You must meet a number of requirements whether or not your product is granted an authorisation.AUTHORISATION GRANTEDIf 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 annual fee
The cost of retaining the right to market a product in Denmark is DKK 500 per annum per authorisation. The registration fee is payable to the Environmental Protection Agency every year in December.
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.
Table on new pesticide tax june 2013
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)
Special record-keeping requirements for producers
Special record-keeping requirements for importers/exporters and distributors/suppliers
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. You can report sales using the enterprise portal virk.dk .Report sales here (in danish)D. Advertising
There are a number of requirements that you must fulfil with regard to advertising your product. Read more on advertising here
AUTHORISATION REFUSEDIf 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.
Important points - the new Pesticides Regulation
Application form for mutal recognition and zonal applications (word)Pre-notification form for planned zonal applications (word)Guideline on collaboration and in particular re-evaluations ind the North zone
Guidance document on evaluation of efficacy in the North zone
Guidance document on work-sharing in the Northern zone, version 2.0.Guidance document on zonal evaluation and mutal recognition under Regulation (EC) No 1107/2009Application form for parallel trade permits
Pesticide Regulation No 1107/2009Classification Regulation (CLP) No 1272/2008Dangerous Preparation Directive 1999/45Labelling Regulation No 547/2011
Danish legislation can be found at www.retsinfo.dk and www.lovtidende.dk
EU legislation is available at http://eur-lex.europa.eu