EUROPEAN COMMISSION
HEALTH AND FOOD SAFETY DIRECTORATE GENERAL
Safety of the food chain
Pesticides and Biocides
CA-Nov15-Doc.2 - Final
MINUTES
61st 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
16-18 September 2015
Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 2 299 11 11
E-mail: [email protected]
1.
Adoption of the agenda
For adoption
CA-Sept15-Doc.1
The draft agenda was adopted.
2.
Adoption of the draft minutes of
the previous CA meeting
For adoption
CA-Sept15-Doc.2 – with comments
from BE, UK and AISE
The draft minutes with comments from BE, UK and AISE were endorsed.
3.
Draft delegated acts
3.1. Corrigendum to Annex II of For information
Commission Delegated Regulation
(EU) No 1062/2014
The Commission informed about the publication on 28/07/2015 of the Corrigendum to
Commission Delegated Regulation (EU) No 1062/2014.
4.
Biocidal products
4.1. Amendment of the same biocidal
product Regulation
For discussion
CA-Sept15-Doc.4.1-rev1
The Commission introduced the document and explained that the format of the proposal still
had to be adapted to an amending Regulation. The Commission also informed the meeting
that at the 13th meeting of the Coordination Group (CG-13), mutual recognition in sequence
of national authorisations granted pursuant to Regulation (EU) No 414/2013 (the SBP
Regulation) was discussed. Several Member States shared concerns that this mutual
recognition in sequence might lead to practical problems and suggested that these could be
prevented by introducing a restriction in the context of the review of the SBP Regulation. The
Commission responded that the legal basis for a mutual recognition in sequence of a national
authorisation is in Regulation (EU) No 528/2012 (the BPR) and that such restriction could
only be set by amending the BPR and not the SBP Regulation.
Upon request of a Member State, the Commission clarified that applications for a SBP of a
product authorised under the simplified procedure shall be always sent to the evaluating
Competent Authority (eCA) and not to Member States where the product is placed on the
market in accordance with Article 27 of the BPR. Once authorised, the SBP must then be
notified to the Member States where the product is going to be placed on the market in
accordance with Article 27.
Another Member State, while recognising the issue of the legal basis, stressed again the
practical problems linked to mutual recognition in sequence of a SBP and referred to further
2
written comments regarding the confidentiality of some data and the renewal of the reference
and same products.
Industry representatives encouraged Member States and the Commission to achieve a speedy
adoption of the revision, as companies need to benefit from the proposed changes as soon as
possible. They also referred to a specific market freeze issue in Member States under the
national transitional rules.
Upon request of a stakeholder organisation, the Commission clarified that the wording in
Article 6 is identical to other Regulations and that "interested parties" and "stakeholders"
should be read as synonyms.
The Chairman invited the meeting to send any comments in writing by 25 September.
4.2. Update of document CA-May15Doc.4.4 - Final - Q&A on SPC
content
For discussion and endorsement
CA-Sept15-Doc.4.2
The Commission introduced document agreed by the CG at CG-12.
A Member State proposed clarifying the sentence in brackets in the first paragraph of the
answer, which should read: (except sites that perform filling operations).
With this change, the Chairman noted the agreement of the CA meeting on the Q&A, which
will be added to the document compiling the Q&A pairs on the content of the SPC.
4.3. Implementation and enforcement of
Article 95 for in situ generated active
substances
For discussion and endorsement
CA-Sept15-Doc.4.3
The Commission introduced the document, which was welcomed by Member States.
A Member State suggested that it would still be useful to clarify the position of users and
manufacturers of devices with regard to Article 95 and whether they could be listed under the
list established by ECHA for the purpose of compliance. The Commission undertook to
clarify the matter for the next CA meeting.
A representative from SMEs drew Member States attention to a translation error in the
German version of the BPR, which under Article 95(2) uses the words ‘placing on the market’
instead of ‘making available’.
The Commission responded that the Council Secretariat had been made aware of the error and
was preparing a corrigendum.
An industry representative regretted that the proposed approach did not address all systems in
the same manner and that it would therefore fail to establish a level playing field, which is the
main objective of Article 95.
The Commission noted the concern but explained that the objective of a level playing field
only applies to substances currently supported under the review programme. For those for
which applications will be submitted later, by virtue of Article 13 of the review programme
3
Regulation or of Article 93 of the BPR, the obligation will only apply once these applications
are submitted. Furthermore, there are systems, for which the obligation cannot apply due to
the very nature of the systems.
After some editorial changes were suggested and agreed by the Commission, Member States
took note of the final document.
4.4. Implementation of paragraph 10 of
Annex VI
For information
The Commission informed the meeting that, in the context of some recent findings, it was
considered appropriate to include this agenda item to remind Member States that paragraph
10 of Annex VI applies to any application for authorisation of products containing an active
substance meeting the exclusion criteria, even for those applications submitted under
Directive 98/8/EC (the BPD) (i.e. by virtue of Article 91). Therefore, in such cases, Member
States must first evaluate whether the conditions for derogation in Article 5(2) can be satisfied
for their territory before assessing the product or carrying out any comparative assessment.
A Member State asked whether paragraph 10 in Annex VI would also apply for the
assessment of applications for a change to products authorised under the BPD. The
Commission responded that while the provisions on comparative assessment are clearer (i.e. it
applies to product authorisations and renewals only), this element could be subject to
interpretation. Further, information on this will be provided at the next CG meeting.
Another Member State asked the Commission whether such consideration is for the reference
Member State only or also for the concerned Member States, and noted that in the absence of
harmonised guidance each Member State might follow different approaches. The Commission
responded that any Member State would have to consider these elements and that, in
principle, there is no need for a fully harmonised guidance, as the situation in the Member
States might be very different.
4.5. Report from Coordination Group
For information
The Commission briefly informed the meeting of the main issues discussed at the 13th CG
meeting:
i) Joost Van Galen, from the Netherlands, was elected in July as chairperson for an 18-month
mandate. The Commission thanked the previous chairperson, Anna Nordberg from Sweden,
for the great job done under her mandate. As no nomination for the vice-chair position was
received, a rotational approach according to the EU presidency was agreed. Patrick Thyes,
from Luxembourg, is thus the vice-chairperson.
ii) In terms of MR disagreements, one formal referral was discussed and closed with a CG
agreement by consensus. No formal or informal referrals are currently on-going.
iii) The working procedures have been updated to improve efficiency and transparency.
iv) The CG agreed two notes for guidance, which will be referred to the 62nd CA meeting for
formal endorsement, on "Handling of changes to the classification and labelling of authorised
biocidal products" and on "Submission of example labels, instructions for use, safety data
4
sheets and models or drafts of the packaging, labelling and leaflets within an application for
product authorisation".
v) The CG agreed the mandate and objectives for a working party on the standardisation of
sentences for the different sections of the SPC for anticoagulant rodenticides
vi) Other issues discussed were the mutual recognition in sequence of a SBP as indicated
above, and some IT issues related to R4BP3, namely some rules blocking mutual recognition
in sequence procedures in concerned Member States where the reference Member State has
not uploaded a complete SPC in xml format for the first authorisation, and the dissemination
of SPCs by ECHA.
For further information, the Commission referred the meeting to the agreed list of conclusions
and actions arising from the CG-13 meeting, which will be made available on the dedicated
CG CIRCABC interest group once agreed by CG members.
4.6. Executive report on product
authorisations
For information
CA-Sept15-Doc.4.6
The Commission briefly introduced document CA-Sept15-Doc.4.6 and CA-Sept15-Doc.4.6.a,
which shows the total number of product authorisations per Member State, and number of
product authorisations per Member State indicating the different asset types. It was noted that
the figures on the total number of product authorisations currently available in the ECHA
website (5.049 on 1/9/15) is higher than those in the reports from R4BP3 (4.434 on the same
date), as the expired assets are not excluded from the former. ECHA will look at this
discrepancy to ensure consistency between figures.
4.7. Executive report on applications for
Union authorisation
For information
CA-Sept15-Doc.4.7
ECHA briefly introduced document CA-Sept15-Doc.4.7, which has been updated to address
the requests at the last CA meeting (e.g. including the evaluating CA and the relevant
deadlines for application for product authorisation). ECHA mentioned that an application has
been submitted without any pre-submission and the Commission encouraged companies to do
so well in advance of the above-mentioned deadline.
A Member State clarified that, for one on-going case, their agreement to act as eCA has not
been confirmed yet. ECHA mentioned that at the pre-submission step sometimes companies
have not received yet a formal confirmation from the eCA, which is only mandatory at the
stage of the submission of the application. Therefore, future updates will clarify whether or
not the eCA has formally agreed to do so.
The Commission encouraged the four eCAs involved in applications for iodine-containing
products to make an effort of additional coordination and collaboration. For this purpose,
ECHA informed the CA that it has already assigned the same dossier manager to all the
applications.
5
4.8. Executive report on referrals to the
Coordination Group in accordance
with Article 35 of the BPR
For information
CA-Sept15-Doc.4.8
The Commission briefly introduced document CA-Sept15-Doc.4.8, underlining the fact that
only 2 cases out of the 15 received by the CG have been referred to the Commission for a
Decision.
5.
Active substances
5.1. Management of in situ generated
active substances under the BPR
5.1.a. Nitrogen
For information
The Commission explained that it had not received any input on the matter since the last
meeting, especially with regard to oxygen scavengers. It therefore explained that it considered
the matter closed and that the question of oxygen scavengers should be addressed in the
context of the guidance provided through the Manual of Decisions having become obsolete
(see also item 7.9).
5.1.b.Free radical-ions and photocatalysts
For discussion and endorsement
CA-Sept15-Doc.5.1.b-rev1
The Commission introduced the document.
The discussion focused on how the substance should be defined at the approval stage. After a
tour de table, it appeared that a majority of Member States supported the Commission
proposal to only mention, for the sake of simplification, the free radical without reference to
the precursor(s) or method of generation.
The section of the note dealing with compliance with Article 95 was removed, as it needed
some further analysis, and the Commission undertook to provide further clarification on the
matter at the next CA meeting.
It was also agreed to develop as a matter of priority more detailed guidance on data to be
submitted for the purpose of substance approval. One Member State undertook to prepare a
proposal for discussion and endorsement at the next CA meeting.
A revision 2 of the note was circulated during the meeting and eventually endorsed.
6
5.2. Progression of the review programme
on active substances
For information
CA-Sept15-Doc.5.2
The Commission presented a state of play of the progress of the review programme of
existing active substances for the 1st and 2nd priority lists. In particular, the Commission
informed that letters are about to be sent to Member States in order to stress the importance of
allocating enough resources for the implementation of the BPR, including for the examination
of biocidal actives substances. The Commission also stressed the importance to submit the
remaining reports for the 1st list and to submit reports from the 2nd priority list now in order
to avoid to high workload for the BPC in the next couple of years.
The Commission invited Member States concerned by the deadlines of the 1st and 2nd
priority lists to contact ECHA to inform about their progress and plans on these dossiers.
5.3. Renewal of anticoagulant
rodenticides
For discussion
CA-Sept15-Doc.5.3
The Commission briefly introduced document CA-Sept15-Doc.5.3 and underlined the key
elements to be considered in order to achieve the renewal of AS within the agreed deadlines:
- Overall, the Commission does not expect a complete reassessment of the active substances.
Member States are invited instead to reflect on how these substances can be used in such a
way as to minimise their negative impacts.
- In principle, there should be no clock stop, as all the elements for the discussion should be
available within the applications. If an eCA considers stopping the clock, that eCA should
consult ECHA and the Commission to explain the added value in doing so.
- Regarding the public consultation, it could be initiated soon since the applications have been
submitted and since there is no need to wait for the eCAs assessment reports.
- Regarding the 'comparison of the respective effects and efficacy of these substances', what is
expected from the BPC is a discussion of the relevant risk mitigation measures with a view to
design a policy regarding the use of these substances (e.g. to recommend whether some of
these substances should be restricted to professional uses, whether, if allowed for amateur use,
they should be restricted to indoor use only, whether for some of them there is evidence of
resistance, etc...).
- In order to facilitate the process, a template for both the AR and the BPC opinion would be
developed by ECHA by the next CA meeting. The annex to the document just provides a very
preliminary idea of what could be at the end the structure of the BPC opinion/approval of the
AS.
- ECHA should play a key coordination role between eCAs.
A Member State asked the Commission how to deal with applications for renewal of an active
substance for which the first approval and the application for renewal contains one safe use
only (e.g. a first generation anticoagulant not including mice as target organism) and whether
the new ongoing ATP might have an impact on the active substance renewal (see also item
10.1). This Member State also mentioned that the proposed approach might lead to extra work
at BPC working group level. Finally this Member State also proposed that the wording in
Annex 1 of the document should be more open as only one safe use might have been
evaluated and therefore only a small part of these RMMs could be considered.
7
The Commission clarified that where relevant, ad hoc meetings before the relevant BPC
meetings should be organised and that this should be included in the revised work programme
for 2016. The Commission also clarified that the active substance renewal should be
conducted independently from the ongoing ATP, as the new ATP will only affect products
containing active substances above the proposed Specific Concentration Limits (i.e. some
reformulated products might still be available for non-professionals).
Another Member State suggested that a safe use should be demonstrated according to the new
emission scenario documents. Regarding the question of the safe use, the Commission
clarified that now that products containing these active substances are authorised, it was less
interested in determining whether there is a safe use than to have a critical comparison of
these substances to establish what restrictions and conditions of use could be harmonised at
the active substance level.
A Member State supported the views of having some extra WG meetings to deal with such
comparison and asked the Commission how the ATP procedure could impact on the agreed
deadlines. The Commission clarified that an update on the ATP will be provided under
agenda item 10.1 and that in principle, the changes to the existing authorisations would occur
at the time of the renewal of the product authorisation with no impact on the active substance
renewal. Upon request from this Member State, it was also clarified that for products
containing warfarin sodium, for which no application for renewal has been submitted, the
period of grace in Article 52 of the BPR will not apply. This Member State also reminded that
at the work-shop a minimum pack-size for professional users was suggested.
Another Member State mentioned that the eCA should have the right to consider all the
available information submitted to them. Upon request of that Member State, the Commission
clarified that for warfarin sodium no assessment report has to be produced. A Member State
noted however that for transparency reasons, the ECHA website should clearly reflect the
expired active substances.
Two Member States asked how comments to assessment reports will be handled. The
Commission clarified that this will be part of the BPC discussions and that it will be up to the
BPC Secretariat to find the best way to organise the discussion process. Upon request of
another Member State, the Commission undertook to have the template for the assessment
report for the eCA ready by the end of October and that it was not expecting the original
Competent Authority reports to be amended. Instead, it proposed that the assessment report
for the renewal should be an addendum to the initial Competent Authority report.
ECHA mentioned the need for additional coordination resources.
Upon request from Industry representatives, the Commission clarified the discussion process
regarding the recommendations in the report on risk mitigations measures for anticoagulant
rodenticides (RMM report). The eCA will take into account both the critical review submitted
by the applicant in the application and the recommendations in the report, read in connection
with the conclusions in the workshop held in March 2014. On the basis of these two inputs,
the eCA will prepare its assessment report, which will be sent to the BPC. Within the BPC,
the discussion of the different assessment reports for all the substances should aim at defining
a strategy of use for these substances in order to minimise their negative impacts. Industry
also proposed that the wording in some sections of Annex 2 of the document should be more
open (would/should) where member States do not reach an agreement on a given RMM.
8
Upon request of a Member State, the Commission clarified that the approach of having
detailed approval conditions in the approval of anticoagulant rodenticides is not in
contradiction with the overall approach proposed under document CA-Sept15-Doc.5.4.
Rodenticides are a very special case of active substances meeting the exclusion criteria and
establishing some more detailed conditions in the active substance approval will help to
ensure that product authorisations are granted under similar conditions in all the Member
States.
The Chair concluded this point by noting the overall support of Member States to the
approach proposed and noted that the Commission undertook to work with ECHA in order to
make the assessment report template available as soon as possible (e.g. by the end of
October).
5.4. New approach on conditions for
approval Regulations
For discussion
CA-Sept15-Doc.5.4
The Commission presented its proposal to simplify the drafting of approval regulations of
active substances. The proposal did not concern the substances, which will benefit from
derogation to the exclusion criteria, as these substances will need strict approval measures.
Almost all Member States supported the proposal, but noted the importance to still discuss the
risk mitigation measures and their applicability during the peer review process. As proposed
in the Commission's document, they should still be mentioned in the section 2.4 of the BPC
opinions as elements to be taken into account at the product authorisation stage. One Member
State considered that the simplification should not give the opposite impression that no issues
are present on substances, especially when the safe use identified is in fact very limited for a
substance presenting a high concern. It was agreed that, in such circumstances, an indication
could be included in the approval. On questioning from one Member State, the Commission
agreed to reflect further on the use of the standard ‘safe operational procedures and PPE’
phrase.
The proposal of the Commission was endorsed, and the ECHA's BPC will be requested to
adopt the approach presented in the documents for all its future opinions, including for the
next BPC at the end of the month.
5.5. Active substances included in Annex
I of the BPR
For discussion
CA-Sept15-Doc.5.5
A discussion took place in relation with the presence of certain active substances in Annex I
which do not meet the criteria set out in Article 28 of the BPR. Some applications for
simplified authorisation procedure were rejected as products containing these substances were
not eligible since the wearing of PPE was necessary for the safe use of these products.
The presence of these substances in Annex I constitutes a dilemma, as they do not meet the
criteria for being listed in the first place, however, as they are now listed, it offers the
possibility for companies to benefit from the simplified authorisation procedure if their
products meet the requirements of Article 25. Some Member States considered that the
substances should be removed, other Member States were still reflecting.
9
The Commission informed that it will check whether the two substances discussed have a
harmonised classification and invited Member States to further reflect on the case for the next
CA meeting.
5.6. Implementation of Article 15
For information
The Commission informed about the recent RAC opinion for thiacloprid, which proposed
harmonised classification that will make it meet one of the exclusion criteria of the BPR. In
that context, the Commission informed that it was analysing if and what further actions
should be taken under the BPR, pursuant to Article.
6.
Treated articles
6.1. Labelling requirements for treated
articles
For information
CA-May15-Doc.6.1-rev1- Final
The Commission informed the CA about the agreement reached at the 44th meeting of the
Standing Committee on Biocidal products on the approach concerning treated articles and
labelling provisions to be introduced in active substance approval Regulations.
Industry expressed concerns that the criteria triggering classification were too broad and
would result in many articles having to be labelled.
The Commission noted these concerns, and stated that these labelling measures were
considered proportionate in the view of the properties of the related substances. The
Commission also pointed out that the approach agreed was only requiring limited additional
information (i.e. statement that a biocidal product was used and name of the active
substance(s) used) to that anyhow required in accordance with Article 58(4) of the BPR.
6.2. Masterbatches
For discussion and endorsement
CA-Sept15-Doc.6.2-rev1
The Commission introduced its revised guidance note on masterbatches, which Member
States but one could broadly support.
Another Member State indicated that it had difficulty to accept the proposal that the product
used to treat an article with a primary biocidal function, and therefore a biocidal product itself,
should not be regarded as a biocidal product, pointing out that according to the definition of
the BPR an article only becomes a treated article if it is treated or intentionally incorporates a
biocidal product.
Several suggestions were made to clarify the document, which the Commission undertook to
make.
With these agreed changes, the guidance note was endorsed.
10
6.3. Limits for biocidal products used in
food contact materials.
For information
This item was discussed under point 7.3.
6.4. Note to the BPC Efficacy Working
Party
For information
CA-Sept15-Doc.6.4
The meeting took notice of the note to the BPC Efficacy Working Party.
6.5. REACH and SVHC in articles
For information
CA-Sept15-Doc.6.5
The Commission invited Member State Competent Authorities and stakeholders to take note
of the recent judgement of the European Court of Justice (ECJ) regarding the notification of
SVHCs in articles according to REACH in the case C-106/14.
7.
Horizontal matters
7.1. Study on ECHA fees
For information
The Commission gave a brief status report of the study on ECHA fees, mentioning in
particular the study would be carried by Ecorys, two representatives of which were present at
the meeting, and that the final report was due for end February 2016.
7.2. ECHA communications
For information
ECHA made a presentation on the latest developments with regard to the number of
applications submitted the status of Article 95 and on the on-going and foreseen IT activities.
On Article 95, a Member State expressed the concern that products may disappear from the
market in view of the relatively low number of applications made. It further suggested to have
a discussion on the consequences of Article 95 at the next CA meeting. The Commission
agreed to have a discussion at the next CA meeting on both the enforcement practices and the
impact on the market.
A discussion took place on the issues related to the SPC xml files, the R4BP 3 requirements
and the future dissemination of their content through the dissemination platform. The two
issues related to SPC xml files are the following: need (in certain cases) for the reference
Member State to update the SPC file of the first national authorisation (i.e. filling of required
data) in order to enable the finalisation of a related mutual recognition by another Member
State and dissemination of the data contained in the SPC xml files through the future
dissemination platform while most SPC files are empty or contain dummy data. Member
States indicated that they would not be able to update the SPC files in one year and a Member
State that is reference Member State for many product authorisations noted that there may be
11
a need to update the corresponding SPC files in a shorter timeframe in order to avoid delaying
mutual recognitions, but that the corresponding workload has not been foreseen, is not
considered manageable and also that it would not be possible to recover the costs involved.
ECHA indicated that they are looking for solutions to reduce the impact on reference Member
States. The Commission while supporting the need to have properly filled in SPC files and
insisting on the importance of the dissemination suggested to consider a stepwise approach
for the progressive dissemination of data from the SPC xml files, possibly based on the date
of last update of the files and asked ECHA to prepare a document for discussion at the next
CA meeting.
7.3. Maximum residue limits
For discussion
CA-Sept15-Doc.7.3
The Commission gave a presentation on state of play on maximum residue limits (MRLs) and
stressed the importance of this subject because of the link to food safety. The Commission
informed that the proposed approach to deal with MRLs setting for biocides would be a riskbased approach to identify the substances for which the setting of MRLs would be required.
For substances not falling within the scope of other legislation dealing with residues (in
particular Regulation (EU) No 396/2005), if it is concluded that limits should be set, then the
contaminants legislation (Regulations (EU) No 315/1993 and 1881/2006) would be used.
While some Member States stated that they would not agree with the proposed approach,
others supported the Commission's proposal as a pragmatic solution, in particular to establish
limits only if necessary. The main issues raised by Member States were the absence of the
system of default levels, the burden on competent authorities instead of the applicants for
monitoring residues of biocidal products, aggregate/cumulative exposure of consumers to
residues, as well as including the acute reference dose (in addition to acceptable daily intake).
Several Member States indicated that they would provide their position on the proposed
approach in writing.
The Commission clarified that there is currently no legal basis to establish a system of default
levels for substances only used in biocidal products. For this, an amendment of Regulation
(EC) 396/2005 or the creation of another legal basis would be necessary, which would take
time. The proposed approach could be a solution in the short and medium term until a longterm solution is established by amending legislation. The Commission also stated that the
exposure of consumers to the same chemical by different types of uses (for example as plant
protection product and biocidal product) should be addressed in the long term.
Several Member State stressed that even if considered an interim solution for the short and
medium term data requirements for biocidal product applications would need to be developed.
In the working document presented to the Committee it should be highlighted more clearly
that in the long term the Commission is looking for a solution that would better take into
account these concerns.
The Commission invited the Member States and stakeholders to provide comments in the
light of these discussions by 10 October 2015, so that they could be further discussed at the
next meeting.
12
7.4. Sustainable use of biocides
For information
CA-Sept15-Doc.7.4
Following a first discussion in the 60th CA meeting in July and a subsequent commenting
round, the Commission presented an updated draft of its Report on Sustainable use of
Biocides to be submitted to the Council and the European Parliament and highlighted the
main elements of it.
One Member State noted that in terms of enforcement, they make distinction between 'best
practice' and 'good practice'. They explained that inspectors are only enforcing against good
practice which is enough to comply with the law.
The same Member State indicated that relevant ideas can be found in the PPP legislation on
sustainable use but that it should not be blindly followed given the specific circumstances of
the use of both biocides and pesticides.
In response to a Member States' request to start up an EU strategy to look at the risks of coand cross-resistance between biocidal active substances and antibiotics, the Commission
suggested referring this to the Action Plan on antimicrobial resistance. The on-going
evaluation of this plan might be the best opportunity to raise this topic and to feed into the
further follow-up actions of this plan.
The Commission invited the Member States and stakeholders to provide comments by 2
October 2015.
7.5. Endocrine Disrupters
For information
The Commission informed the CA about state of play as regards the impact assessment on the
identification of criteria to define endocrine disruptors.
7.6. Guidance note on the concept of
placing on the market
For discussion and endorsement
CA-Sept15-Doc.7.6-rev1
The Commission introduced the final version of the draft guidance note, which was welcomed
by Member States as a useful clarification of many issues that enforcement authorities will be
confronted with.
One Member State suggested to clarify that the notion of intention was going beyond the
mere claim made by the person placing the product on the market and that all characteristics
of the product need to be taken into account in deciding whether the product is a biocidal
product or not. That Member State also suggested deleting the fourth paragraph on page 4 of
the note. The Commission agreed with the suggestions and undertook to make the necessary
changes.
Another Member State pointed out that it still had a number of questions that are not fully
addressed by the note and that it would submit them in writing to the Commission. The
Commission agreed to wait until 25 September to receive these comments and to see whether
there would be some substantial concerns to be addressed.
13
A last Member State pointed out that it did not share the Commission’s view that Article
17(1) of the BPR prohibits the use of a biocidal product that is not authorised under the BPR
and that for the prohibition to apply the product being used must meet the definition of a
biocidal product. That Member State explained that from an enforcement perspective, it
would anticipate difficulty in proving that an end-user is wilfully or intentionally using a
biocidal product if the end-user claims that they were unaware that this was the case. Besides,
it pointed out that, as recognised in the Blue Book, there are duties on manufacturers to look
beyond what they consider to be the intended use of a biocidal product and place themselves
in the position of the average user of that product and envisage in what way they would
reasonably consider to use the product.
The Commission noted the position and recalled its previous explanations that such an
approach could be at odds with the approach followed in particular for precursors of in situ
generated active substances or for commodity chemicals, for which persons placing these
precursors or commodity chemicals on the market could too easily claim that they were not
aware that their product would be used by the end-user for a biocidal purpose and escape their
regulatory obligations.
The document was eventually endorsed subject to the changes agreed and to the comments to
be received by 25 September.
7.7. Directive 98/34 and Article 37 of the
BPR
For information
The Chairman reported that there had been no new development on this item since the last
meeting.
7.8. Data protection
For discussion
CA-Sept15-Doc.7.8
The Commission introduced the question, which was referred by a Member State, following
inconclusive discussions within Helpex.
After some discussions, it was agreed that the data generated by an applicant for the purpose
of refining an exposure scenario (e.g. the average depth of a harbour, the average amount of
ships in a harbour or the number of footbaths in a country) and used for the assessment should
be eligible for data protection when they have been obtained through a commissioned study
except when the data were already published or when the information is of public knowledge
(e.g. number of cows in a country). Although it was noted that published data may be covered
by copyright. Consequently, if the data are eligible for protection, they should not be used for
the benefit of a subsequent applicant, unless that applicant has obtained access to them.
7.9. Repeal of earlier guidance provided
by the Commission
For information
CA-Sept15-Doc.7.9
The Commission presented the note that it proposed to publish to formally declare the Manual
of Decisions obsolete and to give to those persons who have relied on the guidance provided
therein to conclude that their products were out of the scope of the former Directive, and
when they now are within the scope of the BPR, a legal remedy.
14
In response to a query from a Member State about communicating this significant change as
widely as possible, the Commission agreed to reflect on how best to do so.
The approach proposed was endorsed.
8.
Requests for opinions
8.1. Article 3(3) request from Germany For discussion
on products consisting of plant CA-Sept15-Doc.8.1
blossoms
The Commission introduced the document, which was based on document CA-March15Doc.8.2 discussed at the previous meeting.
A Member State raised the point of the food and feed derogation under the BPR, so that if
food or feed made available on the market with a biocidal claim falls under the BPR scope,
flowers with a biocidal claim should also be considered as a biocidal product. Another
Member State suggested being careful with the interpretation of REACH guidance under the
BPR, and asked how Article 3(3) decisions might create precedents for similar but not
identical cases in future.
The Commission responded that the note for guidance CA-Dec13-Doc.11.3 – Final would
need to be clarified in the light of the decision to be taken (i.e. adding that products consisting
of food or feed but not being a “substance" or a "mixture” would also be excluded from the
scope of the BPR, even though there might be an intention to make them available for a
biocidal purpose). Concerning the setting of precedents, the Commission responded that it
was precisely the purpose of such decisions under Article 3(3) to set precedents and to
provide greater legal certainty, so that the case of similar products could be easily clarified
without the need for new discussions or formal Article 3(3) decisions.
A Member State considered that looking at the intended biocidal function of the product, it
meets the definition of a biocidal product. The Commission clarified that to fully meet the
definition of a biocidal product, it has also to meet the definition of a "substance" or a
"mixture" according to REACH. The Commission noted too that these products would
anyhow be subject to the provisions of Directive 2001/95/EC on general product safety as
well as to Directive 2006/114/EC on misleading and comparative advertising.
The Chairman noted an almost unanimous support to the proposal outlined in the paper and
informed the meeting that the formal decision would now be prepared for discussion at a
forthcoming meeting of the Standing Committee on Biocidal products.
8.2. Biocidal product used for odour For discussion and agreement
mitigation in textiles
CA-Sept15-Doc.8.2
The Commission informed that only one comment was received since the last CA meeting.
Having considered the case and all the comments received since the beginning of the
discussion, the Commission maintained its proposal of interpretation as presented in the
document.
15
A few Member States informed that it would be difficult to enforce, and one Member State
had still some concerns about the interpretation. The Commission answered that this
interpretation was the only one that it could propose based on the text of the BPR and the
product-type definitions set out in Annex V. It was clarified that not only the claim but also
the intention has to be taken into consideration to define whether a product is in the scope of
the BPR.
The proposal was eventually endorsed.
8.3. Curative use of preservatives
For discussion
CA-Sept15-Doc.8.3
A Member State requested clarifications as to whether biocidal product-type 10 includes
products with a curative action.
Taking into consideration the intention during the negotiation of the BPR, and its reading of
it, the Commission clarified that all curative products of materials remain under product-types
of main group 2, with the only exception of algaecides for remedial treatment of construction
materials which now belongs to PT2.
One Member State considered that the description of the main group 2 in Annex V is poorly
written, and could also lead to a different interpretation. Other Member States supported the
interpretation.
The clarification was therefore endorsed.
8.4. Products
for
disinfection
surgical
hand For discussion
CA-Sept15-Doc.8.4
The Commission introduced document CA-Sept15-Doc.8.4 and apologized for the late upload
of the document. The Commission explained that this scope issue arose very shortly before
the CA meeting and that it considered appropriate discussing the issue in the September
meeting with a view to conclude the discussion at the next meeting.
All the Member States having taken the floor but one agreed with the Commission views that
these products are biocidal products and belong to product-type 1. Aside of this discussion,
some Member States clarified that products to be used for pre-surgical disinfection of the skin
of patients would be considered as medicinal products. This might be an issue for products
having a dual use. Industry representatives mentioned that products for pre-surgical
disinfection of the skin should also be considered as biocidal products.
The Chairman invited Member States to check back home the proposal in the paper with the
CAs for medicinal products and to send written comments by 10 October 2015.
The Commission also undertook to consult the Unit responsible for medicinal products within
DG SANTE.
16
9.
Enforcement issues
9.1. Enforcement, controls and
monitoring
For discussion
CA-Sept15-Doc.9.1
The Commission introduced document CA-Sept15-Doc.9.1.
Following discussions in the CA meeting in March and May 2015, and taking into account the
received comments, the Commission explained that it proposes to establish a structure at EU
level for enforcement, controls and monitoring. This structure could be a working group of
the CA meeting to kick-start co-operation on enforcement between Member States and to
decide within three years whether biocides could be integrated in ECHA Forum. The
Commission indicated that in their comments Member States supported the development of a
structure at EU level, the key questions appears the type of structure.
The Commission further reported that there is willingness at ECHA Forum to include
biocides, however, for biocides activities additional resources for the ECHA Forum need to
be arranged and the tasks should be clearly determined.
Several Member States were reluctant to establish a new group because of the additional
resources required at Member States level to participate at these meetings. From that point of
view, as Member States participation is already arranged in ECHA Forum, the use of the
ECHA Forum would be best use of resources. Representatives also indicated that the
functioning, mandate and task description of EU structure should be more detailed. The
Commission however pointed out that meetings of the ECHA Forum were already very busy
and that adding biocides might imply some changes to the way the ECHA forum is currently
operating. In addition, it stressed that there is a need to start as soon as possible the cooperation on controls, in particular for Article 95 and treated articles. Integration of biocides
in ECHA Forum will require time and therefore probably will delay the process. Several
representatives could see the benefit of a phase preparing the inclusion of biocides in ECHA
Forum.
The Chairman noted that a majority of Member States supports the inclusion of biocides
under the ECHA Forum and invited Member States to send written comments before the end
of October, in particular the type of co-ordination that should take place, the activities and
priorities (for example Article 95 and treated article), and to propose ideas how to organise
the inclusion of biocides in ECHA Forum (resources).
9.2. Notifications of national penalties
For information
The Chairman reminded Member States of communicating to the Commission details of their
national provisions on penalties applicable to infringement of the BPR.
17
10.
New policy developments which
may affect the biocides regulatory
framework
10.1. Update on the ATP regarding the
classification of anticoagulant
rodenticides
For information
The Commission, through a representative from DG GROW, updated the meeting on the state
of play of the next (9th) adaptation to technical process (ATP) to the CLP Regulation, which
affects 47 substances (including the 8 anticoagulant rodenticides). It indicated that it will
support the classification proposed by ECHA Risk Assessment Committee for the
anticoagulant rodenticides. This ATP is still in internal consultation, and taking into account
the whole adoption procedure, it could be published around June 2016. Regarding the date of
application of the new classification, the Commission informed the meeting that an 18-month
period post-publication would be proposed. In that way, the timelines would be aligned with
those of the renewal of the biocidal products authorisations, which are expected by the end of
2017.
An industry representative reminded the serious concerns of industry regarding the
consequences of the implementation of the new classification if finally adopted by the
Commission and asked whether Article 19(5) of the BPR could be amended to include a
derogation similar to the one existing for PBT substances. The Commission responded that
this could only be done through a co-decision procedure, which was not foreseen in the shortterm.
Member States did not raise any questions.
11.
International Matters
11.1. OECD
For information
The Chairman gave a short report of the meeting of the OECD Task Force on Biocides held
on 9-10 September in Berlin.
12.
AOB
12.1. List of Competent Authorities and For information
other Contact Points
CA-Sept15-Doc.12.1
The Chairman invited the Committee to take note of the list and to inform the Commission by
email of any update or correction to be made to that list.
18
12.2. Proposal from AISE
For discussion
CA-Sept15-Doc.12.2
The proposal from AISE to organise an event on professional use of disinfectants was
welcomed and it was agreed to have this event on 15 March to allow attendance of both
participants to CG and CA meetings. This implies that the first day of the March CG meeting
will have to be moved to Monday 14 March and that the CA meeting will start on Wednesday
16 March.
19