Low Risk active substances and products

Date: 28 April 2020

Contrary to several non-EU regulatory frameworks, the EU Plant Protection Product REGULATION (EC) No 1107/2009 does not include a specific definition for biological or natural active substances or products. Rather, the EU Regulation differentiates between conventional and low risk active substances and products irrespective of their natural, biological or chemical origin. Updated criteria for low risk active substances are provided in REGULATION (EU) No 2017/1432. According to this Regulation, an active substance, other than a micro-organism, shall not be considered as being of low-risk where it corresponds to any of the following:

(a) It is or has to be classified in accordance with REGULATION (EC) No 1272/2008 as any of the following: — carcinogenic category 1A, 1B or 2, — mutagenic category 1A, 1B or 2, — toxic to reproduction category 1A, 1B or 2, — skin sensitiser category 1, — serious damage to eye category 1, — respiratory sensitiser category 1, — acute toxicity category 1, 2 or 3, — specific Target Organ Toxicant, category 1 or 2, — toxic to aquatic life of acute and chronic category 1 on the basis of appropriate standard tests, — explosive, — skin corrosive, category 1A, 1B or 1C;
(b) It has been identified as priority substance under Directive 2000/60/EC;
(c) It is deemed to be an endocrine disruptor or
(d) It has neurotoxic or immunotoxic effects.

In addition, an active substance, other than a micro-organism, shall not be considered as being of low-risk where it is persistent (half-life in soil is more than 60 days) or its bio-concentration factor is higher than 100. However, a naturally occurring active substance which does not correspond to any of points (a) to (d) may be considered as being of low-risk, even if it is persistent (half-life in soil is more than 60 days) or its bio-concentration factor is higher than 100. Furthermore, an active substance, other than a micro-organism, emitted and used by plants, animals and other organisms for communication, shall be considered as being of low- risk where it does not correspond to any of points (a) to (d).

An active substance which is a micro-organism may be considered as being of low-risk unless at strain level it has demonstrated multiple resistances to anti-microbials used in human or veterinary medicine whereat baculoviruses shall be considered as being of low-risk unless at strain level they have demonstrated adverse effects on non-target insects. Additional criteria for micro-organisms are currently under development.

On product level, all products containing only low-risk active substances can be authorised as low-risk plant protection products.

Low risk active substances and products are encouraged by regulatory authorities. Applicants receive benefits, such as extended approval periods and data protection, while fees can be tremendously lower (depending on Member state). Moreover, the evaluation time for low-risk plant protection products is 120 days, which is shorter compared to conventional plant protection products.

Carla Lorenz