In Annex I to Directive 98/8/EC, the following entry is added:
| a The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 11. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated substance. | ||||||||
| b For products containing more than one active substance covered by Article 16(2), the deadline for compliance with Article 16(3) is that of the last of its active substances to be included in this Annex. For products for which the first authorisation has been granted later than 120 days before the deadline for compliance with Article 16(3) and a complete application has been submitted for mutual recognition in accordance with Article 4(1) within 60 days of the granting of the first authorisation, the deadline for compliance with Article 16(3) in relation to that application is extended to 120 days after the date of reception of the complete application for mutual recognition. For products for which a Member State has proposed to derogate from mutual recognition in accordance with Article 4(4), the deadline for compliance with Article 16(3) is extended to 30 days after the date of the Commission Decision adopted in accordance with the second subparagraph of Article 4(4). | ||||||||
| c For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm | ||||||||
| No | Common Name | IUPAC NameIdentification Numbers | Minimum degree of purity of the active substancea | Date of inclusion | Deadline for compliance with Article 16(3), unless one of the exceptions indicated in the footnote to this heading appliesb | Expiry date of inclusion | Product type | Specific provisionsc |
|---|---|---|---|---|---|---|---|---|
| ‘63 | diflubenzuron | 1-(4-chlorophenyl)-3-(2,6-difluorobenzoyl)urea EC No: 252-529-3 CAS No: 35367-38-5 | 960 g/kg | 1 February 2015 | 31 January 2017 | 31 January 2025 | 18 | The Union level risk assessment did not address all potential uses and exposure scenarios; certain uses and exposure scenarios, such as outdoor use, use by non-professionals, and exposure of livestock were excluded. When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment. For products containing diflubenzuron that may lead to residues in food or feed, Member States shall verify the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 or Regulation (EC) No 396/2005, with special consideration to the in vivo genotoxic metabolite PCA, and take any appropriate risk mitigation measures ensuring that the applicable MRLs are not exceeded. Member States shall ensure that authorisations are subject to the following conditions unless it can be demonstrated in the application for product authorisation that the risks can be reduced to an acceptable level: (1) Professional users shall wear appropriate personal protective equipment. (2) Product information shall include the requirement that products shall only be used on dry manure, and that the manure must undergo complete aerobic composting by professionals prior to application on arable land. (3) Products shall not be used in water systems.’ |