Applications for approval of pesticides and biocides
In the Newsletter from March 2009, The Danish Environmental Protection Agency urge all applicants, as far as possible, to send electronic applications, as this will considerably reduce the processing time.
Please send applications, enclosing a CD/DVD (or a paper dossier) to:
Pesticides and Gene Technology Miljøstyrelsen Strandgade 29 1401 Copenhagen K
See more information about guidelines and format requirements here.
Electronic applications should be submitted to
Update of the framework for assessment of plant protection products in relation to cumulative effects of combination products
The Environmental Protection Agency document; “Framework for assessment of plant preservative” has been updated. The framework has been revised concerning cumulative effects of combination products. These changes have been discussed in the Pesticides Council.
The new administrative practice is included in Annex 1 of the framework for health assessment and in Annex 18 for the framework for environmental assessment.
See the framework here.
The Environmental Protection Agency will start by making the necessary evaluations and re- evaluations in relation to the assessment of applications. The results will be sent to applicants for hearing, if changes to the approval are required.
From 1 May 2010, a dossier for products with several active substances and/or problematical auxiliary substances is expected to contain assessments according to the new principles.
These guidelines apply for biocides in the transition phase until the active substances are included in Annex 1.
Draft Guidance document on the Nordic-Baltic cooperation of product assessments for plant protection products.
The authorities in the Nordic and Baltic countries are working on a more formalized collaboration on the evaluation of plant protection products. In this matter, a draft proposal has been prepared for the Nordic work-sharing guidance, a document containing suggestions for new procedures as well as deadlines for applications and evaluations.
See the draft and the commentary table here.
The procedures are in accordance with the latest guidance documents of the Commission as regarding, for instance, the submission of applications in the format of a “Draft Registration Report”, which will be implemented for applications submitted after October 2. 2010 Applicants should take notice of this. See "Guidance document on the presentation and evaluation of dossiers according to annex III of Directive 91/414/EEC in the format of a (draft) Registration Report (SANCO/6895/2009 rev 1 02 October 2009)".
Comments to the draft can be submitted to the Environmental Protection Agency untill 1 February 2010 at the latest.
Digital reporting on pesticide and biocide sales – burden relief for the industry
The requirement for an accountant certification of the account holders’ yearly statement on sold Pesticides has been cancelled on December 18. 2009. This means a burden relief for the entire industry, financially as well as administratively. This cancellation allows, at the same time, account holders to be exempted from the accountant certification in current submitted reports on sold Pesticides and Biocides in 2009. The deadline for the submission of the report is 1 February 2010 at: www.virk.dk
Deadline for applications and procedures for biocides with active substances which have been included in Annex 1, 1A or 1B of the Biocidal Products Directive
Once an active substance has been included in annex I/IA of the Biocidal Products Directive, the products containing these substances should be nationally approved in accordance with the principles of the Biocidal Products Directive.
In order to keep a biocidal product on the Danish market, while the application is being evaluated, the deadline for the submittal of the application should be the date of the active substance formal admission in annex 1. If a product contains several active substances, the deadline for the product follows the date of the last included active substance’s inclusion.
Applicants can choose Denmark as first approval country or apply for an approval in accordance with the regulations on mutual recognitions. The regulations on mutual recognition give the applicant the possibility to get a product approved in one EU country, allowing him subsequently to apply for a mutual recognition of the authorisation or registration in other EU countries.
Application deadlines for the first six months of 2010:
Application deadlines for wood preservatives containing:
Clothianidin 1 February 2010 (RMS: Germany) Etophenprox 1 February 2010 (RMS: Austria) Tebuconazol 1 April 2010 (RMS: Denmark) Propiconazol 1 April 2010 (RMS: Finland) K-HDO 1 July 2010 (RMS: Austria) Thiabendazol 1 July 2010 (RMS: Spain) Thiamethoxam 1 July 2010 (RMS: Spain) IPBC 1 July 2010 (RMS: Denmark)
Deadline for applications for rodenticides containing:
Difenacoum 1 April 2010 (RMS: Finland)
Failure to submit an application will result in withdrawal of approval and immediate ban of sale and use of the concerned products. The regulations are stated in section 4, subsection 6 and annex 8 of the Executive Order on pesticides.
How to apply? For products where the active substance is listed in annex 1, the application must include the following elements:
• First part of the application form is in the common EU database (“European Register for Biocidal products”, abbreviated R4BP). The company should create a user profile (industrial user) in the system. The application R4BP contains details about the applicant and the product. The applicant should state which country he chooses for the first product approval and in which countries he wishes to apply for mutual recognition. Furthermore, he should indicate the country where the product is already marketed. The application form will eventually be available in Danish.
• The second part of the application form is a document enclosing information about scientific data on the product. Until a common EU format for this part of the form has been defined, the environmental Protection Agency can be e-mailed at for more information about this EU-application form.
• The dossier must include information about the efficacy of the product, its physical-chemical properties, effect on health, human and environmental exposure to the product and finally the dossier should include a risk assessment of the product. The instructions for the preparation of the dossier can be seen in “TNsG on Dossier Preparation”. The Environmental Protection Agency prefers an English version of the dossier, but it could be in Danish as well. Documents I and II of the dossier should be in Word format, document III in Word or in IUCLID5 format. • Check lists for active substances and product information, listed on “TNSG on Dossier Preparation”. • Specific information for the Danish market: draft for Danish labels, Danish user guide and safety data sheets for auxiliary substances.
Denmark as first Country or mutual recognition in Denmark? It is possible to apply for mutual recognition for products with active substances which have been included in Annex I of the biocide directive. The application for mutual recognition takes place in two phases. It is recommended to choose the “rapporteur” country for the active substances as Reference Member State (“first country”). In the first step, the application which is sent to the first country should contain a full dossier as described earlier. In the second step, other countries which have been chosen for the same product (Concerned Member States) will consider the application on mutual recognition based on the evaluation of the first country.
• If Denmark is the first country, a full dossier containing a signed print of the R4BP application form and two copies of the entire application written onto 2 CD´s should be submitted to the Environmental Protection Agency (with a copy of the signed R4BP, the scientific part of the application form, a complete dossier, the active substance and product data check list, safety data documentation for auxiliary substances, instructions in Danish and a draft for the Danish label.)
In case Denmark is not the first country, but a country where one applies for mutual recognition, then the following documentation should be submitted to the Environmental Protection Agency in step 1, i.e. when the active substance is included in Annex I:
• A full report stating that the application has been sent to the first country for approval and also an application form for mutual recognition in Denmark (using the R4BP) • A signed print of the R4BP application form • A copy of the “summary dossier” sent to the first country. The Environmental Protection Agency is entitled to require an English translation of the dossier.
In step 2, the following information should be submitted within 2 months from the date of the first approval by the first country (where the approval has been granted):
• A copy of the first approval and a translation in Danish or English • A product assessment report prepared by the first country • A copy of the applicant’s summary dossier containing a study evaluation from the first country (completed evaluation forms for each study) • Updated instructions in Danish, a draft for Danish labels according to the primary approval and safety data sheets • In addition, The Environmental Protection Agency may ask for the original study reports (i.e. document IV of the full dossier) which was sent to the first country, in English.
Fees Fees will be charged on different application types. For more information about fees, please see the announcement on pesticides and biocides in section 56.https://www.retsinformation.dk/Forms/R0710.aspx?id=12666
The fees are index regulated on a yearly basis and the actual rates are available here.
Links:More information about the Biocidal Products Directive on the Commission’s homepage at:http://ec.europa.eu/environment/biocides/index.htm
See “TNsG on dossier preparation” (word) at ex-ECB´s homepage.