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L 167/17

COMMISSION IMPLEMENTING REGULATION (EU) No 564/2013
of 18 June 2013
on the fees and charges payable to the European Chemicals Agency pursuant to Regulation (EU) No
528/2012 of the European Parliament and of the Council concerning the making available on themarket and use of biocidal products(Text with EEA relevance)

biocides sector combined with the interest of avoiding
excessive fees for other enterprises while ensuring that
the Agency’s work is fully financed. For the purpose of
discouraging applications for products containing active
substances fulfilling one of the substitution criteria listed
in Article 10(1) of Regulation (EU) No 528/2012, as well
as of such active substances, reductions should not apply
to applications for such biocidal products or active
substances.

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European
Union,
Having regard to Regulation (EU) No 528/2012 of 22 May
2012 of the European Parliament and of the Council
concerning the making available on the market and use of
biocidal products (1), and in particular Article 80(1) thereof,(5)

Taking into account the Agency’s work required tohandle an appeal lodged in accordance with Article 77
of Regulation (EU) No 528/2012, it is appropriate to levy
a fee for such appeals in accordance with the third
subparagraph of Article 77(1) of that Regulation.
However, to avoid penalising persons launchingjustified appeals, it is appropriate to refund such fees
where the appeal is well founded.

(6)

Taking into account the reduced work required by the
Agency in cases where applications are rejected before or
during validation, or withdrawn during their assessment,
it is appropriate to provide for partial refund of fees insuch cases.

(7)

For the purpose of encouraging applications for approvalof active substances that are suitable alternatives toapproved active substances fulfilling one of the
exclusion criteria listed in Article 5(1) of Regulation(EU) No 528/2012, it is appropriate to provide forreimbursement of the fee for such applications.

(8)

The fee for applications for inclusion in Annex I to
Regulation (EU) No 528/2012 of active substances that
do not give rise to concern should take into account theestimated work required by the Agency to handle suchapplications, as well as the public interest in allowing
products containing such substances to be authorised.

(9)

For the purpose of discouraging applications for approvalor renewal of approval of active substances fulfilling oneof the substitution criteria listed in Article 10(1) of Regu­
lation (EU) No 528/2012 as well as applications for auth­orisation or renewal of products requiring a comparative
assessment in accordance with Article 23 of Regulation(EU) No 528/2012, and of contributing to financing thewaivers and reductions provided for by this Regulation, it
is appropriate to provide for increased fees for suchapplications.

Whereas:(1)

The structure and amount of the fees payable to theEuropean Chemicals Agency, (hereinafter referred to as‘the Agency’), as well as the conditions for payment
should be established.

(2)

The structure and amount of the fees should takeaccount of the work required by Regulation (EU) No
528/2012 to be carried out by the Agency. Fees
should be set at such a level as to ensure that therevenue derived from them, when combined with othersources of the Agency’s revenue, is sufficient to cover thecost of the services delivered.

(3)

(4)

It follows from Article 80(3)(d) of Regulation (EU) No
528/2012 that the structure and amount of fees is totake into account whether information has been
submitted jointly or separately. In order to reflect theactual work load of the Agency and to promote joint
submission of information, it is appropriate to only levy
one fee per application, in case several persons apply
jointly for the approval of an active substance or the
renewal of an approval of an active substance.
To take into account the specific needs of small andmedium-sized enterprises within the meaning ofCommission Recommendation 2003/361/EC of 6 May
2003 concerning the definition of micro, small andmedium sized enterprises (2) (hereinafter ‘SMEs’) estab­lished in the Union, reduced fees for active substanceapproval, renewal of approval or inclusion in Annex I
to Regulation (EU) No 528/2012 and biocidal productauthorisation or renewal should apply to suchcompanies. The levels of the reductions should take
into account the significant proportion of SMEs in the(1) OJ L 167, 27.6.2012, p. 1.
(2) OJ L 124, 20.5.2003, p. 36.

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(10)

(11)

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In view of the Agency’s work required to handle arequest for an opinion on the classification of a changein accordance with Commission Implementing Regu­
lation (EU) No 354/2013 of 18 April 2013 onchanges of biocidal products authorised in accordancewith Regulation (EU) No 528/2012 of the European
Parliament and of the Council (1), it is appropriate tolevy a fee for such requests. However, to avoid, to theextent possible, penalising applicants whose requests tohave a change classified as minor or administrative are
justified, it is appropriate to grant a fee reduction to thesubsequent application for a change, where the request
leads to a recommendation to classify the change as anadministrative or minor change.

Given the Agency’s work required to treat submissions
for inclusion in the list of relevant persons referred to in
Article 95 of Regulation (EU) No 528/2012, it is appro­
priate to levy a fee for such submissions. The amount ofwork required for such submission will vary significantly
depending on whether the relevant person submits aletter of access or a new dossier, since, in the latter
case, the Agency will have to check that the dossiercomplies with Annex II to Regulation (EU) No
528/2012 or, where appropriate, Annex IIA to
Directive 98/8/EC of the European Parliament and of
the Council of 16 February 1998 concerning theplacing on the market of biocidal products (2). It isappropriate to differentiate the fee accordingly.

19.6.2013

should be fixed taking due account of the deadlines ofthe procedures provided for in that Regulation.

(15)

The fees set out in this Regulation should be reviewed at
appropriate intervals, with a view to aligning the feeswith the inflation rate and with the actual costs to the
Agency of the services provided. These reviews shouldtake into account the Agency’s increased experience indealing with applications under the Regulation and theefficiencies thereby gained.

(16)

The Standing Committee on Biocidal Products referred toin Article 82(1) of Regulation (EU) No 528/2012 did notdeliver an opinion on the measures provided for in thisRegulation. Since an implementing act was deemed to benecessary, the chair submitted the draft implementing act
to the appeal committee for further deliberation. The
appeal committee did not deliver an opinion,

HAS ADOPTED THIS REGULATION:

CHAPTER I
FEES

Article 1
Fees for work in relation to active substances(12)

Given the Agency’s work required to handle a request for
confidentiality in accordance with Article 66(4) of Regu­
lation (EU) No 528/2012, it is appropriate to levy a fee
for such requests.

(13)

Since the Agency’s budget is drawn up and implemented
in euro, and its accounts are also presented in euro inaccordance with Article 19 of Regulation (EU, Euratom)
No 966/2012 of the European Parliament and of theCouncil of 25 October 2012 on the financial rules
applicable to the general budget of the Union andrepealing Council Regulation (EC, Euratom) No
1605/2002 (3), with Article 17 of Commission Regu­
lation (EC, Euratom) No 2343/2002 of 23 December
2002 on the framework Financial Regulation for thebodies referred to in Article 185 of Council Regulation(EC, Euratom) No 1605/2002 on the Financial Regu­
lation applicable to the general budget of the European
Communities (4) and with Article 17 of the Financial
Regulation of the European Chemicals Agency of
24 September 2008 (5), it is appropriate to levy fees
only in euro.

(14)

It follows from Article 80(3)(f) of Regulation (EU) No
528/2012 that the deadlines for the payment of fees(1) OJ L 109, 19.4.2013, p. 4.
(2) OJ L 123, 24.2.1998, p. 1.
(3) OJ L 298, 26.10.2012, p. 1.
(4) OJ L 357, 31.12.2002, p. 72.
(5) MB/53/2008 final.

The Agency shall levy the fees provided for in Table 1 of Annex
I for work required by Regulation (EU) No 528/2012 to be
carried out in relation to approval and renewal of approval ofactive substances, as well as inclusion in Annex I to that Regu­
lation.
Article 2Fees for work in relation to Union authorisation of
biocidal products
The Agency shall levy the fees provided for in Table 1 of Annex
II for work required by Regulation (EU) No 528/2012 to be
carried out in relation to Union authorisation of biocidal
products.
Article 3
Other fees
1.
The Agency shall levy the fees provided for in Annex III
for work required by Regulation (EU) No 528/2012 to be
carried out in relation to establishment of technical equivalence,
applications for mutual recognition, requests for inclusion in thelist of relevant persons, and requests for confidential treatment
of information submitted to the Agency.
2.
The Agency shall levy the annual fees provided for in
Annex III for every biocidal product or biocidal productfamily authorised by the Union. The annual fee shall be dueon the first and each subsequent anniversary of the entry into
force of the authorisation. It shall relate to the preceding year.

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Article 4Fees for appeals against a decision of the Agency under
Article 77 of Regulation (EU) No 528/2012
1.
For any appeal against a decision of the Agency under
Article 77 of Regulation (EU) No 528/2012, the Agency shalllevy a fee as set out in Annex III.
2.
An appeal shall not be considered to be received by the
Board of Appeal until the relevant fee has been received by the
Agency.
3.
If the appeal is considered inadmissible by the Board of
Appeal, the fee shall not be refunded.
4.
The Agency shall refund the fee levied in accordance withparagraph 1 if the Executive Director of the Agency rectifies adecision in accordance with Article 93(1) of Regulation (EU) No
1907/2006 of the European Parliament and of the Council (1),or if the appeal is decided in favour of the appellant.
Article 5
Reimbursement possibility for alternatives to approved
active substances fulfilling one of the exclusion criteria
1.
Upon submission of an application to the Agency for theapproval of an active substance, which may be a suitable alter­
native, within the meaning of the second subparagraph of
Article 5(2) of Regulation (EU) No 528/2012, to an approved
active substance fulfilling one of the exclusion criteria pursuant
to Article 5(1) of that Regulation, an applicant may request
reimbursement of the fee to be paid to the Agency.
2.
Upon receipt of the opinion from the Agency inaccordance with Article 8(4) of Regulation (EU) No
528/2012, which shall also include a recommendation onwhether the active substance is a suitable alternative within
the meaning of the second subparagraph of Article 5(2) ofRegulation (EU) No 528/2012, the Commission shall decideon the request.
3.
Where the Commission decides that the active substanceis a suitable alternative, the Agency shall inform the applicant
thereof and fully reimburse the fee referred to in paragraph 1.

L 167/19(EU) No 528/2012, the question shall be determined byreference to the active substance manufacturer that is repre­
sented by the prospective applicant. In case of an application
for product authorisation or renewal of product authorisation,
the question shall be determined by reference to the prospective
authorisation holder.
3.
The Agency shall publish a list of the relevant elements tobe submitted in accordance with paragraph 1.
4.
Within 45 days of receipt of all the relevant elements
referred to in paragraph 1, the Agency shall decide what SME
status, if any, can be recognised.
5.
A recognition of an enterprise as an SME shall be valid for
applications submitted under Regulation (EU) No 528/2012 for
two years.
6.
An appeal may be brought, in accordance with Article 77
of Regulation (EU) No 528/2012 against a decision taken by
the Agency under paragraph 4.
Article 7
Fee Reductions
1.
Reductions of fees payable to the Agency as set out inTable 2 of Annex I and Table 2 of Annex II shall be granted to
SMEs established in the Union.
2.
Reductions for applications for active substance approval,
renewal of approval or inclusion in Annex I to Regulation (EU)No 528/2012 shall only be granted when the active substanceis not a candidate for substitution.
3.
Reductions for applications for biocidal product authori­sation or renewal of authorisation shall only be granted when
the product does not contain an active substance which is acandidate for substitution.
CHAPTER III
PAYMENTS

Article 8

CHAPTER II

Mode of payment

SUPPORT FOR SMEs

1.
The fees provided for by this Regulation shall be paid in
euro.

Article 6
Recognition of SME status
1.
Before submission of an application to the Agency for
approval, renewal or inclusion in Annex I to Regulation (EU)No 528/2012 of an active substance or for Union authorisationof a biocidal product or biocidal product family, submitted inaccordance with Articles 7(1), 13(1), 28(4), 43(1) or 45(1) ofthat Regulation respectively, containing a claim for SME
reduction, the prospective applicant shall submit to the
Agency the relevant elements proving entitlement to such
reduction by virtue of the status of SME in the meaning ofRecommendation 2003/361/EC.
2.
In the case of an application for approval, renewal or
inclusion of an active substance in Annex I to Regulation(1) OJ L 396, 30.12.2006, p. 1.

2.
Payments shall be made only after the Agency has issued
an invoice.
3.
By derogation from paragraph 2, payments due under
Article 4 shall be made at the time of the submission of theappeal.
4.
Payments shall be made by means of a transfer to thebank account of the Agency.
Article 9
Identification of the payment
1.
Every payment, with the exception of payments referred
to in Article 8(3), shall indicate in the reference field the invoice
number.

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2.
Payments referred to in Article 8(3) shall indicate, in thereference field, the identity of the appellant(s) and, if available,
the number of the decision that is being appealed against.
3.
If the purpose of the payment cannot be established, theAgency shall set a deadline by which the paying party must
notify it in writing of the purpose of the payment. If the Agency
does not receive a notification of the purpose of the payment
before expiry of that deadline, the payment shall be consideredinvalid and the amount concerned shall be refunded to thepaying party.
Article 10
Date of payment
1.
Unless otherwise provided, fees shall be paid within 30
days from the date on which the invoice is notified by the
Agency.

19.6.2013

Article 13
Refunds of amounts in case of applications rejected before
or during validation or withdrawn during the assessment
1.
The Agency shall reimburse 90 % of the fee collected
where an application for active substance approval or biocidal
product authorisation, submitted in accordance withrespectively Article 7(1) or 43(1) of Regulation (EU) No
528/2012, or an application for a minor or major change ofa product, is rejected before or during the validation phase.

2.
The Agency shall reimburse 75 % of the fee collected
where an application for active substance approval or biocidal
product authorisation, submitted in accordance withrespectively Article 7(1) or 43(1) of Regulation (EU) No
528/2012, or an application for a major change of a product,
is withdrawn before the evaluating Competent Authority has
transmitted its assessment report to the Agency.

2.
The date on which the full amount of the payment isdeposited in a bank account held by the Agency shall beconsidered to be the date on which the payment has been
made.

The fee collected shall not be reimbursed where an application
is withdrawn after the evaluating Competent Authority has
transmitted its assessment report to the Agency.

3.
The payment shall be considered to have been made intime where sufficient documentary evidence is produced toshow that the paying party ordered the transfer to the bankaccount indicated on the invoice before expiry of the relevant
deadline. A confirmation of the transfer order issued by afinancial institution shall be regarded as sufficient evidence.

3.
The arrangements for the refund of the remaining amountto the paying party shall be fixed by the Executive Director of
the Agency and published on the website of the Agency.

CHAPTER IV
FINAL PROVISIONS

Article 11

Article 14

Insufficient payment

Reimbursement of rapporteurs

1.
A deadline for payment shall be considered to have been
observed only if the full amount of the fee has been paid in due
time.

Members of the Biocidal Product Committee acting as
rapporteurs shall be reimbursed through the fees paid inaccordance with Article 80(2) to the Member States’
competent authorities acting as evaluating competent authority.

2.
When an invoice relates to a group of transactions, theAgency may attribute any under-payment to any of the relevanttransactions. The criteria for the attribution of payments shallbe laid down by the Management Board of the Agency.
Article 12
Refund of amounts paid in excess
1.
The arrangements for the refund to the paying party ofamounts paid in excess of a fee shall be fixed by the Executive
Director of the Agency and published on the website of the
Agency.
However, where an amount paid in excess is below EUR 200
and the party concerned has not expressly requested a refund,the amount paid in excess shall not be refunded.
2.
It shall not be possible to count any amount paid inexcess and not refunded as being made towards future
payments to the Agency.

Article 15
Charges
1.
Subject to a favourable opinion from the Commission, theAgency may establish by decision of its Management Board
charges for administrative or technical services that it provides
in accordance with Regulation (EU) No 528/2012 at the requestof a party in order to facilitate its implementation. The
Executive Director of the Agency may decide not to levy acharge on international organisations or countries that request
assistance from the Agency.

2.
The charges shall be set at such a level as to cover thecosts of the services delivered by the Agency and shall not
exceed what is necessary to cover those costs.

3.
The charge shall be paid within 30 calendar days from thedate on which the invoice is notified by the Agency.

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Article 16
Provisional estimate
The Management Board of the Agency shall, when producing
an estimate of the overall expenditure and income for thefollowing financial year in accordance with Article 96(5) ofRegulation (EC) No 1907/2006 of the European Parliamentand of the Council (1), include a specific provisional estimate
of income from fees and charges from activities entrusted to the
Agency in accordance with Regulation (EU) No 528/2012
which is separate from income from any subsidy from theUnion.
Article 17

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as published by Eurostat. A first review shall be carried out atthe latest by 1 January 2015.
The Commission shall also keep this Regulation under continual
review in the light of significant information becoming available
in relation to the underlying assumptions for anticipatedincome and expenditure of the Agency. At the latest by
1 January 2015, the Commission shall review this Regulation
with a view to amend it, if appropriate, taking into account inparticular the resources required by the Agency and thoserequired by the competent authorities of the Member States
for services of a similar nature. The review shall take into
consideration the impacts on the SMEs, and review the fee
reduction rates allowable to SMEs where appropriate.

Review

Article 18

The Commission shall review the fees and charges provided forin this Regulation annually by reference to the inflation rate asmeasured by means of the European Index of Consumer Prices

This Regulation shall enter into force on the twentieth day
following that of its publication in the Official Journal of theEuropean Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 18 June 2013.
For the Commission
The President
José Manuel BARROSO(1) OJ L 396, 30.12.2006, p. 1.

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ANNEX I
Fees relating to active substances
Table 1
Standard fees
General description of task; relevant provision
in Regulation (EU) No 528/2012

Approval of an active substance;
Article 7(2)Renewal of an approval; Article 13(3)Inclusion in Annex I of an active
substance; Article 28

Notification in accordance with Article 3aof Regulation (EC) No 1451/2007

Specific condition or task description

Fee (EUR)

Fee for the first product-type for which that active
substance is approved

120 000

Additional fee per additional product-type

40 000Additional fee per product-type (for both the first producttype and any additional product-type) if the active substanceis a candidate for substitution in accordance with Article 10of Regulation (EU) No 528/2012

20 000Fee for the amendment of an approval, other than the
addition of a product-type.

20 000Fee for the first product-type for which renewal of that
active substance is sought

15 000Additional fee per additional product-type

1 500

Additional fee for the first product-type for which renewalof that active substance is sought in case a full evaluation isfound necessary in accordance with Article 14(1) of Regu­
lation (EU) No 528/2012

25 000Additional fee per additional product-type in case a fullevaluation is found necessary in accordance with
Article 14(1) of Regulation (EU) No 528/2012

2 500

Additional fee per product-type (for both the first producttype and any additional product-type) if the active substanceis a candidate for substitution in accordance with Article 10of Regulation (EU) No 528/2012

20 000Fee for the first inclusion in Annex I of an active substance

10 000Fee for the amendment of an inclusion of an active
substance in Annex I

2 000

Fee per substance/product-type combination.

10 000The fee for the notification shall be deducted from thesubsequent application in accordance with Article 7 ofRegulation (EU) No 528/2012.

Table 2
Fee reductions for applications for the approval, renewal of approval, inclusion in Annex I of active substances
if the active substance manufacturer is an SME established in the Union, except where the active substance is acandidate for substitution

Type of enterprise

Reduction (% of the standard fee)

Micro enterprise

60

Small enterprise

40

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ANNEX II
Fees for Union authorisation of biocidal products
Table 1
Standard fees
General description of task; relevant provision
in Regulation (EU) No 528/2012

Specific condition or task description

Fee (EUR)

Fee per product not identical with (one of) the represen­tative product(s) assessed for the purpose of the substanceapproval

80 000Fee per product identical with (one of) the representative
product(s) assessed for the purpose of the substanceapproval

40 000Additional fee per product when comparative assessment inaccordance with Article 23 of Regulation (EU) No
528/2012 is required

40 000Additional fee per product when the requested authori­sation is provisional in accordance with Article 55(2) ofRegulation (EU) No 528/2012

10 000Fee per family

150 000

Additional fee per family when comparative assessment inaccordance with Article 23 of Regulation (EU) No
528/2012 is required

60 000Additional fee per family when the requested authorisation
is provisional in accordance with Article 55(2) of Regu­
lation (EU) No 528/2012

15 000

Notification to the Agency of anadditional product within a biocidal
product family; Article 17(6)Fee per additional product

2 000

Union authorisation of a same biocidal
product; Article 17(7)Fee per product constituting a ‘same product’ within themeaning of Commission Implementing Regulation (EU) No
414/2013 of 6 May 2013 specifying a procedure for theauthorisation of same biocidal products in accordance with
Regulation (EU) No 528/2012 of the European Parliamentand of the Council (1)2 000

Major change of an authorised product or
product family; Article 50(2)Fee per application

40 000Minor change of an authorised productor product family; Article 50(2)Fee per application

15 000Administrative change of an authorised
product or product family; Article 50(2)Fee per notification

2 000

Recommendation on the classification ofa change of an authorised product or
product family; Article 50(2)Fee per request in accordance with Regulation (EU) No
354/2013.

2 000

Granting of Union authorisation, single
product; Article 43(2)Granting of Union authorisation, biocidal
product family; Article 43(2)If the recommendation is to classify the change as anadministrative or minor change, the fee for the request shallbe deducted from the subsequent application or notificationin accordance with Regulation (EU) No 354/2013.

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General description of task; relevant provision
in Regulation (EU) No 528/2012

Renewal of Union authorisation, single
product; Article 45(3)Renewal of Union authorisation, biocidal
product family; Article 45(3)19.6.2013

Specific condition or task description

Fee (EUR)

Fee per product

5 000

Additional fee per product in case a full evaluation is foundnecessary in accordance with Article 14(1) of Regulation(EU) No 528/2012

15 000Additional fee per product when comparative assessment inaccordance with Article 23 of Regulation (EU) No
528/2012 is required

40 000Fee per product family

7 500

Additional fee per product family in case a full evaluation isfound necessary in accordance with Article 14(1) of Regu­
lation (EU) No 528/2012

22 500Additional fee per product family when comparative
assessment in accordance with Article 23 of Regulation (EU)No 528/2012 is required

60 000(1) OJ L 125, 7.5.2013, p. 4.

Table 2
Fee reductions for applications for the granting and renewal of Union authorisation of biocidal products or
biocidal product families, if the prospective authorisation holder is an SME established in the Union, except
where the product contains an active substance which is a candidate for substitution

Type of enterprise

Reduction (% of the standard fee)

Micro enterprise

30

Small enterprise

20

Medium enterprise10

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ANNEX III
Other fees
General description of task; relevant provision
in Regulation (EU) No 528/2012)

Specific condition or task description

Fee (EUR)

Fee, when difference between the active substance sources islimited to a change in manufacturing location, and appli­
cation is based solely on analytical data

5 000

Fee, when difference between the active substance sources
goes beyond a change in the manufacturing location, andapplication is based solely on analytical data

20 000Fee when previous conditions are not met.

40 000Fee per Union authorisation of a biocidal product10 000Fee per Union authorisation of a biocidal product family

20 000

Mutual Recognition Submission fee;
Article 80(1)(a)Fee per product or product family concerned by an appli­
cation for mutual recognition, per Member State wheremutual recognition is sought

700

Appeal; Article 77(1)Fee per appeal

2 500

Submission for inclusion in the list of
relevant persons; Article 95

Fee per submission of a letter of access to a dossier alreadyfound complete by the Agency or an evaluating Competent
Authority

2 000

Fee per submission of a letter of access to part of a dossieralready found complete by the Agency or an evaluating
Competent Authority, together with complementary data

20 000Fee per submission of a new dossier

40 000Fee per item for which confidentiality is requested

1 000

Technical equivalence; Article 54(3)Annual fee for biocidal products auth­orised by the Union; Article 80(1)(a)Requests under Article 66(4) submitted to
the Agency