Minor / non significant or administrative changes

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.

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.

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

• This notification will be confirmed by e-mail. No offical decision will be submitted.

Non-significant changes in the composition of the product

Changing of the production process of the product

This notification will be confirmed by e-mail. No offical decision will be submitted.

This notification is for free.

Non-significant changes composition (product)

Non-significant changes include:

1. Exchanging of co-formulants for the same amount of chemically equivalent co-formulants with the following considered as acceptable:

- co-formulants have the same composition and the same or less severe hazard classification,
- alternate source of same co-formulant,
- cation exchange for anionic surfactants/dispersants,
- adding a marker substance for authentication (in case the marker is not of toxicological or ecotoxicological concern and the concentration in the formulation is below 0.1 %)

2. Change in the declared composition of a plant protection product due to use of a new source of technical active ingredient in the formulation.
In general: for a non-significant change no studies have to be submitted and no risk assessments have to be prepared.

Any other changes fall under the procedure of application for an amendment of an authorisation for which a zonal assessment is necessary.

If you are not sure whether your application fulfils the criteria for a non-significant change according to SANCO/12638/2011 20 November 2012 rev. 2, you can send the information to our service desk. The service desk can advise you on what type of application is suitable. .

Composition statement

Instruction composition statement

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.

WYG (change of labelling)

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)

WYG (change of packaging)

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).

change of labelling (WYG)

Administrative changes product

• WNT (name changes for products)

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

• WNAW (name and address changes for companies)

• OT (transfers of authorisations to a different company)

• INTR (withdrawals of authorisations) free application

• 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.