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Minor or administrative changes

The legal basis for this type of application for plant protection products is Regulation 1107/2009 Article 45. The chapter bellow refers to minor changes of the active substances, minor changes of the product and administrative changes of the product.

Characteristics of application

Instructions for submission

Period of handling*

Minor changes active substance:
  • When equivalence is not reviewed in another member state:

Ctgb draws up a equivalence report, based on the submitted data.

The report will published by the Ctgb on CircaBC, member states have 4 weeks to give comments.

Ctgb will process the comments received, and finalise the decision.

 Form WI, choose PWSG

Data to be submitted for Change in production process and/or the production location of the active substance; see: Summary document

Note: Ctgb will assess equivalence of active substances for which The Netherlands is Rapporteur Member state. For equivalence checks of other active substances, please refer to the Rapporteur member state of that substance.

 12 weeks
  • When the equivalence is reviewed in another member state ánd published on CircaBC:

This notification will be confirmed by e-mail. So you don’t receive an official decision.

 Form WI, choose PWSG-C 4 weeks

Minor changes composition product

Changing of the production process of the product

This notification will be confirmed by e-mail. So you don’t receive  an official decision.

This notification is for free.

 Form WI 4 weeks

Minor changes composition (product)

Examples of minor changes in the composition:

  • replacing a co-formulant or auxiliary formula with a chemically comparable one that does not have a more severe classification and/or labelling than the original co-formulant.
  • changing the percentage of co-formulant, auxiliary formula or active substance. This percentage must not change significantly. For an auxiliary formula, this change can be no more than 25% relative to the previous formula. The content of active substance can change by no more than 10%.

In general: for a minor change no studies have to be submitted and no risk assessments have to be prepared.

If you are not sure whether there is a minor change you can send the information to our service desk. The service desk can advise you on what type of application is applicable.

 Form WI, choose WSGNW

Composition statement

Instruction composition statement

 12 weeks

Minor change to legal instructions for use (WG/WGGA)

 Minor change to legal instructions for use (WG/WGGA)

Change of labelling

The changes applied for have to be explained. When the CLH change is based on new studies with the formulation, these have to be submitted, together with a reference list. Evaluation costs for these studies will be calculated according the tariff decree.

NOTE: for studies to be conducted with animals,  a request for information has to be submitted to the Ctgb. Conducting animal studies is not allowed without this request and the approval of the Ctgb.

 Form WI, choose on this form:

WYG (change of labelling)

 12 weeks

Change of packaging

Information to be submitted:

  • Shelf life following storage at ambient temperature (OECD Annex IIIA point 2.7.5)
  • Description and specification of the packaging and materials used in packaging, size, capacity, size of openings, types of closure and seals (OECD Annex IIIA point 4.1.1)
 Form WI, choose on this form:

WYG (change of packaging)

 12 weeks

Change of shelf life

Data are required to demonstrate that the product is stable in storage under the conditions and for the shelf life claimed for the product.

Data must be generated in the worst case commercial packaging to support the ambient storage of the product for the claimed shelf life.

For all proposed packaging types, packaging suitability should be addressed. Technical characteristics applicable to the formulation type must be addressed. Where relevant these must be generated to cover the maximum and minimum in use concentrations specified for the product.

Information on the relevant physical, chemical and technical properties for different formulation types is outlined in the FAO manual (FAO, 2010).

 Form WI, choose on this form:

change of labelling (WYG)

 12 weeks

Administrative changes product
The following applications concerning administrative changes:
  • WNT (name changes for products)

NOTE: Information about acceptable product names can be found in the policy note about naming (Goverment Gazette, in Dutch).

 Form WI – choose WNT 4 weeks
  • WNAW (name and address changes for companies)
 Form WI – choose WNAW 4 weeks
  • OT (transfers of authorisations to a different company)
 Form WI – Choose OT 4 weeks
Form WI – Choose INTR 8 weeks
  • NLWATG (minor changes WGGA/WG: Amendment label instructions: GAP doesn’t change and risk review is not necessary. Or restricted field of use.)
    Note: For this type of changes the WG will change: a grace period  can be applied for. The new WG will have a new version number.
 Form WI – Choose NLWATG 4 weeks

*: No rights can be derived from these handling periods. Period starts when application and payment have been received.

Characteristics

Legal basis

Article 45 of Regulation (EC) No. 1107/2009 describes the possibility of withdrawing or amending an authorization at the request of the authorisation holder.

For changes that do not require a substantive assessment, it is not necessary to follow the zonal procedure. In those cases, the assessment can be evaluated at national level, without an European commentary round. For this purpose the Ctgb has various national application types, each with their own specific requirements.

Form