EUROPEAN COMMISSION
DIRECTORATE-GENERAL
ENVIRONMENT
Directorate A – Green Economy
ENV.A.3 - Chemicals
CA-Nov14-Doc.6.2
58th meeting of representatives of Members States Competent
Authorities for the implementation of Regulation 528/2012 concerning
the making available on the market and use of biocidal products
NOTE ON THE SPECIFIC CONDITIONS TO BE SET IN THE APPROVAL OF ACTIVE
SUBSTANCES IN RELATION WITH TREATED ARTICLES
1.
Purpose of the document
A treated article cannot be placed on the market unless all active substances contained in
the biocidal products that it was treated with or incorporates are included in the list drawn
up in accordance with Article 9(2), for the relevant product-type and use, or in Annex I,
and any conditions or restrictions specified therein are met. As a consequence, as
indicated in the Note for guidance on treated articles1 and the Note on the principles for
taking decisions on the approval of active substances under the BPR2, restrictions or
conditions can be established in the approval of an active substance in relation to treated
articles.
At the occasion of meetings of the Working Groups of the BPC, and a plenary session of
the BPC, some proposals were discussed to restrict the placing on the market of certain
treated articles, and/or impose labelling of others, which went beyond the agreements
reached during the discussion on the principles for approval that took place in CA
meetings in 2013.
The objective of this document is to ensure a common understanding of the
implementation of the agreed principles for approval, of the cases where provisions need
to be established in the approvals in relation to treated articles and how such provisions
should be formulated. It is important that these elements are taken into account at each
stage of the process, in particular during the preparation of an opinion by the BPC and its
working groups. Moreover, a consistent approach needs to be ensured across all product-
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2
See document CA-Sept13-Doc.5.1.e endorsed at the 53rd CA meeting of September 2013.
See document CA-March14-Doc.4.1 - Final endorsed at the 55th CA meeting of March 2014
types that are relevant for the treatment or incorporation of a biocide in substances,
mixtures or articles.
2.
OBJECTIVES OF THE PROVISIONS ON TREATED ARTICLES IN THE BPR
The introduction of measures on treated articles in the BPR was based on the following
considerations and objectives:

Protect human health, animal health and the environment

Avoid discrimination between treated articles manufactured in the Union and
treated articles imported from third countries

Enable consumers to make informed choices
To that end, it has been established that:

all treated articles placed on the internal market should contain only approved
active substances

where needed, treated articles should be appropriately labelled.

where a consumer so requests, the supplier of a treated article shall provide that
consumer, within 45 days, free of charge, with information on the biocidal
treatment of the treated article.
The labelling provisions should contribute to achieve the objectives of the BPR, and
facilitate the implementation by stakeholders and authorities.
In accordance with Article 1(2)(e), the BPR lays down rules for the placing on the market
of treated articles, and does not directly regulate the making available on the market of
treated articles nor their use.
Furthermore:

Article 4(3)(d) provides the basis to regulate the use of an active substance (and
biocidal products containing it) in treated articles;

Article 58(2) provides the basis to regulate the placing on the market of
substances, mixtures or articles treated with or incorporating an active substance;

Article 58(3) provides the basis to regulate the labelling of substances, mixtures
or articles treated with or incorporating an active substance.
The BPR thus provides the possibility to regulate the use of an active substance but it
does not provide the basis to directly regulate the use of the treated article itself.
However, indirectly, through the labelling provisions of Article 58(3)(e), the relevant
instructions for use can be set, in order to indicate on the label that the treated articles
shall not be used for specified applications, or shall only be used in a certain way.
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3.
PRINCIPLES
FOR APPROVAL OF ACTIVE SUBSTANCES IN RELATION TO TREATED
ARTICLES
The Note on the principles for taking decisions on the approval of active substances
under the BPR3 establishes the following principles:
- Concerning the limitation on the possibility to use of an active substance in
treated articles, the same approach as for the approval of the active substance for
use in biocidal product shall be followed with some adaptations:

Restrictions concerning the use of the active substance in treated articles shall
only be introduced where a major concern is identified.

In such cases, the approval shall indicate which categories of articles can or,
as appropriate, cannot be treated with a biocidal product containing the active
substance.

Major concern shall correspond to cases:
o Where the active substance meets the exclusion criteria set in Article
5(1), but would benefit from derogation to the exclusion on the basis
of Article 5(2).
o When there are reasons for major concern linked to the nature of the
critical effect, which in combination with certain foreseeable use
pattern could pose such a risk to human health (the user of a treated
article, the general public etc.), or to the environment.

In relation to food contact materials4, for any active substance to be approved
under product-type 4, a condition shall be set to forbid the use in food contact
materials unless a specific migration limit has been established or it has been
decided in accordance with Regulation (EC) 1935/2004 that such a limit was
no needed.
- Concerning labelling:

4.
Labelling of treated articles shall be required through a specific condition in
the approval, if, based on a case-by-case assessment, a concern has been
identified.
IMPLEMENTATION OF THESE PRINCIPLES
4.1.
Provisions to limit the use of an active substance in treated articles
At the occasion of some BPC Working Groups and at the 6th BPC in June 2014, a
proposal has been made by a member to only approve uses of an active substance in
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4
See document CA-March14-Doc.4.1 - Final endorsed at the 55th CA meeting of March 2014
Item "CA-July13-Doc.5.1i" of the 52nd CA meeting of July 2013
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treated article that had been included in the assessment, combined with a proposal to
established use categories for the PT in question.
Similar discussion already took place in late 2005 - early 2006 in the CA meetings in
order to define how to approve active substances, whether a positive listing of used
assessed should be made, or whether restrictions should be made when unacceptable risks
are assessed and identified5.
Considering that a positive listing would de facto prevent the authorisation of unassessed
uses, that the requirement in the legislation is to submit only one acceptable reference use
to get an approval, and that it would be impossible to assess every potential use at the
approval stage of an active substance, it was agreed at that time to restrict the use of the
active substance only when unacceptable risks are identified.
Extensive discussions on how to deal with the approval of active substances in relation to
use in treated articles took place during CA meetings in 2013, and the same approach as
for the approval of active substances themselves has been agreed for the same reasons.
Furthermore, at the time of submission of the active substance dossiers for the current
assessments under the review programme, there was no legal obligation to provide the
data enabling an in-depth assessment of such uses and the later regulation of treated
articles under the BPR was not known to the applicant. When the BPR came into force, it
foresaw no specific requirement or formal mechanism to submit additional information in
relation to treated articled for the substances already under review. Therefore, restrictions
of the use of an active substance in treated articles only to uses that have been assessed
cannot be justified at this stage. Moreover, it would mean making large numbers of
commercial goods illegal and causing major trade disruptions. Doing so without a sound
reason connected with a major safety concern does carry a high risk of being challenged
in court by the concerned business operators.
As a consequence, as agreed in the Note on the principles for taking decisions on the
approval of active substances under the BPR:

Restrictions concerning the use of the active substance in treated articles shall
only be introduced where a major concern is identified.

In such cases, the approval shall indicate which categories of articles can or, as
appropriate, cannot be treated with a biocidal product containing the active
substance.
Furthermore :
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
the measure should be equally applicable to and make no difference between
treated articles manufactured in the EU and those manufactured in third countries.

the description of the use restricted should be sufficiently specific in order that the
restriction only applies to those categories of treated articles for which the major
concern is identified and relevant.
Document CA-Dec05-Doc.7.4 discussed at the 20th CA meeting of December 2005
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4.2.
Provisions on labelling of treated articles
Article 58(3) establishes that a specific labelling of treated articles can be required in the
conditions for approval of an active substance.
Article 58(4) establishes that, even if no claim on the biocidal properties of the treated
article are made, or even if no condition was set in the approval of the active substance,
the person responsible for the placing on the market of a treated article shall provide
information when it is needed to protect humans, animals or the environment.
The provisions of Article 58(4) therefore establish a general duty for the person
responsible for the placing on the market to provide appropriate information when
needed to protect humans, animals or the environment.
Having considered these elements as well as the objectives of the BPR with regards to
treated articles, several aspects needs to be taken into account when establishing labelling
conditions in the approval of active substances:

a concern has been identified in connection with the presence of the active
substance in treated articles

the measure should be equally applicable to and make no difference between
treated articles manufactured in the EU and those manufactured in third countries.

the provisions of article 58(4) already provide a general duty on the person
responsible for the placing on the market of a treated article to label it when it is
needed to protect humans, animals and the environment. Therefore, a provision
should be set in the approval through article 58(3) when it is considered that the
protection of humans, animals and environment would be better ensured via
such a provision.
This would be the case when:
o a use (or more), among others, of an active substance is eventually not
approved because of a major concern and that there would be a need to
ensure that the placing on the market of substance, mixtures or articles
lawfully treated with that substance for other purposes, do not lead to the
same major concern, which was the very reason of the non-approval6.
o the active substance has intrinsic properties that presents a serious concern
which justifies to enforce a systematic labelling of treated articles in
accordance with Article 58(3).
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This could for instance be the case of a wood preservative when the approval of the active substance
specifies that "Products shall not be authorised for the in situ treatment of wood outdoors, or for wood
that will be exposed to weathering", without the possibility to provide additional information at
product authorisation to overturn this restriction. In such cases, it would be important to reinforce this
ban, and ensure that the labelling of wood treated with such a preservative contain the information that
it cannot be exposed to weathering, or be used for outdoor constructions.
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
proportionality of the proposed measures needs to be ensured. The area of
treated articles is a new area regulated through the BPR, for which only little
knowledge is available and is under development. Introducing measures in
approvals can lead to many treated articles being labelled without necessarily
discriminating between what is of major or serious concern and what is of lesser
concern.

the measure should be clear to ensure a proper enforcement by both economic
operators and control bodies in Member States.
Finally, it is important to recall that, in accordance with Article 58(8), an approval can be
reviewed if, based on more experience and further evidence, there are significant
indications that the presence of the substance in the treated articles poses unacceptable
risks. The knowledge about treated articles and the active substances present therein will
increase over the next years, in particular through control activities, and if problems come
up, appropriate actions can be taken without waiting for the renewal when necessary.
4.3.
Renewal of approval of active substances
At the renewal stage, more experience and expertise will have been acquired on the uses
of active substances and biocidal products in treated articles, on those uses that lead to
unacceptable risks and that could not be authorised at all, as well as relevant labelling that
might be usefully included on the label of treated articles.
Such relevant restrictions and labelling provisions should be taken into consideration at
the time of the renewal and could, where relevant, be included in the conditions of
approval of the active substances.
5.
Action
The Commission services invite Member States to confirm the principles already
endorsed concerning the use of active substances in treated articles (i.e. section 4.1 of the
document) and to discuss and endorse the new ones concerning labelling of treated
articles (i.e. section 4.2).
Should these be the case, it will then be important to ensure that these principles are taken
into account at each stage of the active substance approval process, and in particular
during the preparation of BPC opinions.
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ANNEX
Relevant Articles of the BPR on treated articles
Article 1(2)(e)
This Regulation lays down rules for: […]
(e) the placing on the market of treated articles.
Article 4(3)(d)
The approval shall specify the following conditions, as appropriate:
[...]
(d) manner and area of use including, where relevant, use in treated articles;
Article 58(2)
A treated article shall not be placed on the market unless all active substances contained in
the biocidal products that it was treated with or incorporates are included in the list drawn
up in accordance with Article 9(2), for the relevant product-type and use, or in Annex I, and
any conditions or restrictions specified therein are met.
Article 58
[…]
3. The person responsible for the placing on the market of such a treated article shall
ensure that the label provides the information listed in the second subparagraph, where:
— in the case of a treated article containing a biocidal product, a claim is made by the
manufacturer of that treated article regarding the biocidal properties of the article, or
— in relation to the active substance(s) concerned, having particular regard to the
possibility of contact with humans or the release into the environment, the conditions
associated with the approval of the active substance(s) so require.
The label referred to in the first subparagraph shall provide the following information:
(a) a statement that the treated article incorporates biocidal products;
(b) where substantiated, the biocidal property attributed to the treated article;
(c) without prejudice to Article 24 of Regulation (EC) No 1272/2008, the name of all active
substances contained in the biocidal products;
(d) the name of all nanomaterials contained in the biocidal products, followed by the word
‘nano’ in brackets;
(e) any relevant instructions for use, including any precautions to be taken because of the
biocidal products with which a treated article was treated or which it incorporates.
This paragraph shall not apply where at least equivalent labelling requirements already
exist under sector-specific legislation for biocidal products in treated articles to meet
information requirements concerning those active substances.
4. Notwithstanding the labelling requirements set out in paragraph 3, the person
responsible for the placing on the market of a treated article shall label it with any relevant
instructions for use, including any precautions to be taken, if this is necessary to protect
humans, animals and the environment.
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