Survey on new biotechnologies in microorganisms

INTERESTED PARTIES ARE INVITED TO SHARE KNOWLEDGE:  The European Commission requested EFSA to produce an opinion in accordance with Article 29 of Regulation (EC) No 178/2002, on new developments in biotechnology applied to microorganisms. This work is related to  i) microorganisms and products of category 4 (see below) to be released into the environment or placed on the market as or in food and feed; ii) products of category 3 (see below) to be placed on the market as or in food and feed. Two tasks will be performed under this mandate^[1]:

Task I: Horizon scanning on microorganisms and their products obtained by new development in biotechnology

Task II: EFSA opinion on potential novel hazards/risks from new developments in biotechnology applied to microorganisms and adequacy of the current EFSA risk assessment guidance

TYPE OF MICROORGANISMS and explanations of the terminology used: For the purpose of this survey and in accordance with the EFSA Guidance on the risk assessment of genetically modified microorganisms (GMM) and their products intended for food and feed use^[2], the following two categories are of interest:

• Category 3: Products derived from GMMs in which GMMs capable of multiplication or of transferring genes are not present, but in which recombinant DNA is still present (e.g. heat-inactivated starter cultures);
• Category 4: Products consisting of or containing GMMs capable of multiplication or of transferring genes (e.g. live starter cultures for fermented foods and feed).

TYPE OF TECHNIQUES: The interested parties are invited to participate to the survey and share what new developments in biotechnologies are being used in microorganisms.

New genomic techniques (NGTs) are defined as techniques of genetic manipulation that have emerged or developed after 2001 (when the Directive 2001/18/EC was published). Examples of NGTs include: 1) Genome editing techniques such as CRISPR-Cas. 2) In vivo mutagenesis techniques such as EvolvR, SCRaMbLE, etc. 3) Epigenetic techniques such as DNA-methylation, miRNA, etc. Conversely, techniques already in use prior to 2001, also called established genomic techniques (EGTs), making use of recombinant nucleic acid molecules are out of scope.

Link to the survey