• Mutual recognition guidance and EFSA’s scientific opinion on health claims.

Mutual recognition guidance and EFSA’s scientific opinion on health claims

2018-07-19T12:26:44+00:00

a&r’s News Digest – We dedicate this month’s issue to the mutual recognition guidance and EFSA’s scientific opinion on health claims.

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We launched in 2017 our a&r MatchMaking Platform. This platform aims to accelerate local and global transactions for in/out-licensing or sale of natural health products. Unlike other platforms, it is focused on the area of natural health products. The platform is now live: https://www.a-r.com/matchmaking-database/

a&r brings its unique combination of passion and expertise to this field. For more than 20 years, we have been developing a strong network in the natural product industry with more than 1000 clients. This allows us to efficiently select the most attractive business partnering opportunities to increase revenue in your future business.

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Dr. Naira Quintana recently joined a&r to lead the MatchMaking Platform. She brings a strong blend of academic expertise in natural products research and industry experience in the OTC business.

Contact Dr. Naira Quintana in order to explore your next business opportunity: matchmaking@a-r.com

Regulatory News

Maximum levels for vitamins and minerals

Due to the lack of action from the EU Commission defining maximum levels for vitamins and minerals, as was foreseen in the directive 2002/46/EC, more and more Member States are setting their own maximum levels. After Belgium, Norway, Denmark, Italy, and France, now the Spanish Council of Ministers has approved a decree containing maximum levels for vitamin and minerals and “other substances”. Germany has not yet legally defined maximum levels, but the BfR has suggested safe levels (read more about it here). Looking at the maximum levels of the different Member States, the values differ considerably, hindering the free movement of goods in the EU. The EU Commission is still planning to find a harmonized solution; however, this will certainly take several years. In the meantime, food business operators have to rely on the Mutual Recognition process (more detailed information below).

a&r comment: If you are interested in an overview of the existing maximum levels in the different Member States, please contact us.

Quick Guide to Mutual Recognition

However, nine years after its enforcement in 2009, an evaluation by the EU Commission brought to light that, in practice, this regulation does not work satisfactorily. The EU has now agreed on an action plan to facilitate the Mutual Recognition process.
The Mutual Recognition regulation EU 764/2008 was set up to support the free movement of goods within the European Union.

What is Mutual Recognition?

The regulation states that products that are lawfully marketed in one EU Member State must in principle be admitted to other Member States as well. If, for instance, a dietary supplement is legally marketed in one Member State, other Member States are supposed to accept the product, unless they have serious concerns about the safety for the local population. The Mutual Recognition process covers only products for which EU regulations are not harmonized, e.g. dietary supplements with vitamins/minerals for which the maximum levels are different in different EU Member States. It does not cover foods for special medical purposes (FSMPs), for which the EU regulations are fully harmonized.

How to start the process of Mutual Recognition?

Contact the product contact points (PCP) of your target market.
The PCPs are the main communication channel between business operators and competent national authorities and are supposed to respond to inquiries within 15 working days.

What can you do in case of problems?

If a national authority does not accept your product, you can contact SOLVIT, a EU-funded body to assist businesses and ascertain their EU rights.
If the problem cannot be resolved through SOLVIT, the EU commission may become involved. In this case, the national authority of the target market has the burden to prove that public health is endangered by the product in question.

What will be improved in the future?

As part of the new strategy, in December 2017 the Commission tabled a legislative proposal to make it easier for companies, especially small and medium-sized enterprises, to sell their products across Europe.
The action plan comprises:
  • Trainings of the national authorities and exchange of officials between Member States to increase awareness of the Mutual Recognition process and to enhance trust in other Member States regulations.
  • Strengthening of the SOLVIT process
  • Implementation of a voluntary “Mutual Recognition Declaration” filled in by the business operator on the product in question to demonstrate to the competent authorities of the target Member State that the product is lawfully marketed in another Member State.

A guidance document on the application of the Mutual Recognition Regulation to food supplements can be found here.

If you have any questions on the mutual recognition process or the expected changes, please contact us.

Health claims

New article 13.5 Health Claims opinions by EFSA (December 2017 – March 2018)

>> POSITIVE OPINION

>> NEGATIVE OPINION

>> NEGATIVE OPINION

>> NEGATIVE OPINION

>> NEGATIVE OPINION

a&r comments: From December 2017 to March 2018, only one positive opinion on article 13.5 health claims was published, in contrast to the 4 negative opinions provided by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA). No EFSA scientific opinion was published for any article 14 health claim. In the meantime, no claim was approved by the EU Commission.

Update on the European Union list entries of herbal substances for THMP

The EU Commission just included Valeriana officinalis L. in the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products established by Commission Decision 2008/911/EC.

This EU list is legally binding for applicants and national competent authorities in the Member States, unlike the EU herbal monographs. Applicants can refer to this list concerning the safety and efficacy of a product when registering a traditional herbal medicine. Still, the quality of the medicinal products will need to be verified prior to approval.

NutraBusiness Intel

Lonza supports consumer health startups 

7 Feb 2018

Hungarian-based Egis acquired Sinuforte OTC nasal spray from Spain’s Hartington for an undisclosed sum. Sinuforte is based on Cyclamen europaeum extract and is indicated to treat sinusitis. Sinuforte is already marketed as Nasodren in different countries across Europe, Asia, and the Americas. This transaction is part of Egis’s strategy of strengthening their presence in key countries through acquisitions.

Herbalife launches a € 80M fund to accelerate growth in China 

13 Feb 2018

US dietary supplements Herbalife has created an investment fund in China to accelerate growth and developing its business in the country. The fund will focus on five key areas: new acquisitions in health and wellness products and companies; expansion of nutrition clubs; increasing and improving technology; providing additional research, learning and training; and public-private partnerships focused on eradicating obesity. Governments in China granted funds to Herbalife as part of an economic development deal for the company’s commitment to the Chinese economy.

Salvat and Noventure enter into distribution agreement 

22 Feb 2018

Salvat prepares to launch Noventure’s nasal medical device in Spain and Portugal in April this year. This product based on xyloglucan will treat the symptoms of rhinitis and rhinosinusitis.

GNC secures investment from Harbin Pharmaceutical

2 March 2018

Harbin Pharma, leader of dietary supplements in China, will invest € 240 million in GNC to become the largest single shareholder. Harbin will hold a 40% stake of the health and wellness retailer GNC. Furthermore, Harbin and GNC have also agreed to create a joint venture for the manufacturing, marketing, sales, and distribution of GNC’s products in China. While GNC was already present in China via e-commerce channels, this joint venture will provide a stronger GNC footprint in this country and accelerate GNC’s global expansion.

Nestlé pulls out of big deals 

2 March 2018

Nestlé CEO Mark Schneider has suggested that an acquisition of Pfizer or Merck KGaA OTC business is not realistic after the recent deal with the dietary supplements Atrium Innovation, according to OTC bulletin.

Egis expands to Russia via Sinuforte acquisition 

2 March 2018

Hungarian-based Egis acquired Sinuforte OTC nasal spray from Spain’s Hartington for an undisclosed sum. Sinuforte is based on Cyclamen europaeum extract and is indicated to treat sinusitis. Sinuforte is already marketed as Nasodren in different countries across Europe, Asia, and the Americas. This transaction is part of Egis’s strategy of strengthening their presence in key countries through acquisitions.

Tabuk enters into agreement with Renapharma AB 

2 March 2018

Tabuk, one of the leading companies in the MENA region, has entered into an exclusive agreement with Renapharma AB on Detremin (Vitamin D3). Renapharma is a family-owned Swedish company that develops pharmaceuticals, nutraceuticals, and medical technology.

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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