# Commission Implementing Regulation (EU) No 564/2013Show full title

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 the market and use of biocidal products (Text with EEA relevance)         

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U.K.

# 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 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 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,                        

Whereas:

(1)The structure and amount of the fees payable 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 should take account 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 the revenue derived from them, when combined with                              other sources of the Agency’s revenue, is sufficient to cover the cost of the services delivered.

(3)It follows from Article 80(3)(d) of Regulation (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 actual 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.

(4)To take into account the specific needs of small and medium-sized enterprises within the meaning of Commission Recommendation                              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 fees for active substance approval, renewal of approval or inclusion                              in Annex I to Regulation (EU) No 528/2012 and biocidal product authorisation or renewal should apply to such companies. The                              levels of the reductions should take into account the significant proportion of SMEs in the 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.

(5)Taking into account the Agency’s work required 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 Article 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 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 in such cases.

(7)For the purpose of encouraging applications for approval of active substances that are suitable alternatives to approved active                              substances fulfilling one of the exclusion criteria listed in Article 5(1) of Regulation (EU) No 528/2012, it is appropriate                              to provide for reimbursement 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 the estimated work required by the Agency to handle 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                              substitution criteria listed in Article 10(1) of Regulation (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 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 with                              Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance                              with Regulation (EU) No 528/2012 of the European Parliament and of the Council(3), 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 reduction                              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 (EU) No 528/2012, it is appropriate to levy a fee for such submissions. 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 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                              the placing on the market of biocidal products(4). It is appropriate to differentiate the fee accordingly.

(12)Given the Agency’s work required to handle a request for confidentiality 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 implemented 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 general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002(5), with Article 17 of Commission Regulation (EC, Euratom) No 2343/2002 of 23 December 2002 on the framework Financial Regulation                              for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable                              to the general budget of the European Communities(6) and with Article 17 of the Financial Regulation of the European Chemicals Agency of 24 September 2008(7), 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 should be fixed                              taking due account of the deadlines of the 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 fees with the                              inflation rate and with the actual costs to the Agency of the services provided. These reviews should take into account the                              Agency’s increased experience in dealing with applications under the Regulation and the efficiencies thereby gained.

(16)The Standing Committee on Biocidal Products referred to in Article 82(1) of Regulation (EU) No 528/2012 did not deliver an                              opinion on the measures provided for in this Regulation. Since an implementing act was deemed to be necessary, 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 IU.K.**FEES**

### Article 1U.K.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.                  

### Article 2U.K.Fees 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 3U.K.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 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 authorised                        by the Union. The annual fee shall be due on the first and each subsequent anniversary of the entry into force of the authorisation.                        It shall relate to the preceding year.                  

### Article 4U.K.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 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 with paragraph 1 if the Executive Director of the Agency rectifies a                        decision in accordance with Article 93(1) of Regulation (EU) No 1907/2006 of the European Parliament and of the Council(8), or if the appeal is decided in favour of the appellant.                  

### Article 5U.K.Reimbursement possibility for alternatives to approved active substances fulfilling one of the exclusion criteria

1.Upon submission of an application to the Agency for the approval of an active substance, which may be a suitable alternative,                        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 in accordance with Article 8(4) of Regulation (EU) No 528/2012, which shall also                        include a recommendation on 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, the Commission shall decide on the request.                  

3.Where the Commission decides that the active substance is a suitable alternative, the Agency shall inform the applicant thereof                        and fully reimburse the fee referred to in paragraph 1.                  

## CHAPTER IIU.K.**SUPPORT FOR SMEs**

### Article 6U.K.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 manufacturer that is represented 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 to be 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 7U.K.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.                  

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 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.                  

## CHAPTER IIIU.K.**PAYMENTS**

### Article 8U.K.Mode of payment

1.The fees provided for by this Regulation 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 transfer to the bank account of the Agency.                  

### Article 9U.K.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.                  

2.Payments referred to in Article 8(3) shall indicate, in the reference 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, 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 notification of the purpose of the payment before                        expiry of that deadline, the payment shall be considered invalid and the amount concerned shall be refunded to the paying                        party.                  

### Article 10U.K.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.                  

2.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.                  

3.The payment shall be considered to have 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 before expiry of the relevant deadline. A confirmation                        of the transfer order issued by a financial institution shall be regarded as sufficient evidence.                  

### Article 11U.K.Insufficient payment

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.                  

2.When an invoice relates to a group of transactions, the Agency may attribute any under-payment to any of the relevant transactions.                        The criteria for the attribution of payments shall be laid down by the Management Board of the Agency.                  

### Article 12U.K.Refund of amounts paid in excess

1.The arrangements for the refund to the paying 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 refund, the                     amount paid in excess shall not be refunded.                  

2.It shall not be possible to count any amount paid in excess and not refunded as being made towards future payments to the                        Agency.                  

### Article 13U.K.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 with respectively Article 7(1) or 43(1) of Regulation (EU) No 528/2012, or an application                        for a minor or major change of a 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 with respectively 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.                  

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

## CHAPTER IVU.K.**FINAL PROVISIONS**

### Article 14U.K.Reimbursement of rapporteurs

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

### Article 15U.K.Charges

1.Subject to a favourable opinion from the Commission, the Agency 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 request of                        a party in order to facilitate its implementation. The Executive 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.                  

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

### Article 16U.K.Provisional estimate

The Management Board of the Agency shall, when producing an estimate of the overall expenditure and income for the following                     financial year in accordance with Article 96(5) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council(9), 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 17U.K.Review

The Commission shall review the fees and charges provided for in this 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 review shall be carried out                     at the 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 anticipated income 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 in particular                     the resources required by the Agency and those required 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.                  

## Article 18U.K.

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, 18 June 2013.

*For the Commission*                            

*The President*                            

José Manuel Barroso                            

## ANNEX IU.K.

### **Fees relating to active substances**

## ANNEX IIU.K.

### **Fees for Union authorisation of biocidal products**

## ANNEX IIIU.K.

### **Other fees**

1

OJ L 167, 27.6.2012, p. 1.                           

2

OJ L 124, 20.5.2003, p. 36.                           

3

OJ L 109, 19.4.2013, p. 4.                           

4

OJ L 123, 24.2.1998, p. 1.                           

5

OJ L 298, 26.10.2012, p. 1.                           

6

OJ L 357, 31.12.2002, p. 72.                           

7

MB/53/2008 final.

8

OJ L 396, 30.12.2006, p. 1.                           

9

OJ L 396, 30.12.2006, p. 1.