Union
authorisation of Biocidal products (Chapter VIII)
General principles
The
possibility to authorise at Union level certain products is intended to enable
holders of Union authorisation to place their biocidal products directly on the
entire Union market.
·
The centralised authorisation procedure will
result in a Union authorisation which will entitle the relevant products to be
placed on the market anywhere in the Union without the need to obtain separate
national authorisations or going through the mutual recognition procedure.
·
The Union authorisation will confer the same
rights and obligations in each Member State as an authorisation issued by the
competent authority of that Member State.
This Union
or centralised procedure will be one of two procedures available to industry to
obtain a product authorisation. The Commission will grant authorisations on the
basis of an ECHA opinion.
Provided
that they have similar conditions of use across the Union, the following
products will be eligible to the centralised procedure:
·
From 1/9/2013, all products containing new
active substances and products belonging to product types 1, 3, 4, 5, 18 and
19;
·
From 1/1/2017, products belonging to product
types 2, 6 and 13;
·
From 1/1/2020, products belonging to the
remaining product types;
Products
belonging to product types 14, 15, 17, 20 and 21 are however excluded from the
scope of Union authorisation, as well as products containing active substances
meeting the exclusion criteria.
The system
of centralised authorisation remains, however, completely voluntary. If, for
whatever reasons (e.g. intention to market only in few Member States), the
applicant is not interested in the centralised authorisation scheme, he can
apply for a national authorisation of the concerned product. In such case, the
provisions on mutual recognition will be applicable.
Procedure
·
Applications for Union authorisations will be
submitted to ECHA.
·
The applicant will choose the competent
authority which shall be responsible for the evaluation of the application
(hereinafter referred to as 'the evaluating competent authority').
·
The evaluation of the application will be done
by the evaluating competent authority (12 months).
·
ECHA will prepare an opinion on the conclusions
of the evaluation prepared by the evaluating competent authority (6 months).
The opinion
of ECHA will be prepared by the Biocidal Products Committee, whose members are
appointed by the Member States.
·
The Commission will eventually adopt a decision
granting the Union authorisation (implementing act) on the basis of ECHA
opinion.
The centralised procedure
compared to mutual recognition
The
centralised procedure is expected bring the following advantages:
·
the costs of a Union
authorisation will be lower than the costs of a single national authorisation
combined with the costs of a mutual recognition procedure;
·
the time for issuing a Union
authorisation will be similar to the time needed to issue a single national
authorisation followed by the mutual recognition;
·
nstant access to the markets of 27
Member States, which will have a positive impact on the product
availabilitywhich would hopefully be improved;
·
benefits to health and the environment as the assessment at the
Union level will improve the overall consistency.
Pre-submission to ECHA
The
Commission also adopted a Note for Guidance on similar conditions of use, which
defines a biocidal product with similar conditions of use as a product for
which it is not likely, at the time of application for authorisation, that one
of the grounds indicated in points (a)-(e) of Article 37(1) of BPR would be
fulfilled in one or more Member States.
In
accordance with this guidance, applicants for Union authorisation are expected
to make a pre-submission to ECHA, at the latest 6 months before the submission
of their applications.
The purpose
of this pre-submission it to allow a consultation of Member States and to give
them the possibility to indicate whether they are likely to advance one of the
grounds listed in points (a)-(e) of Article 37(1) of BPR. It will
also allow the Commission to analyse whether the objections are likely to be
well founded.
For further
details see: CA-Feb13-Doc.5.1.e -
Final - Note for Guidance on similar conditions of use.doc
NEWSLINKSREACHBIOCIDESEndocrine
Disruptors
Note for Guidance
on the
Definition of Similar Conditions of Use across the Union
General principles
Procedure
The centralised procedure
compared to mutual recognition
Pre-submission to ECHA
Note for Guidance
on the
Definition of Similar Conditions of Use across the Union
1.
Executive summary
It is proposed to
define a biocidal product with similar conditions of use as a product for which
it is not likely, at the time of application for authorisation, that one of the
grounds indicated in points (a)-(e) of Article 37(1) of BPR would be fulfilled
in one or more Member States.
It is proposed to
request applicants for Union authorisation to make a pre-submission to ECHA,
allowing Member States to indicate whether they are likely to advance one of
the grounds listed in points (a)-(e) of Article 37(1) of BPR, and the
Commission to analyse whether the objections are likely to be well founded.
It is proposed to
define a biocidal product with similar conditions of use as a product for which
it is not likely, at the time of application for authorisation, that one of the
grounds indicated in points (a)-(e) of Article 37(1) of BPR would be fulfilled
in one or more Member States.
It is proposed to
request applicants for Union authorisation to make a pre-submission to ECHA,
allowing Member States to indicate whether they are likely to advance one of
the grounds listed in points (a)-(e) of Article 37(1) of BPR, and the
Commission to analyse whether the objections are likely to be well founded.
2.
Document background and purpose
According to Article 42(2) of Regulation No 528/2012 (hereinafter
'BPR'), the Commission shall, by 1 September 2013, draw up guidance documents on
the definition of "similar conditions of use across the Union ".
The interpretation of this definition will be of great importance, since it
will be decisive for the eligibility for Union authorisation of biocidal
products.
This document has been drafted by the
Commission services responsible for biocidal products with the aim to agree, to
the extent possible, with Member States' competent authorities and other stake
holders about the definition in question before the Commission's position is
formalised.
The document proposes criteria as well as a
procedure for the identification of products with similar conditions of use.
According to Article 42(2) of Regulation No 528/2012 (hereinafter
'BPR'), the Commission shall, by 1 September 2013, draw up guidance documents on
the definition of "similar conditions of use across the Union ".
The interpretation of this definition will be of great importance, since it
will be decisive for the eligibility for Union authorisation of biocidal
products.
This document has been drafted by the
Commission services responsible for biocidal products with the aim to agree, to
the extent possible, with Member States' competent authorities and other stake
holders about the definition in question before the Commission's position is
formalised.
The document proposes criteria as well as a
procedure for the identification of products with similar conditions of use.
3.
Justification for the proposed criteria
for 'similar conditions of use'
Union authorisations granted under BPR will, in principle, be valid in
all Member States subject to the same terms and conditions. That is why,
according to Article 42(1) of BPR, only products which have "similar
conditions of use across the Union " are
eligible.
BPR does not describe
this concept. However, points (a)-(e) of Article 37(1) of BPR appear
to provide a relatively exhaustive list of grounds based on which different
conditions of use could be justified.
Evidence of this can
be found in the first sentence of Article 42(1) of BPR, which excludes
certain product-types ('PTs') from the scope of the Union authorisation. The
excluded PTs cover products which are banned in certain Member States, or for
which harmonisation of the conditions of use have proven particularly difficult
in the mutual recognition procedure, for reasons similar to those listed in
points (a)-(e) of Article 37(1) of BPR.
Points (a)-(c) of
Article 42(1) of BPR list the eligible PTs, and recital 26 of BPR
describes those PTs as "categories of biocidal products with similar
conditions of use in all Member States". It can therefore be concluded
that the PTs generally believed to require different
conditions of use across the Union have already been identified and excluded
from the scope of Union authorisation by virtue of the first sentence of
Article 42(1) BPR itself.
Further evidence can be found in the second paragraph of Article 44(5)
of BPR, which allows different conditions of use, or even a ban, to be imposed in
certain Member States even where a Union authorisation is granted, but only
based on one of the grounds listed in points (a)-(e) of Article 37(1)
of BPR.
In conclusion, both the exclusion of
certain PTs and the reference to "similar conditions of
use" in Article 42(1) of BPR should be read as seeking to prevent a
situation where Union authorisations are granted with different conditions of use, or even a ban in certain Member
States, based on the second subparagraph of Article 44(5) of BPR in
combination with Article 37(1) of BPR. The possibility in
Article 44(5) should be seen as an extra safeguard for Member States to
adjust conditions or ban products, while allowing Union authorisations to be
granted where applications for such authorisations have been accepted.
Therefore,
a biocidal product with similar conditions of use should be defined as a
product for which it is not likely, at the time of application for
authorisation, that on one of the grounds indicated in points (a)-(e) of
Article 37(1) of BPR would be fulfilled in one or more Member States.
The legislator did not choose to exclude from Union authorisation all
products which are subject to comparative assessment. Therefore, such products
are also eligible, although national variations in the availability of adequate
alternatives, as referred to in Article 23(3) of BPR, will be of relevance
for justifications based on one of the grounds indicated in points (a)-(e) of
Article 37(1) of BPR.
For products which are subject to a comparative assessment and also
eligible for Union authorisation, the comparative assessment will have to be
organised at Union level. Where it shows that adequate alternatives exist in
certain Member States and not in others, adjustments or bans will have to be
decided based on one of the grounds indicated in points (a)-(e) of Article
37(1) of BPR in accordance with the second subparagraph of Article 44(5) of the
Regulation.
Union authorisations granted under BPR will, in principle, be valid in
all Member States subject to the same terms and conditions. That is why,
according to Article 42(1) of BPR, only products which have "similar
conditions of use across the Union " are
eligible.
BPR does not describe
this concept. However, points (a)-(e) of Article 37(1) of BPR appear
to provide a relatively exhaustive list of grounds based on which different
conditions of use could be justified.
Evidence of this can
be found in the first sentence of Article 42(1) of BPR, which excludes
certain product-types ('PTs') from the scope of the Union authorisation. The
excluded PTs cover products which are banned in certain Member States, or for
which harmonisation of the conditions of use have proven particularly difficult
in the mutual recognition procedure, for reasons similar to those listed in
points (a)-(e) of Article 37(1) of BPR.
Points (a)-(c) of
Article 42(1) of BPR list the eligible PTs, and recital 26 of BPR
describes those PTs as "categories of biocidal products with similar
conditions of use in all Member States". It can therefore be concluded
that the PTs generally believed to require different
conditions of use across the Union have already been identified and excluded
from the scope of Union authorisation by virtue of the first sentence of
Article 42(1) BPR itself.
Further evidence can be found in the second paragraph of Article 44(5)
of BPR, which allows different conditions of use, or even a ban, to be imposed in
certain Member States even where a Union authorisation is granted, but only
based on one of the grounds listed in points (a)-(e) of Article 37(1)
of BPR.
In conclusion, both the exclusion of
certain PTs and the reference to "similar conditions of
use" in Article 42(1) of BPR should be read as seeking to prevent a
situation where Union authorisations are granted with different conditions of use, or even a ban in certain Member
States, based on the second subparagraph of Article 44(5) of BPR in
combination with Article 37(1) of BPR. The possibility in
Article 44(5) should be seen as an extra safeguard for Member States to
adjust conditions or ban products, while allowing Union authorisations to be
granted where applications for such authorisations have been accepted.
Therefore,
a biocidal product with similar conditions of use should be defined as a
product for which it is not likely, at the time of application for
authorisation, that on one of the grounds indicated in points (a)-(e) of
Article 37(1) of BPR would be fulfilled in one or more Member States.
The legislator did not choose to exclude from Union authorisation all
products which are subject to comparative assessment. Therefore, such products
are also eligible, although national variations in the availability of adequate
alternatives, as referred to in Article 23(3) of BPR, will be of relevance
for justifications based on one of the grounds indicated in points (a)-(e) of
Article 37(1) of BPR.
For products which are subject to a comparative assessment and also
eligible for Union authorisation, the comparative assessment will have to be
organised at Union level. Where it shows that adequate alternatives exist in
certain Member States and not in others, adjustments or bans will have to be
decided based on one of the grounds indicated in points (a)-(e) of Article
37(1) of BPR in accordance with the second subparagraph of Article 44(5) of the
Regulation.
4.
Details of the proposed
procedure for the identification of products with similar conditions of use
4.1.1.
Point of departure
Since the PTs generally
believed to require different
conditions of use have already been identified and excluded from the scope of
Union authorisation by virtue of the first sentence of Article 42(1) of BPR,
the point of departure for other PTs should be that products belonging to them
can have similar conditions of use.
Since the PTs generally
believed to require different
conditions of use have already been identified and excluded from the scope of
Union authorisation by virtue of the first sentence of Article 42(1) of BPR,
the point of departure for other PTs should be that products belonging to them
can have similar conditions of use.
4.1.1.
General submission of
information by Member States
For products containing an active substance which is a
candidate for substitution, the public consultation of third parties provided
for by Article 10(3) of BPR provides a first opportunity for Member States
to reverse the presumption where relevant, by indicating whether they have
alternative products complying with points (a) and (b) of Article 23(3) of
BPR. Member States should therefore systematically notify ECHA of the
availability of alternatives on the occasion of the public consultation
foreseen under Article 10(3) of BPR. Biocidal products subject to
comparative assessment should not be regarded as having 'similar conditions of
use' if it is clear already at the time of submission of an application for
Union authorisation that the comparative assessment would lead to different
conditions of use from one Member State to another.
Furthermore, Member States are invited to inform the
Commission about any general circumstances which could justify derogation in
accordance with Article 37 of BPR.
For products containing an active substance which is a
candidate for substitution, the public consultation of third parties provided
for by Article 10(3) of BPR provides a first opportunity for Member States
to reverse the presumption where relevant, by indicating whether they have
alternative products complying with points (a) and (b) of Article 23(3) of
BPR. Member States should therefore systematically notify ECHA of the
availability of alternatives on the occasion of the public consultation
foreseen under Article 10(3) of BPR. Biocidal products subject to
comparative assessment should not be regarded as having 'similar conditions of
use' if it is clear already at the time of submission of an application for
Union authorisation that the comparative assessment would lead to different
conditions of use from one Member State to another.
Furthermore, Member States are invited to inform the
Commission about any general circumstances which could justify derogation in
accordance with Article 37 of BPR.
4.1.2.
Applicant pre-submission
At the latest 6 months before the
submission of its application, a prospective applicant for Union authorisation
should submit to the Agency through the R4BP a draft of the summary of the
product characteristics for which it intends to submit an application for Union
authorisation.
This pre-submission, and the subsequent procedure,
will not only serve the purpose of obtaining the confirmation required in
accordance with Article 43(1) of BPR that the product would have similar
conditions of use, but can also serve to seek confirmation that the product
falls within the scope of BPR, and to identify the appropriate PT. Hence, such
issues should not need to be discussed further during the Union authorisation
procedure itself.
As the definition of which uses belong to
which PT may remain an issue, it is critical that this and other scope issues
are fully addressed and agreed by Member States competent authorities and the
Commission before submission of the application. This will be especially
important when the biocidal product has not been considered during the approval
process for the active substance; when the active substance is approved for use
in more than one PT; when the product contains substances with different
functions (e.g. combination of a repellent and of an insecticide, of a wood
preservative and an insecticide); or when uses may be near the borderline
between different but similar PTs, e.g. PT 2, 3 and 4.
Differences between Member States in their
consideration of the scope of a PT is not an argument to support that a product
has different conditions of use. In case of such differences, the Commission
should be requested to take a decision in accordance with Article 3(3).
At the latest 6 months before the
submission of its application, a prospective applicant for Union authorisation
should submit to the Agency through the R4BP a draft of the summary of the
product characteristics for which it intends to submit an application for Union
authorisation.
This pre-submission, and the subsequent procedure,
will not only serve the purpose of obtaining the confirmation required in
accordance with Article 43(1) of BPR that the product would have similar
conditions of use, but can also serve to seek confirmation that the product
falls within the scope of BPR, and to identify the appropriate PT. Hence, such
issues should not need to be discussed further during the Union authorisation
procedure itself.
As the definition of which uses belong to
which PT may remain an issue, it is critical that this and other scope issues
are fully addressed and agreed by Member States competent authorities and the
Commission before submission of the application. This will be especially
important when the biocidal product has not been considered during the approval
process for the active substance; when the active substance is approved for use
in more than one PT; when the product contains substances with different
functions (e.g. combination of a repellent and of an insecticide, of a wood
preservative and an insecticide); or when uses may be near the borderline
between different but similar PTs, e.g. PT 2, 3 and 4.
Differences between Member States in their
consideration of the scope of a PT is not an argument to support that a product
has different conditions of use. In case of such differences, the Commission
should be requested to take a decision in accordance with Article 3(3).
4.1.3.
Consultation of Member States
Upon receipt of the draft of the summary of
the product characteristics, the Agency will notify Member States competent
authorities and the Commission that it has received a pre-submission to an
application for Union authorisation and make available to them the draft of the
summary of the product characteristics.
The purpose of this notification is to
allow Member States competent authorities and the Commission to verify that the
product fall within the scope of BPR, that it has been attributed the correct
PTs and that Member States would not have well-founded grounds preventing the
conditions of use of the product from being similar across the Union .
Where a Member State or, as the case may
be, the Commission considers that the product does not fall within the scope of
BPR, that the product has not been attributed the correct PTs or that it has
well-founded grounds to request a derogation in accordance with Article 37 of BPR, it should inform the Agency, the Commission and the other Member
States within 30 days of the notification being made.
Where neither a Member State ,
nor the Commission reacts within 30 days to the notification of the Agency, the
product should be deemed to have similar conditions of use and to be eligible
for Union authorisation.
Where a Member State, or as the case may be
the Commission, reacts within 30 days to
the notification of the Agency, the confirmation as to whether the product
should be deemed to have similar conditions of use and to be eligible for Union
authorisation will require further discussions.
Upon receipt of the draft of the summary of
the product characteristics, the Agency will notify Member States competent
authorities and the Commission that it has received a pre-submission to an
application for Union authorisation and make available to them the draft of the
summary of the product characteristics.
The purpose of this notification is to
allow Member States competent authorities and the Commission to verify that the
product fall within the scope of BPR, that it has been attributed the correct
PTs and that Member States would not have well-founded grounds preventing the
conditions of use of the product from being similar across the Union .
Where a Member State or, as the case may
be, the Commission considers that the product does not fall within the scope of
BPR, that the product has not been attributed the correct PTs or that it has
well-founded grounds to request a derogation in accordance with Article 37 of BPR, it should inform the Agency, the Commission and the other Member
States within 30 days of the notification being made.
Where neither a Member State ,
nor the Commission reacts within 30 days to the notification of the Agency, the
product should be deemed to have similar conditions of use and to be eligible
for Union authorisation.
Where a Member State, or as the case may be
the Commission, reacts within 30 days to
the notification of the Agency, the confirmation as to whether the product
should be deemed to have similar conditions of use and to be eligible for Union
authorisation will require further discussions.
4.1.4.
Objections to the scope
Where it is contested that the product
falls within the scope of BPR, or that it has been attributed the correct PTs,
the matter should be discussed between Member States, with a view to find an
agreement.
When no agreement can be found, a Member
State, and in particular, the Member State having first raised the matter, should
request the Commission to take a decision on the matter in accordance with
Article 3(3).
Where it is contested that the product
falls within the scope of BPR, or that it has been attributed the correct PTs,
the matter should be discussed between Member States, with a view to find an
agreement.
When no agreement can be found, a Member
State, and in particular, the Member State having first raised the matter, should
request the Commission to take a decision on the matter in accordance with
Article 3(3).
4.1.5.
Objections on the basis of
grounds referred to in Article 37
In case a Member State believes that it
will have well-founded grounds to request a derogation in accordance with Article 37 of BPR, it
should inform ECHA accordingly and provide a justification for its objection.
In case a Member State believes that it
will have well-founded grounds to request a derogation in accordance with Article 37 of BPR, it
should inform ECHA accordingly and provide a justification for its objection.
4.1.6.
Feedback to the applicant
The Agency should inform the prospective
applicant of the outcome of the pre-submission consultation within 180 days of
the submission of the SPC by the applicant.
Where relevant, the Agency should confirm
to the applicant that neither a Member State nor the Commission has objected
that product would fall outside of the scope of the BPR, have been attributed
the correct PTs, or have non-similar conditions of use. The applicant can refer
to the confirmation from the Agency at the time of the submission of the
application in accordance with Article 43(1). This confirmation will however be
without prejudice to requests that Member
States may address to the Commission to adjust certain conditions of the
authorisation for their territory, or to decide that the authorisation does not
apply in their territory, in accordance with the second paragraph of Article
44(5), in particular when products contain substances candidates for submission
and must undergo a comparative assessment in accordance with Article 23.
The Agency should inform the prospective
applicant of the outcome of the pre-submission consultation within 180 days of
the submission of the SPC by the applicant.
Where relevant, the Agency should confirm
to the applicant that neither a Member State nor the Commission has objected
that product would fall outside of the scope of the BPR, have been attributed
the correct PTs, or have non-similar conditions of use. The applicant can refer
to the confirmation from the Agency at the time of the submission of the
application in accordance with Article 43(1). This confirmation will however be
without prejudice to requests that Member
States may address to the Commission to adjust certain conditions of the
authorisation for their territory, or to decide that the authorisation does not
apply in their territory, in accordance with the second paragraph of Article
44(5), in particular when products contain substances candidates for submission
and must undergo a comparative assessment in accordance with Article 23.
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