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27.6.2012 Official
Journal
of
the
European
Union L
167/1
I
(Legislative acts)
REGULATIONS
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
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
placed on the market unless all active substances
EUROPEAN UNION,
contained in the biocidal products with which they
were treated or which they incorporate are approved in
accordance with this Regulation.
Having regard to the Treaty on the Functioning of the European
Union, and in particular Article 114 thereof,
(3)
The purpose of this Regulation is to improve the free
movement of biocidal products within the Union while
ensuring a high level of protection of both human and
Having regard to the proposal from the European Commission,
animal health and the environment. Particular attention
should be paid to the protection of vulnerable groups,
such as pregnant women and children. This Regulation
should be underpinned by the precautionary principle to
Having regard to the opinion of the European Economic and
ensure that the manufacturing and making available on
Social Committee ( 1 ),
the market of active substances and biocidal products do
not result in harmful effects on human or animal health
or unacceptable effects on the environment. With a view
to removing, as far as possible, obstacles to trade in
Acting in accordance with the ordinary legislative procedure ( 2 ),
biocidal products, rules should be laid down for the
approval of active substances and the making available
on the market and use of biocidal products, including
rules on the mutual recognition of authorisations and on
Whereas:
parallel trade.
(1) Biocidal
products
are
necessary
for
the
control
of (4) To
ensure
a
high
level
of
protection
for
human
health,
organisms that are harmful to human or animal health
animal health and the environment, this Regulation
and for the control of organisms that cause damage to
should apply without prejudice to Union legislation on
natural or manufactured materials. However, biocidal
safety in the workplace and environmental and consumer
products can pose risks to humans, animals and the
protection.
environment due to their intrinsic properties and
associated use patterns.
(5)
Rules concerning the making available on the market of
biocidal products within the Community were established
(2) Biocidal
products
should
neither
be
made
available
on
by Directive 98/8/EC of the European Parliament and of
the market nor used unless authorised in accordance
the Council ( 3 ). It is necessary to adapt those rules in the
with this Regulation. Treated articles should not be
light of experience and in particular the report on the
first seven years of the implementation submitted by the
( 1 ) OJ C 347, 18.12.2010, p. 62.
Commission to the European Parliament and the Council,
( 2 ) Position of the European Parliament of 22 September 2010
which analyses problems with and weaknesses of that
(OJ C 50 E, 21.2.2012, p. 73) and position of the Council at first
Directive.
reading of 21 June 2011 (OJ C 320 E, 1.11.2011, p. 1). Position of
the European Parliament of 19 January 2012 (not yet published in
the Official Journal) and decision of the Council of 10 May 2012.
( 3 ) OJ L 123, 24.4.1998, p. 1.

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L 167/2
EN
Official Journal of the European Union
27.6.2012
(6) Taking
into
account
the
main
changes
that
should
be (11) This
Regulation
applies
without
prejudice
to
Regulation
made to the existing rules, a regulation is the appropriate
(EC) No 1907/2006 of the European Parliament and of
legal instrument to replace Directive 98/8/EC to lay
the Council of 18 December 2006 concerning the Regis
down clear, detailed and directly applicable rules.
tration, Evaluation, Authorisation and Restriction of
Moreover, a regulation ensures that legal requirements
Chemicals (REACH) and establishing a European
are implemented at the same time and in a harmonised
Chemicals Agency ( 1 ). Under certain conditions, biocidal
manner throughout the Union.
active substances are exempt from the relevant provisions
of that Regulation.
(7) A
distinction
should
be
drawn
between
existing
active
substances which were on the market in biocidal
products on the transposition date set in Directive
(12) With
a
view
to
achieving
a
high
level
of
protection
of
98/8/EC and new active substances which were not yet
human health, animal health and the environment, active
on the market in biocidal products on that date. During
substances with the worst hazard profiles should not be
the ongoing review of existing active substances, Member
approved for use in biocidal products except in specific
States should continue to allow biocidal products
situations. These should include situations when approval
containing such substances to be made available on the
is justified because of the negligible risk from exposure to
market according to their national rules until a decision
the substance, human health, animal health or environ
is taken on approval of those active substances.
mental reasons or the disproportionate negative impact
Following such a decision Member States, or, where
for society of non-approval. When deciding if such active
appropriate, the Commission, should grant, cancel or
substances may be approved, the availability of suitable
modify authorisations as appropriate. New active
and sufficient alternative substances or technologies
substances should be reviewed before biocidal products
should also be taken into account.
containing them are placed on the market, so as to
ensure that new products that are placed on the
market comply with the requirements of this Regulation.
However, to encourage the development of new active
(13) The active substances in the Union list should be
substances, the evaluation procedure for new active
regularly examined to take account of developments in
substances should not prevent Member States or the
science and technology. Where there are significant indi
Commission from authorising, for a limited period of
cations that an active substance used in biocidal products
time, biocidal products containing an active substance
or treated articles does not meet the requirements of this
before it is approved, provided that a full dossier has
Regulation, the Commission should be able to review the
been submitted and it is believed that the active
approval of the active substance.
substance and the biocidal product satisfy the conditions
set out in this Regulation.
(14) Active
substances
should
be
designated
as
candidates
for
(8) To
ensure
the
equal
treatment
of
persons
placing
active
substitution if they have certain intrinsic hazardous prop
substances on the market, they should be required to
erties. In order to allow for a regular examination of
hold a dossier, or have a letter of access to a dossier,
substances identified as candidates for substitution, the
or to relevant data in a dossier, for each of the active
approval period for those substances should not, even
substances they manufacture or import for use in
in the case of renewal, exceed seven years.
biocidal products. Biocidal products containing active
substances for which the relevant person does not
comply with that obligation should no longer be made
available on the market. In such cases, there should be
appropriate phase-out periods for disposal and use of
(15) In the course of granting or renewing the authorisation
existing stocks of biocidal products.
of a biocidal product that contains an active substance

that is a candidate for substitution, it should be possible
to compare the biocidal product with other authorised
biocidal products, non-chemical means of control and
(9) This
Regulation
should
apply
to
biocidal
products
that,
in
prevention methods with regard to risks they pose and
the form in which they are supplied to the user, consist
benefits from their use. As a result of such a comparative
of, contain or generate one or more active substances.
assessment, a biocidal product containing active
substances identified as candidates for substitution
should be prohibited or restricted where it is demon
strated that other authorised biocidal products or non-
(10) In
order
to
ensure
legal
certainty,
it
is
necessary
to
chemical control or prevention methods that present a
establish a Union list of active substances approved for
significantly lower overall risk for human health, animal
use in biocidal products. A procedure should be laid
health and the environment, are sufficiently effective and
down for assessing whether or not an active substance
present no other significant economic or practical
can be entered in that list. The information that
disadvantages. Appropriate phase-out periods should be
interested parties should submit in support of an appli
provided for in such cases.
cation for approval of an active substance and its
inclusion in the list should be specified.
( 1 ) OJ L 396, 30.12.2006, p. 1.

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EN
27.6.2012 Official
Journal
of
the
European
Union L
167/3
(16) In order to avoid unnecessary administrative and
(21) The
safety
of
food
and
feed
is
subject
to
Union
legis
financial burdens for industry and competent authorities,
lation, in particular Regulation (EC) No 178/2002 of the
a full in-depth evaluation of an application to renew the
European Parliament and of the Council of 28 January
approval of an active substance or the authorisation of a
2002 laying down the general principles and
biocidal product should be carried out only if the
requirements of food law, establishing the European
competent authority that was responsible for the initial
Food Safety Authority and laying down procedures in
evaluation decides that this is necessary on the basis of
matters of food safety ( 5 ). Therefore, the present Regu
the available information.
lation should not apply to food and feed used as
repellents or attractants.
(17) There
is
a
need
to
ensure
effective
coordination
and
management of the technical, scientific and adminis
(22) Processing aids are covered by existing Union legislation,
trative aspects of this Regulation at Union level. The
in particular Regulation (EC) No 1831/2003 of the
European Chemicals Agency set up under Regulation
European Parliament and of the Council of 22 September
(EC) No 1907/2006 (‘the Agency’) should carry out
2003 on additives for use in animal nutrition ( 6 ) and
specified tasks with regard to the evaluation of active
Regulation (EC) No
1333/2008 of the European
substances as well as the Union authorisation of certain
Parliament and of the Council of 16 December 2008
categories of biocidal products and related tasks.
on food additives ( 7 ). Therefore, it is appropriate to
Consequently, a Biocidal Products Committee should be
exclude them from the scope of this Regulation.
established within the Agency to carry out certain tasks
conferred on the Agency by this Regulation.
(23) As products used for the preservation of food or feed by
the control of harmful organisms, previously covered by
(18) Certain
biocidal
products
and
treated
articles
as
defined
product-type 20, are covered by Regulation (EC)
in the Regulation are also regulated by other Union legis
No 1831/2003 and Regulation (EC) No 1333/2008, it
lation. It is therefore necessary to draw clear borderlines
is not appropriate to maintain that product-type.
in order to ensure legal certainty. A list of product-types
covered by this Regulation with an indicative set of
descriptions within each type should be set out in an
Annex to this Regulation.
(24) As
the
International
Convention
for
the
Control
and
Management of Ships’ Ballast Water and Sediments
provides for an effective assessment of the risks posed
(19) Biocidal
products
intended
to
be
used
not
only
for
the
by ballast water management systems, the final approval
purposes of this Regulation, but also in connection with
and subsequent type-approval of such systems should be
medical devices, such as disinfectants used to disinfect
considered equivalent to the product authorisation
surfaces in hospitals and medical devices, may pose
required under this Regulation.
risks other than those with which this Regulation is
concerned. Therefore, such biocidal products should
comply, in addition to the requirements laid down in
this Regulation, with the relevant essential requirements
(25) To
avoid
possible
negative
effects
on
the
environment,
set out in Annex I to Council Directive 90/385/EEC of
biocidal products that can no longer lawfully be made
20 June 1990 on the approximation of the laws of the
available on the market should be dealt with in
Member States relating to active implantable medical
accordance with Union legislation on waste, in particular
devices ( 1 ), Council Directive 93/42/EEC of 14 June
Directive 2008/98/EC of the European Parliament and of
1993 concerning medical devices
( 2 ) and Directive
the Council of 19 November 2008 on waste ( 8 ), as well
98/79/EC of the European Parliament and of the
as national legislation implementing that legislation.
Council of 27 October 1998 on in vitro diagnostic
medical devices ( 3 ).
(26) To facilitate the making available on the market
throughout the Union of certain biocidal products with
(20) Where a product has a biocidal function that is inherent
similar conditions of use in all Member States, it is
to its cosmetic function, or where that biocidal function
appropriate to provide for Union authorisation of those
is considered to be a secondary claim of a cosmetic
products. In order to allow some time for the Agency to
product and is therefore regulated under Regulation
build up the necessary capacity and to gain experience
(EC) No 1223/2009 of the European Parliament and of
with this procedure, the possibility to apply for Union
the Council of 30 November 2009 on cosmetic prod
authorisation should be extended through a step-wise
ucts ( 4 ), that function and the product should remain
approach to further categories of biocidal products with
outside the scope of this Regulation.
similar conditions of use in all Member States.
( 1 ) OJ L 189, 20.7.1990, p. 17.
( 5 ) OJ L 31, 1.2.2002, p. 1.
( 2 ) OJ L 169, 12.7.1993, p. 1.
( 6 ) OJ L 268, 18.10.2003, p. 29.
( 3 ) OJ L 331, 7.12.1998, p. 1.
( 7 ) OJ L 354, 31.12.2008, p. 16.
( 4 ) OJ L 342, 22.12.2009, p. 59.
( 8 ) OJ L 312, 22.11.2008, p. 3.

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L 167/4
EN
Official Journal of the European Union
27.6.2012
(27) The Commission should review experience with the
(34) In
order
to
help
applicants,
and
in
particular
small
and
provisions on Union authorisations and report to the
medium-sized enterprises (SMEs), to comply with the
European Parliament and the Council by 31 December
requirements of this Regulation, Member States should
2017, accompanying its report with proposals for
provide advice, for example by establishing helpdesks.
changes if appropriate.
This advice should be in addition to the operational
guidance documents and other advice and assistance
provided by the Agency.
(28) To ensure that only biocidal products that comply with
the relevant provisions of this Regulation are made
available on the market, biocidal products should be
subject to authorisation either by competent authorities
(35) In
particular,
to
ensure
that
applicants
can
effectively
exercise the right to request the adaptation of data
for making available on the market and use within the
requirements, Member States should provide advice on
territory of a Member State or part of it, or by the
this possibility and the grounds on which such requests
Commission for making available on the market and
could be made.
use within the Union.


(29) To
encourage
the
use
of
products
with
a
more
favourable
(36) To
facilitate
access
to
the
market
it
should
be
possible
to
environmental or human or animal health profile, it is
authorise a group of biocidal products as a biocidal
appropriate to provide for simplified authorisation
product family. Biocidal products within a biocidal
procedures for such biocidal products. Once authorised
product family should have similar uses and the same
in at least one Member State, those products should be
active substances. Variations in the composition or the
allowed to be made available on the market in all
replacement of non-active substances should be specified,
Member States without the need for mutual recognition,
but may not adversely affect the level of risk or signifi
under certain conditions.
cantly reduce the efficacy of the products.
(30) To
identify biocidal products which are eligible for
(37) When
authorising
biocidal
products
it
is
necessary
to
simplified authorisation procedures, it is appropriate to
ensure that, when properly used for the purpose
establish a specific list of the active substances that those
intended, they are sufficiently effective and have no
products may contain. That list should, initially, contain
unacceptable effect on the target organisms such as resis
substances identified as presenting a low risk under
tance, or, in the case of vertebrates, unnecessary suffering
Regulation (EC) No 1907/2006 or Directive 98/8/EC,
and pain. Furthermore, they may not have, in the light of
substances identified as food additives, pheromones and
current scientific and technical knowledge, any
other substances considered to have low toxicity, such as
unacceptable effect on human health, animal health or
weak acids, alcohols and vegetable oils used in cosmetics
on the environment. Where appropriate, maximum
and food.
residue limits for food and feed should be established
with respect to active substances contained in a
biocidal product to protect human and animal health.
(31) It
is
necessary
to
provide
common
principles
for
the
When these requirements are not met, biocidal
evaluation and authorisation of biocidal products to
products shall not be authorised unless their authori
ensure a harmonised approach by competent authorities.
sation is justified because of the disproportionate
negative impact for society of not authorising them
when compared to the risks arising from their use.
(32) To
evaluate
the
risks
that
would
arise
from
proposed
uses of biocidal products, it is appropriate that applicants
submit dossiers which contain the necessary information.
Defining a data set for active substances and for biocidal
(38) Where possible, the presence of harmful organisms
products in which they are contained is necessary so as
should be avoided by means of suitable precautionary
to assist both applicants seeking authorisation and
steps, such as proper warehousing of goods, compliance
competent authorities carrying out an evaluation to
with relevant hygiene standards and immediate disposal
decide on authorisation.
of waste. As far as possible, biocidal products that pose

lower risks for humans, animals and the environment
should be used whenever they provide an effective
remedy, and biocidal products that are intended to
(33) In the light of the diversity of both active substances and
harm, kill or destroy animals that are capable of experi
biocidal products not subject to the simplified authori
encing pain and distress should be used only as a last
sation procedure, the data and test requirements should
resort.
suit the individual circumstances and allow an overall
risk assessment. Therefore, an applicant should be able
to request the adaptation of the data requirements, as
appropriate, including the waiving of data requirements
(39) Some
authorised
biocidal
products
may
present
certain
which are not necessary or are impossible to submit in
risks if used by the general public. It is therefore appro
view of the nature or the proposed uses of the product.
priate to provide that certain biocidal products should
Applicants should provide appropriate technical and
not generally be authorised for making available on the
scientific justification to support their requests.
market for use by the general public.

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EN
27.6.2012 Official
Journal
of
the
European
Union L
167/5
(40) To
avoid
duplication
of
the
evaluation
procedures
and
to
Member State, official or scientific bodies should be able
ensure free movement of biocidal products within the
to apply for an authorisation. If they are granted an
Union, procedures should be established to ensure that
authorisation, they should have the same rights and
product authorisations granted in one Member State are
obligations as any other authorisation holder.
recognised in other Member States.
(47) To
take
account
of
scientific
and
technical
developments
(41) To
enable
closer
cooperation
between
Member
States
in
as well as the needs of authorisation holders, it is appro
the evaluation of biocidal products and to facilitate
priate to specify under which conditions authorisations
biocidal products’ market access, it should be possible
can be cancelled, reviewed or amended. The notification
to launch the mutual recognition procedure when
and exchange of information which may affect authori
applying for the first national authorisation.
sations is also necessary to enable competent authorities
and the Commission to take appropriate action.
(42) It is appropriate to lay down procedures for the mutual
(48) In
the
event
of
an
unforeseen
danger
threatening
public
recognition of national authorisations and, in particular,
health or the environment which cannot be contained by
to resolve any disagreements without undue delay. If a
other means, it should be possible for Member States to
competent authority refuses mutual recognition of an
permit, for a limited period of time, the making available
authorisation or proposes to restrict it, a coordination
on the market of biocidal products which do not comply
group should try to reach an agreement on the action
with the requirements of this Regulation.
to be taken. If the coordination group does not succeed
in finding an agreement within a specified time limit, the
Commission should be empowered to take a decision. In
case of technical or scientific questions, the Commission
(49) To encourage research and development in active
may consult the Agency before preparing its decision.
substances and biocidal products, it is necessary to
establish rules concerning the making available on the
market and use of unauthorised biocidal products and
non-approved active substances for the purposes of
(43) However, considerations related to public policy or
research and development.
public security, environmental and human and animal
health protection, the protection of national treasures
and the absence of the target organisms might justify,
following agreement with the applicant, Member States’
(50) In view of the benefits for the internal market and for the
refusal to grant an authorisation or decision to adjust the
consumer, it is desirable to establish harmonised rules for
terms and conditions of the authorisation to be granted.
parallel trade in identical biocidal products authorised in
If no agreement with the applicant can be found, the
different Member States.
Commission should be empowered to take a decision.
(51) To
determine,
where
necessary,
the
similarity
of
active
substances, it is appropriate to lay down rules concerning
(44) The use of biocidal products of certain product-types
technical equivalence.
might give rise to animal welfare concerns. Therefore,
Member States should be allowed to derogate from the
principle of mutual recognition for biocidal products
falling under such product-types, in so far as such dero
(52) To protect human health, animal health and the
gations are justified and do not jeopardise the purpose of
environment, and to avoid discrimination between
this Regulation regarding an appropriate level of
treated articles originating in the Union and treated
protection of the internal market.
articles imported from third countries, all treated
articles placed on the internal market should contain
only approved active substances.
(45) In order to facilitate the functioning of the authorisation
and mutual recognition procedures, it is appropriate to
(53) To enable consumers to make informed choices, to
establish a system for the mutual exchange of
facilitate enforcement and to provide an overview of
information. To accomplish this, a Register for Biocidal
their use, treated articles should be appropriately labelled.
Products should be established. Member States, the
Commission and the Agency should use this Register
to make available to each other the particulars and
scientific documentation submitted in connection with
(54) Applicants
that
have
invested
in
supporting
the
approval
applications for authorisation of biocidal products.
of an active substance or the authorisation of a biocidal
product in accordance with this Regulation or Directive
98/8/EC should be able to recover part of their
investment by receiving equitable compensation
(46) If the use of a biocidal product is in the interests of a
whenever use of proprietary information which they
Member State, but there is no applicant interested in
submitted in support of such approval or authorisation
making available on the market such a product in the
is made for the benefit of subsequent applicants.

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L 167/6
EN
Official Journal of the European Union
27.6.2012
(55) With
a
view
to
ensuring
that
all
proprietary
information
should maintain a suitable and proportionate quality
submitted in support of the approval of an active
control system. To this end, it may be appropriate for
substance or the authorisation of a biocidal product is
Member States to take action together.
protected from the moment of its submission and to
prevent situations where some information is without
protection, the data protection periods should also
(61) Effective communication of information on risks
apply to information submitted for the purposes of
resulting from biocidal products and risk management
Directive 98/8/EC.
measures is an essential part of the system established
by this Regulation. While facilitating access to
information, competent authorities, the Agency and the
Commission should respect the principle of confiden
(56) To
encourage
the
development
of
new
active
substances
tiality and avoid any disclosure of information which
and biocidal products containing them, it is necessary to
could be harmful to the commercial interests of the
provide for a period of protection with respect to the
person concerned, except where it is necessary for the
proprietary information submitted in support of the
protection of human health, safety or the environment or
approval of such active substances or the authorisation
for other reasons of overriding public interest.
of biocidal products containing them which is longer
than the period of protection for information concerning
existing active substances and biocidal products
containing them.
(62) To
increase
the
efficiency
of
monitoring
and
control,
and
to provide information relevant for addressing the risks
of biocidal products, authorisation holders should keep
records of the products they place on the market.
(57) It
is
essential
to
minimise
the
number
of
tests
on
animals
and for testing with biocidal products, or active
substances contained in biocidal products, to be carried
(63) It
is
necessary
to
specify
that
provisions
concerning
the
out only when the purpose and use of a product so
Agency laid down in Regulation (EC) No 1907/2006
requires. Applicants should share, and not duplicate,
should apply accordingly in the context of biocidal
studies on vertebrates in exchange for equitable compen
active substances and products. Where separate
sation. In the absence of an agreement on sharing of
provisions need to be made with respect to the tasks
studies on vertebrates between the data owner and the
and functioning of the Agency under this Regulation,
prospective applicant, the Agency should allow the use of
they should be specified in this Regulation.
the studies by the prospective applicant without prejudice
to any decision on compensation made by national
courts. Competent authorities and the Agency should
have access to the contact details of the owners of
(64) The costs of the procedures associated with the operation
of this Regulation need to be recovered from those
such studies via a Union register so as to inform pros
making biocidal products available on the market and
pective applicants.
those seeking to do so in addition to those supporting
the approval of active substances. To promote the
smooth operation of the internal market, it is appropriate
to establish certain common principles applicable both to
(58) A level playing field should be established as quickly as
fees payable to the Agency and to Member States’
possible on the market for existing active substances,
competent authorities, including the need to take into
taking into account the objectives of reducing
account, as appropriate, the specific needs of SMEs.
unnecessary tests and costs to the minimum, in particular
for SMEs, of avoiding the establishment of monopolies,
of sustaining free competition between economic
operators and of equitable compensation of the costs
(65) It is necessary to provide for the possibility of an appeal
borne by data owners.
against certain decisions of the Agency. The Board of
Appeal set up within the Agency by Regulation (EC)
No 1907/2006 should also process appeals against
decisions adopted by the Agency under this Regulation.
(59) The
generation
of
information
by
alternative
means
not
involving tests on animals which are equivalent to
prescribed tests and test methods should also be
(66) There is scientific uncertainty about the safety of nano
encouraged. In addition, the adaptation of data
materials for human health, animal health and the
requirements should be used to prevent unnecessary
environment. In order to ensure a high level of
costs related to testing.
consumer protection, free movement of goods and
legal certainty for manufacturers, it is necessary to
develop a uniform definition for nanomaterials, if
possible based on the work of appropriate international
(60) To
ensure
that
the
requirements
laid
down
with
respect
forums and to specify that the approval of an active
to the safety and quality of authorised biocidal products
substance does not include the nanomaterial form
are satisfied when they are made available on the market,
unless explicitly mentioned. The Commission should
Member States should take measures for appropriate
regularly review the provisions on nanomaterials in the
control and inspection arrangements and manufacturers
light of scientific progress.

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EN
27.6.2012 Official
Journal
of
the
European
Union L
167/7
(67) To ensure a smooth transition, it is appropriate to
(74) In
order
to
ensure
uniform
conditions
for
the
implemen
provide for a deferred application of this Regulation
tation of this Regulation, implementing powers should be
and to provide for specific measures concerning the
conferred on the Commission. Those powers should be
assessment of applications for the approval of active
exercised in accordance with Regulation (EU)
substances and authorisation of biocidal products
No 182/2011 of the European Parliament and of the
submitted before the application of this Regulation.
Council of 16 February 2011 laying down the rules
and general principles concerning mechanisms for
control by the Member States of the Commission’s
exercise of implementing powers ( 1 ).
(68) The
Agency
should
take
over
the
coordination
and
facili
tation tasks for new submissions for approval of active
substances as of the date of applicability of this Regu
(75) The
Commission
should
adopt
immediately
applicable
lation. However, in view of the high number of historical
implementing acts where, in duly justified cases relating
dossiers it is appropriate to allow some time for the
to the approval of an active substance or to the
Agency to prepare for the new tasks related to dossiers
cancelling of an approval, imperative grounds of
submitted under Directive 98/8/EC.
urgency so require.
(69) To
respect
the
legitimate
expectations
of
companies
with
(76) Since the objective of this Regulation, namely, to
respect to the placing on the market and use of low-risk
improve the functioning of the internal market for
biocidal products covered by Directive 98/8/EC, those
biocidal products, whilst ensuring a high level of
companies should be allowed to make such products
protection of both human and animal health and the
available on the market if they comply with the rules
environment cannot be sufficiently achieved by the
on the registration of low-risk biocidal products under
Member States, and can therefore, by reason of its
that Directive. However, this Regulation should apply
scale and effects, be better achieved at Union level, the
after the expiry of the first registration.
Union may adopt measures, in accordance with the
principle of subsidiarity as set out in Article 5 of the
Treaty on European Union. In accordance with the
principle of proportionality, as set out in that Article,
(70) Taking
into
consideration
that
some
products
were
not
this Regulation does not go beyond what is necessary
covered by Community legislation on biocidal products,
in order to achieve that objective,
it is appropriate to provide for transitional periods for
such products and treated articles.
HAVE ADOPTED THIS REGULATION:
(71) This
Regulation
should
take
account,
as
appropriate,
of
other work programmes concerned with the review or
CHAPTER I
authorisation of substances and products, or relevant
SCOPE AND DEFINITIONS
international Conventions. In particular, it should
contribute to the fulfilment of the Strategic Approach
Article 1
to International Chemicals Management adopted on
Purpose and subject matter
6 February 2006 in Dubai.
1. The
purpose
of
this
Regulation
is
to
improve
the
func
tioning of the internal market through the harmonisation of the
rules on the making available on the market and the use of
(72) In
order
to
supplement
or
amend
this
Regulation,
the
biocidal products, whilst ensuring a high level of protection of
power to adopt acts in accordance with Article 290 of
both human and animal health and the environment. The
the Treaty on the Functioning of the European Union
provisions of this Regulation are underpinned by the
should be delegated to the Commission in respect of
precautionary principle, the aim of which is to safeguard the
certain non-essential elements of this Regulation. It is
health of humans, the health of animals and the environment.
of particular importance that the Commission carry out
Particular attention shall be paid to the protection of vulnerable
appropriate consultations during its preparatory work,
groups.
including at expert level. The Commission, when
preparing and drawing up delegated acts, should ensure
a simultaneous, timely and appropriate transmission of
2. This
Regulation
lays
down
rules
for:
relevant documents to the European Parliament and to
the Council.
(a) the establishment at Union level of a list of active
substances which may be used in biocidal products;
(73) The
Commission
should
adopt
immediately
applicable
delegated acts where, in duly justified cases relating to
the restriction of an active substance in Annex I or to the
(b) the authorisation of biocidal products;
removal of an active substance from that Annex,
imperative grounds of urgency so require.
( 1 ) OJ L 55, 28.2.2011, p. 13.

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(c) the mutual recognition of authorisations within the Union;
(g) Regulation (EC) No 1334/2008 of the European Parliament
and of the Council of 16 December 2008 on flavourings
and certain food ingredients with flavouring properties for
(d) the making available on the market and the use of biocidal
use in and on foods ( 7 );
products within one or more Member States or the Union;
(e) the placing on the market of treated articles.
(h) Regulation (EC) No 767/2009 of the European Parliament
and of the Council of 13 July 2009 on the placing on the
market and use of feed ( 8 );
Article 2
Scope
(i) Regulation (EC) No 1107/2009 of the European Parliament
1. This
Regulation
shall
apply
to
biocidal
products
and
and of the Council of 21 October 2009 concerning the
treated articles. A list of the types of biocidal products
placing of plant protection products on the market ( 9 );
covered by this Regulation and their descriptions is set out in
Annex V.
(j) Regulation (EC) No 1223/2009;
2. Subject to any explicit provision to the contrary in this
Regulation or other Union legislation, this Regulation shall not
apply to biocidal products or treated articles that are within the
(k) Directive 2009/48/EC of the European Parliament and of
scope of the following instruments:
the Council of 18 June 2009 on the safety of toys ( 10 ).
(a) Council Directive 90/167/EEC of 26 March 1990 laying
Notwithstanding the first subparagraph, when a biocidal
down the conditions governing the preparation, placing
product falls within the scope of one of the abovementioned
on the market and use of medicated feedingstuffs in the
instruments and is intended to be used for purposes not
Community ( 1 );
covered by those instruments, this Regulation shall also apply
to that biocidal product insofar as those purposes are not
addressed by those instruments.
(b) Directive 90/385/EEC, Directive 93/42/EEC and Directive
98/79/EC;
3. Subject to any explicit provision to the contrary in this
(c) Directive 2001/82/EC of the European Parliament and of
Regulation or other Union legislation, this Regulation shall be
the Council of 6 November 2001 on the Community
without prejudice to the following instruments:
code relating to veterinary medicinal products ( 2 ), Directive
2001/83/EC of the European Parliament and of the Council
of 6 November 2001 on the Community code relating to
(a) Council Directive 67/548/EEC of 27 June 1967 on the
medicinal products for human use ( 3 ) and Regulation (EC)
approximation of laws, regulations and administrative
No 726/2004 of the European Parliament and of the
provisions relating to the classification, packaging and
Council of 31 March 2004 laying down Community
labelling of dangerous substances ( 11 );
procedures for the authorisation and supervision of
medicinal products for human and veterinary use and estab
lishing a European Medicines Agency ( 4 );
(b) Council Directive 89/391/EEC of 12 June 1989 on the
introduction of measures to encourage improvements in
the safety and health of workers at work (
(d) Regulation (EC) No 1831/2003;

12 );
(e) Regulation (EC) No 852/2004 of the European Parliament
(c) Council Directive 98/24/EC of 7 April 1998 on the
and of the Council of 29 April 2004 on the hygiene of
protection of the health and safety of workers from the
foodstuffs ( 5 ) and Regulation (EC) No 853/2004 of the
risks related to chemical agents at work ( 13 );
European Parliament and of the Council of 29 April 2004
laying down specific hygiene rules for food of animal
origin ( 6 );
(d) Council Directive 98/83/EC of 3 November 1998 on the
quality of water intended for human consumption ( 14 );
(f) Regulation (EC) No 1333/2008;
( 7 ) OJ L 354, 31.12.2008, p. 34.
( 8 ) OJ L 229, 1.9.2009, p. 1.
( 1 ) OJ L 92, 7.4.1990, p. 42.
( 9 ) OJ L 309, 24.11.2009, p. 1.
( 2 ) OJ L 311, 28.11.2001, p. 1.
( 10 ) OJ L 170, 30.6.2009, p. 1.
( 3 ) OJ L 311, 28.11.2001, p. 67.
( 11 ) OJ 196, 16.8.1967, p. 1.
( 4 ) OJ L 136, 30.4.2004, p. 1.
( 12 ) OJ L 183, 29.6.1989, p. 1.
( 5 ) OJ L 139, 30.4.2004, p. 1.
( 13 ) OJ L 131, 5.5.1998, p. 11.
( 6 ) OJ L 139, 30.4.2004, p. 55.
( 14 ) OJ L 330, 5.12.1998, p. 32.

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27.6.2012 Official
Journal
of
the
European
Union L
167/9
(e) Directive 1999/45/EC of the European Parliament and of
(p) Directive 2010/63/EU of the European Parliament and of
the Council of 31 May 1999 concerning the approximation
the Council of 22 September 2010 on the protection of
of the laws, regulations and administrative provisions of the
animals used for scientific purposes ( 11 );
Member States relating to the classification, packaging and
labelling of dangerous preparations ( 1 );
(q) Directive 2010/75/EU of the European Parliament and of
the Council of 24 November 2010 on industrial
(f) Directive 2000/54/EC of the European Parliament and of
emissions ( 12 ).
the Council of 18 September 2000 on the protection of
workers from risks related to exposure to biological agents
at work ( 2 );
4. Article
69
shall
not
apply
to
the
carriage
of
biocidal
products by rail, road, inland waterway, sea or air.
(g) Directive 2000/60/EC of the European Parliament and of
the Council of 23 October 2000 establishing a framework
5. This
Regulation
shall
not
apply
to:
for Community action in the field of water policy ( 3 );
(a) food or feed used as repellents or attractants;
(h) Directive 2004/37/EC of the European Parliament and of
the Council of 29 April 2004 on the protection of workers
from the risks related to exposure to carcinogens or
(b) biocidal products when used as processing aids.
mutagens at work ( 4 );
6. Biocidal
products
which
obtained
final
approval
under
the
(i) Regulation
(EC)
No
850/2004
of
the
European
Parliament
International Convention for the Control and Management of
and of the Council of 29 April 2004 on persistent organic
Ships’ Ballast Water and Sediments shall be considered as auth
pollutants ( 5 );
orised under Chapter VIII of this Regulation. Articles 47 and 68
shall apply accordingly.
(j) Regulation
(EC)
No
1907/2006;
7. Nothing
in
this
Regulation
shall
prevent
Member
States
from restricting or banning the use of biocidal products in the
(k) Directive 2006/114/EC of the European Parliament and of
public supply of drinking water.
the Council of 12 December 2006 concerning misleading
and comparative advertising ( 6 );
8. Member
States
may
allow
for
exemptions
from
this
Regu
lation in specific cases for certain biocidal products, on their
(l) Regulation
(EC)
No
689/2008
of
the
European
Parliament
own or in a treated article, where necessary in the interests of
and of the Council of 17 June 2008 concerning the export
defence.
and import of dangerous chemicals ( 7 );
9. The
disposal
of
active
substances
and
biocidal
products
(m) Regulation (EC) No 1272/2008 of the European Parliament
shall be carried out in accordance with the Union and
and of the Council of 16 December 2008 on classification,
national waste legislation in force.
labelling and packaging of substances and mixtures ( 8 );
Article 3
(n) Directive 2009/128/EC of the European Parliament and of
Definitions
the Council of 21 October 2009 establishing a framework
for Community action to achieve the sustainable use of
1. For the purposes of this Regulation, the following defi
pesticides ( 9 );
nitions shall apply:
(o) Regulation (EC) No 1005/2009 of the European Parliament
(a) ‘biocidal
product’ means
and of the Council of 16 September 2009 on substances
that deplete the ozone layer ( 10 );
— any substance or mixture, in the form in which it is
supplied to the user, consisting of, containing or
( 1 ) OJ L 200, 30.7.1999, p. 1.
generating one or more active substances, with the
( 2 ) OJ L 262, 17.10.2000, p. 21.
( 3 ) OJ L 327, 22.12.2000, p. 1.
intention of destroying, deterring, rendering harmless,
( 4 ) OJ L 158, 30.4.2004, p. 50.
preventing the action of, or otherwise exerting a
( 5 ) OJ L 158, 30.4.2004, p. 7.
controlling effect on, any harmful organism by any
( 6 ) OJ L 376, 27.12.2006, p. 21.
means other than mere physical or mechanical action,
( 7 ) OJ L 204, 31.7.2008, p. 1.
( 8 ) OJ L 353, 31.12.2008, p. 1.
( 9 ) OJ L 309, 24.11.2009, p. 71.
( 11 ) OJ L 276, 20.10.2010, p. 33.
( 10 ) OJ L 286, 31.10.2009, p. 1.
( 12 ) OJ L 334, 17.12.2010, p. 17.

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— any substance or mixture, generated from substances or
— a substance which meets the criteria for being a
mixtures which do not themselves fall under the first
persistent organic pollutant (POP) under Regulation
indent, to be used with the intention of destroying,
(EC) No 850/2004, or which meets the criteria for
deterring, rendering harmless, preventing the action
being persistent, bio-accumulative and toxic (PBT) or
of, or otherwise exerting a controlling effect on, any
very persistent and very bio-accumulative (vPvB) in
harmful organism by any means other than mere
accordance with Annex XIII to Regulation (EC)
physical or mechanical action.
No 1907/2006;
A treated article that has a primary biocidal function shall
(g) ‘harmful organism’ means an organism, including
be considered a biocidal product.
pathogenic agents, which has an unwanted presence or a
detrimental effect on humans, their activities or the
products they use or produce, on animals or the
environment;
(b) ‘micro-organism’ means any microbiological entity, cellular
or non-cellular, capable of replication or of transferring
genetic material, including lower fungi, viruses, bacteria,
(h) ‘residue’ means a substance present in or on products of
yeasts, moulds, algae, protozoa and microscopic parasitic
plant or animal origin, water resources, drinking water,
helminths;
food, feed or elsewhere in the environment and resulting
from the use of a biocidal product, including such a
substance’s metabolites, breakdown or reaction products;
(c) ‘active substance’ means a substance or a micro-organism
that has an action on or against harmful organisms;
(i) ‘making
available
on
the
market’
means
any
supply
of
a
biocidal product or of a treated article for distribution or
(d) ‘existing
active
substance’ means a
substance
which
was
on
use in the course of a commercial activity, whether in
the market on 14 May 2000 as an active substance of a
return for payment or free of charge;
biocidal product for purposes other than scientific or
product and process-orientated research and development;
(j) ‘placing on the market’ means the first making available on
the market of a biocidal product or of a treated article;
(e) ‘new active substance’ means a substance which was not
on the market on 14 May 2000 as an active substance of a
(k) ‘use’ means all operations carried out with a biocidal
biocidal product for purposes other than scientific or
product, including storage, handling, mixing and appli
product and process-orientated research and development;
cation, except any such operation carried out with a
view to exporting the biocidal product or the treated
article outside the Union;
(f) ‘substance
of
concern’
means
any
substance,
other
than
the
active substance, which has an inherent capacity to cause
an adverse effect, immediately or in the more distant
(l) ‘treated article’ means any
substance,
mixture
or article
future, on humans, in particular vulnerable groups,
which has been treated with, or intentionally incorporates,
animals or the environment and is present or is
one or more biocidal products;
produced in a biocidal product in sufficient concentration
to present risks of such an effect.
(m) ‘national authorisation’ means an administrative act by
which the competent authority of a Member State auth
Such a substance would, unless there are other grounds for
orises the making available on the market and the use of a
concern, normally be:
biocidal product or a biocidal product family in its territory
or in a part thereof;
— a substance classified as dangerous or that meets the
(n) ‘Union authorisation’ means an administrative
act by which
criteria to be classified as dangerous according to
the Commission authorises the making available on the
Directive 67/548/EEC, and that is present in the
market and the use of a biocidal product or a biocidal
biocidal product at a concentration leading the
product family in the territory of the Union or in a part
product to be regarded as dangerous within the
thereof;
meaning of Articles 5, 6 and 7 of Directive
1999/45/EC, or
(o) ‘authorisation’ means national authorisation, Union auth
orisation or authorisation in accordance with Article 26;
— a substance classified as hazardous or that meets the
criteria for classification as hazardous according to
Regulation (EC) No 1272/2008, and that is present in
(p) ‘authorisation holder’ means the person established within
the biocidal product at a concentration leading the
the Union who is responsible for the placing on the
product to be regarded as hazardous within the
market of a biocidal product in a particular Member
meaning of that Regulation,
State or in the Union and specified in the authorisation;

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(q) ‘product-type’ means one of the product-types specified in
For the purposes of the definition of nanomaterial, ‘par
Annex V;
ticle’, ‘agglomerate’ and ‘aggregate’ are defined as follows:
(r) ‘single
biocidal
product’
means
a
biocidal
product
with
no
— ‘particle’ means a minute piece of matter with defined
intended variations as to the percentage of the active or
physical boundaries,
non-active substances it contains;
— ‘agglomerate’ means a collection of weakly bound
particles or aggregates where the resulting external
(s) ‘biocidal product family’ means a group of biocidal
surface area is similar to the sum of the surface areas
products having similar uses, the active substances of
of the individual components,
which have the same specifications, and presenting
specified variations in their composition which do not
adversely affect the level of risk or significantly reduce
— ‘aggregate’ means a particle comprising strongly bound
the efficacy of the products;
or fused particles;
(aa) ‘administrative change’ means an amendment of an existing
(t) ‘letter
of
access’
means
an
original
document,
signed
by
the
authorisation of a purely administrative nature involving
data owner or its representative, which states that the data
no change to the properties or efficacy of the biocidal
may be used for the benefit of a third party by competent
product or biocidal product family;
authorities, the Agency, or the Commission for the
purposes of this Regulation;
(ab) ‘minor change’ means an amendment of an existing auth
orisation that is not of a purely administrative nature and
(u) ‘food’ and ‘feed’ mean food as defined in Article 2 of
requires only a limited re-assessment of the properties or
Regulation (EC) No 178/2002 and feed as defined in
efficacy of the biocidal product or biocidal product family;
Article 3(4) of that Regulation;
(ac) ‘major change’ means an amendment of an existing auth
orisation which is neither an administrative change nor a
(v) ‘processing aid’ means any substance falling within the
minor change;
definition of point (b) of Article 3(2) of Regulation (EC)
No 1333/2008 or point (h) of Article 2(2) of Regulation
(EC) No 1831/2003;
(ad) ‘vulnerable groups’ means persons needing specific
consideration when assessing the acute and chronic
health effects of biocidal products. These include
(w) ‘technical equivalence’ means similarity, as regards the
pregnant and nursing women, the unborn, infants and
chemical composition and hazard profile, of a substance
children, the elderly and, when subject to high exposure
produced either from a source different to the reference
to biocidal products over the long term, workers and resi
source, or from the reference source but following a
dents;
change to the manufacturing process and/or manufacturing
location, compared to the substance of the reference source
(ae) ‘small and medium-sized enterprises’ or ‘SMEs’ means small
in respect of which the initial risk assessment was carried
and medium-sized enterprises as defined in Commission
out, as established in Article 54;
Recommendation 2003/361/EC of 6 May 2003
concerning the definition of micro, small and medium-
sized enterprises ( 1 ).
(x) ‘Agency’ means the European Chemicals Agency estab
lished by Regulation (EC) No 1907/2006;
2. For the purposes of this Regulation, the definitions laid
down in Article 3 of Regulation (EC) No 1907/2006 shall apply
(y) ‘advertisement’ means a means of promoting the sale or
for the following terms:
use of biocidal products by printed, electronic or other
media;
(a) ‘substance’;
(z) ‘nanomaterial’ means a natural or manufactured active
(b) ‘mixture’;
substance or non-active substance containing particles, in
an unbound state or as an aggregate or as an agglomerate
and where, for 50 % or more of the particles in the
(c) ‘article’;
number size distribution, one or more external dimensions
is in the size range 1-100 nm.
(d) ‘product and process-orientated research and development’;
Fullerenes, graphene flakes and single-wall carbon
(e) ‘scientific research and development’.
nanotubes with one or more external dimensions below
1 nm shall be considered as nanomaterials.
( 1 ) OJ L 124, 20.5.2003, p. 36.

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3. The Commission may, at the request of a Member State,
4. The
approval
of
an
active
substance
shall
not
cover
nano
decide, by means of implementing acts, whether a substance is a
materials except where explicitly mentioned.
nanomaterial, having regard in particular to Commission
Recommendation 2011/696/EU of 18 October 2011 on the
definition of nanomaterial ( 1 ), and whether a specific product
Article 5
or group of products is a biocidal product or a treated article or
neither. Those implementing acts shall be adopted in
Exclusion criteria
accordance with the examination procedure referred to in
1. Subject
to
paragraph
2,
the
following
active
substances
Article 82(3).
shall not be approved:
4. The
Commission
shall
be
empowered
to
adopt
delegated
acts in accordance with Article 83 in order to adapt the defi
(a) active substances which have been classified in accordance
nition of nanomaterial set out in point (z) of paragraph 1 of
with Regulation (EC) No 1272/2008 as, or which meet the
this Article in view of technical and scientific progress and
criteria to be classified as, carcinogen category 1A or 1B;
taking into account the Recommendation 2011/696/EU.
(b) active substances which have been classified in accordance
CHAPTER II
with Regulation (EC) No 1272/2008 as, or which meet the
APPROVAL OF ACTIVE SUBSTANCES
criteria to be classified as, mutagen category 1A or 1B;
Article 4
Conditions for approval
(c) active substances which have been classified in accordance
with Regulation (EC) No 1272/2008 as, or which meet the
1. An
active
substance
shall
be
approved
for
an
initial
period
criteria to be classified as, toxic for reproduction category
not exceeding 10 years if at least one biocidal product
1A or 1B;
containing that active substance may be expected to meet the
criteria laid down in point (b) of Article 19(1) taking into
account the factors set out in Article 19(2) and (5). An active
(d) active substances which, on the basis of the criteria specified
substance that falls under Article 5 may only be approved for
pursuant to the first subparagraph of paragraph 3 or,
an initial period not exceeding five years.
pending the adoption of those criteria, on the basis of the
second and third subparagraphs of paragraph 3, are
considered as having endocrine-disrupting properties that
2. The
approval
of
an
active
substance
shall
be
restricted
to
may cause adverse effects in humans or which are identified
those product-types for which relevant data have been
in accordance with Articles 57(f) and 59(1) of Regulation
submitted in accordance with Article 6.
(EC) No 1907/2006 as having endocrine disrupting prop
erties;
3. The
approval
shall
specify
the
following
conditions,
as
appropriate:
(e) active substances which meet the criteria for being PBT or
vPvB according to Annex XIII to Regulation (EC)
(a) the minimum degree of purity of the active substance;
No 1907/2006.
(b) the nature and maximum content of certain impurities;
2. Without
prejudice
to
Article
4(1),
active
substances
referred to in paragraph 1 of this Article may be approved if
(c) the product-type;
it is shown that at least one of the following conditions is met:
(d) manner and area of use including, where relevant, use in
treated articles;
(a) the risk to humans, animals or the environment from
exposure to the active substance in a biocidal product,
under realistic worst case conditions of use, is negligible,
(e) designation of categories of users;
in particular where the product is used in closed systems
or under other conditions which aim at excluding contact
with humans and release into the environment;
(f) where relevant, characterisation of the chemical identity
with regard to stereoisomers;
(b) it is shown by evidence that the active substance is essential
(g) other particular conditions based on the evaluation of the
to prevent or control a serious danger to human health,
information related to that active substance;
animal health or the environment; or
(h) the date of approval and the expiry date of the approval of
(c) not approving the active substance would have a dispropor
the active substance.
tionate negative impact on society when compared with the
risk to human health, animal health or the environment
( 1 ) OJ L 275, 20.10.2011, p. 38.
arising from the use of the substance.

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When deciding whether an active substance may be approved in
However, sufficient data shall be provided in order to make it
accordance with the first subparagraph, the availability of
possible to determine whether an active substance meets the
suitable and sufficient alternative substances or technologies
criteria referred to in Article 5(1) or Article 10(1), if required
shall be a key consideration.
by the evaluating competent authority under Article 8(2).
The use of a biocidal product containing active substances
3. An
applicant
may
propose
to
adapt
the
data
as
part
of
the
approved in accordance with this paragraph shall be subject
dossiers required under points (a) and (b) of paragraph 1 in
to appropriate risk-mitigation measures to ensure that
accordance with Annex IV. The justification for the proposed
exposure of humans, animals and the environment to those
adaptations to the data requirements shall be clearly stated in
active substances is minimised. The use of the biocidal
the application with a reference to the specific rules in Annex
product with the active substances concerned shall be restricted
IV.
to Member States in which at least one of the conditions set out
in this paragraph is met.
4. The
Commission
shall
be
empowered
to
adopt
delegated
3. No
later
than
13
December
2013,
the
Commission
shall acts in accordance with Article 83 specifying criteria for deter
adopt delegated acts in accordance with Article 83 specifying
mining what constitutes adequate justification to adapt the data
scientific criteria for the determination of endocrine-disrupting
requirements under paragraph 1 of this Article on the grounds
properties.
referred to in point (a) of paragraph 2 of this Article.
Pending the adoption of those criteria, active substances that are
Article 7
classified in accordance with Regulation (EC) No 1272/2008 as,
or meet the criteria to be classified as, carcinogen category 2
Submission and validation of applications
and toxic for reproduction category 2, shall be considered as
1. The
applicant
shall
submit
an
application
for
approval
of
having endocrine-disrupting properties.
an active substance, or for making subsequent amendments to
the conditions of approval of an active substance, to the
Substances such as those that are classified in accordance with
Agency, informing it of the name of the competent authority
Regulation (EC) No 1272/2008 as, or that meet the criteria to
of the Member State that it proposes should evaluate the appli
be classified as, toxic for reproduction category 2 and that have
cation and providing written confirmation that that competent
toxic effects on the endocrine organs, may be considered as
authority agrees to do so. That competent authority shall be the
having endocrine-disrupting properties.
evaluating competent authority.
Article 6
2. The Agency shall inform the applicant of the fees payable
under Article 80(1) and shall reject the application if the
Data requirements for an application
applicant fails to pay the fees within 30 days. It shall inform
1. An
application
for
approval
of
an
active
substance
shall the applicant and the evaluating competent authority accord
contain at least the following elements:
ingly.
(a) a dossier for the active substance satisfying the requirements
Upon receipt of the fees payable under Article 80(1), the
set out in Annex II;
Agency shall accept the application and inform the applicant
and the evaluating competent authority accordingly, indicating
the date of the acceptance of the application and its unique
(b) a dossier satisfying the requirements set out in Annex III for
identification code.
at least one representative biocidal product that contains the
active substance; and
3. Within
30
days
of
the
Agency
accepting
an
application,
(c) if the active substance meets at least one of the exclusion
the evaluating competent authority shall validate the application
criteria listed in Article 5(1), evidence that Article 5(2) is
if the data required in accordance with points (a) and (b) and,
applicable.
where relevant, point (c) of Article 6(1), and any justifications
for the adaptation of data requirements, have been submitted.
2. Notwithstanding
paragraph
1,
the
applicant
need
not
provide data as part of the dossiers required under points (a)
In the context of the validation referred to in the first subpara
and (b) of paragraph 1 where any of the following applies:
graph, the evaluating competent authority shall not make an
assessment of the quality or the adequacy of the data or justifi
cations submitted.
(a) the data are not necessary owing to the exposure associated
with the proposed uses;
The evaluating competent authority shall, as soon as possible
(b) it is not scientifically necessary to supply the data; or
after the Agency has accepted an application, inform the
applicant of the fees payable under Article 80(2) and shall
reject the application if the applicant fails to pay the fees
(c) it is not technically possible to generate the data.
within 30 days. It shall inform the applicant accordingly.

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Official Journal of the European Union
27.6.2012
4. Where
the
evaluating
competent
authority
considers
that the information is received. The suspension shall not exceed
the application is incomplete, it shall inform the applicant as to
180 days in total unless it is justified by the nature of the
what additional information is required for the validation of the
data requested or by exceptional circumstances.
application and shall set a reasonable time limit for the
submission of that information. That time limit shall not
normally exceed 90 days.
3. Where
the
evaluating
competent
authority
considers
that
there are concerns for human health, animal health or the
environment as a result of the cumulative effects from the
use of biocidal products containing the same or different
The evaluating competent authority shall, within 30 days of
active substances, it shall document its concerns in accordance
receipt of the additional information, validate the application
with the requirements of the relevant parts of Section II.3 of
if it determines that the additional information submitted is
Annex XV to Regulation (EC) No 1907/2006 and include this
sufficient to comply with the requirement laid down in
as part of its conclusions.
paragraph 3.
4. Within 270 days of receipt of the conclusions of the
The evaluating competent authority shall reject the application
evaluation, the Agency shall prepare and submit to the
if the applicant fails to submit the requested information within
Commission an opinion on the approval of the active
the deadline and shall inform the applicant and the Agency
substance having regard to the conclusions of the evaluating
accordingly. In such cases, part of the fees paid in accordance
competent authority.
with Article 80(1) and (2) shall be reimbursed.
Article 9
5. On
validating
an
application
in
accordance
with
paragraph
Approval of an active substance
3 or 4, the evaluating competent authority shall without delay
inform the applicant, the Agency and other competent auth
1. The Commission shall, on receipt of the opinion of the
orities accordingly, indicating the date of the validation.
Agency referred to in Article 8(4), either:
(a) adopt an implementing Regulation providing that an active
6. An
appeal
may
be
brought,
in
accordance
with
Article
77,
substance is approved, and under which conditions,
against decisions of the Agency under paragraph 2 of this
including the dates of approval and of expiry of the
Article.
approval; or
(b) in cases where the conditions laid down in Article 4(1) or,
Article 8
where applicable, the conditions set out in Article 5(2), are
Evaluation of applications
not satisfied or where the requisite information and data
have not been submitted within the prescribed period,
1. The
evaluating
competent
authority
shall,
within
365
days
adopt an implementing decision that an active substance
of the validation of an application, evaluate it in accordance
is not approved.
with Articles 4 and 5, including, where relevant, any proposal
to adapt data requirements submitted in accordance with
Article 6(3), and send an assessment report and the conclusions
Those implementing acts shall be adopted in accordance with
of its evaluation to the Agency.
the examination procedure referred to in Article 82(3).
Prior to submitting its conclusions to the Agency, the evaluating
2. Approved
active
substances
shall
be
included
in
a
Union
competent authority shall give the applicant the opportunity to
list of approved active substances. The Commission shall keep
provide written comments on the assessment report and on the
the list up to date and make it electronically available to the
conclusions of the evaluation within 30 days. The evaluating
public.
competent authority shall take due account of those comments
when finalising its evaluation.
Article 10
Active substances which are candidates for substitution
2. Where
it
appears
that
additional
information
is
necessary 1. An active substance shall be considered a candidate for
to carry out the evaluation, the evaluating competent authority
substitution if any of the following conditions are met:
shall ask the applicant to submit such information within a
specified time limit, and shall inform the Agency accordingly.
As specified in the second subparagraph of Article 6(2), the
(a) it meets at least one of the exclusion criteria listed in
evaluating competent authority may, as appropriate, require
Article 5(1) but may be approved in accordance with
the applicant to provide sufficient data to permit a deter
Article 5(2);
mination of whether an active substance meets the criteria
referred to in Article 5(1) or Article 10(1). The 365-day
period referred to in paragraph 1 of this Article shall be
(b) it meets the criteria to be classified, in accordance with
suspended from the date of issue of the request until the date
Regulation (EC) No 1272/2008, as a respiratory sensitiser;

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EN
27.6.2012 Official
Journal
of
the
European
Union L
167/15
(c) its acceptable daily intake, acute reference dose or acceptable
down in Article 4(1) or, where applicable, the conditions set out
operator exposure level, as appropriate, is significantly lower
in Article 5(2).
than those of the majority of approved active substances for
the same product-type and use scenario;
2. In
the
light
of
scientific
and
technical
progress,
the
Commission shall review and, where appropriate, amend the
(d) it meets two of the criteria for being PBT in accordance
conditions specified for the active substance referred to in
with Annex XIII to Regulation (EC) No 1907/2006;
Article 4(3).
(e) there are reasons for concern linked to the nature of the
critical effects which, in combination with the use patterns,
3. The renewal of an approval of an active substance shall be
amount to use that could still cause concern, such as high
for 15 years for all product-types to which the approval applies,
potential of risk to groundwater, even with very restrictive
unless a shorter period is specified in the implementing regu
risk management measures;
lation adopted in accordance with point (a) of Article 14(4)
renewing such an approval.
(f) it contains a significant proportion of non-active isomers or
impurities.
Article 13
Submission and acceptance of applications
2. When
preparing
its
opinion
on
the
approval
or
renewal
of 1. Applicants wishing to seek renewal of the approval of an
the approval of an active substance, the Agency shall examine
active substance for one or more product-types shall submit an
whether the active substance fulfils any of the criteria listed in
application to the Agency at least 550 days before the expiry of
paragraph 1 and address the matter in its opinion.
the approval. Where there are different expiry dates for different
product-types, the application shall be submitted at least 550
days before the earliest expiry date.
3. Prior
to
submitting
its
opinion
on
the
approval
or
renewal
of the approval of an active substance to the Commission, the
Agency shall make publicly available, without prejudice to
2. When applying for the renewal of the approval of the
Articles 66 and 67, information on potential candidates for
active substance, the applicant shall submit:
substitution during a period of no more than 60 days, during
which time interested third parties may submit relevant
information, including information on available substitutes.
(a) without prejudice to Article 21(1), all relevant data required
The Agency shall take due account of the information
under Article 20 that it has generated since the initial
received when finalising its opinion.
approval or, as appropriate, previous renewal; and
4. By
way
of
derogation
from
Article
4(1)
and
Article
12(3),
the approval of an active substance that is considered as a
(b) its assessment of whether the conclusions of the initial or
candidate for substitution and each renewal shall be for a
previous assessment of the active substance remain valid
period not exceeding seven years.
and any supporting information.
5. Active
substances
that
are
considered
as
candidates
for
3. The applicant shall also submit the name of the
substitution in accordance with paragraph 1 shall be identified
competent authority of the Member State that it proposes
as such in the relevant Regulation adopted in accordance with
should evaluate the application for renewal and provide
Article 9.
written confirmation that that competent authority agrees to
do so. That competent authority shall be the evaluating
competent authority.
Article 11
Technical guidance notes
The Agency shall inform the applicant of the fees payable under
The Commission shall draw up technical guidance notes to
Article 80(1) and shall reject the application if the applicant fails
facilitate the implementation of this Chapter, in particular
to pay the fees within 30 days. It shall inform the applicant and
Article 5(2) and Article 10(1).
the evaluating competent authority accordingly.
CHAPTER III
Upon receipt of the fees payable under Article 80(1), the
RENEWAL AND REVIEW OF APPROVAL OF AN ACTIVE
Agency shall accept the application and inform the applicant
SUBSTANCE
and the evaluating competent authority accordingly, indicating
the date of the acceptance.
Article 12
Conditions for renewal
4. An
appeal
may
be
brought,
in
accordance
with
Article
77,
1. The
Commission
shall
renew
the
approval
of
an
active against decisions of the Agency under paragraph 3 of this
substance if the active substance still meets the conditions laid
Article.

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L 167/16
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Official Journal of the European Union
27.6.2012
Article 14
examine the application. Those implementing acts shall be
adopted in accordance with the advisory procedure referred to
Evaluation of applications for renewal
in Article 82(2).
1. On the basis of an assessment of the available information
and the need to review the conclusions of the initial evaluation
of the application for approval or, as appropriate, the previous
renewal, the evaluating competent authority shall, within 90
6. Where
the
Commission
decides
not
to
renew
or
decides
days of the Agency accepting an application in accordance
to amend the approval of an active substance for one or more
with Article 13(3), decide whether, in the light of current
product-types, the Member States or, in the case of a Union
scientific knowledge, a full evaluation of the application for
authorisation, the Commission shall cancel or, where appro
renewal is necessary taking account of all product-types for
priate, amend the authorisations of biocidal products of the
which renewal is requested.
product-type(s) concerned containing that active substance.
Articles 48 and 52 shall apply accordingly.
2. Where
the
evaluating
competent
authority
decides
that
a
full evaluation of the application is necessary, the evaluation
shall be carried out in accordance with paragraphs 1, 2 and 3
Article 15
of Article 8.
Review of approval of an active substance
1. The
Commission
may
review
the
approval
of
an
active
Where the evaluating competent authority decides that a full
substance for one or more product-types at any time where
evaluation of the application is not necessary, it shall, within
there are significant indications that the conditions laid down
180 days of the Agency accepting the application in accordance
in Article 4(1) or, where applicable, the conditions set out in
with Article 13(3), prepare and submit to the Agency a recom
Article 5(2) are no longer met. The Commission may also
mendation on the renewal of the approval of the active
review the approval of an active substance for one or more
substance. It shall provide the applicant with a copy of its
product-types at the request of a Member State if there are
recommendation.
indications that the use of the active substance in biocidal
products or treated articles raises significant concerns about
the safety of such biocidal products or treated articles. The
The evaluating competent authority shall, as soon as possible
Commission shall make publicly available the information
after the Agency has accepted an application, notify the
that it is carrying out a review and shall provide an opportunity
applicant of the fees payable under Article 80(2). The evaluating
for applicant to submit comments. The Commission shall take
competent authority shall reject the application if the applicant
due account of those comments in its review.
fails to pay the fees within 30 days of the notification and shall
inform the applicant accordingly.
Where those indications are confirmed, the Commission shall
3. Within
270
days
of
receipt
of
a
recommendation
from
the adopt an implementing Regulation amending the conditions of
evaluating competent authority, if it has carried out a full
approval of an active substance or cancelling its approval. That
evaluation of the application, or 90 days otherwise, the
implementing Regulation shall be adopted in accordance with
Agency shall prepare and submit to the Commission an
the examination procedure referred to in Article 82(3).
opinion on renewal of the approval of the active substance.
Article 9(2) shall apply. The Commission shall inform the
initial applicants for the approval accordingly.
4. The Commission shall, on receipt of the opinion of the
Agency, adopt:
On duly justified imperative grounds of urgency the
(a) an implementing regulation providing that the approval of
Commission shall adopt immediately applicable implementing
an active substance is renewed for one or more product-
acts in accordance with the procedure referred to in
types, and under which conditions; or
Article 82(4).
(b) an implementing decision that the approval of an active
substance is not renewed.
2. The
Commission
may
consult
the
Agency
on
any
questions of a scientific or technical nature related to the
review of approval of an active substance. The Agency shall,
Those implementing acts shall be adopted in accordance with
within 270 days of the request, prepare an opinion and submit
the examination procedure referred to in Article 82(3).
it to the Commission.
Article 9(2) shall apply.
3. Where
the
Commission
decides
to
cancel
or
amend
the
approval of an active substance for one or more product-types,
5. Where, for reasons beyond the control of the applicant,
the Member States or, in the case of a Union authorisation, the
the approval of the active substance is likely to expire before a
Commission shall cancel or, where appropriate, amend the
decision has been taken on its renewal, the Commission shall,
authorisations of biocidal products of the product-type(s)
by means of implementing acts, adopt a decision postponing
concerned containing that active substance. Articles 48 and
the expiry date of approval for a period sufficient to enable it to
52 shall apply accordingly.

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27.6.2012 Official
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of
the
European
Union L
167/17
Article 16
6. The
authorisation
holder
shall
notify
each
competent
authority that has granted a national authorisation for a
Implementing measures
biocidal product family of each product within the biocidal
The Commission may adopt, by means of implementing acts,
product family at least 30 days before placing it on the
detailed measures for the implementation of Articles 12 to 15,
market, except where a particular product is explicitly identified
further specifying the procedures for the renewal and review of
in the authorisation or the variation in composition concerns
the approval of an active substance. Those implementing acts
only pigments, perfumes and dyes within the permitted vari
shall be adopted in accordance with the examination procedure
ations. The notification shall indicate the exact composition,
referred to in Article 82(3).
trade name and suffix to the authorisation number. In the
case of a Union authorisation, the authorisation holder shall
notify the Agency and the Commission.
CHAPTER IV
GENERAL PRINCIPLES CONCERNING THE AUTHORISATION
7. The
Commission
shall,
by
means
of
an
implementing
act,
OF BIOCIDAL PRODUCTS
specify procedures for the authorisation of the same biocidal
Article 17
products by the same or different enterprises under the same
terms and conditions. That implementing act shall be adopted
Making available on the market and use of biocidal
in accordance with the examination procedure referred to in
products
Article 82(3).
1. Biocidal
products
shall
not
be
made
available
on
the
market or used unless authorised in accordance with this Regu
lation.
Article 18
Measures geared to the sustainable use of biocidal products
2. Applications
for
authorisation
shall
be
made
by,
or
on
By 18 July 2015 the Commission shall, on the basis of
behalf of, the prospective authorisation holder.
experience gained with the application of this Regulation,
submit to the European Parliament and the Council a report
on how this Regulation is contributing to the sustainable use of
Applications for national authorisation in a Member State shall
biocidal products, including on the need to introduce additional
be submitted to the competent authority of that Member State
measures, in particular for professional users, to reduce the risks
(‘the receiving competent authority’).
posed to human health, animal health and the environment by
biocidal products. That report shall, inter alia, examine:
Applications for Union authorisation shall be submitted to the
Agency.
(a) the promotion of best practices as a means of reducing the
use of biocidal products to a minimum;
3. An
authorisation
may
be
granted
for
a
single
biocidal
product or a biocidal product family.
(b) the most effective approaches for monitoring the use of
biocidal products;
4. An
authorisation
shall
be
granted
for
a
maximum
period
of 10 years.
(c) the development and application of integrated pest
management principles with respect to the use of biocidal
products;
5. Biocidal
products
shall
be
used
in
compliance
with
the
terms and conditions of the authorisation stipulated in
accordance with Article 22(1) and the labelling and packaging
requirements laid down in Article 69.
(d) the risks posed by the use of biocidal products in specific
areas such as schools, workplaces, kindergartens, public
spaces, geriatric care centres or in the vicinity of surface
water or groundwater and whether additional measures
Proper use shall involve the rational application of a
are needed to address those risks;
combination of physical, biological, chemical or other
measures as appropriate, whereby the use of biocidal products
is limited to the minimum nece