Active Substance Approvals: January 2017
Changes due to Brexit
Your health and safety responsibilities will not change when the UK leaves the EU. This guidance is under review.
Regulatory Update: 02/2017
Issued: 11th January 2017
Updating your authorisation
HSE does not directly notify product authorisation holders where a change or update of a current authorisation is required because of a change by the EC to an approval of an active substance. Authorisation holders are advised to check the EU Pesticides database where new, or changes to, active substance approvals and review reports are published.
Active substance approvals
At the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF) it was agreed:
To approve under Regulation (EC) 1107/2009:
- Iodosulfuron-methyl-sodium AIR3
- Sulfuryl fluoride: Amendment of approval conditions
- Sunflower oil (as a basic substance)
- Thiabendazole AIR2
To not renew approval under Regulation (EC) 1107/2009 for:
- Linuron AIR3
Thiabendazole and iodosulfuron were considered under the second and third stages of the renewal programme (governed by Commission Regulations 1141/2010 and 844/2012 respectively). Authorisations for products containing these substances will need to be renewed in accordance with Article 43 of Regulation (EC) 1107/2009, with applications required by 30 June 2017. For further information see Guidance on UK Procedures for product renewal applications.
Sulfuryl fluoride amendment of approval
Part A of the approval specific provisions is amended as follows:
‘Only uses as insecticide/nematicide (fumigant) applied by professional users in sealable structures may be authorised insofar as:
(a) these structures are empty; or
(b) where food or feed commodities are present in a fumigated facility, the users and the food business operators ensure that only the food or feed commodities compliant with the existing maximum residue levels for sulfuryl fluoride and fluoride ion set by Regulation (EC) 396/2005 may enter the food and feed chain; to this purpose, the users and the food business operators shall fully implement measures equivalent to the Hazard analysis and critical control points (HACCP) principles as laid down in Article 5 of Regulation (EC) No 852/2004; in particular, the users shall identify the critical control point at which control is essential to prevent maximum residue levels being exceeded, and establish and implement effective monitoring procedures at that critical control point.’
The Part B specific provisions include the following requirement:
‘The notifier shall submit to the Commission, Member States and the Authority, monitoring data on tropospheric concentrations of sulfuryl fluoride every fifth year, starting from 30th June 2017. The limit of detection for the analysis shall be at least 0.5 ppt (equivalent to 2.1 ng sulfuryl fluoride/m3 of tropospheric air).’
This was approved as a basic substance for an unlimited period according to the criteria under Article 23 of Regulation (EC) 1107/2009.
Linuron (approval not renewed)
Approval for this substance was not renewed because it is classified as toxic for reproduction category 1B, in accordance with Regulation (EC) No 1272/2008, and negligible exposure could not be demonstrated. Furthermore, in addition to the classification of linuron as toxic for reproduction category 1B, linuron is also classified as carcinogenic category 2 in accordance with Regulation (EC) No 1272/2008 and therefore shall be considered to have endocrine disrupting properties in accordance with Point 3.6.5 of Annex II to Regulation (EC) No 1107/2009. In addition, the available evidence showed that linuron has endocrine disrupting properties that may cause adverse effects on endocrine organs in humans and non-target organisms. A high risk to certain non-target species was also identified.
Member States are required to withdraw authorisations for plant protection products containing linuron by 3 months from the date of entry into force of the non-renewal implementing regulation at the latest.