EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
CA-Dec12-Doc. 
[…](2013) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
on the fees and charges payable to the European Chem icals Agency pursuant to 
Regulation (EU) No 528/2012 of the European Parliament and of the Council concernin g 
the making available on the market and use of biocidal products 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
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 the market and use of biocidal products 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the 
Council concerning the making available on th e market and use of biocidal products
1, and in 
particular Article 80(1) thereof,  
Whereas:  
(1) The structure and amount of the fees pa yable to the European 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 s hould take account of th e 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 the revenue  derived from them, when combined with 
other sources of the Agency's revenue, is su fficient to cover the cost of the services 
delivered.  
(3) It follows from Article 80(3)(d) of Regulat ion (EU) No 528/2012 that the structure and 
amount of fees is to take into account whether information has been submitted jointly or separately. In order to reflect the actua l work load of the Agency and to promote 
joint submission of information, it is appropria te 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. 
(4) To take into account the specific needs of small and medium-sized enterprises within 
the meaning of Commission Recomme ndation 2003/361/EC of 6 May 2003 
concerning the definition of micro, small and medium sized enterprises
2 (hereinafter 
'SMEs') established in the Union, reduced f ees for active substance approval, renewal 
of approval or inclusion in Annex I to  Regulation (EU) No 528/2012 and biocidal 
                                                 
1 OJ L 167, 27.6.2012, p. 1.  
2 OJ L 124, 20.5.2003, p. 36.  
EN 3   EN product authorisation or renewa l should apply to such comp anies. The levels of the 
reductions should take into account the signif icant proportion of SMEs in the biocides 
sector combined with the interest of avoidi ng excessive fees for other enterprises while 
ensuring that the Agency's work is fully  financed. For the purpose of discouraging 
applications for products cont aining active substances fulfil ling 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 a pply to applications for such biocidal 
products or active substances. 
(5) Taking into account the Agency's work re quired to handle 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 Ar ticle 77(1) of that 
Regulation. However, to avoid penalising persons launching justified appeals, it is 
appropriate to refund such fees where the appeal is well founded.  
(6) Taking into account the reduced work re quired by the Agency in cases where 
applications are rejected before or dur ing validation, or withdrawn after their 
submission, it is appropriate to provide fo r partial refund of fees in such cases.   
(7) For the purpose of encouragi ng applications for approval of  active substances that are 
suitable alternatives to approved active s ubstances fulfilling one of the exclusion 
criteria listed in Article 5(1) of Regul ation (EU) No 528/2012, it is appropriate to 
provide for reimbursement of the fee for such applications. 
(8) The fee for applications fo r inclusion in Annex I to Regulation (EU) No 528/2012 of 
active substances that do not give rise to concern should ta ke into account the 
estimated work required by the Agency to ha ndle such applications, as well as the 
public interest in allowing products containing such substances to be authorised. 
(9) For the purpose of discouraging applications for approval or renewal of approval of 
active substances fulfilling one of the subst itution criteria listed in Article 10(1) of 
Regulation (EU) No 528/2012 as well as appli cations for authorisation or renewal of 
products requiring a comparative assessm ent in accordance with Article 23 of 
Regulation (EU) No 528/2012, and of contri buting to financing the waivers and 
reductions provided for by this Regulation, it is appropriate to provide for increased 
fees for such applications. 
(10) In view of the Agency's work required to handle a request for an opinion on the 
classification of a change in accordance wi th [the Regulation on Changes], it is 
appropriate to levy a fee for such requests. However, to avoid, to the extent possible, 
penalising applicants whose requests to have a change classified as minor or 
administrative are justified, it is appropriate to grant a fee reducti on to the subsequent 
application for a change, where the request leads to a recommendation to classify the change as an administrative or minor change. 
(11) Given the Agency's work required to treat submissions for inclusion in the list of 
relevant persons referred to in Article  95 of Regulation (E U) No 528/2012, it is 
appropriate to levy a fee for such submissi ons. The amount of work required for such 
submission will vary significantly depending on whether the relevant person submits a 
letter of access or a new dossier, since, in the latter case, the Agency will have to check that the dossier complies with A nnex II to Regulation (EU) No 528/2012 or,  
EN 4   EN where appropriate, Annex IIA to Directive 98/ 8/EC of the European  Parliament and of 
the Council of 16 February 1998 concerning the placing on the market of biocidal 
products3. It is appropriate to diffe rentiate the fee accordingly. 
(12) Given the Agency's work required to handle a request for confiden tiality in accordance 
with Article 66(4) of Regulation (EU) No  528/2012, it is appropriate to levy a fee for 
such requests. 
(13) Since the Agency's budget is drawn up and im plemented in euro, and its accounts are 
also presented in euro in accordance with Article 19 of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the gene ral budget of the Union and repealing Council 
Regulation (EC, Euratom) No 1605/2002
4, with Article 17 of Commission Regulation 
(EC, Euratom) No 2343/2002 on the framewor k Financial Regulation for the bodies 
referred to in Article 185 of Council Re gulation (EC, Euratom) No 1605/2002 on the 
Financial Regulation applicable to the general budget of the European Communities5 
and with Article 17 of the Financial Regula tion of the European Chemicals Agency of 
24 September 20086, it is appropriate to levy fees only in euro. 
(14) It follows from Article 80(3)(f) of Regulat ion (EU) No 528/2012 th at the deadlines for 
the payment of fees should be fixed ta king due account of the deadlines of the 
procedures provided fo r in that Regulation. 
(15) The fees set out in this Regulation should be reviewed at appropriate  intervals, with a 
view to aligning the fees with the inflation rate and with the actual costs to the Agency 
of the services provided. Thes e reviews should aim to re duce fees in line with the 
Agency’s increased experience in deali ng with applications  under the Regulation. 
(16) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Biocid al Products referred to in Article 82(1) of 
Regulation (EU) No 528/2012,  
HAS ADOPTED THIS REGULATION: 
CHAPTER I 
FEES 
Article 1 
Fees for work in relation to active substances 
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 of active substances, as well as inclusion in Annex I to that Regulation. 
                                                 
3 OJ L 123, 24.2.1998, p. 1. 
4 OJ L 298, 26.10.2012, p. 1. 
5 OJ L 357, 31.12.2002, p. 72. 
6 MB/53/2008 final.  
EN 5   EN Article 2 
Fees for work in relation to Uni on 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 Uni on 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 es tablishment of 
technical equivalence, applic ations for mutual recognition, requests for inclusion in 
the list 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 product family authoris ed by the Union. The annual fee shall be 
due on the first and each subsequent annive rsary of the notification of the marketing 
authorisation decision. It shall be payable within 45 days of the due date. The annual 
fee shall relate to the preceding year. 
Article 4 
Fees 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 shall levy a fee as set out in Annex III. 
2. An appeal shall not be cons idered to be received by th e Board of Appe al 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 with paragraph 1 if the 
Executive Director of the Agency rect ifies a decision in accordance with 
Article 93(1) of Regulation (EU) No 1907/ 2006 of the European Parliament and of 
the Council7, or if the appeal is decided in favour of the appellant. 
Article 5 
Waivers for alternatives to appr oved active substances fulfilli ng one of the exclusion criteria 
1. Upon submission of an application to th e Agency for the approval of an active 
substance, which may be a suitable altern ative, within the meaning of the second 
subparagraph of Article 5(2) of Regulat ion (EU) No 528/2012, to an approved active 
substance fulfilling one of the exclusion cr iteria pursuant to Article 5(1) of that 
                                                 
7 OJ L 396, 30.12.2006, p. 1.  
EN 6   EN Regulation, a prospective appl icant may request reimbursement  of the fee to be paid 
to the Agency. 
2. After evaluation of the application, th e Commission shall decide on the question 
whether the active substance is a suitable alternative within the meaning of the 
second subparagraph of Article 5(2) of  Regulation (EU) No 528/2012. Where the 
Commission decides that the active substan ce is a suitable altern ative, the Agency 
shall inform the applicant thereof and reim burse the fee referred to in paragraph 1. 
CHAPTER II 
SUPPORT FOR SMEs 
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 
authorisation of a biocidal product or biocidal product family, submitted in accordance with Articles 7(1), 13(1), 28(4) , 43(1) or 45(1) of that 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 of Recommendation 2003/361/EC. 
2. In the case of an application for approval, renewal or inclusion of  an active substance 
in Annex I to Regulation (EU) No 528/ 2012, the question shall be determined by 
reference to the active substance manufactur er that is represented by the prospective 
applicant. In case of an a pplication for product authoris ation or renewal of product 
authorisation, the question shall be dete rmined by reference to the prospective 
authorisation holder. 
3. The Agency shall publish a list of the relevant elements to be submitted in 
accordance with paragraph 1. 
4. Within 30 days of receipt of all the releva nt elements referred to in paragraph 1, the 
Agency shall decide what SME st atus, if any, can be recognised. 
5. A recognition of an enterprise as an  SME shall be valid for two years.  
6. An appeal may be brought, in accordan ce 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 in Table 2 of Annex I and Table 
2 of Annex II shall be granted to SMEs established in the Union.   
EN 7   EN 2. Reductions for applications for active subs tance approval, renewal of approval or 
inclusion in Annex I to Regulation (EU) No 528/2012 shall only be granted when the 
active substance is 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 a candidate for substitution.  
EN 8   EN CHAPTER III 
PAYMENTS 
Article 8 
Mode of payment 
1. The fees provided for by this Re gulation shall be paid in euro. 
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 the appeal. 
4. Payments shall be made by means of a tran sfer to the bank account of the Agency. 
Article 9 
Identification of the payment 
1. Every payment, with the exception of paymen ts referred to in Article 8(3), shall 
indicate in the reference field the invoice number.  
2. Payments referred to in Article 8(3) shall i ndicate, in the reference field, the identity 
of the appellant(s) and, if available, the num ber of the decision that is being appealed 
against. 
3. If the purpose of the payment cannot be es tablished, the Agency 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 notificati on of the purpose of the payment before 
expiry of that deadline, the payment sh all be considered invalid and the amount 
concerned shall be refunde d to the paying party. 
Article 10 
Date of payment 
1. The date on which the full amount of the payment is deposited in a bank account 
held by the Agency shall be considered to be the date on which the payment has been made. 
2. The payment shall be considered to ha ve been made in time where sufficient 
documentary evidence is produced to show that the paying party ordered the transfer to the bank account indicated on the invoice befo re expiry of the re levant deadline. A 
confirmation of the transfer order issued by a financial institution shall be regarded 
as sufficient evidence.  
EN 9   EN Article 11 
Insufficient payment 
1. A deadline for payment shall be considered to have been observ ed only if the full 
amount of the fee has been paid in due time. 
2. When an invoice relates to a group of tr ansactions, the Agency  may attribute any 
under-payment to any of the relevant transact ions. The criteria for the attribution of 
payments shall be 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 payi ng party of amounts 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 re fund, the amount paid in excess shall not 
be refunded. 
2. It shall not be possible to count any amount paid in exces s and not refunded as being 
made towards future payments to the Agency. 
Article 13 
Refunds of amounts in case of applications for active substance approval and biocidal 
product authorisation 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 au thorisation, submitted in accordance with 
respectively Article 7(1) or 43(1) of Regul ation (EU) No 528/2012, 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 au thorisation, submitted in accordance with 
respectively Article 7(1) or 43(1) of Regulation (E U) No 528/2012, is withdrawn 
before the evaluating Competent Authority has transmitted its assessment report to the Agency. 
The fee collected shall not be reimbursed wh ere an application is withdrawn after the 
evaluating Competent Authority has transm itted its assessment report to the Agency. 
3. The arrangements for the refund of the rema ining amount to the paying party shall be 
fixed by the Executive Director of the Ag ency and published on the website of the 
Agency.  
EN 10   EN CHAPTER IV 
FINAL PROVISIONS 
Article 14 
Reimbursement of rapporteurs 
Members of the Biocidal Product Committee acting as rapporteurs shall be reimbursed 
through the fees paid in accordance with Arti cle 80(2) to the Member States' competent 
authorities acting as evaluating competent authority. 
Article 15 
Charges 
1. Subject to a favourable opinion from the Commission, the Agency may establish by 
decision of its Management Board charges fo r administrative or technical services 
that it provides in accordance with Regula tion (EU) No 528/2012 at  the request of a 
party in order to f acilitate its implementation. The Ex ecutive Director of the Agency 
may decide not to levy a charge on international organisations or countries that request assistance from the Agency. 
2. The charges shall be set at such a level as to cover the costs of the services delivered 
by the Agency and shall not exceed what is necessary to cover those costs. Charges 
shall be calculated based on a daily rate of 890 EUR.. 
3. The charge shall be paid within 30 calenda r days from the date on which the invoice 
is notified by the Agency. 
Article 16 
Provisional estimate 
The Management Board of the Agency shall, when producing an es timate of the overall 
expenditure and income for the following financia l year in accordance with Article 96(5) of 
Regulation (EU) No 1907/2006, 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 the Union. 
Article 17 
Review 
The Commission shall review the fees and char ges provided for in th is Regulation annually 
by reference to the inflation rate as measured  by means of the European Index of Consumer 
Prices as published by Eurostat. A first re view shall be carried out at the latest by 
1 January 2015. 
The Commission shall also keep this Regula tion under continual review in the light of 
significant information becoming available in  relation to the underlying assumptions for 
anticipated income and expenditure of the Agency. At the latest  by 1 January 2015, the  
EN 11   EN Commission shall review this Regulation with a view to amend it, if appropriate, taking into 
account in particular the costs of  the Agency and the related cost s of the services provided by 
the competent authorities of the Member States. The review shall take into consideration the 
impacts on the SMEs, and review the fee reduction rates allowable to SMEs where appropriate.  
Article 18 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union . 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels,  
 For the Commission 
 The President  José Manuel BARROSO   
EN 12   EN ANNEX I  
Fees relating to active substances 
Table 1  
Standard fees 
General description of task; relevant 
provision in Regulation (EU) No 528/2012 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 40.000 
Additional fee per product-type (for both the first product-type and any 
additional product-type) if the ac tive substance is a candidate for 
substitution in accordance with Ar ticle 10 of Regulation (EU) No 
528/2012 20.000 Approval of an active substance; Article 7(2) 
Fee for the amendment of an approva l, other than the addition of a 
product-type. 20.000 
Fee for the first product-type for which renewal of that active substance is 
sought  15.000 
Additional fee per additional product-type  1.500 
Additional fee for the first product-type for which renewal of that active 
substance is sought in case a full evaluation is found necessary in 
accordance with Article 14(1) of  Regulation (EU) No 528/2012 25.000 
Additional fee per additional product-type in case a full evaluation is 
found necessary in accordance with Article 14(1) of Regulation (EU) 
No 528/2012 2.500 Renewal of an approval; Article 13(3) 
Additional fee per product-type (for both the first product-type and any 
additional product-type) if the ac tive substance is a candidate for 
substitution in accordance with Ar ticle 10 of Regulation (EU) No 
528/2012 20.000 
Fee for the first inclusion in Annex I of an active substance 10.000 Inclusion in Annex I of an active substance; 
Article 28 
Fee for the amendment of an inclusion of an active substance in Annex I 2.000 
Notification in accordance with Article 3a of 
Regulation (EC) No 1451/2007 Fee per substance/product-type combination. 
The fee for the notification shall be deducted from the subsequent 
application in accordance with Article  7 of Regulation (EU) No 528/2012. 10.000 
  
EN 13   EN Table 2  
Fee reductions for applications fo r the approval, renewal of appr oval, inclusion in Annex I of 
active substances if the active substance manuf acturer is an SME established in the Union, 
except where the active substance is a candidate for substitution 
Type of enterprise Reduction (% of the 
standard fee) 
Micro enterprise 60  
Small enterprise 40 
Medium enterprise 20 
 
  
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) 
Granting of Union authorisation, single product; 
Article 43(2) Fee per product not identical with (one of) the representative 
product(s) assessed for the purpose of the substance approval 80.000 
 Fee per product identical with (one of) the representative 
product(s) assessed for the purpose of the substance approval 40.000 
 Additional fee per product when comparative assessment in 
accordance with Article 23 of Regulation (EU) No 528/2012 is required 40.000 
 Additional fee per product when the requested authorisation is 
provisional in accordance with Artic le 55(2) of Regulation (EU) 
No 528/2012 10.000 
Granting of Union authorisation, biocidal product 
family; Article 43(2) Fee per family 150.000 
 
 Additional fee per family when comparative assessment in 
accordance with Article 23 of Regulation (EU) No 528/2012 is 
required 60.000 
 Additional fee per family when the requested authorisation is 
provisional in accordance with Artic le 55(2) of Regulation (EU) 
No 528/2012 15.000 
Notification to the Agency  of an additional product 
within a biocidal product family; Article 17(6) Fee per additional product 2.000  
EN 14   EN Union authorisation of a same biocidal product; 
Article 17(7) Fee per product constituting a "same product" within the 
meaning of [the Same  Products Regulation] 2.000 
Major change of an authorised product or product 
family; Article 50(2) Fee per application  40.000 
Minor change of an authorised product or product 
family; Article 50(2) Fee per application  15.000 
Administrative change of an authorised product or 
product family; Article 50(2) Fee per notification  2.000 
Recommendation on the classification of a change 
of an authorised product or product family; 
Article 50(2) Fee per request in accordance with [the Regulation on 
Changes]. 
If the recommendation is to classify the change as an 
administrative or minor change, the fee for the request shall be deducted from the subsequent ap plication or notification in 
accordance with [the Regulation on Changes].  2.000 
Renewal of Union authorisation, single product; 
Article 45(3) Fee per product  5.000 
 Additional fee per product in case a full evaluation is found 
necessary in accordance with Artic le 14(1) of Regulation (EU) 
No 528/2012 15.000 
 Additional fee per product when comparative assessment in 
accordance with Article 23 of Regulation (EU) No 528/2012 is required 40.000 
Renewal of Union authoris ation, biocidal product 
family; Article 45(3) Fee per product family  7.500 
 Additional fee per product family in case a full evaluation is 
found necessary in accordance with  Article 14(1) of Regulation 
(EU) No 528/2012 22.500 
 Additional fee per product family when comparative assessment 
in accordance with Article 23 of Regulation (EU) No 528/2012 is required 60.000 
  
Table 2 
Fee reductions for applications fo r the granting and renewal of Un ion authorisation of biocidal 
products or biocidal product families, if the prospective authorisation holder is an SME 
established in the Union, except where the produ ct contains an active substance which is a 
candidate for substitution 
Type of enterprise Reduction (% of the 
standard fee)  
Micro enterprise 30  
EN 15   EN Small enterprise 20 
Medium enterprise 10 
 
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 activ e substance sources is limited to a 
change in manufacturing location, a nd application is based solely on 
analytical data 5.000 
Fee, when difference between the act ive substance sources goes beyond a 
change in the manufacturing location,  and application is based solely on 
analytical data 20.000 Technical equivalence; Article 54(3) 
Fee when previous conditions are not met. 40.000 
Fee per Union authorisation of a biocidal product 10.000 Annual fee for biocidal products authorised 
by the Union; Article 80(1)(a) 
Fee per Union authorisation of a biocidal product family 20.000 
Mutual Recognition Submission fee; 
Article 80(1)(a) Fee per product or product family concer ned by an application for mutual 
recognition 700 
Appeal; Article 77(1) Fee per appeal 2.500 
Fee per submission of a letter of access to a dossier already found 
complete by the Agency or an evaluating Competent Authority 2.000 
Fee per submission of a letter of access to part of a dossier already found 
complete by the Agency or an eval uating Competent Authority, together 
with complementary data 20.000 Submission for inclusion in the list of 
relevant persons; Article 95 
Fee per submission of a new dossier 40.000 
Requests under Article 66(4) submitted to 
the Agency Fee per item for which confidentiality is requested 1.000