Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products Text with EEA relevance

Where the receiving competent authority considers that the application is incomplete, it shall inform the applicant as to what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information. That time limit shall not normally exceed 90 days.

Where the Register for Biocidal Products referred to in Article 71 shows that a competent authority other than the receiving competent authority is examining an application relating to the same biocidal product or has already authorised the same biocidal product, the receiving competent authority shall decline to evaluate the application. In that event, the receiving competent authority shall inform the applicant of the possibility of seeking mutual recognition in accordance with Article 33 or 34.

If paragraph 3 does not apply and the receiving competent authority considers that the application is complete, it shall validate the application and without delay inform the applicant accordingly, indicating the date of the validation.

The receiving competent authority shall, within 365 days of the validation of an application in accordance with Article 29, decide whether to grant an authorisation in accordance with Article 19. It shall take into account the results of the comparative assessment carried out in accordance with Article 23, if applicable.

Where it appears that additional information is necessary to carry out the evaluation, the receiving competent authority shall ask the applicant to submit such information within a specified time limit. The 365-day period referred to in paragraph 1 shall be suspended from the date of issue of the request until the date the information is received. The suspension shall not exceed 180 days in total unless it is justified by the nature of the data requested or by exceptional circumstances.

Within the 365-day period referred to in paragraph 1, the receiving competent authority shall:

An application by or on behalf of an authorisation holder wishing to seek the renewal of a national authorisation for one or more product-types shall be submitted to the receiving competent authority at least 550 days before the expiry date of the authorisation. Where renewal is sought for more than one product-type, the application shall be submitted at least 550 days before the earliest expiry date.

The receiving competent authority shall renew the national authorisation, provided that the conditions set out in Article 19 are still satisfied. It shall take into account the results of the comparative assessment carried out in accordance with Article 23, if applicable.

When applying for renewal, the applicant shall submit:

The receiving competent authority shall inform the applicant of the fees payable under Article 80(2) and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant accordingly.

On the basis of an assessment of the available information and the need to review the conclusions of the initial evaluation of the application for authorisation or, as appropriate, the previous renewal, the receiving competent authority shall, within 90 days of accepting an application in accordance with paragraph 4, decide whether, in the light of current scientific knowledge, a full evaluation of the application for renewal is necessary taking account of all product-types for which renewal is requested.

Where the receiving competent authority decides that a full evaluation of the application is necessary, it shall decide on the renewal of the authorisation after carrying out an evaluation of the application in accordance with paragraphs 1, 2 and 3 of Article 30.

Where, for reasons beyond the control of the holder of a national authorisation, no decision is taken on the renewal of that authorisation before its expiry, the receiving competent authority shall grant a renewal for the period necessary to complete the evaluation.

Applications for mutual recognition of a national authorisation shall be made in accordance with the procedures set out in Article 33 (mutual recognition in sequence) or Article 34 (mutual recognition in parallel).

Without prejudice to Article 37, all Member States receiving applications for mutual recognition of a national authorisation for a biocidal product shall, in accordance with and subject to the procedures set out in this Chapter, authorise the biocidal product under the same terms and conditions.

Applicants wishing to seek the mutual recognition in sequence, in one or more Member States (‘the Member States concerned’), of the national authorisation of a biocidal product already granted in another Member State in accordance with Article 17 (‘the reference Member State’) shall submit an application to each of the competent authorities of the Member States concerned containing, in each case, a translation of the national authorisation granted by the reference Member State into such official languages of the Member State concerned as it may require.

Within 30 days of acceptance referred to in paragraph 1, the Member States concerned shall validate the application and inform the applicant accordingly, indicating the date of the validation.

Within 30 days of reaching agreement, each of the Member States concerned shall authorise the biocidal product in conformity with the agreed summary of biocidal product characteristics.

Without prejudice to Articles 35, 36, and 37, if no agreement is reached within the 90-day period referred to in the second subparagraph of paragraph 2, each Member State that agrees to the summary of biocidal product characteristics referred to in paragraph 2, may authorise the product accordingly.

Applicants wishing to seek the mutual recognition in parallel of a biocidal product which has not yet been authorised in accordance with Article 17 in any Member State shall submit to the competent authority of the Member State of its choice (‘the reference Member State’) an application containing:

The applicant shall, at the same time as submitting the application to the reference Member State in accordance with paragraph 1, submit to the competent authorities of each of the Member States concerned an application for mutual recognition of the authorisation for which it has applied to the reference Member State. This application shall contain:

The competent authorities of the reference Member State and of the Member States concerned shall inform the applicant of the fees payable in accordance with Article 80 and shall reject the application if the applicant fails to pay the fees within 30 days. They shall inform the applicant and the other competent authorities accordingly. Upon receipt of the fees payable under Article 80, the competent authorities of the reference Member State and of the Member States concerned shall accept the application and inform the applicant indicating the date of acceptance.

The reference Member State shall validate the application in accordance with Article 29(2) and (3) and inform the applicant and the Member States concerned accordingly.

Within 90 days of receipt of the documents referred to in paragraph 4, and subject to Articles 35, 36 and 37, the Member States concerned shall agree on the summary of biocidal product characteristics, and shall record their agreement in the Register for Biocidal Products. The reference Member State shall enter the agreed summary of biocidal product characteristics and the final assessment report in the Register for Biocidal Products, together with any agreed terms or conditions imposed on the making available on the market or use of the biocidal product.

Within 30 days of reaching agreement, the reference Member State and each of the Member States concerned shall authorise the biocidal product in conformity with the agreed summary of biocidal product characteristics.

Without prejudice to Articles 35, 36, and 37, if no agreement is reached within the 90-day period referred to in paragraph 5, each Member State that agrees to the summary of biocidal product characteristics referred to in paragraph 5 may authorise the product accordingly.

A coordination group shall be set up to examine any question, other than matters referred to in Article 37, relating to whether a biocidal product for which an application for mutual recognition has been made in accordance with Article 33 or 34 meets the conditions for granting an authorisation laid down in Article 19.

If any of the Member States concerned considers that a biocidal product assessed by the reference Member State does not meet the conditions laid down in Article 19, it shall send a detailed explanation of the points of disagreement and the reasons for its position to the reference Member State, the other Member States concerned, the applicant, and, where applicable, to the authorisation holder. The points of disagreement shall be referred without delay to the coordination group.

Within the coordination group, all Member States referred to in paragraph 2 of this Article shall use their best endeavours to reach agreement on the action to be taken. They shall allow the applicant the opportunity to make its point of view known. Where they reach agreement within 60 days of the referral of the points of disagreement referred to in paragraph 2 of this Article, the reference Member State shall record the agreement in the Register for Biocidal Products. The procedure shall then be considered to be closed and the reference Member State and each of the Member States concerned shall authorise the biocidal product in accordance with Article 33(3) or 34(6) as appropriate.

If the Member States referred to in Article 35(2) fail to reach agreement within the 60-day period laid down in Article 35(3), the reference Member State shall immediately inform the Commission, and provide it with a detailed statement of the matters on which Member States have been unable to reach agreement and the reasons for their disagreement. A copy of that statement shall be forwarded to the Member States concerned, the applicant and, where applicable, the authorisation holder.

The Commission may ask the Agency for an opinion on scientific or technical questions raised by Member States. Where the Commission does not ask the Agency for an opinion it shall provide the applicant and, where applicable, the authorisation holder with the opportunity to provide written comments within 30 days.

The Commission shall adopt, by means of implementing acts, a decision on the matter referred to it. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).

The decision referred to in paragraph 3 shall be addressed to all Member States and reported for information to the applicant and, where applicable, the authorisation holder. The Member States concerned and the reference Member State shall, within 30 days of notification of the decision, either grant, refuse to grant or cancel the authorisation, or vary its terms and conditions as necessary to comply with the decision.

By way of derogation from Article 32(2), any of the Member States concerned may propose to refuse to grant an authorisation or to adjust the terms and conditions of the authorisation to be granted, provided that such a measure can be justified on grounds of:

The Member State concerned shall communicate to the applicant a detailed statement of the grounds for seeking a derogation pursuant to paragraph 1 and shall seek to reach an agreement with the applicant on the proposed derogation.

If the Commission has not adopted a decision pursuant to paragraph 2 within 90 days of being informed in accordance with the second subparagraph of paragraph 2, the Member State concerned may implement the derogation proposed pursuant to paragraph 1.

By way of derogation from Article 32(2), a Member State may refuse to grant authorisations for product-types 15, 17 and 20 on grounds of animal welfare. Member States shall without delay inform other Member States and the Commission of any decision taken in this respect and its justification.

If so requested by the Commission pursuant to Article 36(2) or Article 37(2), the Agency shall issue an opinion within 120 days from the date on which the matter in question was referred to it.

Before issuing its opinion, the Agency shall provide the applicant and, where applicable, the authorisation holder with an opportunity to provide written comments within a specified time limit not exceeding 30 days.

Where no application for a national authorisation has been submitted in a Member State for a biocidal product that is already authorised in another Member State, official or scientific bodies involved in pest control activities or the protection of public health may apply, under the mutual recognition procedure provided for in Article 33 and with the consent of the authorisation holder in that other Member State, for a national authorisation for the same biocidal product, with the same use and the same conditions for use as in that Member State.

Where the competent authority of the Member State concerned considers that the biocidal product fulfils the conditions referred to in Article 19 and the conditions under this Article are met, the competent authority shall authorise the making available on the market and use of the biocidal product. In that case, the body that made the application shall have the same rights and obligations as other authorisation holders.

Applicants may apply for Union authorisation for biocidal products which have similar conditions of use across the Union with the exception of biocidal products that contain active substances that fall under Article 5 and those of product-types 14, 15, 17, 20 and 21. The Union authorisation may be granted:

The Commission shall by 1 September 2013 draw up guidance documents on the definition of ‘similar conditions of use across the Union’.

The Commission shall submit a report to the European Parliament and the Council on the application of this Article by 31 December 2017. That report shall contain an assessment of the exclusion of product-types 14, 15, 17, 20 and 21 from the Union authorisation.

Applicants wishing to apply for Union authorisation in accordance with Article 42(1) shall submit an application to the Agency, including a confirmation that the biocidal product would have similar conditions of use across the Union, informing the Agency of the name of the competent authority of the Member State that they propose should evaluate the application and providing written confirmation that that competent authority agrees to do so. That competent authority shall be the evaluating competent authority.

The Agency shall inform the applicant of the fees payable under Article 80(1), and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant and the evaluating competent authority accordingly.

Within 30 days of the Agency accepting an application, the evaluating competent authority shall validate the application if the relevant information referred to in Article 20 has been submitted.

Where the evaluating competent authority considers that the application is incomplete, it shall inform the applicant what additional information is required for the evaluation of the application and shall set a reasonable time limit for the submission of that information. That time limit shall not normally exceed 90 days.

On validating the application in accordance with paragraph 3 or 4, the evaluating competent authority shall, without delay, inform the applicant, the Agency and other competent authorities accordingly, indicating the date of the validation.

An appeal may be brought, in accordance with Article 77, against decisions of the Agency under paragraph 2 of this Article.

The evaluating competent authority shall, within 365 days of the validation of an application, evaluate it in accordance with Article 19, including, where relevant, any proposal to adapt data requirements submitted in accordance with Article 21(2), and send an assessment report and the conclusions of its evaluation to the Agency.

Where it appears that additional information is necessary to carry out the evaluation, the evaluating competent authority shall ask the applicant to submit such information within a specified time limit, and shall inform the Agency accordingly. The 365-day period referred to in paragraph 1 shall be suspended from the date of issue of the request until the date the information is received. However, the suspension shall not exceed 180 days in total other than in exceptional cases and where justified by the nature of the information requested.

Within 180 days of receipt of the conclusions of the evaluation, the Agency shall prepare and submit to the Commission an opinion on the authorisation of the biocidal product.

Within 30 days of submitting its opinion to the Commission, the Agency shall transmit to the Commission, in all the official languages of the Union, the draft summary of the biocidal product characteristics, as referred to in Article 22(2), where applicable.

On receipt of the opinion of the Agency, the Commission shall adopt either an implementing regulation granting the Union authorisation to the biocidal product or an implementing decision stating that the Union authorisation of the biocidal product has not been granted. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).

An application by or on behalf of an authorisation holder wishing to seek the renewal of a Union authorisation shall be submitted to the Agency at least 550 days before the expiry date of the authorisation.

When applying for renewal, the applicant shall submit:

The applicant shall also submit the name of the competent authority of the Member State that it proposes should evaluate the application for renewal and provide written confirmation that that competent authority agrees to do so. That competent authority shall be the evaluating competent authority.

An appeal may be brought, in accordance with Article 77, against decisions of the Agency under paragraph 3 of this Article.

On the basis of an assessment of the available information and the need to review the conclusions of the initial evaluation of the application for Union authorisation or, as appropriate, the previous renewal, the evaluating competent authority shall, within 30 days of the Agency accepting the application in accordance with Article 45(3), decide whether, in the light of current scientific knowledge, a full evaluation of the application for renewal is necessary.

Where the evaluating competent authority decides that a full evaluation of the application is necessary, the evaluation shall be carried out in accordance with paragraphs 1 and 2 of Article 44.

Within 180 days of receipt of a recommendation from the evaluating competent authority, the Agency shall prepare and submit to the Commission an opinion on the renewal of the Union authorisation.

On receipt of the opinion of the Agency, the Commission shall adopt either an implementing Regulation to renew the Union authorisation or an implementing decision to refuse to renew the Union authorisation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).

Where, for reasons beyond the control of the holder of the Union authorisation, no decision is taken on the renewal of the authorisation before its expiry, the Commission shall grant the renewal of the Union authorisation for the period necessary to complete the evaluation by means of implementing acts. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 82(2).

On becoming aware of information concerning the authorised biocidal product, or the active substance(s) it contains, that may affect the authorisation, the holder of an authorisation shall without delay notify the competent authority that granted the national authorisation and the Agency or, in the case of a Union authorisation, the Commission and the Agency. In particular, the following shall be notified:

The competent authority that granted the national authorisation or, in the case of a Union authorisation, the Agency, shall examine whether the authorisation needs to be amended or cancelled in accordance with Article 48.

The competent authority that granted the national authorisation or, in the case of a Union authorisation, the Agency, shall without delay notify competent authorities of other Member States and, where appropriate, the Commission of any such data or information it receives.

Without prejudice to Article 23, the competent authority of a Member State or, in the case of a Union authorisation, the Commission shall at any time cancel or amend an authorisation it has granted where it considers that:

Where the competent authority or, in the case of a Union authorisation, the Commission, intends to cancel or amend an authorisation, it shall inform the authorisation holder thereof and give it the opportunity to submit comments or additional information within a specified time limit. The evaluating competent authority or, in the case of a Union authorisation, the Commission, shall take due account of those comments when finalising its decision.

Where the competent authority or, in the case of a Union authorisation, the Commission, cancels or amends an authorisation in accordance with paragraph 1, it shall without delay notify the authorisation holder, the competent authorities of other Member States and, where relevant, the Commission.

Amendments to the terms and conditions of an authorisation shall be made only by the competent authority that authorised the biocidal product concerned, or in the case of a Union authorisation, by the Commission.

An authorisation holder seeking to change any of the information submitted in relation to the initial application for authorisation of the product shall apply to the competent authorities of relevant Member States having authorised the biocidal product concerned, or in the case of a Union authorisation, the Agency. Those competent authorities shall decide, or, in the case of a Union authorisation, the Agency shall examine and the Commission decide whether the conditions of Article 19 or, where relevant, Article 25 are still met and whether the terms and conditions of the authorisation need to be amended.

An amendment to an existing authorisation shall fall under one of the following categories of changes:

By way of derogation from Article 17, a competent authority of a Member State (‘Member State of introduction’) shall, at the request of the applicant, grant a parallel trade permit for a biocidal product that is authorised in another Member State (‘Member State of origin’) to be made available on the market and used in the Member State of introduction, if it determines in accordance with paragraph 3 that the biocidal product is identical to a biocidal product already authorised in the Member State of introduction (‘the reference product’).

Where the competent authority of the Member State of introduction determines that a biocidal product is identical to the reference product, it shall grant a parallel trade permit within 60 days of receipt of the fees payable under Article 80(2). The competent authority of the Member State of introduction may request from the competent authority of the Member State of origin additional information necessary to determine whether the product is identical to the reference product. The competent authority of the Member State of origin shall provide the requested information within 30 days of receiving the request.

A biocidal product shall be considered as identical to the reference product only if all the following conditions are met:

An application for a parallel trade permit shall include the following information and items:

The parallel trade permit shall prescribe the same conditions for making available on the market and use as the authorisation of the reference product.

The parallel trade permit shall be valid for the duration of authorisation of the reference product in the Member State of introduction.

Without prejudice to specific provisions in this Article, Articles 47 to 50 and Chapter XV shall apply mutatis mutandis to biocidal products made available on the market under a parallel trade permit.

The competent authority of the Member State of introduction may withdraw a parallel trade permit if the authorisation of the introduced biocidal product is withdrawn in the Member State of origin because of safety or efficacy reasons.

Where it is necessary to establish the technical equivalence of active substances, the person seeking to establish that equivalence (‘the applicant’) shall submit an application to the Agency.

The applicant shall submit all data that the Agency requires to assess technical equivalence.

The Agency shall inform the applicant of the fees payable under Article 80(1) and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant accordingly.

After giving the applicant the opportunity to submit comments, the Agency shall take a decision within 90 days of receipt of the application referred to in paragraph 1 and shall communicate it to Member States and to the applicant.

Where, in the opinion of the Agency, additional information is necessary to carry out the assessment of technical equivalence, the Agency shall ask the applicant to submit such information within a time limit specified by the Agency. The Agency shall reject the application if the applicant fails to submit the additional information within the specified time limit. The 90-day period referred to in paragraph 4 shall be suspended from the date of issue of the request until the information is received. The suspension shall not exceed 180 days except where justified by the nature of the data requested or in exceptional circumstances.

Where appropriate, the Agency may consult the competent authority of the Member State which acted as the evaluating competent authority for the evaluation of the active substance.

An appeal may be brought, in accordance with Article 77, against decisions of the Agency under paragraphs 3, 4 and 5 of this Article.

The Agency shall draw up technical guidance notes to facilitate the implementation of this Article.

By way of derogation from Articles 17 and 19, a competent authority may permit, for a period not exceeding 180 days, the making available on the market or use of a biocidal product which does not fulfil the conditions for authorisation laid down in this Regulation, for a limited and controlled use under the supervision of the competent authority, if such a measure is necessary because of a danger to public health, animal health or the environment which cannot be contained by other means.

By way of derogation from point (a) of Article 19(1) and until an active substance is approved, competent authorities and the Commission may authorise, for a period not exceeding three years, a biocidal product containing a new active substance.

By way of derogation from point (a) of Article 19(1), the Commission may, by means of implementing acts, allow a Member State to authorise a biocidal product containing a non-approved active substance if it is satisfied that that active substance is essential for the protection of cultural heritage and that no appropriate alternatives are available. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 82(2). A Member State wishing to obtain such a derogation shall apply to the Commission, providing due justification.

By way of derogation from Article 17, an experiment or a test for the purposes of scientific or product and process-orientated research and development involving an unauthorised biocidal product or a non-approved active substance intended exclusively for use in a biocidal product (‘experiment’ or ‘test’) may take place only under the conditions provided for in this Article.

Any person intending to carry out an experiment or test that may involve, or result in, release of the biocidal product into the environment shall first notify the competent authority of the Member State where the experiment or test will occur. The notification shall include the identity of the biocidal product or active substance, labelling data and quantities supplied, and all available data on possible effects on human or animal health or impact on the environment. The person concerned shall make available any other information requested by the competent authorities.

If the experiments or tests could have harmful effects, whether immediate or delayed, on the health of humans, particularly of vulnerable groups, or animals, or any unacceptable adverse effect on humans, animals or the environment, the relevant competent authority of the Member State concerned may prohibit them or allow them subject to such conditions as it considers necessary to prevent those consequences. The competent authority shall, without delay, inform the Commission and other competent authorities of its decision.

The Commission shall be empowered to adopt delegated acts in accordance with Article 83 specifying detailed rules supplementing this Article.

This Article shall apply exclusively to treated articles that are not biocidal products. It shall not apply to treated articles where the sole treatment undertaken was the fumigation or disinfection of premises or containers used for storage or transport and where no residues are expected to remain from such treatment.

A treated article shall not be placed on the market unless all active substances contained in the biocidal products that it was treated with or incorporates are included in the list drawn up in accordance with Article 9(2), for the relevant product-type and use, or in Annex I, and any conditions or restrictions specified therein are met.

The person responsible for the placing on the market of a treated article shall ensure that the label provides the information listed in the second subparagraph, where:

Notwithstanding the labelling requirements set out in paragraph 3, the person responsible for the placing on the market of a treated article shall label it with any relevant instructions for use, including any precautions to be taken, if this is necessary to protect humans, animals and the environment.

Notwithstanding the labelling requirements set out in paragraph 3, the supplier of a treated article shall, where a consumer so requests, provide that consumer, within 45 days, free of charge, with information on the biocidal treatment of the treated article.

The labelling shall be clearly visible, easily legible and appropriately durable. Where necessary because of the size or the function of the treated article, the labelling shall be printed on the packaging, on the instructions for use or on the warranty in the official language or languages of the Member State of introduction, unless that Member State provides otherwise. In the case of treated articles that are not produced as part of a series but rather designed and manufactured to meet a specific order, the manufacturer may agree other methods of providing the customer with the relevant information.

The Commission may adopt implementing acts for the application of paragraph 2 of this Article, including appropriate notification procedures, possibly involving the Agency, and further specifying the labelling requirements under paragraphs 3, 4 and 6 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).

Where there are significant indications that an active substance contained in a biocidal product with which a treated article is treated or which it incorporates does not meet the conditions laid down in Article 4(1), Article 5(2) or Article 25, the Commission shall review the approval of that active substance or its inclusion in Annex I in accordance with Article 15(1) or Article 28(2).

Without prejudice to Articles 62 and 63, data submitted for the purposes of Directive 98/8/EC or of this Regulation shall not be used by competent authorities or the Agency for the benefit of a subsequent applicant, except where:

When submitting data to a competent authority or to the Agency for the purposes of this Regulation the applicant shall, where relevant, indicate the name and contact details of the data owner for all data submitted. The applicant shall also specify whether it is the data owner or holds a letter of access.

The applicant shall, without delay, inform the competent authority or the Agency about any changes to the ownership of the data.

The advisory scientific committees set up under Commission Decision 2004/210/EC of 3 March 2004 setting up Scientific Committees in the field of consumer safety, public health and the environment ([^E0034]) shall also have access to the data referred to in paragraph 1 of this Article.

Data submitted for the purposes of Directive 98/8/EC or of this Regulation shall benefit from data protection under the conditions laid down in this Article. The protection period for the data shall start when they are submitted for the first time.

The protection period for data submitted with a view to the approval of an existing active substance shall end 10 years from the first day of the month following the date of adoption of a decision in accordance with Article 9 on the approval of the relevant active substance for the particular product-type.

The protection period for data submitted with a view to the authorisation of a biocidal product containing only existing active substances shall end 10 years from the first day of the month following the first decision concerning the authorisation of the product taken in accordance with Article 26(3), 30(1), 33(3), 33(4), 34(6), 34(7), 36(4), 37(2), 37(3) or 44(5).

A letter of access shall contain at least the following information:

Revocation of a letter of access shall not affect the validity of the authorisation issued on the basis of the letter of access in question.

In order to avoid animal testing, testing on vertebrates for the purposes of this Regulation shall be undertaken only as a last resort. Testing on vertebrates shall not be repeated for the purposes of this Regulation.

Any person intending to perform tests or studies (‘the prospective applicant’)

Where a request has been made in accordance with Article 62(2), the prospective applicant and the data owner shall make every effort to reach an agreement on the sharing of the results of the tests or studies requested by the prospective applicant. Such an agreement may be replaced by submission of the matter to an arbitration body and a commitment to accept the arbitration order.

Where such agreement is reached, the data owner shall make all the scientific and technical data related to the tests and studies concerned available to the prospective applicant or shall give the prospective applicant permission to refer to the data owner’s tests or studies when submitting applications under this Regulation.

Where no agreement is reached with respect to data involving tests or studies on vertebrates, the prospective applicant shall inform the Agency and the data owner thereof, at the earliest one month after the prospective applicant receives the name and address of the data submitter from the Agency.

Compensation for data sharing shall be determined in a fair, transparent and non-discriminatory manner, having regard to the guidance established by the Agency ([^E0035]). The prospective applicant shall be required to share only in the costs of information that it is required to submit for the purposes of this Regulation.

An appeal may be brought, in accordance with Article 77, against decisions of the Agency under paragraph 3 of this Article.

Where the relevant data protection period according to Article 60 has expired in relation to an active substance, the receiving competent authority or the Agency may agree that a subsequent applicant for authorisation may refer to data provided by the first applicant in so far as the subsequent applicant can provide evidence that the active substance is technically equivalent to the active substance for which the data protection period has expired, including the degree of purity and the nature of any relevant impurities.

Notwithstanding paragraph 1, subsequent applicants shall provide the following data accordingly to the receiving competent authority or the Agency, as applicable:

Member States shall make the necessary arrangements for the monitoring of biocidal products and treated articles which have been placed on the market to establish whether they comply with the requirements of this Regulation. Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products ([^E0036]) shall apply accordingly.

Member States shall make the necessary arrangements for official controls to be carried out in order to enforce compliance with this Regulation.

Every five years, from 1 September 2015, Member States shall submit to the Commission a report on the implementation of this Regulation in their respective territories. The report shall include in particular:

On the basis of the reports received in accordance with paragraph 3, and within 12 months from the date referred to in the second subparagraph of that paragraph, the Commission shall draw up a composite report on the implementation of this Regulation, in particular Article 58. The Commission shall submit the report to the European Parliament and to the Council.

Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents ([^E0037]) and the rules of the Management Board of the Agency, adopted in accordance with Article 118(3) of Regulation (EC) No 1907/2006, shall apply to documents held by the Agency for the purposes of this Regulation.