The applicant submitted that information to the rapporteur Member State Sweden within the time period provided for its submission.

Sweden assessed the information submitted by the applicant. It submitted its assessment, in the form of an addendum to the draft assessment report, to the other Member States, the Commission and the European Food Safety Authority, hereinafter ‘the Authority’, on 20 December 2011.

Although the results of genotoxicity studies indicated that PCA is an in vivo genotoxic agent, and PCA is a carcinogenic agent, a genotoxic and carcinogenic potential were not observed in studies with an appropriate animal model for human exposure to diflubenzuron, and hence to PCA as a metabolite and impurity. In light of the information submitted by the applicant, the Commission considered that the confirmatory information required had been provided.

In its conclusion, given the genotoxic properties of PCA identified on the basis of the confirmatory information, and given the carcinogenic properties of PCA and the absence of a threshold for acceptable exposure, the Authority however identified a new concern on potential exposure to PCA as a residue.

The Commission initiated a review of the approval of the active substance diflubenzuron. The Commission considered that, in the light of the new scientific and technical knowledge described above, there were indications that the approval of the active substance diflubenzuron no longer satisfied the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 with respect to its potential harmful effect on human health, through exposure to PCA as a residue. It invited the applicant to submit information as regards the potential exposure to PCA as a residue and, if exposure is confirmed, consideration of the potential toxicological relevance.

The applicant submitted that information to Sweden within the time period provided for its submission.

Sweden assessed the information submitted by the applicant. It submitted its assessment, in the form of an addendum to the draft assessment report, to the other Member States, the Commission and the Authority on 23 July 2014.

The Commission considers that the information submitted in the review process did not demonstrate that the risk from the potential exposure of consumers to PCA as a residue is acceptable. In particular, the presence of PCA in the metabolic pathway has been demonstrated in some plants and livestock and could not be excluded in others. Moreover, studies indicated a significant transformation of diflubenzuron residues into PCA under conditions similar or equal to food sterilisation processes, and such transformation could not be excluded for household processing practices.

Given the genotoxic and carcinogenic properties of PCA and the absence of a threshold for acceptable exposure, it was not established that the exposure of consumers to PCA as a residue, consequent on application consistent with good plant protection practice, has no harmful effects. Since toxicological reference values for PCA cannot be set and as consequently no safe residue levels can be identified, any exposure of consumers to PCA should be prevented.

The Commission invited the applicant to submit its comments on the review report. The comments of the applicant did not alleviate the concerns on consumer safety through exposure to PCA.

The draft assessment report, the addendum and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on Plants, Animals, Food and Feed and finalised on 23 March 2017 in the format of the Commission review report for diflubenzuron.

The Commission concluded that exposure of consumers to PCA cannot be excluded except by imposing further restrictions. In particular, the use of diflubenzuron should be limited to non-edible crops only, and crops treated with diflubenzuron should not enter the food and feed chain. In order to minimise the exposure of consumers to PCA, it is therefore appropriate to amend the conditions of use of diflubenzuron.

The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

Member States should be provided with time to amend or withdraw authorisations for plant protection products containing diflubenzuron.

For plant protection products containing diflubenzuron, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should expire at the latest 15 months after the entry into force of this Regulation.

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,