The Review Regulation of the EU Biocides Regulation 528/2012 (EU BPR)
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This page highlights the key aspects of the Review Regulation of the EU Biocides Regulation 528/2012 (EU BPR)
The Review Regulation (Regulation EU No. 1062/2014) of the EU Biocides Regulation 528/2012 (EU BPR) was published in the Official Journal of the European Union on 10 October 2014 and enters into force on 30 October 2014.
It repeals the Fifth Review Regulation (Regulation EU No. 1451/2007) of the Biocidal Products Directive 98/8/EC (BPD).
Active substance review programme - List active substances
The list of active substances/product type combinations that are included in the biocides active substance review programme can be found in Part 1 of Annex II (page 14 to 28). Note that this may not list those active substance/product type combinations for which an Approval decision had already been taken before 4 August 2014.
The EU Commission has clarified that only two of the active substances notified for review are the nano form of those active substances, these are entries 1017 and 1019. For all other active substances listed in Part 1 of Annex II nano-forms of those active substance are not considered to be included in the review programme, however the regulation introduces a time-limited opportunity for interested parties to support such nano-forms for review.
Active substance review programme - Withdrawal notice
If an active substance is withdrawn from the review programme or where the active substance has been redefined, Articles 11 to 14 explain the process for taking over the role of participant.
The Review Regulation includes, at Part 2 of Annex II (page 28 to 33), details of active substance/product type combinations that are no longer considered to be in the biocides active substance review programme, and this is the “withdrawal notice” for these active substance/product type combinations. Anyone wishing to take over the role of participant of these active substance/product type combinations should complete the notification procedure in Article 17 of the Review Regulation by 30 October 2015.
As nano-forms of active substance/product type combinations listed in Part 1 of Annex II are no longer considered to be included in the review programme (with the exception of specific nano-forms of entries 1017 and 1019), the review regulation also includes the opportunity for new participants to take over support for nano-forms of those active substances. Anyone wishing to take over the role of participant for nano-forms of those active substance/product type combinations should complete the notification procedure in Article 17 of the Review Regulation by 30 October 2015
Joining or replacing a participant
The Review Regulation allows a company to join or replace an active substance participant by mutual agreements. The existing and prospective participant must make a notification to the European Chemicals Agency via R4BP3. Further details can be found in Article 10 of the Review Regulation.
Supporting active substance/product type combinations now under the scope of EU BPR, which are not part of the active substance review programme.
As the scope of the EU BPR is different in some aspects from the Biocidal Products Directive, Articles 15 to 19 explain the declaration and notification process to have active substances affected by these changes included in the review programme. This process only applies to active substances that weren’t included in the review programme previously for certain specific reasons:
- due to incorrect advice from the EU Commission or Competent Authority;
- it benefited from a food and feed derogation in the Fifth Review Regulation; and/or
- due to change of the scope of the product type.
Following the acceptance of a notification, Articles 3 to 9 of the regulation explain the evaluation process for active substances joining or rejoining the review programme. The UK CAs understanding of this process is outlined on our active substance eligible for inclusion in the biocides active substance review programme webpage.
The Review Regulation includes the option for a derogation for ‘essential use’ (in Article 22). However, such an essential use derogation has to be applied for within 18 months of the decision not to approve the active substance/product type combination in question.
Completion of the active substance review programme
To ensure that the biocides active substance review programme is complete by the end 2024, Annex III of the Regulation established the legally binding deadlines for competent authorities to submit their assessment reports to the European Chemicals Agency (ECHA) and deadlines for ECHA to submit their approval/non- approval opinions to the EU Commission.