice was issued which detailed the grace period for approval holders and ‘others’. Following the entry into force of Regulation (EC) No 1107/2009 when an authorisation or permit is withdrawn a withdrawal notice will be issued detailing the grace period for authorisation/permit holders and ‘others’. As stated above Article 46 allows a maximum 6 months for the sale and distribution and an additional maximum of 1 year for the disposal, storage and use of existing stocks.
When will my authorisations/permits be withdrawn?
Details of when authorisations/permits will be withdrawn and the grace period that will apply can be found in the Applicant Guide and the attached table.
What will happen to existing expiry/revocation dates
Any products or authorisations/permits that are currently the subject of a phased revocation will not have their revocation dates altered and the expiry dates on the current revocation notices will remain in place.
The Applicant Guide has been updated to reflect the changes.
If you have any questions relating to this Regulatory Update, please contact CRD Pesticides Branch and your enquiry will be sent to the appropriate person to respond:
Postal address: Pesticides Branch, Chemicals Regulation Directorate, Mallard House, Kings Pool, 3 Peasholme Green, York, YO1 7PX, UK.