EXPLANATION with the APPLICATION FOR A PERMIT FOR TRIAL PURPOSES OF A
PLANT PROTECTION PRODUCT
Februari 2014
Statutory provisions
- Article 54 Regulation No. 1107/2009/EC
- Article 37 Plant protection products and biocides act (Wgb)
- Article for the record only Regeling gewasbeschermingsmiddelen en biociden
[Regulations on plant protection products and biocides]:
Definitions
Plant protection products:
Regulation 1107/2009 Article 2 provides the following definition: Products, in the form in which they are supplied to the user, consisting of or containing active substances, safeners or synergists, and intended for one of the following uses: a) protecting plants or plant products against all harmful organisms or preventing the action of such organisms, unless the main purpose of these products is considered to be for reasons of hygiene rather than for the protection of plants or plant products; b) influencing the life processes of plants, such as substances influencing their growth, other than as a nutrient; c) preserving plant products, in so far as such substances or products are not subject to special Community provisions on preservatives; d) destroying undesired plants or parts of plants, except algae unless the products are applied on soil or water to protect plants;
e) checking or preventing undesired growth of plants, except algae unless the products are applied on soil or water to protect plants.
The point in time when the product is actually used. Initiation of the trial:
General provisions
If you have a permit for conducting a trial with a plant protection product, you can conduct experiments or trials for research or development purposes, during which a non-authorised plant protection product is introduced into the environment or which involves the non-authorised use of a plant protection product.
You do not need a permit if you have a TNG erkenning (ratification of the use of non-authorised plant protection products). Companies with a TNG erkenning are allowed to conduct certain types of field studies with non-authorised plant protection products without having to request an authorisation.
Applications for a TNG erkenning can be submitted to the Nieuwe Voedsel en Waren Autoriteit
[Food and Consumer Product Safety Authority], Divisie Plant, Afdeling Toezicht voorbereiding en -evaluatie in Wageningen; you can also contact the above office for questions about the
TNG erkenning .
Explanation form PG – Februari 2014
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Other conditions and additional information about the TNG erkenning can be found on our website (this information is only available in Dutch).
Conditions
An application for a permit for trial purposes must be submitted in the Member State in which the trial will be conducted.
To prevent harmful consequences for the health of people or animals, or unacceptably harmful consequences for the environment, the trial permit is limited to small areas of land and small quantities of products to be treated. This is explained below. Restrictions can be imposed to prevent harmful residues in food or feed.
The trials must be conducted in accordance with the appropriate guidelines, to the extent guidelines are available.
If a permit is granted more than twice for trial purposes for the same crop/product combination and for the same purpose, the applicant must indicate how the requested trial differs from the previous trial or why a repetition or continuation of the trial is necessary (Table 4).
The duration of a trial permit is no more than 2 years. If you want to conduct trials after this period has elapsed, then a new application must be submitted.
Method of submission
The application must be submitted both on paper and on CD-ROM/DVD. We accept only a
Word file . Label the CD-ROM/DVD with the name of the product and, if known, the application number and application type (for example20130122 PG). Make sure that the individual files have logical names. For example: “submission letter”, “application form”, “legal conditions for use/in structions for use (WGGA)”.
Application costs
The application fee must be paid simultaneously when the application is submitted. The application costs are specified in the Ctgb Tariffs Decree on our website. The application will not be taken into consideration until the application has been received and the application fee has been paid. It is therefore important to make the payment immediately!
If the application is not accepted for consideration, if it is no longer being considered or if it is rejected, the application fee will not be refunded.
Decision
You will receive a response from us by regular mail. This will be in the form of a decision.
Publication on the Internet and in De Staatscourant
The decision will be published in De Staatscourant (government gazette) .
Explanation form PG – Februari 2014
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Trials with plant protection products based on genetically modified organisms
For experiments or trials where a genetically modified organism is introduced into the environment, no permit for experimental purposes is granted, unless such an introduction was accepted pursuant to Directive 2001/18/EC.
Maximal areas to be treated per trial
For a specification of the crop groups listed below, refer to the DTG list [Definition list of crops for plant production products] formerly the SOT-list ). On the application form, do not list crop types or groups, but specific crops!
Crop group Maximum area per trial, per crop
Maximum area per trial, per crop
Unprotecte d cultivation
Protected cultivation
Arable crops
Cultivated grassland
5 ha
5 ha
-
-
Fruit crops, Large fruits and Nuts
Fruit crops, Small fruits and Other fruits
Vegetable crops
Herb crops
Edible fungi
Ornamental crops
Public landscaping
Maximal quantities to be treated per trial ware potatoes and starch potatoes seed potatoes daffodil bulbs hyacinth bulbs tulip bulbs lily bulbs iris bulbs/rhizomes gladiolus bulbs other flower bulbs crocus bulbs apples pears
Maximum quantity per trial, per crop
225 tonnes
2500 kg
25 tonnes
13 tonnes
10 tonnes
10 tonnes
7 tonnes
4 tonnes
10 tonnes
7.5 tonnes
20 tonnes
20 tonnes
2 ha
1 ha
1 ha
1 ha
-
1 ha
2 ha
0.5 ha
0.5 ha
0.5 ha
0.5 ha
1000 m 2
0.5 ha
-
Explanation form PG – Februari 2014
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Statutory timelines for applications, plant protection products
The Ctgb aims to complete your application assessment within 8 weeks. However, we recommend that you plan your trials with an additional time margin.
Points for attention
- The application must be complete. If the application is not complete when it is submitted, you risk not obtaining the permit on time. If data are missing from the application, you will only have one opportunity to correct this omission, and if you do not use this opportunity, your application will not be taken into consideration.
- Report the desired starting date of the trial on the application form. When dealing with the applications, we will do our best to take this date into account.
- If you want to demonstrate that the product has no unacceptable effects for public health, then provide clear references.
- The trial cannot begin before the date on the decision and until the Ctgb has been informed about the trial locations (including cadastral number).
Explanation form PG – Februari 2014
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