TABLE OF CONTENTS
Like Aromatherapy and Phytotherapy, Supplements Based On Pure Mushrooms (MANY Considered Novel Foods) Are Classified as Food Supplements.
As Such, There Is a Specific European and National Regulatory Framework that regulaters the formulation, marketing, labelling and advertising of these production.
Currently, as is the case with phytotherapy, No Declaration of ITS PROPERTIES IS AUTHORIZED ON ITS LABELLING.
Because? Can This Sition Change? We Analyze It in the Following Lines
Regulations on Food Supplements
To Understand Why Health Claims Are Not Currently Added To Mushroom-Based Supplements, We Must Talk About Novel Food and The Regulations that apply at the European Level.
Pure Mushrooms, A Special Case
In Europe, Products Made from Pure Mushrooms Are Considers Food Supplements. At the Same Time, Eu Member State Transpose European Regulations at National Level, Which implies Slight Variations. In Spain, for Example, Mushrooms Are Considers "Special Cases".
In Other Words, The Specific Regulatory Texts of Phytotherapy Apply to Mushrooms If it is collected that Their Use is not novel In Food Supplements Within The Meaning of Regulation (EU) N ° 2015/2283 KNOWN AS THE “NOVEL FOOD” Regulation.
The Novel Food Concept
In Force Since January 1, 2018, The "Novel Food" Regulation Applies Throunge the Union. This Means That All Foods consumed by Humans to a negligible extension in the eu Before 15 May 1997 Are Covered by This Regulation.
As You May have deduced, The Consumption of Most Mushrooms in Europe Falls Under This Regulation. Generally Speaking, Mushroom Mycelium are Consider New Foods. Therefore, Before Mycelia Can Be Placed on The Eu Market, The Regulation required Safety Assessment. Currently, Only Shiitake and Cordyceps Sinensis Mycelia Are Authorized in the EU.
Allegations of Food Supplements
Health Claims May Appear on The Labelling Or Advertising of Food Products. Sub functional Foods Use Them, But They Mainly Refer To Food Supplements.
This is Any Word, image or symbol that states, suggests or impies the existence of a relationship Between a category of food production, A Food Or One of ITS Compounds and Health.
A Well-Known Example is vitamin C: About This Component and under Certain Conditions, for Example, It is positive to say: "It contributes to the functioning of the immune system."
Health Claims Attribution Process
As part of the process, The Declarations Are First Evaluated by a Group of Experts from the EFSA (European Food Safety Agency). To do This, The Applicant Provides Data That Supports The Writing of the Declaration present to the commission. Scientific and Safety Evaluations Are The Carried Out. This Works Reure that the Allegions Studied are Well Fount and Accurate.
If the Verdet is positive, there is a good chance that the ingredient Claim Will Be available for Commercial Use. On the other hand, a negative Verdict usually Prevents The Declaration From Being used, For Several Reasons:
- Too vague
- WHOSE RELATIONSHIP WITH HEALTH IS UNCLECE
- The ingredients of the formula are not suffficiently defined
- When Scientific Data Does Not Support The Claim Being Made.
It must be take into accounts, However, that effsa opinions are Merely Advisory, and that it is the European Commission that you decide whether or not to publish a new regulation.
If you are intersted in consulting the results of the efsa evaluations, you can consult The Commission's Website Here.
WHY ADD Health Claims?
The Existence of Health Claims is beneficial for Everyone:
- For the consumer, they help guide and facilitate the choice among the plethora of products offered,
- provides unbiased Health Information
- They Guarantee Healthy Competition Between Operators in The Sector
- They Guarantee The Proper Functioning of the Internal Market.
However, This Information Must Be Clear to The Consumer. The ESFA Periodically Evaluates Applications and Publishes The Results in a Journal.
Health Claims and Supplements
Ongoing and Pending Allegions
Only a SMALL NUMBER OF CLAIMS HAVE REQUIVED IN FAVORABLE OPINION FROM EFSA. OF THE 4,637 APPLICATIONS, ONLY 229, Mainly RELATING TO VITAMINS OR MINERALS, Have Been Accepthed.
Of this list, submiss 1,550 Applications RELATING TO PLANTS ARE AWAITING A DECISSION BY THE COMMISSION. Sub Mushrooms Are On This To-Do List:
- Reishi ( Ganoderma lucidum ): "You contribute to natural defenses" and "Helps Maininin Circulation Functions."
- Sun Mushroom ( Agaricus Blazei ): "Helps Natural Defenses", "You contribute to Normal Immune Response", "Promotes The Immune System", "Promotes The Human Complement System", "Is Rich in Beta-Glucans That contributes to Immune Activity", "Helps The Body to Resist Biological Aggressions".
This suspension is explained by the need to evaluate the Application of the Regulation for Plants and Mushrooms. The Question Also Arises Whether Tradition Can Be Taken Into Account in the Scientific Evaluation to Justify the Health Effects of these Products.
In May 2020, The Conclusions of the Evaluation indicate that there are implementation difficulties, specially in the criteria for evaluation the claims. We are Still Waiting for Clarifications from the Commission on This Issue.
Allegations present
Between 2009 and 2011, A Large Number of Health Claims Related to Mushrooms Were Submitted To Efsa, But Have Not Yet Been Approved.
The Reasons for First Rejections are All Related to The Need to Provide More Scientific Evidence to the Commission with the Application. At the moment they are pending Approval:
- Cordyceps (Cordyceps sinensis): "Helps Strengthen The Body, Stimulates The Immune System", "Invigolates The Body", "Promotes The Body's Alertness", "Increases Performance and Resistance During Intense Exercise or Physical Activity",
- Reishi (Ganoderma lucidum): "Stimulalates The Tirad Body",
- Maitake (tap lush): "You contribute to the body's natural defendances", "Controls Blood Sugar Levels",
- Shiitake (Edodes lentinula): "You contribute to natural defenses",
- Oyster Mushroom (Pleurotus eryngii): "Regulates The Physiology of the Pancreas and Fat Metabolism,"
- Oyster Mushroom (Pleurotus ostreatus): "You contribute to Natural Defences", "Antioxidant".
This Lark Number of Non-Efsa-Approved Health Claims Is Notique To Mushroom-Based Supplements. For Example, in 2009, no Health Claims Reting to Herbal Medicine presized to Favourable Evaluation.
EVALUATION PROCEDURES
The Commission's Assessment of Scientific Evidence is similar to that of medicines. Therefore, it is very difficult for dietary supplement to demonstrate to BENEFICAL CLINICAL EFFECT In Healthy People.
EFSA Collection that The Lack of Adequate Studies in Humans Remains One of the Main Reasons for Rejecting Applications For Authorization of Claims. That is Why it suspended the evaluation of Health Claims for Pure Plants and Mushrooms in 2010.
Another Reason there are Few Health Claims On Supplements Is The Cost of Claims. According to Synadiet (The French Food Supplement Trade Association), Applying for a Health Claim Costs Between € 500,000 and € 1,000,000. This cost is too high for must in the sector.
The Existence of Health Claims in Mushroom-Based Supplements
If you Think about it, You'll Remember Seeing Claims in The Advertising Or Labeling of Mushroom Supplements, and It's Quite Likely.
An allegation linked to another component
As We have be Before, The Majority of Health Claims Currently Accepted by The European Commission Refer To Vitamins and Minerals. Therefore, If Mushroom-Based Products Incorpola also Substances in Their Formulation and Meet The Adhesion Conditions, It is positive to Claim The Associated Effects. The Statement you have seen does not actual refer to the mushroom, but to a component of its formulation (vitamin, zinc, etc.).
Claim Awaiting Trial
As you already know, there is a Waiting List of Around 1,550 Health Claims for Plant Substances (Including Mushrooms). Pending at the end of Decision, before allegations may continue to be used.
The Future of Mushroom Supplements
Finally, If the Costs, The Level of Demand and the Risks of An Application Being Rejected Are Taken into Account, It is Clear That Innovation in Mushroom-Based Supplements, specially novel food, is going to be complicated.
Like the Phytotherapy Sector, We Are Vry Attendive To What the European Commission Decide on Future Control Procedures for Health Claims. We Will Be Sure To Promptly Inform You of Any News in This Regard.
LEAVE YOU DIFFFICULTIES IN OBTATING PILTINITION, WE CONTINUED INVESTIGING. AT Hifas da Terra We Know The Benefits of Mushrooms and We Allocate an Importent Part of Our Profits to Research and the Implementation of Innovation and Clinical Projects That Help Obtain New Claims for Our Products. However, The Road Is Long. At The Same Time, we are pleased to see that the Mushroom Supplement Industry you have a majority of Scientific Growth Over the Past Ten Years.
Although Clinical Studies (In Humans) Remain Scarce. There is no Doubt That, in the coming years, public and private research Will Have Provided Evidence That Meets Efsa's Demands.
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