LegalizeCommission 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
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.
Article 2
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 3
Other fees
Article 4
Fees for appeals against a decision of the Agency under Article 77 of Regulation (EU) No 528/2012
Article 5
Reimbursement possibility for alternatives to approved active substances fulfilling one of the exclusion criteria
CHAPTER II
SUPPORT FOR SMEs
Article 6
Recognition of SME status
Article 7
Fee Reductions
CHAPTER III
PAYMENTS
Article 8
Mode of payment
Article 9
Identification of the payment
Article 10
Date of payment
Article 11
Insufficient payment
Article 12
Refund of amounts paid in excess
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.
Article 13
Refunds of amounts in case of applications rejected before or during validation or withdrawn during the assessment
The fee collected shall not be reimbursed where an application is withdrawn after the evaluating Competent Authority has transmitted its assessment report to the Agency.
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 Article 80(2) to the Member States’ competent authorities acting as evaluating competent authority.
Article 15
Charges
Article 16
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 (2), 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 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 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.
ANNEX I
Fees relating to active substances
| General description of task; relevant provision in Regulation (EU) No 528/2012 | Specific condition or task description | Fee (EUR) |
|---|---|---|
| Approval of an active substance; Article 7(2) | 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 active substance is a candidate for substitution in accordance with Article 10 of Regulation (EU) No 528/2012 | 20 000 | |
| Fee for the amendment of an approval, other than the addition of a product-type. | 20 000 | |
| Renewal of an approval; Article 13(3) | 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 | |
| Additional fee per product-type (for both the first product-type and any additional product-type) if the active substance is a candidate for substitution in accordance with Article 10 of Regulation (EU) No 528/2012 | 20 000 | |
| Inclusion in Annex I of an active substance; Article 28 | Fee for the first inclusion in Annex I of an active substance | 10 000 |
| 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 |
| 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
| 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 Article 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 Article 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 |
| Union authorisation of a same biocidal product; Article 17(7) | Fee per product constituting a ‘same product’ within the meaning of Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (1) | 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 Regulation (EU) No 354/2013. 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 application or notification in accordance with Regulation (EU) No 354/2013. | 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 Article 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 authorisation, 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 | |
| (1) OJ L 125, 7.5.2013, p. 4. | ||
| Type of enterprise | Reduction (% of the standard fee) | |
| --- | --- | |
| Micro enterprise | 30 | |
| Small enterprise | 20 | |
| Medium enterprise | 10 |
ANNEX III
| General description of task; relevant provision in Regulation (EU) No 528/2012) | Specific condition or task description | Fee (EUR) |
|---|---|---|
| Technical equivalence; Article 54(3) | Fee, when difference between the active substance sources is limited to a change in manufacturing location, and application is based solely on analytical data | 5 000 |
| Fee, when difference between the active substance sources goes beyond a change in the manufacturing location, and application is based solely on analytical data | 20 000 | |
| Fee when previous conditions are not met. | 40 000 | |
| Annual fee for biocidal products authorised by the Union; Article 80(1)(a) | Fee per Union authorisation of a biocidal product | 10 000 |
| 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 concerned by an application for mutual recognition, per Member State where mutual 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 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 evaluating Competent Authority, together with complementary data | 20 000 | |
| 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 |