EFSA statement on the microorganisms used for the production of food enzymes introduces whole genom sequencing as a major molecular characterisation tool

EFSA statement on the microorganisms used for the production of food enzymes introduces whole genome sequencing as a major molecular characterisation tool

EFSA CEP Panel published on 11 June 2019 a statement on the characterisation of microorganisms used for the production of food enzymes. This has been expected since February 2018 when the FEEDAP Panel adopted a guidance on the characterisation of microorganisms used as a production organisms mainly for enzymes, amino acids and vitamins. The statement covers only aspects directly linked to the production strain and excludes technical and toxicological aspects, which are covered by existing guidance documents. In agreement with the FEEDAP guidance, a requirement for the deposition of the production strain in an internationally recognised culture collection is now clearly stated, even though this is not explicitely indicated in the food enzyme legislation. As in the FEEDAP guidance, whole genome sequencing is now required for the characterisation of bacteria and yeasts and recommended for fungi. Concerning antimicrobial susceptibility, the requirements are identical to those in the FEEDAP guidance except for the adjustment of the table indicating the microbiological cut-off values. The corresponding cut-off values have not been modified, but Pseudomonas is included in the table and the relevant cut-off values have been drawn from EUCAST. The toxigenicity and pathogenicity section as well as molecular characterisation of the microorganism also follow the FEEDAP guidance requirements. Analysis of the absence of viable cells or DNA from the product is also identical. In conclusion, with this statement the CEP Panel harmonises the requirements for the assessment of the microorganisms used for the production of food enzymes with the corresponding FEEDAP guidance. In both cases the whole genome sequencing approach has been taken extensively into use, which is a logical step considering the rapid scientific development.

Link to the statement:

The safety requirements of microbial products in the EU 2-3 April 2019, Helsinki

Register for training:
The safety requirements of microbial products in the EU 2-3 April 2019, Helsinki

Microorganisms are used in the food chain as production organisms or viable microorganisms. The safety assessment related to the characteristics of the microbial strain are the same regardless of the food sector area. There are, however, specific safety criteria for fermentation products or genetically modified microorganisms and, different rules may apply according to the intended use of the microbial product.
This course provides an update on safety requirements for microbial feed additives, (food) enzymes and live microorganisms used in food. The workshops enable delegates to solve practical problems together to gain better understanding of the practicalities related to fulfilling the EFSA guidance requirements.

microbial food products

Satefy requirements of microbial products

Who should attend?
Business Development
Feed & Food business operators
R&D Scientists
Project managers
Registration managers

Further information
+358 40 640 3225

Early Bird by 22.2. 900€ + VAT
By 18.3. 1100 € + VAT
The fee includes meals, refreshments and the course material.

Cancellations by 2.3. with 10% administration fee. Payment is due within 30 days upon receipt of the invoice or prior to the course, whichever is first. If in the unlikely event that the course is cancelled Biosafe is not responsible for airfare, hotel or other costs incurred by registered delegates.

Aviapolis, Vantaa, Seminar room Hekla
Teknobulevardi 3-5, 01530 Vantaa
Easy access from the Airport


Tuesday 2.4.2019
13.00 Registration and lunch
14.00 Welcome, Biosafe
14.05 EU Feed Additives regulator framework & EFSA data requirements
Laura Payo Lewis, Pen&Tec
15.00 Safety assessment of food cultures and probiotics
Prof. Seppo Salminen, UTU
16.15 Discussion and refreshments
16.45 Whole genome sequencing and interpretation of results
Dr. Pauliina Halimaa, Biosafe
17.45 Networking reception
18.30 End of day one
Wednesday 3.4.2019
9.00 Safety of enzymes in the European context
Prof. Sirpa Kärenlampi, Biosafe
10.30 Refreshments
10.45 Safety Aspects of Feed Additives
Prof. Atte von Wright, Biosafe
12.15 Lunch
13.00 Laboratory in vitro study design, practical points
Dr. Jouni Heikkinen, Biosafe
14.15 Refreshments and discussion
15.00 End of day two

Suggested hotels:
Clarion Hotel Helsinki Airport
Scandic Helsinki Aviapolis

Book a moment with one of our experts to discuss the safety aspects of your product!


Laura Payo Lewis holds a Master in Biotechnology from the University of Salamanca, and interned in the cell culture quality control department of Intervet/Schering-Plough Animal Health in 2010. She specialises in both EU food and feed product registrations. She has more than 7 years experience in regulatory affairs, helping numerous clients take their products to market, such as enzymes used as animal digestibility enhancers or microorganisms used as gut flora stabilizers. She provides training sessions on all aspects of the EU registration process, on topics such as understanding data requirements for the risk assessment of food and feed products derived from genetically modified microorganisms.
Sirpa Kärenlampi
Professor Sirpa Kärenlampi is microbial biochemist by training and has strong background in molecular biology. She has extensive experience in risk assessment of applications submitted to the European Commission for authorisation. She was a member of the EC Scientific Committee on Plants (in particular genetically modified plants), followed by the European Food Safety Authority (EFSA), where she served as a scientific expert for 15 years. The EFSA Panels included GMO (GM plants and microorganisms), FEEDAP (GM microorganism -derived products) and CEF (in particular food enzymes).
Atte vonWright
Professor Atte von Wright is an expert in food toxicology, food microbiology and hygiene and in technological and probiotic applications of lactic acid bacteria. His past research experience includes appointments both in industry and in academia. He has also participated in the expert functions of the EU (in the former Scientific Committee on Animal Nutrition and in scientific panels and working groups of the European Food Safety Authority). Professor von Wright is currently the Scientific Director of Biosafe.
Seppo Salminen
Professor Seppo Salminen is expert in food microbiology and gut health, and has received several international prizes for his work. He has served as an expert member in several regulatory committees on food and health in Finland and in the EU (EFSA NDA panel, Novel Food working group), and holds currently a Fellow of the Australia New Zealand Food Authority ANZFA. He is also a board member and president of ISAPP (International Scientific Society of Probiotics and Prebiotics).
Pauliina Halimaa
Dr. Pauliina Halimaa is expert in the safety aspects of microbial genomes and the related guidance by EFSA. She has helped numerous customers analyze and interpret antimicrobial resistance genes, as well as genes for toxins and virulence factors. She is also expert in genetically modified microorganisms intended for food and feed use and their safety assessment. Keeping in mind the big picture, she also has an eye for detail.
Jouni Heikkinen
Dr. Jouni Heikkinen is expert in food microbiology, in vitro safety and efficacy assessment of microbial feed additives and method development of microbiological analyses. His research experience with fish probiotics and pathogen inhibition studies provides strong know-how for applications for cold-blooded animals.

New EFSA guidance on feed microorganisms into force

New EFSA guidance on feed microorganisms into force

The new “Guidance on the characterisation of microorganisms used as feed additives or as production organisms” by the FEEDAP Panel of EFSA entered into force in the beginning of September 2018. This guidance assists the applicants seeking authorization for their products in proper characterization of the microorganism, whether genetically modified or not. Compared to previous guidance, one significant change is that whole genome sequence analysis is required for bacteria and yeasts and also recommended for fungi. This serves the purpose of improved overall characterization of the microorganism, including taxonomic identification and the presence of both intrinsic and introduced antibiotic resistance genes or virulence factors. A particular attention has been paid to the antimicrobials considered by World Health Organization as critically or highly important.
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Biosafe is proud to sponsor the Feed Additives 2018 conference on 26 – 28 September in Amsterdam

Biosafe is proud to sponsor the Feed Additives 2018 conference on 26-28 September in Amsterdam

Feed Additives 2018 is an annual gathering for leading feed additives producers, traders and users. It is a three-day opportunity for relationship building, hearing about the latest scientific advancements from high-level speakers and getting practical guidance for improving your business.
Our Scientific Director, Professor Atte von Wright, and Research Manager, PhD Pauliina Halimaa will be available throughout the three-day conference at our stand. Please take the opportunity to ask us about feed additive regulations and how to assess microbial safety. Atte’s interview is available at https://www.feedadditives-global.com/biosafe/. More information about Biosafe’s services regarding feed additives can be found from  http://www.biosafe.fi/en/en-biosafefeed

As a partner, we can offer discounted tickets. Subsidised tickets to Compound Feed Mills and Premixers are available at the following rates:

1 day ticket = 299€ +VAT
2 day ticket = 499€ +VAT3 day ticket = 699€ +VAT
These rates are not available through the website. Feed mills or premixers who wants to register at this discounted rate please contact pauliina.halimaa@biosafe.fi

For any other firms, please use our unique discount code FABIOSAFE18 which allows you to book through the website with a 15% discount.

Ticket bookings can be made at https://www.feedadditives-global.com/global/registration/

Feel free to contact us directly or book a meeting via the FeedAdditives app!


Press release 3 April 2017


The European Committee for Standardization (CEN) is ordering an industry standard for the assessment of additives in animal feed from Biosafe Ltd. Biosafe Ltd will produce a common approach for obtaining the genetic “fingerprints” of feed additives. The industry standard will enable improved assessment of feed additives. In the future, the entire European feed industry will use the same standardised methods in the assessment of feed additives. This is a unique opportunity for Finnish biotechnology competence.

Biosafe is able to fulfil the order thanks to its excellence in biotechnology, international networks and specialisation in the safety assessment of additives in animal feed. Biosafe Ltd operates in the global market and has an export rate of around 80%. The company currently employs 10 people. The objective of Biosafe Ltd is to be its industry’s leading company in Europe by the year 2020.

Feed additives are biotechnological hightech products. Approximately 200 new or improved feed additives are annually introduced to the European market. Different kinds of feed additives have major commercial significance for the feed industry. The use of feed additives aims at enhancing the nutrient intake of livestock, maintaining the animals’ health and reducing related environmental harm. Feed additives also reduce the use of antibiotics. The consumer is the final beneficiary. The use of feed additives is already carefully monitored in Europe. The EFSA (European Food Safety Authority), an agency of the European Union, is in charge of monitoring the safety and market authorisation procedure of additives used in animal feed.

There is a huge need for improving the efficacy of feed use both in the feed industry as well as in primary agricultural production. The total annual production of the European feed industry is around 150 million tonnes. Turnover of the European compound feed industry is estimated at 50 billion €. The use of animal protein grows by 1.7% each year. The global animal feed production should be growing significantly faster.

“This is a major deal for us. We are taking a giant leap towards our goal. The deal will make the company more well-known and increase its appeal as a partner globally. This is an example of Finnish export of services at its best. Our main market area is Europe. Within the previous six months, we have also attracted new customers from the United States, Japan, India, China, Singapore and New Zealand. The prospects for Biosafe Ltd’s export of biotechnological services are highly promising”, says Petri Pietikäinen, Chairman of the Board of Biosafe Ltd.

Further information:
Petri Pietikäinen
Chairman of the Board
Biosafe Biological Safety Solutions Ltd/Oy
Microkatu 1 (PL 1199)
70211 KUOPIO
tel. +358 40 728 43 50