Go to content

Characteristics

Legal basis

Application types

Below some examples of the different types of administrative changes and minor changes.

Administrative changes of products requiring prior notification before implementation (Section 1)

Name of the biocidal product

  • Changes of the name of the biocidal product where there is no risk of confusion with the names of other biocidal products.
  • Addition of a name for the biocidal product where there is no risk of confusion with the names of other biocidal products.

Authorisation holder

  • Transfer of the authorisation to a new holder established in the European Economic Area (EEA).
  • Change in the name or address of the authorisation holder, which remains in the EEA.

Manufacturer(s) of the active substance(s)

Addition of a manufacturer of the active substance or change in the manufacturer’s identity or in manufacturing location or process, where the technical equivalence between the substances from the two manufacturers, manufacturing locations and processes has been established by the Agency in accordance with Article 54 of Regulation (EU) No 528/2012, and the manufacturer or importer is listed in accordance with Article 95(2) of Regulation (EU) No 528/2012.

Biocidal product family

Authorisation as a biocidal product family of a number of authorised products falling within the specifications of a frame-formulation established

Administrative changes of products which can be notified after implementation (Section 2)

Authorisation holder

Change in other administrative details of the authorisation holder than the name and address.

Formulator(s) of the biocidal product

  • Change in the name, the administrative details or the formulating location of the biocidal product formulator, where the biocidal product composition and the formulating process remain unchanged.
  • Deletion of a formulating location or a formulator of the biocidal product
  • Addition of a formulator of the biocidal product, where the biocidal product composition and the formulating process remain unchanged.

Manufacturer(s) of the active substance(s)

  • Change in the name or the administrative details of a manufacturer of the active substance, where the manufacturing location and process remain unchanged and the manufacturer remains listed in accordance with Article 95(2) of Regulation (EU) No 528/2012
  • Deletion of a manufacturer or a manufacturing location of the active substance

Conditions of use

  • More precise instructions for use, where only wording but not content of instructions are changed.
  • Removal of a particular claim, such as a specific target organism or a specific use.
  • Removal of a category of users.
  • Addition, replacement or modification of a measuring or administration device not relevant for the risk assessment and not regarded as a risk mitigation measure.

Classification and labelling

Change to the classification and labelling, where the change is limited to what is necessary to comply with newly applicable requirements of Regulation (EC) No 1272/2008 of the European Parliament and of the Council. See also: Note for Guidance: Handling of changes to the classification and labelling of authorised biocidal products (CA-Nov15-Doc.4.1-Final)

Minor changes of products

Composition

Increase or reduction, addition, deletion or replacement of a non-active substance intentionally incorporated in the product, where:

  • The added or increased non active-substance is not a substance of concern.
  • The deletion or reduction of the non-active substance does not lead to an increase of an active substance or a substance of concern.
  • The physical-chemical properties and the shelf-life of the product are expected to remain the same.
  • The risk and efficacy profile are expected to remain the same.
  • A new quantitative risk assessment is not expected to be necessary
  • Increase, reduction, addition or deletion, or replacement of a non-active substance intentionally incorporated in a biocidal product family outside the authorised range, where:
  • The added or increased non-active substance is not a substance of concern.
  • The deletion or reduction of the non-active substance does not lead to an increase of an active substance or a substance of concern.
  • The physical-chemical properties and the shelf-life of the products of the biocidal product family remain the same
  • The risk and efficacy profile are expected to remain the same.
  • A new quantitative risk assessment is not expected to be necessary.

Conditions of use

Changed instructions for use, where the changes do not adversely affect the exposure

Addition, replacement or modification of a measuring or administration device relevant for the risk assessment and regarded as a risk mitigation measure, where:

  • The new device accurately delivers the required dose for the biocidal product concerned in line with the approved conditions of use;
  • The new device is compatible with the biocidal product;
  • The change is not expected to adversely affect the exposure.

Shelf-life and conditions of storage

Change in the shelf-life.

Change in the conditions of storage

Pack size

Change in the pack size range, where:

  • New range is consistent with the dose rate and instructions for use as approved in the summary of the biocidal product characteristics;
  • No change of user category;
  • The same risk-mitigation measures apply.

Cancellation (withdrawal) of authorisation on request

Cancellation of a national authorisation can be applied for in R4BP. The national competent authorities will execute the request. For union authorisations, the Agency (ECHA) will take care of the request and cancel the authorisation.

Application type criteria

  • Changes can be made to both single products and to biocidal product families, and to national authorisations as well as Union authorisations.
  • Independent of how the authorisation of a product was originally granted (national application, mutual recognition, same biocidal product or Union authorisation), it can be changed.
  • Changes of national authorisations can be applied for in single countries, or in various countries in parallel. Applications for administrative changes are handled by the MS independently. Minor and major changes can be applied for in parallel.
  • Changes of Union authorisations must be addressed to the European Chemicals Agency (ECHA) – in R4BP.

Information requirements

Article 5 of Commission Implementing Regulation (EU) No 354/2013 lists the requirements for an application for a change of the authorisation of a biocidal product.

Communication

The notifications for administrative applications can be found in R4BP and on the ctgb-website (no confirmation will be send by regular mail). The changes will not be published in De Staatscourant (Dutch government gazette).

Changes of the address will not be published on our website or in De Staatscourant (Dutch government gazette). The changes will only be made in the Ctgb systems.