Active substance approvals and re-registration requirements: June 2015
The UK has left the EU, new rules from January 2021
The transition period after Brexit comes to an end this year.
Regulatory Update 09/2015
Issued:15th July 2015
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) on 29 May 2015 it was agreed to approve under Regulation (EC) 1107/2009:
- Terpenoid blend QRD 460
- Pepino mosaic virus strain CH2 isolate 1906
- Ferric phosphate (as a low risk substance)
- Lecithins (as a basic substance)
- Salix cortex (as a basic substance)
- Vinegar (as a basic substance)
Lecithins, Salix cortex, vinegar approvals
These substances were approved as a basic substance for an unlimited period according to the criteria under Article 23 of Regulation (EC) 1107/2009.
Fenhexamid, pyridate, sulfosulfuron, ferric phosphate approvals
These substances were considered under the second stage of the renewal programme (governed by Commission Regulation 1141/2010). Also, authorisations for products containing these substances 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.
Ferric phosphate was also approved as a low risk substance, meeting the criteria established for this at point 5, Annex II of Regulation (EC) 1107/2009.
When various draft documents are published (eg data lists, review reports and approval regulations) we will update the 'table of recent deadlines' (for substances with extant CRD step 2 re-registration deadlines) if required. You should check this table on a regular basis to determine if, for example, lists of protected studies are now available. Also, please note amendments made to the conditions of approval, review reports or endpoints of the following substances:
The following amended tox endpoints have been noted for this active substance:
ADI 0.0025 mg/kg bw per day
AOEL 0.00063 mg/kg bw per day
ARfD 0.005 mg/kg bw
If you have any questions relating to this Regulatory Update, please contact us: Link to Contact details page
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