欧盟Eurlex法规详细信息

EURLEX ID:32013R0354

OJ编号:OJ L 109, 19.4.2013, p. 4-13

中文标题:委员会实施条例(EU) No 354/2013,根据欧洲议会和理事会条例(EU) No 528/2012,关于生物农药产品授权上的变化(1)

原文标题:Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council Text with EEA relevance

分类:13.30.99_统一法的其它部分

文件类型:二级立法 Regulation|条例

生效日期:2013-05-09

废止日期:2058-12-31

法规全文:查看欧盟官方文件

L 109/4
EN
Official Journal of the European Union
19.4.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 354/2013
of 18 April 2013
on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the
European Parliament and of the Council
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
should be notified within 12 months following imple
mentation. However, other types of changes of an
Having regard to the Treaty on the Functioning of the European
administrative nature, whose immediate reporting and
Union,
prior examination is necessary for the continuous super
vision of the biocidal product concerned should not be
Having regard to Regulation (EU) No 528/2012 of the
subject to the annual reporting system.
European Parliament and of the Council of 22 May 2012
concerning the making available on the market and use of
(6) Each
change
should
require
a
separate
submission.
biocidal products ( 1 ), and in particular Article 51 thereof,
Grouping of changes should nevertheless be allowed in
certain cases, in order to facilitate the review of the
Whereas:
changes and reduce the administrative burden.
(1) In
order
to
ensure
a
harmonised
approach,
it
is
appro
(7) Provisions
should
be
introduced
regarding
the
role
of
the
priate to adopt provisions for changes of biocidal
coordination group established under Regulation (EU) No
products in respect of any of the information
528/2012 to increase cooperation between Member
submitted in relation to the initial application for the
States and allow for the settlement of disagreements in
authorisation or registration of biocidal products and
the evaluation of certain changes.
biocidal product families authorised or registered in
accordance with Directive 98/8/EC of the European
Parliament and of the Council of 16 February 1998
(8) This
Regulation
should
clarify
when
the
authorisation
concerning the placing of biocidal products on the
holder is allowed to implement a given change, as such
market (
clarification is essential for economic operators.

2 ) and Regulation (EU) No 528/2012.
(2) Proposed
changes
of
biocidal
products
should
be
clas
(9) The
measures
provided
for
in
this
Regulation
are
in
sified in different categories, taking into account the
accordance with the opinion of the Standing
extent to which they require a reassessment of the risk
Committee on Biocidal Products,
for human or animal health or the environment and of
the efficacy of the biocidal product or biocidal product
family. It is appropriate to establish the criteria to be
HAS ADOPTED THIS REGULATION:
used for classifying a change of a product in one of
the categories referred to in Article 50(3) of Regulation
CHAPTER I
(EU) No 528/2012.
GENERAL PROVISIONS
(3) In
order
to
bring
further
predictability,
the
European
Article 1
Chemicals Agency (hereinafter ‘the Agency’) should
issue opinions on the classification of changes of
Subject matter
products. The Agency should also issue guidelines on
This Regulation lays down provisions concerning changes of
the details of the various categories of changes. Those
biocidal products sought in accordance with Article 50(2) of
guidelines should be regularly updated in the light of
Regulation (EU) No 528/2012 with regard to any of the
scientific and technical progress.
information submitted in relation to the initial application for
the authorisation of biocidal products or biocidal product
(4) It
is
necessary
to
clarify
the
procedure
which
will
lead
to families in accordance with Directive 98/8/EC and Regulation
a decision by the Commission in accordance with the
(EU) No 528/2012 (hereinafter ‘changes of products’).
first subparagraph of Article 50(2) of Regulation (EU)
No 528/2012 and, where relevant, Article 44(5) thereof.
Article 2
(5) In
order
to
reduce
the
overall
number
of
possible
appli
Classification of changes of products
cations and to enable Member States, the Agency and the
Commission to focus on those changes that have a
1. Changes of products are classified in accordance with the
genuine impact on the properties of biocidal products,
criteria laid down in the Annex to this Regulation. Certain
an annual reporting system should be introduced for
categories of changes are listed in the tables of the Annex.
certain changes of an administrative nature. Such
changes should not require any prior agreement and
2. The
holder
of
an
authorisation
may
request
the
Agency
to
provide an opinion on the classification in accordance with the
( 1 ) OJ L 167, 27.6.2012, p. 1.
criteria laid down in the Annex to this Regulation of a change
( 2 ) OJ L 123, 24.4.1998, p. 1.
not listed in one of the tables of that Annex.

EN
19.4.2013 Official
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Union L
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The opinion shall be delivered within 45 days following receipt
The single applications referred to in points (c) and (d) of the
of the request and payment of the fee referred to in
first subparagraph shall be made in accordance with Article 7 or
Article 80(1)(a) of Regulation (EU) No 528/2012.
12 where at least one of the proposed changes is a minor
change of the product and none of the proposed changes is a
The Agency shall publish the opinion after deletion of all
major change of the product, and with Article 8 or 13 where at
information of commercial confidential nature.
least one of the proposed changes is a major change of the
product.
Article 3
Article 5
Guidelines on classification
Information requirements
1. The
Agency
shall,
after
consulting
the
Member
States,
the
Commission and interested parties, draw up guidelines on the
An application submitted in accordance with Article 50(2) of
details of the various categories of changes of products.
Regulation (EU) No 528/2012 shall contain the following:
2. Those
guidelines
shall
be
regularly
updated,
taking
into
(1) the relevant filled application form as available from the
account the opinions taken in accordance with Article 2(2),
Register for Biocidal Products, which shall contain:
contributions from Member States as well as scientific and
technical progress.
(a) a list of all the authorisations affected by the proposed
change(s);
Article 4
Grouping of changes
(b) a list indicating all the Member States in which the
1. Where
several
changes
of
products
are
sought,
a
separate
product is authorised and the changes are sought (here
notification or application shall be submitted in respect of each
inafter the ‘Member States concerned’);
change sought.
(c) for products authorised by national authorisation, the
2. By
way
of
derogation
from
paragraph
1,
the
following
Member State which evaluated the initial application
rules shall apply:
for authorisation of the biocidal product or, if the
changes are not sought in that Member State, the
Member State having been chosen by the applicant
(a) a single notification may cover a series of proposed admin
together with written confirmation that that Member
istrative changes affecting different products in the same
State agrees to be reference Member State (hereinafter
manner;
referred to as the ‘reference Member State’);
(b) a single notification may cover a series of proposed admin
istrative changes affecting the same product;
(d) for major changes of products authorised by Union
authorisation, the Member State who evaluated the
initial application for authorisation of the biocidal
(c) a single application may cover more than one proposed
product or, if the changes are not sought in that
change of the same product in the following cases:
Member State, the Member State having been chosen
by the applicant together with written confirmation
(1) one of the proposed changes in the group is a major
that that Member State agrees to evaluate the appli
change of the product; all other proposed changes in
cation of the change;
the group are a direct consequence of that change;
(e) where relevant, a draft revised summary of the biocidal
(2) one of the proposed changes in the group is a minor
product characteristics in, as appropriate,
change; all other proposed changes in the group are a
direct consequence of that change;
(1) for products authorised by national authorisation,
the official language(s) of all the Member States
(3) all changes in the group are a direct consequence of a
concerned;
new classification of the active substance(s) or non-
active substance(s) contained in the product or of the
product itself;
(2) for products authorised by Union authorisation, one
of the official languages of the Union, which in case
of major changes must be a language accepted by
(4) all changes in the group are a direct consequence of a
the Member State referred to in point (c) at the time
specific condition of the authorisation;
of application;
(d) a single application may cover more than one proposed
(2) a description of all the changes sought;
change if the Member State evaluating the application in
accordance with Article 7(4) or 8(4), or, in the case of a
change of a Union authorisation, the Agency, confirms that
(3) where a change leads to or is the consequence of other
it is practically feasible to handle those changes in the same
changes of the terms of the same authorisation, a
procedure.
description of the relation between these changes;

L 109/6
EN
Official Journal of the European Union
19.4.2013
(4) all relevant supporting documents to demonstrate that the
3. The
reference
Member
State
shall
validate
the
application
proposed change would not adversely affect the conclusions
within 30 days of its acceptance, if it complies with the
previously reached concerning the compliance with the
requirements laid down in Article 5 and inform the applicant
conditions set out in Article 19 or 25 of Regulation (EU)
and the Member States concerned accordingly.
No 528/2012;
In the context of the validation referred to in the first subpara
(5) where relevant, the opinion issued by the Agency in
graph, the reference Member State shall not make an assessment
accordance with Article 3 of this Regulation.
of the quality or the adequacy of the data or justifications
submitted.
CHAPTER II
Where the reference Member State considers that the appli
CHANGES OF PRODUCTS AUTHORISED BY MEMBER STATES
cation is incomplete, it shall inform the applicant as to what
Article 6
additional information is required for the application to be
completed and shall set a reasonable time limit for the
Notification procedure for administrative changes of
submission of that information. That time limit shall not
products
normally exceed 45 days.
1. The
authorisation
holder,
or
its
representative,
shall
submit simultaneously to all Member States concerned a notifi
The reference Member State shall, within 30 days of receipt of
cation complying with Article 5 and, in each of those Member
the additional information, validate the application if the
States, pay the fee payable in accordance with Article 80(2) of
additional information submitted is sufficient to comply with
Regulation (EU) No 528/2012.
the requirements laid down in Article 5.
2. Without prejudice to the second subparagraph, the notifi
The reference Member State shall reject the application if the
cation shall be submitted within 12 months following the
applicant fails to submit the requested information within the
implementation of the change.
deadline and shall inform the applicant and the Member States
concerned accordingly.
In case of a change referred to in Section 1 of Title 1 of the
Annex to this Regulation, the notification shall be submitted
4. Within
90
days
of
validating
an
application,
the
reference
before the implementation of the change.
Member State shall evaluate the application and draft an
assessment report and shall send its assessment report and,
3. Within
30
days
following
receipt
of
the
notification, where relevant, the revised summary of the biocidal product
where one of the Member States concerned disagrees with the
characteristics to the Member States concerned and to the
change or the relevant fee has not been paid, that Member State
applicant.
shall inform the authorisation holder, or its representative, and
the other Member States concerned that the change is rejected
5. Where
it
appears
that
additional
information
is
necessary
and the grounds for the rejection.
to carry out the evaluation, the reference Member State shall ask
the applicant to submit such information within a specified
If, within 30 days following receipt of the notification, a
time limit. The period referred to in paragraph 4, shall be
Member State concerned has not expressed its disagreement,
suspended from the date of the request until the date the
that Member State shall be deemed to have agreed with the
information is received. The time limit given to the applicant
change.
shall not exceed 45 days in total unless justified by the nature
of the data requested or by exceptional circumstances.
4. Each
of
the
Member
States
concerned
which
has
not
rejected the change in accordance with paragraph 3 shall,
The reference Member State shall reject the application if the
where relevant, amend the authorisation of the biocidal
applicant fails to submit the requested information within the
product in conformity with the agreed change.
deadline and shall inform the applicant and the Member States
concerned accordingly.
Article 7
Procedure for minor changes of products
6. If,
within
45
days
of
receipt
of
the
assessment
report
and,
where relevant, of the revised summary of the biocidal product
1. The
authorisation
holder,
or
its
representative,
shall characteristics, the Member States concerned express no
submit simultaneously to all Member States concerned an appli
disagreement in accordance with Article 10, those Member
cation complying with Article 5.
States shall be deemed to have agreed with the conclusions of
the assessment report and, where relevant, the revised summary
2. Each
Member
State
concerned
shall
inform
the
applicant of the biocidal product characteristics.
of the fee payable in accordance with Article 80(2) of Regu
lation (EU) No 528/2012. If the applicant fails to pay the fee
7. Within
30
days
of
reaching
agreement,
the
reference
within 30 days, the Member State concerned shall reject the
Member State shall inform the applicant of the agreement
application and inform the applicant and the other Member
and make it available in the Register for Biocidal Products
States concerned accordingly. Upon receipt of the fee, the
referred to in Article 71 of Regulation (EU) No 528/2012.
Member State concerned shall accept the application and
The reference Member State and each of the Member States
inform the applicant accordingly indicating the date of
concerned shall, where relevant, amend the authorisations of
acceptance.
the biocidal product in conformity with the agreed change.

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European
Union L
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Article 8
characteristics, the Member States concerned express no
disagreement in accordance with Article 10, those Member
Procedure for major changes of products
States shall be deemed to agree with the conclusions of the
1. The
authorisation
holder,
or
its
representative,
shall assessment report and, where appropriate, the revised
submit simultaneously to all Member States concerned an appli
summary of the biocidal product characteristics.
cation complying with Article 5.
7. Within
30
days
of
reaching
agreement,
the
reference
2. Each
Member
State
concerned
shall
inform
the
applicant Member State shall inform the applicant of the agreement,
of the fee payable in accordance with Article 80(2) of Regu
and the reference Member State and each of the Member
lation (EU) No 528/2012. If the applicant fails to pay the fee
States concerned shall, where relevant, amend the authorisations
within 30 days, the Member State concerned shall reject the
of the biocidal product in conformity with the agreed change.
application and inform the applicant and the other Member
States concerned accordingly. Upon receipt of the fee, the
Article 9
Member State concerned shall accept the application and
inform the applicant accordingly indicating the date of
Biocidal products authorised in accordance with Article 26
acceptance.
of Regulation (EU) No 528/2012
3. The
reference
Member
State
shall
validate
the
application 1. Where the authorisation has been granted in accordance
within 30 days of its acceptance if it complies with the
with Article 26 of Regulation (EU) No 528/2012, the authori
requirements laid down in Article 5 and inform the applicant
sation holder or its representative shall notify each Member
and the Member States concerned accordingly.
State, on the territory of which the biocidal product is made
available, of notifications or applications made to the reference
In the context of the validation referred to in the first subpara
Member State in accordance with Article 6, 7 or 8 of this
graph, the reference Member State shall not make an assessment
Regulation.
of the quality or the adequacy of the data or justifications
submitted.
2. Where a reference Member State has agreed with a revised
Where the reference Member State considers that the appli
summary of the biocidal product characteristics, the authori
cation is incomplete, it shall inform the applicant as to what
sation holder or its representative shall submit the revised
additional information is required for the validation of the
summary to each Member State on the territory of which the
application and shall set a reasonable time limit for the
biocidal product is made available in the official language(s) of
submission of that information. That time limit shall not
that Member State.
normally exceed 90 days.
Article 9a
The reference Member State shall, within 30 days of receipt of
the additional information, validate the application if it
Procedure for changes already agreed by other Member
determines that the additional information submitted is
States
sufficient to comply with the requirements laid down in
1. Where
an
administrative
change
has
already
been
agreed
Article 5.
in one or more Member States and the authorisation holder
seeks the same administrative change in an additional
The reference Member State shall reject the application if the
Member State concerned, the authorisation holder or its repre
applicant fails to submit the requested information within the
sentative shall submit a notification in accordance with
deadline and shall inform the applicant and the Member States
Article 6(1) to the additional Member State concerned.
concerned accordingly.
4. Within
180
days
of
validating
an
application,
the 2. Where
a
minor
or
a
major
change
has
already
been
agreed
reference Member State shall evaluate the application and
in one or more Member States and the authorisation holder
draft an assessment report and shall send its assessment
seeks the same minor or major change in an additional
report and, where relevant, the revised summary of the
Member State concerned, the authorisation holder, or its repre
biocidal product characteristics to the Member States
sentative, shall submit an application complying with Article 5
concerned and to the applicant.
to the additional Member State concerned.
5. Where
it
appears
that
additional
information
is
necessary 3. The
Member
State
concerned
shall
inform
the
applicant
of
to carry out the evaluation, the reference Member State shall ask
the fee payable in accordance with Article 80(2) of Regulation
the applicant to submit such information within a specified
(EU) No 528/2012. If the applicant fails to pay the fee within
time limit. The period referred to in paragraph 4 shall be
30 days, the Member State concerned shall reject the application
suspended from the date of the request until the date on
and inform the applicant and the other Member States
which the information is received. The time limit given to the
concerned accordingly. Upon receipt of the fee, the Member
applicant shall not exceed 90 days in total unless justified by
State concerned shall accept the application and inform the
the nature of the data requested or by exceptional circum
applicant accordingly indicating the date of acceptance.
stances.
The reference Member State shall reject the application if the
4. If within 45 days in the case of a minor change, or 90
applicant fails to submit the requested information within the
days in the case of a major change, of the date of acceptance,
deadline and shall inform the applicant and the Member States
the Member State concerned express no disagreement in
concerned accordingly.
accordance with Article 10, it shall be deemed to agree with
the conclusions of the assessment report and, where appro
6. If, within 90 days of receipt of the assessment report and,
priate, the revised summary of the biocidal product character
where relevant, of the revised summary of the biocidal product
istics.

L 109/8
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Official Journal of the European Union
19.4.2013
5. Within
30
days
of
the
agreement
referred
to
in
paragraph official languages of the Union, a draft revised summary of the
4, the Member State concerned shall inform the applicant of the
biocidal product characteristics.
agreement, and, where relevant, amend the authorisation of the
biocidal product in conformity with the agreed change.
6. Within 30 days of the submission of its opinion to the
Commission, the Agency shall, where relevant, transmit to the
Article 10
Commission, in all the official languages of the Union, the
revised summary of the biocidal product characteristics, as
Coordination group, arbitration and derogation from
referred to in Article 22(2) of Regulation (EU) No 528/2012.
mutual recognition
1. A
Member
State
concerned
may
propose
to
refuse
to
Article 12
grant an authorisation or to adjust the terms and conditions
Procedure for minor changes of products
of the authorisation in accordance with Article 37 of Regulation
(EU) No 528/2012.
1. The
authorisation
holder,
or
its
representative,
shall
submit to the Agency an application complying with the
2. Where,
regarding
matters
other
than
those
referred
to
in Article 5.
paragraph 1, the Member States concerned do not reach an
agreement on the conclusions of the assessment report or,
2. The Agency shall inform the applicant of the fee payable
where relevant, on the revised summary of the biocidal
under Article 80(1)(a) of Regulation (EU) No 528/2012, and
product characteristics in accordance with Article 7(6) or 8(6),
shall reject the application if the applicant fails to pay the fee
or a Member State concerned has disagreed in accordance with
within 30 days. It shall inform the applicant accordingly.
Article 6(3), the reference Member State shall refer the matter to
the coordination group referred to in Article 35 of Regulation
Upon receipt of the fee, the Agency shall accept the application
(EU) No 528/2012.
and inform the applicant accordingly.
Where a Member State concerned is in disagreement with the
An appeal may be brought, in accordance with Article 77 of
reference Member State, the former shall give a detailed
Regulation (EU) No 528/2012, against Agency decisions under
statement of the reasons for its position to all Member States
this paragraph.
concerned and to the applicant.
3. The Agency shall validate the application within 30 days
3. Articles 35 and 36 of Regulation (EU) No 528/2012 shall
of the date of acceptance if it complies with the requirements
apply to matters of disagreement referred to in paragraph 2.
laid down in Article 5.
CHAPTER III
In the context of the validation referred to in the first subpara
graph, the Agency shall not make an assessment of the quality
CHANGES OF PRODUCTS AUTHORISED BY THE
or the adequacy of the data or justifications submitted.
COMMISSION
Article 11
Where the Agency considers that the application is incomplete,
it shall inform the applicant as to what additional information is
Notification procedure for administrative changes of
required for the completeness of the application and shall set a
products
reasonable time limit for the submission of that information.
1. The
authorisation
holder,
or
its
representative,
shall That time limit shall not normally exceed 45 days.
submit to the Agency a notification complying with Article 5
The Agency shall, within 30 days of receipt of the additional
and pay the fee referred to in Article 80(1)(a) of Regulation (EU)
information, validate the application if it determines that the
No 528/2012.
additional information submitted is sufficient to comply with
2. Without
prejudice
to
the
second
subparagraph,
that
notifi
the requirements laid down in Article 5.
cation shall be submitted within 12 months following imple
The Agency shall reject the application if the applicant fails to
mentation of the change.
submit the requested information within the deadline and
In case of a change referred to in Section 1 of Title 1 of the
inform the applicant accordingly. In such cases, part of the
Annex to this Regulation, the notification shall be submitted
fee paid in accordance with paragraph 2 shall be reimbursed.
before the implementation of the change.
An appeal may be brought, in accordance with Article 77 of
3. Within
30
days
following
receipt
of
the
notification
and Regulation (EU) No 528/2012, against Agency decisions under
subject to the payment of the relevant fee, the Agency shall
this paragraph.
prepare and submit to the Commission an opinion on the
proposed change.
4. Within
90
days
of
accepting
an
application
as
valid,
the
Agency shall prepare and submit to the Commission an opinion
4. If,
within
30
days
following
receipt
of
the
notification,
the on the proposed change. In case of a favourable opinion, the
relevant fee has not been paid, the Agency shall reject the
Agency shall indicate whether the proposed change would
application and inform the applicant accordingly.
require an amendment of the authorisation.
An appeal may be brought, in accordance with Article 77 of
The Agency shall inform the applicant of its opinion and make
Regulation (EU) No 528/2012, against Agency decisions under
it available in the Register for Biocidal Products referred to in
this paragraph.
Article 71 of Regulation (EU) No 528/2012, and shall, where
relevant, request the applicant to submit in all the official
5. The
Agency
shall
inform
the
applicant
of
its
opinion
and languages of the Union, a draft revised summary of the
shall, where relevant, request the applicant to submit in all the
biocidal product characteristics.

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5. Where
it
appears
that
additional
information
is
necessary if it determines that the additional information submitted is
to carry out the evaluation, the Agency shall ask the applicant
sufficient to comply with the requirements laid down in
to submit such information within a specified time limit. The
Article 5.
period referred to in paragraph 4 shall be suspended from the
date of the request until the date the information is received.
The time limit given to the applicant shall not exceed 45 days
The evaluating competent authority shall reject the application
in total unless justified by the nature of the data requested or by
if the applicant fails to submit the requested information within
exceptional circumstances.
the deadline and shall inform the applicant and the Agency
accordingly. In such cases, part of the fee paid in accordance
with paragraph 2 shall be reimbursed.
6. Within 30 days of the submission of its opinion to the
Commission, the Agency shall, where relevant, transmit to the
Commission, in all the official languages of the Union, the
5. The
evaluating
competent
authority
shall,
within
180
days
revised summary of the biocidal product characteristics, as
of the validation of an application, evaluate it and send an
referred to in Article 22(2) of Regulation (EU) No 528/2012.
assessment report and the conclusions of its evaluation,
including, where relevant, a draft revised summary of the
Article 13
product characteristics, to the Agency.
Procedure for major changes of products
Prior to submitting its conclusions to the Agency, the evaluating
1. The
authorisation
holder,
or
its
representative,
shall competent authority shall provide the applicant with the oppor
submit to the Agency an application complying with Article 5.
tunity to provide written comments on the conclusions of the
evaluation within 30 days. The evaluating competent authority
2. The
Agency
shall
inform
the
applicant
of
the
fee
payable shall take due account of those comments when finalising its
under Article 80(1)(a) of Regulation (EU) No 528/2012, and
evaluation.
shall reject the application if the applicant fails to pay the fee
within 30 days. It shall inform the applicant and the competent
authority of the Member State referred to in Article 5(1)(d)
6. Where
it
appears
that
additional
information
is
necessary
(hereinafter referred to as the ‘evaluating competent authority’)
to carry out the evaluation, the evaluating competent authority
accordingly.
shall ask the applicant to submit such information within a
specified time limit, and shall inform the Agency accordingly.
The period referred to in paragraph 5 shall be suspended from
Upon receipt of the fee, the Agency shall accept the application
the date of the request until the date the information is received.
and inform the applicant and the evaluating competent
The time limit given to the applicant shall not exceed 90 days
authority accordingly.
in total unless justified by the nature of the data requested or by
exceptional circumstances.
An appeal may be brought, in accordance with Article 77 of
Regulation (EU) No 528/2012, against decisions of the Agency
under this paragraph.
7. Within 90 days of receipt of the conclusions of the evalu
ation, the Agency shall prepare and submit to the Commission
an opinion on the proposed change. In case of a favourable
3. Within
30
days
of
the
Agency
accepting
an
application, opinion, the Agency shall indicate whether the proposed change
the evaluating competent authority shall validate the application
would require an amendment of the authorisation.
if it complies with the requirements laid down in Article 5.
The Agency shall inform the applicant of its opinion and shall,
In the context of the validation referred to in the first subpara
where relevant, request the applicant to submit, in all the official
graph, the evaluating competent authority shall not make an
languages of the Union, a draft revised summary of the biocidal
assessment of the quality or the adequacy of the data or justifi
product characteristics.
cations submitted.
The evaluating competent authority shall, within 15 days from
8. Within 30 days of the submission of its opinion to the
the Agency’s acceptance of an application, inform the applicant
Commission, the Agency shall, where relevant, transmit to the
of the fee payable under Article 80(2) of Regulation (EU) No
Commission, in all the official languages of the Union, the draft
528/2012 and shall reject the application if the applicant fails
revised summary of the biocidal product characteristics, as
to pay the fee within 30 days.
referred to in Article 22(2) of Regulation (EU) No 528/2012.
4. Where
the
evaluating
competent
authority
considers
that
CHAPTER IV
the application is incomplete, it shall inform the applicant as to
what additional information is required for the completeness of
IMPLEMENTATION OF CHANGES
the application and shall set a reasonable time limit for the
Article 14
submission of that information. That time limit shall not
normally exceed 90 days.
Administrative changes of products
1. Administrative changes referred to in Section 2 of Title 1
The evaluating competent authority shall, within 30 days of
of the Annex may be implemented any time before completion
receipt of the additional information, validate the application
of the procedures laid down in Articles 6 and 11.

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Official Journal of the European Union
19.4.2013
Administrative changes referred to in Section 1 of Title 1 of the
Article 16
Annex may be implemented at the earliest on the date when the
Member State or, in the case of changes of a product authorised
Major changes
by Union authorisation, the Commission explicitly agrees with
Major changes may only be implemented after the concerned
the change, or 45 days following receipt of the notification
Member States have or, in the case of changes of a product
submitted in accordance with Articles 6 and 11, whichever is
authorised by Union authorisation, the Commission has agreed
earliest.
with the change and, where relevant, amended the decision
2. Where
one
of
the
changes
referred
to
in
paragraph
1
is granting the authorisation by the decision referred to in
rejected, the authorisation holder shall cease to apply the
Article 50(2) of Regulation (EU) No 528/2012.
concerned change within 30 days following notification of
the decision of the relevant Member States or, in the case of
CHAPTER V
changes of a product authorised by Union authorisation, the
Commission.
FINAL PROVISIONS
Article 15
Article 17
Minor changes
Continuous monitoring of implementation of changes
1. Subject
to
a
favourable
opinion
from
the
Agency,
minor
Where requested by a Member State, the Agency or the
changes of a product authorised by Union authorisation may be
Commission and for the purpose of monitoring biocidal
implemented any time after the Agency’s opinion has been
products placed on the market, authorisation holders shall
made available in the Register for Biocidal Products in
without delay supply the requesting authority with any
accordance with Article 12(4).
information related to the implementation of a given change.
2. Where the proposed minor change of the product is
rejected by the Commission in accordance with Article 50(2)
Article 18
of Regulation (EU) No 528/2012, the authorisation holder shall
Entry into force
cease to apply the proposed change within 30 days following
notification of the decision of the Commission.
This Regulation shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
3. Minor
changes
of
a
product
authorised
by
Member
States European Union.
may be implemented any time after the reference Member State
has made the agreement available in the Register for Biocidal
Products in accordance with Article 7(7).
It shall apply from 1 September 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 18 April 2013.
For the Commission
The President
José Manuel BARROSO

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109/11
ANNEX
CLASSIFICATION OF CHANGES OF PRODUCTS
TITLE 1
Administrative changes of products
An administrative change of a product is a change following which any change of the existing authorisation can be
expected to be only administrative within the meaning of Article 3(1)(aa) of Regulation (EU) No 528/2012.
SECTION 1
Administrative changes of products requiring prior notification before implementation
An administrative change of a product requiring prior notification before implementation is an administrative change, the
knowledge of which is important for purposes of control and enforcement. Such changes include those listed in the
following table, provided that the conditions therein are met:
Name of the biocidal product
1.
Changes of the name of the biocidal product where there is no risk of confusion with the names of
other biocidal products.
2.
Addition of a name for the biocidal product where there is no risk of confusion with the names of other
biocidal products.
Authorisation holder
3.
Transfer of the authorisation to a new holder established in the European Economic Area (EEA).
4.
Change in the name or address of the authorisation holder, which remains in the EEA.
Manufacturer(s) of the active substance(s)
5.
Addition of a manufacturer of the active substance or change in the manufacturer’s identity or in
manufacturing location or process, where the technical equivalence between the substances from the
two manufacturers, manufacturing locations and processes has been established by the Agency in
accordance with Article 54 of Regulation (EU) No 528/2012, and the manufacturer or importer is
listed in accordance with Article 95(2) of Regulation (EU) No 528/2012.
Biocidal product family
6.
Authorisation as a biocidal product family of a number of authorised products falling within the
specifications of a frame-formulation established in accordance with Directive 98/8/EC in accordance
with the same terms and conditions.
SECTION 2
Administrative changes of products which can be notified after implementation
An administrative change of a product which can be notified after implementation is an administrative change, the
knowledge of which is not important for purposes of control and enforcement. Such changes include those listed in the
following table, provided that the conditions therein are met:
Authorisation holder
1. Change
in
other
administrative
details
of
the
authorisation
holder
than
the
name
and
address.
Formulator(s) of the biocidal product
2.
Change in the name, the administrative details or the formulating location of the biocidal product
formulator, where the biocidal product composition and the formulating process remain unchanged.

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Official Journal of the European Union
19.4.2013
3.
Deletion of a formulating location or a formulator of the biocidal product
4.
Addition of a formulator of the biocidal product, where the biocidal product composition and the
formulating process remain unchanged.
Manufacturer(s) of the active substance(s)
5.
Change in the name or the administrative details of a manufacturer of the active substance, where the
manufacturing location and process remain unchanged and the manufacturer remains listed in
accordance with Article 95(2) of Regulation (EU) No 528/2012
6.
Deletion of a manufacturer or a manufacturing location of the active substance
Conditions of use
7.
More precise instructions for use, where only wording but not content of instructions are changed.
8.
Removal of a particular claim, such as a specific target organism or a specific use.
9.
Removal of a category of users.
10.
Addition, replacement or modification of a measuring or administration device not relevant for the risk
assessment and not regarded as a risk mitigation measure.
Classification and labelling
11.
Change to the classification and labelling, where the change is limited to what is necessary to comply
with newly applicable requirements of Regulation (EC) No 1272/2008 of the European Parliament and
of the Council ( 1 ).
( 1 ) OJ L 353, 31.12.2008, p. 1.
TITLE 2
Minor changes of products
A minor change of a product is a change, following which any change of the existing authorisation can be expected to be
minor within the meaning of Article 3(1)(ab) of Regulation (EU) No 528/2012, since the change of the product is not
expected to affect the conclusion with regard to the fulfilment of the conditions of Article 19 or 25 of that Regulation.
Such changes include the changes listed in the following table, provided that the conditions therein are met:
Composition
1. Increase
or
reduction,
addition,
deletion
or
replacement
of
a
non-active
substance
intentionally
incor
porated in the product, where:
— The added or increased non active-substance is not a substance of concern.
— The deletion or reduction of the non-active substance does not lead to an increase of an active
substance or a substance of concern.
— The physical-chemical properties and the shelf-life of the product are expected to remain the same.
— The risk and efficacy profile are expected to remain the same.
— A new quantitative risk assessment is not expected to be necessary
2. Increase,
reduction,
addition
or
deletion,
or
replacement
of
a
non-active
substance
intentionally
incor
porated in a biocidal product family outside the authorised range, where:
— The added or increased non-active substance is not a substance of concern.
— The deletion or reduction of the non-active substance does not lead to an increase of an active
substance or a substance of concern.
— The physical-chemical properties and the shelf-life of the products of the biocidal product family
remain the same.
— The risk and efficacy profile are expected to remain the same.
— A new quantitative risk assessment is not expected to be necessary.
Conditions of use
3.
Changed instructions for use, where the changes do not adversely affect the exposure
4.
Addition, replacement or modification of a measuring or administration device relevant for the risk
assessment and regarded as a risk mitigation measure, where:
— The new device accurately delivers the required dose for the biocidal product concerned in line with
the approved conditions of use.
— The new device is compatible with the biocidal product.
— The change is not expected to adversely affect the exposure.

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Shelf-life and conditions of storage
5. Change
in
the
shelf-life.
6. Change
in
the
conditions
of
storage
Pack size
7. Change
in
the
pack
size
range,
where:
— New range is consistent with the dose rate and instructions for use as approved in the summary of
the biocidal product characteristics.
— No change of user category.
— The same risk-mitigation measures apply.
TITLE 3
Major changes of products
A major change of a product is a change, following which any change of the existing authorisation can be expected to be
major within the meaning of Article 3(1)(ac) of Regulation (EU) No 528/2012, since the change of the product can be
expected to affect the conclusion with regard to the fulfilment of the conditions of Article 19 or 25 of that Regulation.

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