Representatives of Member States Competent Authorities for the Placing of Biocidal Products

PA&MRFG-July12-Doc.5

CA-July12-Doc.5.1.a

/ COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 24.11.2011

xxx

Preliminary Draft

Commission Implementing Regulation (EU) No xxx/2012

of […]

concerning changes to authorised biocidal products

EN EN

Preliminary Draft

Commission Implementing Regulation (EU) No xxx/2012

of […]

concerning changes to authorised biocidal products

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 of 22 May 2012 concerning the placing on the market and use of biocidal products, and in particular Article 51 thereof,

Whereas:

(1) It is appropriate to adopt provisions for changes to information submitted in relation to biocidal products and biocidal product families authorised in accordance with Directive 98/8/EC and Regulation (EU) No 528/2012.

(2) Changes are classified in different categories, taking into account the extent to which a re-assessment of the risk for human or animal health or the environment and of the efficacy of the biocidal product or biocidal product family is necessary. In order to bring further predictability, guidelines on the details of the various categories of changes should be established and regularly updated in the light of scientific and technical progress. The European Chemicals Agency (hereinafter "the Agency") and the Member States should also be empowered to give recommendations on the classification of unforeseen changes.

(3) In order to reduce the overall number of possible applications and to enable Member States, the Agency and the Commission to focus on those changes that have a genuine impact on the properties of biocidal products, an annual reporting system should be introduced for certain administrative changes. Such changes should not require any prior approval and should be notified within twelve months following implementation. However, other types of administrative changes whose immediate reporting and prior examination is necessary for the continuous supervision of the biocidal product concerned should not be subject to the annual reporting system.

(4) Each change should require a separate submission. Grouping of changes should nevertheless be allowed in certain cases, in order to facilitate the review of the changes and reduce the administrative burden. Grouping of changes should be allowed only insofar as all concerned biocidal products are affected by the exact same group of changes.

(5) Provisions should be established regarding the role of the coordination group established under Regulation (EU) No 528/2012 to increase cooperation between Member States and allow for the settlement of disagreements in the evaluation of certain changes.

(6) This Regulation should clarify when the authorisation holder is allowed to implement a given change, as such clarification is essential for economic operators.

HAS ADOPTED THIS REGULATION:

CHAPTER I
General provisions

Article 1
Subject matter and scope

This Regulation lays down provisions concerning changes to information submitted in relation to biocidal products and biocidal product families authorised in accordance with Directive 98/8/EC and Regulation (EU) No 528/2012.
Chapter II shall apply only to changes to biocidal products and biocidal product families authorised by Member States.
Chapter III shall apply only to changes to biocidal products and biocidal product families authorised by the Commission.

Article 2
Definitions

1. For the purposes of this Regulation, the following definitions shall apply:

(1) ‘Member State concerned’ means a Member State which has authorised the biocidal product and received an application for a change;

(2) 'Reference Member State' means the Member State which carried out the assessment of the application for the first authorisation of the biocidal product or, when this Member State is not concerned by the application to be examined, the Member State chosen by the applicant.

(3) 'non-active substance' means any substance or mixture, other than active substances, intentionally incorporated in a biocidal product.

2. For the purposes of this Regulation, the definitions laid down in Article 3 of Regulation (EU) No 528/2012 shall apply for the following terms:

(1) ‘Administrative change’;

(2) ‘Minor change’;

(3) ‘Major change'.

Article 3
Classification of changes

The classification laid down in Annex I shall apply.
A change, whose classification is not provided for in AnnexI shall, by default, be considered a major change.
By way of derogation from paragraph 2, a change, whose classification is not provided for in AnnexI, shall, upon request from the applicant, when submitting the change, be considered an administrative or a minor change, where the reference Member State or, in the case of a Union authorisation, the Agency concludes, following the assessment of validity of the notification or application, as the case may be, and taking into account the recommendations delivered pursuant to the following paragraph, that the change may require no re-assessment or a limited re-assessment of the efficacy of the biocidal product and of the risk for human or animal health or the environment.
Prior to submission of a change whose classification is not provided for in Annex I, the prospective applicant may request the reference Member State or, in the case of a change relating to a product authorised by the Commission, the Agency to provide a recommendation on the classification of the change.

The reference Member State may refer the request to the coordination group referred to in Article 35 of Regulation (EU) No 528/2012 (hereinafter "the coordination group") to provide a recommendation on the classification of the change.

The recommendation referred to in the first subparagraph shall be delivered within 45 days following receipt of the request and, where appropriate, payment of the fee payable in accordance with Article 80(1) of Regulation (EU) No 528/2012.

Member States, the Agency and the coordination group shall cooperate to ensure the coherence of the recommendations delivered in accordance with paragraph 4. The Agency shall publish those recommendations after deletion of all information of commercial confidential nature.

Article 4
Guidelines

The Agency shall, after consulting the Member States, the Commission and interested parties, draw up guidelines on the details of the various categories of changes.
These guidelines shall be regularly updated, taking into account the recommendations delivered in accordance with Article 3 as well as scientific and technical progress.

Article 5
Grouping of changes

Where several changes are notified or applied for, a separate notification or application, as appropriate, shall be submitted in respect of each change sought.
By way of derogation from paragraph 1, the following shall apply:

(a) a single notification as referred to in Articles 6 and 10 may cover a series of administrative changes affecting different products in the same manner;

(b) a single notification as referred to in Articles 6 and 10 may cover a series of administrative changes affecting the same product;

(c) a single application may cover more than one change to the same product provided that the changes concerned fall within one of the cases listed in Annex II or, if they do not fall within one of those cases, provided that the reference Member State or, in the case of a Union authorisation, the Agency agrees to subject those changes to the same procedure.

The single application referred to in point (c) of the first subparagraph shall be made in accordance:

– with Articles 7 and 11 where at least one of the changes is a minor change and none of the changes is a major one;

– with Articles 8 and 12 where at least one of the changes is a major change;

CHAPTER II
Changes to products authorised by Member States

Article 6
Notification procedure for administrative changes

The authorisation holder, or its representative, shall submit simultaneously to all Member States concerned a notification complying with the requirements laid down in Annex III and pay the fees payable in accordance with Article 80(2) of Regulation (EU) No 528/2012.
Without prejudice to the next subparagraph, the notification shall be submitted within twelve months following the implementation of the change.

The notification shall be submitted before the implementation of the change in the case of administrative changes requiring a prior notification for the continuous supervision of the biocidal product concerned, as listed in Annex I.

Within 30 days following receipt of the notification, where a Member State concerned disagrees with the change or if the relevant fee has not been paid, it shall inform the authorisation holder, or its representative, and the other Member State concerned that the change is rejected and the grounds for the rejection.

If, within 30 days following receipt of the notification, a Member State concerned has not expressed its disagreement, the change shall be deemed acceptable by that Member State concerned.

Within the next 30 days, each of the Member State concerned shall, where relevant, amend the authorisation of the biocidal product in conformity with the agreed change.

Article 7
Procedure for minor changes

The authorisation holder, or its representative, shall submit simultaneously to all Member State concerned an application complying with the requirements laid down in Annex III.
The Member States concerned shall inform the applicant of the fees payable in accordance with Article 80(2) of Regulation (EU) No 528/2012 and shall reject the application if the applicant fails to pay the fee within 30 days. They shall inform the applicant and the other Member States concerned accordingly. Upon receipt of the fees, the Member States concerned shall accept the application and inform the applicant accordingly indicating the date of acceptance.
Within 30 days of acceptance, the reference Member State shall validate the application if it complies with the requirements laid down in Annex III and inform the applicant and the Member States concerned accordingly.

In the context of the validation referred to in the first subparagraph, the reference Member State shall not make an assessment of the quality or the adequacy of the data or justifications submitted.

Where the reference Member State 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 45 days.

The reference Member State shall, within 30 days of receipt of the additional information, validate the application if it determines that the additional information submitted is sufficient to comply with the requirements laid down in Annex III.

The reference Member State shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicantand the Member States concerned accordingly.

Within 90 days of validating an application, the reference Member State shall evaluate the application and draft an assessment report and shall send its assessment report and, where relevant, the revised summary of the biocidal product characteristics to the Member States concerned and to the applicant.
Where it appears that additional information is necessary to carry out the evaluation, the reference Member State shall ask the applicant to submit such information within a specified time limit. The period referred to in paragraph 4, shall be suspended from the date of issue of the request until the date the information is received. The suspension shall not exceed 45 days in total unless it is justified by the nature of the data requested or by exceptional circumstances.

Within 45 days of receipt of the assessment report and, where relevant, of the revised the summary of the biocidal product characteristics, without prejudice to Article 9, the Member States concerned shall agree on the conclusions of the assessment report and, where relevant, the revised summary of the biocidal product characteristics.

If, within the period referred to in the first subparagraph, a Member State concerned has not expressed its disagreement in accordance with Article 9, the conclusions of the assessment report and, where relevant, the revised summary of the biocidal product characteristics shall be deemed acceptable to that Member State.

Within 30 days of reaching agreement, the Reference Member State and each of the Member States concerned shall, where relevant, amend the authorisation of the biocidal product in conformity with the agreed change.

Article 8
Procedure for major changes

The authorisation holder, or its representative, shall submit simultaneously to all Member State concerned an application complying with the requirements laid down in Annex III.
The Member States concerned shall inform the applicant of the fees payable in accordance with Article 80(2) of Regulation (EU) No 528/2012 and shall reject the application if the applicant fails to pay the fee within 30 days. They shall inform the applicant and the other Member States concerned accordingly. Upon receipt of the fees, the Member States concerned shall accept the application and inform the applicant accordingly indicating the date of acceptance.
Within 30 days of acceptance, the reference Member State shall validate the application if it complies with the requirements laid down in Annex III and inform the applicant and the Member States concerned accordingly.

In the context of the validation referred to in the first subparagraph, the reference Member State shall not make an assessment of the quality or the adequacy of the data or justifications submitted.

Within 180 days of validating an application, the reference Member State shall evaluate the application and draft an assessment report and shall send its assessment report and, where relevant, the revised summary of the biocidal product characteristics to the Member States concerned and to the applicant.
Where it appears that additional information is necessary to carry out the evaluation, reference Member State shall ask the applicant to submit such information within a specified time limit. The period referred to in paragraph 4, shall be suspended from the date of issue of the request until the date the information is received. The suspension shall not exceed 90 days in total unless it is justified by the nature of the data requested or by exceptional circumstances.