a&r’s News Digest – We dedicate this month’s issue to regulatory affairs

analyze realize news digest july 2016

B2B communication falls within the scope of the EU Nutrition and Health Claims Regulation

On 14th July, the Court of Justice of the European Union (Case C-19/15) decided that B2B commercial communication for food products falls within the scope of Regulation (EC) No 1924/2006 on Nutrition and Health Claims (NHC Regulation). From now on, the NHC Regulation is not only applicable to commercial communication addressed to consumers (B2C), but also to commercial communication addressed to professionals (B2B).

a&r comments: Careful review of existing and future B2B communication is advised in the wake of this Court’s ruling.

analyze realize news digest july 2016

EFSA – a new approach to Botanicals

EFSA took the first steps towards a web-based version of a Compendium on Botanicals. This searchable database is still under development with the final version set to be released by the beginning of 2017. The Compendium comprises a database of all botanicals that may be present in food and that are reported to contain natural substances of possible concern for human health. The purpose of this Compendium is facilitating the safety assessment of botanicals and botanical preparations that may be used in food, including supplements, by easing hazard identification. The Compendium will also include non-European botanical species.

a&r comments: This is a very valuable source of information providing safety information on botanicals as well as information on the abundance of substances in European plants with relevance to food. The database uses Adobe Acrobat Flash Player, which might require adaptation of browser settings.

Brexit – what to expect?

With the United Kingdom’s (UK) referendum of 23rd June, voters decided against the UK’s continued membership in the EU. This raises immediate questions for the food industry as well as regulatory uncertainty for drug companies. Effects on the exchange rate British pound to Euro can already be observed, with the pound dropping sharply. However, the process of leaving the EU will take two years, during which the UK will remain a EU Member State. The impact of this decision will be extensive.

a&r comments: The outcome and impact of this decision now depends on the UK government and its negotiations with the Member States. For now, the take-home message is that things will stay the same until the UK initiates the exit procedure. According to the European Medicines Agency (EMA) (statement from 6th July) its operations will continue as usual in accordance with its rules and regulations. However, without clarity, everyone will suffer the consequences of a prolonged period of uncertainty. We are monitoring the situation closely and will provide updates as they occur.

analyze realize news digest july 2016

4th Revision of MEDDEV 2.71 published by EU Commission

On 29th of June 2016, the 4th revision of the MEDDEV 2.7.1 – Clinical Evaluation has been published. Generally, the MEDDEV guidance documents are provided by the Commission to assist Notified Bodies and manufacturers in implementing directives related to medical devices. Even though these guidelines are not legally binding, evaluating Notified Bodies expect the guidance to be followed. There is no transition period for those documents, which means that from now on, clinical evaluations should be done according to the revised guidance. The requirements for the documentation, literature evaluation, and clinical evaluations have increased.

What’s new:

  • The identification, analysis, and extraction of data necessary for the clinical evaluation report have to be much more detailed and of higher complexity, beginning with a log file for the search and ending with the final literature attached to the report.
  • The reports have to be updated more frequently
  • The qualifications of the evaluator are increased and defined
  • The term “equivalence” is narrowed to an extent, in that equivalence means having a nearly identical device, which probably will require new, device-specific clinical trials

a&r comments: Together with the upcoming new medical device regulation (expected to come into force at the beginning of 2020), we assume that a number of medical devices will have to update their clinical evaluation accordingly. New clinical evaluation reports, even for simple devices, will entail increased costs and cost expenditures.

analyze realize news digest july 2016

Rejected health claims by EFSA

a&r comments: During the period between April and June 2016, two article 13.5 health claims were rejected. No health claim was accepted.

4 caffeine health claims vetoed by Members of European Parliament (MEP)

MEPs have vetoed the authorization of four caffeine health claims in a resolution adopted at the Strasbourg plenary session on 7 July. Much debate centers on the use of these claims in energy drinks and on considering restrictions of marketing these products to children and adolescents.

a&r comments: Despite approval of these claims in the respective EFSA safety opinions, the MEPs’ vetoes focus on the use of these claims for energy drinks targeted at teenagers and children. Not the scientific support of the claims is in question, but rather safety concerns for children and young people have been raised. This decision is symptomatic and part of the larger issue of health claims for products that are perceived as “unhealthy”, so, in a way, it is not surprising that the MEPs made this decision.

Glycaemia control claim

According to article 13.5 on health claims, products can use a induces a lower blood glucose rise claim, when using non-digestible carbohydrates as sugar replacers. The claim was fully authorized by the European Commission on the 20th June 2016. Non-digestible carbohydrates are neither digested nor absorbed in the small intestine. For the health claim to be applicable, the products (food and drinks) should contain at least 30 % less sugars than the reference product.

a&r comments: Keeping blood sugar under control is apparently a very attractive claim, consumer research revealed.

analyze realize news digest july 2016

Vitafoods Asia – 1-2 September 2016, Hong Kong

SupplySide West – 4-8 October 2016, Las Vegas

Your experts

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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