Plant protection products – Applying for an authorisation extension for minor uses

It is possible to ask the Portuguese National Authority for Animal Health (DGAV) to extend the authorisation of a plant protection product that has already been authorised in Portugal to minor uses that are not yet covered by that authorisation.

This additional authorisation allows the product to be used on minor crops, or on major crops in order to resolve specific phytosanitary problems such as pests or diseases.

 

Service channels

  • By email

    Download the form and send all documents to paula.barros@dgav.pt

  • By post, on paper and on CD, to:

    Direção-Geral de Alimentação e Veterinária
    Direção de Serviços de Meios de Defesa Sanitária
    Divisão de Gestão e Autorização de Produtos Fitofarmacêuticos
    Campo Grande, 50
    1700-093 Lisboa (Portugal)

Who can apply for an authorisation extension for minor uses?

The following can apply for an extension of authorisation of a plant protection product already authorised in Portugal for minor uses:

  • the plant protection product authorisation holder
  • official or scientific bodies involved in agriculture
  • professional agricultural organisations
  • professional users

When should I apply for an authorisation extension for minor uses?

An authorisation extension can be applied for if all of the following conditions are met:

  • if you want to make a minor use of the product (for a minor crop or for exceptional use of the product in a major crop)
  • there are no suitable alternative products or methods to solve the phytosanitary problem
  • there are no risks to the environment or to human and animal health
  • the extension is in the public interest

If the crop is not classified as major, the use is automatically considered to be a minor use.

A use is considered a minor use within a major crop when at least one authorisation has already been granted for that use. This means that the use was recognised as minor and of sufficient importance to justify the authorisation extension.

Find out more about minor uses and the public interest of extending an authorisation under ‘Additional Data’.

Procedure and requirements

Documentos and requirements

In order to apply for an authorisation extension for minor uses, you will need to meet one of the following conditions:

  1. Prove that the phytosanitary problem exists and is causing damage
    To do so, you should contact the Community and National Reference Laboratories (LNR) for the identification of plant pests and diseases, or the DGAV’s Regional Offices and/or the laboratory services of the DGAV’s Regional Offices.
  2. Confirm that the phytosanitary problem appears occasionally and causes damage
    This is confirmed through documents issued by the DGAV or other entities recognised as having technical competence (such as public or private entities of the National Agricultural Notices Office).

To apply for an authorisation extension for minor uses, you will also have to meet the following two conditions:

  1. Demonstrate that the phytosanitary problem is localised
    You must demonstrate that the problem is localised and limited to a particular geographical area or that its incidence at national level represents no more than around 5% of the total surface area of the crop in the country. To do so, you should make use of the relevant Regional Offices of the Ministry of Agriculture and the Sea and of DGAV recognition.
  2. Confirm that the purpose is not already covered
    The purpose is considered to be covered already when there are authorised plant protection products containing different active substances, with at least four different modes of action. To do so, you should consult the lists of the Resistance Action Committees for fungicides (FRAC code list), insecticides (IRAC mode of action) and herbicides (HRAC mode of action).

Additionally, you must ensure that the plant protection product complies with the requirements laid down in Article 29 of Regulation (EC) No 1107/2009 (‘Requirements for the authorisation for placing on the market’).

In order to apply for an authorisation extension for minor uses, you will need to send:

Provided that the person making the application and the plant protection product are the same, it is accepted that the application for extension of authorisation for minor uses concerns more than one use. However, the uses applied for must always be identified individually. It is essential to identify the crop and the pest or the effect to be achieved (examples: ‘powdery mildew on melons’ or ‘cabbage fly on cauliflower’).

To check the status of your application, you must be registered on the SIFITO platform.

Procedure

These authorisations are not initial authorisations. They are extension applications which require an already existing authorisation to be in place for the product concerned.

Therefore, in order to apply for an extension of an already existing authorisation for minor uses, you must send all the documents by one of the following means:

  • By post, on paper and on a CD, to:
    Direção-Geral de Alimentação e Veterinária
    Direção de Serviços de Meios de Defesa Sanitária
    Divisão de Gestão e Autorização de Produtos Fitofarmacêuticos
    Campo Grande, 50
    1700-093 Lisboa
    You must scan all the documents and include them on the CD
    Print the letter and enclose it with the CD so that the process can be identified

Examination of the application

If any documents are missing, the DGAV will send an email indicating what still needs to be submitted.

Once your application is complete, you can track the status of the procedure in your private area on the SIFITO platform . Through this platform you can:

  • find out the date of the preliminary hearing, which is essential for the approval of the authorisation extension
  • access the decision of the National Authority for Animal Health (DGAV)

Updating the label after the authorisation extension is accepted

When the DGAV approves an authorisation extension for a minor use, it informs the plant protection product holder and asks the holder to update the label with that new indication.

If the holder does not agree to change the label, the DGAV ensures that professional users have access to the full instructions for use by publishing this information on the SIFITO platform.

Consult the Manual on the Labelling of Plant Protection Products.

How much

An authorisation extension for minor uses costs EUR 285.40 (for each minor use, i.e. for each product/crop/pest). Example: use of an insecticide on cabbage to combat cabbage fly).

Payment can only be made after the DGAV has issued the invoice, which will be sent:

  • by email
  • by letter (if the email does not work)

Payment can be made in two ways:

  • using a ‘multibanco’ reference (preferably)
  • by bank transfer.

The invoice will provide all the payment information needed to make the payment.

How to pay

If you are paying using a multibanco reference, you do not need to send any proof of payment.

If you are paying by bank transfer, the payment details are as follows:
Name: Direção-Geral de Alimentação e Veterinária
Bank: IGCP - Instituto de Gestão da Tesouraria e do Crédito Público, IP
IBAN: PT50 0781 011 200 000 007 784 96
SWIFT: IGCPPTPL

In this case, proof of payment must be sent to the email address indicated on the invoice.

All payments not made by multibanco must include proof of payment with all the details identifying the paying entity/company and the relevant product/service (the reference is on the invoice).

Validity

An authorisation for extended use for minor crops in Portugal has the same validity as the main authorisation for the plant protection product to which it is associated.

Review of the authorisation extension

The extension will be reviewed whenever the product undergoes a reassessment, in the following situations:

  • when the product authorisation is renewed or revised,
  • when there is any relevant new technical and scientific data,
  • when there are changes in the authorisation of the active substances in the product.

Cancellation of the authorisation extension

If an authorisation extension for a minor use is cancelled or restricted, a grace period is granted to allow products with outdated labels to still be used or sold.

If the reason for cancellation is related to the protection of human health, animal health or the environment, there is no grace period.

Indicative grace periods for selling and distributing the product:

  • 6 months for selling and distributing the product with an outdated label;
  • 12 months for use, storage or disposal of the product.

These periods may be extended if deemed necessary.

Automatic transfer of authorisation

If a plant protection product authorised for minor use is sold to another company or changes its trade name, the authorisation remains valid.

The authorisation is automatically transferred to the new company or is associated with the new product name.

Additional Data

Minor use

Minor use refers to the use of a plant protection product (such as a pesticide, fungicide or herbicide) on a crop or against a pest that is not included in the main authorisation for that product, either because it is a small-scale situation (minor crops) or is a large-scale situation but is to address a specific plant health problem (minor use on a major crop).

Examples of minor uses:

  • using a fungicide authorised for vines also on currants, for justified reasons
  • applying an insecticide authorised for potatoes also on beetroot, to treat the same pest

Characteristics of minor uses:

  • they relate to crops that are smaller in terms of cultivated area or with more localised production (such as aromatic and medicinal plants, rare fruits or regional crops)
  • they may also relate to pests or diseases that occur occasionally
  • they are essential for preventing losses and maintaining phytosanitary protection in less-represented agricultural sectors

In the European Union, the legislation provides mechanisms for authorising such uses, recognising that there is not always sufficient commercial interest to register the product for all crops or pests.

To help apply this concept, there is an official list of crops considered to be ‘major’ crops. Anything not included on this list may be treated as a minor use.

Public interest in extending an authorisation

The DGAV does not consider an authorisation extension of a plant protection product for minor uses to be in the public interest if:

  • the way the product will be used in the minor crop does not follow the good practices already defined for major crops in the same chemical family (even if those rules are not defined for the minor crop, what is established for the major crop should apply)
  • the product has no effect on the pest or problem that it is supposed to control, based on its action spectrum (i.e. what the product is able to combat)

To help predict the action spectrum (in other words, the effectiveness) of a plant protection product on different crops, you can consult the extrapolation tables published by the European and Mediterranean Plant Protection Organization (EPPO).

The extrapolation rules vary depending on the type of product.

  • Fungicides:
    • if a product is effective against a disease in one crop, it may also be effective against the same disease in another crop
    • if it controls different diseases in various situations, it may also work against diseases of the same type in other similar conditions
  • Insecticides:
    • it may be possible to use the same product on several species within the same group of pests, such as caterpillars, aphids or mites
    • some pests attack various crops. In these cases, the effectiveness of the product is likely to be similar in other host crops
    • if the product is effective against insects or mites that attack the same part of the plant at the same stage of the crop cycle, it may also work for other insects with similar behaviour
  • Herbicides:
    • the use of herbicides varies according to the crop, the production system, when they are applied and when the crop is sowed or planted

Legislation, refusals, contests, claims

Legislation

  • Regulation (EC) No 1107/2009 of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC
  • Order No 3509/2024 of 1 April – Annual update of the fees in Ministerial Implementing Order No 86/2017 of 27 February concerning applications relating to maximum residue limits, the placing on the market of plant protection products and adjuvants, and the distribution, sale and application of plant protection products for professional use

Reasons for refusal

  • Challenge before the courts
    • Administrative action
    • Interim measure
    • Call for provision of information, access to files or issue of certificates
    • Call for the protection of rights, freedoms and guarantees
  • Administrative challenge
    • Complaint
    • Administrative appeal
  • Complaint to the Ombudsman

Competent Entity

Direção-Geral de Alimentação e Veterinária