Regulation (EU) No 528/2012 of the European Parliament and of the CouncilShow full title

Article 80 Fees and charges

1. The Commission shall adopt, on the basis of the principles set out in paragraph 3, an implementing Regulation specifying:

(a) the fees payable to the Agency, including an annual fee for products granted a Union authorisation in accordance with Chapter VIII and a fee for applications for mutual recognition in accordance with Chapter VII;

(b) the rules defining conditions for reduced fees, fee waivers and the reimbursement of the member of the Biocidal Products Committee who acts as a rapporteur; and

(c) conditions of payment.

That implementing Regulation shall be adopted in accordance with the examination procedure referred to in Article 82(3). It shall apply only with respect to fees paid to the Agency.

The Agency may collect charges for other services it provides.

The fees payable to the Agency shall be set at such a level as to ensure that the revenue derived from the fees, when combined with other sources of the Agency’s revenue pursuant to this Regulation, is sufficient to cover the cost of the services delivered. The fees payable shall be published by the Agency.

2. Member States shall directly charge applicants fees for services that they provide with respect to the procedures under this Regulation, including the services undertaken by Member States’ competent authorities when acting as evaluating competent authority.

Based on the principles set out in paragraph 3, the Commission shall issue guidance concerning a harmonised structure of fees.

Member States may levy annual fees with respect to biocidal products made available on their markets.

Member States may collect charges for other services they provide.

Member States shall set and publish the amount of fees payable to their competent authorities.

3. Both the implementing Regulation referred to in paragraph 1 and Member States’ own rules concerning fees shall respect the following principles:

(a) fees shall be set at such a level as to ensure that the revenue derived from the fees is, in principle, sufficient to cover the cost of the services delivered and shall not exceed what is necessary to cover those costs;

(b) partial reimbursement of the fee if the applicant fails to submit the information requested within the specified time limit;

(c) the specific needs of SMEs shall be taken into account, as appropriate, including the possibility of splitting payments into several instalments and phases;

(d) the structure and amount of fees shall take into account whether information has been submitted jointly or separately;

(e) in duly justified circumstances, and where it is accepted by the Agency or the competent authority, the whole fee or a part of it may be waived; and

(f) the deadlines for the payment of fees shall be fixed taking due account of the deadlines of the procedures provided for in this Regulation.