This Regulation lays down rules for the carrying out of the work programme for the systematic examination of all existing active substances referred to in Article 89 of Regulation (EU) No 528/2012.
Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)
Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)
CHAPTER 1 SUBJECT MATTER AND DEFINITIONS
Article 1 Subject matter
Article 2 Definitions
For the purposes of this Regulation, the following definitions shall apply:
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‘non-approval decision’ means a decision not to approve a substance/product-type combination pursuant to Article 9(1)(b) of Regulation (EU) No 528/2012 or to the third subparagraph of Article 89(1) of that Regulation, or not to include it in Annex I or IA to Directive 98/8/EC;
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‘substance/product-type combination included in the review programme’ means a substance/product-type combination listed in Annex II which complies with the following conditions:
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it has not been the subject of either of the following:
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a Directive on inclusion in Annex I or IA to Directive 98/8/EC,
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a Regulation providing that it is approved pursuant to the third subparagraph of Article 89(1) of Regulation (EU) No 528/2012;
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it has not been the subject of any non-approval decision or the latest non-approval decision concerning it has been repealed;
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‘participant’ means a person who has submitted an application for a substance/product-type combination included in the review programme, or has submitted a notification found compliant pursuant to Article 17(5) of this Regulation, or on whose behalf such application or notification has been submitted.
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‘evaluating competent authority’ means the competent authority designated pursuant to Article 81 of Regulation (EU) No 528/2012 of the Member State indicated in Annex II to this Regulation.
CHAPTER 2 PROCESS FOR EVALUATION OF DOSSIERS
Article 3 Application for approval or inclusion in Annex I to Regulation (EU) No 528/2012
An application for approval or inclusion in Annex I to Regulation (EU) No 528/2012 may be submitted only by a participant whose notification has been found compliant by the Agency pursuant to Article 17(5) of this Regulation.
Where the application concerns inclusion in Annex I to Regulation (EU) No 528/2012, it may only concern category 1, 2, 3, 4, 5 or 6 of that Annex.
Applications referred to in paragraph 1 shall be submitted to the Agency within two years of the declaration of compliance pursuant to Article 17(5).