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Biosafe joins EuropaBio as an associate member

Biosafe is now a member of EuropaBio

We are glad to announce that we have been accepted as an associate member of EuropaBio, Europe’s largest and most influential biotech industry organization.

Biosafe joins EuropaBio as an associate member

On September 3, 2020, Biosafe Oy was accepted as a member of EuropaBio, Europe’s largest and most influential biotech industry organization.

EuropaBio aims to actively promote the competitiveness of the EU biotech industry by ethical and socially responsible means. EuropaBio has a direct dialogue with both the European Parliament and the Commission. EuropaBio’s three main areas of activity include healthcare, industrial, and agriculture and food biotechnology.

EuropaBio represents 81 corporate and associate members, as well as regional biotechnology players and 15 national biotechnology organizations, representing more than 1 800 biotechnology SMEs across Europe. From Finland, the organization includes the Finnish Bioindustry Association as a national industry association and one Finnish bioindustrial company as an associate member. Biosafe Oy is the second Finnish company to be accepted as an associate member.

Biosafe Oy is a Kuopio-based company offering laboratory and consultation services. The company’s core expertise is to investigate the safety and to help authorize new ingredients developed by food and feed industry customers.  Most of our customers are global companies, and about 95% of our turnover comes from outside Finland. We help our customers commercialize products on the European market that require the prior approval of the Commission, including food enzymes, novel foods and feed additives. The European Food Safety Authority (EFSA) has developed detailed guidance on the safety studies required for such approval. “We specialize in such safety studies,” explains Pauliina Halimaa, CEO of Biosafe Oy, “we work with companies and authorities and ensure that the studies submitted for authorization can receive a favorable decision from EFSA.”

Even before being accepted as a member of EuropaBio, Biosafe has been invited to participate in several working groups of EuropaBio. The issues that have been raised relate to the far-reaching problems identified in the legislation and its interpretations, with a view to finding lasting solutions. “It has been eye-opening how strong competitors are acting together and finding common grounds for important issues affecting the future,” says Halimaa. Biosafe is proud of its membership and is grateful for the opportunity to actively contribute to the development and success of European biotechnology.

More information about the EuropaBio network is available here: https://www.europabio.org/

For any questions or collaborations, please contact our Biosafe team.

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Regulated microbes and their products: News and challenges in EU risk assessment – Register for the seminar

Regulated microbes and their products: News and challenges in EU risk assessment
Online interactive seminar series – Register here

Introduction
Microorganisms are used in the food chain as well as production organisms or viable microorganisms. This 4-part series of online, interactive seminars provides an overview of the relevant regulatory bodies within the EU, with an emphasis on the use and regulation of microorganisms in the food chain. The new EFSA regulation concerning transparency and sustainability in the food chain and its consequences will be addressed in depth. Further, questions and problems that are regularly encountered by the applicants will be considered at the practical level.

In case of technical problems, please contact teemu.kuhmonen@biosafe.fi.

Program and schedule

Timeslots for questions and discussion are available during and after each talk. Questions can be asked throughout the interactive seminar. If you would prefer to ask a question anonymously, please send your question(s) to info@biosafe.fi as early as possible.

September 16, 2020: 9.00-10.30 CET (10.00-11.30 EST)
8.45 Welcome and webinar instructions. Please join the seminar to make sure the connection works
9.00 Risk assessment of microorganisms intentionally used in the food chain with a focus on feed additives
Dr. Montserrat Anguita (EFSA)
9.45 Qualified Presumption of Safety: Can my microbe get a QPS status and what should I do to get it? What is the advantage of having the status?
Lieve Herman (ILVO, Belgium, Chair of the EFSA QPS working group)

October 14, 2020: 9.00-10.30 CET

8.45 Welcome and webinar instructions
9.00 Case of microbes/microbial products in feed additives
Prof. Atte von Wright (Biosafe)
9.45 Quality criteria for analytical studies
Dr. Jouni Heikkinen (Biosafe)
November 12, 2020: 9.00-10.30 CET
8.45 Welcome and webinar instructions
9.00 Genes of concern (primarily concerning AMR)
Prof. Sirpa Kärenlampi (Biosafe)
9.45 Absence of cells, presence of DNA; sampling and other things to consider
Dr. Pauliina Halimaa (Biosafe)

December 10, 2020: 9.00-10.30 CET

8.45 Welcome and webinar instructions
9.00 Transparency regulation, what are the consequences for the industry?
Ruud Bremmers, (Managing Director, Regal B.V.)
9.45 Whole genome sequencing and bioinformatics analysis; new guidance from EFSA; how to understand/use the data; what can WGS achieve/not achieve
Dr. Jenny Makkonen and Dr. Daniel Blande (Biosafe)

Please send any queries or advance session questions to info@biosafe.fi. All sessions will be recorded and made available for download to registered participants.

Price: 200 €* / company unit / four seminars (max 3 attendees/company unit)
Individual seminar 50 €*

*Does not include VAT (if applicable). The participation fee is non-refundable.

Please remember to register for the second seminar by 12.00 CET on October 13, 2020.

Register here

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More information
Pauliina Halimaa
pauliina.halimaa@biosafe.fi
+35840 640 3225

Amendments to EU General Food Law are coming. What will change?

Amendments to EU General Food Law are coming. What will change?

On Friday, 6 September 2019, a Regulation amending the General Food Law from 2002 was published in the EU Official Journal. The initiation to amend the Regulation has its roots in the heated arguments around the safety of glyphosate and the claims about the lack of transparency in the risk assessment. Besides plant protection products like glyphosate, the amendment now covers also genetically modified organisms, food and feed additives, food enzymes and flavourings, smoke flavourings, novel foods and food contact materials.

To increase transparency, applications for authorisation submitted to EFSA for scientific evaluation will be made public. This includes all non-confidential information and studies supporting the application. This is not, in fact, an entirely novel procedure. The Food Standards Australia New Zealand (FSANZ) has already had this practice at least for food enzymes. Thus anybody interested has had a possibility to scroll through, even download, an over 1000-page application if (s)he so wishes. The data requirements by FSANZ and EFSA are not much different so one can have a pretty good idea about the content of applications submitted in the EU. FSANZ has also a consultation procedure for the submitted applications.

 

What is clearly new is that applicants and laboratories carrying out studies will have a notification obligation, basically meaning that studies with undesirable outcome cannot be hidden anymore by excluding them from the application. Further guidance is obviously needed how to fulfil this obligation. How is this accomplished with applicants coming from ouside the EU? There will be a grey area between studies carried out in the R & D phase, and those carried out with the final product.

For the applicants, the Regulation brings a very welcome improvement in that EFSA will provide pre-submission advice on the required content of an application dossier. Currently all legislation and guidelines are available as well-organised packages in EFSA homepage. The new approach must then go clearly further than that. The more innovative the applications are, the more there will be a need to consult EFSA to achieve an optimal outcome from both applicant’s and EFSA’s point of view.

For the laboratories, perhaps the major change will be the Commission fact-finding missions to ensure the compliance of laboratories/studies with appropriate standards. This has a good chance of improving the quality of the studies. However, this should not cause extra financial burden to the laboratories.

The amendment becomes applicable by the end of March 2021. Hopefully this one and a half year is sufficient to ensure that not only Commission and EFSA but also all other parties down the line, Biosafe Ltd included, will be fully prepared to the changes needed.