facebook
youtube
linkedIn
instagram
Rapid advancements in food technologies introducing innovative production processes—such as nanotechnology, 3D printing, and cell/tissue culture—into our daily lives have also brought forth next-generation food products developed in laboratory environments.
Globally defined as “Novel Foods,” these products are subject to stringent regulations in international markets and undergo comprehensive safety assessments and audits in Europe under Regulation (EU) 2015/2015/2283.
In Türkiye, this field has established a brand-new legal framework with the “Regulation on Novel Foods” and the “Turkish Food Codex Communiqué on Novel Foods,” which entered into force upon publication in the Official Gazette on May 20, 2026.
Today, launching any innovative food item without a history of significant consumption is no longer just a commercial milestone; it is a critical compliance process that demands accurate determination of legal status and full alignment with Ministry expectations.
Key Client Profile
- Innovative Food Entrepreneurs: Tailored for R&D-driven companies producing next-generation food through cell/tissue culture, 3D food printing, or nanotechnological methods.
- Importers of Next-Generation Ingredients: Ideal for companies looking to import novel raw materials or dietary supplement ingredients from European or other global markets that do not yet have a consumption history in Türkiye.
- Non-Traditional Product Developers: Perfect for brands planning to incorporate novel ingredients synthesized in laboratory environments or obtained through specialized extraction techniques into their product formulations.
- Industry Professionals Seeking to Minimize Regulatory Risks: Suitable for companies wanting to determine whether their product falls under the “Novel Food” classification and obtain a pre-assessment prior to official submissions.
Key Areas Evaluated During the Process
Product status and compliance with EU 2015/2283 regulations.
Production technology and innovative process specifications.
Ingredient complexity and technical compliance.
History of safe use and toxicological data.
Ministry technical dossier architecture and application strategy.
Why Is This Process Important?
The market placement process for a product categorized as a novel food requires a significantly higher level of scientific and technical precision compared to standard food approvals. What may externally appear to be the direct registration or declaration of an innovative idea can result in an immediate rejection of the application if technical data in the submission dossier is incomplete, production details are ambiguous, or ingredient complexities are mismanaged.
Even the slightest coordination error or incorrect classification within the regulatory framework can invalidate your R&D investments, delay market entry for years, and burden your company with exorbitant analysis and operational costs—ultimately leaving you behind your competitors.At OMNIREGULA, anticipating all the dynamics and institutional expectations of the 2026 regulatory period, we strategically map out both the legal and technical dimensions of the process with a holistic vision to ensure your next-generation foods achieve secure, first-time approval.
Frequently Asked Questions
The primary criterion for a food or ingredient to be classified under this status is the absence of a history of significant and safe consumption within a specific timeframe (particularly within the borders of the EU and local jurisdictions). Additionally, being produced via next-generation technologies such as nanotechnology, cell culture, or 3D printing is a key determining factor.
The newly published “Regulation on Novel Foods” and its implementing communiqué have officially established clear rules for the approval, authorization, and market placement procedures of novel foods in Türkiye. It is now mandatory to complete the technical dossier preparation and risk assessment processes outlined in this communiqué before launching innovative foods into the market.
Comprehensive technical and scientific documentation regarding the product’s production process details, ingredient quality, toxicological data, allergenicity, nutritional profile, and—if applicable—history of use in other countries must be submitted. Assessments are conducted strictly based on the compliance and adequacy of these documents.
No. Any food product that lacks a history of significant consumption and involves innovative processes (nanotechnology, 3D printing, cell/tissue culture, etc.) requires the formal determination of its legal status and an approval process aligned with Ministry expectations prior to market placement.
