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Ensure the fastest route to market for your food ingredient
There is a growing demand for innovative and healthier food options. Advances in food science and technology have made it possible to develop new food products. Successfully navigating the regulatory landscape can provide a competitive edge and market exclusivity, as well as build consumer trust in product safety and efficacy. However, navigating the regulatory landscape to bring these products to market can be a significant challenge. With a dedicated regulatory affairs team, Argenta is well-equipped to guide you to success.
Navigating the complex regulatory landscape can be filled with difficulties
Overall, while the market for innovative food products presents significant opportunities, companies must carefully navigate regulatory, technical, and market challenges to succeed.
Ensuring that products meet safety standards is crucial. This often involves extensive testing and documentation, which can be a lengthy and expensive process
Each region (e.g., EU, US, Canada, Singapore) has its own regulatory requirements and processes
Gaining approval for novel foods and food ingredients involves navigating complex regulatory landscapes, which can be time-consuming and costly
Overcome regulatory barriers
It is essential to correctly identify the legal classification of your food ingredient and decide on a realistic and appropriate registration strategy at an early stage of a project
This helps to avoid delays and minimise costs. At Argenta we can help unravel the complex maze of regulations and guidelines
Our services are tailored to your needs and we are available to offer assistance at any phase of a project or evaluation process.
Do you have a specific question regarding your product?
Our 20 years of regulatory and scientific experience expertise in food regulations across the EU, UK, USA and Singapore, allows our team to anticipate many questions from the authorities and potential pitfalls, assuring a smooth application process. Our team will be happy to cooperate with you to develop the most efficient strategy to bring your product to market quickly, save your time and money.
Contact us to discuss your needs and discover how we can assist you every step of the way.
Services
Enzymes, Additives & Flavours
- Initial assessment of the legal status of the substance to identify the correct regulatory pathway and ensure fastest route to market
- Add a food improvement agent to the Union List
- Change the conditions of use, specifications or restrictions of already approved substances
- Evaluate existing data and identify missing information in a GAP analysis
- Provide expert advice for the generation of additional data or justifications for omissions
- Assist collecting technical and scientific additional data, monitor studies and review study reports
- Perform systematic literature reviews to support the safety of the substance
- Estimate dietary exposure and provide scientific and regulatory support for the consumer safety assessment
- Compile, write and submit food enzyme, additive or flavourings dossiers
- Post-submission support: liaise with EFSA and European Commission, answer supplementary information requests and provide regulatory support
- Support with activities related to the transparency regulation: pre submission advice, notification of studies, confidentiality requests
Health Claims
- Design and review clinical studies to determine if they qualify for a health claim and identify probability of success
- Perform thorough literature reviews, ensuring all relevant information available in the public domain is used to support a health claim
- Compile, write and submit health claim applications
- Post-submission support: liaise with EFSA and Member State Rapporteur, answer supplementary information requests and provide regulatory support