In late June Fera Science held a webinar entitled “From Research to Regulation: A deep dive into bacteriophage applications and challenges”, the webinar focused on bacteriophages (viruses that devour bacteria) as a form of biocontrol against microbial pathogens. The webinar featured five guest speakers who discussed academic research, regulation, and commercial applications of bacteriophages.
The final presenter of the webinar was Thijs De Langhe from DCM, Belgium who gave a presentation around one of their products, entitled “PEA-02®: From development to field application”. DCM started in the 1970’s as an organic fertiliser company and has broadened its portfolio to include biostimulant and biocontrol products. He talked about another pathogenic bacterium of concern; Erwinia amylovora (fireblight). E. amylovora commonly infects apple and pear (and other members of the Rosaceae family) and is present in every country that produces these fruits (including Ireland). The pathogen spreads through the tree’s vascular system and once the roots are affected, death of the plant often occurs. This bacterium and disease led DCM to create PEA-02® which is a mixture of bacteriophages that specifically target E. amylovora. The active substance dossier was submitted to the EU regulatory authorities in March of 2023 and DCM are predicting that it will be presumably deemed low risk with no expected maximum residue levels (MRLs).
The product development mirrors that of other bacteriophage research as the bacterial population within Europe and northern Africa was screened; followed by screening of bacteriophage candidates against E. amylovora and an investigation into the compilation of bacteriophage mixtures to cover the genetic diversity was conducted. Thijs also mentioned the recommended application times for the product which occur around important times of infection such as flowering and at the end of vegetative growth. He noted that in field trials when areas of trees were covered (not applied with the product directly) eventually the bacteriophage was found in these areas, showcasing translocation of the product within the plant. Finally, field trial results with pears were presented that took place in Romania in 2023. The results showed a clear dose effect and efficacy reached up to 95% in treated groups.
As bacteriophage research is highly specific and quite new, often it is a topic focused a lot within academic circles. Presentations such as that by Mr. De Langhe demonstrate the tangible applications that can be created by industry within the field of biocontrol and the real-world positive impacts of using such products.
If you need any support with the registration of biocontrol or plant protection products in Europe please do not hesitate in contacting one of our regulatory consultants at info@kerona.ie