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 
EUROPEAN UNION,  
Having regard to the Treaty on the Functioning of the European 
Union, and in particular Article 114 thereof,  
Having regard to the proposal from the European Commission,  
Having regard to the opinion of the European Economic and 
Social Committee (  1 ), 
Acting in accordance with the ordinary legislative procedure (  2 ), 
Whereas:  
(1) Biocidal products are necessary for the control of 
organisms that are harmful to human or animal health 
and for the control of organisms that cause damage to 
natural or manufactured materials. However, biocidal 
products can pose risks to humans, animals and the 
environment due to their intrinsic properties and 
associated use patterns.  
(2) Biocidal products should neither be made available on 
the market nor used unless authorised in accordance 
with this Regulation. Treated articles should not be placed on the market unless all active substances 
contained in the biocidal products with which they 
were treated or which they incorporate are approved in 
accordance with this Regulation.  
(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 
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 
ensure that the manufacturing and making available on 
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 
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 
parallel trade.  
(4) To ensure a high level of protection for human health, 
animal health and the environment, this Regulation 
should apply without prejudice to Union legislation on 
safety in the workplace and environmental and consumer 
protection.  
(5) Rules concerning the making available on the market of 
biocidal products within the Community were established 
by Directive 98/8/EC of the European Parliament and of 
the Council (  3 ). It is necessary to adapt those rules in the 
light of experience and in particular the report on the 
first seven years of the implementation submitted by the 
Commission to the European Parliament and the Council, 
which analyses problems with and weaknesses of that 
Directive.EN 27.6.2012 Official Journal of the European Union L 167/1  
( 1 ) OJ C 347, 18.12.2010, p. 62.  
( 2 ) Position of the European Parliament of 22 September 2010 
(OJ C 50 E, 21.2.2012, p. 73) and position of the Council at first 
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.
Ref. Ares(2013)71006 - 21/01/2013(6) Taking into account the main changes that should be 
made to the existing rules, a regulation is the appropriate 
legal instrument to replace Directive 98/8/EC to lay 
down clear, detailed and directly applicable rules. 
Moreover, a regulation ensures that legal requirements 
are implemented at the same time and in a harmonised 
manner throughout the Union.  
(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 
98/8/EC and new active substances which were not yet 
on the market in biocidal products on that date. During 
the ongoing review of existing active substances, Member 
States should continue to allow biocidal products 
containing such substances to be made available on the 
market according to their national rules until a decision 
is taken on approval of those active substances. 
Following such a decision Member States, or, where 
appropriate, the Commission, should grant, cancel or 
modify authorisations as appropriate. New active 
substances should be reviewed before biocidal products 
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 
substances, the evaluation procedure for new active 
substances should not prevent Member States or the 
Commission from authorising, for a limited period of 
time, biocidal products containing an active substance 
before it is approved, provided that a full dossier has 
been submitted and it is believed that the active 
substance and the biocidal product satisfy the conditions 
set out in this Regulation.  
(8) To ensure the equal treatment of persons placing active 
substances on the market, they should be required to 
hold a dossier, or have a letter of access to a dossier, 
or to relevant data in a dossier, for each of the active 
substances they manufacture or import for use in 
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 
existing stocks of biocidal products.  
(9) This Regulation should apply to biocidal products that, in 
the form in which they are supplied to the user, consist 
of, contain or generate one or more active substances.  
(10) In order to ensure legal certainty, it is necessary to 
establish a Union list of active substances approved for 
use in biocidal products. A procedure should be laid 
down for assessing whether or not an active substance 
can be entered in that list. The information that 
interested parties should submit in support of an appli ­
cation for approval of an active substance and its 
inclusion in the list should be specified.  (11) This Regulation applies without prejudice to Regulation 
(EC) No 1907/2006 of the European Parliament and of 
the Council of 18 December 2006 concerning the Regis ­
tration, Evaluation, Authorisation and Restriction of 
Chemicals (REACH) and establishing a European 
Chemicals Agency (  1 ). Under certain conditions, biocidal 
active substances are exempt from the relevant provisions 
of that Regulation.  
(12) With a view to achieving a high level of protection of 
human health, animal health and the environment, active 
substances with the worst hazard profiles should not be 
approved for use in biocidal products except in specific 
situations. These should include situations when approval 
is justified because of the negligible risk from exposure to 
the substance, human health, animal health or environ ­
mental reasons or the disproportionate negative impact 
for society of non-approval. When deciding if such active 
substances may be approved, the availability of suitable 
and sufficient alternative substances or technologies 
should also be taken into account.  
(13) The active substances in the Union list should be 
regularly examined to take account of developments in 
science and technology. Where there are significant indi ­
cations that an active substance used in biocidal products 
or treated articles does not meet the requirements of this 
Regulation, the Commission should be able to review the 
approval of the active substance.  
(14) Active substances should be designated as candidates for 
substitution if they have certain intrinsic hazardous prop ­
erties. In order to allow for a regular examination of 
substances identified as candidates for substitution, the 
approval period for those substances should not, even 
in the case of renewal, exceed seven years.  
(15) In the course of granting or renewing the authorisation 
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 
prevention methods with regard to risks they pose and 
benefits from their use. As a result of such a comparative 
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- 
chemical control or prevention methods that present a 
significantly lower overall risk for human health, animal 
health and the environment, are sufficiently effective and 
present no other significant economic or practical 
disadvantages. Appropriate phase-out periods should be 
provided for in such cases.EN L 167/2 Official Journal of the European Union 27.6.2012  
( 1 ) OJ L 396, 30.12.2006, p. 1.(16) In order to avoid unnecessary administrative and 
financial burdens for industry and competent authorities, 
a full in-depth evaluation of an application to renew the 
approval of an active substance or the authorisation of a 
biocidal product should be carried out only if the 
competent authority that was responsible for the initial 
evaluation decides that this is necessary on the basis of 
the available information.  
(17) There is a need to ensure effective coordination and 
management of the technical, scientific and adminis ­
trative aspects of this Regulation at Union level. The 
European Chemicals Agency set up under Regulation 
(EC) No 1907/2006 (‘the Agency’) should carry out 
specified tasks with regard to the evaluation of active 
substances as well as the Union authorisation of certain 
categories of biocidal products and related tasks. 
Consequently, a Biocidal Products Committee should be 
established within the Agency to carry out certain tasks 
conferred on the Agency by this Regulation.  
(18) Certain biocidal products and treated articles as defined 
in the Regulation are also regulated by other Union legis ­
lation. It is therefore necessary to draw clear borderlines 
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.  
(19) Biocidal products intended to be used not only for the 
purposes of this Regulation, but also in connection with 
medical devices, such as disinfectants used to disinfect 
surfaces in hospitals and medical devices, may pose 
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 
set out in Annex I to Council Directive 90/385/EEC of 
20 June 1990 on the approximation of the laws of the 
Member States relating to active implantable medical 
devices (  1 ), Council Directive 93/42/EEC of 14 June 
1993 concerning medical devices (  2 ) and Directive 
98/79/EC of the European Parliament and of the 
Council of 27 October 1998 on in vitro diagnostic 
medical devices (  3 ). 
(20) Where a product has a biocidal function that is inherent 
to its cosmetic function, or where that biocidal function 
is considered to be a secondary claim of a cosmetic 
product and is therefore regulated under Regulation 
(EC) No 1223/2009 of the European Parliament and of 
the Council of 30 November 2009 on cosmetic prod ­
ucts (  4 ), that function and the product should remain 
outside the scope of this Regulation.  (21) The safety of food and feed is subject to Union legis ­
lation, in particular Regulation (EC) No 178/2002 of the 
European Parliament and of the Council of 28 January 
2002 laying down the general principles and 
requirements of food law, establishing the European 
Food Safety Authority and laying down procedures in 
matters of food safety (  5 ). Therefore, the present Regu ­
lation should not apply to food and feed used as 
repellents or attractants.  
(22) Processing aids are covered by existing Union legislation, 
in particular Regulation (EC) No 1831/2003 of the 
European Parliament and of the Council of 22 September 
2003 on additives for use in animal nutrition (  6 ) and 
Regulation (EC) No 1333/2008 of the European 
Parliament and of the Council of 16 December 2008 
on food additives (  7 ). Therefore, it is appropriate to 
exclude them from the scope of this Regulation.  
(23) As products used for the preservation of food or feed by 
the control of harmful organisms, previously covered by 
product-type 20, are covered by Regulation (EC) 
No 1831/2003 and Regulation (EC) No 1333/2008, it 
is not appropriate to maintain that product-type.  
(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 
by ballast water management systems, the final approval 
and subsequent type-approval of such systems should be 
considered equivalent to the product authorisation 
required under this Regulation.  
(25) To avoid possible negative effects on the environment, 
biocidal products that can no longer lawfully be made 
available on the market should be dealt with in 
accordance with Union legislation on waste, in particular 
Directive 2008/98/EC of the European Parliament and of 
the Council of 19 November 2008 on waste (  8 ), as well 
as national legislation implementing that legislation.  
(26) To facilitate the making available on the market 
throughout the Union of certain biocidal products with 
similar conditions of use in all Member States, it is 
appropriate to provide for Union authorisation of those 
products. In order to allow some time for the Agency to 
build up the necessary capacity and to gain experience 
with this procedure, the possibility to apply for Union 
authorisation should be extended through a step-wise 
approach to further categories of biocidal products with 
similar conditions of use in all Member States.EN 27.6.2012 Official Journal of the European Union L 167/3  
( 1 ) OJ L 189, 20.7.1990, p. 17.  
( 2 ) OJ L 169, 12.7.1993, p. 1.  
( 3 ) OJ L 331, 7.12.1998, p. 1.  
( 4 ) OJ L 342, 22.12.2009, p. 59.  ( 5 ) OJ L 31, 1.2.2002, p. 1.  
( 6 ) OJ L 268, 18.10.2003, p. 29.  
( 7 ) OJ L 354, 31.12.2008, p. 16.  
( 8 ) OJ L 312, 22.11.2008, p. 3.(27) The Commission should review experience with the 
provisions on Union authorisations and report to the 
European Parliament and the Council by 31 December 
2017, accompanying its report with proposals for 
changes if appropriate.  
(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 
for making available on the market and use within the 
territory of a Member State or part of it, or by the 
Commission for making available on the market and 
use within the Union.  
(29) To encourage the use of products with a more favourable 
environmental or human or animal health profile, it is 
appropriate to provide for simplified authorisation 
procedures for such biocidal products. Once authorised 
in at least one Member State, those products should be 
allowed to be made available on the market in all 
Member States without the need for mutual recognition, 
under certain conditions.  
(30) To identify biocidal products which are eligible for 
simplified authorisation procedures, it is appropriate to 
establish a specific list of the active substances that those 
products may contain. That list should, initially, contain 
substances identified as presenting a low risk under 
Regulation (EC) No 1907/2006 or Directive 98/8/EC, 
substances identified as food additives, pheromones and 
other substances considered to have low toxicity, such as 
weak acids, alcohols and vegetable oils used in cosmetics 
and food.  
(31) It is necessary to provide common principles for the 
evaluation and authorisation of biocidal products to 
ensure a harmonised approach by competent authorities.  
(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 
products in which they are contained is necessary so as 
to assist both applicants seeking authorisation and 
competent authorities carrying out an evaluation to 
decide on authorisation.  
(33) In the light of the diversity of both active substances and 
biocidal products not subject to the simplified authori ­
sation procedure, the data and test requirements should 
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 
which are not necessary or are impossible to submit in 
view of the nature or the proposed uses of the product. 
Applicants should provide appropriate technical and 
scientific justification to support their requests.  (34) In order to help applicants, and in particular small and 
medium-sized enterprises (SMEs), to comply with the 
requirements of this Regulation, Member States should 
provide advice, for example by establishing helpdesks. 
This advice should be in addition to the operational 
guidance documents and other advice and assistance 
provided by the Agency.  
(35) In particular, to ensure that applicants can effectively 
exercise the right to request the adaptation of data 
requirements, Member States should provide advice on 
this possibility and the grounds on which such requests 
could be made.  
(36) To facilitate access to the market it should be possible to 
authorise a group of biocidal products as a biocidal 
product family. Biocidal products within a biocidal 
product family should have similar uses and the same 
active substances. Variations in the composition or the 
replacement of non-active substances should be specified, 
but may not adversely affect the level of risk or signifi ­
cantly reduce the efficacy of the products.  
(37) When authorising biocidal products it is necessary to 
ensure that, when properly used for the purpose 
intended, they are sufficiently effective and have no 
unacceptable effect on the target organisms such as resis ­
tance, or, in the case of vertebrates, unnecessary suffering 
and pain. Furthermore, they may not have, in the light of 
current scientific and technical knowledge, any 
unacceptable effect on human health, animal health or 
on the environment. Where appropriate, maximum 
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. 
When these requirements are not met, biocidal 
products shall not be authorised unless their authori ­
sation is justified because of the disproportionate 
negative impact for society of not authorising them 
when compared to the risks arising from their use.  
(38) Where possible, the presence of harmful organisms 
should be avoided by means of suitable precautionary 
steps, such as proper warehousing of goods, compliance 
with relevant hygiene standards and immediate disposal 
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 
harm, kill or destroy animals that are capable of experi ­
encing pain and distress should be used only as a last 
resort.  
(39) Some authorised biocidal products may present certain 
risks if used by the general public. It is therefore appro ­
priate to provide that certain biocidal products should 
not generally be authorised for making available on the 
market for use by the general public.EN L 167/4 Official Journal of the European Union 27.6.2012(40) To avoid duplication of the evaluation procedures and to 
ensure free movement of biocidal products within the 
Union, procedures should be established to ensure that 
product authorisations granted in one Member State are 
recognised in other Member States.  
(41) To enable closer cooperation between Member States in 
the evaluation of biocidal products and to facilitate 
biocidal products’ market access, it should be possible 
to launch the mutual recognition procedure when 
applying for the first national authorisation.  
(42) It is appropriate to lay down procedures for the mutual 
recognition of national authorisations and, in particular, 
to resolve any disagreements without undue delay. If a 
competent authority refuses mutual recognition of an 
authorisation or proposes to restrict it, a coordination 
group should try to reach an agreement on the action 
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 
may consult the Agency before preparing its decision.  
(43) However, considerations related to public policy or 
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’ 
refusal to grant an authorisation or decision to adjust the 
terms and conditions of the authorisation to be granted. 
If no agreement with the applicant can be found, the 
Commission should be empowered to take a decision.  
(44) The use of biocidal products of certain product-types 
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 ­
gations are justified and do not jeopardise the purpose of 
this Regulation regarding an appropriate level of 
protection of the internal market.  
(45) In order to facilitate the functioning of the authorisation 
and mutual recognition procedures, it is appropriate to 
establish a system for the mutual exchange of 
information. To accomplish this, a Register for Biocidal 
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 
applications for authorisation of biocidal products.  
(46) If the use of a biocidal product is in the interests of a 
Member State, but there is no applicant interested in 
making available on the market such a product in the Member State, official or scientific bodies should be able 
to apply for an authorisation. If they are granted an 
authorisation, they should have the same rights and 
obligations as any other authorisation holder.  
(47) To take account of scientific and technical developments 
as well as the needs of authorisation holders, it is appro ­
priate to specify under which conditions authorisations 
can be cancelled, reviewed or amended. The notification 
and exchange of information which may affect authori ­
sations is also necessary to enable competent authorities 
and the Commission to take appropriate action.  
(48) In the event of an unforeseen danger threatening public 
health or the environment which cannot be contained by 
other means, it should be possible for Member States to 
permit, for a limited period of time, the making available 
on the market of biocidal products which do not comply 
with the requirements of this Regulation.  
(49) To encourage research and development in active 
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 
research and development.  
(50) In view of the benefits for the internal market and for the 
consumer, it is desirable to establish harmonised rules for 
parallel trade in identical biocidal products authorised in 
different Member States.  
(51) To determine, where necessary, the similarity of active 
substances, it is appropriate to lay down rules concerning 
technical equivalence.  
(52) To protect human health, animal health and the 
environment, and to avoid discrimination between 
treated articles originating in the Union and treated 
articles imported from third countries, all treated 
articles placed on the internal market should contain 
only approved active substances.  
(53) To enable consumers to make informed choices, to 
facilitate enforcement and to provide an overview of 
their use, treated articles should be appropriately labelled.  
(54) Applicants that have invested in supporting the approval 
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 
whenever use of proprietary information which they 
submitted in support of such approval or authorisation 
is made for the benefit of subsequent applicants.EN 27.6.2012 Official Journal of the European Union L 167/5(55) With a view to ensuring that all proprietary information 
submitted in support of the approval of an active 
substance or the authorisation of a biocidal product is 
protected from the moment of its submission and to 
prevent situations where some information is without 
protection, the data protection periods should also 
apply to information submitted for the purposes of 
Directive 98/8/EC.  
(56) To encourage the development of new active substances 
and biocidal products containing them, it is necessary to 
provide for a period of protection with respect to the 
proprietary information submitted in support of the 
approval of such active substances or the authorisation 
of biocidal products containing them which is longer 
than the period of protection for information concerning 
existing active substances and biocidal products 
containing them.  
(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 
out only when the purpose and use of a product so 
requires. Applicants should share, and not duplicate, 
studies on vertebrates in exchange for equitable compen ­
sation. In the absence of an agreement on sharing of 
studies on vertebrates between the data owner and the 
prospective applicant, the Agency should allow the use of 
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 
such studies via a Union register so as to inform pros ­
pective applicants.  
(58) A level playing field should be established as quickly as 
possible on the market for existing active substances, 
taking into account the objectives of reducing 
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 
borne by data owners.  
(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 
encouraged. In addition, the adaptation of data 
requirements should be used to prevent unnecessary 
costs related to testing.  
(60) To ensure that the requirements laid down with respect 
to the safety and quality of authorised biocidal products 
are satisfied when they are made available on the market, 
Member States should take measures for appropriate 
control and inspection arrangements and manufacturers should maintain a suitable and proportionate quality 
control system. To this end, it may be appropriate for 
Member States to take action together.  
(61) Effective communication of information on risks 
resulting from biocidal products and risk management 
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 ­
tiality and avoid any disclosure of information which 
could be harmful to the commercial interests of the 
person concerned, except where it is necessary for the 
protection of human health, safety or the environment or 
for other reasons of overriding public interest.  
(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.  
(63) It is necessary to specify that provisions concerning the 
Agency laid down in Regulation (EC) No 1907/2006 
should apply accordingly in the context of biocidal 
active substances and products. Where separate 
provisions need to be made with respect to the tasks 
and functioning of the Agency under this Regulation, 
they should be specified in this Regulation.  
(64) The costs of the procedures associated with the operation 
of this Regulation need to be recovered from those 
making biocidal products available on the market and 
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 
fees payable to the Agency and to Member States’ 
competent authorities, including the need to take into 
account, as appropriate, the specific needs of SMEs.  
(65) It is necessary to provide for the possibility of an appeal 
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.  
(66) There is scientific uncertainty about the safety of nano ­
materials for human health, animal health and the 
environment. In order to ensure a high level of 
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 
forums and to specify that the approval of an active 
substance does not include the nanomaterial form 
unless explicitly mentioned. The Commission should 
regularly review the provisions on nanomaterials in the 
light of scientific progress.EN L 167/6 Official Journal of the European Union 27.6.2012(67) To ensure a smooth transition, it is appropriate to 
provide for a deferred application of this Regulation 
and to provide for specific measures concerning the 
assessment of applications for the approval of active 
substances and authorisation of biocidal products 
submitted before the application of this Regulation.  
(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 ­
lation. However, in view of the high number of historical 
dossiers it is appropriate to allow some time for the 
Agency to prepare for the new tasks related to dossiers 
submitted under Directive 98/8/EC.  
(69) To respect the legitimate expectations of companies with 
respect to the placing on the market and use of low-risk 
biocidal products covered by Directive 98/8/EC, those 
companies should be allowed to make such products 
available on the market if they comply with the rules 
on the registration of low-risk biocidal products under 
that Directive. However, this Regulation should apply 
after the expiry of the first registration.  
(70) Taking into consideration that some products were not 
covered by Community legislation on biocidal products, 
it is appropriate to provide for transitional periods for 
such products and treated articles.  
(71) This Regulation should take account, as appropriate, of 
other work programmes concerned with the review or 
authorisation of substances and products, or relevant 
international Conventions. In particular, it should 
contribute to the fulfilment of the Strategic Approach 
to International Chemicals Management adopted on 
6 February 2006 in Dubai.  
(72) In order to supplement or amend this Regulation, the 
power to adopt acts in accordance with Article 290 of 
the Treaty on the Functioning of the European Union 
should be delegated to the Commission in respect of 
certain non-essential elements of this Regulation. It is 
of particular importance that the Commission carry out 
appropriate consultations during its preparatory work, 
including at expert level. The Commission, when 
preparing and drawing up delegated acts, should ensure 
a simultaneous, timely and appropriate transmission of 
relevant documents to the European Parliament and to 
the Council.  
(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 
removal of an active substance from that Annex, 
imperative grounds of urgency so require.  (74) In order to ensure uniform conditions for the implemen ­
tation of this Regulation, implementing powers should be 
conferred on the Commission. Those powers should be 
exercised in accordance with Regulation (EU) 
No 182/2011 of the European Parliament and of the 
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 ). 
(75) The Commission should adopt immediately applicable 
implementing acts where, in duly justified cases relating 
to the approval of an active substance or to the 
cancelling of an approval, imperative grounds of 
urgency so require.  
(76) Since the objective of this Regulation, namely, to 
improve the functioning of the internal market for 
biocidal products, whilst ensuring a high level of 
protection of both human and animal health and the 
environment cannot be sufficiently achieved by the 
Member States, and can therefore, by reason of its 
scale and effects, be better achieved at Union level, the 
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, 
this Regulation does not go beyond what is necessary 
in order to achieve that objective,  
HAVE ADOPTED THIS REGULATION:  
CHAPTER I  
SCOPE AND DEFINITIONS  
Article 1  
Purpose and subject matter  
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 
biocidal products, whilst ensuring a high level of protection of 
both human and animal health and the environment. The 
provisions of this Regulation are underpinned by the 
precautionary principle, the aim of which is to safeguard the 
health of humans, the health of animals and the environment. 
Particular attention shall be paid to the protection of vulnerable 
groups.  
2. This Regulation lays down rules for:  
(a) the establishment at Union level of a list of active 
substances which may be used in biocidal products;  
(b) the authorisation of biocidal products;EN 27.6.2012 Official Journal of the European Union L 167/7  
( 1 ) OJ L 55, 28.2.2011, p. 13.(c) the mutual recognition of authorisations within the Union;  
(d) the making available on the market and the use of biocidal 
products within one or more Member States or the Union;  
(e) the placing on the market of treated articles.  
Article 2  
Scope  
1. This Regulation shall apply to biocidal products and 
treated articles. A list of the types of biocidal products 
covered by this Regulation and their descriptions is set out in 
Annex V.  
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 
scope of the following instruments:  
(a) Council Directive 90/167/EEC of 26 March 1990 laying 
down the conditions governing the preparation, placing 
on the market and use of medicated feedingstuffs in the 
Community (  1 ); 
(b) Directive 90/385/EEC, Directive 93/42/EEC and Directive 
98/79/EC;  
(c) Directive 2001/82/EC of the European Parliament and of 
the Council of 6 November 2001 on the Community 
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 
medicinal products for human use (  3 ) and Regulation (EC) 
No 726/2004 of the European Parliament and of the 
Council of 31 March 2004 laying down Community 
procedures for the authorisation and supervision of 
medicinal products for human and veterinary use and estab ­
lishing a European Medicines Agency (  4 ); 
(d) Regulation (EC) No 1831/2003;  
(e) Regulation (EC) No 852/2004 of the European Parliament 
and of the Council of 29 April 2004 on the hygiene of 
foodstuffs (  5 ) and Regulation (EC) No 853/2004 of the 
European Parliament and of the Council of 29 April 2004 
laying down specific hygiene rules for food of animal 
origin (  6 ); 
(f) Regulation (EC) No 1333/2008;  (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 
use in and on foods (  7 ); 
(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 ); 
(i) Regulation (EC) No 1107/2009 of the European Parliament 
and of the Council of 21 October 2009 concerning the 
placing of plant protection products on the market (  9 ); 
(j) Regulation (EC) No 1223/2009;  
(k) Directive 2009/48/EC of the European Parliament and of 
the Council of 18 June 2009 on the safety of toys (  10 ). 
Notwithstanding the first subparagraph, when a biocidal 
product falls within the scope of one of the abovementioned 
instruments and is intended to be used for purposes not 
covered by those instruments, this Regulation shall also apply 
to that biocidal product insofar as those purposes are not 
addressed by those instruments.  
3. Subject to any explicit provision to the contrary in this 
Regulation or other Union legislation, this Regulation shall be 
without prejudice to the following instruments:  
(a) Council Directive 67/548/EEC of 27 June 1967 on the 
approximation of laws, regulations and administrative 
provisions relating to the classification, packaging and 
labelling of dangerous substances (  11 ); 
(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 (  12 ); 
(c) Council Directive 98/24/EC of 7 April 1998 on the 
protection of the health and safety of workers from the 
risks related to chemical agents at work (  13 ); 
(d) Council Directive 98/83/EC of 3 November 1998 on the 
quality of water intended for human consumption (  14 );EN L 167/8 Official Journal of the European Union 27.6.2012  
( 1 ) OJ L 92, 7.4.1990, p. 42.  
( 2 ) OJ L 311, 28.11.2001, p. 1.  
( 3 ) OJ L 311, 28.11.2001, p. 67.  
( 4 ) OJ L 136, 30.4.2004, p. 1.  
( 5 ) OJ L 139, 30.4.2004, p. 1.  
( 6 ) OJ L 139, 30.4.2004, p. 55.  ( 7 ) OJ L 354, 31.12.2008, p. 34.  
( 8 ) OJ L 229, 1.9.2009, p. 1.  
( 9 ) OJ L 309, 24.11.2009, p. 1.  
( 10 ) OJ L 170, 30.6.2009, p. 1.  
( 11 ) OJ 196, 16.8.1967, p. 1.  
( 12 ) OJ L 183, 29.6.1989, p. 1.  
( 13 ) OJ L 131, 5.5.1998, p. 11.  
( 14 ) OJ L 330, 5.12.1998, p. 32.(e) Directive 1999/45/EC of the European Parliament and of 
the Council of 31 May 1999 concerning the approximation 
of the laws, regulations and administrative provisions of the 
Member States relating to the classification, packaging and 
labelling of dangerous preparations (  1 ); 
(f) Directive 2000/54/EC of the European Parliament and of 
the Council of 18 September 2000 on the protection of 
workers from risks related to exposure to biological agents 
at work (  2 ); 
(g) Directive 2000/60/EC of the European Parliament and of 
the Council of 23 October 2000 establishing a framework 
for Community action in the field of water policy (  3 ); 
(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 
mutagens at work (  4 ); 
(i) Regulation (EC) No 850/2004 of the European Parliament 
and of the Council of 29 April 2004 on persistent organic 
pollutants (  5 ); 
(j) Regulation (EC) No 1907/2006;  
(k) Directive 2006/114/EC of the European Parliament and of 
the Council of 12 December 2006 concerning misleading 
and comparative advertising (  6 ); 
(l) Regulation (EC) No 689/2008 of the European Parliament 
and of the Council of 17 June 2008 concerning the export 
and import of dangerous chemicals (  7 ); 
(m) Regulation (EC) No 1272/2008 of the European Parliament 
and of the Council of 16 December 2008 on classification, 
labelling and packaging of substances and mixtures (  8 ); 
(n) Directive 2009/128/EC of the European Parliament and of 
the Council of 21 October 2009 establishing a framework 
for Community action to achieve the sustainable use of 
pesticides (  9 ); 
(o) Regulation (EC) No 1005/2009 of the European Parliament 
and of the Council of 16 September 2009 on substances 
that deplete the ozone layer (  10 ); (p) Directive 2010/63/EU of the European Parliament and of 
the Council of 22 September 2010 on the protection of 
animals used for scientific purposes (  11 ); 
(q) Directive 2010/75/EU of the European Parliament and of 
the Council of 24 November 2010 on industrial 
emissions (  12 ). 
4. Article 69 shall not apply to the carriage of biocidal 
products by rail, road, inland waterway, sea or air.  
5. This Regulation shall not apply to:  
(a) food or feed used as repellents or attractants;  
(b) biocidal products when used as processing aids.  
6. Biocidal products which obtained final approval under the 
International Convention for the Control and Management of 
Ships’ Ballast Water and Sediments shall be considered as auth ­
orised under Chapter VIII of this Regulation. Articles 47 and 68 
shall apply accordingly.  
7. Nothing in this Regulation shall prevent Member States 
from restricting or banning the use of biocidal products in the 
public supply of drinking water.  
8. Member States may allow for exemptions from this Regu ­
lation in specific cases for certain biocidal products, on their 
own or in a treated article, where necessary in the interests of 
defence.  
9. The disposal of active substances and biocidal products 
shall be carried out in accordance with the Union and 
national waste legislation in force.  
Article 3  
Definitions  
1. For the purposes of this Regulation, the following defi ­
nitions shall apply:  
(a) ‘biocidal product’ means  
— any substance or mixture, in the form in which it is 
supplied to the user, consisting of, containing or 
generating one or more active substances, with the 
intention of destroying, deterring, rendering harmless, 
preventing the action of, or otherwise exerting a 
controlling effect on, any harmful organism by any 
means other than mere physical or mechanical action,EN 27.6.2012 Official Journal of the European Union L 167/9  
( 1 ) OJ L 200, 30.7.1999, p. 1.  
( 2 ) OJ L 262, 17.10.2000, p. 21.  
( 3 ) OJ L 327, 22.12.2000, p. 1.  
( 4 ) OJ L 158, 30.4.2004, p. 50.  
( 5 ) OJ L 158, 30.4.2004, p. 7.  
( 6 ) OJ L 376, 27.12.2006, p. 21.  
( 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.  
( 10 ) OJ L 286, 31.10.2009, p. 1.  ( 11 ) OJ L 276, 20.10.2010, p. 33.  
( 12 ) OJ L 334, 17.12.2010, p. 17.— any substance or mixture, generated from substances or 
mixtures which do not themselves fall under the first 
indent, to be used with the intention of destroying, 
deterring, rendering harmless, preventing the action 
of, or otherwise exerting a controlling effect on, any 
harmful organism by any means other than mere 
physical or mechanical action.  
A treated article that has a primary biocidal function shall 
be considered a biocidal product.  
(b) ‘micro-organism’ means any microbiological entity, cellular 
or non-cellular, capable of replication or of transferring 
genetic material, including lower fungi, viruses, bacteria, 
yeasts, moulds, algae, protozoa and microscopic parasitic 
helminths;  
(c) ‘active substance’ means a substance or a micro-organism 
that has an action on or against harmful organisms;  
(d) ‘existing active substance’ means a substance which was on 
the market on 14 May 2000 as an active substance of a 
biocidal product for purposes other than scientific or 
product and process-orientated research and development;  
(e) ‘new active substance’ means a substance which was not 
on the market on 14 May 2000 as an active substance of a 
biocidal product for purposes other than scientific or 
product and process-orientated research and development;  
(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 
future, on humans, in particular vulnerable groups, 
animals or the environment and is present or is 
produced in a biocidal product in sufficient concentration 
to present risks of such an effect.  
Such a substance would, unless there are other grounds for 
concern, normally be:  
— a substance classified as dangerous or that meets the 
criteria to be classified as dangerous according to 
Directive 67/548/EEC, and that is present in the 
biocidal product at a concentration leading the 
product to be regarded as dangerous within the 
meaning of Articles 5, 6 and 7 of Directive 
1999/45/EC, or  
— 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 
the biocidal product at a concentration leading the 
product to be regarded as hazardous within the 
meaning of that Regulation,  — a substance which meets the criteria for being a 
persistent organic pollutant (POP) under Regulation 
(EC) No 850/2004, or which meets the criteria for 
being persistent, bio-accumulative and toxic (PBT) or 
very persistent and very bio-accumulative (vPvB) in 
accordance with Annex XIII to Regulation (EC) 
No 1907/2006;  
(g) ‘harmful organism’ means an organism, including 
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;  
(h) ‘residue’ means a substance present in or on products of 
plant or animal origin, water resources, drinking water, 
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;  
(i) ‘making available on the market’ means any supply of a 
biocidal product or of a treated article for distribution or 
use in the course of a commercial activity, whether in 
return for payment or free of charge;  
(j) ‘placing on the market’ means the first making available on 
the market of a biocidal product or of a treated article;  
(k) ‘use’ means all operations carried out with a biocidal 
product, including storage, handling, mixing and appli ­
cation, except any such operation carried out with a 
view to exporting the biocidal product or the treated 
article outside the Union;  
(l) ‘treated article’ means any substance, mixture or article 
which has been treated with, or intentionally incorporates, 
one or more biocidal products;  
(m) ‘national authorisation’ means an administrative act by 
which the competent authority of a Member State auth ­
orises the making available on the market and the use of a 
biocidal product or a biocidal product family in its territory 
or in a part thereof;  
(n) ‘Union authorisation’ means an administrative act by which 
the Commission authorises the making available on the 
market and the use of a biocidal product or a biocidal 
product family in the territory of the Union or in a part 
thereof;  
(o) ‘authorisation’ means national authorisation, Union auth ­
orisation or authorisation in accordance with Article 26;  
(p) ‘authorisation holder’ means the person established within 
the Union who is responsible for the placing on the 
market of a biocidal product in a particular Member 
State or in the Union and specified in the authorisation;EN L 167/10 Official Journal of the European Union 27.6.2012(q) ‘product-type’ means one of the product-types specified in 
Annex V;  
(r) ‘single biocidal product’ means a biocidal product with no 
intended variations as to the percentage of the active or 
non-active substances it contains;  
(s) ‘biocidal product family’ means a group of biocidal 
products having similar uses, the active substances of 
which have the same specifications, and presenting 
specified variations in their composition which do not 
adversely affect the level of risk or significantly reduce 
the efficacy of the products;  
(t) ‘letter of access’ means an original document, signed by the 
data owner or its representative, which states that the data 
may be used for the benefit of a third party by competent 
authorities, the Agency, or the Commission for the 
purposes of this Regulation;  
(u) ‘food’ and ‘feed’ mean food as defined in Article 2 of 
Regulation (EC) No 178/2002 and feed as defined in 
Article 3(4) of that Regulation;  
(v) ‘processing aid’ means any substance falling within the 
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;  
(w) ‘technical equivalence’ means similarity, as regards the 
chemical composition and hazard profile, of a substance 
produced either from a source different to the reference 
source, or from the reference source but following a 
change to the manufacturing process and/or manufacturing 
location, compared to the substance of the reference source 
in respect of which the initial risk assessment was carried 
out, as established in Article 54;  
(x) ‘Agency’ means the European Chemicals Agency estab ­
lished by Regulation (EC) No 1907/2006;  
(y) ‘advertisement’ means a means of promoting the sale or 
use of biocidal products by printed, electronic or other 
media;  
(z) ‘nanomaterial’ means a natural or manufactured active 
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 
number size distribution, one or more external dimensions 
is in the size range 1-100 nm.  
Fullerenes, graphene flakes and single-wall carbon 
nanotubes with one or more external dimensions below 
1 nm shall be considered as nanomaterials.  For the purposes of the definition of nanomaterial, ‘par ­
ticle’, ‘agglomerate’ and ‘aggregate’ are defined as follows:  
— ‘particle’ means a minute piece of matter with defined 
physical boundaries,  
— ‘agglomerate’ means a collection of weakly bound 
particles or aggregates where the resulting external 
surface area is similar to the sum of the surface areas 
of the individual components,  
— ‘aggregate’ means a particle comprising strongly bound 
or fused particles;  
(aa) ‘administrative change’ means an amendment of an existing 
authorisation of a purely administrative nature involving 
no change to the properties or efficacy of the biocidal 
product or biocidal product family;  
(ab) ‘minor change’ means an amendment of an existing auth ­
orisation that is not of a purely administrative nature and 
requires only a limited re-assessment of the properties or 
efficacy of the biocidal product or biocidal product family;  
(ac) ‘major change’ means an amendment of an existing auth ­
orisation which is neither an administrative change nor a 
minor change;  
(ad) ‘vulnerable groups’ means persons needing specific 
consideration when assessing the acute and chronic 
health effects of biocidal products. These include 
pregnant and nursing women, the unborn, infants and 
children, the elderly and, when subject to high exposure 
to biocidal products over the long term, workers and resi ­
dents;  
(ae) ‘small and medium-sized enterprises’ or ‘SMEs’ means small 
and medium-sized enterprises as defined in Commission 
Recommendation 2003/361/EC of 6 May 2003 
concerning the definition of micro, small and medium- 
sized enterprises (  1 ). 
2. For the purposes of this Regulation, the definitions laid 
down in Article 3 of Regulation (EC) No 1907/2006 shall apply 
for the following terms:  
(a) ‘substance’;  
(b) ‘mixture’;  
(c) ‘article’;  
(d) ‘product and process-orientated research and development’;  
(e) ‘scientific research and development’.EN 27.6.2012 Official Journal of the European Union L 167/11  
( 1 ) OJ L 124, 20.5.2003, p. 36.3. The Commission may, at the request of a Member State, 
decide, by means of implementing acts, whether a substance is a 
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 
or group of products is a biocidal product or a treated article or 
neither. Those implementing acts shall be adopted in 
accordance with the examination procedure referred to in 
Article 82(3).  
4. The Commission shall be empowered to adopt delegated 
acts in accordance with Article 83 in order to adapt the defi ­
nition of nanomaterial set out in point (z) of paragraph 1 of 
this Article in view of technical and scientific progress and 
taking into account the Recommendation 2011/696/EU.  
CHAPTER II  
APPROVAL OF ACTIVE SUBSTANCES  
Article 4  
Conditions for approval  
1. An active substance shall be approved for an initial period 
not exceeding 10 years if at least one biocidal product 
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 
substance that falls under Article 5 may only be approved for 
an initial period not exceeding five years.  
2. The approval of an active substance shall be restricted to 
those product-types for which relevant data have been 
submitted in accordance with Article 6.  
3. The approval shall specify the following conditions, as 
appropriate:  
(a) the minimum degree of purity of the active substance;  
(b) the nature and maximum content of certain impurities;  
(c) the product-type;  
(d) manner and area of use including, where relevant, use in 
treated articles;  
(e) designation of categories of users;  
(f) where relevant, characterisation of the chemical identity 
with regard to stereoisomers;  
(g) other particular conditions based on the evaluation of the 
information related to that active substance;  
(h) the date of approval and the expiry date of the approval of 
the active substance.  4. The approval of an active substance shall not cover nano ­
materials except where explicitly mentioned.  
Article 5  
Exclusion criteria  
1. Subject to paragraph 2, the following active substances 
shall not be approved:  
(a) active substances which have been classified in accordance 
with Regulation (EC) No 1272/2008 as, or which meet the 
criteria to be classified as, carcinogen category 1A or 1B;  
(b) active substances which have been classified in accordance 
with Regulation (EC) No 1272/2008 as, or which meet the 
criteria to be classified as, mutagen category 1A or 1B;  
(c) active substances which have been classified in accordance 
with Regulation (EC) No 1272/2008 as, or which meet the 
criteria to be classified as, toxic for reproduction category 
1A or 1B;  
(d) active substances which, on the basis of the criteria specified 
pursuant to the first subparagraph of paragraph 3 or, 
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 
may cause adverse effects in humans or which are identified 
in accordance with Articles 57(f) and 59(1) of Regulation 
(EC) No 1907/2006 as having endocrine disrupting prop ­
erties;  
(e) active substances which meet the criteria for being PBT or 
vPvB according to Annex XIII to Regulation (EC) 
No 1907/2006.  
2. Without prejudice to Article 4(1), active substances 
referred to in paragraph 1 of this Article may be approved if 
it is shown that at least one of the following conditions is met:  
(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, 
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;  
(b) it is shown by evidence that the active substance is essential 
to prevent or control a serious danger to human health, 
animal health or the environment; or  
(c) not approving the active substance would have a dispropor ­
tionate negative impact on society when compared with the 
risk to human health, animal health or the environment 
arising from the use of the substance.EN L 167/12 Official Journal of the European Union 27.6.2012  
( 1 ) OJ L 275, 20.10.2011, p. 38.When deciding whether an active substance may be approved in 
accordance with the first subparagraph, the availability of 
suitable and sufficient alternative substances or technologies 
shall be a key consideration.  
The use of a biocidal product containing active substances 
approved in accordance with this paragraph shall be subject 
to appropriate risk-mitigation measures to ensure that 
exposure of humans, animals and the environment to those 
active substances is minimised. The use of the biocidal 
product with the active substances concerned shall be restricted 
to Member States in which at least one of the conditions set out 
in this paragraph is met.  
3. No later than 13 December 2013, the Commission shall 
adopt delegated acts in accordance with Article 83 specifying 
scientific criteria for the determination of endocrine-disrupting 
properties.  
Pending the adoption of those criteria, active substances that are 
classified in accordance with Regulation (EC) No 1272/2008 as, 
or meet the criteria to be classified as, carcinogen category 2 
and toxic for reproduction category 2, shall be considered as 
having endocrine-disrupting properties.  
Substances such as those that are classified in accordance with 
Regulation (EC) No 1272/2008 as, or that meet the criteria to 
be classified as, toxic for reproduction category 2 and that have 
toxic effects on the endocrine organs, may be considered as 
having endocrine-disrupting properties.  
Article 6  
Data requirements for an application  
1. An application for approval of an active substance shall 
contain at least the following elements:  
(a) a dossier for the active substance satisfying the requirements 
set out in Annex II;  
(b) a dossier satisfying the requirements set out in Annex III for 
at least one representative biocidal product that contains the 
active substance; and  
(c) if the active substance meets at least one of the exclusion 
criteria listed in Article 5(1), evidence that Article 5(2) is 
applicable.  
2. Notwithstanding paragraph 1, the applicant need not 
provide data as part of the dossiers required under points (a) 
and (b) of paragraph 1 where any of the following applies:  
(a) the data are not necessary owing to the exposure associated 
with the proposed uses;  
(b) it is not scientifically necessary to supply the data; or  
(c) it is not technically possible to generate the data.  However, sufficient data shall be provided in order to make it 
possible to determine whether an active substance meets the 
criteria referred to in Article 5(1) or Article 10(1), if required 
by the evaluating competent authority under Article 8(2).  
3. An applicant may propose to adapt the data as part of the 
dossiers required under points (a) and (b) of paragraph 1 in 
accordance with Annex IV. The justification for the proposed 
adaptations to the data requirements shall be clearly stated in 
the application with a reference to the specific rules in Annex 
IV. 
4. The Commission shall be empowered to adopt delegated 
acts in accordance with Article 83 specifying criteria for deter ­
mining what constitutes adequate justification to adapt the data 
requirements under paragraph 1 of this Article on the grounds 
referred to in point (a) of paragraph 2 of this Article.  
Article 7  
Submission and validation of applications  
1. The applicant shall submit an application for approval of 
an active substance, or for making subsequent amendments to 
the conditions of approval of an active substance, to the 
Agency, informing it of the name of the competent authority 
of the Member State that it proposes should evaluate the appli ­
cation and providing written confirmation that that competent 
authority agrees to do so. That competent authority shall be the 
evaluating competent authority.  
2. The Agency shall inform the applicant of the fees payable 
under Article 80(1) and shall reject the application if the 
applicant fails to pay the fees within 30 days. It shall inform 
the applicant and the evaluating competent authority accord ­
ingly.  
Upon receipt of the fees payable under Article 80(1), the 
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 
identification code.  
3. Within 30 days of the Agency accepting an application, 
the evaluating competent authority shall validate the application 
if the data required in accordance with points (a) and (b) and, 
where relevant, point (c) of Article 6(1), and any justifications 
for the adaptation of data requirements, have been submitted.  
In the context of the validation referred to in the first subpara ­
graph, the evaluating competent authority shall not make an 
assessment of the quality or the adequacy of the data or justifi ­
cations submitted.  
The evaluating competent authority shall, as soon as possible 
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 
within 30 days. It shall inform the applicant accordingly.EN 27.6.2012 Official Journal of the European Union L 167/134. Where the evaluating competent authority considers that 
the application is incomplete, it shall inform the applicant as to 
what additional information is required for the validation of the 
application and shall set a reasonable time limit for the 
submission of that information. That time limit shall not 
normally exceed 90 days.  
The evaluating competent authority shall, within 30 days of 
receipt of the additional information, validate the application 
if it determines that the additional information submitted is 
sufficient to comply with the requirement laid down in 
paragraph 3.  
The evaluating competent authority shall reject the application 
if the applicant fails to submit the requested information within 
the deadline and shall inform the applicant and the Agency 
accordingly. In such cases, part of the fees paid in accordance 
with Article 80(1) and (2) shall be reimbursed.  
5. On validating an application in accordance with paragraph 
3 or 4, the evaluating competent authority shall without delay 
inform the applicant, the Agency and other competent auth ­
orities accordingly, indicating the date of the validation.  
6. An appeal may be brought, in accordance with Article 77, 
against decisions of the Agency under paragraph 2 of this 
Article.  
Article 8  
Evaluation of applications  
1. The evaluating competent authority shall, within 365 days 
of the validation of an application, evaluate it in accordance 
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 
of its evaluation to the Agency.  
Prior to submitting its conclusions to the Agency, the evaluating 
competent authority shall give the applicant the opportunity to 
provide written comments on the assessment report and on the 
conclusions of the evaluation within 30 days. The evaluating 
competent authority shall take due account of those comments 
when finalising its evaluation.  
2. Where it appears that additional information is necessary 
to carry out the evaluation, the evaluating competent authority 
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 
evaluating competent authority may, as appropriate, require 
the applicant to provide sufficient data to permit a deter ­
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 
suspended from the date of issue of the request until the date the information is received. The suspension shall not exceed 
180 days in total unless it is justified by the nature of the 
data requested or by exceptional circumstances.  
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 
active substances, it shall document its concerns in accordance 
with the requirements of the relevant parts of Section II.3 of 
Annex XV to Regulation (EC) No 1907/2006 and include this 
as part of its conclusions.  
4. Within 270 days of receipt of the conclusions of the 
evaluation, the Agency shall prepare and submit to the 
Commission an opinion on the approval of the active 
substance having regard to the conclusions of the evaluating 
competent authority.  
Article 9  
Approval of an active substance  
1. The Commission shall, on receipt of the opinion of the 
Agency referred to in Article 8(4), either:  
(a) adopt an implementing Regulation providing that an active 
substance is approved, and under which conditions, 
including the dates of approval and of expiry of the 
approval; or  
(b) in cases where the conditions laid down in Article 4(1) or, 
where applicable, the conditions set out in Article 5(2), are 
not satisfied or where the requisite information and data 
have not been submitted within the prescribed period, 
adopt an implementing decision that an active substance 
is not approved.  
Those implementing acts shall be adopted in accordance with 
the examination procedure referred to in Article 82(3).  
2. Approved active substances shall be included in a Union 
list of approved active substances. The Commission shall keep 
the list up to date and make it electronically available to the 
public.  
Article 10  
Active substances which are candidates for substitution  
1. An active substance shall be considered a candidate for 
substitution if any of the following conditions are met:  
(a) it meets at least one of the exclusion criteria listed in 
Article 5(1) but may be approved in accordance with 
Article 5(2);  
(b) it meets the criteria to be classified, in accordance with 
Regulation (EC) No 1272/2008, as a respiratory sensitiser;EN L 167/14 Official Journal of the European Union 27.6.2012(c) its acceptable daily intake, acute reference dose or acceptable 
operator exposure level, as appropriate, is significantly lower 
than those of the majority of approved active substances for 
the same product-type and use scenario;  
(d) it meets two of the criteria for being PBT in accordance 
with Annex XIII to Regulation (EC) No 1907/2006;  
(e) there are reasons for concern linked to the nature of the 
critical effects which, in combination with the use patterns, 
amount to use that could still cause concern, such as high 
potential of risk to groundwater, even with very restrictive 
risk management measures;  
(f) it contains a significant proportion of non-active isomers or 
impurities.  
2. When preparing its opinion on the approval or renewal of 
the approval of an active substance, the Agency shall examine 
whether the active substance fulfils any of the criteria listed in 
paragraph 1 and address the matter in its opinion.  
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 
Articles 66 and 67, information on potential candidates for 
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. 
The Agency shall take due account of the information 
received when finalising its opinion.  
4. By way of derogation from Article 4(1) and Article 12(3), 
the approval of an active substance that is considered as a 
candidate for substitution and each renewal shall be for a 
period not exceeding seven years.  
5. Active substances that are considered as candidates for 
substitution in accordance with paragraph 1 shall be identified 
as such in the relevant Regulation adopted in accordance with 
Article 9.  
Article 11  
Technical guidance notes  
The Commission shall draw up technical guidance notes to 
facilitate the implementation of this Chapter, in particular 
Article 5(2) and Article 10(1).  
CHAPTER III  
RENEWAL AND REVIEW OF APPROVAL OF AN ACTIVE 
SUBSTANCE  
Article 12  
Conditions for renewal  
1. The Commission shall renew the approval of an active 
substance if the active substance still meets the conditions laid down in Article 4(1) or, where applicable, the conditions set out 
in Article 5(2).  
2. In the light of scientific and technical progress, the 
Commission shall review and, where appropriate, amend the 
conditions specified for the active substance referred to in 
Article 4(3).  
3. The renewal of an approval of an active substance shall be 
for 15 years for all product-types to which the approval applies, 
unless a shorter period is specified in the implementing regu ­
lation adopted in accordance with point (a) of Article 14(4) 
renewing such an approval.  
Article 13  
Submission and acceptance of applications  
1. Applicants wishing to seek renewal of the approval of an 
active substance for one or more product-types shall submit an 
application to the Agency at least 550 days before the expiry of 
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.  
2. When applying for the renewal of the approval of the 
active substance, the applicant shall submit:  
(a) without prejudice to Article 21(1), all relevant data required 
under Article 20 that it has generated since the initial 
approval or, as appropriate, previous renewal; and  
(b) its assessment of whether the conclusions of the initial or 
previous assessment of the active substance remain valid 
and any supporting information.  
3. The applicant shall also submit the name of the 
competent authority of the Member State that it proposes 
should evaluate the application for renewal and provide 
written confirmation that that competent authority agrees to 
do so. That competent authority shall be the evaluating 
competent authority.  
The Agency shall inform the applicant of the fees payable under 
Article 80(1) and shall reject the application if the applicant fails 
to pay the fees within 30 days. It shall inform the applicant and 
the evaluating competent authority accordingly.  
Upon receipt of the fees payable under Article 80(1), the 
Agency shall accept the application and inform the applicant 
and the evaluating competent authority accordingly, indicating 
the date of the acceptance.  
4. An appeal may be brought, in accordance with Article 77, 
against decisions of the Agency under paragraph 3 of this 
Article.EN 27.6.2012 Official Journal of the European Union L 167/15Article 14  
Evaluation of applications for renewal  
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 
days of the Agency accepting an application in accordance 
with Article 13(3), decide whether, in the light of current 
scientific knowledge, a full evaluation of the application for 
renewal is necessary taking account of all product-types for 
which renewal is requested.  
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 
of Article 8.  
Where the evaluating competent authority decides that a full 
evaluation of the application is not necessary, it shall, within 
180 days of the Agency accepting the application in accordance 
with Article 13(3), prepare and submit to the Agency a recom ­
mendation on the renewal of the approval of the active 
substance. It shall provide the applicant with a copy of its 
recommendation.  
The evaluating competent authority shall, as soon as possible 
after the Agency has accepted an application, notify the 
applicant of the fees payable under Article 80(2). The evaluating 
competent authority shall reject the application if the applicant 
fails to pay the fees within 30 days of the notification and shall 
inform the applicant accordingly.  
3. Within 270 days of receipt of a recommendation from the 
evaluating competent authority, if it has carried out a full 
evaluation of the application, or 90 days otherwise, the 
Agency shall prepare and submit to the Commission an 
opinion on renewal of the approval of the active substance.  
4. The Commission shall, on receipt of the opinion of the 
Agency, adopt:  
(a) an implementing regulation providing that the approval of 
an active substance is renewed for one or more product- 
types, and under which conditions; or  
(b) an implementing decision that the approval of an active 
substance is not renewed.  
Those implementing acts shall be adopted in accordance with 
the examination procedure referred to in Article 82(3).  
Article 9(2) shall apply.  
5. Where, for reasons beyond the control of the applicant, 
the approval of the active substance is likely to expire before a 
decision has been taken on its renewal, the Commission shall, 
by means of implementing acts, adopt a decision postponing 
the expiry date of approval for a period sufficient to enable it to examine the application. Those implementing acts shall be 
adopted in accordance with the advisory procedure referred to 
in Article 82(2).  
6. Where the Commission decides not to renew or decides 
to amend the approval of an active substance for one or more 
product-types, the Member States or, in the case of a Union 
authorisation, the Commission shall cancel or, where appro ­
priate, amend the authorisations of biocidal products of the 
product-type(s) concerned containing that active substance. 
Articles 48 and 52 shall apply accordingly.  
Article 15  
Review of approval of an active substance  
1. The Commission may review the approval of an active 
substance for one or more product-types at any time where 
there are significant indications that the conditions laid down 
in Article 4(1) or, where applicable, the conditions set out in 
Article 5(2) are no longer met. The Commission may also 
review the approval of an active substance for one or more 
product-types at the request of a Member State if there are 
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 
Commission shall make publicly available the information 
that it is carrying out a review and shall provide an opportunity 
for applicant to submit comments. The Commission shall take 
due account of those comments in its review.  
Where those indications are confirmed, the Commission shall 
adopt an implementing Regulation amending the conditions of 
approval of an active substance or cancelling its approval. That 
implementing Regulation shall be adopted in accordance with 
the examination procedure referred to in Article 82(3). 
Article 9(2) shall apply. The Commission shall inform the 
initial applicants for the approval accordingly.  
On duly justified imperative grounds of urgency the 
Commission shall adopt immediately applicable implementing 
acts in accordance with the procedure referred to in 
Article 82(4).  
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, 
within 270 days of the request, prepare an opinion and submit 
it to the Commission.  
3. Where the Commission decides to cancel or amend the 
approval of an active substance for one or more product-types, 
the Member States or, in the case of a Union authorisation, the 
Commission shall cancel or, where appropriate, amend the 
authorisations of biocidal products of the product-type(s) 
concerned containing that active substance. Articles 48 and 
52 shall apply accordingly.EN L 167/16 Official Journal of the European Union 27.6.2012Article 16  
Implementing measures  
The Commission may adopt, by means of implementing acts, 
detailed measures for the implementation of Articles 12 to 15, 
further specifying the procedures for the renewal and review of 
the approval of an active substance. Those implementing acts 
shall be adopted in accordance with the examination procedure 
referred to in Article 82(3).  
CHAPTER IV  
GENERAL PRINCIPLES CONCERNING THE AUTHORISATION 
OF BIOCIDAL PRODUCTS  
Article 17  
Making available on the market and use of biocidal 
products  
1. Biocidal products shall not be made available on the 
market or used unless authorised in accordance with this Regu ­
lation.  
2. Applications for authorisation shall be made by, or on 
behalf of, the prospective authorisation holder.  
Applications for national authorisation in a Member State shall 
be submitted to the competent authority of that Member State 
(‘the receiving competent authority’).  
Applications for Union authorisation shall be submitted to the 
Agency.  
3. An authorisation may be granted for a single biocidal 
product or a biocidal product family.  
4. An authorisation shall be granted for a maximum period 
of 10 years.  
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.  
Proper use shall involve the rational application of a 
combination of physical, biological, chemical or other 
measures as appropriate, whereby the use of biocidal products 
is limited to the minimum necessary and appropriate 
precautionary steps are taken.  
Member States shall take necessary measures to provide the 
public with appropriate information about the benefits and 
risks associated with biocidal products and ways of minimising 
their use.  6. The authorisation holder shall notify each competent 
authority that has granted a national authorisation for a 
biocidal product family of each product within the biocidal 
product family at least 30 days before placing it on the 
market, except where a particular product is explicitly identified 
in the authorisation or the variation in composition concerns 
only pigments, perfumes and dyes within the permitted vari ­
ations. The notification shall indicate the exact composition, 
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.  
7. The Commission shall, by means of an implementing act, 
specify procedures for the authorisation of the same biocidal 
products by the same or different enterprises under the same 
terms and conditions. That implementing act shall be adopted 
in accordance with the examination procedure referred to in 
Article 82(3).  
Article 18  
Measures geared to the sustainable use of biocidal products  
By 18 July 2015 the Commission shall, on the basis of 
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 
biocidal products, including on the need to introduce additional 
measures, in particular for professional users, to reduce the risks 
posed to human health, animal health and the environment by 
biocidal products. That report shall, inter alia, examine:  
(a) the promotion of best practices as a means of reducing the 
use of biocidal products to a minimum;  
(b) the most effective approaches for monitoring the use of 
biocidal products;  
(c) the development and application of integrated pest 
management principles with respect to the use of biocidal 
products;  
(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 
are needed to address those risks;  
(e) the role that improved performance of the equipment used 
for applying biocidal products could play in sustainable use.  
On basis of that report, the Commission shall, if appropriate, 
submit a proposal for adoption in accordance with the ordinary 
legislative procedure.EN 27.6.2012 Official Journal of the European Union L 167/17Article 19  
Conditions for granting an authorisation  
1. A biocidal product other than those eligible for the 
simplified authorisation procedure in accordance with Article 25 
shall be authorised provided the following conditions are met:  
(a) the active substances are approved for the relevant product- 
type and any conditions specified for those active substances 
are met;  
(b) it is established, according to the common principles for the 
evaluation of dossiers for biocidal products laid down in 
Annex VI, that the biocidal product, when used as auth ­
orised and having regard to the factors referred to in 
paragraph 2 of this Article, fulfils the following criteria:  
(i) the biocidal product is sufficiently effective;  
(ii) the biocidal product has no unacceptable effects on the 
target organisms, in particular unacceptable resistance 
or cross-resistance or unnecessary suffering and pain 
for vertebrates;  
(iii) the biocidal product has no immediate or delayed 
unacceptable effects itself, or as a result of its 
residues, on the health of humans, including that of 
vulnerable groups, or animals, directly or through 
drinking water, food, feed, air, or through other 
indirect effects;  
(iv) the biocidal product has no unacceptable effects itself, 
or as a result of its residues, on the environment, 
having particular regard to the following considerations:  
— the fate and distribution of the biocidal product in 
the environment,  
— contamination of surface waters (including estuarial 
and seawater), groundwater and drinking water, air 
and soil, taking into account locations distant from 
its use following long-range environmental trans ­
portation,  
— the impact of the biocidal product on non-target 
organisms,  
— the impact of the biocidal product on biodiversity 
and the ecosystem;  
(c) the chemical identity, quantity and technical equivalence of 
active substances in the biocidal product and, where appro ­
priate, any toxicologically or ecotoxicologically significant 
and relevant impurities and non-active substances, and its 
residues of toxicological or environmental significance, which result from uses to be authorised, can be determined 
according to the relevant requirements in Annexes II and III;  
(d) the physical and chemical properties of the biocidal product 
have been determined and deemed acceptable for the 
purposes of the appropriate use and transport of the 
product;  
(e) where appropriate, maximum residue limits for food and 
feed have been established with respect to active substances 
contained in a biocidal product in accordance with Council 
Regulation (EEC) No 315/93 of 8 February 1993 laying 
down Community procedures for contaminants in 
food (  1 ), Regulation (EC) No 1935/2004 of the European 
Parliament and of the Council of 27 October 2004 on 
materials and articles intended to come into contact with 
food (  2 ), Regulation (EC) No 396/2005 of the European 
Parliament and of the Council of 23 February 2005 on 
maximum residue levels of pesticides in or on food and 
feed of plant and animal origin (  3 ), Regulation (EC) 
No 470/2009 of the European Parliament and of the 
Council of 6 May 2009 laying down Community 
procedures for the establishment of residue limits of phar ­
macologically active substances in foodstuffs of animal 
origin (  4 ) or Directive 2002/32/EC of the European 
Parliament and of the Council of 7 May 2002 on unde ­
sirable substances in animal feed (  5 ); 
(f) where nanomaterials are used in that product, the risk to 
human health, animal health and the environment has been 
assessed separately.  
2. The evaluation of whether a biocidal product fulfils the 
criteria set out in point (b) of paragraph 1 shall take into 
account the following factors:  
(a) realistic worst case conditions under which the biocidal 
product may be used;  
(b) the way in which treated articles treated with the biocidal 
product or containing the biocidal product may be used;  
(c) the consequences of use and disposal of the biocidal 
product;  
(d) cumulative effects;  
(e) synergistic effects.  
3. A biocidal product shall only be authorised for uses for 
which relevant information has been submitted in accordance 
with Article 20.EN L 167/18 Official Journal of the European Union 27.6.2012  
( 1 ) OJ L 37, 13.2.1993, p. 1.  
( 2 ) OJ L 338, 13.11.2004, p. 4.  
( 3 ) OJ L 70, 16.3.2005, p. 1.  
( 4 ) OJ L 152, 16.6.2009, p. 11.  
( 5 ) OJ L 140, 30.5.2002, p. 10.4. A biocidal product shall not be authorised for making 
available on the market for use by the general public where:  
(a) it meets the criteria according to Directive 1999/45/EC for 
classification as:  
— toxic or very toxic,  
— a category 1 or 2 carcinogen,  
— a category 1 or 2 mutagen, or  
— toxic for reproduction category 1 or 2;  
(b) it meets the criteria according to Regulation (EC) 
No 1272/2008 for classification as:  
— acute oral toxicity category 1 or 2 or 3,  
— acute dermal toxicity category 1 or 2 or 3,  
— acute inhalation toxicity (gases and dust/mist) category 1 
or 2 or 3,  
— acute inhalation toxicity (vapours) category 1 or 2,  
— a category 1A or 1B carcinogen,  
— a category 1A or 1B mutagen, or  
— toxic for reproduction category 1A or 1B;  
(c) it meets the criteria for being PBT or vPvB in accordance 
with Annex XIII to Regulation (EC) No 1907/2006;  
(d) it has endocrine-disrupting properties; or  
(e) it has developmental neurotoxic or immunotoxic effects.  
5. Notwithstanding paragraphs 1 and 4, a biocidal product 
may be authorised when the conditions laid down in paragraph 
1(b)(iii) and (iv) are not fully met, or may be authorised for 
making available on the market for use by the general public 
when the criteria referred to in paragraph 4(c) are met, where 
not authorising the biocidal product would result in dispropor ­
tionate negative impacts for society when compared to the risks 
to human health, animal health or the environment arising 
from the use of the biocidal product under the conditions 
laid down in the authorisation.  
The use of a biocidal product authorised pursuant to this 
paragraph shall be subject to appropriate risk mitigation 
measures to ensure that exposure of humans and the 
environment to that biocidal product is minimised. The use 
of a biocidal product authorised pursuant to this paragraph 
shall be restricted to Member States in which the condition of 
the first subparagraph is met.  6. In the case of a biocidal product family, a reduction in the 
percentage of one or more active substances may be allowed, 
and/or a variation in percentage of one or more non-active 
substances, and/or the replacement of one or more non-active 
substances by other specified substances presenting the same or 
lower risk. The classification, hazard and precautionary 
statements for each product within the biocidal product 
family shall be the same (with the exception of a biocidal 
product family comprising a concentrate for professional use 
and ready-for-use products obtained through dilution of that 
concentrate).  
A biocidal product family shall be authorised only if all the 
biocidal products within it, taking into account the permitted 
variations referred to in the first subparagraph, are expected to 
comply with the conditions set out in paragraph 1.  
7. Where appropriate, the prospective authorisation holder 
or its representative shall apply for the establishment of 
maximum residue limits with respect to active substances 
contained in a biocidal product in accordance with Regulation 
(EEC) No 315/93, Regulation (EC) No 1935/2004, Regulation 
(EC) No 396/2005, Regulation (EC) No 470/2009 or Directive 
2002/32/EC.  
8. Where, for active substances covered by Article 10(1)(a) of 
Regulation (EC) No 470/2009, no maximum residue limit has 
been established in accordance with Article 9 of that Regulation 
at the time of the approval of the active substance, or where a 
limit established in accordance with Article 9 of that Regulation 
needs to be amended, the maximum residue limit shall be 
established or amended in accordance with the procedure 
referred to in Article 10(1)(b) of that Regulation.  
9. Where a biocidal product is intended for direct application 
to the external parts of the human body (epidermis, hair system, 
nails, lips and external genital organs), or to the teeth and the 
mucous membranes of the oral cavity, it shall not contain any 
non-active substance that may not be included in a cosmetic 
product pursuant to Regulation (EC) No 1223/2009.  
Article 20  
Requirements for applications for authorisation  
1. The applicant for an authorisation shall submit the 
following documents together with the application:  
(a) for biocidal products other than biocidal products meeting 
the conditions laid down in Article 25:  
(i) a dossier or letter of access for the biocidal product 
satisfying the requirements set out in Annex III;  
(ii) a summary of the biocidal product characteristics 
including the information referred to in points (a), (b) 
and (e) to (q) of Article 22(2), as applicable;EN 27.6.2012 Official Journal of the European Union L 167/19(iii) a dossier or a letter of access for the biocidal product 
satisfying the requirements set out in Annex II for each 
active substance in the biocidal product;  
(b) for biocidal products that the applicant considers meet the 
conditions laid down in Article 25:  
(i) a summary of the biocidal product characteristics as 
referred to in point (a)(ii) of this paragraph;  
(ii) efficacy data; and  
(iii) any other relevant information in support of the 
conclusion that the biocidal product meets the 
conditions laid down in Article 25.  
2. The receiving competent authority may require that appli ­
cations for national authorisation be submitted in one or more 
of the official languages of the Member State where that 
competent authority is situated.  
3. For applications for Union authorisations submitted under 
Article 43, the applicant shall submit the summary of the 
biocidal product characteristics referred to in point (ii) of 
paragraph (1)(a) of this Article in one of the official languages 
of the Union accepted by the evaluating competent authority at 
the time of application and in all official languages of the Union 
before the authorisation of the biocidal product.  
Article 21  
Waiving of data requirements  
1. By way of derogation from Article 20, the applicant need 
not provide data required under that Article where any of the 
following applies:  
(a) the data are not necessary owing to the exposure associated 
with the proposed uses;  
(b) it is not scientifically necessary to supply the data; or  
(c) it is not technically possible to generate the data.  
2. The applicant may propose to adapt the data requirements 
of Article 20 in accordance with Annex IV. The justification for 
the proposed adaptations to the data requirements shall be 
clearly stated in the application with reference to the specific 
rules in Annex IV.  
3. In order to ensure the harmonised application of 
paragraph 1(a) of this Article, the Commission shall be 
empowered to adopt delegated acts in accordance with 
Article 83 specifying criteria for defining when the exposure 
associated with the proposed uses would justify adapting the 
data requirements of Article 20.  Article 22  
Content of authorisation  
1. An authorisation shall stipulate the terms and conditions 
relating to the making available on the market and use of the 
single biocidal product or the biocidal product family and 
include a summary of the biocidal product characteristics.  
2. Without prejudice to Articles 66 and 67, the summary of 
the biocidal product characteristics for a single biocidal product 
or, in the case of a biocidal product family, the biocidal 
products within that biocidal product family, shall include the 
following information:  
(a) trade name of the biocidal product;  
(b) name and address of the authorisation holder;  
(c) date of the authorisation and its date of expiry;  
(d) authorisation number of the biocidal product, together 
with, in the case of a biocidal product family, the suffixes 
to apply to individual biocidal products within the biocidal 
product family;  
(e) qualitative and quantitative composition in terms of the 
active substances and non-active substances, knowledge of 
which is essential for proper use of biocidal products; and 
in the case of a biocidal product family, the quantitative 
composition shall indicate a minimum and maximum 
percentage for each active and non-active substance, 
where the minimum percentage indicated for certain 
substances may be 0 %;  
(f) manufacturers of the biocidal product (names and addresses 
including location of manufacturing sites);  
(g) manufacturers of the active substances (names and 
addresses including location of manufacturing sites);  
(h) type of formulation of the biocidal product;  
(i) hazard and precautionary statements;  
(j) product-type and, where relevant, an exact description of 
the authorised use;  
(k) target harmful organisms;  
(l) application doses and instructions for use;  
(m) categories of users;  
(n) particulars of likely direct or indirect adverse effects and 
first aid instructions and emergency measures to protect 
the environment;EN L 167/20 Official Journal of the European Union 27.6.2012(o) instructions for safe disposal of the product and its pack ­
aging;  
(p) conditions of storage and shelf-life of the biocidal product 
under normal conditions of storage;  
(q) where relevant, other information about the biocidal 
product.  
Article 23  
Comparative assessment of biocidal products  
1. The receiving competent authority or, in the case of an 
evaluation of an application for a Union authorisation, the 
evaluating competent authority, shall perform a comparative 
assessment as part of the evaluation of an application for auth ­
orisation or for renewal of authorisation of a biocidal product 
containing an active substance that is a candidate for substi ­
tution in accordance with Article 10(1).  
2. The results of the comparative assessment shall be 
forwarded, without delay, to the competent authorities of 
other Member States and the Agency and, in the case of 
evaluation of an application for a Union authorisation, also to 
the Commission.  
3. The receiving competent authority or, in the case of a 
decision on an application for a Union authorisation, the 
Commission shall prohibit or restrict the making available on 
the market or the use of a biocidal product containing an active 
substance that is a candidate for substitution where the 
comparative assessment in accordance with Annex VI (‘com ­
parative assessment’) demonstrates that both of the following 
criteria are met:  
(a) for the uses specified in the application, another authorised 
biocidal product or a non-chemical control or prevention 
method already exists which presents a significantly lower 
overall risk for human health, animal health and the 
environment, is sufficiently effective and presents no other 
significant economic or practical disadvantages;  
(b) the chemical diversity of the active substances is adequate to 
minimise the occurrence of resistance in the target harmful 
organism.  
4. By way of derogation from paragraph 1, a biocidal 
product containing an active substance that is a candidate for 
substitution may be authorised for a period of up to four years 
without comparative assessment in exceptional cases where it is 
necessary to acquire experience first through using that product 
in practice.  
5. Where the comparative assessment involves a question 
which, by reason of its scale or consequences, would be 
better addressed at Union level, in particular where it is 
relevant to two or more competent authorities, the receiving competent authority may refer the question to the Commission 
for a decision. The Commission shall adopt that decision by 
means of implementing acts in accordance with the exam ­
ination procedure referred to in Article 82(3).  
The Commission shall be empowered to adopt delegated acts in 
accordance with Article 83 specifying the criteria for deter ­
mining when comparative assessments involve questions 
better addressed at Union level and the procedures for such 
comparative assessments.  
6. Notwithstanding Article 17(4), and without prejudice to 
paragraph 4 of this Article, an authorisation for a biocidal 
product containing an active substance that is a candidate for 
substitution shall be granted for a period not exceeding five 
years and renewed for a period not exceeding five years.  
7. Where it is decided not to authorise or to restrict the use 
of a biocidal product pursuant to paragraph 3, that cancellation 
or amendment of the authorisation shall take effect four years 
after that decision. However, where the approval of the active 
substance which is a candidate for substitution expires on an 
earlier date, the cancellation of the authorisation shall take effect 
on that earlier date.  
Article 24  
Technical guidance notes  
The Commission shall draw up technical guidance notes to 
facilitate the implementation of this Chapter and, in particular, 
Article 22(2) and Article 23(3).  
CHAPTER V  
SIMPLIFIED AUTHORISATION PROCEDURE  
Article 25  
Eligibility for the simplified authorisation procedure  
For eligible biocidal products, an application for authorisation 
may be made under a simplified authorisation procedure. A 
biocidal product shall be eligible if all the following conditions 
are met:  
(a) all the active substances contained in the biocidal product 
appear in Annex I and satisfy any restriction specified in 
that Annex;  
(b) the biocidal product does not contain any substance of 
concern;  
(c) the biocidal product does not contain any nanomaterials;  
(d) the biocidal product is sufficiently effective; and  
(e) the handling of the biocidal product and its intended use do 
not require personal protective equipment.EN 27.6.2012 Official Journal of the European Union L 167/21Article 26  
Applicable procedure  
1. Applicants seeking the authorisation of a biocidal product 
meeting the conditions of Article 25 shall submit an application 
to the Agency, informing it of the name of the competent 
authority of the Member State that it proposes should 
evaluate the application and providing written confirmation 
that that competent authority agrees to do so. That 
competent authority shall be the evaluating competent auth ­
ority.  
2. The evaluating competent authority shall inform the 
applicant of the fees payable under Article 80(2) and shall 
reject the application if the applicant fails to pay the fees 
within 30 days. It shall inform the applicant accordingly.  
Upon receipt of the fees payable under Article 80(2), the 
evaluating competent authority shall accept the application 
and inform the applicant accordingly, indicating the date of 
the acceptance.  
3. Within 90 days of accepting an application, the evaluating 
competent authority shall authorise the biocidal product if 
satisfied that the product meets the conditions laid down in 
Article 25.  
4. Where the evaluating competent authority considers that 
the application is incomplete, it shall inform the applicant as to 
what additional information is required and shall set a 
reasonable time limit for the submission of that information. 
That time limit shall not normally exceed 90 days.  
The evaluating competent authority shall, within 90 days of 
receipt of the additional information, authorise the biocidal 
product if satisfied, on the basis of the additional information 
submitted, that the product meets the conditions laid down in 
Article 25.  
The evaluating competent authority shall reject the application 
if the applicant fails to submit the requested information within 
the deadline and shall inform the applicant accordingly. In such 
cases, where fees have been paid, part of the fees paid in 
accordance with Article 80(2) shall be reimbursed.  
Article 27  
Making available on the market of biocidal products 
authorised in accordance with the simplified 
authorisation procedure  
1. A biocidal product authorised in accordance with 
Article 26 may be made available on the market in all 
Member States without the need for mutual recognition. 
However, the authorisation holder shall notify each Member 
State no later than 30 days before placing the biocidal 
product on the market within the territory of that Member State and shall use the official language or languages of that 
Member State in the product’s labelling, unless that Member 
State provides otherwise.  
2. Where a Member State other than that of the evaluating 
competent authority considers that a biocidal product auth ­
orised in accordance with Article 26 has not been notified or 
labelled in accordance with paragraph 1 of this Article or does 
not meet the requirements of Article 25, it may refer that 
matter to the coordination group established in accordance 
with Article 35(1). Article 35(3) and Article 36 shall apply  
mutatis mutandis . 
Where a Member State has valid reasons to consider that a 
biocidal product authorised in accordance with Article 26 
does not meet the criteria laid down in Article 25 and a 
decision pursuant to Articles 35 and 36 has not yet been 
taken, that Member State may provisionally restrict or 
prohibit making available on the market or use of that 
product on its territory.  
Article 28  
Amendment of Annex I  
1. The Commission shall be empowered to adopt delegated 
acts in accordance with Article 83 amending Annex I, after 
receiving the opinion of the Agency, in order to include 
active substances provided that there is evidence that they do 
not give rise to concern according to paragraph 2 of this 
Article.  
2. Active substances give rise to concern where:  
(a) they meet the criteria for classification according to Regu ­
lation (EC) No 1272/2008 as:  
— explosive/highly flammable,  
— organic peroxide,  
— acutely toxic of category 1, 2 or 3,  
— corrosive of category 1A, 1B or 1C,  
— respiratory sensitiser,  
— skin sensitiser,  
— germ cell mutagen of category 1 or 2;  
— carcinogen of category 1 or 2,  
— human reproductive toxicant of category 1 or 2 or with 
effects on or via lactation,  
— specific target organ toxicant by single or repeated 
exposure, or  
— toxic to aquatic life of acute category 1;EN L 167/22 Official Journal of the European Union 27.6.2012(b) they fulfil any of the substitution criteria set out in 
Article 10(1); or  
(c) they have neurotoxic or immunotoxic properties.  
Active substances also give rise to concern, even if none of the 
specific criteria in points (a) to (c) are met, where a level of 
concern equivalent to that arising from points (a) to (c) can be 
reasonably demonstrated based on reliable information.  
3. The Commission shall also be empowered to adopt 
delegated acts in accordance with Article 83 amending Annex 
I, after receiving the opinion of the Agency, in order to restrict 
or to remove the entry for an active substance if there is 
evidence that biocidal products containing that substance do 
not, in certain circumstances, satisfy the conditions set out in 
paragraph 1 of this Article or in Article 25. Where imperative 
grounds of urgency so require, the procedure provided for in 
Article 84 shall apply to delegated acts adopted pursuant to this 
paragraph.  
4. The Commission shall apply paragraph 1 or 3 at its own 
initiative or at the request of an economic operator or a 
Member State providing the necessary evidence as referred to 
in those paragraphs.  
Whenever the Commission amends Annex I it shall adopt a 
separate delegated act in respect of each substance.  
5. The Commission may adopt implementing acts further 
specifying the procedures to be followed with respect to an 
amendment of Annex I. Those implementing acts shall be 
adopted in accordance with the examination procedure 
referred to in Article 82(3).  
CHAPTER VI  
NATIONAL AUTHORISATIONS OF BIOCIDAL PRODUCTS  
Article 29  
Submission and validation of applications  
1. Applicants wishing to apply for a national authorisation in 
accordance with Article 17 shall submit an application to the 
receiving competent authority. The receiving competent 
authority shall inform the applicant of the fees payable under 
Article 80(2), and shall reject the application if the applicant 
fails to pay the fees within 30 days. It shall inform the applicant 
accordingly. Upon receipt of the fees payable under 
Article 80(2), the receiving competent authority shall accept 
the application and inform the applicant accordingly, indicating 
the date of the acceptance.  
2. Within 30 days of acceptance, the receiving competent 
authority shall validate the application if it complies with the 
following requirements:  (a) the relevant information referred to in Article 20 has been 
submitted; and  
(b) the applicant states that it has not applied to any other 
competent authority for a national authorisation for the 
same biocidal product for the same use(s).  
In the context of the validation referred to in the first subpara ­
graph, the receiving competent authority shall not make an 
assessment of the quality or the adequacy of the data or justifi ­
cations submitted.  
3. Where the receiving competent authority considers that 
the application is incomplete, it shall inform the applicant as 
to what additional information is required for the validation of 
the application and shall set a reasonable time limit for the 
submission of that information. That time limit shall not 
normally exceed 90 days.  
The receiving competent authority shall, within 30 days of 
receipt of the additional information, validate the application 
if it determines that the additional information submitted is 
sufficient to comply with the requirements laid down in 
paragraph 2.  
The receiving competent authority shall reject the application if 
the applicant fails to submit the requested information within 
the deadline and shall inform the applicant accordingly.  
4. Where the Register for Biocidal Products referred to in 
Article 71 shows that a competent authority other than the 
receiving competent authority is examining an application 
relating to the same biocidal product or has already authorised 
the same biocidal product, the receiving competent authority 
shall decline to evaluate the application. In that event, the 
receiving competent authority shall inform the applicant of 
the possibility of seeking mutual recognition in accordance 
with Article 33 or 34.  
5. If paragraph 3 does not apply and the receiving 
competent authority considers that the application is 
complete, it shall validate the application and without delay 
inform the applicant accordingly, indicating the date of the 
validation.  
Article 30  
Evaluation of applications  
1. The receiving competent authority shall, within 365 days 
of the validation of an application in accordance with Article 29, 
decide whether to grant an authorisation in accordance with 
Article 19. It shall take into account the results of the 
comparative assessment carried out in accordance with 
Article 23, if applicable.EN 27.6.2012 Official Journal of the European Union L 167/232. Where it appears that additional information is necessary 
to carry out the evaluation, the receiving competent authority 
shall ask the applicant to submit such information within a 
specified time limit. The 365-day period referred to in 
paragraph 1 shall be suspended from the date of issue of the 
request until the date the information is received. The 
suspension shall not exceed 180 days in total unless it is 
justified by the nature of the data requested or by exceptional 
circumstances.  
The receiving competent authority shall reject the application if 
the applicant fails to submit the requested information within 
the deadline and shall inform the applicant accordingly.  
3. Within the 365-day period referred to in paragraph 1, the 
receiving competent authority shall:  
(a) draft a report summarising the conclusions of its assessment 
and the reasons for authorising the biocidal product or for 
refusing to grant an authorisation (the ‘assessment report’);  
(b) send an electronic copy of the draft assessment report to the 
applicant and provide it with the opportunity to submit 
comments within 30 days; and  
(c) take due account of those comments when finalising its 
assessment.  
Article 31  
Renewal of a national authorisation  
1. An application by or on behalf of an authorisation holder 
wishing to seek the renewal of a national authorisation for one 
or more product-types shall be submitted to the receiving 
competent authority at least 550 days before the expiry date 
of the authorisation. Where renewal is sought for more than 
one product-type, the application shall be submitted at least 
550 days before the earliest expiry date.  
2. The receiving competent authority shall renew the 
national authorisation, provided that the conditions set out in 
Article 19 are still satisfied. It shall take into account the results 
of the comparative assessment carried out in accordance with 
Article 23, if applicable.  
3. When applying for renewal, the applicant shall submit:  
(a) without prejudice to Article 21(1), all relevant data required 
under Article 20 that it has generated since the initial auth ­
orisation or, as appropriate, previous renewal; and  
(b) its assessment of whether the conclusions of the initial or 
previous assessment of the biocidal product remain valid 
and any supporting information.  4. The receiving competent authority shall inform the 
applicant of the fees payable under Article 80(2) and shall 
reject the application if the applicant fails to pay the fees 
within 30 days. It shall inform the applicant accordingly.  
Upon receipt of the fees payable under Article 80(2), the 
receiving competent authority shall accept the application and 
inform the applicant accordingly, indicating the date of the 
acceptance.  
5. 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 authorisation or, as appropriate, the 
previous renewal, the receiving competent authority shall, 
within 90 days of accepting an application in accordance 
with paragraph 4, decide whether, in the light of current 
scientific knowledge, a full evaluation of the application for 
renewal is necessary taking account of all product-types for 
which renewal is requested.  
6. Where the receiving competent authority decides that a 
full evaluation of the application is necessary, it shall decide on 
the renewal of the authorisation after carrying out an evaluation 
of the application in accordance with paragraphs 1, 2 and 3 of 
Article 30.  
Where the receiving competent authority decides that a full 
evaluation of the application is not necessary, it shall decide 
on the renewal of the authorisation within 180 days of 
accepting the application in accordance with paragraph 4 of 
this Article.  
7. Where, for reasons beyond the control of the holder of a 
national authorisation, no decision is taken on the renewal of 
that authorisation before its expiry, the receiving competent 
authority shall grant a renewal for the period necessary to 
complete the evaluation.  
CHAPTER VII  
MUTUAL RECOGNITION PROCEDURES  
Article 32  
Authorisation through mutual recognition  
1. Applications for mutual recognition of a national auth ­
orisation shall be made in accordance with the procedures set 
out in Article 33 (mutual recognition in sequence) or Article 34 
(mutual recognition in parallel).  
2. Without prejudice to Article 37, all Member States 
receiving applications for mutual recognition of a national auth ­
orisation for a biocidal product shall, in accordance with and 
subject to the procedures set out in this Chapter, authorise the 
biocidal product under the same terms and conditions.EN L 167/24 Official Journal of the European Union 27.6.2012Article 33  
Mutual recognition in sequence  
1. Applicants wishing to seek the mutual recognition in 
sequence, in one or more Member States (‘the Member States 
concerned’), of the national authorisation of a biocidal product 
already granted in another Member State in accordance with 
Article 17 (‘the reference Member State’) shall submit an appli ­
cation to each of the competent authorities of the Member 
States concerned containing, in each case, a translation of the 
national authorisation granted by the reference Member State 
into such official languages of the Member State concerned as it 
may require.  
The competent authorities of the Member States concerned shall 
inform the applicant of the fees payable under Article 80 and 
shall reject the application if the applicant fails to pay the fees 
within 30 days. They shall inform the applicant and the other 
competent authorities accordingly. Upon receipt of the fees 
payable under Article 80, the competent authorities of the 
Member States concerned shall accept the application and 
inform the applicant indicating the date of acceptance.  
2. Within 30 days of acceptance referred to in paragraph 1, 
the Member States concerned shall validate the application and 
inform the applicant accordingly, indicating the date of the 
validation.  
Within 90 days of validating the application, and subject to 
Articles 35, 36 and 37, the Member States concerned shall 
agree on the summary of biocidal product characteristics 
referred to in Article 22(2) and shall record their agreement 
in the Register for Biocidal Products.  
3. Within 30 days of reaching agreement, each of the 
Member States concerned shall authorise the biocidal product 
in conformity with the agreed summary of biocidal product 
characteristics.  
4. Without prejudice to Articles 35, 36, and 37, if no 
agreement is reached within the 90-day period referred to in 
the second subparagraph of paragraph 2, each Member State 
that agrees to the summary of biocidal product characteristics 
referred to in paragraph 2, may authorise the product accord ­
ingly.  
Article 34  
Mutual recognition in parallel  
1. Applicants wishing to seek the mutual recognition in 
parallel of a biocidal product which has not yet been authorised 
in accordance with Article 17 in any Member State shall submit 
to the competent authority of the Member State of its choice 
(‘the reference Member State’) an application containing:  
(a) the information referred to in Article 20;  (b) a list of all other Member States where a national auth ­
orisation is sought (‘the Member States concerned’).  
The reference Member State shall be responsible for the 
evaluation of the application.  
2. The applicant shall, at the same time as submitting the 
application to the reference Member State in accordance with 
paragraph 1, submit to the competent authorities of each of the 
Member States concerned an application for mutual recognition 
of the authorisation for which it has applied to the reference 
Member State. This application shall contain:  
(a) the names of the reference Member State and of the 
Member States concerned;  
(b) the summary of biocidal product characteristics referred to 
in Article 20(1)(a)(ii) in such official languages of the 
Member States concerned as they may require.  
3. The competent authorities of the reference Member State 
and of the Member States concerned shall inform the applicant 
of the fees payable in accordance with Article 80 and shall 
reject the application if the applicant fails to pay the fees 
within 30 days. They shall inform the applicant and the other 
competent authorities accordingly. Upon receipt of the fees 
payable under Article 80, the competent authorities of the 
reference Member State and of the Member States concerned 
shall accept the application and inform the applicant indicating 
the date of acceptance.  
4. The reference Member State shall validate the application 
in accordance with Article 29(2) and (3) and inform the 
applicant and the Member States concerned accordingly.  
Within 365 days of validating an application, the reference 
Member State shall evaluate the application and draft an 
assessment report in accordance with Article 30(3) and shall 
send its assessment report and the summary of biocidal 
product characteristics to the Member States concerned and to 
the applicant.  
5. Within 90 days of receipt of the documents referred to in 
paragraph 4, and subject to Articles 35, 36 and 37, the Member 
States concerned shall agree on the summary of biocidal 
product characteristics, and shall record their agreement in the 
Register for Biocidal Products. The reference Member State shall 
enter the agreed summary of biocidal product characteristics 
and the final assessment report in the Register for Biocidal 
Products, together with any agreed terms or conditions 
imposed on the making available on the market or use of the 
biocidal product.EN 27.6.2012 Official Journal of the European Union L 167/256. Within 30 days of reaching agreement, the reference 
Member State and each of the Member States concerned shall 
authorise the biocidal product in conformity with the agreed 
summary of biocidal product characteristics.  
7. Without prejudice to Articles 35, 36, and 37, if no 
agreement is reached within the 90-day period referred to in 
paragraph 5, each Member State that agrees to the summary of 
biocidal product characteristics referred to in paragraph 5 may 
authorise the product accordingly.  
Article 35  
Referral of objections to the coordination group  
1. A coordination group shall be set up to examine any 
question, other than matters referred to in Article 37, relating 
to whether a biocidal product for which an application for 
mutual recognition has been made in accordance with Article 33 
or 34 meets the conditions for granting an authorisation laid 
down in Article 19.  
All Member States and the Commission shall be entitled to 
participate in the work of the coordination group. The 
Agency shall provide the secretariat of the coordination group.  
The coordination group shall establish its rules of procedure.  
2. If any of the Member States concerned considers that a 
biocidal product assessed by the reference Member State does 
not meet the conditions laid down in Article 19, it shall send a 
detailed explanation of the points of disagreement and the 
reasons for its position to the reference Member State, the 
other Member States concerned, the applicant, and, where appli ­
cable, to the authorisation holder. The points of disagreement 
shall be referred without delay to the coordination group.  
3. Within the coordination group, all Member States referred 
to in paragraph 2 of this Article shall use their best endeavours 
to reach agreement on the action to be taken. They shall allow 
the applicant the opportunity to make its point of view known. 
Where they reach agreement within 60 days of the referral of 
the points of disagreement referred to in paragraph 2 of this 
Article, the reference Member State shall record the agreement 
in the Register for Biocidal Products. The procedure shall then 
be considered to be closed and the reference Member State and 
each of the Member States concerned shall authorise the 
biocidal product in accordance with Article 33(4) or 
Article 34(6) as appropriate.  
Article 36  
Referral of unresolved objections to the Commission  
1. If the Member States referred to in Article 35(2) fail to 
reach agreement within the 60-day period laid down in Article 35(3), the reference Member State shall immediately 
inform the Commission, and provide it with a detailed 
statement of the matters on which Member States have been 
unable to reach agreement and the reasons for their 
disagreement. A copy of that statement shall be forwarded to 
the Member States concerned, the applicant and, where appli ­
cable, the authorisation holder.  
2. The Commission may ask the Agency for an opinion on 
scientific or technical questions raised by Member States. Where 
the Commission does not ask the Agency for an opinion it shall 
provide the applicant and, where applicable, the authorisation 
holder with the opportunity to provide written comments 
within 30 days.  
3. The Commission shall adopt, by means of implementing 
acts, a decision on the matter referred to it. Those implementing 
acts shall be adopted in accordance with the examination 
procedure referred to in Article 82(3).  
4. The decision referred to in paragraph 3 shall be addressed 
to all Member States and reported for information to the 
applicant and, where applicable, the authorisation holder. The 
Member States concerned and the reference Member State shall, 
within 30 days of notification of the decision, either grant, 
refuse to grant or cancel the authorisation, or vary its terms 
and conditions as necessary to comply with the decision.  
Article 37  
Derogations from mutual recognition  
1. By way of derogation from Article 32(2), any of the 
Member States concerned may propose to refuse to grant an 
authorisation or to adjust the terms and conditions of the auth ­
orisation to be granted, provided that such a measure can be 
justified on grounds of:  
(a) the protection of the environment;  
(b) public policy or public security;  
(c) the protection of health and life of humans, particularly of 
vulnerable groups, or of animals or plants;  
(d) the protection of national treasures possessing artistic, 
historic or archaeological value; or  
(e) the target organisms not being present in harmful quan ­
tities.EN L 167/26 Official Journal of the European Union 27.6.2012Any of the Member States concerned may, in particular, 
propose in accordance with the first subparagraph to refuse 
to grant an authorisation or to adjust the terms and conditions 
of the authorisation to be granted for a biocidal product 
containing an active substance to which Article 5(2) or 
Article 10(1) applies.  
2. The Member State concerned shall communicate to the 
applicant a detailed statement of the grounds for seeking a 
derogation pursuant to paragraph 1 and shall seek to reach 
an agreement with the applicant on the proposed derogation.  
If the Member State concerned is unable to reach agreement 
with the applicant or receives no reply from the applicant 
within 60 days of that communication it shall inform the 
Commission. In that case, the Commission:  
(a) may ask the Agency for an opinion on scientific or 
technical questions raised by the applicant or the Member 
State concerned;  
(b) shall adopt a decision on the derogation in accordance with 
the examination procedure referred to in Article 82(3).  
The Commission’s decision shall be addressed to the Member 
State concerned and the Commission shall inform the applicant 
thereof.  
The Member State concerned shall take necessary measures to 
comply with the Commission’s decision within 30 days of its 
notification.  
3. If the Commission has not adopted a decision pursuant to 
paragraph 2 within 90 days of being informed in accordance 
with the second subparagraph of paragraph 2, the Member State 
concerned may implement the derogation proposed pursuant to 
paragraph 1.  
While the procedure under this Article is ongoing, the Member 
States’ obligation to authorise a biocidal product within two 
years of the date of approval, referred to in the first 
subparagraph of Article 89(3), shall be temporarily suspended.  
4. By way of derogation from Article 32(2), a Member State 
may refuse to grant authorisations for product-types 15, 17 and 
20 on grounds of animal welfare. Member States shall without 
delay inform other Member States and the Commission of any 
decision taken in this respect and its justification.  
Article 38  
Opinion of the Agency  
1. If so requested by the Commission pursuant to 
Article 36(2) or Article 37(2), the Agency shall issue an opinion within 120 days from the date on which the matter 
in question was referred to it.  
2. Before issuing its opinion, the Agency shall provide the 
applicant and, where applicable, the authorisation holder with 
an opportunity to provide written comments within a specified 
time limit not exceeding 30 days.  
The Agency may suspend the time limit referred to in 
paragraph 1 to allow the applicant or the authorisation 
holder to prepare the comments.  
Article 39  
Application for mutual recognition by official or scientific 
bodies  
1. Where no application for a national authorisation has 
been submitted in a Member State for a biocidal product that 
is already authorised in another Member State, official or 
scientific bodies involved in pest control activities or the 
protection of public health may apply, under the mutual recog ­
nition procedure provided for in Article 33 and with the 
consent of the authorisation holder in that other Member 
State, for a national authorisation for the same biocidal 
product, with the same use and the same conditions for use 
as in that Member State.  
The applicant shall demonstrate that the use of such a biocidal 
product is of general interest for that Member State.  
The application shall be accompanied by the fees payable under 
Article 80.  
2. Where the competent authority of the Member State 
concerned considers that the biocidal product fulfils the 
conditions referred to in Article 19 and the conditions under 
this Article are met, the competent authority shall authorise the 
making available on the market and use of the biocidal product. 
In that case, the body that made the application shall have the 
same rights and obligations as other authorisation holders.  
Article 40  
Supplementary rules and technical guidance notes  
The Commission shall be empowered to adopt delegated acts in 
accordance with Article 83 laying down supplementary rules for 
the renewal of authorisations subject to mutual recognition.  
The Commission shall also draw up technical guidance notes to 
facilitate the implementation of this Chapter and, in particular, 
Articles 37 and 39.EN 27.6.2012 Official Journal of the European Union L 167/27CHAPTER VIII  
UNION AUTHORISATIONS OF BIOCIDAL PRODUCTS  
SECTION 1  
Granting of Union authorisations  
Article 41  
Union authorisation  
A Union authorisation issued by the Commission in accordance 
with this Section shall be valid throughout the Union unless 
otherwise specified. It shall confer the same rights and 
obligations in each Member State as a national authorisation. 
For those categories of biocidal products referred to in 
Article 42(1), the applicant may apply for Union authorisation 
as an alternative to applying for a national authorisation and 
mutual recognition.  
Article 42  
Biocidal products for which Union authorisation may be 
granted  
1. Applicants may apply for Union authorisation for biocidal 
products which have similar conditions of use across the Union 
with the exception of biocidal products that contain active 
substances that fall under Article 5 and those of product- 
types 14, 15, 17, 20 and 21. The Union authorisation may 
be granted:  
(a) from 1 September 2013, to biocidal products containing 
one or more new active substances and biocidal products 
of product-types 1, 3, 4, 5, 18 and 19;  
(b) from 1 January 2017, to biocidal products of product-types 
2, 6 and 13; and  
(c) from 1 January 2020, to biocidal products of all remaining 
product-types.  
2. The Commission shall by 1 September 2013 draw up 
guidance documents on the definition of ‘similar conditions 
of use across the Union’.  
3. The Commission shall submit a report to the European 
Parliament and the Council on the application of this Article by 
31 December 2017. That report shall contain an assessment of 
the exclusion of product-types 14, 15, 17, 20 and 21 from the 
Union authorisation.  
The report shall, if appropriate, be accompanied by relevant 
proposals for adoption in accordance with the ordinary legis ­
lative procedure.  
Article 43  
Submission and validation of applications  
1. Applicants wishing to apply for Union authorisation in 
accordance with Article 42(1) shall submit an application to the Agency, including a confirmation that the biocidal 
product would have similar conditions of use across the 
Union, informing the Agency of the name of the competent 
authority of the Member State that they propose should 
evaluate the application and providing written confirmation 
that that competent authority agrees to do so. That 
competent authority shall be the evaluating competent auth ­
ority.  
2. The Agency shall inform the applicant of the fees payable 
under Article 80(1), and shall reject the application if the 
applicant fails to pay the fees within 30 days. It shall inform 
the applicant and the evaluating competent authority accord ­
ingly.  
Upon receipt of the fees payable under Article 80(1), the 
Agency shall accept the application and inform the applicant 
and the evaluating competent authority accordingly, indicating 
the date of acceptance.  
3. Within 30 days of the Agency accepting an application, 
the evaluating competent authority shall validate the application 
if the relevant information referred to in Article 20 has been 
submitted.  
In the context of the validation referred to in the first subpara ­
graph, the evaluating competent authority shall not make an 
assessment of the quality or the adequacy of the data or justifi ­
cations submitted.  
The evaluating competent authority shall, as soon as possible 
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 
within 30 days. It shall inform the applicant accordingly.  
4. Where the evaluating competent authority considers that 
the application is incomplete, it shall inform the applicant what 
additional information is required for the evaluation of the 
application and shall set a reasonable time limit for the 
submission of that information. That time limit shall not 
normally exceed 90 days.  
The evaluating competent authority shall, within 30 days of 
receipt of the additional information, validate the application 
if it determines that the additional information submitted is 
sufficient to comply with the requirement laid down in 
paragraph 3.  
The evaluating competent authority shall reject the application 
if the applicant fails to submit the requested information within 
the deadline and shall inform the applicant accordingly. In such 
cases, part of the fees paid in accordance with Article 80(1) and 
(2) shall be reimbursed.EN L 167/28 Official Journal of the European Union 27.6.20125. On validating the application in accordance with 
paragraph 3 or 4, the evaluating competent authority shall, 
without delay, inform the applicant, the Agency and other 
competent authorities accordingly, indicating the date of the 
validation.  
6. An appeal may be brought, in accordance with Article 77, 
against decisions of the Agency under paragraph 2 of this 
Article.  
Article 44  
Evaluation of applications  
1. The evaluating competent authority shall, within 365 days 
of the validation of an application, evaluate it in accordance 
with Article 19, including, where relevant, any proposal to 
adapt data requirements submitted in accordance with 
Article 21(2), and send an assessment report and the 
conclusions of its evaluation to the Agency.  
Prior to submitting its conclusions to the Agency, the evaluating 
competent authority shall provide the applicant with the oppor ­
tunity to provide written comments on the conclusions of the 
evaluation within 30 days. The evaluating competent authority 
shall take due account of those comments when finalising its 
evaluation.  
2. Where it appears that additional information is necessary 
to carry out the evaluation, the evaluating competent authority 
shall ask the applicant to submit such information within a 
specified time limit, and shall inform the Agency accordingly. 
The 365-day period referred to in paragraph 1 shall be 
suspended from the date of issue of the request until the date 
the information is received. However, the suspension shall not 
exceed 180 days in total other than in exceptional cases and 
where justified by the nature of the information requested.  
3. Within 180 days of receipt of the conclusions of the 
evaluation, the Agency shall prepare and submit to the 
Commission an opinion on the authorisation of the biocidal 
product.  
If the Agency recommends the authorisation of the biocidal 
product, the opinion shall contain at least the following 
elements:  
(a) a statement on whether the conditions laid down in 
Article 19(1) are fulfilled, and a draft summary of biocidal 
product characteristics, as referred to in Article 22(2);  
(b) where relevant, details of any terms or conditions which 
should be imposed on the making available on the 
market or use of the biocidal product;  (c) the final assessment report on the biocidal product.  
4. Within 30 days of submitting its opinion to the 
Commission, the Agency shall transmit to the Commission, in 
all the official languages of the Union, the draft summary of the 
biocidal product characteristics, as referred to in Article 22(2), 
where applicable.  
5. On receipt of the opinion of the Agency, the Commission 
shall adopt either an implementing regulation granting the 
Union authorisation to the biocidal product or an implementing 
decision stating that the Union authorisation of the biocidal 
product has not been granted. Those implementing acts shall 
be adopted in accordance with the examination procedure 
referred to in Article 82(3).  
The Commission shall, at the request of a Member State, decide 
to adjust certain conditions of a Union authorisation specifically 
for the territory of that Member State or decide that a Union 
authorisation shall not apply in the territory of that Member 
State, provided that such a request can be justified on one or 
more of the grounds referred to in Article 37(1).  
SECTION 2  
Renewal of Union authorisations  
Article 45  
Submission and acceptance of applications  
1. An application by or on behalf of an authorisation holder 
wishing to seek the renewal of a Union authorisation shall be 
submitted to the Agency at least 550 days before the expiry 
date of the authorisation.  
The application shall be accompanied by the fees payable under 
Article 80(1).  
2. When applying for renewal, the applicant shall submit:  
(a) without prejudice to Article 21(1), all relevant data required 
under Article 20 that it has generated since the initial auth ­
orisation or, as appropriate, previous renewal; and  
(b) its assessment of whether the conclusions of the initial or 
previous assessment of the biocidal product remain valid 
and any supporting information.  
3. The applicant shall also submit the name of the 
competent authority of the Member State that it proposes 
should evaluate the application for renewal and provide 
written confirmation that that competent authority agrees to 
do so. That competent authority shall be the evaluating 
competent authority.EN 27.6.2012 Official Journal of the European Union L 167/29The Agency shall inform the applicant of the fees payable to it 
under Article 80(1) and shall reject the application if the 
applicant fails to pay the fees within 30 days. It shall inform 
the applicant and the evaluating competent authority accord ­
ingly.  
Upon receipt of the fees payable to it under Article 80(1), the 
Agency shall accept the application and inform the applicant 
and the evaluating competent authority accordingly, indicating 
the date of acceptance.  
4. An appeal may be brought, in accordance with Article 77, 
against decisions of the Agency under paragraph 3 of this 
Article.  
Article 46  
Evaluation of applications for renewal  
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 Union authorisation or, as appropriate, 
the previous renewal, the evaluating competent authority shall, 
within 30 days of the Agency accepting the application in 
accordance with Article 45(3), decide whether, in the light of 
current scientific knowledge, a full evaluation of the application 
for renewal is necessary.  
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 and 2 
of Article 44.  
Where the evaluating competent authority decides that a full 
evaluation of the application is not necessary, it shall, within 
180 days of the Agency accepting the application, prepare and 
submit to the Agency a recommendation on the renewal of the 
authorisation. It shall provide the applicant with a copy of its 
recommendation.  
The evaluating competent authority shall, as soon as possible 
after the Agency has accepted the 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 
within 30 days. It shall inform the applicant accordingly.  
3. Within 180 days of receipt of a recommendation from the 
evaluating competent authority, the Agency shall prepare and 
submit to the Commission an opinion on the renewal of the 
Union authorisation.  
4. On receipt of the opinion of the Agency, the Commission 
shall adopt either an implementing Regulation to renew the 
Union authorisation or an implementing decision to refuse to 
renew the Union authorisation. Those implementing acts shall 
be adopted in accordance with the examination procedure 
referred to in Article 82(3).  The Commission shall renew a Union authorisation, provided 
that the conditions set out in Article 19 are still satisfied.  
5. Where, for reasons beyond the control of the holder of 
the Union authorisation, no decision is taken on the renewal of 
the authorisation before its expiry, the Commission shall grant 
the renewal of the Union authorisation for the period necessary 
to complete the evaluation by means of implementing acts. 
Those implementing acts shall be adopted in accordance with 
the advisory procedure referred to in Article 82(2).  
CHAPTER IX  
CANCELLATION, REVIEW AND AMENDMENT OF AUTHORI ­
SATIONS  
Article 47  
Obligation for notification of unexpected or adverse effects  
1. On becoming aware of information concerning the auth ­
orised biocidal product, or the active substance(s) it contains, 
that may affect the authorisation, the holder of an authorisation 
shall without delay notify the competent authority that granted 
the national authorisation and the Agency or, in the case of a 
Union authorisation, the Commission and the Agency. In 
particular, the following shall be notified:  
(a) new data or information on the adverse effects of the active 
substance or biocidal product for humans, in particular 
vulnerable groups, animals or the environment;  
(b) any data indicating the potential of the active substance for 
the development of resistance;  
(c) new data or information indicating that the biocidal product 
is not sufficiently effective.  
2. The competent authority that granted the national auth ­
orisation or, in the case of a Union authorisation, the Agency, 
shall examine whether the authorisation needs to be amended 
or cancelled in accordance with Article 48.  
3. The competent authority that granted the national auth ­
orisation or, in the case of a Union authorisation, the Agency, 
shall without delay notify competent authorities of other 
Member States and, where appropriate, the Commission of 
any such data or information it receives.  
Competent authorities of Member States that have issued a 
national authorisation for the same biocidal product under 
the mutual recognition procedure shall examine whether the 
authorisation needs to be amended or cancelled in accordance 
with Article 48.EN L 167/30 Official Journal of the European Union 27.6.2012Article 48  
Cancellation or amendment of an authorisation  
1. Without prejudice to Article 23, the competent authority 
of a Member State or, in the case of a Union authorisation, the 
Commission shall at any time cancel or amend an authorisation 
it has granted where it considers that:  
(a) the conditions referred to in Article 19 or, where relevant, 
in Article 25 are not satisfied;  
(b) the authorisation was granted on the basis of false or 
misleading information; or  
(c) the authorisation holder has failed to comply with its 
obligations under the authorisation or this Regulation.  
2. Where the competent authority or, in the case of a Union 
authorisation, the Commission, intends to cancel or amend an 
authorisation, it shall inform the authorisation holder thereof 
and give it the opportunity to submit comments or additional 
information within a specified time limit. The evaluating 
competent authority or, in the case of a Union authorisation, 
the Commission, shall take due account of those comments 
when finalising its decision.  
3. Where the competent authority or, in the case of a Union 
authorisation, the Commission, cancels or amends an authori ­
sation in accordance with paragraph 1, it shall without delay 
notify the authorisation holder, the competent authorities of 
other Member States and, where relevant, the Commission.  
Competent authorities that have issued authorisations under the 
mutual recognition procedure for biocidal products for which 
the authorisation has been cancelled or amended shall, within 
120 days of the notification, cancel or amend the authorisations 
and shall notify the Commission accordingly.  
In the case of disagreement between competent authorities of 
certain Member States concerning national authorisations 
subject to mutual recognition the procedures laid down in 
Articles 35 and 36 shall apply  mutatis mutandis . 
Article 49  
Cancellation of an authorisation at the request of the 
authorisation holder  
At the reasoned request of an authorisation holder, the 
competent authority that granted the national authorisation 
or, in the case of Union authorisation, the Commission shall 
cancel the authorisation. Where such a request concerns a 
Union authorisation, it shall be submitted to the Agency.  Article 50  
Amendment of an authorisation at the request of the 
authorisation holder  
1. Amendments to the terms and conditions of an authori ­
sation shall be made only by the competent authority that 
authorised the biocidal product concerned, or in the case of a 
Union authorisation, by the Commission.  
2. An authorisation holder seeking to change any of the 
information submitted in relation to the initial application for 
authorisation of the product shall apply to the competent auth ­
orities of relevant Member States having authorised the biocidal 
product concerned, or in the case of a Union authorisation, the 
Agency. Those competent authorities shall decide, or, in the 
case of a Union authorisation, the Agency shall examine and 
the Commission decide whether the conditions of Article 19 or, 
where relevant, Article 25 are still met and whether the terms 
and conditions of the authorisation need to be amended.  
The application shall be accompanied by the fees payable under 
Article 80(1) and (2).  
3. An amendment to an existing authorisation shall fall 
under one of the following categories of changes:  
(a) administrative change;  
(b) minor change; or  
(c) major change.  
Article 51  
Detailed rules  
In order to ensure a harmonised approach to the cancellation 
and amendment of authorisations, the Commission shall lay 
down detailed rules for the application of Articles 47 to 50 
by means of implementing acts. Those implementing acts 
shall be adopted in accordance with the examination 
procedure referred to in Article 82(3).  
The rules referred to in the first paragraph of this Article shall 
be based, inter alia, on the following principles:  
(a) a simplified notification procedure shall be applied for 
administrative changes;  
(b) a reduced evaluation period shall be established for minor 
changes;  
(c) in the case of major changes, the evaluation period shall be 
proportionate to the extent of the proposed change.EN 27.6.2012 Official Journal of the European Union L 167/31Article 52  
Period of grace  
Notwithstanding Article 89, where the competent authority or, 
in the case of a biocidal product authorised at Union level, the 
Commission, cancels or amends an authorisation or decides not 
to renew it, it shall grant a period of grace for the disposal, 
making available on the market and use of existing stocks, 
except in cases where continued making available on the 
market or use of the biocidal product would constitute an 
unacceptable risk to human health, animal health or the 
environment.  
The period of grace shall not exceed 180 days for the making 
available on the market and an additional maximum period of 
180 days for the disposal and use of existing stocks of the 
biocidal products concerned.  
CHAPTER X  
PARALLEL TRADE  
Article 53  
Parallel trade  
1. A competent authority of a Member State (‘Member State 
of introduction’) shall, at the request of the applicant, grant a 
parallel trade permit for a biocidal product that is authorised in 
another Member State (‘Member State of origin’) to be made 
available on the market and used in the Member State of intro ­
duction, if it determines in accordance with paragraph 3 that 
the biocidal product is identical to a biocidal product already 
authorised in the Member State of introduction (‘the reference 
product’).  
The applicant who intends to place the biocidal product on the 
market in the Member State of introduction shall submit the 
application for a parallel trade permit to the competent 
authority of the Member State of introduction.  
The application shall be accompanied by the information 
referred to in paragraph 4 and all other information necessary 
to demonstrate that the biocidal product is identical to the 
reference product as defined in paragraph 3.  
2. Where the competent authority of the Member State of 
introduction determines that a biocidal product is identical to 
the reference product, it shall grant a parallel trade permit 
within 60 days of receipt of the fees payable under Article 80(2). 
The competent authority of the Member State of introduction 
may request from the competent authority of the Member State 
of origin additional information necessary to determine whether 
the product is identical to the reference product. The competent 
authority of the Member State of origin shall provide the 
requested information within 30 days of receiving the request.  
3. A biocidal product shall be considered as identical to the 
reference product only if all the following conditions are met:  
(a) they have been manufactured by the same company, by an 
associated undertaking or under license in accordance with 
the same manufacturing process;  (b) they are identical in specification and content in respect of 
the active substances and the type of formulation;  
(c) they are the same in respect of the non-active substances 
present; and  
(d) they are either the same or equivalent in packaging size, 
material or form, in terms of the potential adverse impact 
on the safety of the product with regard to human health, 
animal health or the environment.  
4. An application for a parallel trade permit shall include the 
following information and items:  
(a) name and authorisation number of the biocidal product in 
the Member State of origin;  
(b) name and address of the competent authority of the 
Member State of origin;  
(c) name and address of the authorisation holder in the 
Member State of origin;  
(d) original label and instructions for use with which the 
biocidal product is distributed in the Member State of 
origin if it is considered as necessary for the examination 
by the competent authority of the Member State of intro ­
duction;  
(e) name and address of the applicant;  
(f) name to be given to the biocidal product to be distributed 
in the Member State of introduction;  
(g) a draft label for the biocidal product intended to be made 
available on the market in the Member State of introduction 
in the official language or languages of the Member State of 
introduction, unless that Member State provides otherwise;  
(h) a sample of the biocidal product which is intended to be 
introduced if it is considered as necessary by the competent 
authority of the Member State of introduction;  
(i) name and authorisation number of the reference product in 
the Member State of introduction.  
The competent authority of the Member State of introduction 
may require a translation of the relevant parts of the original 
instructions for the use referred to in point (d).EN L 167/32 Official Journal of the European Union 27.6.20125. The parallel trade permit shall prescribe the same 
conditions for making available on the market and use as the 
authorisation of the reference product.  
6. The parallel trade permit shall be valid for the duration of 
authorisation of the reference product in the Member State of 
introduction.  
If the authorisation holder of the reference product applies for 
cancellation of authorisation in accordance with Article 49 and 
the requirements of Article 19 are still fulfilled, the validity of 
the parallel trade permit shall expire on the date on which the 
authorisation of the reference product would normally have 
expired.  
7. Without prejudice to specific provisions in this Article, 
Articles 47 to 50 and Chapter XV shall apply  mutatis mutandis  
to biocidal products made available on the market under a 
parallel trade permit.  
8. The competent authority of the Member State of intro ­
duction may withdraw a parallel trade permit if the authori ­
sation of the introduced biocidal product is withdrawn in the 
Member State of origin because of safety or efficacy reasons.  
CHAPTER XI  
TECHNICAL EQUIVALENCE  
Article 54  
Assessment of technical equivalence  
1. Where it is necessary to establish the technical equivalence 
of active substances, the person seeking to establish that equiv ­
alence (‘the applicant’) shall submit an application to the Agency 
and pay the applicable fees in accordance with Article 80(1).  
2. The applicant shall submit all data that the Agency 
requires to assess technical equivalence.  
3. The Agency shall inform the applicant of the fees payable 
under Article 80(1), and shall reject the application if the 
applicant fails to pay the fees within 30 days. It shall inform 
the applicant and the evaluating competent authority accord ­
ingly.  
4. After giving the applicant the opportunity to submit 
comments, the Agency shall take a decision within 90 days 
of receipt of the application referred to in paragraph 1 and 
shall communicate it to Member States and to the applicant.  
5. Where, in the opinion of the Agency, additional 
information is necessary to carry out the assessment of 
technical equivalence, the Agency shall ask the applicant to 
submit such information within a time limit specified by the 
Agency. The Agency shall reject the application if the applicant fails to submit the additional information within the specified 
time limit. The 90-day period referred to in paragraph 4 shall 
be suspended from the date of issue of the request until the 
information is received. The suspension shall not exceed 180 
days except where justified by the nature of the data requested 
or in exceptional circumstances.  
6. Where appropriate, the Agency may consult the 
competent authority of the Member State which acted as the 
evaluating competent authority for the evaluation of the active 
substance.  
7. An appeal may be brought, in accordance with Article 77, 
against decisions of the Agency under paragraphs 3, 4 and 5 of 
this Article.  
8. The Agency shall draw up technical guidance notes to 
facilitate the implementation of this Article.  
CHAPTER XII  
DEROGATIONS  
Article 55  
Derogation from the requirements  
1. By way of derogation from Articles 17 and 19, a 
competent authority may permit, for a period not exceeding 
180 days, the making available on the market or use of a 
biocidal product which does not fulfil the conditions for auth ­
orisation laid down in this Regulation, for a limited and 
controlled use under the supervision of the competent auth ­
ority, if such a measure is necessary because of a danger to 
public health, animal health or the environment which cannot 
be contained by other means.  
The competent authority referred to in the first subparagraph 
shall, without delay, inform the other competent authorities and 
the Commission of its action and the justification for it. The 
competent authority shall, without delay, inform the other 
competent authorities and the Commission of the revocation 
of such action.  
On receipt of a reasoned request from the competent authority, 
the Commission shall, without delay and by means of imple ­
menting acts, decide whether, and under what conditions, the 
action taken by that competent authority may be extended, for 
a period not exceeding 550 days. Those implementing acts shall 
be adopted in accordance with the examination procedure 
referred to in Article 82(3).  
2. By way of derogation from point (a) of Article 19(1) and 
until an active substance is approved, competent authorities and 
the Commission may authorise, for a period not exceeding three 
years, a biocidal product containing a new active substance.EN 27.6.2012 Official Journal of the European Union L 167/33Such a provisional authorisation may be issued only if, after 
dossiers have been evaluated in accordance with Article 8, the 
evaluating competent authority has submitted a recommen ­
dation for approval of the new active substance and the 
competent authorities which received the application for the 
provisional authorisation or, in the case of a provisional 
Union authorisation, the Agency, consider that the biocidal 
product is expected to comply with points (b), (c) and (d) of 
Article 19(1) taking into account the factors set out in 
Article 19(2).  
If the Commission decides not to approve the new active 
substance, the competent authorities which granted the 
provisional authorisation or the Commission shall cancel that 
authorisation.  
Where a decision on the approval of the new active substance 
has not yet been adopted by the Commission when the period 
of three years expires, the competent authorities which granted 
the provisional authorisation, or the Commission, may extend 
the provisional authorisation for a period not exceeding one 
year, provided that there are good reasons to believe that the 
active substance will satisfy the conditions laid down in 
Article 4(1) or, where applicable, the conditions set out in 
Article 5(2). Competent authorities which extend the 
provisional authorisation shall inform the other competent 
authorities and the Commission of such action.  
3. By way of derogation from point (a) of Article 19(1), the 
Commission may, by means of implementing acts, allow a 
Member State to authorise a biocidal product containing a 
non-approved active substance if it is satisfied that that active 
substance is essential for the protection of cultural heritage and 
that no appropriate alternatives are available. Those imple ­
menting acts shall be adopted in accordance with the advisory 
procedure referred to in Article 82(2). A Member State wishing 
to obtain such a derogation shall apply to the Commission, 
providing due justification.  
Article 56  
Research and development  
1. By way of derogation from Article 17, an experiment or a 
test for the purposes of research or development involving an 
unauthorised biocidal product or a non-approved active 
substance intended exclusively for use in a biocidal product 
(‘experiment’ or ‘test’) may take place only under the conditions 
laid down in this Article.  
Persons carrying out an experiment or test shall draw up and 
maintain written records detailing the identity of the biocidal 
product or active substance, labelling data, quantities supplied 
and the names and addresses of those persons receiving the 
biocidal product or active substance, and shall compile a 
dossier containing all available data on possible effects on 
human or animal health or impact on the environment. They 
shall make this information available to the competent authority 
on request.  2. Any person intending to carry out an experiment or test 
that may involve, or result in, release of the biocidal product 
into the environment shall first notify the competent authority 
of the Member State where the experiment or test will occur. 
The notification shall include the identity of the biocidal 
product or active substance, labelling data and quantities 
supplied, and all available data on possible effects on human 
or animal health or impact on the environment. The person 
concerned shall make available any other information requested 
by the competent authorities.  
In the absence of an opinion from the competent authority 
within 45 days of the notification referred to in the first 
subparagraph, the notified experiment or test may take place.  
3. If the experiments or tests could have harmful effects, 
whether immediate or delayed, on the health of humans, 
particularly of vulnerable groups, or animals, or any 
unacceptable adverse effect on humans, animals or the 
environment, the relevant competent authority of the Member 
State concerned may prohibit them or allow them subject to 
such conditions as it considers necessary to prevent those 
consequences. The competent authority shall, without delay, 
inform the Commission and other competent authorities of 
its decision.  
4. The Commission shall be empowered to adopt delegated 
acts in accordance with Article 83 specifying detailed rules 
supplementing this Article.  
Article 57  
Exemption from registration under Regulation (EC) 
No 1907/2006  
In addition to the active substances referred to in Article 15(2) 
of Regulation (EC) No 1907/2006, active substances manu ­
factured or imported for use in biocidal products authorised 
for placing on the market in accordance with Article 27, 55 
or 56 shall be regarded as being registered and the registration 
as completed for manufacture or import for use in a biocidal 
product and therefore as fulfilling the requirements of Chapters 
1 and 5, Title II of Regulation (EC) No 1907/2006.  
CHAPTER XIII  
TREATED ARTICLES  
Article 58  
Placing on the market of treated articles  
1. This Article shall apply exclusively to treated articles that 
are not biocidal products. It shall not apply to treated articles 
where the sole treatment undertaken was the fumigation or 
disinfection of premises or containers used for storage or 
transport and where no residues are expected to remain from 
such treatment.EN L 167/34 Official Journal of the European Union 27.6.20122. 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.  
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 legis ­
lation 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.  5. Notwithstanding the labelling requirements set out in 
paragraph 3, the supplier of a treated article shall, where a 
consumer so requests, provide that consumer, within 45 days, 
free of charge, with information on the biocidal treatment of 
the treated article.  
6. The labelling shall be clearly visible, easily legible and 
appropriately durable. Where necessary because of the size or 
the function of the treated article, the labelling shall be printed 
on the packaging, on the instructions for use or on the 
warranty in the official language or languages of the Member 
State of introduction, unless that Member State provides 
otherwise. In the case of treated articles that are not produced 
as part of a series but rather designed and manufactured to 
meet a specific order, the manufacturer may agree other 
methods of providing the customer with the relevant 
information.  
7. The Commission may adopt implementing acts for the 
application of paragraph 2 of this Article, including appropriate 
notification procedures, possibly involving the Agency, and 
further specifying the labelling requirements under paragraphs 
3, 4 and 6 of this Article. Those implementing acts shall be 
adopted in accordance with the examination procedure referred 
to in Article 82(3).  
8. Where there are significant indications that an active 
substance contained in a biocidal product with which a 
treated article is treated or which it incorporates does not 
meet the conditions laid down in Article 4(1), Article 5(2) or 
Article 25, the Commission shall review the approval of that 
active substance or its inclusion in Annex I in accordance with 
Article 15(1) or Article 28(2).  
CHAPTER XIV  
DATA PROTECTION AND DATA-SHARING  
Article 59  
Protection of data held by competent authorities or the 
Agency  
1. Without prejudice to Articles 62 and 63, data submitted 
for the purposes of Directive 98/8/EC or of this Regulation shall 
not be used by competent authorities or the Agency for the 
benefit of a subsequent applicant, except where:  
(a) the subsequent applicant submits a letter of access; or  
(b) the relevant time limit for data protection has expired.  
2. When submitting data to a competent authority or to the 
Agency for the purposes of this Regulation the applicant shall, 
where relevant, indicate the name and contact details of the data 
owner for all data submitted. The applicant shall also specify 
whether it is the data owner or holds a letter of access.EN 27.6.2012 Official Journal of the European Union L 167/353. The applicant shall, without delay, inform the competent 
authority or the Agency about any changes to the ownership of 
the data.  
4. The advisory scientific committees set up under 
Commission Decision 2004/210/EC of 3 March 2004 setting 
up Scientific Committees in the field of consumer safety, public 
health and the environment (  1 ) shall also have access to the data 
referred to in paragraph 1 of this Article.  
Article 60  
Data protection periods  
1. Data submitted for the purposes of Directive 98/8/EC or 
of this Regulation shall benefit from data protection under the 
conditions laid down in this Article. The protection period for 
the data shall start when they are submitted for the first time.  
Data protected under this Article or for which the protection 
period under this Article has expired shall not be protected 
again.  
2. The protection period for data submitted with a view to 
the approval of an existing active substance shall end 10 years 
from the first day of the month following the date of adoption 
of a decision in accordance with Article 9 on the approval of 
the relevant active substance for the particular product-type.  
The protection period for data submitted with a view to the 
approval of a new active substance shall end 15 years from the 
first day of the month following the date of adoption of a 
decision in accordance with Article 9 on the approval of the 
relevant active substance for the particular product-type.  
The protection period for new data submitted with a view to 
the renewal or review of the approval of an active substance 
shall end five years from the first day of the month following 
the date of the adoption of a decision in accordance with 
Article 14(4) concerning the renewal or the review.  
3. The protection period for data submitted with a view to 
the authorisation of a biocidal product containing only existing 
active substances shall end 10 years from the first day of the 
month following the first decision concerning the authorisation 
of the product taken in accordance with Article 30(4), 
Article 34(6) or Article 44(4).  
The protection period for data submitted with a view to the 
authorisation of a biocidal product containing a new active 
substance shall end 15 years from the first day of the month 
following the first decision concerning the authorisation of the 
product taken in accordance with Article 30(4), Article 34(6) or 
Article 44(4).  The protection period for new data submitted with a view to 
the renewal or amendment of the authorisation of a biocidal 
product shall end five years from the first day of the month 
following the decision concerning the renewal or amendment of 
the authorisation.  
Article 61  
Letter of access  
1. A letter of access shall contain at least the following 
information:  
(a) the name and contact details of the data owner and the 
beneficiary;  
(b) the name of the active substance or biocidal product for 
which access to the data is authorised;  
(c) the date on which the letter of access takes effect;  
(d) a list of the submitted data to which the letter of access 
grants citation rights.  
2. Revocation of a letter of access shall not affect the validity 
of the authorisation issued on the basis of the letter of access in 
question.  
Article 62  
Data sharing  
1. In order to avoid animal testing, testing on vertebrates for 
the purposes of this Regulation shall be undertaken only as a 
last resort. Testing on vertebrates shall not be repeated for the 
purposes of this Regulation.  
2. Any person intending to perform tests or studies (‘the 
prospective applicant’)  
(a) shall, in the case of data involving tests on vertebrates; and  
(b) may, in the case of data not involving tests on vertebrates,  
submit a written request to the Agency to determine whether 
such tests or studies have already been submitted to the Agency 
or to a competent authority in connection with a previous 
application under this Regulation or Directive 98/8/EC. The 
Agency shall verify whether such tests or studies have already 
been submitted.  
Where such tests or studies have already been submitted to the 
Agency or to a competent authority in connection with a 
previous application, under this Regulation or Directive 
98/8/EC, the Agency shall, without delay, communicate the 
name and contact details of the data submitter and data 
owner to the prospective applicant.EN L 167/36 Official Journal of the European Union 27.6.2012  
( 1 ) OJ L 66, 4.3.2004, p. 45.The data submitter shall, where relevant, facilitate contacts 
between the prospective applicant and the data owner.  
Where the data acquired under those tests or studies are still 
protected under Article 60, the prospective applicant:  
(a) shall, in the case of data involving tests on vertebrates; and  
(b) may, in the case of data not involving tests on vertebrates,  
request from the data owner all the scientific and technical data 
related to the tests and studies concerned as well as the right to 
refer to these data when submitting applications under this 
Regulation.  
Article 63  
Compensation for data sharing  
1. Where a request has been made in accordance with 
Article 62(2), the prospective applicant and the data owner 
shall make every effort to reach an agreement on the sharing 
of the results of the tests or studies requested by the prospective 
applicant. Such an agreement may be replaced by submission of 
the matter to an arbitration body and a commitment to accept 
the arbitration order.  
2. Where such agreement is reached, the data owner shall 
make all the scientific and technical data related to the tests and 
studies concerned available to the prospective applicant or shall 
give the prospective applicant permission to refer to the data 
owner’s tests or studies when submitting applications under this 
Regulation.  
3. Where no agreement is reached with respect to data 
involving tests or studies on vertebrates, the prospective 
applicant shall inform the Agency and the data owner 
thereof, at the earliest one month after the prospective 
applicant receives the name and address of the data submitter 
from the Agency.  
Within 60 days of being informed, the Agency shall give the 
prospective applicant permission to refer to the requested tests 
or studies on vertebrates, provided that the prospective 
applicant demonstrates that every effort has been made to 
reach an agreement and that the prospective applicant has 
paid the data owner a share of the costs incurred. Where the 
prospective applicant and data owner cannot agree, national 
courts shall decide on the proportionate share of the cost that 
the prospective applicant is to pay to the data owner.  
The data owner shall not refuse to accept any payment offered 
pursuant to the second subparagraph. Any acceptance is 
without prejudice, however, to his right to have the propor ­
tionate share of the cost determined by a national court, in 
accordance with the second subparagraph.  4. Compensation for data sharing shall be determined in a 
fair, transparent and non-discriminatory manner, having regard 
to the guidance established by the Agency (  1 ). The prospective 
applicant shall be required to share only in the costs of 
information that it is required to submit for the purposes of 
this Regulation.  
5. An appeal may be brought, in accordance with Article 77, 
against decisions of the Agency under paragraph 3 of this 
Article.  
Article 64  
Use of data for subsequent applications  
1. Where the relevant data protection period according to 
Article 60 has expired in relation to an active substance, the 
receiving competent authority or the Agency may agree that a 
subsequent applicant for authorisation may refer to data 
provided by the first applicant in so far as the subsequent 
applicant can provide evidence that the active substance is tech ­
nically equivalent to the active substance for which the data 
protection period has expired, including the degree of purity 
and the nature of any relevant impurities.  
Where the relevant data protection period according to 
Article 60 has expired in relation to a biocidal product, the 
receiving competent authority or the Agency may agree that a 
subsequent applicant for authorisation may refer to data 
provided by the first applicant in so far as the subsequent 
applicant can provide evidence that the biocidal product is 
the same as the one already authorised, or the differences 
between them are not significant in relation to the risk 
assessment and the active substance(s) in the biocidal product 
are technically equivalent to those in the biocidal product 
already authorised, including the degree of purity and the 
nature of any impurities.  
An appeal may be brought, in accordance with Article 77, 
against decisions of the Agency under the first and second 
subparagraphs of this paragraph.  
2. Notwithstanding paragraph 1, subsequent applicants shall 
provide the following data accordingly to the receiving 
competent authority or the Agency, as applicable:  
(a) all necessary data for the identification of the biocidal 
product, including its composition;  
(b) the data needed to identify the active substance and to 
establish technical equivalence of the active substance;  
(c) the data needed to demonstrate the comparability of the 
risk from and efficacy of the biocidal product to that of 
the authorised biocidal product.EN 27.6.2012 Official Journal of the European Union L 167/37  
( 1 ) Guidance on data sharing established in accordance with Regulation 
(EC) No 1907/2006.CHAPTER XV  
INFORMATION AND COMMUNICATION  
SECTION 1  
Monitoring and reporting  
Article 65  
Compliance with requirements  
1. Member States shall make the necessary arrangements for 
the monitoring of biocidal products and treated articles which 
have been placed on the market to establish whether they 
comply with the requirements of this Regulation. Regulation 
(EC) No 765/2008 of the European Parliament and of the 
Council of 9 July 2008 setting out the requirements for accredi ­
tation and market surveillance relating to the marketing of 
products (  1 ) shall apply accordingly.  
2. Member States shall make the necessary arrangements for 
official controls to be carried out in order to enforce 
compliance with this Regulation.  
In order to facilitate such enforcement, manufacturers of 
biocidal products placed on the Union market shall maintain, 
in relation to the manufacturing process, appropriate documen ­
tation in paper or electronic format relevant for the quality and 
safety of the biocidal product to be placed on the market and 
shall store production batch samples. The documentation shall 
include as a minimum:  
(a) safety data sheets and specifications of active substances and 
other ingredients used for manufacturing the biocidal 
product;  
(b) records of the various manufacturing operations performed;  
(c) results of internal quality controls;  
(d) identification of production batches.  
Where necessary in order to ensure uniform application of this 
paragraph, the Commission may adopt implementing acts in 
accordance with the examination procedure referred to in 
Article 82(3).  
Measures taken pursuant to this paragraph shall avoid causing 
disproportionate administrative burden to economic operators 
and Member States.  
3. Every five years, from 1 September 2015, Member States 
shall submit to the Commission a report on the implementation 
of this Regulation in their respective territories. The report shall 
include in particular:  
(a) information on the results of official controls carried out in 
accordance with paragraph 2;  (b) information on any poisonings and, where available, occu ­
pational diseases involving biocidal products, especially 
regarding vulnerable groups, and any specific measures 
taken to mitigate the risk of future cases;  
(c) any available information on adverse environmental effects 
experienced through using biocidal products;  
(d) information on the use of nanomaterials in biocidal 
products and the potential risks thereof.  
Reports shall be submitted by 30 June of the relevant year and 
shall cover the period until 31 December of the year preceding 
their submission.  
The reports shall be published on the relevant website of the 
Commission.  
4. On the basis of the reports received in accordance with 
paragraph 3, and within 12 months from the date referred to in 
the second subparagraph of that paragraph, the Commission 
shall draw up a composite report on the implementation of 
this Regulation, in particular Article 58. The Commission 
shall submit the report to the European Parliament and to the 
Council.  
Article 66  
Confidentiality  
1. Regulation (EC) No 1049/2001 of the European 
Parliament and of the Council of 30 May 2001 regarding 
public access to European Parliament, Council and Commission 
documents (  2 ) and the rules of the Management Board of the 
Agency, adopted in accordance with Article 118(3) of Regu ­
lation (EC) No 1907/2006, shall apply to documents held by 
the Agency for the purposes of this Regulation.  
2. The Agency and the competent authorities shall refuse 
access to information where disclosure would undermine the 
protection of the commercial interests or the privacy or safety 
of the persons concerned.  
Disclosure of the following information shall normally be 
deemed to undermine the protection of the commercial 
interests or the privacy or safety of the persons concerned:  
(a) details of the full composition of a biocidal product;  
(b) the precise tonnage of the active substance or biocidal 
product manufactured or made available on the market;EN L 167/38 Official Journal of the European Union 27.6.2012  
( 1 ) OJ L 218, 13.8.2008, p. 30.  (  2 ) OJ L 145, 31.5.2001, p. 43.(c) links between a manufacturer of an active substance and the 
person responsible for the placing of a biocidal product on 
the market or between the person responsible for the 
placing of a biocidal product on the market and the 
distributors of the product;  
(d) names and addresses of persons involved in testing on 
vertebrates.  
However, where urgent action is essential to protect human 
health, animal health, safety or the environment or for other 
reasons of overriding public interest, the Agency or the 
competent authorities shall disclose the information referred 
to in this paragraph.  
3. Notwithstanding paragraph 2, after the authorisation has 
been granted, access to the following information shall not in 
any case be refused:  
(a) the name and address of the authorisation holder;  
(b) the name and address of the biocidal product manufacturer;  
(c) the name and address of the active substance manufacturer;  
(d) the content of the active substance or substances in the 
biocidal product and the name of the biocidal product;  
(e) physical and chemical data concerning the biocidal product;  
(f) any methods for rendering the active substance or biocidal 
product harmless;  
(g) a summary of the results of the tests required pursuant to 
Article 20 to establish the product’s efficacy and effects on 
humans, animals and the environment and, where appli ­
cable, its ability to promote resistance;  
(h) recommended methods and precautions to reduce dangers 
from handling, transport and use as well as from fire or 
other hazards;  
(i) safety data sheets;  
(j) methods of analysis referred to in Article 19(1)(c);  
(k) methods of disposal of the product and of its packaging;  
(l) procedures to be followed and measures to be taken in the 
case of spillage or leakage;  
(m) first aid and medical advice to be given in the case of injury 
to persons.  4. Any person submitting information related to an active 
substance or a biocidal product to the Agency or a competent 
authority for the purposes of this Regulation can request that 
the information in Article 67(3) shall not be made available, 
including a justification as to why the disclosure of the 
information could be harmful for their commercial interests 
or those of any other party concerned.  
Article 67  
Electronic public access  
1. From the date on which an active substance is approved, 
the following up-to-date information held by the Agency or the 
Commission on active substances shall be made publicly and 
easily available free of charge:  
(a) where available, the ISO name and the name in the Inter ­
national Union of Pure and Applied Chemistry (IUPAC) 
nomenclature;  
(b) if applicable, the name as given in the European Inventory 
of Existing Commercial Chemical Substances;  
(c) the classification and labelling, including whether the active 
substance meets any of the criteria set out in Article 5(1);  
(d) physicochemical endpoints and data on pathways and envi ­
ronmental fate and behaviour;  
(e) the result of each toxicological and ecotoxicological study;  
(f) acceptable exposure level or predicted no-effect concen ­
tration established in accordance with Annex VI;  
(g) the guidance on safe use provided in accordance with 
Annexes II and III;  
(h) analytical methods referred to under Sections 5.2 and 5.3 of 
Title 1, and Section 4.2 of Title 2 of Annex II.  
2. From the date on which a biocidal product is authorised, 
the Agency shall make publicly and easily available free of 
charge the following up-to-date information:  
(a) the terms and conditions of the authorisation;  
(b) the summary of the biocidal product characteristics; and  
(c) analytical methods referred to under Sections 5.2 and 5.3 of 
Title 1, and Section 5.2 of Title 2 of Annex III.EN 27.6.2012 Official Journal of the European Union L 167/393. From the date on which an active substance is approved, 
the Agency shall, except where the data supplier submits a 
justification in accordance with Article 66(4) accepted as valid 
by the competent authority or the Agency as to why such 
publication is potentially harmful for its commercial interests 
or any other party concerned, make publicly available, free of 
charge, the following up-to-date information on active 
substances:  
(a) if essential to classification and labelling, the degree of 
purity of the substance and the identity of impurities 
and/or additives of active substances which are known to 
be hazardous;  
(b) the study summaries or robust study summaries of studies 
submitted to support the approval of the active substance;  
(c) information, other than that listed in paragraph 1 of this 
Article, contained in the safety data sheet;  
(d) the trade name(s) of the substance;  
(e) the assessment report.  
4. From the date on which a biocidal product is authorised, 
the Agency shall, except where the data supplier submits a 
justification in accordance with Article 66(4) accepted as valid 
by the competent authority or the Agency as to why such 
publication is potentially harmful for its commercial interests 
or any other party concerned, make publicly available, free of 
charge, the following up-to date information:  
(a) study summaries, or robust study summaries, of studies 
submitted to support the biocidal product authorisation; 
and 
(b) the assessment report.  
Article 68  
Record-keeping and reporting  
1. Authorisation holders shall keep records of the biocidal 
products they place on the market for at least 10 years after 
placing on the market, or 10 years after the date on which the 
authorisation was cancelled or expired, whichever is the earlier. 
They shall make available the relevant information contained in 
these records to the competent authority on request.  
2. To ensure the uniform application of paragraph 1 of this 
Article, the Commission shall adopt implementing acts to 
specify the form and content of the information in records. 
Those implementing acts shall be adopted in accordance with 
the advisory procedure referred to in Article 82(2).  SECTION 2  
Information about biocidal products  
Article 69  
Classification, packaging and labelling of biocidal products  
1. Authorisation holders shall ensure that biocidal products 
are classified, packaged and labelled in accordance with the 
approved summary of biocidal product characteristics, in 
particular the hazard statements and the precautionary state ­
ments, as referred to in point (i) of Article 22(2), and with 
Directive 1999/45/EC and, where applicable, Regulation (EC) 
No 1272/2008.  
In addition, products which may be mistaken for food, 
including drink, or feed shall be packaged to minimise the 
likelihood of such a mistake being made. If they are available 
to the general public, they shall contain components to 
discourage their consumption and, in particular, shall not be 
attractive to children.  
2. In addition to compliance with paragraph 1, authorisation 
holders shall ensure that labels are not misleading in respect of 
the risks from the product to human health, animal health or 
the environment or its efficacy and, in any case, do not mention 
the indications ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’, 
‘natural’, ‘environmentally friendly’, ‘animal friendly’ or similar 
indications. In addition, the label must show clearly and 
indelibly the following information:  
(a) the identity of every active substance and its concentration 
in metric units;  
(b) the nanomaterials contained in the product, if any, and any 
specific related risks, and, following each reference to nano ­
materials, the word ‘nano’ in brackets;  
(c) the authorisation number allocated to the biocidal product 
by the competent authority or the Commission;  
(d) the name and address of the authorisation holder;  
(e) the type of formulation;  
(f) the uses for which the biocidal product is authorised;  
(g) directions for use, frequency of application and dose rate, 
expressed in metric units, in a manner which is meaningful 
and comprehensible to the user, for each use provided for 
under the terms of the authorisation;  
(h) particulars of likely direct or indirect adverse side effects 
and any directions for first aid;EN L 167/40 Official Journal of the European Union 27.6.2012(i) if accompanied by a leaflet, the sentence ‘Read attached 
instructions before use’ and, where applicable, warnings 
for vulnerable groups;  
(j) directions for the safe disposal of the biocidal product and 
its packaging, including, where relevant, any prohibition on 
the reuse of packaging;  
(k) the formulation batch number or designation and the 
expiry date relevant to normal conditions of storage;  
(l) where applicable, the period of time needed for the biocidal 
effect, the interval to be observed between applications of 
the biocidal product or between application and the next 
use of the product treated, or the next access by humans or 
animals to the area where the biocidal product has been 
used, including particulars concerning decontamination 
means and measures and duration of necessary ventilation 
of treated areas; particulars for adequate cleaning of 
equipment; particulars concerning precautionary measures 
during use and transport;  
(m) where applicable, the categories of users to which the 
biocidal product is restricted;  
(n) where applicable, information on any specific danger to the 
environment particularly concerning protection of non- 
target organisms and avoidance of contamination of water;  
(o) for biocidal products containing micro-organisms, labelling 
requirements in accordance with Directive 2000/54/EC.  
By way of derogation from the first subparagraph, where this is 
necessary because of the size or the function of the biocidal 
product, the information referred to in points (e), (g), (h), (j), (k), 
(l) and (n) may be indicated on the packaging or on an accom ­
panying leaflet integral to the packaging.  
3. Member States may require:  
(a) the provision of models or drafts of the packaging, labelling 
and leaflets;  
(b) that biocidal products made available on the market in their 
territories be labelled in their official language or languages.  
Article 70  
Safety data sheets  
Safety data sheets for active substances and biocidal products 
shall be prepared and made available in accordance with 
Article 31 of Regulation (EC) No 1907/2006, where applicable.  Article 71  
Register for Biocidal Products  
1. The Agency shall establish and maintain an information 
system which shall be referred to as the Register for Biocidal 
Products.  
2. The Register for Biocidal Products shall be used for the 
exchange of information between competent authorities, the 
Agency and the Commission and between applicants and 
competent authorities, the Agency and the Commission.  
3. Applicants shall use the Register for Biocidal Products to 
submit applications and data for all procedures covered by this 
Regulation.  
4. Upon submission of applications and data by applicants, 
the Agency shall check that these have been submitted in the 
correct format and notify the relevant competent authority 
accordingly without delay.  
Where the Agency decides that the application has not been 
submitted in the correct format, it shall reject the application 
and inform the applicant accordingly.  
5. Once the relevant competent authority has validated or 
accepted an application, it shall be made available via the 
Register for Biocidal Products to all other competent authorities 
and to the Agency.  
6. The competent authorities and the Commission shall use 
the Register for Biocidal Products to record and communicate 
the decisions they have taken in relation to the authorisations of 
biocidal products and shall update the information in the 
Register for Biocidal Products at the time such decisions are 
taken. The competent authorities shall, in particular, update 
the information in the Register for Biocidal Products relating 
to biocidal products which have been authorised within their 
territory or for which a national authorisation has been refused, 
amended, renewed or cancelled, or for which a parallel trade 
permit has been granted, refused or cancelled. The Commission 
shall, in particular, update the information relating to biocidal 
products which have been authorised in the Union or for which 
a Union authorisation has been refused, amended, renewed or 
cancelled.  
The information to be introduced into the Register for Biocidal 
Products shall include, as appropriate:  
(a) the terms and conditions of the authorisation;  
(b) the summary of the biocidal product characteristics referred 
to in Article 22(2);  
(c) the assessment report of the biocidal product.EN 27.6.2012 Official Journal of the European Union L 167/41The information referred to in this paragraph shall also be made 
available to the applicant through the Register for Biocidal 
Products.  
7. In the event that the Register for Biocidal Products is not 
fully operational by 1 September 2013 or ceases to be oper ­
ational after that date, all obligations in relation to submissions 
and communication placed upon Member States, competent 
authorities, the Commission and applicants by this Regulation 
shall continue to apply. With a view to ensuring the uniform 
application of this paragraph, particularly with regard to the 
format in which information may be submitted and exchanged, 
the Commission shall adopt the necessary measures in 
accordance with the examination procedure referred to in 
Article 82(3). Those measures shall be limited in time to the 
period strictly necessary for the Register for Biocidal Products to 
become fully operational.  
8. The Commission may adopt implementing acts laying 
down detailed rules on the types of information to be entered 
in the Register for Biocidal Products. Those implementing acts 
shall be adopted in accordance with the advisory procedure 
referred to in Article 82(2).  
9. The Commission shall be empowered to adopt delegated 
acts in accordance with Article 83 laying down supplementary 
rules for the use of the Register.  
Article 72  
Advertising  
1. Any advertisement for biocidal products shall, in addition 
to complying with Regulation (EC) No 1272/2008, include the 
sentences ‘Use biocides safely. Always read the label and 
product information before use.’. The sentences shall be 
clearly distinguishable and legible in relation to the whole 
advertisement.  
2. Advertisers may replace the word ‘biocides’ in the 
prescribed sentences with a clear reference to the product-type 
being advertised.  
3. Advertisements for biocidal products shall not refer to the 
product in a manner which is misleading in respect of the risks 
from the product to human health, animal health or the 
environment or its efficacy. In any case, the advertising of a 
biocidal product shall not mention ‘low-risk biocidal product’, 
‘non-toxic’, ‘harmless’, ‘natural’, ‘environmentally friendly’, 
‘animal friendly’ or any similar indication.  
Article 73  
Poison control  
Article 45 of Regulation (EC) No 1272/2008 shall apply for the 
purposes of this Regulation.  CHAPTER XVI  
THE AGENCY  
Article 74  
Role of the Agency  
1. The Agency shall carry out the tasks conferred on it by 
this Regulation.  
2. Articles 78 to 84, 89 and 90 of Regulation (EC) 
No 1907/2006 shall apply  mutatis mutandis  taking into 
account the role of the Agency with respect to this Regulation.  
Article 75  
Biocidal Products Committee  
1. A Biocidal Products Committee is hereby established 
within the Agency.  
The Biocidal Products Committee shall be responsible for 
preparing the opinion of the Agency on the following issues:  
(a) applications for approval and renewal of approval of active 
substances;  
(b) review of approval of active substances;  
(c) applications for inclusion in Annex I of active substances 
meeting the conditions laid down in Article 28 and review 
of the inclusion of such active substances in Annex I;  
(d) identification of active substances which are candidates for 
substitution;  
(e) applications for Union authorisation of biocidal products 
and for renewal, cancellation and amendments of Union 
authorisations, except where the applications are for admin ­
istrative changes;  
(f) scientific and technical matters concerning mutual recog ­
nition in accordance with Article 38;  
(g) at the request of the Commission or of Member States’ 
competent authorities, any other questions that arise from 
the operation of this Regulation relating to technical 
guidance or risks to human health, animal health or the 
environment.  
2. Each Member State shall be entitled to appoint a member 
of the Biocidal Products Committee. Member States may also 
appoint an alternate member.EN L 167/42 Official Journal of the European Union 27.6.2012In order to facilitate its work, the Committee may, by a decision 
of the Management Board of the Agency in agreement with the 
Commission, be divided into two or more parallel committees. 
Each parallel committee shall be responsible for the tasks of the 
Biocidal Products Committee assigned to it. Each Member State 
shall be entitled to appoint one Member for each of the parallel 
committees. The same person may be appointed to more than 
one parallel committee.  
3. Committee members shall be appointed on the basis of 
their experience relevant to performing the tasks specified in 
paragraph 1 and may work within a competent authority. 
They shall be supported by the scientific and technical 
resources available to Member States. To this end, Member 
States shall provide adequate scientific and technical resources 
to Committee members that they have nominated.  
4. Article 85, paragraphs 4, 5, 8 and 9, and Articles 87 and 
88 of Regulation (EC) No 1907/2006 shall apply  mutatis 
mutandis  to the Biocidal Products Committee.  
Article 76  
Secretariat of the Agency  
1. The Secretariat of the Agency referred to in point (g) of 
Article 76(1) of Regulation (EC) No 1907/2006 shall undertake 
the following tasks:  
(a) establishing and maintaining the Register for Biocidal 
Products;  
(b) performing the tasks relating to the acceptance of the appli ­
cations covered by this Regulation;  
(c) establishing technical equivalence;  
(d) providing technical and scientific guidance and tools for the 
application of this Regulation by the Commission and 
Member States’ competent authorities and providing 
support to national helpdesks;  
(e) providing advice and assistance to applicants, in particular 
to SMEs, for the approval of an active substance or its 
inclusion in Annex I to this Regulation or for a Union 
authorisation;  
(f) preparing explanatory information on this Regulation;  
(g) establishing and maintaining database(s) with information 
on active substances and biocidal products;  
(h) at the request of the Commission, providing technical and 
scientific support to improve cooperation between the 
Union competent authorities, international organisations 
and third countries on scientific and technical issues 
relating to biocidal products;  (i) notification of decisions taken by the Agency;  
(j) specification of formats and software packages for the 
submission of information to the Agency;  
(k) providing support and assistance to Member States in order 
to avoid the parallel assessment of applications relating to 
the same or similar biocidal products referred to in 
Article 29(4);  
2. The Secretariat shall make the information identified in 
Article 67 publicly available, free of charge, over the internet, 
except where a request made under Article 66(4) is considered 
justified. The Agency shall make other information available on 
request in accordance with Article 66.  
Article 77  
Appeal  
1. Appeals against decisions of the Agency taken pursuant to 
Article 7(2), Article 13(3), Article 26(2), Article 43(2), 
Article 45(3), Article 54(3), (4) and (5), Article 63(3) and 
Article 64(1) shall lie with the Board of Appeal set up in 
accordance with Regulation (EC) No 1907/2006.  
Article 92(1) and (2) and Articles 93 and 94 of Regulation (EC) 
No 1907/2006 shall apply to appeal procedures lodged under 
this Regulation.  
Fees may be payable, in accordance with Article 80(1) of this 
Regulation, by the person bringing an appeal.  
2. An appeal lodged pursuant to paragraph 1 shall have 
suspensive effect.  
Article 78  
The budget of the Agency  
1. For the purposes of this Regulation, the revenues of the 
Agency shall consist of:  
(a) a subsidy from the Union, entered in the general budget of 
the European Union (Commission Section);  
(b) the fees paid to the Agency in accordance with this Regu ­
lation;  
(c) any charges paid to the Agency for services that it provides 
under this Regulation;  
(d) any voluntary contributions from Member States.  
2. Revenue and expenditure for activities related to this 
Regulation and to Regulation (EC) No 1907/2006 shall be 
dealt with separately in the Agency’s budget and shall have 
separate budgetary and accounting reporting.EN 27.6.2012 Official Journal of the European Union L 167/43Revenue of the Agency referred to in Article 96(1) of Regu ­
lation (EC) No 1907/2006 shall not be used for carrying out 
tasks under this Regulation. Revenue of the Agency referred to 
in paragraph 1 of this Article shall not be used for carrying out 
tasks under Regulation (EC) No 1907/2006.  
Article 79  
Formats and software for submission of information to the 
Agency  
The Agency shall specify formats and software packages and 
make them available free of charge on its website for 
submissions to the Agency. The competent authorities and 
applicants shall use these formats and packages in their 
submissions pursuant to this Regulation.  
The technical dossier referred to in Article 6(1) and Article 20 
shall be submitted using the IUCLID software package.  
CHAPTER XVII  
FINAL PROVISIONS  
Article 80  
Fees and charges  
1. The Commission shall adopt, on the basis of the prin ­
ciples set out in paragraph 3, an implementing Regulation spec ­
ifying:  
(a) the fees payable to the Agency, including an annual fee for 
products granted a Union authorisation in accordance with 
Chapter VIII and a fee for applications for mutual recog ­
nition in accordance with Chapter VII;  
(b) the rules defining conditions for reduced fees, fee waivers 
and the reimbursement of the member of the Biocidal 
Products Committee who acts as a rapporteur; and  
(c) conditions of payment.  
That implementing Regulation shall be adopted in accordance 
with the examination procedure referred to in Article 82(3). It 
shall apply only with respect to fees paid to the Agency.  
The Agency may collect charges for other services it provides.  
The fees payable to the Agency shall be set at such a level as to 
ensure that the revenue derived from the fees, when combined 
with other sources of the Agency’s revenue pursuant to this 
Regulation, is sufficient to cover the cost of the services 
delivered. The fees payable shall be published by the Agency.  
2. Member States shall directly charge applicants fees for 
services that they provide with respect to the procedures 
under this Regulation, including the services undertaken by 
Member States’ competent authorities when acting as evaluating 
competent authority.  Based on the principles set out in paragraph 3, the Commission 
shall issue guidance concerning a harmonised structure of fees.  
Member States may levy annual fees with respect to biocidal 
products made available on their markets.  
Member States may collect charges for other services they 
provide.  
Member States shall set and publish the amount of fees payable 
to their competent authorities.  
3. Both the implementing Regulation referred to in 
paragraph 1 and Member States’ own rules concerning fees 
shall respect the following principles:  
(a) fees shall be set at such a level as to ensure that the revenue 
derived from the fees is, in principle, sufficient to cover the 
cost of the services delivered and shall not exceed what is 
necessary to cover those costs;  
(b) partial reimbursement of the fee if the applicant fails to 
submit the information requested within the specified time 
limit;  
(c) the specific needs of SMEs shall be taken into account, as 
appropriate, including the possibility of splitting payments 
into several instalments and phases;  
(d) the structure and amount of fees shall take into account 
whether information has been submitted jointly or separ ­
ately;  
(e) in duly justified circumstances, and where it is accepted by 
the Agency or the competent authority, the whole fee or a 
part of it may be waived; and  
(f) the deadlines for the payment of fees shall be fixed taking 
due account of the deadlines of the procedures provided for 
in this Regulation.  
Article 81  
Competent authorities  
1. Member States shall designate a competent authority or 
competent authorities responsible for the application of this 
Regulation.  
Member States shall ensure that competent authorities have a 
sufficient number of suitably qualified and experienced staff so 
that the obligations laid down in this Regulation can be carried 
out efficiently and effectively.EN L 167/44 Official Journal of the European Union 27.6.20122. Competent authorities shall provide advice to applicants, 
in particular to SMEs, and to any other interested parties on 
their respective responsibilities and obligations under this Regu ­
lation. That shall include the provision of advice about the 
possibility of adapting the data requirements of Articles 6 and 
20, the grounds on which such an adaptation can be made, and 
on how to prepare a proposal. It shall be in addition to the 
advice and assistance that the Secretariat of the Agency shall 
provide in accordance with Article 76(1)(d).  
Competent authorities may in particular provide advice by 
establishing helpdesks. Helpdesks already established under 
Regulation (EC) No 1907/2006 may act as helpdesks under 
this Regulation.  
3. Member States shall inform the Commission of the names 
and addresses of the designated competent authorities and, 
where they exist, helpdesks by 1 September 2013. Member 
States shall, without undue delay, inform the Commission of 
any changes to the names and addresses of the competent 
authorities or helpdesks.  
The Commission shall make publicly available a list of 
competent authorities and helpdesks.  
Article 82  
Committee procedure  
1. The Commission shall be assisted by the Standing 
Committee on Biocidal Products (‘the committee’). That 
committee shall be a committee within the meaning of Regu ­
lation (EU) No 182/2011.  
2. Where reference is made to this paragraph, Article 4 of 
Regulation (EU) No 182/2011 shall apply.  
3. Where reference is made to this paragraph, Article 5 of 
Regulation (EU) No 182/2011 shall apply.  
Where the committee delivers no opinion, the Commission 
shall not adopt the draft implementing act and the third 
subparagraph of Article 5(4) of Regulation (EU) No 182/2011 
shall apply.  
4. Where reference is made to this paragraph, Article 8 of 
Regulation (EU) No 182/2011 shall apply.  
Article 83  
Exercise of the delegation  
1. The power to adopt delegated acts is conferred on the 
Commission subject to the conditions laid down in this Article.  
2. The power to adopt delegated acts referred to in 
Article 3(4), Article 5(3), Article 6(4), Article 21(3), 
Article 23(5), Article 28(1) and (3), Article 40, Article 56(4), 
Article 71(9), Article 85 and Article 89(1) shall be conferred on the Commission for a period of five years from 17 July 2012. 
The Commission shall draw up a report in respect of the 
delegation of power not later than nine months before the 
end of the five-year period. The delegation of power shall be 
tacitly extended for periods of an identical duration, unless the 
European Parliament or the Council opposes such extension not 
later than three months before the end of each period.  
3. The delegation of power referred to in Article 3(4), 
Article 5(3), Article 6(4), Article 21(3), Article 23(5), 
Article 28(1) and (3), Article 40, Article 56(4), Article 71(9), 
Article 85 and Article 89(1) may be revoked at any time by the 
European Parliament or by the Council. A decision to revoke 
shall put an end to the delegation of the power specified in that 
decision. It shall take effect the day following the publication of 
the decision in the  Official Journal of the European Union  or at a 
later date specified therein. It shall not affect the validity of any 
delegated acts already in force.  
4. As soon as it adopts a delegated act, the Commission shall 
notify it simultaneously to the European Parliament and to the 
Council.  
5. A delegated act adopted pursuant to Article 3(4), 
Article 5(3), Article 6(4), Article 21(3), Article 23(5), 
Article 28(1) and (3), Article 40, Article 56(4), Article 71(9), 
Article 85 and Article 89(1) shall enter into force only if no 
objection has been expressed either by the European Parliament 
or the Council within a period of two months of notification of 
that act to the European Parliament and the Council or if, 
before the expiry of that period, the European Parliament and 
the Council have both informed the Commission that they will 
not object. That period shall be extended by two months at the 
initiative of the European Parliament or of the Council.  
Article 84  
Urgency procedure  
1. Delegated acts adopted under this Article shall enter into 
force without delay and shall apply as long as no objection is 
expressed in accordance with paragraph 2. The notification of a 
delegated act to the European Parliament and to the Council 
shall state the reasons for the use of the urgency procedure.  
2. Either the European Parliament or the Council may object 
to a delegated act in accordance with the procedure referred to 
in Article 83(5). In such a case, the Commission shall repeal the 
act without delay following the notification of the decision to 
object by the European Parliament or by the Council.  
Article 85  
Adaptation to scientific and technical progress  
In order to allow the provisions of this Regulation to be 
adapted to scientific and technical progress, the Commission 
shall be empowered to adopt delegated acts in accordance 
with Article 83 concerning the adaptation of Annexes II, III 
and IV to such scientific and technical progress.EN 27.6.2012 Official Journal of the European Union L 167/45Article 86  
Active substances included in Annex I to Directive 98/8/EC  
The active substances included in Annex I to Directive 98/8/EC 
shall be deemed to have been approved under this Regulation 
and shall be included in the list referred to in Article 9(2).  
Article 87  
Penalties  
Member States shall lay down the provisions on penalties 
applicable to infringement of the provisions of this Regulation 
and shall take all measures necessary to ensure that they are 
implemented. The penalties provided for must be effective, 
proportionate and dissuasive. The Member States shall notify 
those provisions to the Commission no later than 
1 September 2013 and shall notify the Commission without 
delay of any subsequent amendment affecting them.  
Article 88  
Safeguard clause  
Where, on the basis of new evidence, a Member State has 
justifiable grounds to consider that a biocidal product, 
although authorised in accordance with this Regulation, 
constitutes a serious immediate or long-term risk to the 
health of humans, particularly of vulnerable groups, or 
animals, or to the environment, it may take appropriate 
provisional measures. The Member State shall, without delay, 
inform the Commission and the other Member States 
accordingly and give reasons for its decision based on the 
new evidence.  
The Commission shall, by means of implementing acts, either 
permit the provisional measure for a time period defined in the 
decision or require the Member State to revoke the provisional 
measure. Those implementing acts shall be adopted in 
accordance with the examination procedure referred to in 
Article 82(3).  
Article 89  
Transitional measures  
1. The Commission shall carry on with the work programme 
for the systematic examination of all existing active substances 
commenced in accordance with Article 16(2) of Directive 
98/8/EC with the aim of achieving it by 14 May 2014. To 
that end, the Commission shall be empowered to adopt 
delegated acts in accordance with Article 83 concerning the 
carrying out of the work programme and specification of the 
related rights and obligations of the competent authorities and 
the participants in the programme.  
Depending upon the progress of the work programme, the 
Commission shall be empowered to adopt delegated acts in 
accordance with Article 83 concerning the extension of the 
duration of the work programme for a determined period.  In order to facilitate a smooth transition from Directive 98/8/EC 
to this Regulation, during the work programme the 
Commission shall adopt either implementing regulations 
providing that an active substance is approved, and under 
which conditions, or, in cases where the conditions laid down 
in Article 4(1) or, where applicable, the conditions set out in 
Article 5(2), are not satisfied or where the requisite information 
and data have not been submitted within the prescribed period, 
implementing decisions stating that an active substance is not 
approved. Those implementing acts shall be adopted in 
accordance with the examination procedure referred to in 
Article 82(3). Regulations approving an active substance shall 
specify the date of approval. Article 9(2) shall apply.  
2. By way of derogation from Article 17(1), Article 19(1) 
and Article 20(1) of this Regulation, and without prejudice to 
paragraphs 1 and 3 of this Article, a Member State may 
continue to apply its current system or practice of making a 
given biocidal product available on the market until two years 
after the date of approval of the last of the active substances to 
be approved in that biocidal product. It may, according to its 
national rules, authorise the making available on the market in 
its territory only of a biocidal product containing existing active 
substances which have been or are being evaluated under 
Commission Regulation (EC) No 1451/2007 of 4 December 
2007 on the second phase of the 10-year work programme 
referred to in Article 16(2) of Directive 98/8/EC (  1 ), but which 
have not yet been approved for that product-type.  
By way of derogation from the first subparagraph, in the case of 
a decision not to approve an active substance, a Member State 
may continue to apply its current system or practice of making 
biocidal products available on the market for up to 12 months 
after the date of the decision not to approve an active substance 
in accordance with the third subparagraph of paragraph 1.  
3. Following a decision to approve a particular active 
substance for a specific product-type Member States shall 
ensure that authorisations for biocidal products of that 
product-type and containing that active substance are granted, 
modified or cancelled as appropriate in accordance with this 
Regulation within two years of the date of approval.  
To that effect, those wishing to apply for the authorisation or 
mutual recognition in parallel of biocidal products of that 
product-type containing no active substances other than 
existing active substances shall submit applications for authori ­
sation or mutual recognition in parallel to Member States’ 
competent authorities no later than the date of approval of 
the active substance(s). In the case of biocidal products 
containing more than one active substance, applications for 
authorisation shall be submitted no later than the date of 
approval of the last active substance for that product-type.EN L 167/46 Official Journal of the European Union 27.6.2012  
( 1 ) OJ L 325, 11.12.2007, p. 3.Where no application for authorisation or mutual recognition 
in parallel has been submitted in accordance with the second 
subparagraph:  
(a) the biocidal product shall no longer be made available on 
the market with effect from 180 days after the date of 
approval of the active substance(s); and  
(b) disposal and use of existing stocks of the biocidal product 
may continue until 365 days after the date of approval of 
the active substance(s).  
4. Where a Member State’s competent authority rejects the 
application for authorisation of a biocidal product submitted 
under paragraph 3 or decides not to grant authorisation, that 
biocidal product shall no longer be made available on the 
market 180 days after the date of such rejection or decision. 
Disposal and use of existing stocks of such biocidal products 
may continue until 365 days after the date of such rejection or 
decision.  
Article 90  
Transitional measures concerning active substances 
evaluated under Directive 98/8/EC  
1. The Agency shall be responsible for coordinating the 
process of evaluation of dossiers submitted after 1 September 
2012 and shall facilitate the evaluation by providing organisa ­
tional and technical support to the Member States and the 
Commission.  
2. Applications submitted for the purposes of Directive 
98/8/EC for which the Member States’ evaluation in accordance 
with Article 11(2) of Directive 98/8/EC has not been completed 
by 1 September 2013 shall be evaluated by the competent 
authorities in accordance with the provisions of this Regulation 
and, where relevant, Regulation (EC) No 1451/2007.  
That evaluation shall be carried out on the basis of the 
information provided in the dossier submitted under Directive 
98/8/EC.  
Where the evaluation identifies concerns arising from the appli ­
cation of provisions of this Regulation which were not included 
in Directive 98/8/EC, the applicant shall be given the oppor ­
tunity to provide additional information.  
Every effort shall be made to avoid additional testing on verte ­
brates and to avoid causing delays to the review programme 
laid down in Regulation (EC) No 1451/2007 as a result of these 
transitional arrangements.  
Notwithstanding paragraph 1, the Agency shall also be 
responsible for coordinating the evaluation process of dossiers 
submitted for the purposes of Directive 98/8/EC for which the 
evaluation has not been completed by 1 September 2013 and shall facilitate the preparation of the evaluation by providing 
organisational and technical support to the Member States and 
the Commission from 1 January 2014.  
Article 91  
Transitional measures concerning applications for biocidal 
product authorisations submitted under Directive 98/8/EC  
Applications for biocidal product authorisations submitted for 
the purposes of Directive 98/8/EC for which the evaluation has 
not been completed by 1 September 2013 shall be evaluated by 
the competent authorities in accordance with that Directive.  
Notwithstanding the first paragraph, the following shall apply:  
— where the risk assessment of the active substance indicates 
that one or more of the criteria listed under Article 5(1) is 
met, the biocidal product shall be authorised in accordance 
with Article 19,  
— where the risk assessment of the active substance indicates 
that one or more of the criteria listed under Article 10 is 
met, the biocidal product shall be authorised in accordance 
with Article 23.  
Where the evaluation identifies concerns arising from the appli ­
cation of provisions of this Regulation which were not included 
in Directive 98/8/EC, the applicant shall be given the oppor ­
tunity to provide additional information.  
Article 92  
Transitional measures concerning biocidal products 
authorised/registered under Directive 98/8/EC  
1. Biocidal products for which an authorisation or regis ­
tration in accordance with Article 3, 4, 15 or 17 of Directive 
98/8/EC was granted before 1 September 2013 can continue to 
be made available on the market and used subject, where appli ­
cable, to any conditions of authorisation or registration 
stipulated under that Directive until the expiry date of the auth ­
orisation or registration or its cancellation.  
2. Notwithstanding paragraph 1, this Regulation shall apply 
to biocidal products referred to in that paragraph from 
1 September 2013.  
Article 93  
Transitional measures concerning biocidal products not 
covered by the scope of Directive 98/8/EC  
1. Without prejudice to Article 89, applications for authori ­
sation of biocidal products not covered by the scope of 
Directive 98/8/EC and falling within the scope of this Regu ­
lation and which were available on the market on 
1 September 2013 shall be submitted at the latest by 
1 September 2017.EN 27.6.2012 Official Journal of the European Union L 167/472. By way of derogation from Article 17(1), biocidal 
products referred to in paragraph 1 of this Article for which 
an application was submitted in accordance with paragraph 1 of 
this Article may continue to be made available on the market or 
used until the date of the decision granting the authorisation. In 
the case of a decision refusing to grant the authorisation, the 
biocidal product shall no longer be made available on the 
market 180 days after such a decision.  
By way of derogation from Article 17(1), biocidal products 
referred to in paragraph 1 of this Article for which an appli ­
cation was not submitted in accordance with paragraph 1 of 
this Article may continue to be made available on the market or 
used until 180 days after 1 September 2017.  
Disposal and use of existing stocks of biocidal products which 
are not authorised for the relevant use by the competent 
authority or the Commission may continue until 365 days 
after the date of the decision referred to in the first 
subparagraph or 12 months after the date referred to in the 
second subparagraph, whichever is the later.  
Article 94  
Transitional measures concerning treated articles  
1. By way of derogation from Article 58 and without 
prejudice to Article 89, treated articles that were available on 
the market on 1 September 2013 may, until the date of a 
decision concerning the approval for the relevant product-type 
of the active substance(s) contained in the biocidal products 
with which the treated articles were treated or which they incor ­
porate, continue to be placed on the market if the application 
for the approval of the active substance(s) for the relevant 
product-type is submitted at the latest by 1 September 2016.  
2. In the case of a decision not to approve an active 
substance for the relevant product-type, treated articles which 
were treated with, or which incorporate, biocidal product(s) 
containing that active substance shall no longer be placed on 
the market 180 days after such a decision or as of 1 September 
2016, whichever is the later, unless an application for the 
approval has been submitted in accordance with paragraph 1.  
Article 95  
Transitional measures concerning access to the active 
substance dossier  
1. As of 1 September 2013, any person wishing to place 
active substance(s) on the Union market on its own or in 
biocidal products (the ‘relevant person’) shall, for every active 
substance that they manufacture or import for use in biocidal 
products, submit to the Agency:  
(a) a dossier complying with the requirements of Annex II or, 
where appropriate, with Annex IIA to Directive 98/8/EC; or  (b) a letter of access to a dossier as referred to under point (a); 
or 
(c) a reference to a dossier as referred to under point (a) and for 
which all data protection periods have expired.  
If the relevant person is not a natural or legal person established 
within the Union, the importer of the biocidal product 
containing such active substance(s) shall submit the information 
required under the first subparagraph.  
For the purposes of this paragraph and for existing active 
substances listed in Annex II to Regulation (EC) No 1451/2007, 
Article 63(3) of this Regulation shall apply to all toxicological 
and ecotoxicological studies including any toxicological and 
ecotoxicological studies not involving tests on vertebrates.  
The relevant person to whom a letter of access to a dossier on 
the active substance has been issued shall be entitled to allow 
applicants for the authorisation of a biocidal product containing 
that active substance to make reference to that letter of access 
for the purposes of Article 20(1).  
By way of derogation from Article 60 of this Regulation, all 
data protection periods for substance/product-type 
combinations listed in Annex II to Regulation (EC) 
No 1451/2007, but not yet approved under this Regulation 
shall end on 31 December 2025.  
2. The Agency shall make publicly available the list of 
persons that have made a submission in accordance with 
paragraph 1 or for whom it has taken a decision in accordance 
with Article 63(3). The list shall also contain the names of 
persons who are participants in the work programme estab ­
lished under the first subparagraph of Article 89(1) or have 
taken over the role of the participant.  
3. Without prejudice to Article 93, as of 1 September 2015, 
a biocidal product shall not be made available on the market if 
the manufacturer or importer of the active substance(s) 
contained in the product, or where relevant, the importer of 
the biocidal product, is not included in the list referred to in 
paragraph 2.  
Without prejudice to Articles 52 and 89, disposal and use of 
existing stocks of biocidal products containing an active 
substance, for which no relevant person is included in the list 
referred to in paragraph 2, may continue until 1 September 
2016.  
4. This Article shall not apply to active substances listed in 
Annex I in categories 1 to 5 and 7 or to biocidal products 
containing only such active substances.EN L 167/48 Official Journal of the European Union 27.6.2012Article 96  
Repeal  
Without prejudice to Articles 86, 89, 90, 91 and 92 of this Regulation, Directive 98/8/EC is hereby repealed 
with effect from 1 September 2013.  
References to the repealed Directive shall be construed as references to this Regulation and read in 
accordance with the correlation table in Annex VII.  
Article 97  
Entry into force  
This Regulation shall enter into force on the twentieth day following that of its publication in the  Official 
Journal of the European Union . 
It shall apply from 1 September 2013.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Strasbourg, 22 May 2012.  
For the European Parliament 
The President  
M. SCHULZ  For the Council 
The President  
N. WAMMENEN 27.6.2012 Official Journal of the European Union L 167/49ANNEX I  
LIST OF ACTIVE SUBSTANCES REFERRED TO IN ARTICLE 25(a)  
EC number  Name/group  Restriction  Comment  
Category 1 — Substances authorised as food additives according to Regulation (EC) No 1333/2008  
200-018-0  Lactic acid  Concentration to be limited so that each biocidal 
product does not require classification according 
to either Directive 1999/45/EC or Regulation (EC) 
No 1272/2008  E 270  
204-823-8  Sodium acetate  Concentration to be limited so that each biocidal 
product does not require classification according 
to either Directive 1999/45/EC or Regulation (EC) 
No 1272/2008  E 262  
208-534-8  Sodium benzoate  Concentration to be limited so that each biocidal 
product does not require classification according 
to either Directive 1999/45/EC or Regulation (EC) 
No 1272/2008  E 211  
201-766-0  (+)-Tartaric acid  Concentration to be limited so that each biocidal 
product does not require classification according 
to either Directive 1999/45/EC or Regulation (EC) 
No 1272/2008  E 334  
200-580-7  Acetic acid  Concentration to be limited so that each biocidal 
product does not require classification according 
to either Directive 1999/45/EC or Regulation (EC) 
No 1272/2008  E 260  
201-176-3  Propionic acid  Concentration to be limited so that each biocidal 
product does not require classification according 
to either Directive 1999/45/EC or Regulation (EC) 
No 1272/2008  E 280  
Category 2 — Substances included in Annex IV to Regulation (EC) No 1907/2006  
200-066-2  Ascorbic acid  
232-278-6  Linseed oil  
Category 3 — Weak acids  
Category 4 — Traditionally used substances of natural origin  
Natural oil  Lavender oil  CAS 8000-28-0  
Natural oil  Peppermint oil  CAS 8006-90-4  
Category 5 — Pheromones  
222-226-0  Oct-1-en-3-ol  
Mixture  Webbing clothes 
moths pheromone  
Category 6 — Substances included in Annex I or IA to Directive 98/8/EC  
204-696-9  Carbon dioxide  Only for use in ready-for-use gas canisters func ­
tioning together with a trapping device  
231-783-9  Nitrogen  Only for use in limited quantities in ready-for-use 
canisters  
250-753-6  (Z,E)-Tetradec- 
9,12-dienyl acetateEN L 167/50 Official Journal of the European Union 27.6.2012EC number  Name/group  Restriction  Comment  
Category 7 — Other  
Baculovirus  
215-108-5  Bentonite  
203-376-6  Citronellal  
231-753-5  Iron sulphateEN 27.6.2012 Official Journal of the European Union L 167/51ANNEX II  
INFORMATION REQUIREMENTS FOR ACTIVE SUBSTANCES  
1. This Annex sets out the information requirements for the preparation of the dossier referred to in point (a) of 
Article 6(1).  
2. The data elements set down in this Annex comprise a Core Data Set (CDS) and an Additional Data Set (ADS). The data 
elements belonging to the CDS are considered as the basic data which should, in principle, be provided for all active 
substances. However, in some cases the physical or chemical properties of the substance may mean that it is 
impossible or unnecessary to provide specific data elements belonging to the CDS.  
With regard to the ADS, the data elements to be provided for a specific active substance shall be determined by 
considering each of the ADS data elements indicated in this Annex taking into account, inter alia, the physical and 
chemical properties of the substance, existing data, information which is part of the CDS and the types of products in 
which the active substance will be used and the exposure patterns related to these uses.  
Specific indications for the inclusion of some data elements are provided in column 1 of the Annex II table. The 
general considerations regarding adaptation of information requirements as set out in Annex IV shall also apply. In 
light of the importance of reducing testing on vertebrates, column 3 of the Annex II table gives specific indications for 
the adaptation of some of the data elements which might require the use of such tests on vertebrates. The information 
submitted shall, in any case, be sufficient to support a risk assessment demonstrating that the criteria referred to in 
Article 4(1) are met.  
The applicant should consult the detailed technical guidance regarding the application of this Annex and the prep ­
aration of the dossier referred to in point (a) of Article 6(1), which is available on the website of the Agency.  
The applicant has the obligation to initiate a pre-submission consultation. In addition to the obligation set down in 
Article 62(2), applicants may also consult with the competent authority that will evaluate the dossier with regard to 
the proposed information requirements and in particular the testing on vertebrates that the applicant proposes to carry 
out.  
Additional information may need to be submitted if it is necessary to carry out the evaluation as indicated in 
Article 8(2).  
3. A detailed and full description of the studies conducted or referred to and of the methods used shall be included. It is 
important to ensure that the data available is relevant and is of sufficient quality to fulfil the requirements. Evidence 
should also be provided to demonstrate that the active substance upon which the tests have been carried out is the 
same as the substance for which the application has been submitted.  
4. The formats made available by the Agency must be used for submission of the dossiers. In addition, IUCLID must be 
used for those parts of the dossiers to which IUCLID applies. Formats and further guidance on data requirements and 
dossier preparation are available on the website of the Agency.  
5. Tests submitted for the purpose of the approval of an active substance shall be conducted according to the methods 
described in Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to 
Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, 
Authorisation and Restriction of Chemicals (REACH) (  1 ). However, if a method is inappropriate or not described, 
other methods shall be used which are scientifically appropriate, whenever possible internationally recognised, and 
their appropriateness must be justified in the application. When test methods are applied to nanomaterials, an 
explanation shall be provided of their scientific appropriateness for nanomaterials, and where applicable, of the 
technical adaptations/adjustments that have been made in order to respond to the specific characteristics of these 
materials.  
6. Tests performed should comply with the relevant requirements of protection of laboratory animals, set out in Directive 
2010/63/EU of the European Parliament and the Council of 22 September 2010 on the protection of animals used for 
scientific purposes (  2 ) and in the case of ecotoxicological and toxicological tests, good laboratory practice, set out in 
Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of 
laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice 
and the verification of their application for tests on chemical substances (  3 ) or other international standards recognised 
as being equivalent by the Commission or the Agency. Tests on physico-chemical properties and safety-relevant 
substance data should be performed at least according to international standards.EN L 167/52 Official Journal of the European Union 27.6.2012  
( 1 ) OJ L 142, 31.5.2008, p. 1.  
( 2 ) OJ L 276, 20.10.2010, p. 33.  
( 3 ) OJ L 50, 20.2.2004, p. 44.7. Where testing is done, a detailed description (specification) of the active substance used and its impurities must be 
provided. Testing should be performed with the active substance as manufactured or, in the case of some of the 
physical and chemical properties (see indications given in column I of the table), with a purified form of the active 
substance.  
8. Where test data exist that have been generated before 1 September 2013 by methods other than those laid down in 
Regulation (EC) No 440/2008, the adequacy of such data for the purposes of this Regulation and the need to conduct 
new tests according to the Regulation (EC) No 440/2008 must be decided by the competent authority of the Member 
State concerned, on a case-by-case basis, taking into account, among other factors, the need to minimise testing on 
vertebrates.  
9. New tests involving vertebrates shall be conducted as the last available option to comply with the data requirements 
set out in this Annex when all the other data sources have been exhausted. In-vivo testing with corrosive substances at 
concentration/dose levels causing corrosivity shall also be avoided.  
TITLE 1  
CHEMICAL SUBSTANCES  
Core data set and additional data set for active substances  
Information required to support the approval of an active substance is listed in the table below.  
Conditions for not requiring a specific test that are set out in the appropriate test methods in the Regulation (EC) 
No 440/2008 and are not repeated in column 3, also apply.  
Column 1 
Information required  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
1. APPLICANT  
1.1. Name and address  
1.2. Contact person  
1.3. Active substance manufacturer (name, address and 
location of manufacturing plant(s))  
2. IDENTITY OF THE ACTIVE SUBSTANCE  
For the active substance, the information given in 
this Section shall be sufficient to enable the active 
substance to be identified. If it is not technically 
possible or if it does not appear scientifically 
necessary to give information on one or more 
of the items below, the reasons shall be clearly 
stated  
2.1. Common name proposed or accepted by ISO and 
synonyms (usual name, trade name, abbreviation)  
2.2. Chemical name (IUPAC and CA nomenclature or 
other international chemical name(s))  
2.3. Manufacturer’s development code number(s)  
2.4. CAS number plus EC, INDEX and CIPAC 
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2.5. Molecular and structural formula (including 
SMILES notation, if available and appropriate)  
2.6. Information on optical activity and full details of 
any isomeric composition (if applicable and 
appropriate)  
2.7. Molar mass  
2.8. Method of manufacture (syntheses pathway) of 
active substance including information on 
starting materials and solvents including suppliers, 
specifications and commercial availability  
2.9. Specification of purity of the active substance as 
manufactured in g/kg, g/l or %w/w (v/v) as appro ­
priate, providing inclusively the upper and lower 
limit  
2.10. The identity of any impurities and additives 
including by-products of synthesis, optical 
isomers, degradation products (if the substance 
is unstable) un-reacted and end-groups etc. of 
polymers and un-reacted starting materials of 
UVC-substances  
2.11. Analytical profile of at least five representative 
batches (g/kg active substance) including 
information on content of the impurities 
referred to in 2.10.  
2.12. The origin of the natural active substance or the 
precursor(s) of the active substance, e.g. an extract 
of a flower  
3. PHYSICAL AND CHEMICAL PROPERTIES OF 
THE ACTIVE SUBSTANCE  
3.1. Appearance (  1 ) 
3.1.1. Aggregate state (at 20 °C and 101,3 kPa)  
3.1.2. Physical state (i.e. viscous, crystalline, powder) 
(at 20 °C and 101,3 kPa)  
3.1.3. Colour (at 20 °C and 101,3 kPa)  
3.1.4. Odour (at 20 °C and 101,3 kPa)  
3.2. Melting/freezing point (  2 ) 
3.3. Acidity, alkalinity  
3.4. Boiling point (  2 )EN L 167/54 Official Journal of the European Union 27.6.2012Column 1 
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3.5. Relative Density (  2 ) 
3.6. Absorption spectra data (UV/VIS, IR, NMR) and a 
mass spectrum, molar extinction coefficient at 
relevant wavelengths, where relevant (  2 ) 
3.7. Vapour pressure (  2 ) 
3.7.1. Henry’s law constant must always be stated for 
solids and liquids if it can be calculated  
3.8. Surface tension (  2 ) 
3.9. Water solubility (  2 ) 
3.10. Partition coefficient (n-octanol/water) and its pH 
dependency (  2 ) 
3.11. Thermal stability, identity of breakdown prod ­
ucts (  2 ) 
3.12. Reactivity towards container material  
3.13. Dissociation constant  ADS  
3.14. Granulometry  
3.15. Viscosity  ADS  
3.16. Solubility in organic solvents, including effect of 
temperature on solubility (  2 ) ADS  
3.17. Stability in organic solvents used in biocidal 
products and identity of relevant breakdown 
products (  1 ) ADS  
4. PHYSICAL HAZARDS AND RESPECTIVE CHAR ­
ACTERISTICS  
4.1. Explosives  
4.2. Flammable gases  
4.3. Flammable aerosols  
4.4. Oxidising gases  
4.5. Gases under pressure  
4.6. Flammable liquids  
4.7. Flammable solids  
4.8. Self-reactive substances and mixtures  
4.9. Pyrophoric liquids  
4.10. Pyrophoric solidsEN 27.6.2012 Official Journal of the European Union L 167/55Column 1 
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4.11. Self-heating substances and mixtures  
4.12. Substances and mixtures which in contact with 
water emit flammable gases  
4.13. Oxidising liquids  
4.14. Oxidising solids  
4.15. Organic peroxides  
4.16. Corrosive to metals  
4.17. Additional physical indicators for hazards  
4.17.1. Auto-ignition temperature (liquids and gases)  
4.17.2. Relative self ignition temperature for solids  
4.17.3. Dust explosion hazard  
5. METHODS OF DETECTION AND IDENTIFI ­
CATION  
5.1. Analytical methods including validation 
parameters for the determination of active 
substance as manufactured and where appro ­
priate, for relevant residues, isomers and 
impurities of the active substance and additives 
(e.g. stabilisers) 
For impurities other than relevant impurities this 
only applies if they are present at ≥ 1 g/kg  
5.2. Analytical methods for monitoring purposes 
including recovery rates and the limits of quan ­
tification and detection for the active substance, 
and for residues thereof in/on the following 
where relevant  
5.2.1. Soil  
5.2.2. Air  
5.2.3. Water (surface, drinking etc.) and sediment  
5.2.4. Animal and human body fluids and tissues  
5.3. Analytical methods for monitoring purposes 
including recovery rates and the limit of quantifi ­
cation and detection for the active substance, and 
for residues thereof, in/on food of plant 
and animal origin or feeding stuffs and other  ADSEN L 167/56 Official Journal of the European Union 27.6.2012Column 1 
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information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
products where relevant (not necessary if neither 
the active substance nor articles treated with it 
come into contact with food-producing animals, 
food of plant or animal origin or feeding stuffs)  
6. EFFECTIVENESS AGAINST TARGET 
ORGANISMS  
6.1. Function, e.g. fungicide, rodenticide, insecticide, 
bactericide and mode of control e.g. attracting, 
killing, inhibiting  
6.2. Representative organism(s) to be controlled and 
products, organisms or objects to be protected  
6.3. Effects on representative target organism(s)  
6.4. Likely concentration at which the active substance 
will be used in products and, where appropriate, 
in treated articles  
6.5. Mode of action (including time delay)  
6.6. Efficacy data to support these claims on biocidal 
products and, where label claims are made, on 
treated articles, including any available standard 
protocols, laboratory tests or field trials used 
including performance standards where appro ­
priate  
6.7. Any known limitations on efficacy  
6.7.1. Information on the occurrence or possible 
occurrence of the development of resistance and 
appropriate management strategies  
6.7.2. Observations on undesirable or unintended side- 
effects, e.g. on beneficial and other non-target 
organisms  
7. INTENDED USES AND EXPOSURE  
7.1. Field of use(s) envisaged for biocidal products and, 
where appropriate, treated articles  
7.2. Product-type(s)  
7.3. Detailed description of the intended use pattern(s) 
including in treated articles  
7.4. Users e.g. industrial, trained professional, profes ­
sional or general public (non-professional)  
7.5. Likely tonnage to be placed on the market per 
year and, where relevant, for the envisaged major 
use categoriesEN 27.6.2012 Official Journal of the European Union L 167/57Column 1 
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information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
7.6. Exposure data in conformity with Annex VI to 
this Regulation  
7.6.1. Information on human exposure associated with 
the intended uses and disposal of the active 
substance  
7.6.2. Information on environmental exposure 
associated with the intended uses and disposal 
of the active substance  
7.6.3. Information on exposure of food- producing 
animals and food and feeding stuffs associated 
with the intended uses of the active substance  
7.6.4. Information on exposure from treated articles 
including leaching data (either laboratory studies 
or model data)  
8. TOXICOLOGICAL PROFILE FOR HUMAN AND 
ANIMAL INCLUDING METABOLISM  
8.1. Skin irritation or skin corrosion 
The assessment of this endpoint shall be carried 
out according to the sequential testing strategy for 
dermal irritation and corrosion set out in the 
Appendix to Test Guideline B.4. Acute Toxicity- 
Dermal Irritation/Corrosion (Annex B.4. to Regu ­
lation (EC) No 440/2008)  
8.2. Eye irritation 
The assessment of this endpoint shall be carried 
out according to the sequential testing strategy for 
eye irritation and corrosion as set down in the 
Appendix to Test Guideline B.5.Acute Toxicity: 
Eye Irritation/Corrosion (Annex B.5. to Regulation 
(EC) No 440/2008)  
8.3. Skin sensitisation 
The assessment of this endpoint shall comprise 
the following consecutive steps: 
1. an assessment of the available human, animal 
and alternative data 
2. in vivo testing 
The Murine Local Lymph Node Assay (LLNA) 
including, where appropriate, the reduced 
variant of the assay, is the first-choice 
method for in vivo testing. If another skin 
sensitisation test is used justification shall be 
provided  Step 2 does not need to be conducted if: 
— the available information indicates that 
the substance should be classified for 
skin sensitisation or corrosivity, or 
— the substance is a strong acid 
(pH < 2,0) or base (pH > 11,5)  
8.4. Respiratory sensitisation  ADSEN L 167/58 Official Journal of the European Union 27.6.2012Column 1 
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information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
8.5. Mutagenicity  
The assessment of this endpoint shall comprise 
the following consecutive steps: 
— an assessment of the available in vivo genot ­
oxicity data 
— an in vitro test for gene mutations in bacteria, 
an in vitro cytogenicity test in mammalian 
cells and an in vitro gene mutation test in 
mammalian cells are required 
— appropriate in vivo genotoxicity studies shall 
be considered in case of a positive result in 
any of the in vitro genotoxicity studies  
8.5.1. In vitro gene mutation study in bacteria  
8.5.2. In vitro cytogenicity study in mammalian cells  
8.5.3. In vitro gene mutation study in mammalian cells  
8.6. In vivo genotoxicity study 
The assessment of this endpoint shall comprise 
the following consecutive steps: 
— If there is a positive result in any of the in 
vitro genotoxicity studies and there are no 
results available from an in vivo study 
already, an appropriate in vivo somatic cell 
genotoxicity study shall be proposed/con ­
ducted by the applicant 
— If either of the in vitro gene mutation tests is 
positive, an in vivo test to investigate 
unscheduled DNA synthesis shall be 
conducted 
— A second in vivo somatic cell test may be 
necessary, depending on the results, quality 
and relevance of all the available data 
— If there is a positive result from an in vivo 
somatic cell study available, the potential for 
germ cell mutagenicity should be considered 
on the basis of all available data, including 
toxicokinetic evidence to demonstrate that 
the substance reached the tested organ. If no 
clear conclusions about germ cell mutage ­
nicity can be made, additional investigations 
shall be considered  ADS  The study/ies do(es) not generally need to 
be conducted if: 
— the results are negative for the three in 
vitro tests and if no metabolites of 
concern are formed in mammals or 
— valid in vivo micronucleus data is 
generated within a repeat dose study 
and the in vivo micronucleus test is 
the appropriate test to be conducted 
to address this information 
requirement 
— the substance is known to be carci ­
nogenic category 1A or 1B or 
mutagenic category 1A, 1B or 2.  
8.7. Acute toxicity 
In addition to the oral route of administration 
(8.7.1), for substances other than gases, the 
information mentioned under 8.7.2 to 8.7.3 
shall be provided for at least one other route of 
administration  The study/ies do(es) not generally need to 
be conducted if: 
— the substance is classified as corrosive 
to the skinEN 27.6.2012 Official Journal of the European Union L 167/59Column 1 
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— The choice for the second route will depend 
on the nature of the substance and the likely 
route of human exposure 
— Gases and volatile liquids should be admin ­
istered by the inhalation route 
— If the only route of exposure is the oral route, 
then information for only that route need be 
provided. If either the dermal or inhalation 
route is the only route of exposure to 
humans then an oral test may be considered. 
Before a new dermal acute toxicity study is 
carried out, an in vitro dermal penetration 
study (OECD 428) should be conducted to 
assess the likely magnitude and rate of 
dermal bioavailability 
— There may be exceptional circumstances 
where all routes of administration are 
deemed necessary  
8.7.1. By oral route 
The Acute Toxic Class Method is the preferred 
method for the determination of this endpoint  The study need not be conducted if: 
— the substance is a gas or a highly 
volatile substance  
8.7.2. By inhalation 
Testing by the inhalation route is appropriate if 
exposure of humans via inhalation is likely taking 
into account: 
— the vapour pressure of the substance (a 
volatile substance has vapour pressure 
> 1 × 10  –2 Pa at 20 °C) and/or 
— the active substance is a powder containing a 
significant proportion (e.g. 1 % on a weight 
basis) of particles with particle size 
MMAD < 50 micrometers or 
— the active substance is included in products 
that are powders or are applied in a manner 
that generates exposure to aerosols, particles 
or droplets of an inhalable size (MMAD < 50 
micrometers) 
— the Acute Toxic Class Method is the preferred 
method for the determination of this endpoint  
8.7.3. By dermal route 
Testing by the dermal route is necessary only if: 
— inhalation of the substance is unlikely, or 
— skin contact in production and/or use is likely, 
and eitherEN L 167/60 Official Journal of the European Union 27.6.2012Column 1 
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— the physicochemical and toxicological prop ­
erties suggest potential for a significant rate 
of absorption through the skin, or 
— the results of an in vitro dermal penetration 
study (OECD 428) demonstrate high dermal 
absorption and bioavailability  
8.8. Toxicokinetics and metabolism studies in 
mammals  
The toxicokinetics and metabolism studies should 
provide basic data about the rate and extent of 
absorption, the tissue distribution and the relevant 
metabolic pathway including the degree of metab ­
olism, the routes and rate of excretion and the 
relevant metabolites  
8.8.1. Further toxicokinetic and metabolism studies in 
mammals 
Additional studies might be required based on the 
outcome of the toxicokinetic and metabolism 
study conducted in rat. These further studies 
shall be required if: 
— there is evidence that metabolism in the rat is 
not relevant for human exposure 
— route-to-route extrapolation from oral to 
dermal/inhalation exposure is not feasible 
Where it is considered appropriate to obtain 
information on dermal absorption, the assessment 
of this endpoint shall proceed using a tiered 
approach for assessment of dermal absorption  ADS  
8.9. Repeated dose toxicity 
In general, only one route of administration is 
necessary and the oral route is the preferred 
route. However, in some cases it may be 
necessary to evaluate more than one route of 
exposure. 
For the evaluation of the safety of consumers in 
relation to active substances that may end up in 
food or feed, it is necessary to conduct toxicity 
studies by the oral route 
Testing by the dermal route shall be considered if: 
— skin contact in production and/or use is likely, 
and 
— inhalation of the substance is unlikely, and  The repeated dose toxicity study (28 or 90 
days) does not need to be conducted if: 
— a substance undergoes immediate 
disintegration and there are sufficient 
data on the cleavage products for 
systemic and local effects and no 
synergistic effects are expected, or 
— relevant human exposure can be 
excluded in accordance with Section 
3 of Annex IV 
In order to reduce testing carried out on 
vertebrates and in particular the need for 
free-standing single-endpoint studies, the 
design of the repeated dose toxicity 
studies shall take account of the possibility 
to explore several endpoints within the 
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testing of vertebrates  
— one of the following conditions is met: 
(i) toxicity is observed in an acute dermal 
toxicity test at lower doses than in the 
oral toxicity test, or 
(ii) information or test data indicate dermal 
absorption is comparable or higher than 
oral absorption, or 
(iii) dermal toxicity is recognised for struc ­
turally related substances and for 
example is observed at lower doses 
than in the oral toxicity test or dermal 
absorption is comparable or higher than 
oral absorption 
Testing by the inhalation route shall be 
considered if: 
— exposure of humans via inhalation is 
likely taking into account the vapour 
pressure of the substance (volatile 
substances and gases have vapour 
pressure > 1 × 10  –2 Pa at 20 °C), and/or 
— there is the possibility of exposure to 
aerosols, particles or droplets of an 
inhalable size (MMAD < 50 micrometers)  
8.9.1. Short-term repeated dose toxicity study (28 days), 
preferred species is rat  The short-term toxicity study (28 days) 
does not need to be conducted if: 
(i) a reliable sub-chronic (90 day) study is 
available, provided that the most 
appropriate species, dosage, solvent 
and route of administration were used, 
(ii) the frequency and duration of human 
exposure indicates that a longer term 
study is appropriate and one of the 
following conditions is met: 
— other available data indicate that 
the substance may have a 
dangerous property that cannot 
be detected in a short-term 
toxicity study, or 
— appropriately designed toxi ­
cokinetic studies reveal accumu ­
lation of the substance or its meta ­
bolites in certain tissues or organs 
which would possibly remain 
undetected in a short term 
toxicity study but which are liable 
to result in adverse effects after 
prolonged exposureEN L 167/62 Official Journal of the European Union 27.6.2012Column 1 
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information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
8.9.2. Sub-chronic repeated dose toxicity study (90 
days), preferred species is rat  The sub-chronic toxicity study (90 days) 
does not need to be conducted if: 
— a reliable short-term toxicity study (28 
days) is available showing severe 
toxicity effects according to the 
criteria for classifying the substance as 
H372 and H373 (Regulation (EC) 
No 1272/2008), for which the 
observed NOAEL-28 days, with the 
application of an appropriate uncer ­
tainty factor allows the extrapolation 
towards the NOAEL-90 days for the 
same route of exposure, and 
— a reliable chronic toxicity study is 
available, provided that an appropriate 
species and route of administration 
were used, or 
— the substance is unreactive, insoluble, 
not bioaccumulative and not inhalable 
and there is no evidence of absorption 
and no evidence of toxicity in a 28-day 
‘limit test’, particularly if such a pattern 
is coupled with limited human 
exposure  
8.9.3. Long-term repeated dose toxicity ( ≥ 12 months)  The long-term toxicity study ( ≥ 12 
months) does not need to be conducted if: 
— Long-term exposure can be excluded 
and no effects have been seen at the 
limit dose in the 90-day study or 
— a combined long-term repeated dose/ 
carcinogenicity study (8.11.1) is under ­
taken  
8.9.4. Further repeat dose studies 
Further repeat dose studies including testing on a 
second species (non-rodent), studies of longer 
duration or through a different route of adminis ­
tration shall be undertaken in case of: 
— no other information on toxicity for a second 
non-rodent species is provided for, or 
— failure to identify a no observed adverse effect 
level (NOAEL) in the 28- or the 90-day study, 
unless the reason is that no effects have been 
observed at the limit dose, or 
— substances bearing positive structural alerts for 
effects for which the rat or mouse is an 
inappropriate or insensitive model, or  ADSEN 27.6.2012 Official Journal of the European Union L 167/63Column 1 
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testing of vertebrates  
— toxicity of particular concern (e.g. serious/ 
severe effects), or 
— indications of an effect for which the available 
data is inadequate for toxicological and/or risk 
characterisation. In such cases it may also be 
more appropriate to perform specific toxico ­
logical studies that are designed to investigate 
these effects (e.g. immunotoxicity, neurotox ­
icity, hormonal activity), or 
— concern regarding local effects for which a 
risk characterisation cannot be performed by 
route-to route extrapolation, or 
— particular concern regarding exposure (e.g. use 
in biocidal products leading to exposure levels 
which are close to the toxicologically relevant 
dose levels), or 
— effects shown in substances with a clear rela ­
tionship in molecular structure with the 
substance being studied were not detected in 
the 28- or the 90-day study, or 
— the route of administration used in the initial 
repeated dose study was inappropriate in 
relation to the expected route of human 
exposure and route-to-route extrapolation 
cannot be made.  
8.10. Reproductive toxicity 
For evaluation of consumer safety of active 
substances that may end up in food or feed, it 
is necessary to conduct toxicity studies by the oral 
route  The studies need not be conducted if: 
— the substance is known to be a 
genotoxic carcinogen and appropriate 
risk management measures are imple ­
mented including measures related to 
reproductive toxicity, or 
— the substance is known to be a germ 
cell mutagen and appropriate risk 
management measures are imple ­
mented including measures related to 
reproductive toxicity, or 
— the substance is of low toxicological 
activity (no evidence of toxicity seen 
in any of the tests available provided 
that the dataset is sufficiently compre ­
hensive and informative), it can be 
proven from toxicokinetic data that 
no systemic absorption occurs via 
relevant routes of exposure (e.g. 
plasma/blood concentrations below 
detection limit using a sensitive 
method and absence of the substance 
and of metabolites of the substance in 
urine, bile or exhaled air) and the 
pattern of use indicates there is no or 
no significant human exposureEN L 167/64 Official Journal of the European Union 27.6.2012Column 1 
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requirements that may require recourse to 
testing of vertebrates  
— If a substance is known to have an 
adverse effect on fertility, meeting the 
criteria for classification as Repro ­
ductive toxicity Cat 1A or 1B: May 
damage fertility (H360F), and the 
available data are adequate to support 
a robust risk assessment, then no 
further testing for fertility will be 
necessary. However, testing for devel ­
opmental toxicity must be considered 
— If a substance is known to cause devel ­
opmental toxicity, meeting the criteria 
for classification as Reproductive 
toxicity Cat 1A or 1B: May damage 
the unborn child (H360D), and the 
available data are adequate to support 
a robust risk assessment, then no 
further testing for developmental 
toxicity will be necessary. However, 
testing for effects on fertility must be 
considered  
8.10.1. Pre-natal developmental toxicity study, preferred 
species is rabbit; oral route of administration is 
the preferred route. 
The study shall be initially performed on one 
species  
8.10.2. Two-generation reproductive toxicity study, rat, 
oral route of administration is the preferred route. 
If another reproductive toxicity test is used justifi ­
cation shall be provided. The extended one- 
generation reproductive toxicity study adopted at 
OECD level shall be considered as an alternative 
approach to the multi-generation study  
8.10.3. Further pre-natal developmental toxicity study. A 
decision on the need to perform additional 
studies on a second species or mechanistic 
studies should be based on the outcome of the 
first test (8.10.1) and all other relevant available 
data (in particular rodent reprotox studies). 
Preferred species is rat, oral route of adminis ­
tration  ADS  
8.11. Carcinogenicity 
See 8.11.1 for new study requirements  A carcinogenicity study does not need to 
be conducted if: 
— the substance is classified as mutagen 
category 1A or 1B. The default 
presumption would be that a 
genotoxic mechanism for carcinoge ­
nicity is likely. In these cases, a carci ­
nogenicity test will normally not be 
required  
8.11.1. Combined carcinogenicity study and long-term 
repeated dose toxicity 
Rat, oral route of administration is the preferred 
route. If an alternative route is proposed a justifi ­
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testing of vertebrates  
For evaluation of consumer safety of active 
substances that may end up in food or feed, it 
is necessary to conduct toxicity studies by the oral 
route  
8.11.2. Carcinogenicity testing in a second species 
— A second carcinogenicity study should 
normally be conducted using the mouse as 
test species 
— For evaluation of consumer safety of active 
substances that may end up in food or feed, 
it is necessary to conduct toxicity studies by 
the oral route  
8.12. Relevant health data, observations and treatments  
Justification should be provided if data is not 
available  
8.12.1. Medical surveillance data on manufacturing plant 
personnel  
8.12.2. Direct observation, e.g. clinical cases, poisoning 
incidents  
8.12.3. Health records, both from industry and any other 
available sources  
8.12.4. Epidemiological studies on the general population  
8.12.5. Diagnosis of poisoning including specific signs of 
poisoning and clinical tests  
8.12.6. Sensitisation/allergenicity observations  
8.12.7. Specific treatment in case of an accident or 
poisoning: first aid measures, antidotes and 
medical treatment, if known  
8.12.8. Prognosis following poisoning  
8.13. Additional studies 
Additional data which may be required depending 
on the characteristics and intended use of the 
active substance 
Other available data: Available data from 
emerging methods and models, including 
toxicity pathway-based risk assessment, in vitro 
and ‘omic’ (genomic, proteomic, metabolomic, 
etc.) studies, systems biology, computational toxi ­
cology, bioinformatics, and high-throughput 
screening shall be submitted in parallel  ADS  
8.13.1. Phototoxicity  ADSEN L 167/66 Official Journal of the European Union 27.6.2012Column 1 
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8.13.2. Neurotoxicity including developmental neur ­
otoxicity 
— The preferred test species is the rat unless 
another test species is justified to be more 
appropriate 
— For delayed neurotoxicity tests the preferred 
species will be the adult hen 
— If anticholinesterase activity is detected a test 
for response to reactivating agents should be 
considered 
If the active substance is an organophosphorus 
compound or if there is any evidence e.g. 
knowledge of the mechanism of action or from 
repeat dose studies that the active substance may 
have neurotoxic or developmental neurotoxic 
properties then additional information or 
specific studies will be required. 
For evaluation of consumer safety of active 
substances that may end up in food or feed, it 
is necessary to conduct toxicity studies by the oral 
route  ADS  
8.13.3. Endocrine disruption 
If there is any evidence from in vitro, repeat dose 
or reproduction toxicity studies, that the active 
substance may have endocrine disrupting prop ­
erties then additional information or specific 
studies shall be required to: 
— elucidate the mode/mechanism of action 
— provide sufficient evidence for relevant adverse 
effects 
For evaluation of consumer safety of active 
substances that may end up in food or feed, it 
is necessary to conduct toxicity studies by the oral 
route  ADS  
8.13.4. Immunotoxicity including developmental 
immunotoxicity 
If there is any evidence, from skin sensitisation, 
repeat dose or reproduction toxicity studies, that 
the active substance may have immunotoxic 
properties then additional information or 
specific studies shall be required to: 
— elucidate the mode/mechanism of action 
— provide sufficient evidence for relevant adverse 
effects in humans 
For evaluation of consumer safety of active 
substances that may end up in food or feed, it 
is necessary to conduct toxicity studies by the oral 
route  ADSEN 27.6.2012 Official Journal of the European Union L 167/67Column 1 
Information required  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
8.13.5. Mechanistic data — any studies necessary to 
clarify effects reported in toxicity studies  ADS  
8.14. Studies related to the exposure of humans to the 
active substance  ADS  
8.15. Toxic effects on livestock and pets  ADS  
8.16. Food and feeding stuffs studies including for 
food-producing animals and their products 
(milk, eggs and honey) 
Additional information related to the exposure of 
humans to the active substance contained in 
biocidal products  ADS  
8.16.1. Proposed acceptable residue levels i.e. maximum 
residue limits (MRL) and the justification of their 
acceptability  ADS  
8.16.2. Behaviour of the residue of the active substance 
on the treated or contaminated food or feeding 
stuffs including the kinetics of disappearance 
Residue definitions should be provided where 
relevant. It is also important to compare 
residues found in toxicity studies with residues 
formed in food-producing animals and their 
products, as well as food and feed  ADS  
8.16.3. Overall material balance for the active substance 
Sufficient residue data from supervised trials on 
food- producing animals and their products, as 
well as food and feed, to demonstrate that 
residues likely to arise from the proposed use 
would not be of concern for human or animal 
health  ADS  
8.16.4. Estimation of potential or actual exposure of 
humans to the active substance and residues 
through diet and other means  ADS  
8.16.5. If residues of the active substance occur in or on 
feeding stuffs for a significant period of time or 
are found in food of animal origin after treatment 
on or around food-producing animals (e.g. direct 
treatment on animals or indirect treatment of 
animal houses or surroundings) then feeding 
and metabolism studies in livestock shall be 
required to permit evaluation of residues in 
food of animal origin  ADS  
8.16.6. Effects of industrial processing and/or domestic 
preparation on the nature and magnitude of 
residues of the active substance  ADS  
8.16.7. Any other available information that is relevant 
It may be appropriate to include information on 
migration into food, especially in the case of 
treatment of food contact materials  ADSEN L 167/68 Official Journal of the European Union 27.6.2012Column 1 
Information required  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
8.16.8. Summary and evaluation of data submitted under 
8.16.1 to 8.16.8 
It is important to establish whether the meta ­
bolites found in food (from animals or plants) 
are the same as those tested in toxicity studies. 
Otherwise values for risk assessment (e.g. ADI) are 
not valid for the residues found  ADS  
8.17. If the active substance is to be used in products 
for action against plants including algae then tests 
shall be required to assess toxic effects of meta ­
bolites from treated plants, if any, where different 
from those identified in animals  ADS  
8.18. Summary of mammalian toxicology 
Provide overall evaluation and conclusion with 
regard to all toxicological data and any other 
information concerning the active substances 
including NOAEL  
9. ECOTOXICOLOGICAL STUDIES  
9.1. Toxicity to Aquatic Organisms  
9.1.1. Short-term toxicity testing on fish 
When short-term fish toxicity data is required the 
threshold approach (tiered strategy) should be 
applied  The study does not need to be conducted 
if: 
— a valid long-term aquatic toxicity study 
on fish is available  
9.1.2. Short-term toxicity testing on aquatic invert ­
ebrates  
9.1.2.1. Daphnia magna  
9.1.2.2. Other species  ADS  
9.1.3. Growth inhibition study on algae  
9.1.3.1. Effects on growth rate of green algae  
9.1.3.2. Effects on growth rate of cyanobacteria or 
diatoms  
9.1.4. Bioconcentration  The experimental determination may not 
need to be carried out if: 
— it can be demonstrated on the basis of 
physico-chemical properties (e.g. log 
Kow < 3) or other evidence that the 
substance has a low potential for 
bioconcentration  9.1.4.1. Estimation methods  
9.1.4.2. Experimental determination  
9.1.5. Inhibition of microbial activity 
The study may be replaced by a nitrification 
inhibition test if available data show that the 
substance is likely to be an inhibitor of 
microbial growth or function, in particular 
nitrifying bacteriaEN 27.6.2012 Official Journal of the European Union L 167/69Column 1 
Information required  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
9.1.6. Further Toxicity Studies on Aquatic Organisms 
If the results of the ecotoxicological studies, 
studies on fate and behaviour and/or the 
intended use(s) of the active substance indicate a 
risk for the aquatic environment, or if long-term 
exposure is expected, then one or more of the 
tests described in this Section shall be conducted  ADS  
9.1.6.1. Long term toxicity testing on Fish 
(a) Fish Early Life Stage (FELS) Test 
(b) Fish short term toxicity test on embryo and 
sack fry stages 
(c) Fish juvenile growth test 
(d) Fish full life cycle test  ADS  
9.1.6.2. Long term toxicity testing on invertebrates 
(a) Daphnia growth and reproduction study 
(b) Other species reproduction and growth (e.g. 
Mysid) 
(c) Other species development and emergence 
(e.g. Chironomus)  ADS  
9.1.7. Bioaccumulation in an appropriate aquatic species  ADS  
9.1.8. Effects on any other specific, non-target 
organisms (flora and fauna) believed to be at risk  ADS  
9.1.9. Studies on sediment- dwelling organisms  ADS  
9.1.10. Effects on aquatic macrophytes  ADS  
9.2. Terrestrial toxicity, initial tests  ADS  
9.2.1. Effects on soil micro-organisms  
9.2.2. Effects on earthworms or other soil- dwelling 
non-target invertebrates  
9.2.3. Acute toxicity to plants  
9.3. Terrestrial tests, long term  ADS  
9.3.1. Reproduction study with earthworms or other 
soil-dwelling non-target invertebrates  
9.4. Effects on birds  ADS  For endpoint 9.4.3 the study does not 
need to be conducted if: 
— the dietary toxicity study shows that 
the LC  50 is above 2 000 mg/kg  9.4.1. Acute oral toxicity  
9.4.2. Short-term toxicity — eight-day dietary study in 
at least one species (other than chickens, ducks 
and geese)EN L 167/70 Official Journal of the European Union 27.6.2012Column 1 
Information required  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
9.4.3. Effects on reproduction  
9.5. Effects on arthropods  ADS  
9.5.1. Effects on honeybees  
9.5.2. Other non-target terrestrial arthropods, e.g. pred ­
ators  
9.6. Bioconcentration, terrestrial  ADS  
9.7. Bioaccumulation, terrestrial  ADS  
9.8. Effects on other non-target, non-aquatic 
organisms  ADS  
9.9. Effects on mammals  ADS  Data are derived from the mammalian 
toxicological assessment. The most 
sensitive relevant mammalian long-term 
toxicological endpoint (NOAEL) expressed 
as mg test compound/kg bw/day shall be 
reported  9.9.1. Acute oral toxicity  
9.9.2. Short term toxicity  
9.9.3. Long term toxicity  
9.9.4. Effects on reproduction  
9.10. Identification of endocrine activity  ADS  
10. ENVIRONMENTAL FATE AND BEHAVIOUR  
10.1. Fate and behaviour in water and sediment  
10.1.1. Degradation, initial studies  
If the assessment performed indicates the need to 
investigate further the degradation of the 
substance and its degradation products or the 
active substance has an overall low or absent 
abiotic degradation, then the tests described in 
10.1.3 and 10.3.2 and where appropriate — in 
10.4 shall be required. The choice of the appro ­
priate test(s) depends on the results of the initial 
assessment performed  
10.1.1.1. Abiotic  
(a) Hydrolysis as a function of pH and identifi ­
cation of breakdown products 
— The identification of breakdown products 
is required when the breakdown products 
at any sampling time are present at 
≥ 10 %  
(b) Phototransformation in water, including 
identification of transformation productsEN 27.6.2012 Official Journal of the European Union L 167/71Column 1 
Information required  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
10.1.1.2. Biotic  
(a) Ready biodegradability  
(b) Inherent biodegradability (where appropriate)  
10.1.2. Adsorption/desorption  
10.1.3. Rate and route of degradation including identifi ­
cation of metabolites and degradation products  
10.1.3.1. Biological sewage treatment  
(a) Aerobic biodegradation  ADS  
(b) Anaerobic biodegradation  ADS  
(c) STP simulation test  ADS  
10.1.3.2. Biodegradation in freshwater  
(a) Aerobic aquatic degradation study  ADS  
(b) Water/sediment degradation test  ADS  
10.1.3.3. Biodegradation in sea water  ADS  
10.1.3.4. Biodegradation during manure storage  ADS  
10.1.4. Adsorption and desorption in water/aquatic 
sediment systems and, where relevant, adsorption 
and desorption of metabolites and degradation 
products  ADS  
10.1.5. Field study on accumulation in sediment  ADS  
10.1.6. Inorganic substances: information on fate and 
behaviour in water  ADS  
10.2. Fate and behaviour in soil  ADS  
10.2.1. Laboratory study on rate and route of degradation 
including identification of the processes involved 
and identification of any metabolites and degra ­
dation products in one soil type (unless pH 
dependent route) under appropriate conditions 
Laboratory studies on rate of degradation in three 
additional soil types  ADS  
10.2.2. Field studies, two soil types  ADS  
10.2.3. Soil accumulation studies  ADSEN L 167/72 Official Journal of the European Union 27.6.2012Column 1 
Information required  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
10.2.4. Adsorption and desorption in at least three soil 
types and, where relevant, adsorption and 
desorption of metabolites and degradation 
products  ADS  
10.2.5. Further studies on sorption  
10.2.6. Mobility in at least three soil types and where 
relevant mobility of metabolites and degradation 
products  ADS  
10.2.6.1. Column leaching studies  
10.2.6.2. Lysimeter studies  
10.2.6.3. Field leaching studies  
10.2.7. Extent and nature of bound residues 
The determination and characteristics of bound 
residues is recommended to be combined with a 
soil simulation study  ADS  
10.2.8. Other soil degradation studies  ADS  
10.2.9. Inorganic substances: information on fate and 
behaviour in soil  
10.3. Fate and behaviour in air  
10.3.1. Phototransformation in air (estimation method) 
Identification of transformation products  
10.3.2. Fate and behaviour in air, further studies  ADS  
10.4. Additional studies on fate and behaviour in the 
environment  ADS  
10.5. Definition of the residue  ADS  
10.5.1. Definition of the residue for risk assessment  
10.5.2. Definition of the residue for monitoring  
10.6. Monitoring data  ADS  
10.6.1. Identification of all degradation products (> 10 %) 
must be included in the studies on degradation in 
soil, water and sediments  
11. MEASURES NECESSARY TO PROTECT 
HUMANS, ANIMALS AND THE ENVIRONMENT  
11.1. Recommended methods and precautions 
concerning handling, use, storage, transport or 
fireEN 27.6.2012 Official Journal of the European Union L 167/73Column 1 
Information required  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
11.2. In case of fire, nature of reaction products, 
combustion gases etc.  
11.3. Emergency measures in case of accident  
11.4. Possibility of destruction or decontamination 
following release in or on the following: 
(a) air 
(b) water, including drinking water 
(c) soil  
11.5. Procedures for waste management of the active 
substance for industry or professional users  
11.6. Possibility of reuse or recycling  
11.7. Possibility of neutralisation of effects  
11.8. Conditions for controlled discharge including 
leachate qualities on disposal  
11.9. Conditions for controlled incineration  
11.10. Identification of any substances falling within the 
scope of List I or List II of the Annex to Council 
Directive 80/68/EEC of 17 December 1979 on 
the protection of groundwater against pollution 
caused by certain dangerous substances (  3 ), of 
Annexes I and II to Directive 2006/118/EC of 
the European Parliament and of the Council of 
12 December 2006 on the protection of 
groundwater against pollution and deterio ­
ration (  4 ), of Annex I to Directive 2008/105/EC 
of the European Parliament and of the Council of 
16 December 2008 on environmental quality 
standards in the field of water policy (  5 ), of Part 
B of Annex I to Directive 98/83/EC or Annexes 
VIII and X to Directive 2000/60/EC  
12. CLASSIFICATION, LABELLING AND PACK ­
AGING  
12.1. State any existing classification and labelling  
12.2. The hazard classification of the substance 
resulting from the application of Regulation (EC) 
No 1272/2008  
In addition, for each entry, the reasons why no 
classification is given for an endpoint should be 
provided  
12.2.1. Hazard classification  
12.2.2. Hazard pictogram  
12.2.3. Signal wordEN L 167/74 Official Journal of the European Union 27.6.2012Column 1 
Information required  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
12.2.4. Hazard statements  
12.2.5. Precautionary statements including prevention, 
response, storage and disposal  
12.3. Specific concentration limits, where applicable, 
resulting from the application of Regulation (EC) 
No 1272/2008  
13. SUMMARY AND EVALUATION 
The key information identified from the 
endpoints in each subsection (2-12) is summa ­
rised, evaluated and a draft risk assessment is 
performed  
( 1 ) The information provided should be for the purified active substance of stated specification or for the active substance as m anufactured, 
if different. 
( 2 ) The information provided should be for the purified active substance of stated specification. 
( 3 ) OJ L 20, 26.1.1980, p. 43. 
( 4 ) OJ L 372, 27.12.2006, p. 19. 
( 5 ) OJ L 348, 24.12.2008, p. 84.EN 27.6.2012 Official Journal of the European Union L 167/75TITLE 2  
MICRO-ORGANISMS  
Core data set and additional data set for active substances  
Information required to support the approval of an active substance is listed in the table below.  
Conditions for not requiring a specific test that are set out in the appropriate test methods in Regulation (EC) 
No 440/2008 that are not repeated in column 3, also apply.  
Column 1 
Information required  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
1. APPLICANT  
1.1. Name and address  
1.2. Contact person  
1.3. Manufacturer (name, address and location of 
manufacturing plant)  
2. IDENTITY OF THE MICRO-ORGANISM  
2.1. Common name of the micro-organism (including 
alternative and superseded names)  
2.2. Taxonomic name and strain  
2.3. Collection and culture reference number where the 
culture is deposited  
2.4. Methods, procedures and criteria used to establish 
the presence and identity of the micro-organism  
2.5. Specification of the technical grade active 
ingredient  
2.6. Method of production and quality control  
2.7. Content of the micro-organism  
2.8. Identity and content of impurities, additives, 
contaminating micro-organisms  
2.9. Analytical profile of batches  
3. BIOLOGICAL PROPERTIES OF THE MICRO- 
ORGANISM  
3.1. General information on the micro-organism  
3.1.1. Historical background  
3.1.2. Historical uses  
3.1.3. Origin, natural occurrence and geographical 
distributionEN L 167/76 Official Journal of the European Union 27.6.2012Column 1 
Information required  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
3.2. Development stages/life cycle of the micro- 
organism  
3.3. Relationships to known plant or animal or human 
pathogens  
3.4. Genetic stability and factors affecting it  
3.5. Information on the production of metabolites 
(especially toxins)  
3.6. Production and resistance to antibiotics and other 
anti-microbial agents  
3.7. Robustness to environmental factors  
3.8. Further information on the micro-organism  
4. METHODS OF DETECTION AND 
IDENTIFICATION  
4.1. Analytical methods for the analysis of the micro- 
organism as manufactured  
4.2. Methods used for monitoring purposes to 
determine and quantify residues (viable or non- 
viable)  
5. EFFECTIVENESS AGAINST TARGET ORGANISM  
5.1. Function and mode of control e.g. attracting, 
killing, inhibiting  
5.2. Infectiveness, dispersal and colonisation ability  
5.3. Representative organism(s) controlled and products, 
organisms or objects to be protected  
5.4. Effects on representative target organism(s) 
Effects on materials, substances and products  
5.5. Likely concentration at which the micro-organism 
will be used  
5.6. Mode of action (including time delay)  
5.7. Efficacy data  
5.8. Any known limitations on efficacy  
5.8.1. Information on the occurrence or possible 
occurrence of the development of resistance of 
the target organism(s) and appropriate 
management strategies  
5.8.2. Observations on undesirable or unintended side 
effects  
5.8.3. Host specificity, range and effects on species other 
than the target organismEN 27.6.2012 Official Journal of the European Union L 167/77Column 1 
Information required  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
5.9. Methods to prevent loss of virulence of seed stock 
of the micro-organism  
6. INTENDED USES AND EXPOSURE  
6.1. Field of use(s) envisaged  
6.2. Product-type(s)  
6.3. Detailed description of the use pattern(s)  
6.4. Category of users for which the micro-organism 
should be approved  
6.5. Exposure data applying, as appropriate, the 
methodologies described in Section 5 of Annex I 
to Regulation (EC) No 1907/2006  
6.5.1. Information on human exposure associated with 
the intended uses and disposal of the active 
substance  
6.5.2. Information on environmental exposure associated 
with the intended uses and disposal of the active 
substance  
6.5.3. Information on exposure of food-producing 
animals and food and feeding stuffs associated 
with the intended uses of the active substance  
7. EFFECT ON HUMAN AND ANIMAL HEALTH  Information requirements in this Section 
may be adapted as appropriate in 
accordance with the specifications of Title 
1 of this Annex.  
7.1. Basic information  
7.1.1. Medical data  
7.1.2. Medical surveillance on manufacturing plant 
personnel  
7.1.3. Sensitisation/allergenicity observations  
7.1.4. Direct observation, e.g. clinical cases 
Any pathogenicity and infectiveness to humans and 
other mammals under conditions of 
immunosuppression  
7.2. Basic studies  
7.2.1. Sensitisation  
7.2.2. Acute toxicity, pathogenicity, and infectiveness  
7.2.2.1. Acute oral toxicity, pathogenicity and infectiveness  
7.2.2.2. Acute inhalatory toxicity, pathogenicity and 
infectiveness  ADS  
7.2.2.3. Intraperitoneal/subcutaneous single dose  ADSEN L 167/78 Official Journal of the European Union 27.6.2012Column 1 
Information required  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
7.2.3. In vitro genotoxicity testing  
7.2.4. Cell culture study  
7.2.5. Information on short-term toxicity and 
pathogenicity  ADS  
7.2.5.1. Health effects after repeated inhalatory exposure  ADS  
7.2.6. Proposed treatment: first aid measures, medical 
treatment  
7.3. Specific toxicity, pathogenicity and infectiveness 
studies  ADS  
7.4. Genotoxicity — in vivo studies in somatic cells  ADS  
7.5. Genotoxicity — in vivo studies in germ cells  ADS  
7.6. Summary of mammalian toxicity, pathogenicity 
and infectiveness and overall evaluation  
7.7. Residues in or on treated articles, food and 
feedingstuffs  ADS  
7.7.1. Persistence and likelihood of multiplication in or 
on treated articles, feedingstuffs or foodstuffs  ADS  
7.7.2. Further information required  ADS  
7.7.2.1. Non-viable residues  ADS  
7.7.2.2. Viable residues  ADS  
7.8. Summary and evaluation of residues in or on 
treated articles, food and feedingstuffs  ADS  
8. EFFECTS ON NON-TARGET ORGANISMS  Information requirements in this Section 
may be adapted as appropriate in 
accordance with the specifications of Title 
1 of this Annex.  
8.1. Effects on aquatic organisms  
8.1.1. Effects on fish  
8.1.2. Effects on freshwater invertebrates  
8.1.3. Effects on algae growth  
8.1.4. Effects on plants other than algae  ADS  
8.2. Effects on earthworms  
8.3. Effects on soil micro-organisms  
8.4. Effects on birds  
8.5. Effects on bees  
8.6. Effects on arthropods other than beesEN 27.6.2012 Official Journal of the European Union L 167/79Column 1 
Information required  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
8.7. Further studies  ADS  
8.7.1. Terrestrial plants  ADS  
8.7.2. Mammals  ADS  
8.7.3. Other relevant species and processes  ADS  
8.8. Summary and evaluation of effects on non-target 
organisms  
9. ENVIRONMENTAL FATE AND BEHAVIOUR  
9.1. Persistence and multiplication  
9.1.1. Soil  
9.1.2. Water  
9.1.3. Air  
9.1.4. Mobility  
9.1.5. Summary and evaluation of fate and behaviour in 
the environment  
10. MEASURES NECESSARY TO PROTECT HUMANS, 
ANIMALS AND THE ENVIRONMENT  
10.1. Recommended methods and precautions 
concerning handling, storage, transport or fire  
10.2. Emergency measures in case of an accident  
10.3. Procedures for destruction or decontamination  
10.4. Procedures for waste management  
10.5. Monitoring plan to be used for the active micro- 
organism including handling, storage, transport 
and use  
11. CLASSIFICATION, LABELLING AND PACKAGING 
OF THE MICRO-ORGANISM  
11.1. Relevant risk group specified in Article 2 of 
Directive 2000/54/EC  
12. SUMMARY AND EVALUATION 
The key information identified from the endpoints 
in each subsection (2-12) is summarised, evaluated 
and a draft risk assessment is performedEN L 167/80 Official Journal of the European Union 27.6.2012ANNEX III  
INFORMATION REQUIREMENTS FOR BIOCIDAL PRODUCTS  
1. This Annex sets out the information requirements that shall be included in the dossier for the biocidal product 
accompanying an application for the approval of an active substance in accordance with point (b) of Article 6(1) and 
the dossier accompanying an application for the authorisation of a biocidal product in accordance with point (a) of 
Article 20(1).  
2. The data elements set down in this Annex comprise a Core Data Set (CDS) and an Additional Data Set (ADS). The data 
elements belonging to the CDS are considered as the basic data which should, in principle, be provided for all biocidal 
products.  
With regard to the ADS, the data elements to be provided for a specific biocidal product shall be determined by 
considering each of the ADS data elements indicated in this Annex taking into account, inter alia, the physical and 
chemical properties of the product, existing data, information which is part of the CDS and the types of products and 
the exposure patterns related to these uses.  
Specific indications for the inclusion of some data elements are provided in column 1 of the Annex III table. The 
general considerations regarding adaptation of information requirements as set out in Annex IV to this Regulation 
shall also apply. In light of the importance of reducing testing on vertebrates, column 3 of the table gives specific 
indications for the adaptation of some of the data elements which might require the use of such tests on vertebrates.  
For some of the information requirements set out in this Annex, it may be possible to satisfy these requirements based 
on available information of the properties of the active substance(s) contained in the product and the properties of 
non-active substance(s) included in the product. For non-active substances, applicants shall use the information 
provided to them in the context of Title IV of Regulation (EC) No 1907/2006, where relevant, and the information 
made available by the Agency in accordance with point (e) of Article 77(2) of that Regulation.  
The relevant calculation methods used for the classification of mixtures as laid down in Regulation (EC) 
No 1272/2008 shall, where appropriate, be applied in the hazard assessment of the biocidal product. Such calculation 
methods shall not be used if, in relation to a particular hazard, synergistic and antagonistic effects between the 
different substances contained in the product are considered likely.  
Detailed technical guidance regarding the application of this Annex and the preparation of the dossier is available on 
the website of the Agency.  
The applicant has the obligation to initiate a pre-submission consultation. In addition to the obligation set out in 
Article 62(2), applicants may also consult with the competent authority that will evaluate the dossier with regard to 
the proposed information requirements and in particular the testing on vertebrates that the applicant proposes to carry 
out.  
Additional information may need to be submitted if necessary to carry out the evaluation as indicated in Article 29(3) 
or Article 44(2).  
The information submitted shall, in any case, be sufficient to support a risk assessment demonstrating that the criteria 
in Article 19(1)(b) are met.  
3. A detailed and full description of studies conducted and of the methods used shall be included. It is important to 
ensure that the data available is relevant and is of sufficient quality to fulfil the requirements.  
4. The formats made available by the Agency shall be used for submission of the dossiers. In addition, IUCLID shall be 
used for those parts of the dossiers to which IUCLID applies. Formats and further guidance on data requirements and 
dossier preparation are available on the Agency homepage.  
5. Tests submitted for the purpose of authorisation shall be conducted according to the methods described in Regulation 
(EC) No 440/2008. However, if a method is inappropriate or not described, other methods shall be used which are 
scientifically appropriate, whenever possible internationally recognised, and their appropriateness must be justified in 
the application. When test methods are applied to nanomaterials, an explanation shall be provided of their scientific 
appropriateness for nanomaterials, and, where applicable, of the technical adaptations/adjustments that have been 
made in order to respond to the specific characteristics of these materials.EN 27.6.2012 Official Journal of the European Union L 167/816. Tests performed should comply with the relevant requirements of protection of laboratory animals, set out in Directive 
2010/63/EU and, in the case of ecotoxicological and toxicological tests, good laboratory practice, set out in Directive 
2004/10/EC or other international standards recognised as being equivalent by the Commission or the Agency. Tests 
on physico-chemical properties and safety-relevant substance data should be performed at least according to inter ­
national standards.  
7. Where testing is done, a detailed quantitative and qualitative description (specification) of the product used for each 
test and its impurities must be provided.  
8. Where test data exist that have been generated before 17 July 2012 by methods other than those laid down in 
Regulation (EC) No 440/2008, the adequacy of such data for the purposes of this Regulation and the need to conduct 
new tests according to the Regulation (EC) No 440/2008 must be decided by the competent authority of the Member 
State, on a case-by-case basis, taking into account, among other factors, the need to avoid unnecessary testing.  
9. New tests involving vertebrates shall be conducted as the last available option to comply with the data requirements 
set out in this Annex when all the other data sources have been exhausted. In vivo testing with corrosive substances at 
concentration/dose levels causing corrosivity shall also be avoided.EN L 167/82 Official Journal of the European Union 27.6.2012TITLE 1  
CHEMICAL PRODUCTS  
Core data set and additional data set for chemical products  
Information required to support the authorisation of a biocidal product is listed in the table below.  
For each information requirement set down in this Annex the indications given in columns 1 and 3 of Annex II for the 
same information requirement shall also apply.  
Column 1 
Information required:  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
1. APPLICANT  
1.1. Name and address, etc.  
1.2. Contact person  
1.3. Manufacturer and formulator of the biocidal 
product and the active substance(s) (names, 
addresses, including location of plant(s))  
2. IDENTITY OF THE BIOCIDAL PRODUCT  
2.1. Trade name or proposed trade name  
2.2. Manufacturer’s development code and number of 
the product, if appropriate  
2.3. Complete quantitative (g/kg, g/l or % w/w (v/v)) 
composition of the biocidal product, i.e. 
declaration of all active substances and non-active 
substances (substance or mixture according to 
Article 3 of Regulation (EC) No 1907/2006), 
which are intentionally added to the biocidal 
product (formulation) as well as detailed quanti ­
tative and qualitative information on the 
composition of the active substance(s) contained 
in the biocidal product. For non-active substances, 
a safety data sheet in compliance with Article 31 of 
Regulation (EC) No 1907/2006 has to be provided. 
In addition, all relevant information on individual 
ingredients, their function and, in the case of a 
reaction mixture, the final composition of the 
biocidal product shall be given  
2.4. Formulation type and nature of the biocidal 
product, e.g. emulsifiable concentrate, wettable 
powder, solution  
3. PHYSICAL, CHEMICAL AND TECHNICAL PROP ­
ERTIES  
3.1. Appearance (at 20 °C and 101,3 kPa)  
3.1.1. Physical state (at 20 °C and 101,3 kPa)  
3.1.2. Colour (at 20 °C and 101,3 kPa)  
3.1.3. Odour (at 20 °C and 101,3 kPa)EN 27.6.2012 Official Journal of the European Union L 167/83Column 1 
Information required:  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
3.2. Acidity/alkalinity 
The test is applicable when the pH of the biocidal 
product or its dispersion in water (1 %) is outside 
the pH range 4-10  
3.3. Relative density (liquids) and bulk, tap density 
(solids)  
3.4. Storage stability, stability and shelf-life  
3.4.1. Storage stability tests  
3.4.1.1. Accelerated storage test  
3.4.1.2. Long term storage test at ambient temperature  
3.4.1.3. Low temperature stability test (liquids)  
3.4.2. Effects on content of the active substance and 
technical characteristics of the biocidal product  
3.4.2.1. Light  
3.4.2.2. Temperature and humidity  
3.4.2.3. Reactivity towards container material  
3.5. Technical characteristics of the biocidal product  
3.5.1. Wettability  
3.5.2. Suspensibility, spontaneity and dispersion stability  
3.5.3. Wet sieve analysis and dry sieve test  
3.5.4. Emulsifiability, re-emulsifiability and emulsion 
stability  
3.5.5. Disintegration time  
3.5.6. Particle size distribution, content of dust/fines, 
attrition, friability  
3.5.7. Persistent foaming  
3.5.8. Flowability/Pourability/Dustability  
3.5.9. Burning rate — smoke generators  
3.5.10. Burning completeness — smoke generators  
3.5.11. Composition of smoke — smoke generators  
3.5.12. Spraying pattern — aerosols  
3.5.13. Other technical characteristics  
3.6. Physical and chemical compatibility with other 
products including other biocidal products with 
which its use is to be authorised  
3.6.1. Physical compatibilityEN L 167/84 Official Journal of the European Union 27.6.2012Column 1 
Information required:  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
3.6.2. Chemical compatibility  
3.7. Degree of dissolution and dilution stability  
3.8. Surface tension  
3.9. Viscosity  
4. PHYSICAL HAZARDS AND RESPECTIVE CHAR ­
ACTERISTICS  
4.1. Explosives  
4.2. Flammable gases  
4.3. Flammable aerosols  
4.4. Oxidising gases  
4.5. Gases under pressure  
4.6. Flammable liquids  
4.7. Flammable solids  
4.8. Self-reactive substances and mixtures  
4.9. Pyrophoric liquids  
4.10. Pyrophoric solids  
4.11. Self-heating substances and mixtures  
4.12. Substances and mixtures which in contact with 
water emit flammable gases  
4.13. Oxidising liquids  
4.14. Oxidising solids  
4.15. Organic peroxides  
4.16. Corrosive to metals  
4.17. Additional physical indications of hazard  
4.17.1. Auto-ignition temperatures of products (liquids and 
gases)  
4.17.2. Relative self-ignition temperature for solids  
4.17.3. Dust explosion hazard  
5. METHODS OF DETECTION AND IDENTIFI ­
CATION  
5.1. Analytical method including validation parameters 
for determining the concentration of the active 
substance(s), residues, relevant impurities and 
substances of concern in the biocidal productEN 27.6.2012 Official Journal of the European Union L 167/85Column 1 
Information required:  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
5.2. In so far as not covered by Annex II 5.2 and 5.3, 
analytical methods for monitoring purposes 
including recovery rates and the limits of deter ­
mination of relevant components of the biocidal 
product and/or residues thereof, where relevant in 
or on the following:  ADS  
5.2.1. Soil  ADS  
5.2.2. Air  ADS  
5.2.3. Water (including drinking water) and sediment  ADS  
5.2.4. Animal and human body fluids and tissues  ADS  
5.3. Analytical methods for monitoring purposes 
including recovery rates and the limit of quantifi ­
cation and detection for the active substance, and 
for residues thereof, in/on food of plant and animal 
origin or feeding stuffs and other products where 
relevant (not necessary if neither the active 
substance nor the material treated with it come 
into contact with food- producing animals, food 
of plant and animal origin or feeding stuffs)  ADS  
6. EFFECTIVENESS AGAINST TARGET ORGANISMS  
6.1. Function, e.g. fungicide, rodenticide, insecticide, 
bactericide 
Mode of control e.g. attracting, killing, inhibiting  
6.2. Representative organism(s) to be controlled and 
products, organisms or objects to be protected  
6.3. Effects on representative target organisms  
6.4. Likely concentration at which the active substance 
will be used  
6.5. Mode of action (including time delay)  
6.6. The proposed label claims for the product and, 
where label claims are made, for treated articles  
6.7. Efficacy data to support these claims, including any 
available standard protocols, laboratory tests or 
field trials used including performance standards 
where appropriate and relevant  
6.8. Any known limitations on efficacy  
6.8.1. Information on the occurrence or possible 
occurrence of the development of resistance and 
appropriate management strategies  
6.8.2. Observations on undesirable or unintended side 
effects e.g. on beneficial and other non-target 
organismsEN L 167/86 Official Journal of the European Union 27.6.2012Column 1 
Information required:  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
6.9. Summary and evaluation  
7. INTENDED USES AND EXPOSURE  
7.1. Field(s) of use envisaged for biocidal products and, 
where appropriate, treated articles  
7.2. Product-type  
7.3. Detailed description of intended use pattern(s) for 
biocidal products and, where appropriate, treated 
articles  
7.4. User e.g. industrial, trained professional, profes ­
sional or general public (non-professional)  
7.5. Likely tonnage to be placed on the market per year 
and, where relevant, for different use categories  
7.6. Method of application and a description of this 
method  
7.7. Application rate and, if appropriate, the final 
concentration of the biocidal product and active 
substance in a treated article or in the system in 
which the product is to be used, e.g. cooling water, 
surface water, water used for heating purposes  
7.8. Number and timing of applications, and where 
relevant, any particular information relating to 
geographical location or climatic variations 
including necessary waiting periods, clearance 
times, withdrawal periods or other precautions to 
protect human health, animal health and the 
environment  
7.9. Proposed instructions for use  
7.10. Exposure data in conformity with Annex VI to this 
Regulation  
7.10.1. Information on human exposure associated with 
production and formulation, proposed/expected 
uses and disposal  
7.10.2. Information on environmental exposure associated 
with production and formulation, proposed/ex ­
pected uses and disposal  
7.10.3. Information on exposure from treated articles 
including leaching data (either laboratory studies 
or model data)  
7.10.4. Information regarding other products that the 
product is likely to be used together with, in 
particular the identity of the active substances in 
these products, if relevant, and the likelihood of 
any interactionsEN 27.6.2012 Official Journal of the European Union L 167/87Column 1 
Information required:  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
8. TOXICOLOGICAL PROFILE FOR HUMANS AND 
ANIMALS  
8.1. Skin corrosion or skin irritation 
The assessment of this endpoint shall be carried 
out according to the sequential testing strategy 
for dermal irritation and corrosion set out in the 
Appendix to Test Guideline B.4. Acute Toxicity- 
Dermal Irritation/Corrosion (Annex B.4. to Regu ­
lation (EC) No 440/2008)  Testing on the product/mixture does not 
need to be conducted if: 
— there are valid data available on each 
of the components in the mixture 
sufficient to allow classification of the 
mixture according to the rules laid 
down in Directive 1999/45/EC and 
Regulation (EC) No 1272/2008 (CLP), 
and synergistic effects between any of 
the components are not expected  
8.2. Eye irritation (  1 ) 
The assessment of this endpoint shall be carried 
out according to the sequential testing strategy 
for eye irritation and corrosion as set down in 
the Appendix to Test Guideline B.5.Acute 
Toxicity: Eye Irritation/Corrosion (Annex B.5. to 
Regulation (EC) No 440/2008)  Testing on the product/mixture does not 
need to be conducted if: 
— there are valid data available on each 
of the components in the mixture to 
allow classification of the mixture 
according to the rules laid down in 
Directive 1999/45/ECand Regulation 
(EC) No 1272/2008 (CLP), and 
synergistic effects between any of the 
components are not expected  
8.3. Skin sensitisationThe assessment of this endpoint 
shall comprise the following consecutive steps: 
1. an assessment of the available human, animal 
and alternative data 
2. in vivo testing 
The Murine Local Lymph Node Assay (LLNA) 
including, where appropriate, the reduced 
variant of the assay, is the first-choice method 
for in vivo testing. If another skin sensitisation 
test is used justification shall be provided  Testing on the product/mixture does not 
need to be conducted if: 
— there are valid data available on each 
of the components in the mixture to 
allow classification of the mixture 
according to the rules laid down in 
Directive 1999/45/EC and Regulation 
(EC) No 1272/2008 (CLP), and 
synergistic effects between any of the 
components are not expected 
— the available information indicates that 
the product should be classified for 
skin sensitisation or corrosivity; or 
— the substance is a strong acid 
(pH < 2,0) or base (pH > 11,5)  
8.4. Respiratory sensitisation  ADS  Testing on the product/mixture does not 
need to be conducted if: 
— there are valid data available on each 
of the components in the mixture to 
allow classification of the mixture 
according to the rules laid down in 
Directive 1999/45/EC and Regulation 
(EC) No 1272/2008 (CLP), and 
synergistic effects between any of the 
components are not expectedEN L 167/88 Official Journal of the European Union 27.6.2012Column 1 
Information required:  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
8.5. Acute toxicity 
— Classification using the tiered approach to clas ­
sification of mixtures for acute toxicity in Regu ­
lation (EC) No 1272/2008 is the default 
approach  Testing on the product/mixture does not 
need to be conducted if: 
— there are valid data available on each 
of the components in the mixture to 
allow classification of the mixture 
according to the rules laid down in 
Directive 1999/45/EC and Regulation 
(EC) No 1272/2008 (CLP), and 
synergistic effects between any of the 
components are not expected  
8.5.1. By oral route  
8.5.2. By inhalation  
8.5.3. By dermal route  
8.5.4. For biocidal products that are intended to be auth ­
orised for use with other biocidal products, the 
risks to human health, animal health and the 
environment arising from the use of these 
product combinations shall be assessed. As an 
alternative to acute toxicity studies, calculations 
can be used. In some cases, for example where 
there are no valid data available of the kind set 
out in column 3, this may require a limited 
number of acute toxicity studies to be carried out 
using combinations of the products  Testing on the mixture of products does 
not need to be conducted if: 
— there are valid data available on each 
of the components in the mixture to 
allow classification of the mixture 
according to the rules laid down in 
Directive 1999/45/EC and Regulation 
(EC) No 1272/2008 (CLP), and 
synergistic effects between any of the 
components are not expected  
8.6. Information on dermal absorption 
Information on dermal absorption when exposure 
occurs to the biocidal product. The assessment of 
this endpoint shall proceed using a tiered approach  
8.7. Available toxicological data relating to: 
— non-active substance(s) (i.e. substance(s) of 
concern), or 
— a mixture that a substance(s) of concern is a 
component of 
If insufficient data are available for a non-active 
substance(s) and cannot be inferred through read- 
across or other accepted non-testing approaches, 
targeted test(s) described in Annex II shall be 
carried out for the substance(s) of concern or a 
mixture that a substance(s) of concern is a 
component of  Testing on the product/mixture does not 
need to be conducted if: 
— there are valid data available on each 
of the components in the mixture to 
allow classification of the mixture 
according to the rules laid down in 
Directive 1999/45/EC and Regulation 
(EC) No 1272/2008 (CLP)  
8.8. Food and feedingstuffs studies  ADS  
8.8.1. If residues of the biocidal product remain in or on 
feedingstuffs for a significant period of time, then 
feeding and metabolism studies in livestock shall 
be required to permit evaluation of residues in 
food of animal origin  ADSEN 27.6.2012 Official Journal of the European Union L 167/89Column 1 
Information required:  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
8.9. Effects of industrial processing and/or domestic 
preparation on the nature and magnitude of 
residues of the biocidal product  ADS  
8.10. Other test(s) related to the exposure to humans 
Suitable test(s) and a reasoned case will be required 
for the biocidal product 
In addition, for certain biocides which are applied 
directly or around livestock (including horses) 
residue studies might be needed  ADS  
9. ECOTOXICOLOGICAL STUDIES  
9.1. Information relating to the ecotoxicity of the 
biocidal product which is sufficient to enable a 
decision to be made concerning the classification 
of the product is required 
— Where there are valid data available on each of 
the components in the mixture and synergistic 
effects between any of the components are not 
expected, classification of the mixture can be 
made according to the rules laid down in 
Directive 1999/45/EC, Regulation (EC) 
No 1907/2006 (REACH) and Regulation (EC) 
No 1272/2008 (CLP) 
— Where valid data on the components are not 
available or where synergistic effects may be 
expected then testing of components and/or 
the biocidal product itself may be necessary  
9.2. Further Ecotoxicological studies 
Further studies chosen from among the endpoints 
referred to in Section 9 of Annex II for relevant 
components of the biocidal product or the biocidal 
product itself may be required if the data on the 
active substance cannot give sufficient information 
and if there are indications of risk due to specific 
properties of the biocidal product  
9.3. Effects on any other specific, non-target organisms 
(flora and fauna) believed to be at risk  ADS  Data for the assessment of hazards to wild 
mammals are derived from the 
mammalian toxicological assessment  
9.4. If the biocidal product is in the form of bait or 
granules the following studies may be required:  
9.4.1. Supervised trials to assess risks to non-target 
organisms under field conditions  
9.4.2. Studies on acceptance by ingestion of the biocidal 
product by any non-target organisms thought to be 
at risk  
9.5. Secondary ecological effect e.g. when a large 
proportion of a specific habitat type is treated  ADSEN L 167/90 Official Journal of the European Union 27.6.2012Column 1 
Information required:  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
10. ENVIRONMENTAL FATE AND BEHAVIOUR  
The test requirements below are applicable only to the 
relevant components of the biocidal product  
10.1. Foreseeable routes of entry into the environment 
on the basis of the use envisaged  
10.2. Further studies on fate and behaviour in the 
environment 
Further studies chosen from among the endpoints 
referred to in Section 10 of Annex II for relevant 
components of the biocidal product or the biocidal 
product itself may be required. 
For products that are used outside, with direct 
emission to soil, water or surfaces, the components 
in the product may influence the fate and 
behaviour (and ecotoxicity) of the active substance. 
Data are required unless it is scientifically justified 
that the fate of the components in the product is 
covered by the data provided for the active 
substance and other identified substances of 
concern  ADS  
10.3. Leaching behaviour  ADS  
10.4. Testing for distribution and dissipation in the 
following:  ADS  
10.4.1. Soil  ADS  
10.4.2. Water and sediment  ADS  
10.4.3. Air  ADS  
10.5. If the biocidal product is to be sprayed near to 
surface waters then an overspray study may be 
required to assess risks to aquatic organisms or 
plants under field conditions  ADS  
10.6. If the biocidal product is to be sprayed outside or if 
potential for large scale formation of dust is given 
then data on overspray behaviour may be required 
to assess risks to bees and non-target arthropods 
under field conditions  ADS  
11. MEASURES TO BE ADOPTED TO PROTECT 
HUMANS, ANIMALS AND THE ENVIRONMENT  
11.1. Recommended methods and precautions 
concerning handling, use, storage, disposal, 
transport or fire  
11.2. Identity of relevant combustion products in cases 
of fire  
11.3. Specific treatment in case of an accident, e.g. first- 
aid measures, antidotes, medical treatment if 
available; emergency measures to protect the 
environmentEN 27.6.2012 Official Journal of the European Union L 167/91Column 1 
Information required:  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
11.4. Possibility of destruction or decontamination 
following release in or on the following:  
11.4.1. Air  
11.4.2. Water, including drinking water  
11.4.3. Soil  
11.5. Procedures for waste management of the biocidal 
product and its packaging for industrial use, use by 
trained professionals, professional users and non- 
professional users (e.g. possibility of reuse or 
recycling, neutralisation, conditions for controlled 
discharge, and incineration)  
11.6. Procedures for cleaning application equipment 
where relevant  
11.7. Specify any repellents or poison control measures 
included in the product that are present to prevent 
action against non-target organisms  
12. CLASSIFICATION, LABELLING, AND PACKAGING  
As established in point (b) of Article 20(1), 
proposals including justification for the hazard 
and precautionary statements in accordance with 
the provisions set in Directive 1999/45/EC and 
Regulation (EC) No 1272/2008 must be submitted. 
Example labels, instructions for use and safety data 
sheets shall be provided  
12.1. Hazard classification  
12.2. Hazard pictogram  
12.3. Signal word  
12.4. Hazard statements  
12.5. Precautionary statements including prevention, 
response, storage and disposal  
12.6. Proposals for safety-data sheets should be provided, 
where appropriate  
12.7. Packaging (type, materials, size, etc.), compatibility 
of the product with proposed packaging materials 
to be included  
13. EVALUATION AND SUMMARY 
The key information identified from the endpoints 
in each subsection (2-12) is summarised, evaluated 
and a draft risk assessment is performed  
( 1 ) Eye-irritation test shall not be necessary where the biocidal product has been shown to have potential corrosive properties.EN L 167/92 Official Journal of the European Union 27.6.2012TITLE 2  
MICRO-ORGANISMS  
Core data set and additional data set  
Information required to support the authorisation of a biocidal product is listed in the table below.  
For each information requirement set down in this Annex the indications given in columns 1 and 3 of Annex II for the 
same information requirement shall also apply.  
Column 1 
Information required:  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
1. APPLICANT  
1.1. Name and address  
1.2. Contact person  
1.3. Manufacturer and formulator of the biocidal 
product and the micro-organism(s) (names, 
addresses, including location of plant(s))  
2. IDENTITY OF THE BIOCIDAL PRODUCTS  
2.1. Trade name or proposed trade name  
2.2. Manufacturer’s development code and number of 
the biocidal product, if appropriate  
2.3. Detailed quantitative (g/kg, g/l or % w/w (v/v)) and 
qualitative information on the constitution, 
composition and function of the biocidal product, 
e.g. micro-organism, active substance(s) and product 
non-active substances and any other relevant 
components. 
All relevant information on individual ingredients 
and the final composition of the biocidal product 
shall be given  
2.4. Formulation type and nature of the biocidal 
product  
3. BIOLOGICAL, PHYSICAL, CHEMICAL AND 
TECHNICAL PROPERTIES OF THE BIOCIDAL 
PRODUCT  
3.1. Biological properties of the micro-organism in the 
biocidal product  
3.2. Appearance (at 20 °C and 101,3 kPa)  
3.2.1. Colour (at 20 °C and 101,3 kPa)  
3.2.2. Odour (at 20 °C and 101,3 kPa)  
3.3. Acidity, alkalinity and pH value  
3.4. Relative density  
3.5. Storage stability, stability and shelf-life  
3.5.1. Effects of lightEN 27.6.2012 Official Journal of the European Union L 167/93Column 1 
Information required:  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
3.5.2. Effects of temperature and humidity  
3.5.3. Reactivity towards the container  
3.5.4. Other factors affecting stability  
3.6. Technical characteristics of the biocidal product  
3.6.1. Wettability  
3.6.2. Suspensibility and suspension stability  
3.6.3. Wet sieve analysis and dry sieve test  
3.6.4. Emulsifiability, re-emulsifiability, emulsion stability  
3.6.5. Particle size distribution content of dust/fines, 
attrition and friability  
3.6.6. Persistent foaming  
3.6.7. Flowability/Pourability/Dustability  
3.6.8. Burning rate — smoke generators  
3.6.9. Burning completeness — smoke generators  
3.6.10. Composition of smoke — smoke generators  
3.6.11. Spraying patterns — aerosols  
3.6.12. Other technical characteristics  
3.7. Physical, chemical and biological compatibility with 
other products including biocidal products with 
which its use is to be authorised or registered  
3.7.1. Physical compatibility  
3.7.2. Chemical compatibility  
3.7.3. Biological compatibility  
3.8. Surface tension  
3.9. Viscosity  
4. PHYSICAL HAZARDS AND RESPECTIVE CHAR ­
ACTERISITICS  
4.1. Explosives  
4.2. Flammable gases  
4.3. Flammable aerosols  
4.4. Oxidising gases  
4.5. Gases under pressureEN L 167/94 Official Journal of the European Union 27.6.2012Column 1 
Information required:  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
4.6. Flammable liquids  
4.7. Flammable solids  
4.8. Oxidising liquids  
4.9. Oxidising solids  
4.10. Organic peroxides  
4.11. Corrosive to metals  
4.12. Other physical indications of hazard  
4.12.1. Auto-ignition temperatures of products (liquids and 
gases)  
4.12.2. Relative self-ignition temperature for solids  
4.12.3. Dust explosion hazard  
5. METHODS OF DETECTION AND IDENTIFI ­
CATION  
5.1. Analytical method for determining the concen ­
tration of the micro-organism(s) and substances of 
concern in the biocidal product  
5.2. Analytical methods for monitoring purposes 
including recovery rates and the limit of quantifi ­
cation and detection for the active substance, and 
for residues thereof, in/on food of plant and animal 
origin or feeding stuffs and other products where 
relevant (not necessary if neither the active 
substance nor the article treated with it does not 
come into contact with food-producing animals, 
food of plant and animal origin or feeding stuffs)  ADS  
6. EFFECTIVENESS AGAINST TARGET ORGANISM  
6.1. Function and mode of control  
6.2. Representative pest organism(s) to be controlled 
and products, organisms or objects to be protected  
6.3. Effects on representative target organisms  
6.4. Likely concentration at which micro-organism will 
be used  
6.5. Mode of action  
6.6. The proposed label claims for the product  
6.7. Efficacy data to support these claims, including any 
available standard protocols, laboratory tests, or 
field trials used including performance standards, 
where appropriate and relevantEN 27.6.2012 Official Journal of the European Union L 167/95Column 1 
Information required:  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
6.8. Any other known limitations on efficacy including 
resistance  
6.8.1. Information on the occurrence or possible 
occurrence of the development of resistance and 
appropriate management strategies  
6.8.2. Observations on undesirable or unintended side 
effects  
7. INTENDED USES AND EXPOSURE  
7.1. Field of use envisaged  
7.2. Product-type  
7.3. Detailed description of intended use  
7.4. User e.g. industrial, trained professional, profes ­
sional or general public (non-professional)  
7.5. Method of application and a description of this 
method  
7.6. Application rate and if appropriate the final concen ­
tration of the biocidal product or the micro- 
organism active substance in a treated article or 
the system in which the product is to be used 
(e.g. in the application device or bait)  
7.7. Number and timing of applications and duration of 
protection 
Any particular information relating to the 
geographical location or climatic variations 
including necessary waiting periods for re-entry or 
necessary withdrawal period or other precautions to 
protect human health, animal health and the 
environment  
7.8. Proposed instructions for use  
7.9. Exposure data  
7.9.1. Information on human exposure associated with 
the proposed/expected uses and disposal  
7.9.2. Information on environmental exposure associated 
with the proposed/expected uses and disposal  
8. TOXICOLOGICAL PROFILE FOR HUMANS AND 
ANIMALS  Testing on the product/mixture does not 
need to be conducted if: 
— there are valid data available on each 
of the components in the mixture to 
allow classification of the mixture 
according to the rules laid down in 
Directive 1999/45/EC, Regulation (EC) 
No 1907/2006 (REACH) and Regu ­
lation (EC) No 1272/2008 (CLP) and 
synergistic effects between any of the 
components are not expectedEN L 167/96 Official Journal of the European Union 27.6.2012Column 1 
Information required:  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
8.1. Skin corrosion or irritation  
8.2. Eye irritation  
8.3. Skin sensitisation  
8.4. Respiratory sensitisation  ADS  
8.5. Acute toxicity 
— Classification using the tiered approach to clas ­
sification of mixtures for acute toxicity in Regu ­
lation (EC) No 1272/2008 is the default 
approach  
8.5.1. Oral  
8.5.2. Inhalation  
8.5.3. Dermal  
8.5.4. Additional acute toxicity studies  
8.6. Information on dermal absorption if required  
8.7. Available toxicological data relating to: 
— non-active substance(s) (i.e. substance(s) of 
concern), or 
— a mixture that a substance(s) of concern is a 
component of 
If insufficient data are available for a non-active 
substance(s) and cannot be inferred through 
read-across or other accepted non-testing 
approaches, targeted test(s) described in Annex 
II, shall be carried out for the substance(s) of 
concern or a mixture that a substance(s) of 
concern is a component of  Testing on the product/mixture does not 
need to be conducted if: 
— there are valid data available on each 
of the components in the mixture to 
allow classification of the mixture 
according to the rules laid down in 
Directive 1999/45/EC, Regulation (EC) 
No 1907/2006 (REACH) and Regu ­
lation (EC) No 1272/2008 (CLP), and 
synergistic effects between any of the 
components are not expected  
8.8. Supplementary studies for combinations of biocidal 
products 
For biocidal products that are intended to be auth ­
orised for use with other biocidal products, the 
risks to humans, animals and the environment 
arising from the use of these product combinations 
shall be assessed. As an alternative to acute toxicity 
studies, calculations can be used. In some cases, for 
example where there are no valid data available of 
the kind set out in column 3, this may require a 
limited number of acute toxicity studies to be 
carried using combinations of the products  Testing on the mixture of products does 
not need to be conducted if: 
— there are valid data available on each 
of the components in the mixture to 
allow classification of the mixture 
according to the rules laid down in 
Directive 1999/45/EC, Regulation (EC) 
No 1907/2006 (REACH) and Regu ­
lation (EC) No 1272/2008 (CLP), and 
synergistic effects between any of the 
components are not expectedEN 27.6.2012 Official Journal of the European Union L 167/97Column 1 
Information required:  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
8.9. Residues in or on treated articles, food and feed ­
ingstuffs  ADS  
9. ECOTOXICOLOGICAL STUDIES  
9.1. Information relating to the ecotoxicity of the 
biocidal product which is sufficient to enable a 
decision to be made concerning the classification 
of the product is required 
— Where there are valid data available on each of 
the components in the mixture and synergistic 
effects between any of the components are not 
expected, classification of the mixture can be 
made according to the rules laid down in 
Directive 1999/45/EC, Regulation (EC) 
No 1907/2006 (REACH) and Regulation (EC) 
No 1272/2008 (CLP) 
— Where valid data on the components are not 
available or where synergistic effects may be 
expected then testing of components and/or 
the biocidal product itself may be necessary  
9.2. Further ecotoxicological studies 
Further studies chosen from among the endpoints 
referred to in Section 8 of Annex II ‘Micro- 
organisms’ for relevant components of the 
biocidal product or the biocidal product itself may 
be required if the data on the active substance 
cannot give sufficient information and if there are 
indications of risk due to specific properties of the 
biocidal product  
9.3. Effects on any other specific non-target organisms 
(flora and fauna) believed to be at risk  ADS  Data for the assessment of hazards to wild 
mammals are derived from the 
mammalian toxicological assessment  
9.4. If the biocidal product is in the form of bait or 
granules  ADS  
9.4.1. Supervised trials to assess risks to non-target 
organisms under field conditions  
9.4.2. Studies on acceptance by ingestion of the biocidal 
product by any non-target organisms thought to be 
at risk  
9.5. Secondary ecological effect e.g. when a large 
proportion of a specific habitat type is treated  ADS  
10. ENVIRONMENTAL FATE AND BEHAVIOUR  
10.1. Foreseeable routes of entry into the environment on 
the basis of the use envisagedEN L 167/98 Official Journal of the European Union 27.6.2012Column 1 
Information required:  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
10.2. Further studies on fate and behaviour in the 
environment 
Where relevant, all the information required in 
Section 9 of Annex II ‘Micro-organisms’ may be 
required for the product 
For products that are used outside, with direct 
emission to soil, water or surfaces, the components 
in the product may influence the fate and behaviour 
(and ecotoxicity) of the active substance. Data are 
required unless it is scientifically justified that the 
fate of the components in the product is covered by 
the data provided for the active substance and other 
identified substances of concern  ADS  
10.3. Leaching behaviour  ADS  
10.4. If the biocidal product is to be sprayed outside or if 
potential for large scale formation of dust is given 
then data on overspray behaviour may be required 
to assess risks to bees under field conditions  ADS  
11. MEASURES TO BE ADOPTED TO PROTECT 
HUMANS, ANIMALS AND THE ENVIRONMENT  
11.1. Recommended methods and precautions 
concerning: handling, storage, transport or fire  
11.2. Measures in the case of an accident  
11.3. Procedures for destruction or decontamination of 
the biocidal product and its packaging  
11.3.1. Controlled incineration  
11.3.2. Others  
11.4. Packaging and compatibility of the biocidal product 
with proposed packaging materials  
11.5. Procedures for cleaning application equipment 
where relevant  
11.6. Monitoring plan to be used for the active micro- 
organism and other micro-organism(s) contained in 
the biocidal product including handling, storage, 
transport and use  
12. CLASSIFICATION, LABELLING AND PACKAGING  
Example labels, instructions for use and safety data 
sheets shall be provided  
12.1. Indication on the need for the biocidal product to 
carry the biohazard sign specified in Annex II to 
Directive 2000/54/ECEN 27.6.2012 Official Journal of the European Union L 167/99Column 1 
Information required:  Column 2 
All data is CDS 
unless indicated 
as ADS  Column 3 
Specific rules for adaptation from standard 
information concerning some of the information 
requirements that may require recourse to 
testing of vertebrates  
12.2. Precautionary statements including prevention, 
response, storage and disposal  
12.3. Proposals for safety-data sheets should be provided, 
where appropriate  
12.4. Packaging (type, materials, size, etc.), compatibility 
of the product with proposed packaging materials 
to be included  
13. SUMMARY AND EVALUATION 
The key information identified from the endpoints 
in each subsection (2-12) is summarised, evaluated 
and a draft risk assessment is performedEN L 167/100 Official Journal of the European Union 27.6.2012ANNEX IV  
GENERAL RULES FOR THE ADAPTATION OF THE DATA REQUIREMENTS  
This Annex sets out rules to be followed when the applicant proposes to adapt the data requirements set out in Annexes 
II and III in accordance with Article 6(2) and (3) or Article 21(1) and (2), without prejudice to the specific rules set out in  
Annex III on the use of the calculation methods for classification of mixtures to avoid testing on vertebrates.  
The reasons for such adaptations to the data requirements must be clearly stated under the appropriate heading of the 
dossier referring to the specific rule(s) of this Annex.  
1. TESTING DOES NOT APPEAR SCIENTIFICALLY NECESSARY  
1.1. Use of existing data  
1.1.1. Data on physical-chemical properties from experiments not carried out according to GLP or the relevant test 
methods.  
Data shall be considered to be equivalent to data generated by the corresponding test methods if the following 
conditions are met:  
(1) adequacy of the data for the purpose of classification and labelling and risk assessment;  
(2) sufficient adequate and reliable documentation is provided to assess the equivalency of the study; and  
(3) the data are valid for the endpoint being investigated and the study is performed using an acceptable level of 
quality assurance.  
1.1.2. Data on human health and environmental properties from experiments not carried out according to GLP or the 
relevant test methods.  
Data shall be considered to be equivalent to data generated by the corresponding test methods if the following 
conditions are met:  
(1) adequacy of the data for the purpose of classification and labelling and risk assessment;  
(2) adequate and reliable coverage of the key parameters/endpoints foreseen to be investigated in the 
corresponding test methods;  
(3) exposure duration comparable to or longer than the corresponding test methods if exposure duration is a 
relevant parameter;  
(4) adequate and reliable documentation of the study is provided; and  
(5) the study is performed using a system of quality assurance.  
1.1.3. Historical human data  
As a general rule, in accordance with Article 7(3) of Regulation (EC) No 1272/2008, tests on humans shall not be 
performed for the purposes of this Regulation. However, existing historical human data, such as epidemiological 
studies on exposed populations, accidental or occupational exposure data, biomonitoring studies, clinical studies 
and human volunteer studies performed in accordance with internationally accepted ethical standards shall be 
considered.  
Data collected on humans shall not be used to lower the safety margins resulting from tests or studies on animals.  
The strength of the data for a specific human health effect depends, among other things, on the type of analysis 
and the parameters covered, and on the magnitude and specificity of the response and consequently the predicta ­
bility of the effect. Criteria for assessing the adequacy of the data include:  
(1) the proper selection and characterisation of the exposed and control groups;EN 27.6.2012 Official Journal of the European Union L 167/101(2) adequate characterisation of exposure;  
(3) sufficient length of follow-up for disease occurrence;  
(4) valid method for observing an effect;  
(5) proper consideration of bias and confounding factors; and  
(6) a reasonable statistical reliability to justify the conclusion.  
In all cases adequate and reliable documentation shall be provided.  
1.2. Weight of evidence  
There may be sufficient weight of evidence from several independent sources of information leading to the 
assumption/conclusion that a substance has or does not have a particular dangerous property, while the 
information from each single source alone is considered insufficient to support this notion. There may be sufficient 
weight of evidence from the use of positive results of newly developed test methods, not yet included in the 
relevant test methods or from an international test method recognised by the Commission as being equivalent, 
leading to the conclusion that a substance has a particular dangerous property. However, if the newly developed 
test method has been approved by the Commission, but has not yet been published, its results may be taken into 
account even where this leads to the conclusion that a substance does not have a particular dangerous property.  
Where consideration of all the available data provides sufficient weight of evidence for the presence or absence of a 
particular dangerous property:  
— further testing on vertebrates for that property shall not be undertaken,  
— further testing not involving vertebrates may be omitted.  
In all cases adequate and reliable documentation shall be provided.  
1.3. Qualitative or Quantitative structure-activity relationship ((Q)SAR)  
Results obtained from valid qualitative or quantitative structure-activity relationship models ((Q)SARs) may indicate 
the presence, but not the absence of a given dangerous property. Results of (Q)SARs may be used instead of testing 
when the following conditions are met:  
— the results are derived from a (Q)SAR model whose scientific validity has been established,  
— the substance falls within the applicability domain of the (Q)SAR model,  
— the results are adequate for the purpose of classification and labelling and risk assessment, and  
— adequate and reliable documentation of the applied method is provided.  
The Agency shall, in collaboration with the Commission, Member States and interested parties, develop and 
provide guidance on the use of (Q)SARs.  
1.4. In vitro methods  
Results obtained from suitable in vitro methods may indicate the presence of a given dangerous property or may 
be important in relation to a mechanistic understanding, which may be important for the assessment. In this 
context, ‘suitable’ means sufficiently well-developed according to internationally agreed test development criteria.  
Where such in vitro tests are positive, it is necessary to confirm the dangerous property by adequate  in vivo  tests. 
However, such confirmation may be waived if the following conditions are met:  
(1) results are derived from an in vitro method whose scientific validity has been established by a validation study, 
according to internationally agreed validation principles;EN L 167/102 Official Journal of the European Union 27.6.2012(2) results are adequate for the purpose of classification and labelling and risk assessment; and  
(3) adequate and reliable documentation of the applied method is provided.  
In the case of negative results, these exemptions do not apply. A confirmation test may be requested on a case- 
by-case basis.  
1.5. Grouping of substances and read-across approach  
Substances whose physico-chemical, toxicological and ecotoxicological properties are similar or follow a regular 
pattern as a result of structural similarity may be considered as a group or ‘category’ of substances. Application of 
the group concept requires that physico-chemical properties, human and animal health effects, and environmental 
effects or environmental fate may be predicted from data for reference substance(s) within the group by inter ­
polation to other substances in the group (read-across approach). This avoids the need to test every substance for 
every endpoint.  
The similarities may be based on:  
(1) a common functional group indicating the presence of dangerous properties;  
(2) common precursors and/or the likelihood of common breakdown products via physical and biological 
processes, which result in structurally similar chemicals and indicates the presence of dangerous properties; or  
(3) a constant pattern in the changing of the potency of the properties across the category.  
If the group concept is applied, substances shall be classified and labelled on this basis.  
In all cases results shall:  
— be adequate for the purpose of classification and labelling and risk assessment,  
— have adequate and reliable coverage of the key parameters addressed in the corresponding test method, and  
— cover an exposure duration comparable to or longer than the corresponding test method if exposure duration 
is a relevant parameter.  
In all cases, adequate and reliable documentation of the applied method shall be provided.  
The Agency shall, in collaboration with the Commission, Member States and interested parties, develop and 
provide guidance on technically and scientifically justified methodology for the grouping of substances.  
2. TESTING IS TECHNICALLY NOT POSSIBLE  
Testing for a specific endpoint may be omitted if it is technically not possible to conduct the study as a 
consequence of the properties of the substance: e.g. very volatile, highly reactive or unstable substances cannot 
be used, mixing of the substance with water may cause danger of fire or explosion, or the radio-labelling of the 
substance required in certain studies may not be possible. The guidance given in the relevant test methods, more 
specifically on the technical limitations of a specific method, shall always be respected.  
3. PRODUCT-TAILORED EXPOSURE-DRIVEN TESTING  
3.1. Testing in accordance with some endpoints in Sections 8 and 9 of Annexes II and III, notwithstanding Article 6(2), 
may be omitted based on exposure considerations, where exposure data in accordance with Annex II or III are 
available.  
In that case, the following conditions shall be met:  
— An exposure assessment shall be performed, covering primary and secondary exposure under realistic worst 
case for all intended uses of the biocidal product that contains the active substance for which approval is 
applied, or of the biocidal product for which the authorisation is sought.EN 27.6.2012 Official Journal of the European Union L 167/103— If a new exposure scenario is introduced at a later stage, during the product authorisation process, additional 
data shall be submitted to assess whether the justification for data adaptation still applies.  
— The reasons why the outcome of the exposure assessment justifies waiving of data requirements shall be clearly 
and transparently explained.  
However, testing cannot be omitted for non-threshold effects. As a consequence, certain core data shall always be 
obligatory, e.g. genotoxicity testing.  
If relevant, the Agency shall, in collaboration with the Commission, Member States and interested parties, develop 
and provide further guidance on the criteria established in accordance with Article 6(4) and Article 21(3).  
3.2. In all cases, adequate justification and documentation shall be provided. The justification shall be based on an 
exposure assessment, in accordance with the relevant Technical Notes for Guidance where available.EN L 167/104 Official Journal of the European Union 27.6.2012ANNEX V  
BIOCIDAL PRODUCT-TYPES AND THEIR DESCRIPTIONS AS REFERRED TO IN ARTICLE 2(1)  
MAIN GROUP 1: Disinfectants  
These product-types exclude cleaning products that are not intended to have a biocidal effect, including washing liquids, 
powders and similar products.  
Product-type 1: Human hygiene  
Products in this group are biocidal products used for human hygiene purposes, applied on or in contact with human skin 
or scalps for the primary purpose of disinfecting the skin or scalp.  
Product-type 2: Disinfectants and algaecides not intended for direct application to humans or animals  
Products used for the disinfection of surfaces, materials, equipment and furniture which are not used for direct contact 
with food or feeding stuffs.  
Usage areas include, inter alia, swimming pools, aquariums, bathing and other waters; air conditioning systems; and walls 
and floors in private, public, and industrial areas and in other areas for professional activities.  
Products used for disinfection of air, water not used for human or animal consumption, chemical toilets, waste water, 
hospital waste and soil.  
Products used as algaecides for treatment of swimming pools, aquariums and other waters and for remedial treatment of 
construction materials.  
Products used to be incorporated in textiles, tissues, masks, paints and other articles or materials with the purpose of 
producing treated articles with disinfecting properties.  
Product-type 3: Veterinary hygiene  
Products used for veterinary hygiene purposes such as disinfectants, disinfecting soaps, oral or corporal hygiene products 
or with anti-microbial function.  
Products used to disinfect the materials and surfaces associated with the housing or transportation of animals.  
Product-type 4: Food and feed area  
Products used for the disinfection of equipment, containers, consumption utensils, surfaces or pipework associated with 
the production, transport, storage or consumption of food or feed (including drinking water) for humans and animals.  
Products used to impregnate materials which may enter into contact with food.  
Product-type 5: Drinking water  
Products used for the disinfection of drinking water for both humans and animals.  
MAIN GROUP 2: Preservatives  
Unless otherwise stated these product-types include only products to prevent microbial and algal development.  
Product-type 6: Preservatives for products during storage  
Products used for the preservation of manufactured products, other than foodstuffs, feedingstuffs, cosmetics or medicinal 
products or medical devices by the control of microbial deterioration to ensure their shelf life.  
Products used as preservatives for the storage or use of rodenticide, insecticide or other baits.  
Product-type 7: Film preservatives  
Products used for the preservation of films or coatings by the control of microbial deterioration or algal growth in order 
to protect the initial properties of the surface of materials or objects such as paints, plastics, sealants, wall adhesives, 
binders, papers, art works.EN 27.6.2012 Official Journal of the European Union L 167/105Product-type 8: Wood preservatives  
Products used for the preservation of wood, from and including the saw-mill stage, or wood products by the control of 
wood-destroying or wood-disfiguring organisms, including insects.  
This product-type includes both preventive and curative products.  
Product-type 9: Fibre, leather, rubber and polymerised materials preservatives  
Products used for the preservation of fibrous or polymerised materials, such as leather, rubber or paper or textile products 
by the control of microbiological deterioration.  
This product-type includes biocidal products which antagonise the settlement of micro-organisms on the surface of 
materials and therefore hamper or prevent the development of odour and/or offer other kinds of benefits.  
Product-type 10: Construction material preservatives  
Products used for the preservation of masonry, composite materials, or other construction materials other than wood by 
the control of microbiological, and algal attack.  
Product-type 11: Preservatives for liquid-cooling and processing systems  
Products used for the preservation of water or other liquids used in cooling and processing systems by the control of 
harmful organisms such as microbes, algae and mussels.  
Products used for the disinfection of drinking water or of water for swimming pools are not included in this product- 
type.  
Product-type 12: Slimicides  
Products used for the prevention or control of slime growth on materials, equipment and structures, used in industrial 
processes, e.g. on wood and paper pulp, porous sand strata in oil extraction.  
Product-type 13: Working or cutting fluid preservatives  
Products to control microbial deterioration in fluids used for working or cutting metal, glass or other materials.  
MAIN GROUP 3: Pest control  
Product-type 14: Rodenticides  
Products used for the control of mice, rats or other rodents, by means other than repulsion or attraction.  
Product-type 15: Avicides  
Products used for the control of birds, by means other than repulsion or attraction.  
Product-type 16: Molluscicides, vermicides and products to control other invertebrates  
Products used for the control of molluscs, worms and invertebrates not covered by other product-types, by means other 
than repulsion or attraction.  
Product-type 17: Piscicides  
Products used for the control of fish, by means other than repulsion or attraction.  
Product-type 18: Insecticides, acaricides and products to control other arthropods  
Products used for the control of arthropods (e.g. insects, arachnids and crustaceans), by means other than repulsion or 
attraction.  
Product-type 19: Repellents and attractants  
Products used to control harmful organisms (invertebrates such as fleas, vertebrates such as birds, fish, rodents), by 
repelling or attracting, including those that are used for human or veterinary hygiene either directly on the skin or 
indirectly in the environment of humans or animals.EN L 167/106 Official Journal of the European Union 27.6.2012Product-type 20: Control of other vertebrates  
Products used for the control of vertebrates other than those already covered by the other product-types of this main 
group, by means other than repulsion or attraction.  
MAIN GROUP 4: Other biocidal products  
Product-type 21: Antifouling products  
Products used to control the growth and settlement of fouling organisms (microbes and higher forms of plant or animal 
species) on vessels, aquaculture equipment or other structures used in water.  
Product-type 22: Embalming and taxidermist fluids  
Products used for the disinfection and preservation of human or animal corpses, or parts thereof.EN 27.6.2012 Official Journal of the European Union L 167/107ANNEX VI  
COMMON PRINCIPLES FOR THE EVALUATION OF DOSSIERS FOR BIOCIDAL PRODUCTS  
CONTENTS  
Terms and definitions  
Introduction  
Assessment  
— General principles  
— Effects on human and animal health  
— Effects on the environment  
— Effects on target organisms  
— Efficacy  
— Summary  
Conclusions  
— General principles  
— Effects on human and animal health  
— Effects on the environment  
— Effects on target organisms  
— Efficacy  
— Summary  
Overall integration of conclusions  
TERMS AND DEFINITIONS  
Correspondence with the criteria set out in Article 19(1)(b)  
The subheadings ‘Effects on human and animal health’, ‘Effects on the Environment’, ‘Effects on Target Organisms’ and 
‘Efficacy’ used in the Sections ‘Assessment’ and ‘Conclusions’ correspond to the four criteria set out in Article 19(1)(b) as 
follows:  
‘Efficacy’ corresponds to criterion (i): ‘is sufficiently effective’.  
‘Effects on target organisms’ corresponds to criterion (ii): ‘has no unacceptable effects on the target organisms, in 
particular unacceptable resistance or cross resistance or unnecessary suffering and pain for vertebrates’.  
‘Effects on human and animal health’ corresponds to criterion (iii): ‘has no immediate or delayed unacceptable effects 
itself, or as a result of its residues, on human health, including that of vulnerable groups (  1 ), or animal health, directly or 
through drinking water, food, feed, air, or through other indirect effects’.  
‘Effects on the environment’ corresponds to criterion iv: ‘has no unacceptable effects itself, or as a result of its residues, on 
the environment, having particular regard to the following considerations:  
— its fate and distribution in the environment,EN L 167/108 Official Journal of the European Union 27.6.2012  
( 1 ) See definition of vulnerable groups in Article 3.— contamination of surface waters (including estuarial and seawater), groundwater and drinking water, air and soil, 
taking into account locations distant from its use following long-range environmental transportation,  
— its impact on non-target organisms,  
— its impact on biodiversity and the ecosystem’.  
Technical definitions  
(a) Hazard identification  
The identification of the adverse effects which a biocidal product has an inherent capacity to cause.  
(b) Dose (concentration) — response (effect) assessment  
The estimate of the relationship between the dose, or level of exposure, of an active substance or substance of 
concern in a biocidal product and the incidence and severity of an effect.  
(c) Exposure assessment  
The determination of the emissions, pathways and rates of movement of an active substance or a substance of 
concern in a biocidal product and its transformation or degradation in order to estimate the concentration/doses to 
which human populations, animals or environmental compartments are or may be exposed.  
(d) Risk characterisation  
The estimation of the incidence and severity of the adverse effects likely to occur in a human population, animals or 
environmental compartments due to actual or predicted exposure to any active substance or substance of concern in a 
biocidal product. This may include ‘risk estimation’, i.e. the quantification of that likelihood.  
(e) Environment  
Water, including sediment, air, soil, wild species of fauna and flora, and any interrelationship between them, as well as 
any relationship with living organisms.  
INTRODUCTION  
1. This Annex sets out the common principles for the evaluation of dossiers for biocidal products referred to in 
Article 19(1)(b). A decision by a Member State or the Commission to authorise a biocidal product shall be taken 
on the basis of the conditions set down in Article 19, taking account of the evaluation carried out according to this 
Annex. Detailed technical guidance regarding the application of this Annex is available on the website of the Agency.  
2. The principles set out in this Annex can be applied in their entirety to the evaluation of biocidal products comprised 
of chemical substances. For biocidal products containing micro-organisms, these principles should be further 
developed in technical guidance taking into account practical experience gained, and be applied taking into 
account the nature of the product and the latest scientific information. In the case of biocidal products containing 
nanomaterials, the principles set out in this Annex will also need to be adapted and elaborated in technical guidance 
to take account of the latest scientific information.  
3. In order to ensure a high and harmonised level of protection of human health, animal health and the environment, 
any risks arising from the use of a biocidal product shall be identified. To achieve this, a risk assessment shall be 
carried out to determine the acceptability or otherwise of any risks that are identified. This is done by carrying out an 
assessment of the risks associated with the relevant individual components of the biocidal product, taking into 
account any cumulative and synergistic effects.  
4. A risk assessment on the active substance(s) present in the biocidal product is always required. This risk assessment 
shall entail hazard identification, and, as appropriate, dose (concentration) - response (effect) assessment, exposure 
assessment and risk characterisation. Where a quantitative risk assessment cannot be made a qualitative assessment 
shall be produced.  
5. Additional risk assessments shall be carried out, in the same manner as described above, on any substance of concern 
present in the biocidal product. Information submitted in the framework of Regulation (EC) No 1907/2006 shall be 
taken into account where appropriate.EN 27.6.2012 Official Journal of the European Union L 167/1096. In order to carry out a risk assessment, data are required. These data are detailed in Annexes II and III and take 
account of the fact that there are a wide variety of applications as well as different product-types and that this has an 
impact on the associated risks. The data required shall be the minimum necessary to carry out an appropriate risk 
assessment. The evaluating body shall take due consideration of the requirements of Articles 6, 21 and 62 in order to 
avoid duplication of data submissions. Data may also be required on a substance of concern present in a biocidal 
product. For in-situ generated active substances, the risk assessment includes also the possible risks from the 
precursor(s).  
7. The results of the risk assessments carried out on the active substance and on the substances of concern present in 
the biocidal product shall be integrated to produce an overall assessment for the biocidal product itself.  
8. When making evaluations of a biocidal product the evaluating body shall:  
(a) take into consideration other relevant technical or scientific information which is reasonably available to them 
with regard to the properties of the biocidal product, its components, metabolites, or residues;  
(b) evaluate, where relevant, justifications submitted by the applicant for not supplying certain data.  
9. The application of these common principles shall, when taken together with the other conditions set out in 
Article 19, lead to the competent authorities or the Commission deciding whether or not a biocidal product can 
be authorised. Such authorisation may include restrictions on use or other conditions. In certain cases the competent 
authorities may conclude that more data are required before an authorisation decision can be made.  
10. In the case of biocidal products containing active substances covered by the exclusion criteria in Article 5(1), the 
competent authorities or the Commission shall also evaluate whether the conditions of Article 5(2) can be satisfied.  
11. During the process of evaluation, applicants and the evaluating bodies shall cooperate in order to resolve quickly any 
questions on the data requirements, to identify at an early stage any additional studies required, to amend any 
proposed conditions for the use of the biocidal product, or to modify its nature or its composition in order to ensure 
full compliance with the requirements of Article 19 and of this Annex. The administrative burden, especially for 
SMEs, shall be kept to the minimum necessary without prejudicing the level of protection afforded to humans, 
animals and the environment.  
12. The judgments made by the evaluating body during the evaluation must be based on scientific principles, preferably 
recognised at international level, and must be made with the benefit of expert advice.  
ASSESSMENT  
General principles  
13. The data submitted in support of an application for authorisation of a biocidal product shall be validated by the 
evaluating or receiving competent authority in accordance with the relevant articles of the Regulation. After vali ­
dation of these data the competent authorities shall utilise them by carrying out a risk assessment based on the 
proposed use. Information submitted in the framework of Regulation (EC) No 1907/2006 shall be taken into account 
where appropriate.  
14. A risk assessment on the active substance present in the biocidal product shall always be carried out. If there are, in 
addition, any substances of concern present in the biocidal product then a risk assessment shall be carried out for 
each of these. The risk assessment shall cover the proposed normal use of the biocidal product, together with a 
realistic worst-case scenario including any relevant production and disposal issue. The assessment shall also take 
account of how any ‘treated articles’ treated with or containing the product may be used and disposed of. Active 
substances that are generated in-situ and the associated precursors shall also be considered.  
15. In carrying out the assessment, the possibility of cumulative or synergistic effects shall also be taken into account. 
The Agency shall, in collaboration with the Commission, Member States and interested parties, develop and provide 
further guidance on the scientific definitions and methodologies for the assessment of cumulative and synergistic 
effects.  
16. For each active substance and each substance of concern present in the biocidal product, the risk assessment shall 
entail hazard identification and the establishment of appropriate reference values for dose or effect concentrations 
such as NOAEL or Predicted No Effect Concentrations (PNEC), where possible. It shall also include, as appropriate, a 
dose (concentration) — response (effect) assessment, together with an exposure assessment and a risk characteri ­
sation.EN L 167/110 Official Journal of the European Union 27.6.201217. The results arrived at from a comparison of the exposure to the appropriate reference values for each of the active 
substances and for any substances of concern shall be integrated to produce an overall risk assessment for the 
biocidal product. Where quantitative results are not available the results of the qualitative assessments shall be 
integrated in a similar manner.  
18. The risk assessment shall determine:  
(a) the hazards due to the physico-chemical properties,  
(b) the risk to humans and animals,  
(c) the risk to the environment,  
(d) the measures necessary to protect humans, animals and the environment, both during the proposed normal use 
of the biocidal product and in a realistic worst-case situation.  
19. In certain cases it may be concluded that further data are required before a risk assessment can be finalised. Any such 
additional data requested shall be the minimum necessary to complete such a risk assessment.  
20. The information provided on the biocidal product family shall permit the evaluating body to reach a decision on 
whether all the products within the biocidal product family comply with the criteria under Article 19(1)(b).  
21. Where relevant the technical equivalence for every active substance contained in the biocidal product shall be 
established with reference to active substances already included in the list of approved active substances.  
Effects on human and animal health  
Effects on human health  
22. The risk assessment shall take account of the following potential effects arising from the use of the biocidal product 
and the populations liable to exposure.  
23. The effects previously mentioned result from the properties of the active substance and any substance of concern 
present. They are:  
— acute toxicity,  
— irritation,  
— corrosivity,  
— sensitisation,  
— repeated dose toxicity,  
— mutagenicity,  
— carcinogenicity,  
— reproductive toxicity,  
— neurotoxicity,  
— immunotoxicity,  
— disruption of the endocrine system,  
— any other special properties of the active substance or substance of concern,  
— other effects due to physico-chemical properties.EN 27.6.2012 Official Journal of the European Union L 167/11124. The populations previously mentioned are:  
— professional users,  
— non-professional users,  
— humans exposed directly or indirectly via the environment.  
In considering these populations, particular attention should be given to the need to protect vulnerable groups within 
these populations.  
25. The hazard identification shall address the properties and potential adverse effects of the active substance and any 
substances of concern present in the biocidal product.  
26. The evaluating body shall apply points 27 to 30 when carrying out a dose (concentration) - response (effect) 
assessment on an active substance or a substance of concern present in a biocidal product.  
27. For repeated dose toxicity and reproductive toxicity the dose-response relationship shall be assessed for each active 
substance or substance of concern and, where possible, a NOAEL identified. If it is not possible to identify a NOAEL, 
the lowest-observed-adverse-effect level (LOAEL) shall be identified. Where appropriate, other dose-effect descriptors 
may be used as reference values.  
28. For acute toxicity, corrosivity and irritation, it is not usually possible to derive a NOAEL or LOAEL on the basis of 
tests conducted in accordance with the requirements of this Regulation. For acute toxicity, the LD  50 (median lethal 
dose) or LC  50 (median lethal concentration) value or another appropriate dose-effect descriptor shall be derived. For 
the other effects it shall be sufficient to determine whether the active substance or substance of concern has an 
inherent capacity to cause such effects during use of the biocidal product.  
29. For mutagenicity and carcinogenicity, a non-threshold assessment should be carried out if the active substance or 
substance of concern is genotoxic and carcinogenic. If the active substance or a substance of concern is not genotoxic 
a threshold assessment shall be carried out.  
30. With respect to skin sensitisation and respiratory sensitisation, in so far as there is no consensus on the possibility of 
identifying a dose/concentration below which adverse effects are unlikely to occur, particularly in a subject already 
sensitised to a given substance, it shall be sufficient to evaluate whether the active substance or substance of concern 
has an inherent capacity to cause such effects as a result of the use of the biocidal product.  
31. When carrying out the risk assessment special consideration shall be given to toxicity data derived from observations 
of human exposure where such data are available, e.g. information gained from manufacture, from poison centres or 
epidemiology surveys.  
32. An exposure assessment shall be carried out for each of the human populations (professional users, non-professional 
users and humans exposed directly or indirectly via the environment), for which exposure to a biocidal product 
occurs or can reasonably be foreseen, with particular attention paid to the pathways of exposure relevant for 
vulnerable groups. The objective of the assessment shall be to make a quantitative or qualitative estimate of the 
dose/concentration of each active substance or substance of concern, including relevant metabolites and degradation 
products to which a population is, or may be exposed during use of the biocidal product and articles treated with 
that product.  
33. The exposure assessment shall be based on the information in the technical dossier provided in conformity with 
Articles 6 and 21 and on any other available and relevant information. Particular account shall be taken, as 
appropriate, of:  
— adequately measured exposure data,  
— the form in which the biocidal product is marketed,  
— the type of biocidal product,  
— the application method and application rate,  
— the physico-chemical properties of the biocidal product,EN L 167/112 Official Journal of the European Union 27.6.2012— the likely routes of exposure and potential for absorption,  
— the frequency and duration of exposure,  
— maximum residue levels,  
— the type and size of specific exposed populations, where such information is available.  
34. When conducting the exposure assessment, special consideration shall be given to adequately measured, represen ­
tative exposure data where such data are available. Where calculation methods are used for the estimation of 
exposure levels, adequate models shall be applied.  
These models shall:  
— make a best possible estimation of all relevant processes taking into account realistic parameters and assumptions,  
— be subjected to an analysis taking into account possible elements of uncertainty,  
— be reliably validated with measurements carried out under circumstances relevant for the use of the model,  
— be relevant to the conditions in the area of use.  
Relevant monitoring data from substances with analogous use and exposure patterns or analogous properties shall 
also be considered.  
35. Where, for any of the effects set out in point 23 a reference value has been identified, the risk characterisation shall 
entail comparison of the reference value with the evaluation of the dose/concentration to which the population will 
be exposed. Where a reference value cannot be established a qualitative approach shall be used.  
Assessment factors account for the extrapolation from animal toxicity to the exposed human population. The setting 
of an overall assessment factor considers the degree of uncertainty in inter-species and intra-species extrapolation. In 
the absence of suitable chemical-specific data, a default assessment factor of 100 is applied to the relevant reference 
value. Additional elements can also be considered for assessment factors, including toxicokinetics and toxicody ­
namics, the nature and severity of the effect, human (sub-)populations, exposure deviations between study results and 
human exposure with regard to frequency and duration, study duration extrapolation (e.g. sub-chronic to chronic), 
dose-response relationship and the overall quality of the toxicity data package.  
Effects on animal health  
36. Using the same relevant principles as described in the section dealing with effects on humans, the evaluating body 
shall consider the risks posed to animals from the biocidal product.  
Effects on the environment  
37. The risk assessment shall take account of any adverse effects arising in any of the three environmental compartments 
— air, soil and water (including sediment) — and of the biota, following the use of the biocidal product.  
38. The hazard identification shall address the properties and potential adverse effects of the active substance and any 
substances of concern present in the biocidal product.  
39. A dose (concentration) — response (effect) assessment shall be carried out in order to predict the concentration 
below which adverse effects in the environmental compartment of concern are not expected to occur. This shall be 
carried out for the active substance and for any substance of concern present in the biocidal product. This concen ­
tration is known as PNEC. However, in some cases, it may not be possible to establish a PNEC and a qualitative 
estimation of the dose (concentration) — response (effect) then has to be made.  
40. The PNEC shall be determined from the data on effects on organisms and ecotoxicity studies submitted in accordance 
with requirements of Articles 6 and 20. It shall be calculated by applying an assessment factor to the reference values 
resulting from tests on organisms, e.g. LD  50 (median lethal dose), LC  50 (median lethal concentration), EC  50 (median 
effective concentration), IC  50 (concentration causing 50 % inhibition of a given parameter, e.g. growth), NOEL(C) (no- 
observed-effect level (concentration)), or LOEL(C) (lowest-observed-effect level (concentration)). Where appropriate, 
other dose-effect descriptors may be used as reference values.EN 27.6.2012 Official Journal of the European Union L 167/11341. An assessment factor is an expression of the degree of uncertainty in extrapolation from test data on a limited 
number of species to the real environment. Therefore, in general, the more extensive the data and the longer the 
duration of the tests, the smaller the degree of uncertainty and the size of the assessment factor.  
42. For each environmental compartment, an exposure assessment shall be carried out in order to predict the likely 
concentration of each active substance or substance of concern present in the biocidal product. This concentration is 
known as the predicted environmental concentration (PEC). However, in some cases it may not be possible to 
establish a PEC and a qualitative estimate of exposure then has to be made.  
43. A PEC, or where necessary a qualitative estimate of exposure, need only be determined for the environmental 
compartments to which emissions, discharges, disposal or distributions (including any relevant contribution from 
articles treated with biocidal products) are known or are reasonably foreseeable.  
44. The PEC, or the qualitative estimation of exposure, shall be determined taking account of, in particular and where 
appropriate:  
— adequately measured exposure data,  
— the form in which the product is marketed,  
— the type of biocidal product,  
— the application method and application rate,  
— the physico-chemical properties,  
— breakdown/transformation products,  
— likely pathways to environmental compartments and potential for adsorption/desorption and degradation,  
— the frequency and duration of exposure,  
— long range environmental transportation.  
45. When conducting the exposure assessment, special consideration shall be given to adequately measured, represen ­
tative exposure data where such data are available. Where calculation methods are used for the estimation of 
exposure levels, adequate models shall be applied. The characteristics of these models shall be as listed in point 
34. Where appropriate, on a case-by-case basis, relevant monitoring data from substances with analogous use and 
exposure patterns or analogous properties should also be considered.  
46. For any given environmental compartment, the risk characterisation shall, as far as possible, entail comparison of the 
PEC with the PNEC so that a PEC/PNEC ratio may be derived.  
47. If it has not been possible to derive a PEC/PNEC ratio, the risk characterisation shall entail a qualitative evaluation of 
the likelihood that an effect is occurring under the current conditions of exposure or will occur under the expected 
conditions of exposure.  
48. The evaluating body shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of 
Article 19(1) if it contains any substance of concern or relevant metabolites or breakdown or reaction products 
fulfilling the criteria for being PBT or vPvB in accordance with Annex XIII to Regulation (EC) No 1907/2006, or if it 
has endocrine-disrupting properties unless it is scientifically demonstrated that under relevant field conditions there is 
no unacceptable effect.  
Effects on target organisms  
49. An assessment shall be made to demonstrate that the biocidal product does not cause unnecessary suffering in its 
effect on target vertebrates. This shall include an evaluation of the mechanism by which the effect is obtained and the 
observed effects on the behaviour and health of the target vertebrates; where the intended effect is to kill the target 
vertebrate, the time necessary to obtain the death of the target vertebrate and the conditions under which death 
occurs shall be evaluated.EN L 167/114 Official Journal of the European Union 27.6.201250. The evaluating body shall, where relevant, evaluate the possibility of the development by the target organism of 
resistance or cross-resistance to an active substance in the biocidal product.  
Efficacy  
51. Data submitted by the applicant shall be sufficient to substantiate the efficacy claims for the product. Data submitted 
by the applicant or held by the evaluating body must be able to demonstrate the efficacy of the biocidal product 
against the target organism when used normally in accordance with the conditions of authorisation.  
52. Testing should be carried out according to Union guidelines where these are available and applicable. Where 
appropriate, other methods from the list below can be used. If relevant acceptable field data exist, these can be used.  
— ISO, CEN or other international standard method  
— national standard method  
— industry standard method (if accepted by the evaluating body)  
— individual producer standard method (if accepted by the evaluating body)  
— data from the actual development of the biocidal product (if accepted by the evaluating body).  
Summary  
53. In each of the areas where risk assessments have been carried out, the evaluating body shall combine the results for 
the active substance together with the results for any substance of concern to produce an overall assessment for the 
biocidal product itself. This shall also take account of any cumulative or synergistic effects.  
54. For biocidal product containing more than one active substance, any adverse effects shall also be considered together 
to produce an overall assessment for the biocidal product itself.  
CONCLUSIONS  
General principles  
55. The purpose of the evaluation is to establish whether or not the product complies with the criteria set down in point 
(b) of Article 19(1). The evaluating body shall reach its conclusion as a result of the integration of the risks arising 
from each active substance together with the risks from each substance of concern present in the biocidal product, 
based on the assessment carried out in accordance with points 13 to 54 of this Annex.  
56. In establishing compliance with the criteria set out in point (b) of Article 19(1), the evaluating body shall arrive at 
one of the following conclusions for each product-type and each area of use of the biocidal product for which 
application has been made:  
(1) that the biocidal product complies with the criteria;  
(2) that, subject to specific conditions/restrictions, the biocidal product can comply with the criteria;  
(3) that it is not possible, without additional data, to establish if the biocidal product complies with the criteria;  
(4) that the biocidal product does not comply with the criteria.  
57. The evaluating body shall, when seeking to establish whether a biocidal product complies with the criteria in point 
(b) of Article 19(1), take into account uncertainty arising from the variability in the data used in the evaluation 
process.  
58. If the conclusion arrived at by the evaluating body is that additional information or data are required, then the 
evaluating body shall justify the need for any such information or data. This additional information or data shall be 
the minimum necessary to carry out a further appropriate risk assessment.EN 27.6.2012 Official Journal of the European Union L 167/115Effects on human and animal health  
Effects on human health  
59. The evaluating body shall consider possible effects on all human populations, namely professional users, non- 
professional users and humans exposed directly or indirectly through the environment. In reaching these conclusions, 
particular attention shall be paid to vulnerable groups among the different populations.  
60. The evaluating body shall examine the relationship between exposure and effect. A number of factors need to be 
considered when examining this relationship. One of the most important factors is the nature of the adverse effect of 
the substance under consideration. These effects include acute toxicity, irritancy, corrosivity, sensitisation, repeated 
dose toxicity, mutagenicity, carcinogenicity, neurotoxicity, immunotoxicity, reproductive toxicity, disruption of the 
endocrine system together with physico-chemical properties, and any other adverse properties of the active substance 
or substance of concern, or of their relevant metabolites or degradation products.  
61. Typically, the margin of exposure (MOE  ref ) — the ratio between the dose descriptor and the exposure concentration 
— is in the region of 100, but a MOE  ref that is higher or lower than this may also be appropriate depending on, 
among other things, the nature of the critical effects and the sensitivity of the population.  
62. The evaluating body shall, where appropriate, conclude that criterion (iii) under point (b) of Article 19(1) can only be 
complied with by application of prevention and protection measures including the design of work processes, 
engineering controls, use of adequate equipment and materials, application of collective protection measures and, 
where exposure cannot be prevented by other means, application of individual protection measures including the 
wearing of personal protective equipment such as respirators, breathing-masks, overalls, gloves and goggles, in order 
to reduce exposure for professional operators.  
63. If, for non-professional users, the wearing of personal protective equipment would be the only possible method for 
reducing exposure to an acceptable level for this population, the product shall not normally be considered as 
complying with criterion (iii) under point (b) of Article 19(1) for this population.  
Effects on animal health  
64. Using the same relevant criteria as described in the section dealing with effects on human health, the evaluating body 
shall consider whether criterion (iii) under point (b) of Article 19(1) is complied with for animal health.  
Effects on the environment  
65. The basic tool used in the decision-making is the PEC/PNEC ratio or, if this is not available, a qualitative estimation. 
Due consideration shall be given to the accuracy of this ratio due to variability in the data used both in 
measurements of concentration and of estimation.  
In the determination of the PEC, the most appropriate model should be used taking into account the environmental 
fate and behaviour of the biocidal product.  
66. For any given environmental compartment, if the PEC/PNEC ratio is equal to or less than 1, the risk characterisation 
shall be that no further information and/or testing is necessary. If the PEC/PNEC ratio is greater than 1, the evaluating 
body shall judge, on the basis of the size of that ratio and on other relevant factors, whether further information 
and/or testing is required to clarify the concern or appropriate risk reduction measures are necessary, or whether the 
biocidal product cannot comply with criterion (iv) under point (b) of Article 19(1).  
Water  
67. The evaluating body shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of 
Article 19(1) where, under the proposed conditions of use, the foreseeable concentration of the active substance or 
any other substance of concern, or of relevant metabolites or breakdown or reaction products in water (or its 
sediments) has an unacceptable impact on non-target organisms in the aquatic, marine or estuarine environment, 
unless it is scientifically demonstrated that under relevant field conditions there is no unacceptable effect. In 
particular, the evaluating body shall conclude that the biocidal product does not comply with criterion (iv) under 
point (b) of Article 19(1), where under the proposed conditions of use, the foreseeable concentration of the active 
substance or any other substance of concern, or of relevant metabolites or breakdown or reaction products in water 
(or its sediments), would undermine the achievement of compliance with the standards laid down in:  
— Directive 2000/60/EC,  
— Directive 2006/118/EC,EN L 167/116 Official Journal of the European Union 27.6.2012— Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework 
for community action in the field of marine environmental policy (  1 ), 
— Directive 2008/105/EC, or  
— international agreements on the protection of river systems or marine waters from pollution.  
68. The evaluating body shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of 
Article 19(1) where, under the proposed conditions of use, the foreseeable concentration of the active substance or 
any other substance of concern, or of relevant metabolites or breakdown or reaction products in groundwater, 
exceeds the lower of the following concentrations:  
— the maximum permissible concentration laid down by Directive 98/83/EC, or  
— the maximum concentration as laid down following the procedure for approving the active substance under this 
Regulation, on the basis of appropriate data, in particular toxicological data,  
unless it is scientifically demonstrated that under relevant field conditions the lower concentration is not exceeded.  
69. The evaluating body shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of 
Article 19(1) where the foreseeable concentration of the active substance or a substance of concern, or of relevant 
metabolites, breakdown or reaction products to be expected in surface water or its sediments after use of the biocidal 
product under the proposed conditions of use:  
— exceeds, where the surface water in or from the area of envisaged use is intended for the abstraction of drinking 
water, the values fixed by:  
— Directive 2000/60/EC,  
— Directive 98/83/EC, or  
— has an impact deemed unacceptable on non-target organisms,  
unless it is scientifically demonstrated that under relevant field conditions this concentration is not exceeded.  
70. The proposed instructions for use of the biocidal product, including procedures for cleaning application equipment, 
must be such that, if followed, they minimise the likelihood of accidental contamination of water or its sediments.  
Soil 
71. The evaluating body shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of 
Article 19(1) where, under the proposed conditions of use, the foreseeable concentration of the active substance or 
any other substance of concern, or of relevant metabolites or breakdown or reaction products in soil, has an 
unacceptable impact on non-target species, unless it is scientifically demonstrated that under relevant field conditions 
there is no unacceptable effect.  
Air 
72. The evaluating body shall conclude that the biocidal product does not comply with criterion (iv) of point (b) of 
Article 19(1) where there is a reasonably foreseeable possibility of unacceptable effect on the air compartment, unless 
it is scientifically demonstrated that under relevant field conditions there is no unacceptable effect.  
Non-target organisms  
73. The evaluating body shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of 
Article 19(1) where there is a reasonably foreseeable possibility of non-target organisms being exposed to the biocidal 
product, if for any active substance or substance of concern:  
— the PEC/PNEC is above 1, or  
— the concentration of the active substance or any other substance of concern, or of relevant metabolites or 
breakdown or reaction products, has an unacceptable impact on non-target species, unless it is scientifically 
demonstrated that under relevant field conditions there is no unacceptable effect.EN 27.6.2012 Official Journal of the European Union L 167/117  
( 1 ) OJ L 164, 25.6.2008, p. 19.74. The evaluating body shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of 
Article 19(1) where there is a reasonably foreseeable possibility of micro-organisms in sewage treatment plants being 
exposed to the biocidal product, if for any active substance, substance of concern, relevant metabolite, breakdown or 
reaction product the PEC/PNEC ratio is above 1, unless it is clearly established in the risk assessment that under field 
conditions no unacceptable impact, either directly or indirectly, occurs on the viability of such micro-organisms.  
Effects on target organisms  
75. Where the development of resistance or cross-resistance to the active substance in the biocidal product is likely, the 
evaluating body shall consider actions to minimise the consequences of this resistance. This may involve modification 
of the conditions under which an authorisation is given. However, where the development of resistance or cross- 
resistance cannot be reduced sufficiently, the evaluating authority shall conclude that the biocidal product does not 
satisfy criterion (ii) under point (b) of Article 19(1).  
76. A biocidal product intended to control vertebrates shall not normally be regarded as satisfying criterion (ii) under 
point (b) of Article 19(1) unless:  
— death is synchronous with the extinction of consciousness, or  
— death occurs immediately, or  
— vital functions are reduced gradually without signs of obvious suffering.  
For repellent products, the intended effect shall be obtained without unnecessary suffering and pain for the target 
vertebrate.  
Efficacy  
77. The level, consistency and duration of protection, control or other intended effects must, as a minimum, be similar to 
those resulting from suitable reference products, where such products exist, or to other means of control. Where no 
reference products exist, the biocidal product must give a defined level of protection or control in the areas of 
proposed use. Conclusions as to the performance of the biocidal product must be valid for all areas of proposed use 
and for all areas in the Member State or, where appropriate, in the Union, except where the biocidal product is 
intended for use in specific circumstances. The evaluating body shall evaluate dose-response data generated in 
appropriate trials (which must include an untreated control) involving dose rates lower than the recommended 
rate, in order to assess if the recommended dose is the minimum necessary to achieve the desired effect.  
Summary  
78. In relation to the criteria set out in points (iii) and (iv) of Article 19(1)(b), the evaluating body shall combine the 
conclusions arrived at for the active substance(s) and the substances of concern to produce overall summary 
conclusions for the biocidal product itself. A summary of the conclusions in relation to the criteria set out in 
points (i) and (ii) of Article 19(1)(b) shall also be made.  
OVERALL INTEGRATION OF CONCLUSIONS  
The evaluating body shall, on the basis of the evaluation carried out in accordance with the principles set down in this 
Annex, come to a conclusion as to whether or not it is established that the biocidal product complies with the criteria 
laid down under point (b) of Article 19(1).EN L 167/118 Official Journal of the European Union 27.6.2012ANNEX VII  
CORRELATION TABLE  
Directive 98/8/EC  This Regulation  
— Article 1  
Article 1  Article 2  
Article 2  Article 3  
Article 10  Article 4  
Article 10  Article 5  
— Article 6  
Article 11(1)(a)  6(1)  
Article 11(1)(a)(i) and (ii)  6(2)  
— 6(3)  
— 6(4)  
— Article 7  
Article 11(1)(a)  7(1)  
— 7(2)  
— 7(3)  
— 7(4)  
— 7(5)  
— 7(6)  
— Article 8  
Article 11(2), first subparagraph  8(1)  
Article 11(2), second subparagraph  8(2)  
Article 10(1), first subparagraph  8(3)  
— 8(4)  
— Article 9  
11(4)  9(1)  
— 9(2)  
— Article 10  
Article 33  Article 11  
Article 10(4)  Article 12  
— 12(1)  
— 12(2)  
— 12(3)  
— Article 13  
— Article 14EN 27.6.2012 Official Journal of the European Union L 167/119Directive 98/8/EC  This Regulation  
— Article 15  
— Article 16  
— Article 17  
Article 3(1)  17(1)  
Article 8(1)  17(2)  
— 17(3)  
Article 3(6)  17(4)  
Article 3(7)  17(5)  
— 17(6)  
— Article 18  
— Article 19  
Article 5(1)  19(1)  
Article 5(1)(b)  19(2)  
— 19(3)  
Article 5(2)  19(4)  
— 19(5)  
Article 2(1)(j)  19(6)  
— 19(7)  
— 19(8)  
— 19(9)  
— Article 20  
Article 8(2)  20(1)  
Article 8(12)  20(2)  
— 20(3)  
— Article 21  
— Article 22  
Article 5(3)  22(1)  
— 22(2)  
— Article 23  
— 23(1)  
Article 10(5)(i)  23(2)  
— 23(3)  
— 23(4)  
— 23(5)  
— 23(6)EN L 167/120 Official Journal of the European Union 27.6.2012Directive 98/8/EC  This Regulation  
Article 33  Article 24  
— Article 25  
— Article 26  
— Article 27  
— Article 28  
— Article 29  
— Article 30  
— Article 31  
Article 4  Article 32  
— Article 33  
— Article 34  
— Article 35  
Article 4(4)  Article 36  
— Article 37  
— Article 38  
— Article 39  
— Article 40  
— Article 41  
— Article 42  
— Article 43  
— Article 44  
— Article 45  
— Article 46  
— Article 47  
Article 7  Article 48  
Article 7  Article 49  
Article 7  Article 50  
— Article 51  
— Article 52  
— Article 53  
— Article 54  
Article 15  Article 55  
Article 17  Article 56  
— Article 57  
— Article 58  
Article 12  Article 59EN 27.6.2012 Official Journal of the European Union L 167/121Directive 98/8/EC  This Regulation  
— Article 60  
— 60(1)  
Article 12(1)(c)(ii) and (1)(b) and (1)(d)(ii)  60(2)  
Article 12(2)(c)(i) and (ii)  60(3)  
— Article 61  
— Article 62  
— Article 63  
Article 13(2)  63(1)  
— 63(2)  
— 63(3)  
Article 13(1)  Article 64  
— Article 65  
Article 24  65(1)  
— 65(2)  
Article 24  65(3)  
— 65(4)  
— Article 66  
— 66(1)  
— 66(2)  
— 66(3)  
Article 19(1)  66(4)  
— Article 67  
— Article 68  
— Article 69  
Article 20(1) and 20(2)  Article 69(1)  
Article 20(3)  Article 69(2)  
Article 20(6)  Article 69(2)  
Article 21, second subparagraph  Article 70  
— Article 71  
— Article 72  
Article 22(1), first and second subparagraphs  72(1)  
Article 22(1), third subparagraph  72(2)  
Article 22(2)  72(3)  
— Article 73EN L 167/122 Official Journal of the European Union 27.6.2012Directive 98/8/EC  This Regulation  
— Article 74  
— Article 75  
— Article 76  
— Article 77  
— Article 78  
— Article 79  
— Article 80  
— 80(1)  
Article 25  80(2)  
— 80(3)  
Article 26  Article 81  
Article 28  Article 82  
— Article 83  
— Article 84  
Article 29  Article 85  
— Article 86  
— Article 87  
Article 32  Article 88  
— Article 89  
— Article 90  
— Article 91  
— Article 92  
— Article 93  
— Article 94  
— Article 95  
— Article 96  
— Article 97  
Annex IA  Annex I  
Annex II A, III A and IV A  Annex II  
Annex II B, III B and IV B  Annex III  
— Annex IV  
Annex V  Annex V  
Annex VI  Annex VIEN 27.6.2012 Official Journal of the European Union L 167/123