The Pesticide Regulation No 1107/2009 entered into force on 14 June 2011 and the Plant Protection Product Directive 91/414 was repealed.
This means that in the future, the Regulation will apply for Plant Protection Products and that the provisions of the Plant Protection Product Directive are repealed (provisions implemented in the Danish Chemicals Act and the Danish Pesticides Order).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 continues to be valid, however, with regard to applications for authorisation or renewal of authorisation of plant protection products, as described below. There are also transitional provisions for some other types of substances/products which will in future require approval/authorisation.
Plant Protection Products
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Existing authorisations are valid until they are amended or withdrawn.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
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.
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.
Applications for authorisations with regard to new Plant Protection Products that are received from 14. June 2011 are processed according to the Regulation.
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.
Safeners and synergists
Safeners and synergists will not require approval in Denmark until the Commission has established a work programme in a separate regulation. The work programme will gradually review safeners and synergists that are on the market at the entry into force of the regulation. The regulation must be adopted no later than 14 December 2014.
On adoption of the regulation, safeners and synergists may be marketed for a maximum of five years without an approval as part of a plant protection product. Over five years the adjustment will be phased in so that approval of safeners and synergists will be required during this time. It is expected that all safeners and synergists will have approval in 2019-2020.
The Danish Environmental Protection Agency will provide advise to applicants when the EU work programme has been adopted.
Co-formulants may, without being approved, continue to be part of plant protection products on the market until their possible inclusion in Annex III of the Pesticides Directive. Annex III is a negative list of co-formulants. After 14 June 2016, co-formulants on the negative list may not be an ingredient in an authorised plant protection product in Denmark.
The Danish Environmental Protection Agency will provide advise to applicants when co-formulants are included in Annex III.
Adjuvants will not require approval in Denmark until specific data requirements, an evaluation programme and approval criteria have been established. The Commission will lay down the rules in a separate regulation. It is not clear when this will happen.
The Danish Environmental Protection Agency will provide advise to applicants when more specific rules have been adopted.