CHAPTER IGENERAL PROVISIONS

Article 1Subject matter

This Regulation lays down provisions concerning changes of biocidal products sought in accordance with Article 50(2) of Regulation (EU) No 528/2012 with regard to any of the information submitted in relation to the initial application for the authorisation of biocidal products or biocidal product families in accordance with Directive 98/8/EC and Regulation (EU) No 528/2012 (hereinafter ‘changes of products’).

Article 2Classification of changes of products

1.

Changes of products are classified in accordance with the criteria laid down in the Annex to this Regulation. Certain categories of changes are listed in the tables of the Annex.

2.

The holder of an authorisation may request the F1competent authority to provide an opinion on the classification in accordance with the criteria laid down in the Annex to this Regulation of a change not listed in one of the tables of that Annex.

F2The opinion must be delivered within 45 days following receipt of the request and payment of the appropriate fee. In this Regulation, “appropriate fee” means the fee payable for the activity concerned in relations made under section 43 of the Health and Safety at Work etc. Act 1974 where the competent authority is appointed in accordance with regulation 5 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013.

The F3competent authority shall publish the opinion after deletion of all information of commercial confidential nature.

F4Article 3Guidelines on classification

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Article 4Grouping of changes

1.

Where several changes of products are sought, a separate notification or application shall be submitted in respect of each change sought.

2.

By way of derogation from paragraph 1, the following rules shall apply:

(a)

a single notification may cover a series of proposed administrative changes affecting different products in the same manner;

(b)

a single notification may cover a series of proposed administrative changes affecting the same product;

(c)

a single application may cover more than one proposed change of the same product in the following cases:

  1. (1)

    one of the proposed changes in the group is a major change of the product; all other proposed changes in the group are a direct consequence of that change;

  2. (2)

    one of the proposed changes in the group is a minor change; all other proposed changes in the group are a direct consequence of that change;

  3. (3)

    all changes in the group are a direct consequence of a new classification of the active substance(s) or non-active substance(s) contained in the product or of the product itself;

  4. (4)

    all changes in the group are a direct consequence of a specific condition of the authorisation;

(d)

a single application may cover more than one proposed change if the F5competent authority confirms that it is practically feasible to handle those changes in the same procedure.

The single applications referred to in points (c) and (d) of the first subparagraph shall be made in accordance with Article 7 F6... where at least one of the proposed changes is a minor change of the product and none of the proposed changes is a major change of the product, and with Article 8 F7... where at least one of the proposed changes is a major change of the product.

Article 5Information requirements

An application submitted in accordance with Article 50(2) of Regulation (EU) No 528/2012 shall contain the following:

  1. (1)

    the relevant filled application form F8..., which shall contain:

    1. (a)

      a list of all the authorisations affected by the proposed change(s);

    2. (b)

      F9...

    3. (c)

      F9...

    4. (d)

      F9...

    5. (e)

      where relevant, a draft revised summary of the biocidal product characteristics F10...,

      1. (1)

        F11...

      2. (2)

        F12...

  2. (2)

    a description of all the changes sought;

  3. (3)

    where a change leads to or is the consequence of other changes of the terms of the same authorisation, a description of the relation between these changes;

  4. (4)

    all relevant supporting documents to demonstrate that the proposed change would not adversely affect the conclusions previously reached concerning the compliance with the conditions set out in Article 19 or 25 of Regulation (EU) No 528/2012; F13, including any further information requested by the competent authority.

  5. (5)

    F14...