• <blockquote id="sqo4s"></blockquote>
  • <rt id="sqo4s"><kbd id="sqo4s"></kbd></rt>
  • <td id="sqo4s"></td>
    Food & Food Contact Materials
    CIRS Group
    Chemicals
    Cosmetic
    Food
    Medical Devices
    Agrochemicals
    CIRS Testing
    Carbon Neutrality
    Search

    Compliance Analysis of Hydroxytyrosol in China, Europe, the US, Australia, and New Zealand

    from CIRS by

    Introduction

    Hydroxytyrosol is a naturally occurring polyphenol primarily found in olives and their products, such as olive oil and olive leaves. It is widely studied for its outstanding antioxidant properties and has numerous applications in the food and cosmetic industries. As a powerful antioxidant, hydroxytyrosol helps reduce oxidation in foods, extending shelf life and preserving flavor. Due to its health benefits, hydroxytyrosol is often added to health foods to support cardiovascular health, boost immunity, and reduce inflammation.

    • Common name (trade name): Hydroxytyrosol;
    • Chemical name: 3,4-Dihydroxyphenylethanol;
    • Molecular formula: C8H10O3;
    • Molecular mass: 154.165 g/mol (according to the 2022 International Standard Relative Atomic Mass); and
    • Structural formula:

    Compliance,Food,China,Europe,US,Australia,New Zealand

    This article analyzes the regulatory status of hydroxytyrosol in China, Europe, the United States, Australia, and New Zealand from a food industry perspective.

    Approval status of hydroxytyrosol in China, Europe, the US, Australia, and New Zealand

    Country/region

    Approval status

    Substance

    Date of approval

    Applicant

    China

    Approved as a new food additive (antioxidant)

    Hydroxytyrosol

    July 25, 2024

    /

    US

    FDA GRAS (GRN No.600)

    Hydroxytyrosol (chemical synthesis)

    October 2, 2015

    Seprox Biotech S.L

    FDA GRAS (GRN No.876)

    Hydroxytyrosol (biosynthesis)

    January 21, 2020

    Nova Mentis Ltd

    FDA GRAS (GRN No.726)

    Phenolic preparation from olive fruit

    February 28, 2018

    DSM Nutritional Products, LLC.

    FDA GRAS (GRN No.978)

    Hydrolyzed aqueous olive pulp extract

    December 10, 2021

    Oliphenol LLC

    FDA GRAS (GRN No.1138)

    Hydroxytyrosol

    Pending

    Hangzhou Viablife Biotech

    EU

    Novel Food

    Hydroxytyrosol (chemical synthesis)

    December 14, 2017

    Seprox Biotech

    Novel Food

    Olive fruit dry extract standardized in hydroxytyrosol (10% or 20%)

    Ongoing Risk Assessment

    NATAC BIOTECH S.L.

    Australia and New Zealand

    Food/Food Ingredients Record of Views

    Olive fruit extract

    Officially published in 2014

    /

    China

    Hydroxytyrosol has been approved as a new food additive in China. It is used as an antioxidant in vegetable oils (food category 02.01.01) to delay oxidation, with a maximum level of 0.05 g/kg. This approval applies to hydroxytyrosol produced from tyrosine through a process involving fermentation with Corynebacterium glutamicum, followed by catalytic conversion, separation, and purification.

    The approval process spanned just over six months from acceptance to public consultation, and only about nine months to receive official approval.

    September 25, 2023

    • Application accepted by China’s National Health Commission (NHC)

    October 18, 2023

    • Issued an extension notice by the China National Center for Food Safety Risk Assessment (CFSA), requiring supplementary materials.

    March 13, 2024

    • Passed the technical review of CFSA and issued for public comment

    July 25, 2024

    • Officially approved by NHC

    US

    In the US, hydroxytyrosol has been approved as a Generally Recognized as Safe (GRAS) substance. Notably, another GRAS substance is hydrolyzed aqueous olive pulp extract, a phenolic preparation. Hydroxytyrosol is primarily intended for use as an antioxidant and antimicrobial in beverages, fats and oils, fresh and processed fruits and vegetables and juices, and gravy and sauces at use levels of 5.0 milligrams per serving.

    EU

    In accordance with Commission Implementing Decision (EU) 2017/2373, hydroxytyrosol derived from chemical synthesis has been authorized as a Novel Food. The authorized food categories include fish and vegetable oils (excluding olive oil and olive pomace oil), as well as spreadable fats, with maximum levels set at 0.215 g/kg and 0.175 g/kg, respectively. Additionally, the European Food Safety Authority (EFSA) has issued a scientific opinion on the safety of hydroxytyrosol as a Novel Food. The opinion states that the expected daily intake of hydroxytyrosol from these uses is comparable to or even lower than the exposure from consuming olive oil and olives. Therefore, the panel concluded that hydroxytyrosol is safe under the specified uses and use levels.

    Australia and New Zealand

    According to the “Food/Food Ingredients Record of Views” by Food Standards Australia New Zealand (FSANZ), the safety assessment for olive fruit extract notes that there are no safety concerns identified at levels of use (up to 20 mg/day of hydroxytyrosol). Therefore, it can be concluded that a daily intake of 20 mg of hydroxytyrosol is considered safe in Australia and New Zealand.

    If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

    Further Information

    CIRS Group Assists Client in Securing Approval for New Antioxidant Hydroxytyrosol

    About the CIRS Global Food Ingredients Application Services

    The CIRS food team offers the following services:

      

    We have launched a LinkedIn newsletter to keep you up to date on the latest developments across the chemical industry including food and FCMs and personal and home care.

    Contact Us
    +353 1 477 3710 (EU)
    +44 20 3239 9430 (UK)
    +1 703 520 1420 (USA)
    +86 571 8720 6574 (CN)
    +82 2 6347 8816 (KR)
    +81 070-9365-8022 (JP)
  • <blockquote id="sqo4s"></blockquote>
  • <rt id="sqo4s"><kbd id="sqo4s"></kbd></rt>
  • <td id="sqo4s"></td>
    丝瓜视频