MIP-0023-E

Application – Extension of authorisation for minor uses (plant protection product)

According to article 51 in Regulation (EC) No 1107/2009

Application – Extension of authorisation for minor uses

The first page of this application form shall be submitted as a signed original. All other documents, including the remainder of this application form may be submitted in digital form, preferably through any cloud service.

Please note, data on efficacy or phytotoxicity is not required for an application for extension of product authorization for a minor use. New environmental and health risk assessments may however be necessary, if the risk assessment already performed, does not cover the applied use.

Signature

If the signature is done by someone other than the applying company, a power of attorney confirming the right to sign the application on behalf of the applicant, shall be submitted.

Product name	Product code
Applying company	Date
Signature
Name

Postal address

Swedish Chemicals Agency
Box 2
SE-172 13 Sundbyberg
Sweden
Delivery address

Swedish Chemicals Agency
Löfströms Allé 5
SE-172 66 Sundbyberg
Sweden

Submission of documentation

Please use a safe file share service to submit the remainder of the documentation. If you wish to use our file share service, please contact kemi@kemi.se. You may also submit the documentation on, for example, CD. In that case, please use the above address.

Application overview

Product name	Authorisation no.
Brief summary of the extended use, including crop(s) and pest(s)
List all the crops concerned and indicate the estimated total cultivation area for each crop in Sweden
Type of product (more than one option may be applicable) Chemical Microorganism Low risk product	Do you want to apply for mutual recognition of minor use according to Article 51.7 in Regulation (EC) 1107/2009? Yes If yes, the Reference Member State´s evaluation and decision shall be attached

Applicant

Official or scientific bodies involved in agricultural activities, professional agricultural organisations and professional users as well as the authorisation holder, may submit an application.

Name	Company´s registration no. (see below)
Address	Telephone no. (incl. country code)
Postal code and town	Contact person
Country	E-mail address
A company/corporation certificate shall be submitted if you have not submitted this before. A certificate is also required if there have been changes since the previous certificate was submitted. Company’s/corporation’s certificate is attached

Temporary representative (if applicable)

Representing the applicant only during the application procedure.

Company name	Company´s registration no. (see below)
Address	Telephone no. (incl. country code)
Postal code and town	Contact person
Country	E-mail address
A representative shall prove the appointed level of representation by the applicant in original. Power of attorney as temporary representative is attached

Permanent representative (if applicable)

Representing the authorisation holder of the extension of authorisation for minor uses during the authorisation period (“ombud” in Swedish).

Company name	Company´s registration no.
Address	Telephone no. (incl. country code)
Postal code and town	Contact person
Country	E-mail address
A company/corporation certificate shall be submitted if you have not submitted this before. A certificate is also required if there have been changes since the previous certificate was submitted. Representing company’s/corporation’s certificate is attached
A representative shall prove the appointed level of representation by the applicant in original. Power of attorney as permanent representative is attached

Invoicing information for application fee

On our website, there is a tool and a list that can give you an estimate of the application fee.

Company name	VAT no.
Invoicing address	Contact person (name/e-mail/tel)
Postal code and town	Country
Peppol-invoice	Peppol-invoice no.
Invoice reference (purchase order no./your reference)

Annexes

Please note that data requirements according to Regulation (EU) No 284/2013 must be met, either by new documentation or by a justification showing that the original product assessment covers the intended extension, except for efficacy or phytotoxicity.

Please use the below check list to ensure that all the documentation necessary to process your application is submitted.

Description	Attached
Company/corporation certificate
Power of attorney – temporary/permanent representative
GAP-table, describing the applied use
If you are the product authorisation holder a user instruction in Swedish, describing the authorised as well as the applied extension, shall be attached
If you are not the product authorisation holder a user instruction in Swedish, describing the applied extended areas of use, shall be attached
If it is possible to refer to the risk assessment already performed, a justification as to why risk assessment can be extrapolated, shall be attached
If it is not possible to refer to the risk assessment already performed, a new risk assessment in dRR format3, shall be attached
Is data submitted in support of the application protected in Sweden and not owned by you? If yes A Letter of Access to protected data shall be attached
A reference list, including all studies required for the extension and, if applicable, a request for data protection for the submitted tests and study reports, shall be attached
Do you request that certain parts of the information submitted with the application should be treated as confidential? The form to be used is available in the “Guidance document on zonal evaluation and mutual recognition, withdrawal and amendment of authorisations under Regulation (EC) No 1107/2009”, SANCO/13169/2010 Rev. 11. If yes A form requesting that certain parts of the information submitted with the application should be treated as confidential is submitted

According to Ordinance (2013:63) on Pesticide Fees

Format of a draft Registration Report – technical guidelines version 2018, https://ec.europa.eu/food/plants/pesticides/approval-active-substances/guidelines-active-substances-and-plant-protection_en