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Approval of basic substances

Regulation (EC) No 1107/2009 has introduced the new category of basic substances into the European legal framework for plant protection.


Basic substances are substances that are not predominantly used for plant protection purposes but nevertheless are useful in plant protection. Further criteria according to article 23 of Regulation (EC) No 1107/2009 are that they are not substances of concern, that they do not have the capacity to cause endocrine disrupting, neurotoxic or immunotoxic effects, and that they are not placed on the market as plant protection products.

Approval procedure

Basic substances do not have to pass through the usual approval procedure for active substances of plant protection product, but are subject to a simplified approval procedure. Applications have to be submitted to the EU Commission. They may be placed not only by manufacturers, but also by interested parties and the Member States.

The necessary documents are described in general form by article 23 paragraph 3 of Regulation (EC) No 1107/2009. Details can be found in the guidance document of the EU Commission on the right-hand margin. This guidance also contains an application template.

Prerequisites for an approval are that the substance has neither immediate or delayed harmful effects on human or animal health, nor an unacceptable effect on the environment.

Approvals for basic substances are not time-limited, but may be reassessed any time if there are indications that the criteria are no longer fulfilled.

Use of basic substances

The use of substances and mixtures which contain only approved basic substances as defined by Regulation (EC) No 1107/2009 does not require an authorisation (§ 12 (4) sentence 1 no. 2 Plant Protection Act). Further information can be found on the web site "Anwendung von Grundstoffen" (in German).

Approved basic substances

The European Commission's database of active substances contains information on the approval status of basic substances. A corresponding link can be found in the right-hand margin. Click on
"Search active substances", then "Advanced search" and select Type = Basic substance.

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