We dedicate this month’s issue to regulatory affairs.


Claims on Botanicals – quick update

In an event in Brussels early in November, Mr. Andriukaitis (EU Commissioner for Health and Food Safety) acknowledged that the current regulatory system for botanicalsis unfit for its purpose and promised to launch a public consultation before the end of the year. This consultation will support the Commission with making a comprehensive decision on the 2,000 pending botanical health claims. It will be done in a 12-week closed-question public consultation and a 8-week online survey for member states, stakeholders, and small and medium-sized enterprises (SMEs).

a&r comments: Since the Commission suspended the evaluation of health claims on foods under the Nutritional and Health Claims Regulation for botanicals in 2010, these may still be used on the basis of the transitional provisions (on-hold claims). Since then, claims on botanicals have been on “stand-by”. Discrepancies between proof of efficacy by EFSA (which requires clinical trials) and evidence needed for Traditional Herbal Medicines (THM) (which requires “traditional use” as evidence), as well as different rulings in the different members states classifying products as food or medicines on a case-by-case basis have led to confusion and disparities between countries. It looks like we can finally expect a solution on this longstanding issue by 2020, before the end of the Commissioner’s mandate.

Novel Food

EFSA has recently published a finalized guidance on Novel And Traditional Foods. The new regulation (EC) 2015/2283 will come into force in January 2018 and will introduce a centralized assessment and authorization procedure replacing the one from 1997. The new guidance explains in detail which type of information applicants need to provide for risk assessment. EU risk managers will then decide whether the product can be marketed in Europe and may ask EFSA to conduct a scientific risk assessment to confirm their safety.

a&r comments: A simpler, cleaner and more efficient authorization procedure fully centralized at EU level is coming into force after the 1st January 2018. A broad overview of the changes on the Novel Food Regulation will be discussed on our January issue. Keep following us for a full expert opinion on this matter.

New article 13.5 Health Claims opinions by EFSA (July-Oct)

  • V0137 (DHA-enriched fish oil) and ‘a reduced loss of cognitive function’.


  • Lp299v (Lactobacillus plantarum 299v) and an increase of non-haem iron absorption.


  • FHI LFC24 (bovine milk-derived casein hydrolysate) and a reduction of post-prandial blood glucose responses.


a&r comments: From July to October 2016, three negative opinions on article 13.5 health claims were published. During the same period, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was requested by the Commission to revise its scientific opinion on short-chain fructooligosaccharides from sucrose and maintenance of normal defecation. No changes were identified and the claim is still negatively assessed.

New article 14 Health Claims opinions by EFSA (July-Oct) for children under 3 years of age

  • Iron and contribution to the normal function of the immune system.


  • Calcium and contribution to the normal development of bones.


  • Vitamin E and protection of DNA, proteins and lipids from oxidative damage.


a&r comments: From July to October 2016, three positive article 14 health claims were published. For iron, the Panel considered that its role in the functioning of the immune system applies to all ages, including infants and young children up to 3 years of age; similarly for calcium and vitamin E for normal bone development and protection of DNA, proteins and lipids from oxidative damage, respectively.

Authorized/refused Health Claims

Authorized claim: Consumption of foods/drinks containing instead of fermentable carbohydrates contributes to the maintenance of tooth mineralization (claim Art.13(5))

Authorized claim: Consumption of foods/drinks containing instead of sugars induces a lower blood glucose rise after their consumption compared to sugar-containing foods/drinks (claim Art.13(5)).

Authorized claim: Vitamin D contributes to the normal function of the immune system in children (claim Art.14(1)(b)).

a&r comments: From January to November 2016, three health claims have been authorized. In the same period of time, the Commission has rejected 20 claims.

HI Europe

29 November – 1 December 2016, Frankfurt am Main

Health Ingredients Europe

Vitafoods Europe

09 – 11 May 2017, Geneva

Irene Wohlfahrt
Irene WohlfahrtSenior Consultant
Dr. Inês Rocha
Dr. Inês RochaScientific Consultant

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.

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