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Approval of low risk substances

The Commission has recently published Regulation (EU) 2017/1432 of 7 August 2017 amending Regulation (EC) No 1107/2009 of the European Parliament and the Council concerning the placing of plant protection products on the market as regards the criteria for the approval of low-risk active substances.

Naturally occurring substances are in principle to be considered as low risk, even if they do not comply with the persistence or bio-concentration criteria.

Semio-chemicals (defined as “active substances, other than a micro-organism, emitted and used by plants, animals and other organisms for communication”) shall be considered as low-risk where they do not correspond to any of the points listed below.

Also micro-organisms may be considered as low-risk, unless they demonstrate multiple resistance to anti-microbials used in human or veterinary medicine. Baculoviruses, unless they have demonstrated adverse effects on non-target insects, shall also be considered as low-risk.

The criteria for determining low risk status for other substances are presented in the form of exclusions as follows:

Classified in accordance with Regulation (EC) No 1272/2008 as any one of the following:

  • Carcinogenic, or mutagenic, or toxic to reproduction: category 1A, 1B or 2
  • Skin sensitiser, or serious damage to eye, or respiratory sensitiser: category 1
  • Acute toxicity: category 1, 2 or 3
  • Specific Target Organ Toxicant: category 1 or 2
  • Toxic to aquatic life: acute and chronic category 1 on the basis of appropriate standard tests
  • Explosive
  • Skin corrosive: category 1A, 1B or 1C
  • Identified as priority substance under Directive 2000/60/EC
  • Deemed to be an endocrine disruptor
  • Has neurotoxic or immunotoxic effects

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.

The criteria apply from 28 August 2017.

For advice on approval of low risk substances and further information on the registration of plant protection products, biocides or general chemicals, or any other regulatory issues, please contact JSC on +44 (0)1423 520245, enquiries@jsci.co.uk

 

Published 6th September 2017
Categories Agrochemicals, News
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