ECHA progress report for Biocides tasks - state of play and status of operational tasks
Item / CA-Dec13-Doc.5.1.aaAction / For informationFor adoptionFor approvalFor decisionFor endorsementFor consultation
Status
Action requested
The CA meeting is invited to take note of the current status of the operation of ECHA’s tasks under the Biocidal Product Regulation (BPR) following the application date (entry into operation – EiO) of BPR on 1 September 2013. It is noted that a similar document is presented to the ECHA Management Board meeting of 26-27 September.
Background
This document provides an overview of the preparations, focusing on following key aspects:
- Development and deployment of the new IT tools (IUCLID 5.5 and R4BP 3);
- Support to the deployment of the IT tools in the Member States Competent Authorities (MSCAs);
- Migration of national authorisations of biocidal products from R4BP2 to R4BP 3
- Guidance, manuals, communication and helpdesk for industry;
- Biocides Stakeholder Day;
- The status of the Biocidal Products Committee (BPC), its Working Groups and the Coordination Group (CG); and
- The operational capacity.
The preparatory phase is still on-going while the operational phase has now started with the first applications submitted on Monday 2 September 2013.
Matters for consideration
Overall, ECHA has reached a reasonable level of operational capacity by 1st September. While work is still intensively ongoing the priority targets were all met. This is considered to be a good achievement taking into account that by EiO ECHA Secretariat is still 30 % below the anticipated staff resources for biocides.
· IUCLID 5.5 and its user manuals were made publicly available in April, well before the Entry into Operation and provide the essential functionalities necessary for industry to meet the BPR obligations. It has been complemented in July by the SPC generator plug-in.
· R4BP 3 and its user manuals for industry as well as MS´s went live on 1 September as planned and the IT has since then been running with good stability and provides for the necessary foundation for BPR processes. The first applications were submitted on Monday 2 September 2013. Because of the strong time constraints under which R4BP 3 has been developed, it still has limitations that have required a number of workarounds for ECHA, generating a need for additional resources in order to be ready to process the applications following the EiO. These limitations also affect the work in the MSCAs.
· Promoting the deployment of the IT tools in the MSCAs has been crucial in order to ensure they can be used from the EiO to serve MSCA tasks under the BPR. For this purpose ECHA has put in place a specific service to support the MSCAs. The availability of this service is extended until end of October 2013 to help the remaining MS’s to get connected as soon as possible.
· On 4 September 2013, in 24 MS at least one Competent Authority has access to the biocides IT tools while two more MS’s (MT, PL) are foreseen to have access by 15 September. For two MSCAs (LU, RO) the date on which they will have access is not known. Finally, among the EEA countries, IS and NO are waiting for the transposition of the BPR in the EEA agreement to get access (foreseen in October). LI has informed ECHA they do not require access to R4BP.
· The ECHA website revamping was finalised at the end of August 2013. A significant number of new webpages have been uploaded to cover many different tasks and processes of the BPR.
· The ECHA helpdesk is providing support to industry for understanding their obligations and usingthe new IT tools; training in the form of webinars is foreseen in October – November.
· ECHA, in cooperation with Commission, has also launched the migration of the national authorisations recorded in R4BP2 into R4BP 3. The first migration cycle was implemented by EiO, and further cycles will take place on regular basis, three being foreseen in September. Discussions with DG ENV on the management of “open cases” in R4BP2 (i.e. applications for national authorisations of biocidal products made under the BPD which are still under evaluation) are on-going.
· ECHA is currently preparing a detailed plan for enhancing the R4BP functionalities in 2014 (with two new versions); this plan will be discussed with MS’s and the Commission. The foreseen date of the first release of R4BP3.1 is end of Q1 2014.
· On 30th August ECHA disseminated via its website the following three lists: list of approved active substances, list of granted product authorisations by MSCAs as of EiO, and the provisional list of active substance suppliers (‘Article 95 list’).
· The priority guidance documents were ready for industry and MS’s at the EiO: information requirements, technical equivalence, active substance suppliers and data sharing. Additional documents are in preparation and the existing documents will be revised as necessary.
· The progress of the action plan to have the Biocidal Products Committee and its working groups fully operational in Q1 2014 is good and in line with what was foreseen. However, the number of opinions to be delivered already in 2014, and beyond, is a significant challenge not only for the ECHA Secretariat but also to MSs who need to ensure sufficient resources to support the work of the Committee and its Working Groups.
· More generally the awareness of the MSs should continue to be raised on the need to have sufficient resources for the work on Biocides to be able to cope with the substantially increased workload at both national and European level that will result from the expected speeding up of the Review Programme.
Attachment:
State of play of the preparation for the biocides tasks
Annex
State of play of the preparation for the biocides tasks
The preparations by ECHA for the EiO of the BPR continued intensively over the summer. This brought the Agency to a reasonable start at the application date of the BPR (1 September 2013), but significant further work remains to be done to progress on items that were postponed due to time and resource limitations.
This document provides an overview of the preparations, focusing on the following key aspects:
- Development and deployment of the new IT tools (IUCLID 5.5 and R4BP3);
- Support to the deployment of the IT tools in the Member States Competent Authorities (MSCAs);
- Migration of national authorisations of biocidal products from R4BP2 to R4BP 3
- Dissemination and Article 95
- Guidance, manuals, communication and helpdesk for industry;
- Biocides Stakeholder Day;
- Building up the operational capacity;
- Getting the Biocidal Products Committee ready for operations; and
- Developing the collaboration with the MSCAs.
1. IT developments and their deployment:
Two main IT tools have been developed to address the biocides needs and fulfil the obligations defined by the BPR: IUCLID 5.5 and R4BP3 (Register for Biocidal Products) which is the central portal to manage biocides applications.
A report generator plug-in for IUCLID 5.5 has been released in July and it allows the generation of the draft Summary of Product Characteristics (SPC).
R4BP 3.0 has been available to MSCAs since 28 August. The respective industry portal went online on 01 September. Most of the required business deployment deliverables have been finalised (manuals, training material). Webinars are planned to take place in autumn for both MSCAs and industry users. At this point R4BP3.0 provides only the essential functionalities necessary to make and process the biocides applications. Workarounds for ECHA and in some case also for the MSCAs have been put in place.
ECHA is developing an overall plan for further extension of the functionalities and other improvements. This plan, which will be constrained due to financial limitations, will be discussed also with the MS authorities and the Commission. Meanwhile, work is already ongoing to define the scope of new versions (major improvements) and patches (smaller corrections and improvements). The specifications of a first patch are defined. The patch is foreseen to be implemented at the beginning of October and will for example enable access to EEA countries’ MSCAs (subject to transposition of BPR into EEA agreement). The development of R4BP3.1 has started. This will aim mainly at developing further automation and functionalities and should become available in Q1 2014.
ECHA has also invested resources in the migration into R4BP 3 of the national authorisations recorded in R4BP2 because this migration is a prerequisite to enable new applications under the BPR linked to those previously established national authorisations. On 1 September 2013, following the first migration cycle, out of 2618 national authorisations recorded in R4BP2, 556 had been successfully migrated into R4BP 3. The reason for the vast majority of those which could not yet be migrated is the absence of the legal entity universal unique identifier (LE UUID) of the authorisation holder in the R4BP2 record; companies have been instructed how to do this. Further migration cycles will take place regularly, three being foreseen in September.
Discussions with DG ENV on the migration of “open cases” in R4BP2 are on-going; this concerns applications for national authorisations of biocidal products made under the old Directive and which are still under evaluation.
2. Support to the IT deployment in MSCAs
The IT deployment in the MSCAs is crucial in order to ensure they can fulfil their obligations according to the BPR from the entry into operations since for this the CA’s need to be able to access the IT tools. For this purpose ECHA had put in place a specific service to support the MSCAs during the preparation and the phase before and shortly after the go-live. The MSCAs IT roll-out team in ECHA focused on identifying the contact points in MSCAs, supporting the preparation and deployment, guiding the preparatory steps to be taken to use the IT systems in the most effective way, preparing a training plan and coordinating the internal ECHA services in their interaction with the MSCAs. The availability of this service has been extended until end of October 2013 to help the remaining MS’s to get connected. Also thereafter ECHA will provide support for MSCA’s, but less in urgency mode, in starting to work with the new systems.
A number of MSCAs had reported difficulties to meet the security requirements by the entry into operation. To ensure that all MSCAs can fulfil their obligations according to the BPR, the ECHA Management Board agreed in June that ECHA can grant a temporary derogation from the measures required by the Security Declaration to enable access to the ECHA IT systems provided that a set of minimum security requirements were fulfilled. Thus far Bulgaria, France and Luxembourg have used this possibility. So far, there has been no request for the remote access.
The “hands-on training programme for MSCAs” was kicked off on 5 August with 600 users at EU-level. The programme is interactive and is based on a simulation of a real-life workflow. The users have the possibility to try out the basic functionalities of the IT tools and get familiarised with the processes within the IT tools. The responsiveness to this programme which was low in the beginning due to the holiday period has progressed more recently. However, to ensure a wide use by MSCAs colleagues it will remain available until the end of October 2013. Further training sessions will be provided to the MSCA users in autumn 2013 in the form of webinars.
After the entry into operation, ECHA provides support to the MSCAs users of ECHA’s Information systems via a dedicated webform http://echa.europa.eu/form_reachit.
3. Biocides dissemination
Active Substances (Art 67)
On 30th August ECHA published on its website a list of approved active substances covering 49 separate entries. The list was sourced from data published by the Commission. It reflects approved active substances as of 1 September 2013.
For all 49 published active substances ECHA published the non-confidential assessment report.
For 12 of these substances ECHA was able to publish a redacted Doc IIIA, which is to contain the data specified to be disseminated by Art 67 of BPR. For the remaining approved active substances:
o ECHA has not yet received a redacted Doc IIIA from industry. In most such cases the Doc IIIA is expected at a later deadline and will be published ASAP once received.
o ECHA has received a Doc IIIA but it is so excessively redacted as to be unpublishable. ECHA is currently performing a legal analysis of this case and how to proceed.
ECHA will continue to update and maintain the list of approved active substances, adding additional substances as they are approved and adding data on already listed substances as it becomes available.
Biocidal Products (Art 67)
On 30th August ECHA published a list of the 2617 product authorisations granted by MSCAs as of 1 September 2013, based on an extract from the R4BP2 system taken on the week of 19th August.
This list was published as a downloadable Excel file.The next steps for dissemination will be to develop a more elaborated system, and to put in place links from R4BP3. With this system there will also be developed search functionalities on the authorisations, and automatic links to the relevant active substance datasets from the products in which they are active ingredients.