Approval of an active substance by the European Commission

The European Commission evaluates every active substance for safety before it reaches the market in a PPP. An application and a dossier are submitted to a Rapporteur Member State (RMS), who prepares a draft assessment report. EFSA then peer-reviews the report and issues its conclusions, the Commission’s Standing Committee votes on approval (or non-approval), and the Commission’s decision is published in the EU Official Journal. The time taken for the approval of an active substance varies greatly, depending on how complete and complex the dossier is.

Authorisation of a PPP in EU Member States

Before a PPP can be used or placed on the market, it must be authorised. An application and a dossier are submitted to the EU Member State(s) where the PPP is intended to be placed on the market. An RMS carries out an assessment, which can be commented upon by other concerned Member States. The RMS and possible other Member States make decisions on whether to grant or refuse authorisation. There are many EU regulations and both Commission and EFSA guidelines that help the applicant in the process of approval of the active substances and authorisation of PPPs.

Microorganisms as active substances

Micro-organisms cover “any microbiological entity” capable of replication or of transferring genetic material. This definition includes bacteria, lower fungi, and viruses. While the number of approved chemicals is decreasing, the number of approved microorganisms is increasing. The EU list of approved active substances includes strains of several Bacillus species, such as B. amyloliquefaciens, B. firmus, B. pumilus, B. subtilis, and B. thuringiensis. Among other bacteria are some Pseudomonas and Streptomyces species. These bacteria are used as bactericides, fungicides, nematicides or insecticides. The approved viruses include e.g. pepino mosaic virus and zucchini yellow mosaic virus, which are used for example as elicitors. Fungi represent the largest group, which includes e.g. Beauveria, Paecilomyces, Phlebiopsis, Saccharomyces, Verticillium and many Trichoderma species/strains. The main uses are as fungicides and insecticides.

Identification and characterisation of the microorganism

The identification and characterisation of the microorganism provide the most important information and represent key points for decision-making. Taxonomic identification at the species level and all known differences between the modified (whether mutant or GMO) and the parent wild strain must be provided. Whole genome sequencing (WGS) is currently the required “best available technology”, complemented with other relevant tests. The WGS can also provide clues to the possible undesirable traits of the microorganism, such as virulence/pathogenicity, antimicrobial resistance or production of harmful metabolites (antimicrobials, toxins). These data should be available already when working in the laboratory or greenhouse or carrying small-scale field studies.

Services provided by Biosafe Ltd

Biosafe Ltd. has extensive experience in the molecular level safety assessment of microorganisms used as active substances. Our services include:

  • Whole genome sequencing using a technology specified case-by-case
  • Bioinformatic analysis of the genome for taxonomic identification, screening for acquired antimicrobial resistance and virulence genes, and potential to produce secondary metabolites
  • CFU counts to estimate the number of microorganisms in specific settings and verifying the microbial strain with strain-specific PCR
  • Genetic stability of the microorganism
  • Cytotoxicity testing & hemolysis testing
  • Literature searches and reviews concerning the safety assessment of the microorganism

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Contact

More information about Biosafe’s services for microorganisms as active substances is available from Jenny Makkonen.

Jenny Makkonen
Project Manager, Ph.D
jenny.makkonen@biosafe.fi
+35840 5474 110

Active substancesuch as chemical or microorganism – is the active component in a plant protection product (PPP)

PPP (pesticide) is the product in the form in which it is supplied to the user, consisting or containing active substances, safeners or synergists, and intended for protecting plants against harmful organisms or influencing their growth; destroying or preventing growth of undesired plants (weeds); or preserving plant products

References/links
REGULATION (EC) No 1107/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL concerning the placing of plant protection products on the marketCommission Regulation (EU) No 283/2013 setting out the data requirements for active substances in accordance with Regulation (EC) No 1107/2009