{"id":2079,"date":"2024-11-22T11:01:51","date_gmt":"2024-11-22T10:01:51","guid":{"rendered":"https:\/\/www.pharmanager-development.com\/?post_type=sector&p=2079"},"modified":"2025-02-03T11:07:00","modified_gmt":"2025-02-03T10:07:00","slug":"novel-foods-regulatory-scientific-consulting","status":"publish","type":"sector","link":"https:\/\/www.pharmanager-development.com\/en\/secteur\/novel-foods-regulatory-scientific-consulting\/","title":{"rendered":"Novel Food"},"content":{"rendered":"\n
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Accueil<\/a><\/span><\/span><\/div> <\/div>\n
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Novel Food<\/span><\/h1>\n

Novel foods refer to food products or ingredients whose human consumption in the European Union was negligible before May 15, 1997. These products must comply with strict regulations to ensure their safety and conformity before being placed on the market.<\/span><\/p>\n

Pharmanager Development, expert reconnu en r\u00e9glementation Novel Food, vous accompagne dans toutes les \u00e9tapes cl\u00e9s : de l\u2019\u00e9valuation du statut r\u00e9glementaire \u00e0 la constitution de dossiers scientifiques complets, en passant par la gestion des soumissions aupr\u00e8s de la Commission Europ\u00e9enne. Gr\u00e2ce \u00e0 notre base de donn\u00e9es Phinn\u00ae, nous vous apportons une veille pr\u00e9cise et des solutions adapt\u00e9es \u00e0 chaque projet.<\/span><\/p>\n

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What are the regulations for Novel Food ingredients?<\/h2>\n <\/div>\n <\/div>\n
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2015\/2283<\/strong>\/EU<\/h3>\n <\/div>\n
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This regulation establishes the legislative framework for Novel Foods in the European Union. It defines the requirements for safety evaluation, traceability, and the authorization procedures necessary before market placement.<\/p>\n <\/div>\n <\/div>\n

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2017\/2470<\/strong>\/EU<\/h3>\n <\/div>\n
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This regulation details the list of authorized Novel Foods in the European Union. It also specifies the conditions of use and the mandatory labeling requirements, ensuring product compliance.<\/p>\n <\/div>\n <\/div>\n <\/div>\n <\/section>\n\n\n

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Novel Food status assessment<\/span><\/h3>\n \n <\/span>\n <\/span>\n <\/span>\n
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We analyze the specifications of your ingredients and manufacturing processes to determine whether they fall under Novel Food status. This critical step allows for a quick feasibility assessment and helps structure an appropriate strategy.<\/p>\n <\/div>\n <\/div>\n

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Consultation with an EU Member State<\/span><\/h3>\n \n <\/span>\n <\/span>\n <\/span>\n
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We assist you in preparing and submitting a consultation dossier to an EU Member State. This process determines the Novel Food status of your product in accordance with Article 4 of Regulation (EU) No 2015\/2283.<\/p>\n <\/div>\n <\/div>\n

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Preparation of Novel Food dossiers <\/strong><\/h3>\n \n <\/span>\n <\/span>\n <\/span>\n
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We compile comprehensive scientific dossiers, including bibliographic research, toxicological evaluations, and exposure analyses for target populations. For traditional foods from third countries, we conduct in-depth studies to justify their safety.<\/p>\n <\/div>\n <\/div>\n

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Electronic submission to the European Commission <\/strong><\/h3>\n \n <\/span>\n <\/span>\n <\/span>\n
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We handle the electronic submission of your dossier to the European Commission and monitor the evaluation process, facilitating interactions with competent authorities.<\/p>\n <\/div>\n <\/div>\n

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Regulatory monitoring via Phinn\u00ae <\/strong><\/h3>\n \n <\/span>\n <\/span>\n <\/span>\n
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With our Phinn\u00ae<\/a> database, we help you anticipate regulatory changes and quickly integrate new updates from the Novel Food catalogue, ensuring continuous compliance for your products.<\/p>\n <\/div>\n <\/div>\n <\/div>\n \n

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Pharmanager Development vous accompagne dans :<\/h2>\n

We assist you in the market launch of your Novel Foods. With our in-depth expertise, we guide you through all necessary steps to ensure the regulatory compliance of your products. We make sure your products meet the requirements of the competent authorities, facilitating their approval and market entry.<\/p>\n

Our approach includes evaluating the regulatory requirements specific to your products, preparing the necessary dossiers, and analyzing and validating claims and labeling. By working with us, you maximize your chances of success by ensuring your products comply with regulatory standards while optimizing their market positioning.<\/p>\n \n

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Want to enhance your expertise?<\/h2>\n

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\n \n View Training Calendar<\/span>\n <\/a>\n <\/div>\n <\/div>\n <\/div>\n<\/section>\n\n\n
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