• 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
    Contract Manufacturing: Trials & Tribulations of Today’s Supply Chains

    Analytical Testing in Nutraceuticals: Methods and Mindsets to Uphold Quality

    Nutrition and Flavor: Formulating for Modern Product Preferences

    What Do Consumers Know About the Gut Microbiome?

    How Will the European Green Deal Impact Dietary Supplements?
    Breaking News
    Certifications, Approvals and Patents
    Exclusives
    Industry & Market News
    People
    Products
    Regulatory
    Research
    Supplier News
    Supplier Insights
    Live From Shows
    Top News
    Charlotte’s Web Sports Product Line to Undergo NSF Certification Process

    ADM and Benson Hill Partner to Scale High Protein Soy for U.S. Market

    Tazo Transitions to Regenerative Organic Agriculture

    Protein Ingredient Formulated for Chronic Kidney Disease Patients

    IADSA Calls for Addressing Discrepancies in Vitamin C Recommendations
    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

    Fact or Myth: Antioxidants Negatively Impact Iron Absorption

    Charlotte’s Web Sports Product Line to Undergo NSF Certification Process

    ADM and Benson Hill Partner to Scale High Protein Soy for U.S. Market

    Tazo Transitions to Regenerative Organic Agriculture

    Protein Ingredient Formulated for Chronic Kidney Disease Patients
    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

    Fact or Myth: Antioxidants Negatively Impact Iron Absorption

    Charlotte’s Web Sports Product Line to Undergo NSF Certification Process

    ADM and Benson Hill Partner to Scale High Protein Soy for U.S. Market

    Tazo Transitions to Regenerative Organic Agriculture

    Protein Ingredient Formulated for Chronic Kidney Disease Patients
    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

    Charlotte’s Web Sports Product Line to Undergo NSF Certification Process

    Caffeine-Free Energy Supplement Linked to Alertness, Fatigue Benefits

    Monk Fruit Sweetener May Have Prebiotic Activity, Study Finds

    People with Low-Fiber Diets Benefit the Most from Fiber Supplements, Study Finds

    Gut Microbiome May Be Part of Link Between Red Meat and Heart Disease Risk
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    JRS Pharma

    Bioenergy Life Science, Inc. (BLS)

    Xsto Solutions

    Botanic Healthcare LLC

    Aiya America, Inc. (Aiya Matcha)
    Companies
    Product Releases
    News Releases
    Literature / Brochures
    White Papers
    Jobs
    VIdeos
    Services
    Add New Company
    International Buyers Guide Companies
    JRS Pharma

    Bioenergy Life Science, Inc. (BLS)

    Xsto Solutions

    Botanic Healthcare LLC

    Aiya America, Inc. (Aiya Matcha)
    • 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

    New Novel Food Regulation: An Overview

    Industry reaction has been generally positive, some questions remain.

    New Novel Food Regulation: An Overview
    Related CONTENT
    • Some Clarity Offered for Label Declarations of Vitamins in the EU
    • Vitafoods Europe Event Info
    • Botanicals in the EU: National Plant Lists Fill Void Without Harmonization
    • Amino Acid Decision in Europe May Represent Small Step Toward Harmonization
    • Focus on Health Compels Brands to Reduce Sugar with Reformulated Foods and Beverages
    By Joerg Gruenwald, analyze & realize ag09.10.18
    On Jan. 1, 2018, the new Novel Foods Regulation ((EU) 2015/2283) went into effect. Its aim is to improve the conditions for food business operators looking to bring new and innovative foods to the EU market without sacrificing the high level of food safety for European consumers that the old regulation afforded. The new regulation replaces the former system of individual national authorizations with a simpler and faster centralized EU procedure.

    On Dec. 20, 2017, the long-awaited core element of the new regulation, the Union List of Novel Foods, was agreed upon and laid down in Implementing Regulation (EU) 2017/2470. From that date on, all authorizations realized under the previous regulation (EC) 258/97 will be generic. The Union List provides the specifications and conditions of use for these generic foods and food ingredients. Food business operators using these ingredients can market their products directly, provided that they meet the specifications in the Union List, and that the authorized conditions of use are observed.

    The most recent version of the Union list, currently dated Dec. 20, 2017, is available at https://bit.ly/2MtIaWg. This list will be updated regularly. Whether and how these updates will also include corrections of mistakes and inconsistencies remains to be seen.

    Analysis & Industry Reaction
    The transition from product specific and business operator specific authorizations to generic ones comes as a big relief for many in the food business. However, manufacturers of the more innovative products are bound to be disappointed. One issue is that protection for proprietary data as per articles 26 and 27 of (EU) 2015/2283 does not apply to those applications that only recently got their Novel Foods authorized while the former regulation was still in effect. Applications that were not finalized under the old regulation will be further processed pursuant to (EU) 2015/2283, but may now have the opportunity to request data protection as per these articles.

    All in all, industry verdict on the new regulation has been positive, with about 20% of professionals surveyed by Vitafoods Europe saying they expect the new rules to have a positive impact, compared to only 10% who think the impact will be negative; 17% of respondents said they are now more likely to undergo a novel food authorization route for their products, while 12% said they were less likely to do so.

    A big advantage of the new regulation is the time-saving factor afforded by the new, centralized procedure. As per the old regulation, the average time to get a novel food approval was 3.5 years, topping out at 5 or 6 years. Industry insiders are hoping the better-defined deadlines of the new process will result in faster approvals. However, only time will tell whether this new, streamlined procedure will hold that promise in practice.

    However, as mentioned, some food business operators fear there may be adverse implications for some intellectual property portfolios. Analyze & realize’s expert Dr. Steffi Dudek pointed out, “The new regulations certainly represent progress for traditional foods from third countries or for relatively simple products—exotic berries for example. But manufacturers of innovative synthetic or fermented ingredients who received an authorization under the old regulation after investing heavily in research will be disappointed that their proprietary data is not respected in the way they had hoped. I’m also concerned that some products that should be subject to their own authorizations might now enter the EU market under a generic authorization. It remains to be seen how companies will take the responsibility to assess the status of their products.”

    On Jan. 5, the Commission launched an electronic submission form that is to be used for all types of future novel food applications. Applicants need to register on the EU login website prior to first use of this submission form. The e-submission format not only makes the application easier, it also allows applicants to follow up on their applications from submission until outcome, which improves transparency of the entire submission process. To support applicants in this application procedure, there is a user guide available at https://bit.ly/2OE7BSF.

    In conclusion, during a time when innovation is becoming more difficult due to certain regulatory restrictions such as in the health claim arena, the majority of food business operators will welcome this simplified, centralized procedure for authorizing innovative ingredients. It remains to be seen how much the market will actually benefit from the new regulation.


    Joerg Gruenwald
    analyze & realize ag

    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
    • Functional Food
    • Regulation
    • Exotic
    • Regulatory
    Related Knowledge Center
    • World Markets
    • Dietary Supplements
    • Regulations
    Suggested For You
    Some Clarity Offered for Label Declarations of Vitamins in the EU Some Clarity Offered for Label Declarations of Vitamins in the EU
    Vitafoods Europe Event Info Vitafoods Europe Event Info
    Botanicals in the EU: National Plant Lists Fill Void Without Harmonization Botanicals in the EU: National Plant Lists Fill Void Without Harmonization
    Amino Acid Decision in Europe May Represent Small Step Toward Harmonization Amino Acid Decision in Europe May Represent Small Step Toward Harmonization
    Focus on Health Compels Brands to Reduce Sugar with Reformulated Foods and Beverages Focus on Health Compels Brands to Reduce Sugar with Reformulated Foods and Beverages
    Frutarom Opens New Markets for NovaSOL Curcumin Frutarom Opens New Markets for NovaSOL Curcumin
    Research Reveals Widespread Support for Plastic Packaging Tax Research Reveals Widespread Support for Plastic Packaging Tax
    Podcast: Cranberry Market Update with Dr. Stefan Gafner of ABC Podcast: Cranberry Market Update with Dr. Stefan Gafner of ABC
    Taking Aim at the Global Heart Health Crisis Taking Aim at the Global Heart Health Crisis
    Understanding New Medical Device Regulations Understanding New Medical Device Regulations
    HP Ingredients Granted EU Patent for NeuroActin HP Ingredients Granted EU Patent for NeuroActin
    Ashland Showcases Ingredients Processing Expertise Ashland Showcases Ingredients Processing Expertise
    Algalif Launches Astaxanthin Finished Formulations Algalif Launches Astaxanthin Finished Formulations
    SEPPIC Launches SEPIBLISS SEPPIC Launches SEPIBLISS
    Naturex Highlights Innovations in Heart Health & Vitamin C Naturex Highlights Innovations in Heart Health & Vitamin C

    Related Columns

    • Dietary Supplements | Regulations | World Markets
      Some Clarity Offered for Label Declarations of Vitamins in the EU

      Some Clarity Offered for Label Declarations of Vitamins in the EU

      A recent case examined the issue of how added nutrients must be declared in ingredient lists for packaged foods.
      By Joerg Gruenwald, analyze & realize GmbH 06.02.22

    • Contract Manufacturing | Dietary Supplements
      Vitafoods Europe Event Info

      Vitafoods Europe Event Info

      The global nutraceutical conference
      04.20.22

    • Herbs & Botanicals | Regulations | World Markets
      Botanicals in the EU: National Plant Lists Fill Void Without Harmonization

      Botanicals in the EU: National Plant Lists Fill Void Without Harmonization

      Germany, Austria, and Switzerland are developing a list of food and medicinal plants that includes fungi.
      By Joerg Gruenwald, analyze & realize GmbH 04.14.22


    • Proteins, Peptides, Amino Acids | Regulations | World Markets
      Amino Acid Decision in Europe May Represent Small Step Toward Harmonization

      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.
      By Joerg Gruenwald, analyze & realize ag 01.26.22

    • Delivery & Dosage Technologies | Diabetes & Blood Sugar Management | Fiber & Carbohydrates | Sweeteners
      Focus on Health Compels Brands to Reduce Sugar with Reformulated Foods and Beverages

      Focus on Health Compels Brands to Reduce Sugar with Reformulated Foods and Beverages

      Cutting the amount of sugar from product formulations has become a priority for many brands as consumers seek healthier solutions.
      By Joerg Gruenwald, analyze & realize ag 09.09.21

    Loading, Please Wait..
    Trending
    • Study Examines Vitamin K2 Content In Cheese
    • Chenland Nutritionals Self-Affirms GRAS For Cumin UP60 Ingredient
    • Pycnogenol Evidenced To Have Skin Benefits In Dermatology Study
    • ADM And Benson Hill Partner To Scale High Protein Soy For U.S. Market
    Breaking News
    • Charlotte’s Web Sports Product Line to Undergo NSF Certification Process
    • ADM and Benson Hill Partner to Scale High Protein Soy for U.S. Market
    • Tazo Transitions to Regenerative Organic Agriculture
    • Protein Ingredient Formulated for Chronic Kidney Disease Patients
    • IADSA Calls for Addressing Discrepancies in Vitamin C Recommendations
    View Breaking News >
    CURRENT ISSUE

    July/August 2022

    • A Growing Herbal Products Market Still Faces Formidable Threats, Challenges
    • Analytical Testing in Nutraceuticals: Methods and Mindsets to Uphold Quality
    • Nutrition and Flavor: Formulating for Modern Product Preferences
    • Contract Manufacturing: Trials & Tribulations of Today’s Supply Chains
    • How Will the European Green Deal Impact Dietary Supplements?
    • What Do Consumers Know About the Gut Microbiome?
    • View More >

    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

    Charlotte’s Web Sports Product Line to Undergo NSF Certification Process
    ADM and Benson Hill Partner to Scale High Protein Soy for U.S. Market
    Tazo Transitions to Regenerative Organic Agriculture
    Coatings World

    Latest Breaking News From Coatings World

    What are you Reading this Week?
    SONGWON Industrial Group Reports Strong Q2 Financial Results
    PPG Completes COLORFUL COMMUNITIES Project for Boys & Girls Clubs of Greater Houston
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MPO's Most-Read Stories This Week—Aug. 13
    'Graft-on-a-Chip' Built to Improve Vascular Graft Success
    Abbott Invests €440 in New Irish Facility
    Contract Pharma

    Latest Breaking News From Contract Pharma

    AskBio Appoints Clinical Ops Executives
    SpectrumX Partners With UK Contract Manufacturer
    GL Chemtec Partners with Edgewater Capital to Accelerate Growth
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Arkay Chairman Emeritus Howard Kaneff Has Died
    Nutricosmetics Market to Hit $13.7 Billion by 2030
    Estée Lauder Pledges 100% Electric Fleet of Vehicles by 2030
    Happi

    Latest Breaking News From Happi

    Consumers are Clamoring for Vintage Glam: Spate
    Kayali’s Lovefest Fragrance, Newell’s New Candle and HydraFacial’s Record Financial Results
    Self Care Trumps Home Care Post-Covid
    Ink World

    Latest Breaking News From Ink World

    Weekly Recap: Printing Ink Primer, Zeller+Gmelin Lead This Week’s News Stories
    Heidelberg Enjoys Successful Start to 2022-23 Fiscal Year
    Mimaki Announces New LATAM Website
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Esko, Constantia Flexibles announce acquisitions and more
    Hybrid Software joins The Flexo Xperience Center
    Flexo Wash LLC and Mike Potter celebrate 20 years
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Weekly Recap: Essity Switches to Recyclable Packs for Feminine Pads, FTC Sues PPE Maker on False Origin Claims & More
    Focke & Co. to Host Destination: Your Hygiene Hub on August 31
    Exports Dominate Chinese Trade of Tissues, Hygiene Products and Wipes
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    ODT's Most-Read Stories This Week—Aug. 13
    Dental 3D Printing Market is Expanding 20% Annually
    Study Results Released for Abbott's Concussion Blood Test
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Weekly Recap: ALTANA, Universal Display and Emerson Top This Week’s Stories
    eMagin Corporation Announces 2Q 2022 Results
    Zebra Technologies’ Emission Reduction Targets Validated by SBTi

    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