Basic substances are products which are already sold for other purposes, e.g. as a foodstuff or a cosmetic, but which can also serve as a plant protection product.*
Their use as a plant protection product usually means that the products enter the environment and/or the food chain, or that the specific application method results in possible exposure for the user.
For the producers of basic substances, the profit margin resulting from the use for plant protection purposes is often insufficient to justify registration costs, with the result that many of these products are used as plant protection products without authorisation, and therefore illegally.
In order to tackle this, a simpler procedure was provided for in the European legislation, whereby basic substances can be placed on a positive list. Once on this positive list (filter on Type: basic substance and Status: active), these basic substances can be used by anyone for the substance's approved use.
The FPS Public Health stresses however that this does not mean that all products on the market can simply be used as plant protection products. If the product is not on the positive list, this means that it is not known what the effects are on the environment, or on the user. And although it often concerns natural products, this does not necessarily mean that they are harmless. Naturally, the dose and application method also play a role, which is why these elements are also indicated on the positive list. If the basic substance is used in another way, for example in a higher dose, it can still constitute a hazard to health or the environment.
Products traded for other purposes, such as plant extract for example, can therefore not be used for the protection of plants as long as they are not approved as a basic substance. Products based on iron sulphate, sulphur, bleach or other approved active substances do not fall under the regulations for basic substances, since these products must be authorised as plant protection products. It is therefore also not authorised to trade iron sulphate and sulphur nor to use these substances as a plant protection product if they are sold in packages without an authorisation number.
Labelling and marketing of products based on basic substances
As previously explained, in the first instance, basic substances have another purpose than protecting plants. This means that they initially need to be placed on the market for another use than that of plant protection.
After the authorisation of a product as a basic substance, the label of the marketed products may be modified referencing its use as a plant protection product.
In all cases, it is authorised to indicate the use as a basic substance on the label. The labelling may also refer to the approval of the active substance as basic substance.
Consequently, a basic substance cannot be commercialised as a plant protection product alone, and the labelling must always indicate the use for which the product was initially and primarily placed on the market. The labelling may also indicate the substance's use as a plant protection product, as this was laid down in the approval as a basic substance.
If only its use as a plant protection product is indicated, the product must be authorised as a plant protection product.
Some rules to be followed when labelling basic substances:
- The product cannot be marketed only as a basic substance.
- The use for which the product was initially and primarily placed on the market needs to be prominently present on the packaging.
- The most important side of the packaging can indicate the authorisation of the product as a basic substance according to art. 23* of Regulation 1107/2009 and the authorized uses may be indicated briefly..
- Information on the conditions for authorisation (use, good agricultural practices, ...) as a basic substance may be indicated on another side.
- If necessary, the labelling should contain all the phrases that are mandatory for the original use for which the product was initially marketed. For example, CLP, hazard symbols, presence of allergents, special recommandations, ...
How can you submit an application for a basic substance?
The approval of a basic substance is a European procedure. The application must therefore be addressed to the European Commission. The procedure to submit an application can be found here.
The Commission has drafted a guide in which the procedure is described, and in which it is indicated in what form a dossier should be submitted (format of the application, documents to be submitted, etc.). The guide can be consulted here.
* Article 23 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC.