Whether it is an innovative new food or supplement ingredient, a product derived from biotechnology or a new health claim, our toxicologists, scientists, and regulatory experts will help you navigate the scientific and regulatory requirements to get these approved.
Understanding the safety and regulatory requirements of the food and supplement industry can be complex and daunting task, especially when considering marketing products in several jurisdictions.
Our global experts have an unparalleled understanding of the intricacies and processes of regulatory agencies and requirements to develop a successful strategy to address your current and future regulatory needs.
We add value to your business objectives by providing the most expedient and cost-effective route to satisfy the necessary requirements and is a valued partner that will lead you every step of the way.
Global Standards provides strategic advice and innovative solutions for the regulatory, scientific, and toxicological requirements to market flavoring ingredients in multiple regions, including the EU, the UK, the U.S., Canada, Japan, China, South Korea, Southeast Asia, and Australia and New Zealand.
The regulatory status of flavorings differs across jurisdictions according to source materials, properties, and production processes, among other factors. Understanding the regulatory classification of flavorings – which impacts authorization and labelling requirements – is critical to a successful global launch.
While flavorings are considered food additives in the U.S. and Japan, their classification in the EU depends on their properties. Specifically, in the EU, flavourings are substances that impart or modify the odour and/or taste of food and are distinct from food additives; however, substances that enhance the existing odour and/or taste of food are classified as flavour enhancers (food additives). As such, organoleptic studies are required to correctly classify the substances (flavouring or flavour enhancer) and determine their route-to-market and labelling requirements.
Authorization
In recent years, scientific bodies like the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the European Food Safety Authority (EFSA) have conducted safety evaluations of flavourings by grouping substances with related chemical structures into structural classes, and have integrated concepts like read-across and the Threshold of Toxicological Concern into their risk assessments.
In the U.S., flavouring substances are authorised via the Flavor and Extract Manufacturers Association’s (FEMA’s) Generally Recognized as Safe (GRAS) program (FEMA GRASTM) – whereby experts evaluate the ingredient as GRAS under the conditions of intended use – or via an application to the Food and Drug Administration (FDA) for food additive status.
In the EU, the 2022 EFSA Guidance on the risk assessment of flavourings updates the approach to demonstrating the safety of flavourings in the EU, highlighting the importance of toxicokinetic studies and experimental genotoxicity data to add rigor to the safety process. When additional toxicity data are needed, a tiered approach is followed – similar to that required for the risk assessment of food additives.
The UK currently follows the pre-2022 EU Guidance.
Having a clear understanding of such region-specific safety requirements is critical to developing an impactful global testing strategy plan.
The Global Standards Advantage
Global Standards' Food Scientific and Regulatory Consulting service is backed by a network of regulatory, science, and toxicology experts with extensive experience in attaining successful authorisation of regulated food ingredients globally, including additives, novel foods, enzymes, and flavourings.
We support companies with strategic advice from concept, to product development, to regulatory classification and substantiation, all the way to successful authorisation.
Global Standards can help companies successfully bring their flavouring ingredients to the EU, UK, U.S., Canada, Japan, China, South Korea, Southeast Asia, and Australia and New Zealand. We help businesses:
Understand the complex regulatory requirements across jurisdictions and develop the appropriate regulatory strategy to market;
Design, conduct, and interpret the appropriate organoleptic studies to support the regulatory classification of flavourings;
Ensure only necessary studies are conducted and in the most efficient way, with ongoing support through the entire product life-cycle as part of our toxicology study management service;
Prepare the necessary regulatory body applications, FEMA GRAS applications, and supporting documentation and assist with electronic filling, where required; and
Navigate the regulatory approval process to authorisation.
Global Standards Helps the natural health and dietary supplement product industry navigate complex global scientific and regulatory requirements.
Regulations for natural health and dietary supplement products vary across global markets. Some jurisdictions regulate these products like food, while others consider them closer to drugs. These differences can pose significant challenges to how companies market their natural health and dietary supplements, including requiring potentially costly modifications to remain in regulatory compliance.
Global Standards multi-disciplinary team of experts have unparalleled experience with the intricacies of marketing natural health and dietary supplement products worldwide. We can help develop a successful global strategy to maximize research and development, prepare successful pre-market submissions, work as a liaison with global regulatory agencies, and much more.
Whether you are currently marketing a product and looking to expand globally, or still developing a product for a given market, Global Standards can help overcome challenges along the way.
Our Services Include:
Global Standards supports the following jurisdictions:
Global Standards novel food services support pre-market approvals for ingredients in major jurisdictions across the globe.
Foods or food ingredients that do not have a history of use within a country are typically considered “novel foods” and will require pre-market authorization.
Obtaining approval for novel foods/ingredients requires careful planning and a solid strategy to support market success. Due to differing pre-market requirements for different countries and an ever-evolving regulatory landscape, obtaining approval can be quite complex. A global strategy is essential to gain approval in multiple markets efficiently and effectively. Global Standards has the regulatory and scientific expertise necessary to provide reliable advice on international novel food regulations and approvals.
Novel Food Services
Global Standards' expert staff has extensive experience navigating regulatory requirements for novel food applications and obtaining approvals across the globe. Our knowledgeable and well-connected global team can help at all stages of product development—from conception, to stewardship with authorities, to final approval.
Global Standards supports the following jurisdictions:
Providing global scientific and regulatory solutions for pet food and animal feed ingredients.
Requirements for gaining market entry and maintaining compliance for pet food and animal feed ingredients are complex and vary widely across jurisdictions. Pet food and animal feed ingredients must demonstrate safety and utility in target animal species to be considered for pre-market approval. In many cases, registration of the ingredient and finished product is required.
Global Standards has a well-connected global team with extensive experience meeting the regulatory requirements for pet food and animal feed ingredients. Our knowledgeable staff provides scientific and regulatory support at all stages of the product lifecycle.
Gaining approval of feed ingredients and additives globally requires a clear, efficient strategy. Global Standards' scientific and regulatory staff has the expertise to identify and outline the challenges across various jurisdictions and provide an actionable plan to address them.
Our services include:
Regulatory frameworks for pre-market approval vary around the world:
Global Standards supports the following jurisdictions:
Global Standards is in the unique position to offer comprehensive scientific and regulatory solutions for medical foods, flavorings, packaged foods, cannabis, and other product categories in major and minor jurisdictions around the world.
Medical Foods
Medical foods are a product class that meets particular dietary needs resulting from a physical, physiological, pathological, or other condition, including diseases, convalescence, pregnancy, lactation, allergic hypersensitivity to food, and being under- or overweight. In the U.S., medical foods were previously regulated as drugs due to their role in mitigating serious diseases; however, in 1972, the U.S. Food and Drug Administration (FDA) reclassified medical foods as Foods for Special Dietary Use. Medical foods are now defined as foods which are formulated to be consumed or administered enterally under the supervision of a physician, intended for the specific dietary management of a disease or condition, for which distinctive nutritional requirements, based on recognized scientific principles, have been established by medical evaluation.
Medical foods must meet the statutory definition of a medical food and be safe and effective in the intended population group. It is insufficient to demonstrate that a dietary substance is effective in treating a disease or condition; the substance must also fulfil a nutritional requirement that arises because of the disease. Substances that are marketed to treat, cure, or mitigate symptoms of a disease are considered drugs. In addition to specific guidance for regulation of medical foods, other applicable requirements for foods must be met, and health claims must not be false or misleading.
Flavorings
Food flavor(ing)s are added to food to impart flavor and give food a specific taste and/or smell. Depending on the jurisdiction, flavorings are not always considered a sub-category of food additives. Flavorings consist of one or more individual flavouring ingredients (referred to as “flavouring substances” or “flavouring agents,” depending on jurisdiction), which can be natural or synthetically derived, and may contain non-flavouring ingredients (flavor adjuvants) and related compounds (e.g., flavor enhancers or modifiers).
Although the exact quantities of flavouring substances present in food are elusive, due to the volatile nature of most flavouring substances, use levels are generally self-limiting due to the adverse effect that high levels often have on taste.
The regulatory framework for flavouring substances varies by jurisdiction, but specialized procedures have been developed specifically for flavouring substances. These procedures are generally based on the threshold of toxicological concern (TTC) approach for assigning exposure thresholds, based on chemical structure, below which exposure is assumed to have no significant risk.
Such procedures have been adopted by some regulatory and scientific advisory bodies for safety evaluations of flavors added to food, and they provide a scientifically sound approach for the evaluation and use-authorization of this unique group of substances.
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