CA-Sept13-Doc.6.2.b Rev.1
Final version after the coordination group meeting of September 2013
EUROPEAN COMMISSION
DIRECTORATE-GENERAL
ENVIRONMENT
Directorate A – Green Economy
ENV.A.3 - Chemicals
NOTE FOR GUIDANCE
This document is an attempt to provide guidance in the interest of consistency, and has
been drafted by the Commission services responsible for biocidal products with the aim
of finding an agreement with all or a majority of the Member States' Competent
Authorities for biocidal products. Please note, however, that neither Member States nor
the Commission are legally obliged to follow the approach set out in this document, since
only the Court of Justice of the European Union can give authoritative interpretations on
the contents of Union law.
Subject:
Authorisation under the Biocidal Products Regulation of products
containing more than one existing active substance or belonging to
more than one product-type
EXECUTIVE SUMMARY
This paper proposes, in summary, the following interpretation of BPR (for details of
the proposed interpretation, please refer to paragraphs 3-42):
The principle, applying to biocidal products containing only existing active
substances, even if the active substances in the product belong to different producttypes, or if the product itself belongs to different product-types:
A. All active substances in a biocidal product contributing to its biocidal
function have to be approved for the product-type(s) corresponding to the
action(s) they will exert before the product can be authorised under BPR.
B. The deadline for applying for and granting product authorisation under
BPR start counting only when the last existing active substance
contributing to its biocidal function has been approved.
C. Before product authorisation, a product can stay on a Member State's
market subject to any national rules if all its active substances are in the
review programme for the product-type(s) corresponding to the action(s)
they will exert.
Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111
D. An application for product authorisation under BPR has to contain data or
LoA:s relating to all active substances in the product contributing to its
biocidal function.
The exception, applying to existing active substances which do not have any
significant contribution to any of the biocidal functions of the product ('silent active
substances'; typically in-can preservatives):
E. A product containing a silent active substance can be authorised under
BPR even before the silent active substance has been approved.
F. The deadline for applying for and granting product authorisation under
BPR for a product containing a silent active substance starts counting
when all the non-silent active substances in the product have been
approved.
G. Before product authorisation, a product containing a silent active
substance can stay on a Member State's market subject to any national
rules if the silent active substance is either approved, included in Annex I
to BPR, or part of the review programme for the product-type
corresponding to the action that it will exert (typically PT 6), subject to
compliance with the conditions under bullet point C for all the non-silent
active substances.
H. In principle, a specific data dossier on the silent active substance does not
have to be submitted for product-authorisation, but some specific data will
be required if the silent active substance is a substance of concern.
DOCUMENT BACKGROUND
(1) This document is a follow-up to the papers PA&MRFG-July12-Doc.4.1, PA&MRFGSept12-Doc.4.1, and PA&MRFG-Dec12-Doc.4.1. It addresses the interpretation of
Regulation (EU) No 528/2012 (hereinafter 'BPR') with regard to the following interlinked questions:
1.
Which active substances (ASs) in a biocidal product have to be
approved before the product can be authorised under BPR?
2.
Which ASs in a biocidal product are decisive for the deadlines for
applying for and granting product authorisation under BPR?
3.
Which ASs can be included in a biocidal product placed on the
market during the transitional period under BPR?
4.
What AS data needs to be provided in an application for product
authorisation under BPR?
(2) The paper has been drafted by the Commission services responsible for biocidal products.
Member States are invited to follow the approach suggested, and to follow the same
approach for granting product authorisations under Directive 98/8/EC (hereinafter 'BPD')
to the extent that is compatible with their national law and does not lead to unequal
treatment.
2
ANALYSIS
Q1: Which active substances ('ASs') in a biocidal product have to be approved
before the product can be authorised under BPR?
(3) According to Article 19(1)(a) of BPR, a biocidal product can only be authorised if the
ASs are approved for the relevant product-type ('PT').
(4) It is suggested to make a distinction between on the one hand ASs that contribute to the
biocidal function(s) of the product and on the other hand 'silent ASs'.
(5) A biocidal product often contains an AS which has no intended biocidal action outside of
the product, typically an 'in-can preservative' aimed at preserving the biocidal product
itself from bacterial deterioration. Such substances, which have a biocidal activity
without contributing to the biocidal function of a biocidal product, are commonly referred
to as 'silent ASs'. Many in-can preservatives and other ASs which are 'silent' in certain
products are still under evaluation, and hence not yet approved. Member States have the
practice of assessing and authorising a product as soon as all ASs contributing to the
biocidal function have been approved. In consequence, Member States have e.g.
authorised a large number of rat poisons as soon as the rodenticidal ASs (having high
priority in the review programme) had been approved, although the in-can preservatives
(having lower priority in the review programme) in the rat poisons are not yet approved.
(6) The main argument in favour of this existing practice is the interest of subjecting
products to authorisation as soon as their most relevant substances have been evaluated.
This is of particular relevance in light of the foreseen duration of the biocides review
programme, which is currently expected to run until 2024. The special regulatory
framework for biocides is justified by the nature of substances contributing to certain
products' biocidal function, as opposed to substances that can be present in any mixture.
It is therefore the properties inherent in those substances that need to be evaluated, and
agreed at EU level, before a proper product risk assessment of the products can be made.
(7) In-can preservatives, by contrast, are present in most ordinary mixtures such as paint or
glue, which do not have a biocidal function in themselves and – as such – are not subject
to authorisation (hereinafter 'ordinary mixtures'). The presence of a silent AS in a biocidal
product does not make the product more hazardous than any ordinary mixture containing
that substance, and normally does not affect the efficacy which has to be assessed for the
purpose of granting product authorisation.
(8) It can therefore be argued that an AS which is silent in a biocidal product should not be
regarded as an 'active substance' for the purpose of regulating that product.1 Support for
this conclusion can be found in Article 19(1)(a) of BPR, which through its requirement of
prior approval "for the relevant product-type" clearly establishes a link between the
approval requirement and the function of the product.
1
If this is accepted, silent ASs should not be covered by the labelling requirement in Article 69(2)(a) of
BPR. This approach is, as far as we know, consistent with current practice in Member States regarding
labelling of biocidal products.
3
(9) In is therefore suggested to read Article 19(1)(a) of BPR as requiring that all the ASs
contributing to the biocidal function of a product, but not any silent ASs in the product,
have to be approved before the product can be authorised based on BPR.
(10) However, through the new rules on treated articles, BPR introduces the general principle
that any normal mixture (e.g. a paint) containing a biocidal product (e.g. a mixture
supplied for the purpose of in-can preservation of paints) can only be placed on the
market if the AS is either approved, included in Annex I to BPR or under evaluation.2
Any other AS of a biocidal product incorporated in an ordinary mixture is therefore not
legally on the EU market. It is obvious that silent ASs in a biocidal product should not be
regarded more leniently than ASs with an equivalent function in ordinary mixtures.
(11) In is therefore suggested to read Article 19(1)(a) of BPR as requiring for product
authorisation based on BPR that all the silent ASs of a product are either approved,
included in Annex I to BPR, or under evaluation on the same conditions as those for
other mixtures laid down in Articles 58 and 94 of BPR.
(12) A product may contain several active substances exerting different actions defined by
different PTs. An example of this is a product supplied to control insects, which contains
both an attractant AS and an insect killing AS. It is suggested to read relevant PT in
Article 19(1)(a) of BPR as referring to the PT corresponding to the action of each AS. In
other words, in the example mentioned, before the product is authorised under BPR, the
attractant AS would have to be approved for PT 19, and the insect killing AS would have
to be approved for PT 18. As far as we know, this is consistent with current practice.
Q2: Which ASs in a biocidal product are decisive for the deadlines for applying
for and granting product authorisation under BPR?
(13) According to Article 89(3) of BPR, the deadlines for applying for and granting product
authorisation start running at the time of approval of a given AS/PT-combination. The
same article states that, where a biocidal product contains more than one AS, the
deadlines start running at the time of approval of the last AS for that PT. Article 89(2) of
BPR aligns Member State's right to apply national rules with the authorisation deadline,
and states that it counts from the approval of the last of the ASs to be approved in that
biocidal product.
(14) The interpretation of these provisions has to be aligned with the suggestions under Q1. It
is therefore proposed to interpret them as meaning that the deadlines are triggered at the
time of approval of the last AS in the product, with exception of any silent ASs in the
product.
(15) It is proposed to adopt this interpretation even for products belonging to several PTs, or
containing substances which are active in several PTs. The reference in Article 89(3) to
the last AS for "that product-type" would then be seen as meaning the PT for which the
substance has to be approved to allow product authorisation to be granted. It follows from
the suggestion under Q1 that this means the PT corresponding to the action(s) of the AS,
regardless of the PT to which the product belongs.
2
The Commission has proposed to slightly revise Article 94, but the key principle remains the same.
4
(16) For many products, this will mean that national rules are applicable even after the first
approval which is relevant for the products. It is recalled that the national conditions for
retaining the product on the market can integrate the conditions for that first relevant
approval, as well as subsequent relevant approvals.
Q3: Which ASs can be included in a biocidal product placed on the market
during the transitional period under BPR?
(17) Article 89(2) of BPR stipulates that Member States may allow the placing on the market
of a biocidal product containing existing ASs which are in the review-programme, but
which have not yet been approved for that PT. As indicated under Q2, this reference
should be seen as meaning the PT for which the substance has to be approved to allow
product authorisation to be granted, i.e. the PT corresponding to the action of the AS,
regardless of the PT to which the product belongs.3
Q4: What AS data needs to be provided in an application for product
authorisation under BPR?
(18) Article 20(1)(a)(iii) of BPR requires the submission of, i.a., a dossier or a LoA for each
AS in the biocidal product. This requirement serves the double purpose of providing the
receiving CA with the data necessary to perform the assessment and ensuring that parties
having financed the generic approval of an AS get the opportunity to recuperate a share
of their investment through data sharing.
(19) It is clear that Article 20(1)(a)(iii) of BPR requires the submission of a dossier or a LoA
for each AS contributing to the biocidal function of a product. For two reasons, though, it
can be argued, that Article 20(1)(a)(iii) of BPR does not cover silent ASs:
(20) First, it is suggested under Q1 that a finalised evaluation of those substances is not a prerequisite for granting product authorisation. If this is accepted, it can also be presumed
that, in most cases, the receiving CA will be in a position to perform an adequate product
risk assessment without a specific data dossier relating to a silent AS.
(21) Second, when it comes to the cost sharing aspect, there is no more reason to request cost
sharing for the silent ASs for biocidal products than for any ordinary mixture containing
silent ASs. In many cases, the in-can preservative biocidal product will have been placed
on the EU market prior to its incorporation into the final biocidal product, or into the
final ordinary mixture. In those cases, for the purpose of authorising the in-can
preservative biocidal product, the person placing that product on the EU market will have
needed a LoA to the data on the in-can preservative AS. In other cases, the in-can
preservative biocidal product will have been placed on the market in a third country, and
any sharing of any regulatory costs for that placing on the market should be dealt with
outside of the EU.
3
It is noted that some ASs are formally included in the review programme for a PT to which the
reference product in reality does not belong. These errors should be formally corrected based on
Commission Regulation (EU) No 613/2013 of 25 June 2013 amending Regulation (EC) No 1451/2007
as regards additional active substances of biocidal products to be examined under the review
programme, and are not further dealt with in this guidance note.
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(22) It is therefore suggested to read Article 20(1)(a)(iii) of BPR as requiring the submission
of a dossier or a LoA for each AS in a product contributing to its biocidal function.
(23) However, this interpretation is based on the concept that a substance with biocidal
activity is not regarded as an 'active substance' for the purpose of regulating a product in
which it is merely silent. Therefore, such a silent AS fulfilling one of the conditions in
Article 3(1)(f) of BPR in a product should be regarded as a substance of concern in that
product, which triggers certain data requirements in accordance with Article 20(1)(a)(i)
of BPR and Annex III to that Regulation.
APPLICATION OF THE PRINCIPLES
(24) Hereunder, the principles set out above are applied to the scenarios identified in the paper
PA&MRFG-July12-Doc.4.1.
Scenario 1: One PT, several existing ASs contributing to the biocidal function
(25) In the first scenario, a product is supplied with a purpose defined by one PT only, and
contains several ASs contributing to that purpose. Examples include

an insecticide with two or more killing agents;

an insecticide with a killing agent and an attractant.
(26) All those ASs have to be approved prior to authorisation of a given product of this kind.
Each of those ASs has to be approved for the PT which is relevant with regard to that
AS's action in the product. In the examples above, the killing agents have to be approved
for PT 18, and the attractants have to be approved for PT 19.
(27) The application for authorisation of such a product has to be submitted only on the date
of the last one of those required approvals, and the deadline for granting product
authorisation in accordance with Article 89(3) of BPR will start counting only as of that
date. Should one of the ASs not be approved for the relevant PT, the product will have to
be removed from the market.
(28) Prior to product authorisation, a product of this kind can remain on the market subject to
any national rules if each AS is in the review programme for the PT which is relevant
with regard to that AS's action in the product when used as intended. In the example of a
PT 18-product containing a killing agent approved for PT 18 and an attracting agent still
under evaluation for PT 19, the product can stay on the market, subject to any national
rules, as long as the attracting agent is under evaluation for PT 19.
(29) The application for authorisation of a product like this has to contain a dossier or a letter
of access for all the ASs.
Scenario 2: One PT, several existing ASs, but only one contributing to the
biocidal function
(30) In the second scenario, the biocidal function of a product is due to one AS, and another
AS is contained in the product but does not contribute to the biocidal function of the
product. Examples can include
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
a rodenticide containing an in-can preservative protecting the product; and

a wood preserving paint containing a film preservative solely protecting the
paint.4
(31) Prior to authorisation of a given product of this kind, approval is required only of the ASs
contributing to the biocidal function of the product. In the examples above (subject to the
caveat in footnote 4), this means that the in-can preservative and the film preservative do
not have to be authorised prior to product authorisation, since they are silent ASs.
(32) The application for authorisation of such a product has to be submitted on the date of the
last one of those required approvals, i.e., in the examples, on the dates of approval of the
ASs evaluated for PT 14 and PT 8 respectively, and the deadline for granting product
authorisations in accordance with Article 89(3) of BPR will start running on that date
(33) Prior to product authorisation, a product of this kind can remain on the market subject to
any national rules if all the ASs (including the silent ASs) are approved or included in the
review programme or in Annex I to BPR for the relevant PT.
(34) A priori, the application for authorisation of a product like this has to contain a dossier or
a LoA only for the ASs having to be approved prior to product authorisation, i.e., in the
examples above, only for the ASs evaluated for PT 14 and PT 8 respectively. However, if
the in-can preservative or the film preservative is a 'substance of concern', certain data
will have to be submitted like for any other substance of concern.
Scenario 3: Several PTs, one existing AS
(35) In this third scenario, a product has only one AS but is supplied with two different
purposes defined by two different PTs. Examples include a product with only one AS,
supplied

both as a wood preservative and an insecticide, or

both as a general disinfectant and a food area disinfectant.
(36) The product can only be authorised once the AS has been approved for both PTs5.
(37) The deadlines for application for and granting of product authorisation will start running
on the approval date of the AS for the last of the two PTs.
(38) Before the authorisation, the product can stay on the market subject to any national rules
if the AS is in the review programme for evaluation in both the relevant PTs, i.e., in the
examples above, both PT 8 and PT 18, or both PT 2 and PT 4. When the AS is approved
4
Sometimes, like in this second example, the fact that one AS lacks relevance for the biocidal function
of the product is not obvious, and will have to be analysed on a case-by-case basis. If the film
preservative does contribute to the preservation of the wood, the example belongs to scenario 1.
5
A company wishing to benefit from the harmonised provisions on authorisation (including mutual
recognition or Union authorisation) as soon as the AS has been approved for the first PT may, subject
to any national rules, have the possibility to physically separate the product in two, and ask for
authorisation only for the PT for which the substance has been approved.
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for the first PT, a MS can choose to align the national conditions for placing on the
market with the conditions of the approval.
(39) The application for authorisation of a product like this has to contain a dossier or a letter
of access for the AS with respect to both PTs.
Scenario 4: Several PTs, several existing ASs
(40) In the fourth scenario, a product is supplied for purposes defined by several PTs and
contains several existing ASs. Examples include

a product supplied both as a wood preservative and a construction material
preservative, which contains two preservative ASs having been notified both
for PT 8 and PT 10, or

a product supplied both as a disinfectant and an insecticide containing one
AS notified for PT 2 and another AS notified for PT 18.
(41) Prior to authorisation of a the product like this, each AS contributing to one or both of
the product's biocidal functions has to be approved. The approval of each AS has to
concern the PT which is relevant with regard to that AS's action in the product when
used as intended. In our first example, both ASs will have to be approved for both PT 8
and PT 10 before the product can be authorised. In our second example, provided that the
disinfectant AS does not contribute to the insecticidal function, and vice versa, the
disinfectant AS has to be approved only for PT 2, and the insecticidal AS only for PT 18,
prior to product authorisation.
(42) The deadlines for application for and granting of product authorisation in accordance
with BPR will start running on the last approval date of the last AS for the last PT. In the
meantime, as under scenario 3, a MS can choose to align the national conditions for
placing on the market with the conditions of the approvals granted.
(43) Before product authorisation, the product can stay on the market subject to any national
rules if both ASs are in the review programme for evaluation in both PTs.
(44) The application for authorisation of a product like this has to contain a dossier or a letter
of access for both ASs with respect to both PTs.
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