The main principles of the Pesticide Regulation
The Pesticide Regulation replaces Council Directive 91/414/EEC concerning the placing of plant protection products on the market, and Council Directive 79/117/EEC prohibiting the placing on the market and use of plant protection products containing certain active substances.
A regulation becomes Danish law from the day of its entry into force. The following is a brief introduction to the main principles of the Pesticide Regulation.
- The EU is divided into three zones, in which authorities share the work regarding the evaluation of new products for the zone. With regard to plant protection products for use in greenhouses, as post-harvest treatments, for treatment of empty storage rooms, or for seed treatments, the evaluation is done for the EU as a whole.
- An application must be made in each specific country where an authorisation is sought. If special conditions exist in one Member State and if the use of a pesticide approved in another Member State in the zone will lead to an unacceptable risk to health or environment, the Member State can refuse to authorise the product.
- It is possible to obtain authorisation for a product authorised in another zone through mutual recognition, though this is voluntary. Generally, Member States must authorise products that require authorisation in the entire EU zone through mutual recognition. It is possible to refuse authorisation however. The off-label principles continue but are now known as minor uses. Mutual recognition of authorisations will be possible.
- A positive list of active substances is being compiled at EU level. Authorisation of pesticides is granted at national level on the basis of the positive list.
- New criteria for the approval of active substances have been introduced and in the future safeners, synergists and adjuvants will also require approval. Co-formulants will in the future not be permitted as ingredients of products if they are on the negative list.
- It is expected that, on re-evaluation in connection with the Regulation and the new criteria for approval of active substances, approvals for several active substances will not be renewed in the EU. The substances involved are carcinogenic, toxic for reproduction and mutagenic as well as substances of very high concern for the environment. These active substances will no longer be included and the risks of using them will not be assessed. This is the so-called 'cut-off' principle.
- The EU Commission will, within four years, propose cut-off criteria for substances with endocrine-disrupting properties. In the interim, provisional criteria apply.
- Maximum processing times have been laid down according to the type of application – these apply to all Member States.
In conjunction with the Regulation's changes, Denmark is introducing amended provisions for classification in respect of the CLP regulation.