• a&r News Digest

NEWS DIGEST by a&r | August 2020


We dedicate this August issue to food enzymes as cornerstones of food processing and drivers of innovation and to the latest EFSA probiotic claim rejection. Also, join us for our next webinar on the upcoming IVDR and connect with our experts next week during Vitafoods Virtual Expo!


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Regulatory News

Food Enzymes – cornerstones of food processing and drivers of innovation

Food enzymes are biocatalysts that make the processing of food ingredients, e.g. starch, economically viable but also allow for tremendous innovations in the nutrition sector, like alternative low-calorie sugars or prebiotics.

Many foods are produced with the help of enzymes, e.g. baking products, or starch-derived goods. Sometimes the enzymes themselves are used as food ingredients (e. g. papain, lactase) and sometimes as processing aids.

Food enzymes are generally processing aids and as such not clearly regulated in the EU. This means that enzymes used for the manufacture of foods require an authorization according to the common authorization procedure for food additives, food enzymes and food flavorings (Regulation (EU) 1331/2008). The specific requirements for food enzymes are laid down in Regulation (EU) 1332/2008.

Food enzymes can be extracted from natural sources like plants, animals, bacteria, or fungi, and are often obtained from genetically modified microorganisms.

The evolution of technologies for tailoring enzyme properties for specific purposes and for manufacturing them on a large scale in microorganisms has triggered – and driven – disruptive innovations in food manufacturing. Hence, food enzyme applications are often closely linked to novel food applications, and a missing enzyme authorization might slow down the authorization of a novel food.

But what does this mean for food enzymes?

In order to be used and or sold on the European market, enzymes have to be evaluated by EFSA to establish their safety and to be included in the Union List of food enzymes. This applies to all food enzymes, whether already established or new.

Many applications have already been submitted, and the publication of the Union list has been delayed to 2023/2024.

Currently, national legislation still applies for food enzymes, but the situation following the publication of the Union List remains unclear at the moment.

As there might be transitional measures for food enzyme applications submitted before the publication of the Union List, we recommend using this opportunity and preparing your food enzyme application now rather than wait for the official list.

What do you have to do in order to get your enzyme included into the Union list?

An application for the authorization of a food enzyme must provide a set of information characterizing the enzyme in question, along with its production process, intended uses, exposure, and its toxicological and allergenic potential.

For enzymes derived from microorganisms, the description of the microorganism used to produce the enzyme has to be provided, adding to the complexity of the application (e. g. inclusion and interpretation of WGS data, AMR gene information, or gDNA detection).

The applicant has to demonstrate that the enzyme in question is well understood, but also that substances present in the final enzyme preparation do not cause potentially toxic or harmful effects.

The extent of the necessary safety data depends on whether or not the enzyme and accompanying material is present in the final product.

How can you prepare?

The guidelines for food enzyme applications and microorganisms used for the production of food enzymes issued by EFSA are a good starting point.

Also, you should decide from the beginning how your enzyme is to be used (e.g. removal or presence in final food) and consider its source, as this will have a large impact on the application strategy and the required information.

But you are not alone. We have many years of experience in the food regulatory business and are happy to support you in all questions regarding food enzyme applications and development to provide you with a quick and efficient route to market for your products. To know more about our services, get in touch with us and join our upcoming seminar on food enzymes.

Our next webinar: “In vitro diagnostic devices for self-testing – what will change under IVDR?”

We are happy to invite you to the next instalment of our webinar series.

Free webinar at analyze & realize GmbH

What does this mean for your IVD, especially for your device for self-testing? Learn about the upcoming changes by attending our webinar – Get ready for IVDR!


Probiotic health claim and lactose digestion rejected by EFSA

EFSA has again rejected a health claim (under article 13.5) related to Bifidobacterium animalis subsp. lactis Bi-07 contributes to increasing lactose digestion from DuPont Nutrition Biosciences ApS.  The claimed effect proposed by the applicant is “improvement of lactose digestion”, which was considered by the panel as a beneficial physiological effect for those suffering from lactose maldigestion and provided that the symptoms of lactose maldigestion are improved.

Despite the fact that the EFSA acknowledged that BI-07 increased lactose digestion in subjects with lactose maldigestion and is able to exhibit lactase activity in vitro in two different studies, an improvement of subsequent gastrointestinal symptoms of lactose maldigestion was not shown. As the latter one was considered to be the key beneficial physiological effect, EFSA rejects the claim.

NutraBusiness Intel

Perrigo to acquires Sanofi’s Eastern Europe OTC self-care brands

Perrigo Company plc, announced the acquisition of three Eastern European OTC skincare and hair loss treatment brands (Emolium®, Iwostin® and Loxon®) from Sanofi for an undisclosed amount. The acquisition will strengthen Perrigo’s international self-care portfolio.

12.08.2020 · Source

Blackstone enters into agreement to buy Takeda’s Japanese OTC business 

Blackstone, a multinational private equity alternative investment management and financial services firm, entered into a definitive agreement to acquire Takeda Consumer Healthcare Company Limited, a subsidiary of Takeda Pharmaceutical Company Limited of over-the-counter (OTC) medicines in Japan, for a total value of JPY 242.0 billion. The portfolio to be divested to Blackstone includes a variety of OTC medicines and health products including Alinamin (a vitamin B1 preparation and top selling product in Japan), and Benza, a cold remedy.

24.08.2020 · Source

Merit Functional Foods partners with Bunge to bring pea and canola protein to market

Canada based company, Merit Functional Foods, announced a new partnership with Bunge Limited. The partnership will boost Merit’s mission to provide plant-based protein ingredients with high purity and quality.

27.08.20202 · Source

Bayer to buy personalized vitamin company Care/of 

Bayer AG agreed to buy 70% of online vitamin and health supplement company Care/of, in a transaction that values the company at $225 million. Bayer is aiming to expand its nutrition business.

31.08.2020 · Source

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Your experts

Irene Wohlfahrt
Irene WohlfahrtSenior Consultant
Dr. Inês Rocha
Dr. Inês RochaDirector of Business Development and Strategic Innovation

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