{"id":2430,"date":"2025-01-13T16:49:56","date_gmt":"2025-01-13T15:49:56","guid":{"rendered":"https:\/\/www.pharmanager-development.com\/?p=2430"},"modified":"2025-02-26T11:01:33","modified_gmt":"2025-02-26T10:01:33","slug":"composition-audit-food-compliance-regulation","status":"publish","type":"post","link":"https:\/\/www.pharmanager-development.com\/en\/composition-audit-food-compliance-regulation\/","title":{"rendered":"Composition Audit of a Food Product: Compliance and Regulation"},"content":{"rendered":"\n
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Regulatory Context: Composition of Food Products in Europe<\/strong><\/strong><\/strong><\/strong><\/h2>\n\n\n\n

The composition of food products in Europe is subject to strict regulations. Belgium, for instance, has a list of prohibited plants (List 1 of the Belgian Royal Decree), while France maintains a list of plants exempt from the pharmaceutical monopoly, identifying those permissible for use in food products.<\/p>\n\n\n\n

At the European level, certain member states have established lists of authorized plants. Additional references include the Council of Europe\u2019s list of flavoring substances and the Novel Food Catalogue, which provides information on the status of plants used in food.<\/p>\n\n\n\n

<\/div>\n\n\n\n

Composition Audit: Ingredient Analysis and Compliance<\/strong><\/strong><\/strong><\/strong><\/h2>\n\n\n\n

Rocket Leaf (Eruca sativa Mill.)<\/strong><\/strong><\/strong><\/strong><\/strong><\/p>\n\n\n\n

– Quantity<\/strong>: 550.5 mg (36.7% per sachet)<\/p>\n\n\n\n

– Status in France<\/strong>: Food ingredient<\/p>\n\n\n\n

– Status in Belgium<\/strong>: Authorized food ingredient in dietary supplements with restrictions<\/p>\n\n\n\n

Commentaire :<\/strong> Novel Food Catalogue: Not listed for all food categories. Not listed by Tea and Herbal Infusions Europe (THIE) as an infusion plant.<\/p>\n\n\n\n

Regulatory Note<\/strong>: In Belgium, its use in dietary supplements is restricted due to goitrin content, which must not exceed 5 mg per day.<\/p>\n\n\n\n

Nettle Leaf (Urtica dioica L.)<\/strong><\/strong><\/strong><\/p>\n\n\n\n

– Quantity<\/strong>: 550.5 mg (36.7% per sachet)<\/p>\n\n\n\n

– Status in France<\/strong>: Exempt from the pharmaceutical monopoly<\/p>\n\n\n\n

– Status in Belgium<\/strong>: Authorized food ingredient in dietary supplements without restrictions<\/p>\n\n\n\n

Comments<\/strong>:<\/p>\n\n\n\n

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  • Novel Food Catalogue: Not listed for all food categories.<\/li>\n\n\n\n
  • Listed in the Council of Europe\u2019s flavoring substances.<\/li>\n\n\n\n
  • Listed by THIE as an infusion plant.<\/li>\n<\/ul>\n\n\n\n

    Regulatory Note<\/strong>: ANSES advises against its use in cases of cardiac or renal-origin edema.<\/p>\n\n\n\n

    Lemon Verbena Leaf (Lippia citriodora H.B. et K.)<\/strong><\/strong><\/strong><\/p>\n\n\n\n

    – Quantit\u00e9 :<\/strong> 400 mg (26.6 % par sachet)\u00a0<\/p>\n\n\n\n

    – Status in France<\/strong>: Exempt from the pharmaceutical monopoly<\/p>\n\n\n\n

    – Status in Belgium<\/strong>: Authorized in dietary supplements<\/p>\n\n\n\n

    Comments<\/strong>:<\/p>\n\n\n\n

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    • Listed by THIE as an infusion plant.<\/li>\n<\/ul>\n\n\n\n
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      • Novel Food Catalogue: Non-concentrated aqueous infusions are non-Novel Food but restricted to dietary supplements.<\/li>\n<\/ul>\n\n\n\n
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        • Listed in the Council of Europe\u2019s flavoring substances.<\/li>\n<\/ul>\n\n\n\n
          <\/div>\n\n\n\n

          Conclusion<\/strong><\/h2>\n\n\n\n

          For both France and Belgium, the formula presents a\u00a0Novel Food risk<\/strong>\u00a0due to lemon verbena, recently added to the Novel Food Catalogue as a new ingredient for food products, except in dietary supplements.<\/p>\n\n\n\n

          The nettle and rocket leaves are compliant, but precautions should be taken:<\/p>\n\n\n\n

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          • For nettle: Include a warning regarding use by individuals with cardiac or renal-origin edema.<\/li>\n<\/ul>\n\n\n\n
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            • For rocket: Verify the goitrin content to meet Belgian requirements for dietary supplements, which could also apply to food products.<\/li>\n<\/ul>\n\n\n\n
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              • To ensure market compliance, evidence of significant consumption before May 15, 1997, must be established.<\/li>\n<\/ul>\n\n\n\n
                <\/div>\n\n\n\n
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