Administrative changes, minor changes and withdrawals

Characteristics

The legal basis

Change Regulation (EU) 354/2013.

Registration process

Do you want to make changes to your authorized product, and these are administrative or minor changes, classified according to the Change Regulation (EU) 354/2013, and the product is authorized under transitional law, then you have to use Form W. The period of handling and the tariff code for this kind of application you can find in the table below:

	Period of handling*
Administrative changes
Change of name authorized product	4 weeks
Change of name, address and/or city (authorization holder does not change)	4 weeks
Transfer of products to another company (changing authorization holder)	4 weeks
Administrative change Directions for use and instructions	4 weeks
Administrative change of CLP labeling (ATP changes) original product	4 weeks
Administrative change of CLP labeling derived/ parallel authorization	4 weeks
Changing of production process product.	4 weeks
Minor changes
Minor change of composition, where the active substance changes derived and parallel authorization	8 weeks
Minor change of composition of original product	12 weeks
Change of shelf life of the original product	8 weeks
Change of labelling of the original product, exception of ATP changes	8 weeks
Minor change WGGA of the original product	8 weeks
Change of packaging of the original product	8 weeks
Withdrawals	8 weeks

* Period starts when application and payment have been received.

Grace period

For information about grace periods, see: grace periods.

Requirements minor change applications of the original products

Minor changes composition of the original 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%.

For a minor change you have to submit a Composition Statement. In general: for a minor change no studies have to be submitted and no risk assessments have to be prepared.

Changes of labelling of the original product

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.

Change of shelf life of the original product

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 packaging of the original product

Section No.	Information, test or study required for biocidal product (for compulsory or conditional requirements, see TNsG on data requirements)	Information, test/study provided Y(n)/P/N/n.a.	Justification provided Y/N	Confidential data Y/N	Reliability indic. 0-4/n.a.	Official use only Data Gap Y/N
3.7	Storage stability – stability and shelf-life
9	PACKAGING (type, materials, size, etc.)

Instructions for submission

Preferably send the application to post@ctgb.nl. We don’t need a paper version. Please mention on the subject line of the e-mail the application type, product/active substance name and company name. Make sure the individual files have logical names. For example: “application form’’, “legal conditions for use/WG”. Please don’t submit a cover letter:  You will mention the changes on the application form clearly. If necessary, you can give an explanation in an appendix. In this case: Refer on the application form to the appendix.

Information about requirements applicant, payment method, language, product name see: Directions for submission biociden

Fees

For administrative and minor change applications you have to pay application fees and an annual fee. The tariffs are published in the Government Gazette. The tariff codes you find under chapter Registration process. For withdrawals fees are not charged.

Important remark

For derived and parallel authorizations, no applications need to be summitted for changes in shelf life, packaging and composition (with the exception of changes in active substance) because this information is only mentioned in the registration report of the original product and is not included in the decision. Derived and parallel authorizations follow the original/reference product.

Other important information

Legal conditions for Use and Instructions for Use (WGGA)

No uses may be listed on the draft  WG(GA) other than the authorised uses for the reference product. If you want to list fewer uses than the original product authorisation, then your application must include a draft proposal of the Legal Conditions for Use and Instructions for Use (WGGA). This must be the text as it will appear on the packaging. If you want a derived trade permit that is identical to the original authorisation, you can indicate that on the application form. In that case, you do not have to include a WG(GA). The text must be the same as that on the packaging of the original product and can be supplemented with technical instructions, if these are not prejudicial to the technical instructions on the label of the original product.

Note

The field of use of the derived trade permit must be the same (or less) than the original authorisation. Frequently, the Ctgb receives applications for a trade permit and applications to amend the field of use for which the “mother”- authorisation (the original authorisation) is not expanded yet. Therefore these applications could not be handled. To avoid large numbers of unfinished applications or rejections, the policy of the Ctgb is that applications for a trade permit and  for expanding the field of use of a derived trade permit, can only be considered when the original authorisation is authorised for this field of use already.