1. ECHA Communications AP 7.2 September 2017 CA meeting Hugues Kenigswald
CA-Sept17-Doc.7.2.
ECHA Communications
AP 7.2
September 2017 CA meeting
Hugues Kenigswald
Biocides assessment Unit
28 September 2017 2

2. Content Status of biocides applications
Progress of the Review Programme
Article 95 list: management of redefinitions and withdrawals
IT tools: new features for 2017 and plans for 2018
4/22/2019

3. Status of applications since EIO BPR*

4. Progress Review Programme and approval new active substances
Status after BPC-21

5. Redefinition of an AS (1/2)
Redefinition of an active substance is initiated by the eCA
Current practice: eCA informs ECHA about the redefinition via and ECHA makes changes in R4BP 3 manually;
In the future: eCA makes the redefinition in R4BP 3 and places the RP participants under the relevant substance entry.
ECHA changes the Article 95 list based on the information received from the eCA;
The ”old” active substance entry is removed from the Article 95 list and a Call for notifications to take over the role of RP participant is published on ECHA website;
If a compliant notification(s) is received, the substance and company information is included in the List of compliant notifications.
The “old” active substance entry becomes (again) a relevant substance after validation by the eCA of an application for its approval. Then it is included (back) in the Article 95 list.
INTERNAL
4/22/2019

6. Redefinition of an AS (2/2)
Alternative suppliers (if any) are initially moved under the ‘redefined’ substance entry.
ECHA informs alternative suppliers of the redefinition, reasons that led for the redefinition and its consequences via R4BP 3.
The alternative supplier shall inform ECHA which substance entry (i.e. old or redefined) is relevant for their active substance.
INTERNAL
4/22/2019

7. Withdrawal of last RP participant supporting an AS/PT combination (1/2)
When the last participant supporting an AS/PT combination withdraws,
Last RP participant stays on the list until the status of AS/PT has been clarified. The inclusion reason is changed to ”Former RP participant”.
In case of first withdrawal of all participants:
A call for notifications to take over the role of the participant in the review programme is published.
Status of AS/PT is indicated in the Article 95 List:
Withdrawn – Call for notifications ongoing
Withdrawn – Notified
Withdrawn – Awaiting for non-approval decision
INTERNAL
4/22/2019

8. Withdrawal of last RP participant supporting an AS/PT combination (2/2)
If a compliant notification to take over the role of the RP participant is received, the substance and company information is included in the List of compliant notifications.
The new RP participant is included in the Article 95 list after validation by the eCA of the application for the approval of the active substance.
INTERNAL
4/22/2019

9. User interface: enhanced search and export
For cases and assets

10. User interface: relation diagram

11. Search and archive communications

12. Case owners can initiate a communication with evaluating CAs

13. Process flow: case withdrawal
Now you can transfer only assets

14. Process flow: case transfer
The second Legal Entity has to accept
Now you can transfer only assets

15. Mutual recognition of SBP
professional & public uses
professional & public uses
public uses (25 ppm) MR
NOW PERMITTED! MR
SBP
professional & public uses
public uses (25 ppm)
MAC

16. Grouping and synchronisation
Synchronisation of the evaluation between reference and concerned Member States in mutual recognitions: transparent process to increase efficiency
Enabled grouped submissions of administrative changes not in mutual recognition (NA, SA, UA)
Now you can transfer only assets

17. New and improved processes
Amendment and cancellations of notifications for simplified authorisations
Review of Active Substance Approval (AS-REV) (3.10)
Essential Use Derogation (DE-APP)
Redefinition of active substance
Streamlined notifications of Simplified Authorisations
Now you can transfer only assets

18. Features planned for 2018
New case type to support article 95 list amendments
Workflow enhancements :
Amendments or cancellations of markets where Union Authorisations are applicable
Union Authorisation in EEA countries
User interface improvements:
Remember filter in search functionality,
Allow amendments of actions done by mistake

19. Features planned for 2018
Communication: further flexibility in the messaging system
Improvements to the SPC editor “compare” feature
Find and replace text in the SPC editor
Performance improvements
Compare biocidal products
Preparations for Brexit

20. Thank you!