• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Exclusives
    • Nutraceuticals
    • Markets
    • Health
    • Jobs
    • Events
    • Buyers' Guide
    • Showcases
    • More
  • Magazine
  • News
  • Exclusives
  • Nutraceuticals
  • Markets
  • Health
  • Jobs
  • Events
  • Buyers' Guide
  • Showcases
  • Current & Past Issues
    Features
    Columns
    Editorials
    Digital Edition
    Subscribe Now
    Advertise Now
    eNewsletter
    Editorial Guidelines
    Top Features
    Nutraceuticals for Men: Muscle Health and Performance Nutrition

    Aging in Place: Healthy Lifestyles Supplement Science-Based Solutions

    Getting an Edge in Esports: Meeting the Health Needs of Competitive Gamers

    Beyond CBD: Cannabis Compounds Warrant Recognition and More Research

    Leveling Out the Energy Segment for Mainstream, and Rethinking Caffeine
    Breaking News
    Certifications, Approvals and Patents
    Exclusives
    Industry & Market News
    People
    Products
    Regulatory
    Research
    Supplier News
    Supplier Insights
    Live From Shows
    Top News
    Thorne Relaunches Gut Health Test with Microbiome Wipe

    Alkemist Labs Announces Alkemist Assured Seal and Next Generation Transparency Reports

    GC Rieber Foundations Expand Philanthropic Efforts

    Danone Celebrates 10th anniversary of Grant Program for Probiotics Research

    Stratum Nutrition’s Patent Portfolio Grows to Europe and Canada
    Exclusives
    Blogs & Guest Articles
    Health E-Insights
    Area Code 420
    eBook
    Antioxidants
    Dairy-Based Ingredients
    Enzymes
    Fatty Acids
    Fiber & Carbohydrates
    Green Foods
    Herbs & Botanicals
    Marine Nutraceuticals
    Minerals
    Omega 3s
    Probiotics & Prebiotics
    Proteins, Peptides, Amino Acids
    Sweeteners
    Vitamins

    GC Rieber Foundations Expand Philanthropic Efforts

    Danone Celebrates 10th anniversary of Grant Program for Probiotics Research

    Botanical Ingredient MorActive Evidenced to Relieve Back Discomfort

    Cargill’s Stevia Sustainability Program Benchmarked by FSA

    GOED Creates Infographic Highlighting Omega-3 Health Claims Approved in Europe
    Consumer Trends
    Contract Manufacturing
    Cosmeceuticals / Nutricosmetics
    Delivery & Dosage Technologies
    Dietary Supplements
    Flavors & Colors
    Functional Foods & Beverages
    Healthcare Trends
    Medical Nutrition
    Mergers & Acquisitions
    Natural/Organic
    Nutrition Bars
    Packaging
    Pet Nutraceuticals
    Quality & Safety
    Regulations
    Research
    Testing
    World Markets

    Thorne Relaunches Gut Health Test with Microbiome Wipe

    Alkemist Labs Announces Alkemist Assured Seal and Next Generation Transparency Reports

    GC Rieber Foundations Expand Philanthropic Efforts

    Danone Celebrates 10th anniversary of Grant Program for Probiotics Research

    Stratum Nutrition’s Patent Portfolio Grows to Europe and Canada
    Bone & Joint Health
    Cancer Risk
    Cardiovascular Health
    Cognitive Function
    Diabetes & Blood Sugar Management
    Digestive Health
    Energy
    Eye Health
    Healthy Aging
    Immune Function
    Infant & Children's Health
    Inflammation
    Men's Health
    Mood Health & Sleep
    Oral Health
    Sexual & Reproductive Health
    Skin Health
    Sports Nutrition
    Weight Management/Weight Loss
    Women's Health

    Thorne Relaunches Gut Health Test with Microbiome Wipe

    Danone Celebrates 10th anniversary of Grant Program for Probiotics Research

    Beyond Raw Launches Concept X Pre-Workout Line

    Botanical Ingredient MorActive Evidenced to Relieve Back Discomfort

    Kyowa Hakko Appoints Dr. Colin Hill to Immuse Scientific Advisory Board
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    Nutrition21, LLC

    Ecuadorian Rainforest

    KLK OLEO

    Xsto Solutions

    ESHA Research
    Companies
    Product Releases
    News Releases
    Literature / Brochures
    White Papers
    Jobs
    VIdeos
    Services
    Add New Company
    International Buyers Guide Companies
    Nutrition21, LLC

    Ecuadorian Rainforest

    KLK OLEO

    Xsto Solutions

    ESHA Research
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Digital Edition
      • eNewsletter Archive
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
    • Breaking News
    • Buyers' Guide
      • All Companies
      • Categories
      • Trade Associations
      • Company Capabilities
    • Nutraceuticals
      • Antioxidants
      • Dairy-Based Ingredients
      • Enzymes
      • Fatty Acids
      • Fiber & Carbohydrates
      • Green Foods
      • Herbs & Botanicals
      • Marine Nutraceuticals
      • Minerals
      • Omega 3s
      • Probiotics & Prebiotics
      • Proteins, Peptides, Amino Acids
      • Sweeteners
      • Vitamins
    • Markets
      • Consumer Trends
      • Contract Manufacturing
      • Cosmeceuticals / Nutricosmetics
      • Delivery & Dosage Technologies
      • Dietary Supplements
      • Flavors & Colors
      • Functional Foods & Beverages
      • Healthcare Trends
      • Medical Nutrition
      • Mergers & Acquisitions
      • Natural/Organic
      • Nutrition Bars
      • Packaging
      • Pet Nutraceuticals
      • Quality & Safety
      • Regulations
      • Research
      • Testing
      • World Markets
    • Health
      • Bone & Joint Health
      • Cancer Risk
      • Cardiovascular Health
      • Cognitive Function
      • Diabetes & Blood Sugar Management
      • Digestive Health
      • Energy
      • Eye Health
      • Healthy Aging
      • Immune Function
      • Infant & Children's Health
      • Inflammation
      • Men's Health
      • Mood Health & Sleep
      • Oral Health
      • Sexual & Reproductive Health
      • Skin Health
      • Sports Nutrition
      • Weight Management/Weight Loss
      • Women's Health
    • Online Exclusives
    • Webinars
    • Slideshows
    • Blogs & Guest Articles
    • Health E-Insights
    • Videos
    • Podcasts
    • Infographics
    • eBook
    • Whitepapers
    • Research
      • TrendSense
      • Monograph Center
      • White Papers
      • Research News
    • Jobs
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Supplier Showcases
      • Companies
      • Product Releases
      • News Releases
      • Literature / Brochures
      • White Papers
      • Jobs
      • VIdeos
      • Services
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Columns

    Amino Acid Decision in Europe May Represent Small Step Toward Harmonization

    Marketing food/dietary supplement ingredients in the E.U. still requires understanding differences among member states.

    Amino Acid Decision in Europe May Represent Small Step Toward Harmonization
    Related CONTENT
    • Autophagy (the Body’s Garbage Disposal) Key to Cellular Renewal
    • AIDP’s Puremune Receives Authorization for Health Claim in Canada
    • Pharmactive Biotech Launches Aged Black Garlic Gummy Ingredient
    • Michelle Martin Combines Passion & Purpose as President and COO of Cypress Systems
    • NAC Supplements Could be Banned Unless FDA Reverses Course
    By Joerg Gruenwald, analyze & realize ag01.26.22
    The harmonization of European food regulations is a lengthy process with some famous ups and downs. On the upside, labeling regulations are now harmonized and health claims are regulated at an E.U. level with only minor wiggle room for E.U. member states as they adopt E.U. regulations into country legislation.

    On the other hand, maximum intake amounts for vitamins/minerals are still regulated at a country level (although there is movement in this area), and there still is no definitive E.U.-wide list of plant parts or “other substances” (i.e., substances other than vitamins/minerals that are permissible in food).

    Hurdles to Harmonization
    So each member state is drawing up its own positive list of which plants can or cannot be used as food (supplement) ingredients, sometimes involving cooperation among individual member states, like for the List of Substances jointly developed by Germany, Austria, and Switzerland. The genesis of these plant lists has put a spotlight on one of the hurdles for food business operators that wish to market a botanical food supplement in more than one E.U. country.

    Yet another example of dis-harmonization is the definition of what constitutes a pharmacological substance, or at which daily intake amount a substance begins to exert a pharmacological effect. Some member states are stricter in this regard than others. A famous case is melatonin, which has received an authorized health claim for reduction of the time to fall asleep at a daily intake amount of at least 1 mg. This is considered within the pharmaceutical range by Germany, where the claim thus cannot be used. Then there is monacolin from red yeast rice for the maintenance of normal blood LDL concentrations, which in Germany is considered a pharmaceutical and therefore not a food substance, full stop.

    Thus, while theoretically all goods can circulate freely within the E.U. single market, there are some obstacles preventing a carefree marketing of food products in more than one E.U. country.

    Amino Acids, Mutual Recognition, and Permissions
    Another more obscure example is amino acids. They can be used as ingredients in food supplements in most E.U. countries. Germany, again however, up until recently ruled that amino acids are drug substances and are, as such, not permissible in food supplements.

    The E.U. has put a process called Mutual Recognition in place, where a product lawfully marketed in one member state must also be marketable in any other. However, member states still retain the right to refuse Mutual Recognition if they decide that a given product is not safe and therefore cannot be marketable after all.

    In fact, Germany has put two such mechanisms in place. One is a way to gain an “exceptional permission” to market a specific product following an application to the German authority, which scrutinizes the product for safety issues. Once an exceptional permission is granted, the product can be marketed. However, if the exception is refused, for whatever reason, the product in question is forever illegal to market in Germany.

    This is a risk for FBOs, since food supplements that are notified for marketing in Germany in the usual way are not scrutinized by the authority for their marketability. Seeking an exception means unavoidable scrutiny, whereas just quietly notifying the product makes it possible, at least for a while, to let it fly under
    the radar.

    Another way to grant market access for food supplements containing substances that Germany does not consider permissible is gaining a “general permission.” This permission is given to a single ingredient at a maximum daily intake amount, again following a safety assessment. Once it is granted, the ingredient in question with that intake amount can be used as a food supplement ingredient by all FBOs, in contrast to the exceptional permission, which only applies to a single product.

    A number of general permissions have been granted to amino acids over the years, making it possible for these—but certainly not all—amino acids to be used as food supplement ingredients.

    Momentum for Harmonization?
    However, all this came to an end in July 2021 when, seemingly without much fanfare, the German general food law regulation was amended, and the paragraphs referring to amino acids as “other substances not permissible in food supplements” was quietly removed.

    With this step, Germany has aligned with the majority of E.U. member states, where using amino acids as food supplement ingredients has always been possible. Still, intake levels must be kept in mind when formulating food supplements containing amino acids for marketing, since the tenet that foods are not allowed to have pharmaceutical effects still holds true.

    FBOs that wish to bring their products to the E.U. market and are uncertain about these finer points of E.U. legislation can eliminate that uncertainty by seeking the advice of experienced consultancies such as analyze & realize GmbH.


    Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100; E-mail: jgruenwald@a-r.com; Website: www.analyze-realize.com.
    Related Searches
    • Proteins, Peptides, Amino Acids
    • Regulations
    • World Markets
    Related Knowledge Center
    • Regulations
    • Proteins, Peptides, Amino Acids
    • World Markets
    Suggested For You
    Autophagy (the Body’s Garbage Disposal) Key to Cellular Renewal Autophagy (the Body’s Garbage Disposal) Key to Cellular Renewal
    AIDP’s Puremune Receives Authorization for Health Claim in Canada AIDP’s Puremune Receives Authorization for Health Claim in Canada
    Pharmactive Biotech Launches Aged Black Garlic Gummy Ingredient Pharmactive Biotech Launches Aged Black Garlic Gummy Ingredient
    Michelle Martin Combines Passion & Purpose as President and COO of Cypress Systems Michelle Martin Combines Passion & Purpose as President and COO of Cypress Systems
    NAC Supplements Could be Banned Unless FDA Reverses Course NAC Supplements Could be Banned Unless FDA Reverses Course
    Bergamot Polyphenolic Fractions May Lower Cholesterol Profile Bergamot Polyphenolic Fractions May Lower Cholesterol Profile
    Botanical Formula Significantly Effects Knee Pain in Five Days, Study Finds Botanical Formula Significantly Effects Knee Pain in Five Days, Study Finds
    AIDP to Distribute Minerals from Cura Global Health Under the Ultimine Brand AIDP to Distribute Minerals from Cura Global Health Under the Ultimine Brand
    CBD Stakeholders Await List of Permitted Products from U.K. Food Standards Agency CBD Stakeholders Await List of Permitted Products from U.K. Food Standards Agency
    About Larch Arabinogalactan Powder About Larch Arabinogalactan Powder
    About Blueberry Fruit Powder About Blueberry Fruit Powder
    About Peppermint Powder About Peppermint Powder
    About Cat About Cat's Claw Powder
    About Chanca Piedra Powder  About Chanca Piedra Powder
    About Kelp Powder (Ascophyllum) About Kelp Powder (Ascophyllum)

    Related Content

    • Dietary Supplements | Healthy Aging | Herbs & Botanicals | Medical Nutrition
      Autophagy (the Body’s Garbage Disposal) Key to Cellular Renewal

      Autophagy (the Body’s Garbage Disposal) Key to Cellular Renewal

      Researchers have been studying autophagy and its role in the development of chronic disease and the physical changes associated with aging.
      By Gregory Stephens, Windrose Partners, and Sheila Campbell, PhD, RD 04.14.22

    • Breaking News | Delivery & Dosage Technologies | Dietary Supplements | Immune Function | Probiotics & Prebiotics | Regulations | Supplier News | World Markets
      AIDP’s Puremune Receives Authorization for Health Claim in Canada

      AIDP’s Puremune Receives Authorization for Health Claim in Canada

      Its insoluble yeast beta-glucan can now be marketed for immune support at a dose of 30 mg.
      04.05.22

    • Breaking News | Cardiovascular Health | Herbs & Botanicals | Natural/Organic | Supplier News | World Markets
      Pharmactive Biotech Launches Aged Black Garlic Gummy Ingredient

      Pharmactive Biotech Launches Aged Black Garlic Gummy Ingredient

      The sweet, odor-free flavor of the extract makes it suitable for the top-trending delivery platform.
      03.16.22


    • Dietary Supplements | Minerals | World Markets
      Michelle Martin Combines Passion & Purpose as President and COO of Cypress Systems

      Michelle Martin Combines Passion & Purpose as President and COO of Cypress Systems

      She discusses strategies for addressing modern business challenges and her plans for company growth.
      By Sheldon Baker 03.02.22

    • Dietary Supplements | Proteins, Peptides, Amino Acids | Regulations
      NAC Supplements Could be Banned Unless FDA Reverses Course

      NAC Supplements Could be Banned Unless FDA Reverses Course

      Warning letters from July 2020 have set off a firestorm, and the stakes are high for medical professionals, patients, and nutraceutical companies.
      By Erik Goldman, Holistic Primary Care 03.02.22

      Trending
      • Leaven Essential To Launch Branded Botanical Extracts To Global Markets | Nutraceuticals World
      • Oregon Files Lawsuit Against GNC | Nutraceuticals World
      • Coca-Cola To Phase Out Honest Tea Brand By Year’s End, Citing Supply Chain Challenges | Nutraceuticals World
      Breaking News
      • Thorne Relaunches Gut Health Test with Microbiome Wipe
      • Alkemist Labs Announces Alkemist Assured Seal and Next Generation Transparency Reports
      • GC Rieber Foundations Expand Philanthropic Efforts
      • Danone Celebrates 10th anniversary of Grant Program for Probiotics Research
      • Stratum Nutrition’s Patent Portfolio Grows to Europe and Canada
      View Breaking News >
      CURRENT ISSUE

      May 2022

      • Aging in Place: Lifestyle Supplements Science-Based Solutions
      • Getting an Edge in Esports: Meeting Health & Nutrition Needs
      • Nutraceuticals for Men: Muscle Health and Performance Nutrition

      Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
      You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

      • About Us
      • Privacy Policy
      • Terms And Conditions
      • Contact Us

      follow us

      Subscribe
      Nutraceuticals World

      Latest Breaking News From Nutraceuticals World

      Thorne Relaunches Gut Health Test with Microbiome Wipe
      Alkemist Labs Announces Alkemist Assured Seal and Next Generation Transparency Reports
      GC Rieber Foundations Expand Philanthropic Efforts
      Coatings World

      Latest Breaking News From Coatings World

      Nippon Paint Automotive Americas Appoints Robert Angart CEO and President
      Sustainability, Economy are Focus of BCF’s Annual Conference
      Demand for Rhino Shield Increases
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      New Breast Implant Surgery Guidelines to Enhance Patient Safety
      Rhythm Management Group Debuts RhythmSynergy Tech Platform
      FDA Approves Trial Completion for Virtual Incision's MIRA Platform
      Contract Pharma

      Latest Breaking News From Contract Pharma

      iECURE Enters Agreement with Center for Breakthrough Medicines
      CPDC Enters Clinical Manufacturing Deal with CellBion
      Olon to Build New R&D Center in Italy
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      K-Beauty Brand Siita Shares Plastic Decomposition Technology with the Beauty Industry
      Shellworks Raises $6.2 Million in Seed Funding
      Ulta Beauty Reports Record First Quarter 2022 Results
      Happi

      Latest Breaking News From Happi

      Honeywell Addresses Critical Issues Such as Sustainability, Workforce Training and Digitalization
      Monat Global Wins Four Stevie Awards in the 20th Annual American Business Awards
      Coty Expands Vegan Beauty Portfolio With New Rimmel Mascara
      Ink World

      Latest Breaking News From Ink World

      Orion to Finish Gas Black Expansion in Germany by Early 2023
      Richard Childress Racing Shows Off New Wraps for 2022 NASCAR Season
      ProAmpac Acquires Specialty Packaging, Inc.
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      UPM Raflatac accelerates label growth with acquisition
      Labelexpo Asia 2022 postponed
      Teklynx software helps Top Clean Injection validate labels
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      Rael Raises $35M in Series B Funding
      Schobertechnologies Offers Rotary Web-fed Converting Solutions
      Thorne Relaunches Gut Health Test with Microbiome Wipe
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      Toetal Solutions Raises $1.02 Million in New Financing
      ManaMed's ManaSport Wearable Ultrasound Earns FDA Nod
      Ekso Bionics Names Jerome Wong as Interim CFO
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      SEMI Foundation Receives $1.5 Million Grant to Bolster Michigan’s Semiconductor Talent Pipeline
      onsemi Recognized by Fortune 500 for Its Transformation Journey
      LG Display Presents AI-Driven NFT Artwork on Transparent OLED

      Copyright © 2022 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

      AD BLOCKER DETECTED

      Our website is made possible by displaying online advertisements to our visitors.
      Please consider supporting us by disabling your ad blocker.


      FREE SUBSCRIPTION Already a subscriber? Login