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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 theEuropean Parliament and of the Council(Text with EEA relevance)

should be notified within 12 months following imple­
mentation. However, other types of changes of an
administrative nature, whose immediate reporting andprior examination is necessary for the continuous super­
vision of the biocidal product concerned should not be
subject to the annual reporting system.

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European
Union,
Having regard to Regulation (EU) No 528/2012 of theEuropean Parliament and of the Council of 22 May 2012
concerning the making available on the market and use of
biocidal products (1), and in particular Article 51 thereof,(6)

Each change should require a separate submission.
Grouping of changes should nevertheless be allowed incertain cases, in order to facilitate the review of thechanges and reduce the administrative burden.

In order to ensure a harmonised approach, it is appro­
priate to adopt provisions for changes of biocidal
products in respect of any of the information
submitted in relation to the initial application for theauthorisation or registration of biocidal products andbiocidal product families authorised or registered inaccordance with Directive 98/8/EC of the European
Parliament and of the Council of 16 February 1998
concerning the placing of biocidal products on themarket (2) and Regulation (EU) No 528/2012.

(7)

Provisions should be introduced regarding the role of thecoordination group established under Regulation (EU) No
528/2012 to increase cooperation between Member
States and allow for the settlement of disagreements inthe evaluation of certain changes.

(8)This Regulation should clarify when the authorisation
holder is allowed to implement a given change, as suchclarification is essential for economic operators.

Proposed changes of biocidal products should be clas­sified in different categories, taking into account theextent to which they require a reassessment of the riskfor human or animal health or the environment and of
the efficacy of the biocidal product or biocidal productfamily. It is appropriate to establish the criteria to be
used for classifying a change of a product in one of
the categories referred to in Article 50(3) of Regulation(EU) No 528/2012.

(9)

The measures provided for in this Regulation are inaccordance with the opinion of the Standing
Committee on Biocidal Products,

Whereas:
(1)

(2)

(3)

(4)

(5)

In order to bring further predictability, the European
Chemicals Agency (hereinafter ‘the Agency’) should
issue opinions on the classification of changes of
products. The Agency should also issue guidelines on
the details of the various categories of changes. Those
guidelines should be regularly updated in the light ofscientific and technical progress.
It is necessary to clarify the procedure which will lead toa decision by the Commission in accordance with thefirst subparagraph of Article 50(2) of Regulation (EU)No 528/2012 and, where relevant, Article 44(5) thereof.
In order to reduce the overall number of possible appli­
cations and to enable Member States, the Agency and theCommission to focus on those changes that have agenuine impact on the properties of biocidal products,
an annual reporting system should be introduced forcertain changes of an administrative nature. Suchchanges should not require any prior agreement and(1) OJ L 167, 27.6.2012, p. 1.
(2) OJ L 123, 24.4.1998, p. 1.

HAS ADOPTED THIS REGULATION:
CHAPTER I
GENERAL PROVISIONS

Article 1
Subject matter
This Regulation lays down provisions concerning changes of
biocidal products sought in accordance with Article 50(2) ofRegulation (EU) No 528/2012 with regard to any of theinformation submitted in relation to the initial application for
the authorisation of biocidal products or biocidal productfamilies in accordance with Directive 98/8/EC and Regulation(EU) No 528/2012 (hereinafter ‘changes of products’).
Article 2Classification of changes of products
1.
Changes of products are classified in accordance with thecriteria laid down in the Annex to this Regulation. Certain
categories of changes are listed in the tables of the Annex.
2.
The holder of an authorisation may request the Agency toprovide an opinion on the classification in accordance with thecriteria laid down in the Annex to this Regulation of a change
not listed in one of the tables of that Annex.

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The opinion shall be delivered within 45 days following receiptof the request and payment of the fee referred to in
Article 80(1)(a) of Regulation (EU) No 528/2012.
The Agency shall publish the opinion after deletion of all
information of commercial confidential nature.
Article 3
Guidelines on classification
1.
The Agency shall, after consulting the Member States, theCommission and interested parties, draw up guidelines on thedetails of the various categories of changes of products.
2.
Those guidelines shall be regularly updated, taking into
account the opinions taken in accordance with Article 2(2),contributions from Member States as well as scientific andtechnical progress.
Article 4Grouping of changes
1.
Where several changes of products are sought, a separate
notification or application shall be submitted in respect of eachchange sought.
2.
By way of derogation from paragraph 1, the following
rules shall apply:(a) a single notification may cover a series of proposed admin­
istrative changes affecting different products in the samemanner;(b) a single notification may cover a series of proposed admin­
istrative changes affecting the same product;(c) a single application may cover more than one proposedchange of the same product in the following cases:(1) one of the proposed changes in the group is a majorchange of the product; all other proposed changes in
the group are a direct consequence of that change;(2) one of the proposed changes in the group is a minorchange; all other proposed changes in the group are adirect consequence of that change;(3) all changes in the group are a direct consequence of a
new classification of the active substance(s) or nonactive substance(s) contained in the product or of the
product itself;(4) all changes in the group are a direct consequence of a
specific condition of the authorisation;(d) a single application may cover more than one proposedchange if the Member State evaluating the application inaccordance with Article 7(4) or 8(4), or, in the case of achange of a Union authorisation, the Agency, confirms that
it is practically feasible to handle those changes in the sameprocedure.

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The single applications referred to in points (c) and (d) of thefirst subparagraph shall be made in accordance with Article 7 or
12 where at least one of the proposed changes is a minorchange of the product and none of the proposed changes is amajor change of the product, and with Article 8 or 13 where atleast one of the proposed changes is a major change of the
product.
Article 5
Information requirements
An application submitted in accordance with Article 50(2) ofRegulation (EU) No 528/2012 shall contain the following:(1) the relevant filled application form as available from theRegister for Biocidal Products, which shall contain:(a) a list of all the authorisations affected by the proposedchange(s);(b) a list indicating all the Member States in which the
product is authorised and the changes are sought (here­
inafter the ‘Member States concerned’);(c) for products authorised by national authorisation, theMember State which evaluated the initial application
for authorisation of the biocidal product or, if thechanges are not sought in that Member State, theMember State having been chosen by the applicant
together with written confirmation that that Member
State agrees to be reference Member State (hereinafterreferred to as the ‘reference Member State’);(d) for major changes of products authorised by Union
authorisation, the Member State who evaluated theinitial application 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 together with written confirmationthat that Member State agrees to evaluate the appli­
cation of the change;(e) where relevant, a draft revised summary of the biocidal
product characteristics in, as appropriate,(1) for products authorised by national authorisation,
the official language(s) of all the Member Statesconcerned;(2) for products authorised by Union authorisation, oneof the official languages of the Union, which in caseof major changes must be a language accepted by
the Member State referred to in point (c) at the timeof application;(2) a description of all the changes sought;(3) where a change leads to or is the consequence of otherchanges of the terms of the same authorisation, adescription of the relation between these changes;

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proposed change would not adversely affect the conclusions
previously reached concerning the compliance with theconditions set out in Article 19 or 25 of Regulation (EU)No 528/2012;(5) where relevant, the opinion issued by the Agency inaccordance with Article 3 of this Regulation.

19.4.20133.
The reference Member State shall validate the application
within 30 days of its acceptance, if it complies with therequirements laid down in Article 5 and inform the applicant
and the Member States concerned accordingly.
In the context of the validation referred to in the first subpara­graph, the reference Member State shall not make an assessmentof the quality or the adequacy of the data or justifications
submitted.

CHAPTER II

Notification procedure for administrative changes of
products

Where the reference Member State considers that the appli­
cation is incomplete, it shall inform the applicant as to what
additional information is required for the application to becompleted and shall set a reasonable time limit for thesubmission of that information. That time limit shall notnormally exceed 45 days.

1.
The authorisation holder, or its representative, shallsubmit simultaneously to all Member States concerned a notifi­
cation complying with Article 5 and, in each of those Member
States, pay the fee payable in accordance with Article 80(2) ofRegulation (EU) No 528/2012.

The reference Member State shall, within 30 days of receipt of
the additional information, validate the application if theadditional information submitted is sufficient to comply withthe requirements laid down in Article 5.

CHANGES OF PRODUCTS AUTHORISED BY MEMBER STATESArticle 62.
Without prejudice to the second subparagraph, the notifi­
cation shall be submitted within 12 months following theimplementation of the change.
In case of a change referred to in Section 1 of Title 1 of theAnnex to this Regulation, the notification shall be submitted
before the implementation of the change.
3.
Within 30 days following receipt of the notification,
where one of the Member States concerned disagrees with thechange or the relevant fee has not been paid, that Member State
shall inform the authorisation holder, or its representative, andthe other Member States concerned that the change is rejected
and the grounds for the rejection.
If, within 30 days following receipt of the notification, aMember State concerned has not expressed its disagreement,that Member State shall be deemed to have agreed with thechange.
4.
Each of the Member States concerned which has not
rejected the change in accordance with paragraph 3 shall,where relevant, amend the authorisation of the biocidal
product in conformity with the agreed change.

The reference Member State shall reject the application if theapplicant fails to submit the requested information within thedeadline and shall inform the applicant and the Member Statesconcerned accordingly.
4.
Within 90 days of validating an application, the reference
Member State shall evaluate the application and draft anassessment report and shall send its assessment report and,
where relevant, the revised summary of the biocidal productcharacteristics to the Member States concerned and to theapplicant.
5.
Where it appears that additional information is necessary
to carry out the evaluation, the reference Member State shall ask
the applicant to submit such information within a specified
time limit. The period referred to in paragraph 4, shall besuspended from the date of the request until the date theinformation is received. The time limit given to the applicant
shall not exceed 45 days in total unless justified by the natureof the data requested or by exceptional circumstances.
The reference Member State shall reject the application if theapplicant fails to submit the requested information within thedeadline and shall inform the applicant and the Member Statesconcerned accordingly.

Article 7
Procedure for minor changes of products
1.
The authorisation holder, or its representative, shallsubmit simultaneously to all Member States concerned an appli­
cation complying with Article 5.
2.
Each Member State concerned shall inform the applicantof the fee payable in accordance with Article 80(2) of Regu­
lation (EU) No 528/2012. If the applicant fails to pay the fee
within 30 days, the Member State concerned shall reject theapplication and inform the applicant and the other Member
States concerned accordingly. Upon receipt of the fee, theMember State concerned shall accept the application andinform the applicant accordingly indicating the date ofacceptance.

6.
If, within 45 days of receipt of the assessment report and,
where relevant, of the revised summary of the biocidal productcharacteristics, the Member States concerned express nodisagreement in accordance with Article 10, those Member
States shall be deemed to have agreed with the conclusions of
the assessment report and, where relevant, the revised summaryof the biocidal product characteristics.
7.
Within 30 days of reaching agreement, the reference
Member State shall inform the applicant of the agreement
and make it available in the Register for Biocidal Products
referred to in Article 71 of Regulation (EU) No 528/2012.
The reference Member State and each of the Member Statesconcerned shall, where relevant, amend the authorisations of
the biocidal product in conformity with the agreed change.

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Article 8
Procedure for major changes of products
1.
The authorisation holder, or its representative, shallsubmit simultaneously to all Member States concerned an appli­
cation complying with Article 5.
2.
Each Member State concerned shall inform the applicantof the fee payable in accordance with Article 80(2) of Regu­
lation (EU) No 528/2012. If the applicant fails to pay the fee
within 30 days, the Member State concerned shall reject theapplication and inform the applicant and the other Member
States concerned accordingly. Upon receipt of the fee, theMember State concerned shall accept the application andinform the applicant accordingly indicating the date ofacceptance.
3.
The reference Member State shall validate the application
within 30 days of its acceptance if it complies with therequirements laid down in Article 5 and inform the applicant
and the Member States concerned accordingly.
In the context of the validation referred to in the first subpara­graph, the reference Member State shall not make an assessmentof the quality or the adequacy of the data or justifications
submitted.
Where the reference Member State considers that the appli­
cation is incomplete, it shall inform the applicant as to what
additional information is required for the validation of theapplication and shall set a reasonable time limit for thesubmission of that information. That time limit shall notnormally exceed 90 days.
The reference Member State shall, within 30 days of receipt of
the additional information, validate the application if it
determines that the additional information submitted issufficient to comply with the requirements laid down in
Article 5.
The reference Member State shall reject the application if theapplicant fails to submit the requested information within thedeadline and shall inform the applicant and the Member Statesconcerned accordingly.

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characteristics, the Member States concerned express nodisagreement in accordance with Article 10, those Member
States shall be deemed to agree with the conclusions of theassessment report and, where appropriate, the revised
summary of the biocidal product characteristics.
7.
Within 30 days of reaching agreement, the reference
Member State shall inform the applicant of the agreement,
and the reference Member State and each of the Member
States concerned shall, where relevant, amend the authorisationsof the biocidal product in conformity with the agreed change.
Article 9
Biocidal products authorised in accordance with Article 26
of Regulation (EU) No 528/2012
1.
Where the authorisation has been granted in accordancewith Article 26 of Regulation (EU) No 528/2012, the authori­sation holder or its representative shall notify each Member
State, on the territory of which the biocidal product is madeavailable, of notifications or applications made to the reference
Member State in accordance with Article 6, 7 or 8 of thisRegulation.
2.
Where a reference Member State has agreed with a revised
summary of the biocidal product characteristics, the authori­sation holder or its representative shall submit the revised
summary to each Member State on the territory of which thebiocidal product is made available in the official language(s) ofthat Member State.
Article 9a
Procedure for changes already agreed by other Member
States1.
Where an administrative change has already been agreed
in one or more Member States and the authorisation holder
seeks the same administrative change in an additional
Member State concerned, the authorisation holder or its repre­
sentative shall submit a notification in accordance with
Article 6(1) to the additional Member State concerned.

4.
Within 180 days of validating an application, thereference Member State shall evaluate the application anddraft an assessment report and shall send its assessment
report and, where relevant, the revised summary of thebiocidal product characteristics to the Member Statesconcerned and to the applicant.

2.
Where a minor or a major change has already been agreed
in one or more Member States and the authorisation holder
seeks the same minor or major change in an additional
Member State concerned, the authorisation holder, or its repre­
sentative, shall submit an application complying with Article 5
to the additional Member State concerned.

5.
Where it appears that additional information is necessary
to carry out the evaluation, the reference Member State shall ask
the applicant to submit such information within a specified
time limit. The period referred to in paragraph 4 shall besuspended from the date of the request until the date on
which the information is received. The time limit given to theapplicant shall not exceed 90 days in total unless justified by
the nature of the data requested or by exceptional circum­
stances.

3.
The Member State concerned shall inform the applicant of
the fee payable in accordance with Article 80(2) of Regulation(EU) No 528/2012. If the applicant fails to pay the fee within
30 days, the Member State concerned shall reject the applicationand inform the applicant and the other Member Statesconcerned accordingly. Upon receipt of the fee, the Member
State concerned shall accept the application and inform theapplicant accordingly indicating the date of acceptance.

The reference Member State shall reject the application if theapplicant fails to submit the requested information within thedeadline and shall inform the applicant and the Member Statesconcerned accordingly.

4.
If within 45 days in the case of a minor change, or 90
days in the case of a major change, of the date of acceptance,
the Member State concerned express no disagreement inaccordance with Article 10, it shall be deemed to agree withthe conclusions of the assessment report and, where appro­
priate, the revised summary of the biocidal product character­istics.

6.
If, within 90 days of receipt of the assessment report and,
where relevant, of the revised summary of the biocidal product

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5.
Within 30 days of the agreement referred to in paragraph
4, the Member State concerned shall inform the applicant of theagreement, and, where relevant, amend the authorisation of thebiocidal product in conformity with the agreed change.
Article 10
Coordination group, arbitration and derogation frommutual recognition
1.
A Member State concerned may propose to refuse to
grant an authorisation or to adjust the terms and conditionsof the authorisation in accordance with Article 37 of Regulation(EU) No 528/2012.
2.
Where, regarding matters other than those referred to inparagraph 1, the Member States concerned do not reach an
agreement on the conclusions of the assessment report or,
where relevant, on the revised summary of the biocidal
product characteristics in accordance with Article 7(6) or 8(6),or a Member State concerned has disagreed in accordance with
Article 6(3), the reference Member State shall refer the matter tothe coordination group referred to in Article 35 of Regulation(EU) No 528/2012.
Where a Member State concerned is in disagreement with thereference Member State, the former shall give a detailed
statement of the reasons for its position to all Member Statesconcerned and to the applicant.
3.
Articles 35 and 36 of Regulation (EU) No 528/2012 shallapply to matters of disagreement referred to in paragraph 2.
CHAPTER III
CHANGESOFPRODUCTSAUTHORISEDCOMMISSION

BY

THE

Article 11
Notification procedure for administrative changes of
products
1.
The authorisation holder, or its representative, shallsubmit to the Agency a notification complying with Article 5
and pay the fee referred to in Article 80(1)(a) of Regulation (EU)No 528/2012.
2.
Without prejudice to the second subparagraph, that notifi­
cation shall be submitted within 12 months following imple­
mentation of the change.
In case of a change referred to in Section 1 of Title 1 of theAnnex to this Regulation, the notification shall be submitted
before the implementation of the change.
3.
Within 30 days following receipt of the notification andsubject to the payment of the relevant fee, the Agency shallprepare and submit to the Commission an opinion on the
proposed change.
4.
If, within 30 days following receipt of the notification, therelevant fee has not been paid, the Agency shall reject theapplication and inform the applicant accordingly.
An appeal may be brought, in accordance with Article 77 ofRegulation (EU) No 528/2012, against Agency decisions under
this paragraph.
5.
The Agency shall inform the applicant of its opinion andshall, where relevant, request the applicant to submit in all the

19.4.2013

official languages of the Union, a draft revised summary of thebiocidal product characteristics.
6.
Within 30 days of the submission of its opinion to theCommission, the Agency shall, where relevant, transmit to theCommission, in all the official languages of the Union, therevised summary of the biocidal product characteristics, as
referred to in Article 22(2) of Regulation (EU) No 528/2012.
Article 12
Procedure for minor changes of products
1.
The authorisation holder, or its representative, shallsubmit to the Agency an application complying with the
Article 5.
2.
The Agency shall inform the applicant of the fee payable
under Article 80(1)(a) of Regulation (EU) No 528/2012, andshall reject the application if the applicant fails to pay the fee
within 30 days. It shall inform the applicant accordingly.
Upon receipt of the fee, the Agency shall accept the applicationand inform the applicant accordingly.
An appeal may be brought, in accordance with Article 77 ofRegulation (EU) No 528/2012, against Agency decisions under
this paragraph.
3.
The Agency shall validate the application within 30 daysof the date of acceptance if it complies with the requirements
laid down in Article 5.
In the context of the validation referred to in the first subpara­graph, the Agency shall not make an assessment of the qualityor the adequacy of the data or justifications submitted.
Where the Agency considers that the application is incomplete,
it shall inform the applicant as to what additional information isrequired for the completeness of the application and shall set a
reasonable time limit for the submission of that information.
That time limit shall not normally exceed 45 days.
The Agency shall, within 30 days of receipt of the additional
information, validate the application if it determines that theadditional information submitted is sufficient to comply withthe requirements laid down in Article 5.
The Agency shall reject the application if the applicant fails to
submit the requested information within the deadline andinform the applicant accordingly. In such cases, part of thefee paid in accordance with paragraph 2 shall be reimbursed.
An appeal may be brought, in accordance with Article 77 ofRegulation (EU) No 528/2012, against Agency decisions under
this paragraph.
4.
Within 90 days of accepting an application as valid, theAgency shall prepare and submit to the Commission an opinion
on the proposed change. In case of a favourable opinion, theAgency shall indicate whether the proposed change would
require an amendment of the authorisation.
The Agency shall inform the applicant of its opinion and makeit available in the Register for Biocidal Products referred to in
Article 71 of Regulation (EU) No 528/2012, and shall, where
relevant, request the applicant to submit in all the official
languages of the Union, a draft revised summary of thebiocidal product characteristics.

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5.
Where it appears that additional information is necessary
to carry out the evaluation, the Agency shall ask the applicant
to submit such information within a specified time limit. The
period referred to in paragraph 4 shall be suspended from thedate of the request until the date the information is received.
The time limit given to the applicant shall not exceed 45 days
in total unless justified by the nature of the data requested or by
exceptional circumstances.
6.
Within 30 days of the submission of its opinion to theCommission, the Agency shall, where relevant, transmit to theCommission, in all the official languages of the Union, therevised summary of the biocidal product characteristics, as
referred to in Article 22(2) of Regulation (EU) No 528/2012.
Article 13
Procedure for major changes of products
1.
The authorisation holder, or its representative, shallsubmit to the Agency an application complying with Article 5.
2.
The Agency shall inform the applicant of the fee payable
under Article 80(1)(a) of Regulation (EU) No 528/2012, andshall reject the application if the applicant fails to pay the fee
within 30 days. It shall inform the applicant and the competentauthority of the Member State referred to in Article 5(1)(d)(hereinafter referred to as the ‘evaluating competent authority’)accordingly.
Upon receipt of the fee, the Agency shall accept the applicationand inform the applicant and the evaluating competentauthority accordingly.
An appeal may be brought, in accordance with Article 77 ofRegulation (EU) No 528/2012, against decisions of the Agency
under this paragraph.
3.
Within 30 days of the Agency accepting an application,
the evaluating competent authority shall validate the application
if it complies with the requirements laid down in Article 5.
In the context of the validation referred to in the first subpara­graph, the evaluating competent authority shall not make anassessment of the quality or the adequacy of the data or justifi­
cations submitted.

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if it determines that the additional information submitted issufficient to comply with the requirements laid down in
Article 5.
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 fee paid in accordancewith paragraph 2 shall be reimbursed.
5.
The evaluating competent authority shall, within 180 daysof the validation of an application, evaluate it and send anassessment report and the conclusions of its evaluation,
including, where relevant, a draft revised summary of the
product characteristics, to the Agency.
Prior to submitting its conclusions to the Agency, the evaluatingcompetent authority shall provide the applicant with the oppor­
tunity to provide written comments on the conclusions of theevaluation within 30 days. The evaluating competent authority
shall take due account of those comments when finalising its
evaluation.
6.
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 period referred to in paragraph 5 shall be suspended fromthe date of the request until the date the information is received.
The time limit given to the applicant shall not exceed 90 days
in total unless justified by the nature of the data requested or by
exceptional circumstances.
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
opinion, the Agency shall indicate whether the proposed change
would require an amendment of the authorisation.
The Agency shall inform the applicant of its opinion and shall,where relevant, request the applicant to submit, in all the official
languages of the Union, a draft revised summary of the biocidal
product characteristics.

The evaluating competent authority shall, within 15 days fromthe Agency’s acceptance of an application, inform the applicantof the fee payable under Article 80(2) of Regulation (EU) No
528/2012 and shall reject the application if the applicant fails
to pay the fee within 30 days.

8.
Within 30 days of the submission of its opinion to theCommission, the Agency shall, where relevant, transmit to theCommission, in all the official languages of the Union, the draft
revised summary of the biocidal product characteristics, as
referred to in Article 22(2) of Regulation (EU) No 528/2012.

4.
Where the evaluating competent authority considers thatthe application is incomplete, it shall inform the applicant as towhat additional information is required for the completeness of
the application and shall set a reasonable time limit for thesubmission of that information. That time limit shall notnormally exceed 90 days.

CHAPTER IV

Administrative changes of products

The evaluating competent authority shall, within 30 days ofreceipt of the additional information, validate the application

1.
Administrative changes referred to in Section 2 of Title 1of the Annex may be implemented any time before completionof the procedures laid down in Articles 6 and 11.

IMPLEMENTATION OF CHANGESArticle 14

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Administrative changes referred to in Section 1 of Title 1 of theAnnex may be implemented at the earliest on the date when theMember State or, in the case of changes of a product authorised
by Union authorisation, the Commission explicitly agrees withthe change, or 45 days following receipt of the notification
submitted in accordance with Articles 6 and 11, whichever isearliest.
2.
Where one of the changes referred to in paragraph 1 isrejected, the authorisation holder shall cease to apply theconcerned change within 30 days following notification of
the decision of the relevant Member States or, in the case ofchanges of a product authorised by Union authorisation, theCommission.

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Article 16
Major changes
Major changes may only be implemented after the concerned
Member States have or, in the case of changes of a productauthorised by Union authorisation, the Commission has agreed
with the change and, where relevant, amended the decision
granting the authorisation by the decision referred to in
Article 50(2) of Regulation (EU) No 528/2012.
CHAPTER V
FINAL PROVISIONS

Article 15

Article 17

Minor changes

Continuous monitoring of implementation of changes

1.
Subject to a favourable opinion from the Agency, minorchanges of a product authorised by Union authorisation may be
implemented any time after the Agency’s opinion has been
made available in the Register for Biocidal Products inaccordance with Article 12(4).

Where requested by a Member State, the Agency or theCommission and for the purpose of monitoring biocidal
products placed on the market, authorisation holders shallwithout delay supply the requesting authority with any
information related to the implementation of a given change.

2.
Where the proposed minor change of the product isrejected by the Commission in accordance with Article 50(2)of Regulation (EU) No 528/2012, the authorisation holder shallcease to apply the proposed change within 30 days following
notification of the decision of the Commission.
3.
Minor changes of a product authorised by Member States
may be implemented any time after the reference Member Statehas made the agreement available in the Register for Biocidal
Products in accordance with Article 7(7).

Article 18
Entry into force
This Regulation shall enter into force on the twentieth day
following that of its publication in the Official Journal of theEuropean 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 Brussels, 18 April 2013.
For the Commission
The President
José Manuel BARROSO

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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, theknowledge of which is important for purposes of control and enforcement. Such changes include those listed in thefollowing table, provided that the conditions therein are met:
Name of the biocidal product1.

Changes of the name of the biocidal product where there is no risk of confusion with the names ofother biocidal products.

2.

Addition of a name for the biocidal product where there is no risk of confusion with the names of otherbiocidal 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 thetwo manufacturers, manufacturing locations and processes has been established by the Agency inaccordance with Article 54 of Regulation (EU) No 528/2012, and the manufacturer or importer islisted 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 thespecifications of a frame-formulation established in accordance with Directive 98/8/EC in accordancewith 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, theknowledge of which is not important for purposes of control and enforcement. Such changes include those listed in thefollowing 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 product2.

Change in the name, the administrative details or the formulating location of the biocidal productformulator, where the biocidal product composition and the formulating process remain unchanged.

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3.

Deletion of a formulating location or a formulator of the biocidal product4.

Addition of a formulator of the biocidal product, where the biocidal product composition and theformulating 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 inaccordance with Article 95(2) of Regulation (EU) No 528/2012

6.

Deletion of a manufacturer or a manufacturing location of the active substanceConditions 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 andof 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 beminor within the meaning of Article 3(1)(ab) of Regulation (EU) No 528/2012, since the change of the product is notexpected 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 withthe 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 3Major 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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