CA-May15-Doc.4.4 – Final. Rev1
(updated as per CA-Sept15-Doc.4.2)
EUROPEAN COMMISSION
HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL
Safety of the food chain
Pesticides and Biocides
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 Member States are not
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:
Q&A concerning the content of some SPC sections
Background and purpose of the document
1
(1)
In the context of the discussions concerning the SPC template for a single
biocidal product1 at the 7th meeting of the Coordination Group and at the 57th
CA meeting, several MSs raised questions regarding the information to be
included in some sections of the SPC.
(2)
This note provides a common understanding of the information to be filled in
within these SPC sections in a Q&A format. The note is intended to be a
living document to which additional Q&A can be added upon discussion and
agreement within the Coordination Group.
See the SPC template agreed under document CA-Sept14-Doc.5.4–Final,
https://circabc.europa.eu/w/browse/8aa3692b-9a69-43c7-b30b-d9db9a276830
available
Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111
at
Questions and answers (Q&A) on information required in the SPC
Section 1. Administrative information
Heading 1.1 – Trade name(s) of the product
(3)
Q: Which trade name(s) have to be listed in the SPC of a national
authorisation?
A: For a national authorisation this field in the SPC is MS-specific, so it will
only include the name(s) authorised in that MS.
Heading 1.2 - Authorisation holder
(4)
Q: Is the field “authorisation holder” (AH) in the SPC MS-specific? In a MR
procedure, can the prospective AH in a CMS be different of the (prospective)
AH in the RefMS?
A: In the context of a MR procedure, an applicant can submit the application
to the target CMS(s) on behalf of different prospective AH(s), who can also
be different to the (prospective) AH in the RefMS. Once the national
authorisation is granted, the AH is MS-specific and the SPC will only
include the name of the AH in that MS.
Heading 1.3 – Manufacturer(s) of the product
(5)
Q: Can the location of the manufacturing sites be regarded as confidential in
accordance with Article 66?
A: No, the location of the manufacturing site(s) for the manufacturer(s) of
the biocidal product has to be mentioned in the published SPC.
(6)
Q: In case of MR procedures, which manufacturing site(s) of the biocidal
product should be listed in the SPC?
A: The draft SPC submitted by the refMS to the CMSs in case of MR in
parallel (or the SPC authorised in case of MR in sequence) should list any
manufacturers of the product, so this would cover the manufacturers in all
the MSs.
(7)
Q: Can the prospective AH in a CMS propose a new/different manufacturer
within the MR procedure?
A: No, this element is part of the SPC so the authorisation in CMSs shall be
subject to the same terms and conditions as in the refMS. Once the CMS has
granted the national authorisation, the AH can notify an administrative
change in order to add a new manufacturer in that MS, provided that the
product composition and the manufacturing process remain unchanged. It
has to be noted that this administrative change would not have any impact
regarding the renewal procedure in accordance with Regulation 492/2014.
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(8)
Q: Have sites where filling operations are carried out by contract
manufacturers to be listed in the SPC?
A: No. Only sites where the manufacturing processes leading to the final2
biocidal product take place (except sites that perform filling operations) or,
where they are different, those which allocate the production batch numbers
referred to in Article 65(2)(d), should be listed in the SPC.
Upon request from a CA, for enforcement purposes for instance, the AH
shall without delay provide information on the different sites involved in the
whole manufacturing process, including contract manufacturers.
It has to be noted though that contract manufacturers carrying out filling
operations are subject to the relevant obligations referred to in Article 65(2)
of the BPR and where relevant, to national legislation regarding the
registration or authorisation of manufacturers of biocidal products.
Heading 1.4 – Manufacturer(s) of the active substance(s)
(9)
Q: Can the location of the manufacturing sites be regarded as confidential in
accordance with Article 66?
A: No, the location of the manufacturing site(s) for the manufacturer(s) of
the active substance(s) has to be mentioned in the published SPC.
Section 2. Product composition and formulation
Heading 2.1 – Qualitative and quantitative information on the composition of the
product
(10)
Q: Should the content of active substance (AS) be expressed in terms of
technical or pure AS? Depending on the way to express this content, it could
lead to significant differences in the final product composition and be
misleading during MR procedures.
A: Without prejudice of any additional information provided by the PAR3,
where both values can be presented, the table in the SPC should refer to the
content in terms of pure AS. Taking into account that detection methods are
based on the pure AS, providing this information in the SPC would allow
official control laboratories to check the content of the AS mentioned in the
label without further investigations on the AS purity.
2
E.g. adding a rodenticide to a mixture of cereals, but not the mixing of cereals itself.
3
E.g. detailed description of the identity of the substance as in the active substance approval.
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Where an AS approval covers two isomers, the SPC should express the
content of pure AS in terms of the mixture of both isomers; e.g. "4% w/w
(mixture of alpha/cis and beta/trans isomers)".
(11)
Q: This section of the SPC will provide information on the non-active
substances knowledge of which is essential for the proper use of the product
only. However, some CAs might wish reflecting the full composition of the
product in the authorisation. How can this be handled?
A: Where a CA wishes to refer to the full composition of the product in the
authorisation decision, that CA can either cross-refer to the composition as
described in the IUCLID file or in the confidential annex to the PAR, or to
an ad hoc document which shall then be uploaded on R4BP3 and kept
confidential.
(12)
Q: Which non-active substances should be considered as those, knowledge
of which is essential for the proper use of the product?
A: This should be addressed on a case by case basis according to the
outcome of the risk assessment, which may depend on the properties and
function of the non-active substances within the biocidal product. Non-active
substances considered as substances of concern should be listed in all cases.
Where required in the approval of the active substance, bittering agents
should be listed indicating the name of the bittering agent.
Section 3. Hazard and precautionary statements
(13)
Q: According to Article 28(3) of the CLP Regulation, in principle not more
than six precautionary statements shall appear on the label. However, how
many P-statements should be listed in the SPC?
A: Article 22(2)(i) of the BPR refers to "precautionary statements" in
general, so this means that any P-statements triggered by the CLP legislation
should be listed in the SPC. However, in accordance with paragraph 8 of
document CA-May13-Doc.5.44, a P-statement that has been proven
unnecessary in the risk assessment because of the intended use of the product
should be left out of the SPC (and of the label).
(14)
Q: Who is responsible for the choice of the six P-statements appearing on
the label among those listed in the SPC? Is the CA or the authorisation
holder?
A: According to Article 69(1) of the BPR, authorisation holders are
responsible to ensure that biocidal products are labelled in accordance with
the approved SPC and the CLP legislation. According to Article 22(3) of the
4
Note for guidance on classification and labelling of biocidal products,
https://circabc.europa.eu/w/browse/e4e143d0-cae8-41cb-b4b6-c762e6f44622
available
at
4/7
CLP Regulation, the labelling of the products will only include the P
statements which are relevant for the intended uses of the products (e.g.
where the product label does not cover all the authorised uses in the SPC).
(15)
Q: If the risk assessment triggers risk mitigation measures (RMMs) that are
listed in the CLP regulation as P-statements, should these P-statements be
listed under the section 3, even if these phrases are not triggered by the
criteria in the CLP Regulation?
A: No, section 3 should only contain P-statements which are triggered by the
criteria in the CLP Regulation (unless they are irrelevant as a result of the
risk assessment – see Q&A 12 above). RMMs resulting from the risk
assessment should be referred to under heading 4.1.2, where they are usespecific, or under heading 5.2 where they are applicable to any of the
authorised uses.
Section 4. Authorised uses
Heading 4.1 – Use description
(16)
Q: What information should be provided under the "name of the use" field?
A: This field should provide a short or synoptic description of the authorised
use, which is further detailed in the associated table below the name of the
use. See some examples below for different PTs:
For PT 14: Mice – non-professionals – indoor; Rats – professional users –
sewers – large blocks,
For PT 8: Wood staining fungi – professional users – spraying – outdoor,
For PT 19: Repellent – (adult) mosquitos – general public (above 12 years) –
spraying – outdoor.
The terms chosen for the description of the authorised use should facilitate
the comprehension by final users and inspectors5.
(17)
Q: What does the field "where relevant, an exact description of the
authorised use" mean within the table describing a use?
A: This field is intended to provide a more specific description of the use for
those PTs where different uses are referred to within the PT description in
Annex V to the BPR (e.g. repellent or attractant in PT 19; disinfectant of
drinking water for humans or for animals in PT 5; insecticide or acaricide in
PT 18, etc.). This field would be empty for other PTs (e.g. rodenticides,
5
This is of particular relevance for SPCs of single biocidal products with a number of authorised uses
for which separate product labels can be placed on the market (see document CA-May14- Doc.5.6Final).
5/7
avicides, piscicides, etc.), so that is why it has to be filled in "where
relevant".
(18)
Q: Can several combinations for e.g. user categories/target organisms/field
of use be presented in the same table? (e.g. for PT18, can both (i)
professional and non-professional users, and (ii) flies & mosquitos and (iii)
indoor and outdoor be described in the "same use"?) And can there be
combinations of different application methods and application rates in the
same table/use? (e.g. as for PT8)
A: Yes, a use can be the result of different combinations of these elements
provided that they are compatible (i.e. for some PTs, the pack sizes for
professional and non-professional users are different). It has to be noted
though that in accordance with the principles set by document CA-May14Doc.5.66, the label of the product shall have full correspondence with that
authorised use as described in the SPC.
Whenever possible, grouping of different user categories, fields of use
should or target organisms7 within a single use should be considered in order
to reduce the size of the SPC.
(19)
Q: In the context of a procedure of MR in parallel, can a RefMS include
within the use description a target organism for which the biocidal product
has been assessed and is effective, but it is not being present in harmful
quantities in that MS?
A: Where a target organism cannot be authorised by the RefMS on the
grounds referred to in Article 37(1)(e) of the BPR, such target organism
should be included in the draft SPC proposed by RefMS (in EN) and be also
reflected in the agreed SPC so that CMSs can authorise the product in
conformity with it. The specific situation in the refMS should be clearly
flagged in the agreed SPC (e.g. by adding a footnote “The target organism
(or use) cannot be authorised in RefMS due to …..”). However, for
consistency and in order to avoid any misunderstanding by the readers of the
final SPC issued by the refMS, section 4 should list the authorised target
organisms only.
6
Note for guidance on the content of label of single biocidal products with regard to the authorised uses
in the SPC, available at https://circabc.europa.eu/w/browse/f818ccf3-207f-408f-a3cf-c62422fdf346
7
This is of particular relevance for some PTs such as insecticides, where a biocidal product can be
authorised against a significant number of insect species. Grouping the individual species within larger
taxonomic groups (e.g. flies, mosquitos, fleas, lice, etc...) would facilitate the use description and
listing within the SPC.
6/7
Section 5. General directions for use
Heading 5.3 – Particulars of likely direct or indirect effects, first aid instructions and
emergency measures to protect the environment
(20)
Q: Concerning first aid instructions; What information should be considered
for the agreement on the SPC in MR procedures? How should CMSs handle
some country-specific information?
A: These elements have been addressed in a specific note for guidance (see
document CA-Sept14-Doc.5.6-Final8).
8
Note for guidance on the consideration of the SPC First Aid instructions in the context of MR
procedures, available at https://circabc.europa.eu/w/browse/8a1c1fb1-8ef2-4028-a511-14f6e291cc04
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