Active substance approvals and re-registration requirements: April 2015
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Regulatory Update 07/2015
Issued: 27th May 2015
This update provides information on the approval of active substances under Regulation (EC) 1107/2009 and announces the approval of the following active substances: Isaria fumosorosea strain Apopka 97, COS-OGA, cerevisane, calcium hydroxide
Updating your Authorisation
Please note that HSE does not directly notify product authorisation holders where a change or update of current authorisation is required because of change by the EC to an approval of an active substance.
Authorisation holders have an obligation under Regulation (EC) 1107/2009 to renew their registration (relevant to substances falling under Article 80 transitional measures of the Regulation). Details of how to do this are given on the post-inclusion deadline and re-registration page of our website.
Active substance approvals
At the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF) it was agreed to approve under Regulation (EC) 1107/2009:
- Isaria fumosorosea strain Apopka 97 (as a low risk substance)
- COS-OGA (as a low risk substance)
- Cerevisane (as a low risk substance)
- Calcium hydroxide (as a basic substance)
Isaria fumosorosea strain Apopka 97, COS-OGA, cerevisane approval
These active substances were approved as low risk substances, meeting the criteria established for this at point 5, Annex II of Regulation (EC) 1107/2009.
Isaria fumosorosea strain Apopka 97 was considered under the second stage of the renewal programme (governed by Commission Regulation 1141/2010), and is the first substance in this programme to have its approval renewed. Also, authorisations for products containing this substance will need to be renewed in accordance with Article 43 of Regulation (EC) 1107/2009. Further information on renewing authorisations will be published on CRD's website in due course.
Calcium hydroxide approval
This substance was approved as a basic substance for an unlimited period according to the criteria under Article 23 of Regulation (EC) 1107/2009.
Various draft documents have been published recently eg (data lists, review reports and approval regulations). So we have updated the 'table of recent deadlines' (for substances with extant CRD step 2 re-registration deadlines). Each time we alert you to new approvals, and the resultant re-registration requirements, we will update the links to the documentation in this table. You should check this table on a regular basis to determine if, for example, lists of protected studies are now available. Also, please note that amendments have been made to the conditions of approval and/or review reports of the following substances:
As a result of the evaluation of confirmatory data on the risk to birds and mammals, the conditions of approval have been amended as follows:
'Only uses as herbicide may be authorised. Only uses with a total application per year of maximum 480 g active substance per hectare shall be authorised.'
Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary amend or withdraw existing authorisations for plant protection products containing triclopyr as active substance by 19 September 2015.
The conditions of approval have been amended for these substances to list a number of confirmatory data requirements under Part B of the specific provisions as follows:
'The notifier shall submit confirmatory information as regards:
(1) the specification of the technical material, as commercially manufactured including information on any relevant impurities;
(2) exposure risk assessment for operators, worker and bystanders;
(3) environmental fate and behaviour of the substance;
(4) exposure risk assessment for non-target organisms.
The notifier shall submit to the Commission, the Member States and the Authority the information set out in points (1) by 30 June 2015 and the information set out in points (2), (3) and (4) by 31 December 2016.'
If you have any questions relating to this Regulatory Update, please contact us: Link to Contact details page.
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