Fact Sheet: Approval of plant protection products
This fact sheet explains the most important points on approval of plant protection products in the Consolidated Act from the Ministry of Environment on Chemical Substances and Products. Please note that only the regulations in the Statutory Order apply. This fact sheet is merely a guide.
What is the scope of the regulations?
The regulations cover chemical and microbiological products intended for:
- Protecting plants against damage from, for example, fungus and insects.
- Removing weeds.
- Influencing the plant’s growth in other ways than through nutrition.
- Protecting products originating from the plant.
What is the purpose of the regulations?
Plant protection products are harmful to the organisms they have to combat. The regulations are designed to protect against the many products that are also harmful to humans or the environment.
What do the regulations say?
Before it is permitted to sell, import or use a chemical plant protection product, it has to be approved by the Danish EPA. The Danish Forest and Nature Agency must approve microbiological plant protection products. The product must be approved for the desired area of use. In other words, the desired crop, with the desired dose and possibly any pests to be protected against. There are two lists of plant protection products that are relevant to approval:
1. The EU list of active substances for use in pesticides (Positive list). This can be found in annex 7 in the Statutory Order on Pesticides.
2. The list of active substances that may not be used in pesticides in Denmark (Negative list). This list can be found in annex 2 in the Consolidated Act from the Ministry of Environment and Energy on Chemical Substances and Products.
The applicant for approval must document:
- That the product works according to its intended use.
- That the product is not especially harmful to health.
- That the product is not especially harmful to the environment.
Analyses and tests must follow the Danish Agency for Trade and Industry regulations on good laboratory practise. The effectiveness of the product must be investigated by a testing unit with GEP approval (Good Experimental Practice) from the Danish Institute of Agricultural Sciences. The approval is temporary and runs over a maximum of ten years. The Minister can prohibit the sale, import and use of the product, at any time, if new information shows that the product is more harmful than was first thought. After this, the approval holder must apply for a renewal.
Who is responsible?
Anyone selling, importing or using pesticides is responsible for complying with the regulations as stated in the Act and the Standing Order. The Danish EPA Chemical Inspection Service supervises the implementation of the regulations and is authorised to issue injunctions and bans. If the regulations are violated this may lead to a fine or up to two years’ imprisonment.
Where can I obtain more information?
The titles of the statutory orders are:
Statutory Order No. 241 of 27 April 1998 on Pesticides , which contains annexes 5.1 – 5.3 with more detailed information as to what an application must contain. Other parts of the Statutory Order have been amended, including the first two standing orders below.
Bekendtgørelse nr. 313 af 5. maj 2000 om ændring af bekendtgørelse om bekæmpelsesmidler ("Statutory Order No. 313 of 5 May 2000 amending the Statutory Order on Pesticides"). Chapter two deals with approvals of pesticides.
Statutory Order No. 241 of 27 April 1998 on Pesticides . The Statutory Order contains annex 7 with the EU list.
Lov nr. 256 af 12. april 2000 om ærning af lov om kemiske stoffer of produkter ("The Ministry of Environment and Energy Act No. 256 of 12 April 2000 amending the Act on Chemical Substances and Products"). This Act amends the Ministry of Environment and Energy Statutory Order No. 21 of 16 January 1996.
The Danish Agency for Trade and Industry Statutory Order No. 745 of 27 September 1999 on accreditation of laboratories for testing etc. and for GLP inspection. Annex 1 contains the principles of good laboratory practise (GLP).
You can find the Statutory Orders, in Danish on the Internet address: www.retsinfo.dk , at the library or you can order them at a bookshop in Denmark