Application for authorisation submitted before 14 June 2011
This section is an introduction to the requirements you must meet if you have an existing authorisation dated before 14 June 2011 or you made an application before that date and we have not yet finished processing the case. Your product is covered by the transitional provisions and does not therefore have to meet the requirements of the new legislation introduced on 14 June 2011.
Please note that your main concern should be compliance with the legislation itself. This website is intended only as a guide.
On 14 June 2011 the Pesticide Regulation No. 1107/2009 became effective, replacing the Plant Protection Product Directive 91/414. This means that the Regulation will be used in the monitoring of plant protection products and that the provisions of the Plant Protection Product Directive are repealed (provisions implemented in the Danish Chemicals Act and the Danish Pesticides Order).
The rules dating from before 14 June 2011 must, however, be observed with regard to certain applications for authorisation or renewal of authorisation for plant protection products, as described below.
There are also transitional provisions for some of the new types of substances/products which will in the future require approval/authorisation.
Plant Protection products
A. Existing authorisations – where the Danish Chemicals Act will apply
Existing authorisations for plant protection products that were granted before 14 June 2011 will continue to be valid after 14 June.
Existing authorisations are valid until they are amended or withdrawn. The amendment or withdrawal of the authorisation will take place under the previous provisions of the Danish Chemicals Act, if the change or withdrawal is the result of:
- the inclusion of the active substance in Annex I of the Plant Protection Product Directive before 14 June 2011 with the ensuing re-evaluation of the plant protection product, but where the case was not fully processed before 14 June 2011, or
- the inclusion of the active substance in the list of approved active substances after 14 June, where the active substance was assessed under the provisions of the Plant Protection Product Directive and where a re-evaluation of the product takes place only after 14 June 2011.
B. Data protection in the transitional period
The previous provisions of the Danish Chemicals Act on data protection with regard to active substances and plant protection products will still apply to the re-evaluation of existing authorisations in respect of active substances covered by one of the two situations mentioned above. However, the following data protection periods will apply:
- 5 years after inclusion or approval of existing substances under Directive 91/414.
- 10 years after inclusion or authorisation of new substances under Directive 91/414.
- 5 years after renewal of the original inclusion or approval of the active substance, if inclusion expires before 24 November 2011.
Denmark only provides data protection on the authorisation of new plant protection products in Denmark after the inclusion of the active substance in Annex I of the Plant Protection Product Directive. Before the implementation of the Plant Protection Product Directive, Denmark did not have national provisions on data protection as part of the Danish Chemicals Act. There is thus no data protection on plant protection products authorised in Denmark before the inclusion of the active substance in Annex I of the Directive.
C. Existing authorisations – where the Regulation will apply
Existing authorisations of plant protection products in which the active substance is not covered by one of the two situations outlined above will be processed under the provisions of the Regulation.
The Regulation will also apply to the withdrawal after 14 June 2011 of an existing authorisation as a result of the non-approval of an active substance.
D. New authorisations
Applications for the authorisation of a plant protection product containing one or more active substances included in Annex I of the Plant Protection Product Directive 91/414 will be processed according to the previously applicable provisions of the Danish Chemicals Act if the application was submitted to the Environmental Protection Agency before 14 June 2011.
Applications for authorisations with regard to new plant protection products that are received from 14 June 2011 are processed according to the Regulation.
E. Labelling of plant protection products
Plant protection products that are labelled or will be labelled in accordance with the Plant Protection Product Directive 91/414 and the Dangerous Preparation Directive 45/1999, may be placed on the market up to 14 June 2015, after which all products must be classified according to the Classification Regulation. Products on the market (at retailers) before 1 June 2015 do not need re-labelling until 1 June 2017.
Read more on labelling
Active substances included in Annex I of the Plant Protection Product Directive before 14 June 2011 are transferred to a separate Regulation under the Pesticide Regulation and thus continue to be approved after the Regulation has entered into force on 14 June 2011.
The provisions of the Plant Protection Product Directive on authorisation will however continue to apply to several active substances, including:
- new active substances where the decision on 'completeness' was published before 14 June 2011 and
- active substances covered by the first Re-evaluation Regulation No. 737/2007.
This includes active substances whose inclusion in Annex I has been extended without prior re-evaluation, but whose re-evaluation is planned.
See Annex I to the Regulation via this link.