Home

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)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)Text with EEA relevance

CHAPTER 1 SUBJECT MATTER AND DEFINITIONS

Article 1 Subject matter

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.

Article 2 Definitions

For the purposes of this Regulation, the following definitions shall apply:

  1. ‘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;

  2. ‘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:

    1. it has not been the subject of either of the following:

      • a Directive on inclusion in Annex I or IA to Directive 98/8/EC,

      • a Regulation providing that it is approved pursuant to the third subparagraph of Article 89(1) of Regulation (EU) No 528/2012;

    2. it has not been the subject of any non-approval decision or the latest non-approval decision concerning it has been repealed;

  3. ‘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.

  4. ‘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

1.

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.

2.

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).

Article 4 Acceptance of applications

Article 5 Validation of applications for approval or inclusion in category 6 of Annex I to Regulation (EU) No 528/2012

Article 6 Evaluation of applications

Article 6a Applications for which the competent authority of the United Kingdom was the evaluating competent authority before 30 March 2019

Article 7 Opinion of the Agency

Article 8 Active substances which are candidates for substitution

Article 9 Commission decision

CHAPTER 3 CHANGES OF ELEMENTS OF THE REVIEW PROGRAMME

Article 10 Joining or replacing participants by mutual agreement

Article 11 Participants' withdrawal

Article 12 Consequences of a timely withdrawal

Article 13 Redefinition of active substances

Article 14 Taking over the role of participant

Article 15 Substance/product-type combinations eligible for inclusion in the review programme

Article 16 Declaration of interest to notify

Article 17 Notification procedure

Article 18 Inclusion in the review programme

Article 19 Information on substances no longer supported under the review programme

Article 20 Commission decisions on substances no longer supported under the review programme

CHAPTER 4 TRANSITIONAL MEASURES

Article 21 Transitional measures for substances referred to in Article 15

Article 22 Essential use

CHAPTER 5 FINAL PROVISIONS

Article 23 Repeal

Article 24 Entry into force

ANNEX IInformation requirements for notifications pursuant to Article 17

ANNEX II

ANNEX IIITime limits