Europa
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| | |EUROPEAN COMMISSION |
| | |HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL |
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| | |Directorate E – Food and feed safety, innovation |
| | |E4 - Pesticides and Biocides |
66th meeting of representatives of Members States Competent Authorities for the implementation of Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products
Subject: Future settlement of Biocides Enforcement Group
The purpose of this document is to present a proposal on the future coordination of BPR enforcement.
1- Introduction
The BPR Competent Authorities (CAs) in 2015 supported the use of existing structures for the coordination of BPR enforcement. COM and CAs indicated[1] that using ECHA’s Forum was considered the best use of resources for that purpose. Expansion of Forum’s remit with BPR would require clarification of legal base and of practical arrangements and appropriate resourcing. Since these could not be provided in a short term, CAs agreed to establish a Biocides Enforcement Group (BEG), a working group of the BPR CA in order to kick-start the co-operation on enforcement of BPR and until involvement of the Forum in BPR activities is clarified.
The legal basis for Forum involvement is clarified by the Commission in a separate document (see point 9.1.a).
Thus, the main remaining question is the clarification of the practical and organisational arrangements for the coordination of BPR enforcement. During BEG-1 in March 2016, COM outlined three options for organising the coordination of BPR enforcement:
1. BPR enforcement coordination is fully integrated in the Forum;
2. BPR enforcement coordination is handled by a subgroup of the Forum;
3. BEG remains as a separate entity (chaired by COM).
The purpose of this paper is to explore and define each of these options as well as describe their advantages and disadvantages to allow the Member State authorities to take an informed decision on the preferred way for coordinating BPR enforcement. The members of FORUM and BEG have been consulted to provide their views on the three options. The result will be summarised in section 4. In the same section the services of the Commission will point out its preference for an option.
2- Three options
he "normal" process for the review of these active substances would be to go through the submission of an application to require the approval or annex I inclusion to the BPR.
2.1 Option 1: Full integration within the Forum
This option assumes that BPR is included in the remit of the Forum along with REACH, CLP[2] and PIC[3]. There would be no separate entity and the current Forum would handle the BPR tasks (with some special arrangements as explained hereafter).
The objective of the Forum in respect to BPR would be the implementation and enforcement of BPR legislation including coordination and cooperation with Member States and stakeholders.
Formal status
The Forum is a formal structure with statutory tasks under REACH. The membership is mandatory. The Forum is obliged to execute its statutory tasks but the actual involvement of specific countries in Forum actions is voluntary.
The Commission paper “Legal mandate for Forum“ presented at this meeting indicates that a legal mandate exists for extending the remit of the Forum to also cover the coordination of the BPR enforcement. According to this interpretation, the Forum could also function as a formal structure for coordinating the BPR enforcement. Similarly to REACH/CLP/PIC, involvement of National Enforcement Authorities (NEAs) in Forum actions, related to BPR is voluntary. However Member States may find it easier to commit their NEA resources to initiatives undertaken by a formal body such as the Forum.
Composition/Membership
Article 86 of REACH allows for only one member of the Forum per Member State. Therefore the coordination of BPR enforcement is done through the Forum Member or his/her alternate. In many countries the BPR responsibilities are handled by authorities different from those responsible for REACH/CLP/PIC. Consequently, it may not always be possible for the same Forum Member to take care of the BPR tasks. There are three ways for Member States to provide BPR competence to the Forum:
a) Through the same Forum Member. This seems suitable for Member States where REACH/CLP/PIC and BPR are in the remit of the same authority.
b) Through the BPR experts who accompany the Forum Member at the BPR-related agenda items. Voting as formal decision making is done by Forum Members, though it is assumed it is done based on the advice of the BPR expert. The expert would be expected to contribute to the discussions and to provide input in the activities of the Forum.
c) Forum Members remain as they are, but they can appoint the BPR expert as an alternate.
During the BPR related agenda items the alternate can independently represent the relevant authority for BPR related matters (if the Forum Member is absent). If the Forum Member is present, then the member will vote and take decisions as normal, though it is assumed that this is done based on the advice of the BPR expert/alternate.
The Forum Secretariat will propose to change the Forum Rules of Procedure to allow for appointment of two alternates in case full integration within the Forum is the preferred option. This would allow Member States to have one alternate specialised in BPR and another alternate focusing on REACH/CLP/PIC. Only the “BPR alternate” would attend the BPR agenda items at the Forum plenary.
Countries are free to make the choice they prefer and to organise themselves accordingly as long as they indicate their preferences to the Forum Secretariat ensuring full transparency. This will allow that countries may organise themselves differently depending on their needs.
Chairmanship
The Forum meetings, including any agenda items related to BPR, will be chaired by the current Chair or Vice-Chairs who have been elected by the Forum members.
In case the elected Chair has no competence in BPR, it is possible to cede the chairmanship of BPR agenda items to one of the Vice-Chairs who is knowledgeable on BPR.
The Forum Secretariat proposes that the Forum Rules of Procedure are modified as to require the Forum to elect at least one of its Vice-Chairs, taking into account his or her competence in BPR, in case the first option would be the preferred option. That “BPR-specialised” Vice-Chair will be designated to chair the BPR agenda items, in cases where the Chair does not have sufficient knowledge on BPR.
Decision making
Voting and formal decision making is done by the Forum Members. If Forum Members are not able to attend the meeting, voting and decision making will be done by their alternates, or a proxy (other MS Forum member), which the absent Forum member will have appointed before the meeting.
Applicable Rules of procedure
The Forum Rules of Procedure will apply, but they will have to be modified to reflect the possibility of two alternates and the need for the Chair and/or Vice-Chairs to be competent in BPR.
How the work will be conducted
The Forum will work exactly as it currently does. The actual work is done through Working Groups and Task Forces. They work mostly by email and through web conferences. When the need arises the WG will also meet physically in Helsinki.
Decisions on and direction of the work of the Forum is given through the plenary meetings. Working Groups report to the plenary and the plenary decides on any new activities and next steps for existing projects.
Meeting frequency and arrangements
Plenary meetings take place three times per year (usually March, June, November). Agenda items related to BPR will be grouped in one block to facilitate travel of participants interested to attend only the BPR parts of the agenda. The BPR block is expected to cover at least half a day and up to a maximum of one day.
Regarding Working Groups, meetings are often audio- or videoconferences. However, on average there is one face-to-face meeting of each working group per year. For 2017 ECHA provisionally requested a budget for 5 BPR-related working group meetings of the Forum (Including the meetings foreseen for the working group dealing with PD-NEA requirements). Frequency and number of BPR working group meetings will need to be adjusted based on experience and applicable/available resources.
Financing
If ECHA receives the requested resources from the Commission, it will fully reimburse attendance of one person to the BPR agenda items of Forum plenaries and physical meetings of the WGs including travel costs, hotel costs and daily allowances (current practice).
Plenary meetings: ECHA currently reimburses the attending Forum member or his replacement and in addition also an invited expert (reimbursement of the invited expert is subject to a frequent cost/benefit review).
If BPR is included in the scope of the Forum, the reimbursement will be available for one person to attend the BPR related parts of the agenda. That person can be:
• Forum Member (who already attends the REACH/CLP/PIC parts of the Forum meeting);
• Forum Member alternate, if the Forum Member is not reimbursed for the BPR agenda items;
• Invited expert knowledgeable on BPR enforcement, if neither the Forum Member nor his alternate are present. Invited experts cannot vote. Consequently, Forum Members should give their proxy to another member.
If the country will choose to send more than one person to the BPR agenda items (e.g. see option (b) under “composition” above), it will remain that only one person will be reimbursed for the participation in the BPR-related items on the agenda of the Forum and the MS should provide the resources for the second participant.
Working groups: ECHA provides full reimbursement for all members of the Working Groups/Task Forces (current practice).
Secretariat
For this option, ECHA would provide the Secretariat. In view of this scenario, the Agency has held respective consultations with the Commission services and expects to be able to recruit an additional staff member of the Forum Secretariat for this purpose.
COM representation
The Commission (DG SANTE) will act as an observer during the BPR agenda items of the Forum plenary meetings. Other Commission Service (DG GROW and DG ENV) will continue to be observers for the REACH, CLP and PIC related agenda items. As an observer, the Commission cannot vote and directly take part in the decision-making. However, the Commission may always voice its opinion. In the REACH, CLP and PIC part of the agenda the Commission has a regular agenda item allowing bringing information and relevant points to the attention of the Forum. The Commission will also be able to take part in Working Groups and Task forces.
2.2 Option 2: BPR Subgroup within the Forum
This option assumes that a parallel sub-structure of the Forum is formed with in effect an alternative composition for dealing with BPR issues. Its sole remit is the coordination of BPR enforcement. Formally the sub-structure would be part of the Forum but would be fully independent from the REACH/CLP/PIC Forum and dealing with BPR enforcement only. This sub-structure of the Forum is in this document referred to as the “BPR Subgroup”.
The objective of the BPR subgroup would be the implementation and enforcement of BPR legislation including coordination and cooperation with Member States and stakeholders.
Formal status
Same as Option 1. The “BPR Subgroup” will be a formal structure.
Composition/Membership
See explanation in Option 1. The difference is that in Option 2 there are only two ways for Member States to provide BPR competence to the BPR Subgroup of the Forum:
a) Through the same Forum member.
b) Through a BPR expert appointed as an alternate. The only difference to Option 1 is that the alternate represents the country during “BPR Subgroup” meetings, rather than just BPR agenda items during Forum plenary. All other considerations described under Option 1 apply (especially the solution to have two alternates, with one being specialised in BPR)
As in option 1, countries are free to make the choice they prefer and to organise themselves accordingly as long as they indicate their preferences to the Forum Secretariat ensuring full transparency. This will allow that countries may organise themselves differently depending on their needs.
Chairmanship
In option 2 the solution for chairmanship is different than in option 1. The BPR Subgroup is chaired by a “BPR Subgroup Chair” elected by the BPR Subgroup itself and who would be Forum Vice-Chair.
This allows for the best democratic representation of the BPR members/alternates in the Forum and also ensures that the person chairing the BPR subgroup has experience in BPR enforcement. The “BPR Vice-Chair” would have the same status as the other Forum Vice-Chairs. The Forum Secretariat will propose to change the Forum Rules of Procedure to make that possible in case option 2 would be favoured by the Member States.
Decision making
Same as option 1.
Applicable Rules of procedure
Similar to option 1, with the exception that the changes to the Forum Rules of Procedure will also have to reflect the existence of the BPR Subgroup and the possibility for it to elect its own chair
How the work will be conducted
Similar to option 1, with the exception that decisions are taken during meetings of “BPR Subgroup” and that its Working Groups and Task forces report at the “BPR Subgroup” meetings rather than the Forum plenary.
Meeting frequency and arrangements
Plenary meetings of the BPR subgroup would take place back to back with Forum plenaries. By default it is foreseen that the subgroup would meet three times per year with every Forum plenary, but that frequency could be lowered if needed. Meetings of BPR subgroup are expected to last from half day to one day.
As regards Working Groups, the same considerations apply as in option 1.
Financing
Same as in option 1. The reimbursement for participation of one person to “BPR agenda items of Forum plenaries” applies to plenary meetings of the “BPR Subgroup”.
Secretariat
Same as in option 1.
COM representation
Same as in option 1.
2.3 Option 3: Separate entity, chaired and supported by COM
This option proposes that a specific entity will be established for co-operation on enforcement under the expert group "Competent Authorities for Biocidal Products and would report to the Competent Authorities meeting. The objective of this entity would be the implementation and enforcement of BPR legislation including coordination and cooperation with Member States and stakeholders in that regard.
Formal status
Formally the entity would be a sub-group of the Competent Authorities for Biocidal Products set up to examine specific questions. The expert group is listed in the Commission Register of Expert Groups[4].
Composition/Membership
The composition can be decided by the Commission. It is proposed that it would consist of experts of Member States' enforcement authorities, other public entities, such as authorities from non-EU countries (including candidate countries) and ECHA.
Chairmanship
The meetings will be chaired by a Commission representative as it is a sub-group of the Commission's expert group
Decision making
Any decision making will take place by agreement of the experts.
Applicable Rules of procedure
Experts groups usually operate in an informal setting without any formal rules of procedure.
How the work will be conducted
It is the Commission that prepares the agendas, organises the meetings and drafts the minutes. Experts could prepare documents.
Most discussion will be assumed to take place during the plenary meetings. If documents will need to be prepared, they will be drafted by the services of the European Commission or experts who informally coordinate between themselves (e.g. by email) between the meetings.
Meeting frequency and arrangements
It is foreseen that the subgroup would meet three times per year but that frequency could be lowered if needed. Meetings of BPR enforcement group are expected to last one day. Meetings will be held within Commission premises in Brussels.
Financing
The reimbursement from the Commission’s budget is limited to the travel costs only and this for participation of one person per Member State.
Secretariat
The Secretariat of the entity will be provided by the European Commission (EC/DG SANTE E.4).
COM representation
The Commission will be chairing, preparing and following-up the meetings.
3. Advantages and disadvantages of the three options
3.1 Option 1: Full integration within the Forum
Option 1 Advantages:
• BPR coordination will become part of an existing body that has good experience and efficient practices in coordinating enforcement;
• BPR coordination will become part of the tasks of a formal structure established by a legal text, where each Member State is bound to have a member. MSs will likely find it easier to commit their NEA resources to activities hosted in a formal structure;
• ECHA will provide the Secretariat for the operation of the Forum;
• The Forum is chaired by a Member State representative elected by the Forum Members from among its members;
• This option allows benefiting from established procedures, practices and experiences with setting up Forum.
• This option allows for an autonomous position of enforcement of biocidal products in the Forum.
This is because any decisions or initiatives related to BPR will be taken by either the Forum members who are knowledgeable in BPR or “BPR specialised” alternates. Both these representatives are mandated to represent their country’s BPR enforcement authorities.
In countries where BPR and REACH are handled by the same authority and the Forum member is knowledgeable in BPR he can directly represent his country’s BPR enforcement authorities.
In countries where BPR is in the remit of different authorities than REACH/CLP/PIC (or where they are in the same authority but the Forum member is not a specialist in BPR), the option to appoint a “BPR specialised” alternate allows for independent representation of BPR authorities, without the need for the “BPR specialised” alternate to cede any decision-making power to the Forum member responsible for REACH/CLP/PIC;
• Most efficient solution for countries where BPR and REACH enforcement responsibilities are located in the same authority – all enforcement coordination is handled by one body;
• Cross-cutting issues exist between enforcement of BPR and other chemicals legislation (for example CLP and articles). This option would allow optimising synergies for enforcement of chemicals legislation.
• Providing opportunities for intensifying co-operation of authorities responsible for chemicals legislation which is particularly important for issues that touch upon the borderline of different legislations involved (e.g. C&L).
• This option allows for coordination of BPR enforcement to be fully independently from REACH enforcement coordination.
Institutional bundling of BPR coordination together with REACH/CLP/PIC coordination, does not affect the content of coordination of BPR enforcement. The BPR-related parts of the agenda will be attended by representatives knowledgeable in BPR and chaired by Chair or Vice-Chair who must also be knowledgeable in BPR. Decisions and activities discussed and decided on BPR parts of the agenda will be independent from those covered in the REACH/CLP part of the meeting.
• ECHA offers full reimbursement (travel, hotel costs and daily allowance) for participation in the activities of the Forum related to coordination of BPR enforcement;
Option 1 Disadvantages:
• For countries where BPR is in the remit of enforcement authorities other than those in charge of REACH/CLP/PIC, there will be a need for agreement between the involved authorities to decide how the BPR enforcement authorities will be represented in the Forum.
• BPR enforcement coordination is bundled together with REACH/CLP/PIC coordination, even though the regulations are quite different and may be managed by different authorities
• If Member State chooses to be represented during the BPR parts of the agenda by a REACH Forum member accompanied by a BPR expert (see point “b” under Composition/Membership in section 2.1), it will imply heavier workload for the Forum member, if he is present during the BPR agenda items. For other participation modes (points “a” and “c” under Composition/Membership in section 2.1) the workload is the same.
• Probably increased duration for Forum meetings.
3.2 Option 2: BPR Subgroup within the Forum
Option 2 Advantages:
• All advantages listed for option 1
• The BPR representatives in the BPR Subgroup can elect their own chair (BPR Subgroup Vice-Chair)
• Since the BPR Subgroup will be separated from the Forum and have its own chair, it may contribute to a heightened sense of identity and commitment among its members.
Option 2 Disadvantages:
• Disadvantages listed for option 1 except for:
o increased duration of Forum meetings (because meetings are separate, but they will still be back to back)
o higher workload for cases where Forum member accompanies the BPR expert during the BPR agenda items (because BPR subgroup is composed only from members or alternates)
• Preparation for BPR Subgroup meetings may be logistically challenging, if a separate pre-meetings needs to be organised for the “BPR Subgroup Chair”.
3.3 Option 3: Separate entity, chaired and supported by COM
Option 3 Advantages:
• Possibility to organise meetings back to back with meetings of the co-ordination group or competent authorities.
• This solution is “making use of existing structures” for coordination of BPR enforcement, as indicated by recital 13[5] of the Regulation 334/2014 amending the BPR Regulation;
• This option sets up group that focus solely on BPR enforcement with its own dynamics and complexity.
• Travel costs of experts can be reimbursed by the Commission.
Option 3 Disadvantages:
• Less synergies with enforcement activities of other regulatory frameworks.
• Not the most efficient solution for authorities where BPR and REACH or PIC enforcement responsibilities are located in the same authority.
• IT tools for controls of BPR will be developed by ECHA and most probably discussed in the separate entity, implying that a specific co-ordination has to be set up between ECHA and the entity for IT tool development and use.
• If the Forum member is also representing his country as an expert in the separate entity, then he will need to travel to two meetings (Forum in Helsinki and the “separate entity” in Brussels)
• Preparation for BPR enforcement group meetings may be logistically challenging because of the lack of sufficient meeting rooms in Brussels.
• Not full reimbursement – hotel costs and daily allowance are not covered.
4. Result of the consultation of BEG and FORUM members and preferred option
The members of BEG and FORUM supported in majority option 2 (34 of 52 responses) followed by option 1 (11 responses) and option 3 (7 responses). Arguments indicated are the need of a group with a clear identity and expertise, to facilitate participation of competent authorities, the benefits of enforcement synergies and exchange of information between BPR/REACH/CLP/PIC, the best use of resources and the use of experiences of Forum with enforcement.
The services of the Commission favour option 2 as it would allow the best use of resources, to take advantage of the know-how and experiences of the FORUM while a group is established with a clear identity and expertise on BPR enforcement. Moreover, it would allow optimising synergies for enforcement of chemicals legislation.
5- Actions requested and next steps
The Commission invites Member States' Competent authorities to reflect on this proposal and, if possible, agree on the future coordination of BPR enforcement.
The Forum is a body of the Agency. Therefore, if option 1 or 2 will be agreed, ECHA will have to look on how the “structure” for BPR enforcement in the most effective and efficient way can be implemented.
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[1] CA-Nov15-Doc.9.1: “EU structure to discuss BPR enforcement, control and monitoring matters”
[2] Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on the classification, labelling and packaging of substances and mixtures
[3] Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals
[4] See link: .
[5] “(13) In order to facilitate good cooperation, coordination and exchange of information between the Member States, the Agency and the Commission regarding enforcement, the Agency should also be given the task of providing support and assistance to Member States with regard to control and enforcement activities by making use of existing structures, where appropriate.”
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