DRAFT MINUTES
6. 93rd
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
28-29 September 2021
Adoption of the agenda
|
For adoption
CA-Sept21-Doc.1
|
|
The agenda was adopted with an AOB point suggested by one Member
State on incidents involving phosphine-releasing products, one point
concerning an update on a Court case and three AOB points for the
closed session. Die Tagesordnung wurde mit einem von einem
Mitgliedstaat vorgeschlagenen AOB-Punkt zu Vorfällen mit
Phosphin-freisetzenden Produkten, einem Punkt zu einem aktuellen
Stand eines Gerichtsfalls und drei AOB-Punkten für die
nichtöffentliche Sitzung angenommen.
Adoption of the draft minutes of the previous CA meeting
|
For adoption
CA-Sept21-Doc.2
|
|
One Member State requested the addition of one sentence in the
section related to future Article 65 reporting. The minutes of the
previous meeting were then adopted.
Ein Mitgliedstaat beantragte die Aufnahme eines Satzes in den
Abschnitt über künftige Meldungen nach Artikel 65. Das Protokoll
der vorangegangenen Sitzung wird dann genehmigt.
3.1. Amendment of Delegated Regulation (EU) No 1062/2014
(Review Programme Regulation)
|
For discussion
CA-Sept21-Doc.3.a
CA-Sept21-Doc.3.b
|
|
The Commission
introduced the draft delegated Regulation amending the Annex II to
the Review Programme Regulation and explained that the aim of the
revision is to reflect the actual state of the Review Programme. It
was further explained that the changes in Annex II derive from:
removal of the active-substance/product-type combinations no longer
supported, of those for which a Commission approval or non-approval
decision, as well as of those which were included into Annex I to the
BPR following the adoption of several delegated acts. In addition,
three active substances were redefined, leading to the inclusion of
new entries corresponding to the new identities. Also two active
substances that benefitted from the food and feed derogations and for
which the notifications were recently found compliant by ECHA have
been included, as well as one entry following a redefinition, which
was omitted in the previous amendment of the Review Programme
Regulation.
The Commission
mentioned that for one of the entries related to the notifications
for food and feed (brandy PT19) there was a need to identify the
rapporteur Member State (point 5.3 on the agenda).
Risk mitigation measures for products and treated articles
4.1. Risikominderungsmaßnahmen für Produkte und behandelte
Artikel
|
For discussion
CA-Sept21-Doc.4.1
|
|
The Commission
introduced the item and invited the Member State who submitted the
document provided for the meeting to introduce the document. This
Member State mentioned that the document was submitted in response to
various questions posed by the Commission in the past months and
discussed at the CA meetings. The paper addresses the issue of
setting specific conditions of use of treated articles at active
substance approval stage. The position of this Member State is that
the conditions of approval must specify which categories of uses are
acceptable. In their view there are too many treated articles on the
market whose use has not been assessed for risks or efficacy, but
exposure - of humans and environment - continues. The proposal is to
reverse the regulatory approach, from specifying forbidden use
categories to specifying allowed use categories. Evaluations of
active substances already include use categories in the assessments.
In the view of this Member State referring problems to the product
authorisation stage is ineffective, which brings a discrepancy of
treatment between treated articles produced in the EU and those which
are imported, which are a big proportion of treated articles on the
market. The approach suggested by this Member State would also bring
benefits for the enforcement activities, since inspectors would have
clarity on the permitted uses.
The Commission
indicated that at the moment internal reflections are ongoing on what
could be the general conditions to be included at active substance
approval and that the Commission is ready to work with competent
authorities and stakeholders in order to get more clarity regarding
treated articles. The Commission had a question on the part in the
document mentioning that the defining of use categories is already
ongoing and asked the Member State who prepared the document to
clarify this. The Member State stated that examples of such work
ongoing are the evaluation of silver where uses were sorted in
different exposure categories, the case of creosote (in this case the
use categories are not triggered by exposure but by consideration of
the necessity of the use) and the environment use categories for
treated wood. The Commission also remarked, as already discussed in
the past, that it is not to be expected that in dossiers already
submitted applicants provided information on all possible use
categories where substances may be used in treated articles. The
Member State states that this might not be true for most of the
cases, as already the Biocidal Products Directive included data
requirements for use in treated articles, which were then called
‘treated materials’.
The Commission added
that problems arise from the fact that at active substance approval
stage companies are requested to provide only one representative
product and not an exhaustive list of possible uses of the active
substance in treated articles. Reference was also made to the work
performed by ECHA and some Member States in the context of the FAST
project, where more targeted assessments are performed. ECHA
indicated that for active substances used in treated articles it
seems is not possible to apply the targeted assessment approach.
One Member State
mentioned they welcome the document and acknowledged the difficulty
of grasping all use categories at active substance approval stage.
Another Member State indicated they support the approach suggested in
the document and stressed that a better and clearer legal framework
for treated articles is needed; however, finalising the Review
Programme is the first priority under the BPR, therefore attentions
should be paid so that the work on treated articles does not
jeopardise the completion of the Review Programme. Another Member
State also welcomed the proposal, but mentioned that it brings some
challenges related to the increased workload during the active
substance assessment.
One Member State
stated that the implementation of the proposed approach will probably
take place in the more distant future, as the concept needs further
refinement and might be firstly implemented in the context of
renewals. It also concurred that additional work that would slow down
the active substance approval process must be avoided. This Member
State suggested in would be beneficial to develop a notification
system as set out in Article 58(7), so that persons placing on the
market a treated article would have to notify it and thought that the
making available and use of treated articles cannot be properly
addressed under the current provisions of Article 58. Another Member
State supported the idea of applying the new approach in the context
of renewals and flagged one element that could not addressed at
active substance approval level, namely mixture toxicity in the case
of multiple active substances contained in treated articles (like for
instance in the case of wood preservatives).
The Commission concluded the discussion noting the willingness of
many Member States to continue working on this topic and informing
that a newsgroup will be opened to collect comments of Member States.
The Commission also highlighted that work on this topic should not be
detrimental to the work for the completion of the Review Programme.
Management of new data on an active substance in an application
for a biocidal product
4.2.
Verwaltung neuer Daten zu einem Wirkstoff in einem Antrag auf ein
Biozidprodukt
|
For discussion and agreement
CA-Sept21-Doc.4.2
|
|
The Commission
presented key principles to agree on to manage new data on an active
substance presented in the context of an application for product
authorisation, and how to manage the Listing of endpoints (LoE).
These principles build on existing procedures defined in BPC and CG
relevant documents that would need to be revised, as well as the
previous discussions in the past CA meetings. Once agreed, ECHA will
be requested to develop the corresponding procedures within its BPC
and in collaboration with the CG.
One Member States
considered that a specific procedure “AS-UDP” should be used in
R4BP in order to manage these data, that the Member States who was
responsible for the assessment of the active substance (eCA) should
be responsible to assess also these new data as they would have to
assess them in the future being also normally responsible for the
assessment of the renewal, and that reference Member State for the
product should be allow to suspend the evaluation of the dossier
pending the common conclusion of the validity of these data and the
whether the corresponding endpoint value needs to be modified. The
Commission responded that this proposal was difficult to follow as
this is not foreseen in the Articles of the BPR related to the
assessment of product authorisation, and there would be also a fee
issue as only the reference Member State (and concerned Member State
in case of mutual recognition) receive a fee to assess the
application for product authorisation, and by extension, the data
submitted in this context, and not the former eCA on the active
substance.
Another Member State
considered that the endpoint value in the LoE should be modified only
when it has an impact on the outcome of the risk assessment; in other
cases, it should not be modified, and it would be studied later in
the context of the renewal of the approval of the active substance.
Another Member State
had concerns concerning the capacity of the BPC to cope with the
potential workload, and would propose that only discussions in the
relevant BPC working groups would be sufficient. That Member State
would expect also that new/additional data of on the active substance
would be submitted to assess additional uses not seen at the approval
stage, considering the FAST project on-going at ECHA level which aims
at limiting the number of uses assessed. It enquired whether a letter
of access would be needed by subsequent applicants for such data.
Another Member State would welcome streamline with a procedure in
R4BP and the possibility to stop the clock and have deadlines. The
Commission clarified that it would not expect to request a new BPC
opinion on the approval the active substance, as the substance is
approved and no early review under Article 15 is made, but rather an
addendum of the assessment report on the active substance to reflect
the common on the new data to help product authorisation and avoid
disagreement in the mutual recognition phase.
Another Member State
expressed concerns about the workload while not making proposals on
how to deal with the new data.
Another Member State would also like to know how to deal with the
cases which are pending.
ECHA expressed concerns on the additional coordination mechanism
referred in the presentation on the workload and on the timelines
will have to be carefully assessed and that the mechanisms might have
to be streamlined, for instance promoting direct communication
between Member States without always involving ECHA (for monitoring
or recording) and avoiding discussion in the BPC or WG when the
reference Member State considers the new information provided not
relevant.
Another Member State asked whether a letter of access would be needed
in case environmental data for outdoor use is presented during in
product authorisation from another applicant, and these data were not
provided at the approval stage as only an indoor use was supported as
reference use. The Commission replied that, in that case and as
indicated in the presentation, a letter of access to these additional
data, or their own data on the environment, would be have to be
submitted by other prospective applicants, as they have to submit a
complete data package (ie. data on the environment would be missing
otherwise from their dossier if they request an outdoor use, as data
on the environment were not originally included in the data package
submitted for the approval of the active substance).
Member States are invited to provide further comments in the
newsgroup that will be open by 27 October 2021.
Consequences for biocidal products authorisations procedures of
relevant information becoming available
4.3.
Konsequenzen für die Zulassungsverfahren von Biozidprodukten,
wenn relevante Informationen verfügbar werden
|
For discussion and agreement
CA-Sept21-Doc.4.3.
|
|
The Commission presented an amended version (CA-Sept21-Doc.4.3) of
the document that was discussed in the CA meeting of June 2021
(CA-June21-Doc.4.5). The document has been amended taking into
account the comments submitted by the Member States and ECHA. A
newsgroup will be opened to provide Member States the opportunity to
submit comments to this version.
The document
summarises how to manage different types of relevant information that
becomes available during the procedure for granting an authorisation
of a biocidal product or once the authorisation has been granted, and
that may impact the fulfilment of the conditions of Article 19 or
Article 25 of Regulation (EU) No 528/2012 (the ‘BPR’).
The cases included in
this document were already addressed in the past, and a way forward
was developed and agreed in previous CA documents, namely
CA-May13-Doc.5.4 - Final.rev1 - Classification and labelling of
biocidal products.doc, CA-March16-Doc.4.15-Final - cut off dates
para. 8a annex VI.doc; CA-Nov15-Doc.4.1 - Final - Handling changes to
C&L and consequences.doc.
The document
CA-March16-Doc.4.15-Final on the possibility to apply cut-off dates
for the application of paragraph 8a of Annex VI to the BPR is
considered not correct, and therefore it is proposed to repeal that
document.
The Commission
clarified that the BPC procedure to decide on the status of an active
substance as regards P/B/T or ED status is to be established by the
BPC. ECHA confirmed that a procedure will be developed and that it
will be kept as pragmatic and simple as possible. The Commission will
reflect internally on the procedures to consider the change of status
of an active substance in ongoing and already granted Union
authorisations.
A Member State
enquired about the consistency with the approach followed for the
plant protection products as regards changes in CLP. The Commission
confirmed that the same approach as proposed in the document is being
applied in plant protection products.
As regards the
updating of the list of active substances meeting exclusion or
substitution criteria made by ECHA, the Commission proposed that the
list is updated after the meeting of RAC committee (4 times per
year).
The Commission
explained the differences between Article 47 and Article 50 of the
BPR. Article 47 establishes an obligation for the authorisation
holder to notify unexpected or adverse effects while Article 50 gives
opportunity to applicants to request a change in the authorisation.
The document will be
tabled for discussion and agreement in the next CA meeting.
Report from the Coordination Group
|
For information
|
|
The Commission made a brief summary of the issues discussed in the
CG-47 and CG-48 meetings.
CG-47:
Five formal referrals were discussed and agreement was reached for
three of the referrals.
The Commission informed the CG on the status of the referrals for
which the points of disagreement are referred to the Commission in
accordance with Article 36 of the BPR. (Closed session)
A Member State presented a revised proposal for the revision of the
CA document in relation to handling carriers (CA-Nov16-Doc.4.3 -
Final) on the basis of a referral. The Member States will provide
further feedback in writing. The initiating Member State (iMS) will
provide a revised document based on the discussion during the meeting
and the comments and discussion will continue at the CA. It was noted
that the discussions concerning a UA at the last BPC meeting also
affecting this CA document were not and will not be taken into
consideration for the revision by the CG, as that is not in the remit
of the CG. (Closed session)
The SECR presented a revised document with proposals for the next
steps in light of the CA document CA-March21_Doc.4.3_Final regarding
the bridging of ED-assessment of biocidal co-formulants with REACH
screening and assessment. The CG agreed that the inventory list of
co-formulants generated from IUCLID will be created and the MSs’
list of co-formulants will not be created. Agreement was also reached
that CG-34-2019-02 will be reviewed and revised by FR, while
CG-41-2020-03 will be recorded obsolete in the minutes and removed
from public CIRCABC. Discussion on the inventory list of
co-formulants generated from IUCLID will continue at the next CG
meeting. (Closed session discussion and open session for information)
The SECR informed the CG that:
the documents prepared by the CG SECR regarding issues identified in
the context of UA and update on questions forwarded from CG to ECHA
will only be updated twice/year instead of each CG meeting.
the documents prepared by the CG SECR regarding the list of active
substances meeting the exclusion or substitution criteria will only
be updated twice/year instead of each CG meeting.
the new PAR templates are available on the ECHA website.
The CG SECR reminded ASOs that in case of referrals the contact
details in R4BP3 are used, therefore these should be updated if
necessary and the provided email address should be checked by the
applicant regularly.
The main CG agreements reached during the CG-47 meeting:
The CG agreed on the amendment of the Rules of the Procedure.
Changes included the distinction of regular (previously CG meetings)
and additional (previously teleconferences for formal referrals)
meetings as well as addressing their differences (e.g. minutes,
upload date of documents etc.); amendment of the RoP every 1.5 years
and rules on the agreement of amendment of the RoP.
The CG agreed on the updated Working Procedure for e-consultations.
A new concept of informal e-consultations now named informal
enquiries has been introduced.
A Member State presented an outcome of a consultation in relation to
topic – PT1 hand disinfectant packaging and labelling. The iMS
will prepare a public version of the document. Member States will
provide further feedback and ASOs were invited to provide comments
as well. Discussion will continue in the open session.
A Member State briefly presented an outcome of an e-consultation in
relation to topic – RMMs for PT18 products. It was agreed that the
iMS would provide a revised document and MSs would provide further
feedback.
CG-48
One formal referral was discussed and agreement was not reached.
The Commission informed the CG on the status of the referrals for
which the points of disagreement are referred to the Commission in
accordance with Article 36 of the BPR. (Closed session)
A Member State introduced a topic in relation to an issue concerning
the minimum purity of the AS in a particular biocidal product and
asked for the view of the CG members how to proceed if the supplier
of the AS confirmed a different minimum purity than any sources’ in
the CAR and the one’s for which he applied for and has been
established technical equivalence. The CG members and COM provided
their view that an active substance with different minimum purity
than any sources’ in the CAR and without established technical
equivalence could not be used for the authorisation of a product.
(Closed session)
The SECR presented a revised document regarding the structure of the
inventory list of co-formulants generated from IUCLID. The CG agreed
on the structure of the list with some minor modifications and that
the list would be made available for CG CPs via S-CIRCABC in a
dedicated folder. The list will be updated twice every year.
The SECR informed the CG about the publication of the updated list of
frequently used sentences in the SPC on the ECHA website.
The Commission made a brief summary of the issues discussed in the
CG-47 and CG-48 meetings.
CG-47:
Five formal referrals were discussed and agreement was reached for
three of the referrals.
The Commission informed the CG on the status of the referrals for
which the points of disagreement are referred to the Commission in
accordance with Article 36 of the BPR. (Closed session)
A Member State presented a revised proposal for the revision of the
CA document in relation to handling carriers (CA-Nov16-Doc.4.3 -
Final) on the basis of a referral. The Member States will provide
further feedback in writing. The initiating Member State (iMS) will
provide a revised document based on the discussion during the meeting
and the comments and discussion will continue at the CA. It was noted
that the discussions concerning a UA at the last BPC meeting also
affecting this CA document were not and will not be taken into
consideration for the revision by the CG, as that is not in the remit
of the CG. (Closed session)
The SECR presented a revised document with proposals for the next
steps in light of the CA document CA-March21_Doc.4.3_Final regarding
the bridging of ED-assessment of biocidal co-formulants with REACH
screening and assessment. The CG agreed that the inventory list of
co-formulants generated from IUCLID will be created and the MSs’
list of co-formulants will not be created. Agreement was also reached
that CG-34-2019-02 will be reviewed and revised by FR, while
CG-41-2020-03 will be recorded obsolete in the minutes and removed
from public CIRCABC. Discussion on the inventory list of
co-formulants generated from IUCLID will continue at the next CG
meeting. (Closed session discussion and open session for information)
The SECR informed the CG that:
the documents prepared by the CG SECR regarding issues identified in
the context of UA and update on questions forwarded from CG to ECHA
will only be updated twice/year instead of each CG meeting.
the documents prepared by the CG SECR regarding the list of active
substances meeting the exclusion or substitution criteria will only
be updated twice/year instead of each CG meeting.
the new PAR templates are available on the ECHA website.
The CG SECR reminded ASOs that in case of referrals the contact
details in R4BP3 are used, therefore these should be updated if
necessary and the provided email address should be checked by the
applicant regularly.
The main CG agreements reached during the CG-47 meeting:
The CG agreed on the amendment of the Rules of the Procedure.
Changes included the distinction of regular (previously CG meetings)
and additional (previously teleconferences for formal referrals)
meetings as well as addressing their differences (e.g. minutes,
upload date of documents etc.); amendment of the RoP every 1.5 years
and rules on the agreement of amendment of the RoP.
The CG agreed on the updated Working Procedure for e-consultations.
A new concept of informal e-consultations now named informal
enquiries has been introduced.
A Member State presented an outcome of a consultation in relation to
topic – PT1 hand disinfectant packaging and labelling. The iMS
will prepare a public version of the document. Member States will
provide further feedback and ASOs were invited to provide comments
as well. Discussion will continue in the open session.
A Member State briefly presented an outcome of an e-consultation in
relation to topic – RMMs for PT18 products. It was agreed that the
iMS would provide a revised document and MSs would provide further
feedback.
CG-48
One formal referral was discussed and agreement was not reached.
The Commission informed the CG on the status of the referrals for
which the points of disagreement are referred to the Commission in
accordance with Article 36 of the BPR. (Closed session)
A Member State introduced a topic in relation to an issue concerning
the minimum purity of the AS in a particular biocidal product and
asked for the view of the CG members how to proceed if the supplier
of the AS confirmed a different minimum purity than any sources’ in
the CAR and the one’s for which he applied for and has been
established technical equivalence. The CG members and COM provided
their view that an active substance with different minimum purity
than any sources’ in the CAR and without established technical
equivalence could not be used for the authorisation of a product.
(Closed session)
The SECR presented a revised document regarding the structure of the
inventory list of co-formulants generated from IUCLID. The CG agreed
on the structure of the list with some minor modifications and that
the list would be made available for CG CPs via S-CIRCABC in a
dedicated folder. The list will be updated twice every year.
The SECR informed the CG about the publication of the updated list of
frequently used sentences in the SPC on the ECHA website.
The Commission gave feedback on the ongoing discussions at the CA
meetings on the List of Endpoints for active substances
The main CG agreements reached during the CG-48 meeting:
The representative from the PL CA was re-elected as the Chair of the
CG and her mandate for the second term will begin on 21 November
2021.
The CG agreed on the amendment of the Standard operating Procedure
and process flow for the mutual recognition process in parallel and
in sequence, as well as on the amendment of the SoP and process flow
for mutual recognition process of minor changes applications Rules
of the Procedure. Changes concerned clarifications in the text of
the SoP, division of the bilateral discussion step into further
substeps and inclusion of the referral submission deadline in the
process flow.
The CG was informed about the coming changes in SPC editor regarding
changes to the draft SPC file in Word format (i.e. that R4BP3 asset
number and details of the asset owner will now be populated and a
sentence will also appear for the validity dates explaining how they
should be calculated) for UA applications and the CG members agreed
to the proposal that this function would be implemented for NA and
SA procedures as well.
The tentative dates for CG meetings in 2022 were communicated and it
was agreed to organise the CG meetings as WebEx meetings, keeping at
least one physical meeting in June held in one of the MSs (if there
would be volunteers), or in Helsinki, if the evolution of the
pandemic would allow.
Topics where further discussion will take place:
The SECR presented a document concerning setting post-authorisation
conditions for physical hazards; physical, chemical and technical
properties, including full long-term storage stability test. The CG
will provide feedback on the document and discussion will continue
at the next CG meeting.
A Member State presented an outcome of an e-consultation in relation
to topic – Storage stability and degradation of active chlorine.
It was agreed that the iMS would provide a revised document and both
MSs and ASOs would provide further feedback. Discussion will
continue at the next CG meeting in the open session.
A Member State presented an outcome of an e-consultation in relation
to topic – PT1 hand disinfectant packaging and labelling. The CG
agreed that the Commission would bring this discussion to the CA
level regarding 1) whether the dispenser should be interpreted
legally as packaging of the product or a device, 2) what key
information should be displayed on dispensers and on what legal
basis the information could be required, 3) clarification concerning
Article 69 of the BPR, whether it is the responsibility of the
authorisation holder to include information on the dispenser.
The Commission presented a proposal regarding the determination of
the dermal absorption value in product authorisation for different
scenarios. The Commission emphasised that new information (i.e. both
data submitted by the applicant and new applicable guidance) should
be taken into consideration for product authorisation. The
Commission will revise the proposal and the CG will provide feedback
on it. Discussion will continue at the next CG meeting.
A Member State
informed the CG about receiving questions and comments about errors
spotted in the overview template for BPFs. It was agreed that the
Member State previously in lead of the creation of the template
would manage its revision and that both Member States and ASOs could
provide feedback on their experiences with the template.
Mutual recognition of same biocidal product authorisations
4.6.
Gegenseitige Anerkennung gleicher Biozidproduktzulassungen
|
For discussion and agreement
CA-Sept21-Doc.4.6
|
|
The Commission
presented the document (CA-Sept21-Doc.4.6) that is identical to the
document discussed in the in the 92nd CA meeting
(CA-June21-Doc.4.12) addressing the question on whether a same
biocidal product authorised in accordance with Commission
Implementing Regulation (EU) No 414/2013 can be subjected to mutual
recognition. The issue was raised by Germany during the 91st
meeting of the Competent Authorities for biocidal products. The
position of that Member State is reflected in the document
CA-March21-Doc 4.16-Mutual recognition of same biocidal products.
According to that Member State, mutual recognition should be
restricted to national authorisations in strict sense only, and
therefore, same biocidal product authorisations can be subjected to
changes but cannot be mutually recognised.
Similar discussions
on whether is it possible that a same biocidal product authorisation
is recognised in other Member States by mutual recognition in
sequence, have taken place in the past, and specifically in the
meeting of the coordination group of September 2015 (CG-13 agenda
point 14(6)), in the 61st meeting of the Competent
Authorities for biocidal products (agenda point 4.1) and the 62nd
meeting of the Competent Authorities for biocidal products (agenda
point 4.2).
The conclusion that
was reached in those discussions is that the BPR does not contain any
provision restricting mutual recognition of same biocidal products
authorisations. Some Member States suggested to introduce such a
provision, preventing that same biocidal products authorisations
could be mutually recognised in the draft of the Commission
Implementing Regulation (EU) No 414/201 (‘SBP Regulation’) that
was being discussed at the time. During these discussions it was
clarified that such a restriction could only be made by modifying the
BPR as such.
The Commission
concluded that same biocidal product authorisations granted in
accordance with Regulation (EU) No 414/2013, can be recognised in
other Member States subjected to mutual recognition procedures, as
established in Chapter VII of the BPR.
Article 3(1)(m) of
the BPR provides the definition of national authorisations. There is
no distinction in the concept of ‘national authorisation’ under
Article 3(1)(m) as to the procedure under which the national
authorisation was granted (whether it was granted through full
application of Chapter VI of the BPR or with some derogations from
that Chapter). Therefore, there is no legal reason to distinguish
national authorisations of ‘same biocidal products’ from other
national authorisations, as both fulfil the definition of ‘national
authorisation’ under Article 3(1)(m).
Article 32(1) of the
BPR establishes that applications for mutual recognition of a
national authorisation can be made. Since there is no distinction in
the concept of ‘national authorisation’ under Article 3(1)(m) as
to the procedure under which the national authorisation was granted,
any national authorisation as defined in Article 3(1)(m) of the BPR
can be recognised in other Member States.
The Member State that
raised the question agrees with the legal analysis but sees practical
problems as the ones described in the document submitted in response
to the proposed approach (CA-Sept21-Doc.4.6- DE comments). One of the
main issues is which of the MSs should act as reference Member States
in case of disagreement in a mutual recognition and also in case of
amendments/cancelations of the authorisations made in accordance with
Article 48 of the BPR on how these procedures could be regulated.
Three other Member States supported this view, and one of them
pointed out that this situation is unlikely to happen, as most of the
time the applicant will not have the letter of access to the
necessary studies in order to apply for a mutual recognition of the
SBP. The Member States that raised the issue confirmed that they have
been confronted already with applications for a mutual recognition of
a SBP.
The Commission
acknowledged that practicalities need to be addressed, either by a
modification of the SBP Regulation or in the rules of procedure of
the coordination group. The Commission will analyse in detail the
practical questions put forward and will try to provide a reply in
the next CA meeting.
Member States agreed
on the document.
Mutual recognition in case of non-authorisation decisions
4.7.
Gegenseitige Anerkennung bei Nichtzulassungsentscheidungen
|
For discussion and agreement
CA-Sept21-Doc.4.7
|
Scheduled on 29 September
|
The Commission
presented the document CA-Sept21-Doc.4.7 that intends to
clarify if, in the context of mutual recognition, it is possible to
raise a disagreement to the coordination group on a non-authorisation
proposal of the reference Member State.
The question of
whether a referral of objections to the Coordination Group in
accordance with Article 35 (2) of Regulation No 528/2012 (the ‘BPR’)
can be initiated if the assessment of the reference Member State
results in a proposal for non-authorisation of a product was
discussed in the Coordination Group in its meeting in February 2020
(CG-39). At the meeting, the Commission provided their interpretation
(CG-39-2020 AP 16.2), concluding that this specific case is not
specifically mentioned in Article 35(2) of the BPR and therefore
cannot be subject to a referral. The same interpretation was
provided to the competent authorities (CA-Feb20-Doc.4.5) in the CA
meeting of February 2020 (87th CA meeting). However, further
clarification is needed on the possibilities to discuss a
non-authorisation proposal in the Coordination Group.
Article 35 (1) of the
BPR establishes that a coordination group shall be set up to examine
any question (emphasis added), other than matters referred to in
Article 37, relating to whether a biocidal product for which an
application for mutual recognition has been made in accordance with
Article 33 or 34 meets the conditions for granting an authorisation
laid down in Article 19. Under Article 34(5), the MS concerned shall
agree on the summary of biocidal product characteristics (the SPC)
and also (even if not explicitly mentioned) on the assessment of the
reference Member State (refMS) in order to have a basis for their
national decision.
Therefore, bearing in
mind Article 35(1) and recital 4 and the nature of the procedure of a
mutual recognition in parallel, it appears that the coordination
group can examine any question relating to whether a biocidal product
for which an application for mutual recognition has been made in
accordance with Article 34 meets the conditions for granting an
authorisation laid down in Article 19, including the case of a
non-authorisation proposal by the reference Member State, even if
this specific case is not specified in Article 35(2) and a referral
in accordance with Article 35(2) cannot be raised.
Some Member States
signalled that the document was not clear. A Member State signalled
that the different wording used in the text of the BPR and in the
Changes Regulation makes the situation confusing. That Member State
recalled some of the points discussed on the application of Article
35(2) of the BPR, where it was concluded that in case of a
non-authorisation decision by the reference Member States the
concerned Member States are not entitled to raise referrals,
including the argument that this will not be possible in case of a
mutual recognition in sequence and that Article 35 and Article 36 of
the BPR apply also to mutual recognition in sequence. Another Member
State supported the Commission views that it is possible to raise a
referral on a non-authorisation decision. ECHA pointed out that a
non-authorisation decision can also be taken if the fees are not
paid, etc. The Commission clarified that the discussion is focused on
non-authorisation decisions because of non-compliance of the biocidal
product on Article 19 of the BPR. A Member State asked how can a
non-authorisation decision be reflected in an SPC. The Commission
replies that they will reflect on this also.
As this issue is
interlinked with the question on the possibility to provide comments
to the decision of a reference Member State that decided not to
authorise an application changes (minor or major)
(CA-Sept21-Doc.4.8), the Commission proposed to present an
amended version of the document addressing the two issues for the
94th CA meeting.
Mutual recognition in relation to minor or major applications
4.8. Gegenseitige Anerkennung bei kleineren oder größeren
Anträgen
|
For discussion and agreement
CA-Sept21-Doc.4.8
|
|
The Commission
presented the document CA-Sept21-Doc.4.8 which is identical to
CA-June21-Doc 4.13.b that was discussed in the 92nd CA
meeting.
The document intends
to clarify that in the context of a minor or major application for
changes (MIC or a MAC) the concerned Member States are entitled to
provide comments to the decision of a reference Member State that
decided not to authorise an application for changes (major or minor).
Regulation No (EU)
354/2013 establishes a procedure for resolving disagreements on the
assessment by the reference Member State on changes applications, in
Article 7(4), Article 7(6), Article 8(4), Article 8(6) and Article
10. Therefore, even in case of non-authorisation of the changes, the
concerned Member States have the right to comment on the conclusions
of the assessment report or, where relevant, on the revised summary
of the biocidal product characteristics of the refMS.
Some MSs noted that
the discussion is interlinked with the document CA-Sept21-Doc. 4.7.,
and it was decided to discuss both documents at the same time.
A revised version of
the document will be prepared for the next CA meeting.
List of pending Article 36 requests
|
For information
CA-Sept21-Doc.4.9
|
Closed session
|
The item was discussed in closed session.
Designation of the biocidal product when free radicals are
generated from a polymer
4.10.
Bezeichnung des Biozidprodukts, wenn aus einem Polymer freie
Radikale erzeugt werden
|
For discussion and agreement
CA-Sept21-Doc.4.10
CA-Sept21-Doc.4.10.b
|
|
The Commission recalled that the objective of the document was to
identify the biocidal product when free radicals are generated in
situ from catalysts embedded in a polymer matrix. Following the
discussion in the last CA meeting and the information received from a
dedicated newsgroup, the initiating Member State proposed to amend
the document CA-July19-Doc.4.1 on the management of product
authorisation in case of in situ to cover this specific case under
the case type 4 described in this document.
The initiating MS recalled that the discussion started because of the
presence on the market of objects incorporating catalysts and
generating free radicals that could not be covered by case type 3.
Following last discussions, this Member State proposed an amendment
to case-type 4 to cover all systems generating free radicals (from
device or objects not falling under case-type 3).
One Member State indicated preference to apply case type 3 to all
free radicals applications. The master batch could be considered as
the biocidal product in that case. A proposal will be sent to the
Commission. The initiating Member State recalled that in most of the
cases, the concentration of the catalyst in the master batch is not
the concentration used in the final plastic object for which efficacy
is demonstrated. In addition, the catalyst might be incorporated in
other materials than polymers like ceramic toilet bowls. It might
therefore not be possible to identify the master batch as the
biocidal product in all cases. The amended case-type 4 would cover
all possible cases of free radicals generated from air and water
which may not be covered with case-type 3. Another Member suggested
to include free radical applications under case type 4.
The initiating Member responded that removing case type 3 and keeping
only case type 4 would mean that the concept of marketable precursor
(the coating) could no longer apply which is an important change to
the agreed policy approach. Another Member State draw the attention
of the CA to the fact that products under case types 3 and 4 fall
under two different indents of the biocidal product definition. It
might be difficult to reconcile this aspect into one case type for
all free radicals applications.
The Commission concluded that a newsgroup to provide comments by 27
October 2021 would be opened to allow those Member States wishing to
cover all free radicals applications under one case type to provide
their suggestions.
Clarification regarding the scope of Regulation No 492/2014
4.11.
Klarstellung zum Anwendungsbereich der Verordnung Nr. 492/2014
|
For discussion and agreement
CA-Sept21-Doc.4.11
|
|
The Commission
presented the document CA-Sept21-Doc.4.11, recalling that the
initiating Member State raised questions on the scope of Regulation
No 492/2014 (Renewal Regulation). The initiating Member State had
asked, more specifically, whether two different scenarios would fall
under the Renewal Regulation. In the first scenario, a major change
is introduced (e.g., a claim is added) in the reference Member State
and not in the concerned Member State. In the second scenario, a
minor change (e.g. a change in shelf-life or pack size) is introduced
in the concerned Member State and not in the reference Member State.
The document
clarifies that Article 1(3)(a), providing that the Renewal Regulation
applies in case of authorisations having different terms and
conditions on aspects “concerning merely information which can be
the subject of an administrative change in accordance with [the
Changes Regulation]”, cannot be interpreted as covering
authorisations that, at the time of renewal, differ with respect to
any information which could, in the future, be subject to an
administrative change.
With regard to the
specific questions put forward by the Member State, it should first
be recalled that the Annex to the Changes Regulation classifies
“removal of a particular claim, such as a specific target organism
or a specific use” as an administrative change; a “change in the
shelf-life” or “change in the pack size range” (under certain
conditions) as a minor change. If, at the time of renewal, the
authorisations differ as a result of a major change (e.g. additional
target organism) or a minor change (e.g. change in shelf-life or pack
size, under certain conditions) that was previously introduced,
Regulation (EU) No 492/2014 does not apply.
The discussion
focused on possible approaches with regard to renewal applications
that have already been submitted. The Commission did not consider it
possible to introduce a transitional period in the document, but
considered that Member States may decide to allow applicants having
already submitted their application to make changes so that the
authorisations concerned fall under the scope of Article 1(3)(a) in
the interpretation clarified in the document.
The Member States agreed on the document.
Renewal of “Same biocidal products” authorisations
4.12.
Erneuerung der Zulassung „Gleiche Biozidprodukte“
|
For discussion and agreement
CA-Sept21-Doc.4.12
|
|
The Commission
presented the document CA-Sept21-Doc.4.12, recalling that it was
drafted in response to questions raised by a Member State on whether
same biocidal product (SBP) authorisations in accordance with
Commission Implementing Regulation (EU) No 414/2013
(‘the SBP Regulation’) can be subjected to renewal and, if so,
what procedure should be followed.
The document
clarifies that renewal of SBP authorisations is possible. As far as
the procedures are concerned, the renewal of a national SBP
authorisation is governed by Article 31 of the BPR, and the renewal
of a Union SBP authorisation is governed by Articles 45 and 46.
Renewal of an SBP authorisation based on a reference product
authorised through mutual recognition falls under the Regulation (EU)
No 492/2014 on renewals of authorisations of BPs subject to mutual
recognition (‘the Renewal Regulation’), provided that the
conditions of Article 1 thereof are satisfied.
With regard to the
case where changes are introduced regarding the related reference
product and/or the SBP, these aspects must be considered already at
the time of introducing the changes (and prior to renewal). Article
7(2), third subparagraph, provides that “in the evaluation of a
proposed change of a same product or of a related reference product,
the receiving competent authority or, where relevant, the Agency
shall consider the appropriateness of cancelling or amending the
authorisation of other products to which the product is linked in the
Register for Biocidal Products”. In considering the appropriateness
of cancelling or amending the linked authorisations, the competent
authorities must have regard to Article 1 of the SBP Regulation,
which provides that the procedural rules laid down therein apply to a
product which is identical to another product “with regard to all
the latest information submitted in relation to the authorisation or
registration, except information which can be the subject of an
administrative change” in accordance with the Changes Regulation.
The initiating Member
State stated that its support for this document depended on the
outcome of the discussion on document CA-Sept21-Doc.4.11 on the scope
of Regulation No 492/2014. The initiating Member State asked for
clarifications on the issue of changes addressed in paragraph 14 and
raised the issue of the letter of access requirements for renewal of
SBP authorisations, suggesting that this could be addressed when
amending the SBP Regulation.
The Commission
indicated that it would reflect on the issue of the letter of access.
The Commission clarified that the CAs’ obligation to “consider
the appropriateness of cancelling or amending the authorisation” of
linked products, established in Article 7(2) of the SBP Regulation,
entails a case-by-case assessment by the national authorities. The
Commission suggested that the reflection on the issues linked to the
handling of changes, which must be considered when the changes are
evaluated, should be carried out separately from the reflection on
renewals. Finally, the Commission underlined that the introduction of
clarifications on these matters could be considered in the context of
the possible amendment of the SBP Regulation.
The Member States agreed on the document.
Authorisation of an in-situ biocidal product: case-type 2 vs.
case-type 4
Zulassung
eines In-situ-Biozidprodukts: Falltyp 2 vs. Falltyp 4
|
For discussion and agreement
CA-Sept21-Doc.4.13
CA-Sept21-Doc.4.13.b
|
|
The Commission introduced this topic by explaining that the
initiating Member State would like to clarify in which circumstances
an application for in situ generation could be classified under case
type 2 or case type 4. The initiating Member State had the particular
example of active chlorine generated from sodium chloride by
electrolysis in mind. It proposed to classify most of the IGS under
case type 2 (where the biocidal product would be the precursor i.e.
sodium chloride in its example) as following its interpretation, this
case type which derives from the first indent of the biocidal product
definition has a priority over case type 4 as being an interpretation
of the second indent of the biocidal product definition. The
Commission clarified that to its best knowledge there is no such
hierarchy between the two indents of the biocidal product Regulation.
The Commission also informed the CA that this question had raised the
attention of two stakeholders that provided recent comments which
were uploaded in CIRCABC just before the meeting.
The initiating Member State informed that its legal interpretation of
the biocidal product definition was shared over the summer with other
Members and that it was not supported by the three replying Members.
The initiating Member State therefore proposed to focus on two main
questions on which an opinion of the Commission and the CA was
sought.
The first question was on whether for the same use and the same type
of application (e.g. for pool disinfection), the two indents of the
biocidal product definition could be used. According to the
initiating Member State, the BPR specifies that the biocidal product
could fall either under the first indent or under the second
indent and that there is no possibility to choose one of the two
options.
The second remark is that the salts used for the disinfection of
swimming pools are clearly marketed for biocidal purposes and this
cannot be ignored by the Competent Authorities. In this particular
case, the salt is the precursor and at the same time the biocidal
product as defined under the first indent of the biocidal product
definition. In this case, case type 4 cannot be applied.
One Member State supported the views of the initiating Member State
that sodium chloride for pool disinfection would probably fall under
case type 2, although it is difficult to understand why a salt would
have biocidal properties.
The Commission clarified that the biocidal ‘character’ of an in
situ generation system might be given by the equipment used to
generate the active substance and not by the precursor itself. The
Commission also recalled that the notion of intention is
mentioned in the two indents of the biocidal product Regulation and
not only in the first indent of the biocidal product definition.
Another Member State indicated that device manufacturers should be
also able to submit authorisation dossier because they are better
placed than salt producers to provide information on the generation
system. Another Member State agreed with this statement.
The initiating Member State added that device manufacturers should
have access to data of salt manufacturers to become authorisation
holder under case-type 4. A stakeholder supporting device
manufactures commented that the authorisation dossier are ready to
submit their applications for authorisation and that the commercial
activities of device manufacturers and salt producers are different
and therefore both should be able to apply if they so wish.
The Commission questioned how the evaluating Member State could
justify the reclassification of an application for authorisation
from case type 4 to case type 2 if it does not know how the product
is marketed in other Member States.
Another Member State indicated that salt manufacturers should be not
be obliged to become authorisation holder if they do not know which
devices would be used with their products and vice versa device
manufacturers would have difficulties to control the manufacturing
process of the salts used in their devices.
The Commission commented that, irrespectively of who would apply, the
submitter would need to get data from the salts and the devices. The
quality of the precursor in the case mentioned above was described in
the approval of the active substance.
Another Member State commented that the first indent of the biocidal
product definition would cover normal products whereas the second
indent is intended to cover in situ. The initiating Member State
disagreed and indicated that the first indent is also used to cover
in situ generation system. According to that Member State, the second
indent is there to capture all the cases where there is no precursor
placed on the market. A legal interpretation of the biocidal product
definition would help to clarify the situation.
The Commission indicated that this question needs to be analysed case
by case as discussed in the past, based on technical information and
the way the product is marketed. A legal interpretation of a case by
case analysis would not help.
The initiating Member State commented that the current national case
law interpret the notion of intention in a broad sense and that, if
it is clear from the circumstances that the product that is placed on
the market has biocidal effects, then it should be identified as the
biocidal product. An observer indicated like the Commission that on
opinion of the Legal Service would not help to solve the issue and
rather recommended a pragmatic approach.
The initiating Member promised to further reflect on the matter and
come back to the Commission in writing. The Commission proposed to
open a newsgroup to collect further information, to which Member
States are invited to contribute by 27 October 2021.
Handling “carriers” in the authorisation of biocidal
products
4.14.
Umgang mit „Trägern“ bei der Zulassung von Biozidprodukten
|
For discussion and agreement
CA-Sept21-Doc.4.14
CA-Nov16-Doc.4.3-Rev1
|
|
Following a
discussion in the frame of a referral to the Coordination Group, an
update of point (18)(a) of the document “CA-Nov16-Doc.4.3 on
handling carriers” was made by the reference Member State (France)
for the biocidal product concerned in the referral, to clarify that
in case of a type A or B carrier based product where the final
biocidal mixture is a liquid, testing for corrosion to metals is
possible.
One Member State
proposed a further amendment to the text but withdrew the request.
Another Member State
proposed further amendment to the document to make it coherent with
the amendment made on paragraph 18 by another Member State. As the
document needs an additional revision to reflect discussions held on
the context of a Union authorisation, the Commission proposed that
the amendment proposed by the second Member State will be discussed
in the CA meeting of December.
Member States agreed on the amended document.
CA-March16-Doc.4.6 Final.rev2 - note for guidance Q&A on
simplified procedure.
4.15.
CA-March16-Doc.4.6 Final.rev2 - Hinweis zur Anleitung für Fragen
und Antworten zum vereinfachten Verfahren.
|
For discussion and agreement
CA-Sept21-Doc.4.15
CA-March16-Doc.4.6
Final-rev3
|
|
The Commission
presented a revised version of CA-March16-Doc.4.6, that includes a
new Q&A (number 17), to clarify that for the active substances
listed in category 1 of Annex I (lactic acid, sodium acetate, sodium
benzoate, (+)-tartaric acid, acetic acid, propionic acid), the
requirement that the concentration is limited so that each biocidal
product does not require classification according to either Directive
1999/45/EC or Regulation (EC) No 1272/2008 refers to the
concentration of the active substance.
Member States agreed
on the revised document and the new Q&A, with the exemption of
Sweden that has further questions on the document that will be sent
to the Commission.
Redefinition of active substances included in the Review
Programme
|
For information
|
|
The Commission informed that the discussions on this item are now
closed, and that ECHA is proposing a project on the clarification of
the identities of active substance (item 5.5 on the agenda). .
Progression of the review programme on active substances
5.2.
Fortgang des Überprüfungsprogramms zu Wirkstoffen
|
For information
CA-Sept21-Doc.5.2
|
|
The CA
meeting took note of the status report.
Inclusion of brandy in the Review Programme
5.3.
Aufnahme von Brandy in das Überprüfungsprogramm
|
For information and agreement
CA-Sept21-Doc.5.3
|
|
The Commission
informed that that ECHA recently declared a notification on brandy
compliant.
Consequently, brandy
needs to be included in the review programme, and the Commission
asked for a voluntary Member States to be appointed as evaluating
Competent Authority (eCA) in the Review Regulation, otherwise the
Commission will have to designated one Member State.
One Member State
indicated to have given its agreement in 2017 to the notifier to act
as eCA, and the notifier contacted them again. However, the
substances was no longer in its planning and in the meantime it
accepted being the eCA for another active substance, and would
appreciate if another Member State would volunteer.
A newsgroup will be
open to provide one month to other Member States to volunteer by 27
October 2021.
It was also discussed whether Member States would consider relevant
to make an Article 75(1)(g) request to ECHA concerning its
eligibility for Annex I inclusion, considering the nature of this
substance and its properties. It was agreed that there was no need to
make such a request to ECHA, and that the normal dossier for approval
will have to be submitted within the review programme, similarly to
other “food and feed” active substances which were not eligible
for Annex I inclusion (e.g. orange extract, capsicum extract).
Progression of the renewal process of approval of active
substances
|
For information
CA-Sept21-Doc.5.4
|
|
The CA
meeting took note of the status report.
ECHA Active Substance Action Plan – progress update
5.5.
ECHA-Aktionsplan für aktive Substanzen –
Fortschrittsaktualisierung
|
For information
CA-Sept21-Doc.5.5
|
|
ECHA gave an update
on the progress of the action plan, as presented in the document.
Biocides For Europe
asked to have further information about the FAST project, the
timelines and purposes. ECHA informed to be working with a small
group of Member States and discussing with the Commission, and that
they will prepare a specific document on the matter for a forthcoming
CA meeting.
The Commission echoed the invitation made by ECHA to identify missing
data in the dossiers, in particular on endocrine disrupting
properties considering that the criteria are now applicable since 3
years and the assessment of these properties is one of the drivers
for delays in the review programme.
Die
ECHA informierte über die Fortschritte des Aktionsplans, wie im
Dokument dargestellt.
Biozide
für Europa bittet um weitere Informationen über das FAST-Projekt,
die Zeitpläne und den Zweck. Die ECHA teilt mit, mit einer kleinen
Gruppe von Mitgliedstaaten zusammenzuarbeiten und mit der Kommission
zu diskutieren, und dass sie ein spezielles Dokument zu diesem Thema
für eine bevorstehende Sitzung der zuständigen Behörde vorbereiten
werden.
Die
Kommission folgte der Aufforderung der ECHA, fehlende Daten in den
Dossiers zu ermitteln, insbesondere zu endokrin wirksamen
Eigenschaften, da die Kriterien nun seit drei Jahren gelten und die
Bewertung dieser Eigenschaften einer der Gründe für Verzögerungen
im Überprüfungsprogramm ist.
Proposal of campaign for verification of substance
identification
|
For discussion and agreement
CA-Sept21-Doc.5.6
|
|
ECHA is proposing a
campaign to verify the substance identity of active substances under
assessment in the review programme, in order to avoid the need for
further re-definition in the future. The Commission supports this
exercise and strongly invites Member States to provide to ECHA the
necessary information, to avoid having re-definition in the future as
it contributes to delaying the completion of the review programme
started almost 20 years ago. Redefinitions should no longer happen
and be exceptional at this stage of implementation of the BPR.
One Member State
asked ECHA to clarify the scope of the exercise, and confirm that it
would not apply to active substances generated in situ. The
Commission noted that the exercise could cover in situ, but noted
that there should normally be no need for these active substances,
considering that a dedicated exercise was already done in 2015 for in
situ active substances. ECHA had reservations about covering in situ
active substance in this exercise.
One Member State
noted that it will have difficulty to check the identity also for
active substances under 5th and 6th priority
lists due to their priority of work, but they will do their utmost to
avoid further late redefinition.
One Member State
noted that it was not in position to support the document for
procedural reasons.
The CA meeting supported the verification campaign proposed by ECHA.
Member States are therefore invited to work along the project defined
in the document and work with ECHA on the matter.
Treated articles
|
No item for information or discussion.
|
Assessment of confidentiality claims
|
For information
CA-Sept21-Doc.7.1
|
|
ECHA introduced the document, announcing it has been published on the
ECHA website, and pointed out that the guidelines reflect the
experience so far, clarify the general principles and provide
practical recommendations. ECHA invited competent authorities to
consult the guidelines when performing confidentiality claims
assessments and stakeholder associations to share the document with
their members. ECHA also informed that an update of the document is
scheduled for the first half of 2024, in light of the experience, and
feedback will be collected in the second half of 2023. One Member
State asked whether it was possible to send comments on the document.
ECHA clarified that the guidelines do not provide any new
interpretation of the obligations under the BPR and for this reason
competent authorities and stakeholders were not consulted when
developing the document. Comments from Member States and stakeholders
will be requested later on, ahead of the revision scheduled for 2024.
ECHA communications
|
For information
CA-Sept21-Doc.7.2
|
|
ECHA gave a
presentation focusing on two topics: (i) progress on the development
of guidance on analysis of alternatives under the BPR and (ii) future
public consultation on anticoagulant rodenticides. On the first topic
ECHA mentioned that the objective of developing such guidance is to
provide a set of elements considered important to evaluate the
availability of suitable alternatives to products containing active
substance subject to exclusion and a structure for reporting this
analysis. The guidance would be used by applicants, competent
authorities, the BPC and third parties. As to the timeline, the
probable adoption will be mid- or second half of 2022.
The second topic was related to the ongoing work of ECHA on the
comparative assessment for anticoagulant rodenticides, for which an
opinion should be delivered by the end of 2022. In this context a
60-day public consultation asking information on non-chemical
alternatives will be launched in October. ECHA also mentioned that,
in gathering information for the performance of the comparative
assessment, bilateral meetings with industries involved might be
beneficial.
ECHA guidance on bees and other non-target arthropod pollinators
|
For information
|
|
The Commission updated the CA-meeting on the state of play and
pointed out that in the Council meeting of 28 June 2021 agreement was
reached on Specific Protection Goals for bees. The Commission
indicated, underlining the differences between biocides and plant
protection products, that these goals should be considered as far as
possible in the development of ECHA guidance for pollinators. One
Member State indicated to understand the wish of having coherence
between plant protection products and biocides, however, pointed out
that for biocides the methodology of PEC/PNEC values apply to assess
environmental effects. This Member State considered that changing the
approach for assessing the risks for the environment should be
broadly discussed and was reflecting whether to submit its concerns
in writing.
Article 65 reporting – Template for future reporting
|
For discussion and agreement
CA-Sept21-Doc.7.4
|
|
The Commission
presented the template for future reporting as agreed at the previous
meeting and mentioned that a few changes were introduced, following
the discussions with the Member State that could not agree to the
template in the previous meeting. Those changes are indicated in
track changes in the document distributed for the meeting and regard:
clarification of ‘unacceptable effects’ in the section regarding
products authorised on the basis of Article 19(5); a modification in
the section on Article 55(1) derogations, where only the number of
permits granted is now requested; clarification that the controls on
end-users should be reported as number of end-users controlled and
non-compliances identified; reporting of controls as number of
controls performed instead of number of products checked and
clarification that the information on nanomaterials in biocidal
products regards both product authorised under the BPR and products
made available under the transitional measures.
One Member State had
a suggestions to clarify the text in one table, which was accepted.
The same Member State asked whether the wording ‘adverse
environmental effect’ could be specified in more detail. Another
Member State had the same request. The Commission stated that the
wording used in the same wording used in Article 65(3) point (c) and
that it is difficult to be more specific. Any available information
on such adverse effects is useful, as it is specifically required to
be included in the reports of Member States.
The amended template for reporting was then agreed by Member States.
The use of biocides in plastic Food Contact Materials
|
For information
|
|
The Commission indicated that internal discussions are on-going on
the 16th amendment of the Plastics Regulation.
Guidance priorities
|
For discussion and agreement
CA-Sept21-Doc.7.6
|
|
ECHA indicated that the document provides the status update of the
current priorities and also includes a proposal for future additional
guidance priorities. Some minor adaptations of the document were made
in order to clarify some elements. One Member State had a question in
relation to the ECHA-EFSA guidance related to water treatment, more
specifically on who is responsible for the development of the
toxicology section of the guidance. ECHA indicated that the specific
section will be developed by the contractor. It was also clarified
that ECHA remains responsible for the guidance document.
BPF training: outcomes of the newsgroup and possible actions
|
For information
|
|
The Commission introduced the topic by explaining the outcomes of a
newsgroup that was opened following a first discussion at the last
CA. There is support (8 Members responded positively) for the
organisation of such trainings as Competent Authorities lacks
resources. The training would help to close knowledge gaps and ensure
a better harmonised interpretation of current guidance documents.
Regarding the scope, the training should clarify how to build a
Biocidal Product Family and how to assess such family. In addition,
it could also include a training on in situ biocidal products and
comparative assessments.
The Commission explained that a framework contract to organise such
event is available in DG SANTE. This contract can employ suggested
trainers from authorities or private consultants to give the
training. A majority of Members still preferred to have it organised
for and by authorities. Two Member States proposed to send trainers
but this should be confirmed at a later stage when the content and
the timing of the trainings would be known.
Update of MSs forecast on submission of active substance and
Union authorisation assessments to ECHA in 2021-2024
7.8.
Aktualisierung der Prognose der Mitgliedstaaten zur Einreichung
von Wirkstoff- und Unionszulassungsbewertungen bei der ECHA im
Zeitraum 2021-2024
|
For discussion
CA-Sept21-Doc.7.8
|
|
ECHA introduced the
document providing an updated forecast of the submission by Member
States of active substance approval and Union authorisation
assessments until 2024. With regard to active substances, according
to the information provided by Member States, around 51% of the
active substance/PT combinations will be submitted around Q3 2023,
meaning that these combinations would meet the deadline of the Review
Programme. By the end of 2024 around 87% of the assessment reports
are likely to be submitted to ECHA. For 33 active
substance/product-type combinations the evaluating CAs were not able
to indicate the approximate timing of submission to ECHA.
For Union authorisation, the expected draft assessment reports are
distributed evenly in 2022 and up to 49 applications are expected to
enter the opinion forming phase. Member States were requested to
update the table as soon as they have new information, as this would
allow all parties involved to better plan their resources. The
Commission noted an error in one of the figures in the document, that
will be corrected. One Member State pointed out that the document
shows an increasing workload for the decision-making bodies (BPC,
Commission) with peaks in some periods, and wondered whether it would
be possible for the future to spread the workload instead of having
these peaks. With regard to the soundness of the forecast, ECHA
indicated that for last year, 1/3 of the expected submissions of
assessment reports for active substances and 3/4 for Union
authorisation materialised, so it might be expected that the peaks
might be less acute than expected.
The revision of the General Product Safety Directive
|
For information
CA-Sept21-Doc.7.10
|
|
A representative of
DJ JUST made a presentation to Member States on the proposal for a
Regulation that will replace the General Product Safety Directive
(GPSD).
On the question of
the applicability of the proposal to treated articles DJ JUST replied
that this will depend also on the type of treated articles and on
whether other harmonised Union legislation is applicable to them
(e.g. Toy Safety Directive), and whether the risks are covered by
that legislation or not. If the risks are not addressed in the EU
specific/sectorial legislation then the GPSD applies.
A Member State asked about the applicability of the GPSD to biocidal
products under transitional rules of Article 89 of the BPR. DG JUST
replied that the GPSD applies for the cases where the risk is not
covered by specific legislation.
Ein Vertreter von DJ JUST präsentierte den Mitgliedstaaten den
Vorschlag für eine Verordnung, die die Richtlinie über die
allgemeine Produktsicherheit (GPSD) ersetzen wird.
Auf die Frage der Anwendbarkeit des Vorschlags auf behandelte
Gegenstände antwortete DJ JUST, dass dies auch von der Art der
behandelten Gegenstände abhänge und davon, ob andere harmonisierte
EU-Rechtsvorschriften auf sie anwendbar seien (z. B. die
Spielzeugrichtlinie) und ob die Risiken abgedeckt seien durch dieses
Gesetz oder nicht. Wenn die Risiken in den spezifischen/sektoralen
EU-Rechtsvorschriften nicht berücksichtigt sind, gilt die RaPS.
Ein Mitgliedstaat fragte nach der Anwendbarkeit der RaPS auf
Biozidprodukte gemäß den Übergangsbestimmungen von Artikel 89 der
BPR. Die GD JUST antwortet, dass die RaPS für die Fälle gilt, in
denen das Risiko nicht durch spezifische Rechtsvorschriften abgedeckt
ist
Risk assessment of skin sensitizers
|
For information
|
|
The Commission explained that discussion had started with ECHA on a
possible mandate under Article 75(1)(g) to clarify the causal link
between the presence of isothiazolinones in paints and detergents and
human health effects. The mandate may also cover an analysis of the
elements to be considered in a quantitative risk assessment approach.
The CA noted the information provided by the Commission.
8.1 Borderline between Regulation (EC) No
1107/2009 on plant protection products and 528/2012 on biocidal
products
|
For discussion
CA-Sept21-Doc.8.1
|
|
The Commission recalled that the point had been raised by one Member.
This Member recalled the previous discussions in recent SCOPAFF for
plant protection products and CA meetings, as well as the Commission
proposal on a decision tree. The goal of the discussion was to reach
further agreement on the borderlines between plant protection
products and biocides. In order to achieve this, this Member State
proposed different criteria that were detailed in the note tabled for
discussion. A central point would be to agree on a list of intended
uses and define whether these uses should fall under the scope of the
PPPR or the BPR.
The Commission recalled that such decision should be taken case by
case and that it would be difficult to propose general rules.
However, in case a product is identified as a PPP, it should no
longer be considered as a BP.
The Commission indicated that the decision tree mentioned above had
been endorsed by the SCOPAFF and incorporated in a scoping document
on borderlines cases that contains already more than 250 entries. It
reported a discussion with enforcement authorities on the matter
where it was mentioned that intended uses are not always matching
with the claims. Such cases should be further investigated. The
Commission clarified that the list presented by the initiating Member
State will be presented at the next SCOPAFF for discussion. If the
authorities cannot take a decision on a borderline case by using the
decision tree proposed by the Commission, the information available
to the authorities should be forwarded to the Commission for further
examination, decision and inclusion in the scoping document of the
SCOPAFF.
The Member State initiating the question requested additional time to
further reflect on the Commission proposal. On the decision tree,
another Member State reminded its concerns about the possibility to
decide on scope issues based on a human protection claim as suggested
in the second row of this tool. In addition, the Commission was asked
to clarify in which case a product used in urban areas should be
considered a PPP. The Commission clarified that the reference to
civil or urbans areas is meant to cover the case of herbicides used
in airports, on railways. The Commission agreed with the Member that
any product aiming at protecting humans against pests should be
considered a biocide but that in some cases, the control of pests to
ensure the protection of consumers could fall under the PPPR.
Finally, at the request of a Member State, the Commission clarified
the scope of the PPPR that covers plants (any living plants or plant
parts) and plant products (product of plant origin after pressing,
milling or drying).
Die Kommission erinnert daran, dass dieser Punkt von einem Mitglied
angesprochen wurde. Dieses Mitglied erinnert an die früheren
Diskussionen im Rahmen der jüngsten SCOPAFF-Sitzungen über
Pflanzenschutzmittel und der zuständigen Behörden sowie an den
Vorschlag der Kommission zu einem Entscheidungsbaum. Ziel der
Diskussion war eine weitere Einigung über die Grenzen zwischen
Pflanzenschutzmitteln und Bioziden. Um dies zu erreichen, schlug
dieser Mitgliedstaat verschiedene Kriterien vor, die in dem zur
Diskussion vorgelegten Vermerk detailliert beschrieben wurden. Ein
zentraler Punkt wäre, sich auf eine Liste von Verwendungszwecken zu
einigen und festzulegen, ob diese Verwendungen in den
Anwendungsbereich der PPPR oder der BPR fallen sollen.
Die Kommission erinnerte daran, dass eine solche Entscheidung von
Fall zu Fall getroffen werden sollte und dass es schwierig wäre,
allgemeine Regeln vorzuschlagen. Wenn ein Produkt jedoch als PSM
identifiziert wird, sollte es nicht mehr als GP betrachtet werden.
Die Kommission wies darauf hin, dass der oben erwähnte
Entscheidungsbaum vom SCOPAFF gebilligt und in ein Scoping-Dokument
zu Grenzfällen aufgenommen wurde, das bereits mehr als 250 Einträge
enthält. Es berichtete über eine Diskussion mit
Vollstreckungsbehörden zu diesem Thema, in der erwähnt wurde, dass
die beabsichtigten Verwendungen nicht immer mit den Behauptungen
übereinstimmen. Solche Fälle sollten weiter untersucht werden. Die
Kommission stellte klar, dass die vom einleitenden Mitgliedstaat
vorgelegte Liste beim nächsten SCOPAFF zur Diskussion vorgelegt
wird. Können die Behörden unter Verwendung des von der Kommission
vorgeschlagenen Entscheidungsbaums keine Entscheidung über einen
Grenzfall treffen, sollten die den Behörden vorliegenden
Informationen zur weiteren Prüfung, Entscheidung und Aufnahme in das
Scoping-Dokument des SCOPAFF an die Kommission weitergeleitet werden.
Der Mitgliedstaat, der die Frage gestellt hat, beantragte zusätzliche
Zeit, um den Kommissionsvorschlag weiter zu überdenken. Im
Entscheidungsbaum erinnerte ein anderer Mitgliedstaat an seine
Bedenken hinsichtlich der Möglichkeit, über Fragen des
Anwendungsbereichs auf der Grundlage eines Personenschutzanspruchs zu
entscheiden, wie in der zweiten Reihe dieses Instruments
vorgeschlagen. Darüber hinaus wurde die Kommission gebeten zu
klären, in welchem Fall ein Produkt, das in städtischen
Gebieten verwendet wird, als Pflanzenschutzmittel betrachtet werden
sollte. Die Kommission stellte klar, dass die Bezugnahme auf zivile
oder städtische Gebiete den Fall von Herbiziden umfassen soll, die
auf Flughäfen oder im Eisenbahnverkehr verwendet werden. Die
Kommission stimmte dem Mitglied zu, dass jedes Produkt, das dem
Schutz des Menschen vor Schädlingen dient, als Biozid anzusehen ist,
dass jedoch in einigen Fällen die Schädlingsbekämpfung zum Schutz
der Verbraucher unter die PPPR fallen könnte.
Schließlich präzisierte die Kommission auf Ersuchen eines
Mitgliedstaats den Anwendungsbereich der PPPR, der Pflanzen (alle
lebenden Pflanzen oder Pflanzenteile) und Pflanzenerzeugnisse
(Erzeugnis pflanzlichen Ursprungs nach Pressen, Mahlen oder Trocknen)
umfasst.
8.2 Toys with biocidal claims
|
For discussion
CA-Sept21-Doc.8.2
|
Closed session
|
The item was discussed in closed session.
Enforcement issues
|
No item for information or discussion
|
International Matters
|
No item for information or discussion
|
(a) List of Competent Authorities and other Contact Points
|
For information
CA-Sept21-Doc.11.a
|
|
(b) Point from NL on phosphine releasing products
|
For
CA-Sept21-Doc.11.b
|
|
The Netherlands introduced this AOB point on incidents with the use
of phosphine producing plant protection products and biocides. A
letter of the Netherlands on this issue has been uploaded on Circabc.
A Newsgroup will be opened for participants to provide their views by
27 October 2021 on which measures could be introduced to increase the
safe use of phosphine containing products.
(c) Products containing active chlorine
|
For discussion
CA-Sept21-Doc.11.c
|
Closed session
|
The item was discussed in closed session.
(d) Union authorisations
|
|
Closed session
|
The item was discussed in closed session.
(e) Update on a Court case
|
|
|
The Commission
informed about the Judgement of the General Court of 15 September
2021 on the cases T-337/18 Laboratoire Pareva v European Commission
and T-347/18 Laboratoire Pareva and Biotech3D Ltd & Co. KG v
European Commission. In its judgment, the General Court dismissed an
action challenging the Commission’s decision non-approving the
active substance PHMB (product-types 1, 5 and 6) and the conditional
approval of that substance (product-types 2 and 4).
Next meetings:
2021
(provisional)
CG
|
CA and SCBP
|
BPR Subgroup Forum
|
BPC
|
BPC's WGs
|
|
|
|
|
|
16-18 February
|
10-12 March
|
|
|
|
|
|
22-23 March
|
1-5 March
|
15-26 March
|
27-29 April
|
|
|
|
|
|
31 May-3 June
|
|
|
|
29-30 June
|
|
22-23 June
|
14-18 June
|
2-11 June
|
1 July
|
|
|
|
|
14-16 September
|
27-30 September
|
|
|
13-24 September
|
|
|
|
4-8 October
|
|
23-25 November
|
|
11-12 November
|
29-30 November
|
15-26 November
|
|
6-9 December
|
|
1-3 December
|
|
2022
(provisional)
CG
|
CA and SCBP
|
BPR Subgroup Forum
|
BPC
|
BPC's WGs
|
|
|
|
|
|
|
9-11 March
|
22-24 March
|
28 Feb-4 March
|
|
|
|
|
|
|
|
|
|
|
|
|
22-24 June
|
21-23 June (or 17 June)
|
13-17 June
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
26-30 September
|
|
|
4-6 October
|
|
|
|
|
|
14-18 November
|
28 Nov-2 December
|
|
|
6-8 December
|
|
|
|
