Requirements subsequent to the decision
You must meet a number of requirements whether or not your product is granted an authorisation.
If you have applied for and received an authorisation, you can start to market the product in the country for which the authorisation has been granted. As an authorisation holder, you must fulfil a number of requirements.
A. Tax and yearly product-fee
The cost of retaining the right to market a product in Denmark is DKK 500 per annum per authorisation. The yearly product-fee is payable to the Environmental Protection Agency every year in the beginning of the year.
In addition, the purchase of plant protection products is subject to a further tax in Denmark. The tax is based on the properties related to the environment and human health, so that the pesticides resulting in the highest load to human health and the environment are subject to the highest taxes, while pesticides resulting in lower loads are subject to relatively lower taxes.
B. Records and reporting requirements
Producers, distributors, importers and exporters must from 14 June 2011 keep records of the products they import, sell, etc. The obligation to store information will apply for at least five years (2011-2016). There are guidelines on how to keep records and on the type of information you must record. There are basic requirements that apply to everyone and more specific requirements for producers, importers, etc.
Basic record-keeping requirements (all)
- Name of the relevant plant protection product.
- Volumes of sales
- Date of activity (directly linked to the activity).
Special record-keeping requirements for producers
- Manufactured/stored plant protection products must be logged
- The country in which the product is placed on the market must be indicated
- The date of placing on the market of the plant protection products must be indicated.
Special record-keeping requirements for importers/exporters and distributors/suppliers
- The date of import/export must be indicated.
- Country of origin/destination of the import/export.
- If products are stored, this must be logged at the importer/exporter.
- Distributors must record the plant protection products they store and distribute.
- Suppliers must keep records of the plant protection products they store.
Control of records
The authorities may request access to the relevant information from records to allow the identification and tracking within the EU of a consignment of plant protection products. The access may take the form of a control visit or a written request. Interested parties such as the drinking water industry, local inhabitants or retailers may ask the authorities for permission to access the information in the records.
The requirements for record-keeping are described in Article 67 of Regulation No 1107/2009.
C. Reporting of sales
Every year, you must send a report on the sales of your product to the Environmental Protection Agency. In December every year, you will receive a statement scheme to fill out and return to the Danish EPA.
There are a number of requirements that you must fulfil with regard to advertising your product. Read more on advertising here
If your application for placing on the market a new or existing plant protection product is refused, you may apply again. You may not sell or import your product whilst the new application is being processed.
You may not advertise your product if it is not authorised.
If your application for a renewal of an existing product authorisation has been refused, sales and import must stop. This must happen within six months.
Sales at subsequent stages, storage and use of the product must stop no later than 18 months after the refusal. This applies to the use of products and to stocks at retailers.
Export certificate for authorised pesticidal or biocidal products
Exporting pesticides to countries outside the EEA collaboration
Some countries and importers require documentation verifying that the product have been granted approval by the Danish Environmental Protection Agency for sale and use in Denmark. This documentation is issued as an export certificate and if you want the Danish EPA to issue an export certificate, we will charge a processing fee on this matter. The export certificate application can be found here. Please send your request to Obfuscated Email.