We dedicate this July issue to clinical research on infant nutrition and immune health, to the ending of the NHCR exemption for trademarks and brand names, and to EFSA’s open consultation on its technical draft for nanoparticles. Also, join us for our next webinar on the upcoming IVDR and prepare to visit our virtual booth at Vitafood’s Virtual Expo!

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Save the date!

Save the date for our 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:

In vitro diagnostic medical devices (IVD) are tests performed on human samples (such as blood, urine or tissues) to provide information on a person’s health. Until 2017 IVDs were regulated by the Directive 98/79/EC on in vitro diagnostic medical devices (IVDD). In May 2017 the new Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) came into force.

The IVDD-to-IVDR transition period will end in May 2022. Get ready for the upcoming changes by attending our webinar!

Date: 22 September 2020
Time: 3 pm CEST

To the registration page

Clinical research

a&r as a Contract Research Organization (CRO) has long-standing experience in designing, planning, implementing, evaluating and publishing clinical trials to obtain or extend product approval or to optimize product marketing.

Clinical trials on Infant nutrition

Are you a manufacturer of infant formula? Do you plan to innovate your portfolio with new ingredients? If the logistics for obtaining a marketing authorization for your new ingredients are what’s holding you back, then a&r may be just the partner for you. Our Clinical Research team has extensive experience in clinical trials for infant nutrition.

Human breast milk is the best nutrition for infants. In cases where it is not possible to follow the recommendations of health authorities worldwide to exclusively breastfeed for 4 – 6 months, infant formula may be the only nutrition for this vulnerable population group.

Due to strict requirements for the demonstration of safety and tolerability, innovation in infant nutrition ingredients beyond the authorized standards is time-consuming and expensive. Nevertheless, manufacturers of infant nutrition are committed to improving their formulas and to mimicking the composition of breastmilk as much as technically possible. However, in order to obtain a market authorization for novel foods as ingredients in infant formulas, or for nutrients or additives that are not yet authorized for this target group, clinical studies with infants might be required.

At a&r, we have conducted several growth and tolerance studies with more than 300 newborns (0 to 14 days after birth old) per study from different EU countries, including complex microbiota (sub)-studies. Thanks to our carefully selected and experienced investigator network including hospitals and a pediatric network, we were able to manage timely recruitment. We have countered challenges of investigational product logistics by developing our sophisticated logistics tool, ensuring a smooth supply for all involved parties.

For more information, get in touch.

Clinical trials on Immune health

In view of the current pandemic, conducting a clinical trial on cough & cold seems challenging. If you are a manufacturer for a product with immunomodulatory activity and wish to generate data substantiating this, a&r’s Clinical Research team can be a partner for you even in these trying times. We have the ideas and the experience to help you conduct a clinical trial on immune health.

The immune system defends us from bacteria, viruses, and other sources of infection. Its actions are influenced by a number of factors, such as age, diet, physical activity, stress level etc., which results in a great variance in its function in the generally healthy population. This renders clinical trials in this area challenging, as the different components of the immune system must be considered when designing such a trial.

A&r has profound know-how and experience with clinical studies with natural products (including food and medical devices) in the area of immune health, such as botanicals, probiotics, fibers, or vitamins. This experience includes various study designs, ranging from short-term studies investigating effects on markers of immune function up to classical large-scale „common cold“ RCTs evaluating incidence/severity of infections.

Assessments of immune markers in food studies may include e.g. changes in lymphoid subpopulations, phagocytic activity, natural killer cells activity, concentration of cellular mediators etc., while applying tailored laboratory methods and appropriate approaches in the statistical evaluation.

A small-scale study of immune markers may serve either as a first step in the characterization of the immunomodulating potential of your natural product – or to provide supplementary scientific evidence to the clinical portfolio.

Contact us today to learn how a&r can assist you!

Regulatory News

Exemption for health claims in trademarks and brand names ends – get prepared

For nearly 15 years, trademarks and brand names that have existed in the EU before January 1, 2005 were granted a temporary exemption to the Nutrition and Health Claims Regulation (EC) No 1924/2006 (Article 27(2) NHCR). This means that names that imply a health claim, e.g. “Vital”, “Healthy” etc, were permitted to be used without being accompanied by a specific authorized health claim. The transition period ends on January 19, 2022.

With the end of the transition period, all companies, including those that have so far enjoyed the exemption, will need to comply with the NHCR in full. This means that all brand names and trademarks that imply a health claim will then need to be accompanied by a specific authorized health claim, or they can no longer be used.

While no particular guidance exists, these specific health claims should be relevant to the implied non-specific health claim, e.g. if the brand name implies immune health, the accompanying authorized health claim should also involve immune health. If this is not possible, because no corresponding authorized health claim exists, e.g. in the case of names including the word “probiotic”, then the name can no longer be used. This may be subject to EU Member States’ individual legislation.

The specific claim should also be located next to or following the general statement, if necessary by use of an asterisk.

Do you have questions or do you need advice on how to achieve full compliance for your brand name or trademark as the transition period ends? Contact us today at business@a-r.com!

EFSA consultation: draft technical guidance on nanoparticles

Calls are open for consultation on the new EFSA guidance on nano-particles and the nutrient definition.

EFSA’s Scientific Committee has launched an open consultation on its draft EFSA Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles. This document sets out information requirements for applications in the regulated food and feed product areas, and establishes criteria for assessing the presence of a fraction of small particles. These requirements apply to particles requiring specific assessment at the nanoscale in conventional materials that do not meet the definition of engineered nanomaterial as set out in the Novel Food Regulation (EU) 2015/2283. This Guidance on Particle-TR complements the Guidance on Nanoscience and Nanotechnology adopted by the EFSA Scientific Committee in 2018.

Interested parties are invited to submit written comments by 09/09/2020.

Meet us at Vitafoods Virtual Expo

a&r will take part in Vitafoods’ virtual event held 7 – 11 September.

In addition to providing a space for the nutraceuticals community to keep connected, the Virtual Expo will also provide the opportunities that an online environment affords, including algorithm-driven ‘matchmaking’ with industry experts and thought leaders, one-to-one secure video meetings, and an innovative digital platform that makes networking, learning, sourcing, selling and sharing feel entirely seamless.

NutraBusiness Intel

Novozymes acquires PrecisionBiotics Group

PrecisionBiotics is a Cork-based firm that has developed a portfolio of probiotics aimed at improving human gut health. The company holds a leading position in the probiotics market with a revenue of €13.4 million in 2019. Through this partnership, Novozymes expects to gain access to the €5 billion human probiotic supplements market. This acquisition agreement will benefit both Novozymes and PrecisionBiotics as it will enable Novozymes to orchestrate a globalized release of probiotics solutions that target the appropriate markets. Depending on future market trends, the deal may prove to provide an advantageous, long term bolt-on solution to its biotech portfolio.

2 July 2020 • Source

Verfora consolidates its leading position in the Swiss CHC market

On 1 July, Galenica acquired the Hedoga Group with its well-known brands Osa®, Osanit® and Carmol®. Verfora has thus secured the rights to strong brands and marketing authorisations with potential that are an ideal complement to the current portfolio. Accordingly, Verfora can consolidate its leading position in the Swiss consumer healthcare (CHC) market and strengthen its positioning as the most important partner for pharmacies and drugstores for over-the-counter medicines and health products. The export business will also be expanded in a targeted manner.

The Hedoga Group includes Swiss-based Iromedica Ltd. and Austria’s Dr. Schmidgall LLC, each with some 20 employees. The focus of the Group is on marketing over-the-counter (OTC) medicines, medical devices, food supplements and cosmetics. In 2019, the Group as a whole generated net sales of CHF 25 million, of which almost half in Switzerland and the remainder in Austria, Germany and selected export markets in particular.

2 July 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

At analyze & realize, we are experts in the field of natural health products, having provided our services for more than 20 years. We offer a unique combination of expertise in natural health products through our scientific, regulatory, and strategic innovation consulting and our clinical research organization with its own clinical trial center in Berlin, Germany. Thanks to our close interaction with the natural product market as well as our extensive network, we are always at the forefront of the latest information and innovation trends. With its international team of 35 employees, a&r is a leading European one-stop-shop ready to guide and support your needs in natural health product innovation.

Don’t hesitate to contact us: newsletter@a-r.com