CA-Nov16-Doc.4.3
EUROPEAN COMMISSION
HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL
Safety of the food chain
Pesticides and Biocides
NOTE1 FOR DISCUSSION WITH COMPETENT AUTHORITIES FOR BIOCIDAL PRODUCTS
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 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:
Handling “carriers” in the authorisation of biocidal products
1.- Background and purpose of the document
(1)
In the context of an agreement reached by the Coordination Group (CG) on a
formal referral2, CG members identified the need to develop some guidance
on how to address in a harmonised way the handling of “carriers” in the
authorisation of biocidal products.
(2)
This note outlines a proposal addressing that identified need.
2.- Relevant provisions in EU legislation and available guidance documents
(3)
For the definitions of the terms "substance", "mixture" and "article", Article
3(2) of the Regulation (EU) No 528/20123 (the "BPR") refers to the
1
This note has been tabled for agreement at the CG-20 meeting on 15 November 2016 (document CG-202016-17 AP 13.1). Should the CG meeting result in any changes to the current version, a rev1 version will
be made available on Circabc.
2
See minutes of CG-12, available at https://webgate.ec.europa.eu/echa-scircabc/w/browse/332f6d00-ad9343e1-8362-753951adbf65
3
Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning
the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).
Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111
definitions in Regulation (EC) No 1907/20064 ("REACH"). Consequently, the
REACH guidance on borderline cases between substance/mixture/article5
should be considered in order to address borderline cases between articles and
mixtures (or substances).
(4)
According to Article 3(1)(a) of the BPR, a treated article that has a primary
biocidal function shall be considered as a biocidal product. Guidance on the
delimitation between treated articles and biocidal products is provided for in
the note for guidance CA-Sept13-Doc5.1.e.Rev16 on "Frequently asked
questions on treated articles". Any relevant Commission decision adopted in
accordance with Article 3(3) of the BPR7 should also be considered.
3.- Carriers and biocidal products – proposed way forward
(5)
Document CA-Sept13-Doc5.1.e.Rev1 specifies that treated mixtures or
substances with a primary biocidal function are “classical” biocidal products
(mixtures). Consequently, while a solvent or inert inorganic constituent (i.e.
silicium dioxide or aluminium oxide) might be considered as a carrier
component in some biocidal products that are mixtures, those “carriers”
however fail the REACH criterion for articles8. Therefore, the rules for
classification, efficacy assessment and description of the composition of these
mixtures are applicable to the biocidal mixture as a whole.
(6)
Biocidal products which, in the form in which they are supplied to the user,
consist in
(a)
an article that meets the REACH criteria to be an article and
(b)
which has been treated with, or intentionally incorporate one or more
biocidal products, and
4
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing
a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC)
No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and
Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
5
See “Guidance on requirements for substances in
http://echa.europa.eu/documents/10162/13632/articles_en.pdf
6
Available at https://circabc.europa.eu/w/browse/d7363efd-d8fb-43e6-8036-5bcc5e87bf22
7
List of all published
regulation/legislation
8
In accordance with the REACH guidance a bulk chemical fails the “shape, surface and design” criterion of
an object: shape, surface and design are not to be confused with physical characteristics that result from the
chemistry of the material(s), and furthermore no production step is involved in the deliberate determination
of the shape, surface or design.
decisions
available
at
articles”
(Chapter
2),
available
at
http://echa.europa.eu/regulations/biocidal-products-
2/8
(c)
which is to be regarded as a treated article having a primary biocidal
function9,
would consequently present a “carrier component”.
(7)
Two types of combinations of a biocidal mixture/substance and a carrier
component may be further distinguished in the context of product
authorisation:
(8)
Type A: Biocidal products in which the carrier component fulfils the function
of a simple carrier matrix, allowing for an easier handling, application or
delivery of the biocidal mixture/substance (“carrier-based biocidal products”).
Normally the carrier would consist of one or more material(s) having
undergone a form-giving process (plastics, tissues, cellulose or paper).
Examples include (window) stickers, (gas generating) strips or disinfecting
wipes (even if they could have a collateral cleaning function).
(9)
Type B: Biocidal products that are treated articles where the article fulfils,
besides the primary function of a biocidal nature, a secondary function beyond
a mere carrier function due their form, surface or design (“functional biocidal
products”). Examples include10 treated nets, clothing, handkerchiefs, covers,
bed lining or facial masks.
(10)
This category includes either products in which the biocidal mixture/substance
is:
(a)
Just coated on the surface or impregnated in the outer layer of the
carrier component. E.g. coated repelling hair bands or bracelets,
cardboard boards painted with an insecticide or a horse rug where only
the outer layer is impregnated with an insecticide or an insect repellent.
(b)
Impregtaned in the whole carrier component, from which it is released
to the carrier's surface to exert the biocidal effect. E.g. silicone
repellent bracelets, insecticide mosquito nets, handkerchiefs
impregnated with disinfectant, etc.
(11)
For the sake of completeness, while not commonly considered as treated
article but rather a combination of a container and a mixture, a third category
of biocidal products should be considered.
(12)
Type C: Biocidal products in a specific type of packaging (container) that is
not removed before use (i.e. to prevent contact with users). Examples include
hangers containing a biocidal liquid in an internal compartment (Anti-moth
biocidal mixture closed in a plastic device/crochet/hanger) or prefilled bait
stations or (pressurized) cartridges.
9
To be determined in accordance with “CA-Sept13-Doc5.1.e.Rev1.
10
Insofar as these articles have a primary biocidal function in accordance with CA-Sept13-Doc 5.1.e.Rev1.
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(13)
The annex to this document provides for a flow chart summarising the
elements to be considered in order to allocate a biocidal products to one of the
three above-mentioned categories.
4.- Practical implementation
4.1.- Describing the product composition
(14)
For types A and B biocidal products, CG members already agreed11 that the
carrier component should not be considered as a part of the composition of the
biocidal product. Therefore, it should not be considered for the calculation of
the AS concentration to be indicated in the SPC12.
(15)
For biocidal products of type C, only the composition of the biocidal
mixture/substance should be considered for the calculation of the AS
concentration to be indicated in the SPC.
4.2.- Classification and labelling
(16)
A treated article that has a primary biocidal function shall be considered a
biocidal product in accordance with article 3(1)a of the BPR. Consequently,
the labelling of treated articles foreseen by article 58 cannot be applied to
these biocidal products13.
(17)
In accordance with article 69 of the BPR, biocidal products are classified,
packaged and labelled in accordance with Regulation (EC) No 1272/200814
(the "CLP Regulation"), as well as in accordance with the approved summary
of product characteristics (SPC), which contains in particular any “hazard and
precautionary statements” (see Article 22(2)(i) of the BPR).
(18)
It is proposed that the hazard and precautionary statements, as well as any
other labelling elements deriving from the CLP Regulation, are based:
11
See Minutes CG-10 (informal referrals) and CG-12 (formal referrals).
12
It is of course important to consider the carrier component, and the distribution of the active substance in
the matrix, when carrying out the risk assessment (see sections 4.5 below).
13
For the article (carrier) itself it has to be checked on a case by case basis if provisions of Article 58 of the
BPR have to be fulfilled (rare cases).
14
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on
classification, labelling and packaging of substances and mixtures (OJ L 353, 31.12.2008, p. 1.).
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(a)
For types A and B biocidal products, and in line with previous CG
agreements15, on the classification of the biocidal mixture/substance
used in the product only16.
There may be cases where the classification of a type B product based
on the classification of the biocidal mixture/substance might lead to
some P-statements that would prevent the product from being
authorised for the general public (e.g. P-280 – wear gloves). It has to
be noted though that a P-statement that has been proven unnecessary in
the risk assessment should be left out of the SPC and of the label17.
Where relevant, document CA-Sept13-Doc.6.2.a – Final.Rev118 would
also apply.
(b)
(19)
For type C biocidal products, on the classification of the biocidal
mixture contained in the article acting as the packaging.
For the sake of consistency, the content of the AS to be indicated in section 2
of the SPC, as well as on the label pursuant to Article 69(2)(a) of the BPR,
should be the same which is considered for classification purposes.
4.3.- Describing the “carrier component”
(20)
For type B biocidal products, the chemical composition of the mixture could
be specified in the application under IUCLID section 2.3 (this section also
includes the field ‘type of formulation’) including the carrier material, and in
such a way, that the composition of the mixture used to treat the article may
easily be deduced19.
(21)
In addition, in order to allow for a maximum flexibility at the meta-SPC level
of a biocidal product family (BPF)20, it is proposed that for all types (A,B,C),
a clear description of the carrier component specifications should be provided
15
See CG agreement on Raid Fly Killer Window Sticker, available at https://webgate.ec.europa.eu/echascircabc/w/browse/e2704db2-19b3-445d-9820-f43a080fde04
16
As the biocidal mixture/substance interacts at the surface of the carrier, its hazard properties will be
relevant.
17
See document CA-May13-Doc.5.4-Final.rev1 on "Classification and labelling of biocidal products",
available at https://circabc.europa.eu/w/browse/e4e143d0-cae8-41cb-b4b6-c762e6f44622
18
"Authorisation of biocidal products classified as skin sensitisers requiring PPE for non-professional users",
available at https://circabc.europa.eu/w/browse/4399ddeb-e8ba-4fe7-92c8-447f277959d3
19
In order to implement this, in addition to the compositional information a clarifying document can be
attached in IUCLID section 2.3, which could also refer to section 12.3 for more details.
20
This information could be included in the information regarding the type of formulation. However, in the
case of a BPF and since one meta-SPC cannot cover multiple types of formulation, this would lead to a
multiplication of meta-SPCs if multiple articles were to be included in a BPF with this approach.
5/8
under IUCLID section 12.3 regarding the packaging of the biocidal product.
(e.g. "ready for use bait station with 0.5 cm diameter opening", for a type C
product).
(22)
These specifications should cover those macroscopic characteristics of the
carrier (e.g. colour, mesh size for nets, size of moth paper when in contact
with skin, etc...) that influence the exposure or efficacy of the product as
supplied to the end-user.
(23)
In case the article is made up of a combination of different materials, the
specifications for each material, as well as the method used to combine these
different materials, should also be provided.
(24)
The identity part of the PAR should include a detailed description of the
carrier, ensuring that clear information is provided regarding:
(25)
(26)
(a)
the carrier dimensions and mass,
(b)
the mass of the amount of biocidal mixture/substance on the carrier21,
(c)
those characteristics that may influence exposure, efficacy physicchemical properties, shelf life, etc.
The draft SPC prepared by the reference MS or the e-CA in case of UA,
should also include a brief description, excluding any confidential
information:
(a)
For type “C” products, under the packaging field of the tables
describing the intended uses in section 4,
(b)
For types “A” and “B” products, under section (6 "Other
information").
The classification of applications for a change affecting the carrier component
of a biocidal product should be considered on a case by case basis, depending
on the extent of the assessment to be performed. Where required, applicants
can request an ECHA opinion in accordance with Article 2 of Regulation
(EU) No 354/201322 (“the changes Regulation).
21
E.g. for a disinfecting wipe it may be relevant to know that every wipe contains x g of the active substance.
This can then be used when making the risk assessment or when deciding which dose/application should be
authorised (e.g. 1 application = 2 wipes).
22
Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products
authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the
Council (OJ L 109, 19.4.2013, p. 4).
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4.4.- Physical-chemical properties
(27)
Product stability tests for biocidal products of type A and B should be carried
out with the product as it is supplied to the user.
(28)
Tests for all other physical-chemical properties may be performed with the
substance/mixture before it is applied to the carrier component.
4.5.- Exposure assessment
(29)
For all types biocidal products (A, B and C), tests (where required) should be
carried out with the product as it is supplied to the user.
(30)
For type C biocidal products, some tests may be carried out on the mixture
only (e.g. dermal absorption).
4.6.- Efficacy testing
(31)
Unless otherwise recommended in agreed EU guidance23, laboratory trials for
type A and B biocidal products should be carried out on a sample of the
biocidal product (mixture and carrier). Where required24, simulated-use or
field trials for type A and B biocidal products must however always be carried
out with the product as supplied to the user.
(32)
Laboratory trials for type C product can be carried out only on the mixture,
while simulated-use or field trials for type C biocidal products shall be carried
out, where relevant, on the product as supplied to the user.
(33)
For some product- types, the test requirements are specifically stated in the
efficacy guidance for the relevant PT (e.g. PT 1 and 2 for "disinfectant
towelettes/wipes"). For these uses, the test requirements according to the
relevant PT guidance should be followed.
5.- Action requested
(34)
The Commission services invite the CA meeting to endorse this document as
agreed by the Coordination Group.
23
See for instance ECHA “Transitional Guidance on Efficacy Assessment for Product Types 1-5,
Disinfectants”, which for disinfecting wipes, the suspension test (phase 2 step 1) “should be done
preferably with the liquid extracted from the wipes, or if difficult to extract, use the liquid as it is before it
is added to the wipes.” Note: When the ECHA Efficacy guidance general part B/C and/or the relevant PTspecific chapters will be finalised, this new document should be considered.
24
For hard surfaces disinfectants in PT2, phase 3 tests (i.e. field tests) are optional (Cf. section 3.3.2.1. of
ECHA “Transitional Guidance on Efficacy Assessment for Product Types 1-5, Disinfectants”.)
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Annex
Does the BP consist of one or
more active substances in a
carrier component?
Yes
No
Is the carrier component a simple
container for a (biocidal) mixture?
Yes
Biocidal product
(Mixture)
e.g. block rodenticide or
disinfecting tablet
No
Does the carrier component provide
a function through its shape (is the
product an article)?
CASE C: Biocidal product
e.g.: Anti-moth biocidal
mixture closed in a plastic
device/crochet/hanger) or
prefilled bait stations or
(pressurized) cartridges
No
Yes
Has the treated article a
primary biocidal function?
No
Treated Article
CASE A: «carrier» Biocidal
product:
e.g. (window) stickers, (gas
generating) strips, disinfecting
wipes and candles
Yes
CASE B: «functional» Biocidal product:
e.g. treated nets, clothing, handkerchiefs, covers,
bed lining or facial masks
8/8