It’s likely we have already encountered and solved this problem
Our specialized regulatory & scientific compliance software on dietary supplements and knowledgeable, experienced scientific and regulatory departments enable us to offer innovative, personalized and strategic solutions. Our wide range of nutraceutical expertise enables our team to solve the greatest challenges and address even the most complex issues.
A novel food is defined in Regulation (EU) 2015/2283 as a food for which human consumption was negligible in the European Union before 15 May 1997, when the first novel food regulation came into force with Regulation (EC) 258/97.
Novel foods may not be placed on the market or used in food for human consumption until they are included in the European Union list.
FoodChain ID provides the services you need to evaluate the regulatory status of the native ingredient before processing.
We provide audits of the regulatory status of ingredients for use in foods and/or dietary supplements in the US, to determine whether the ingredient is an old dietary ingredient (ODI) or has to be notified to the Food and Drug Administration (NDI or GRAS notification depending on the case).
FoodChain ID helps you determine what needs to be done and provides professional support during every step of the FDA application process.
Product notification is mandatory in most EU countries before a product is placed on the market. A notification must be made for each product and each country it will be marketed in. Each country has its own regulations and procedures and its own deadlines for evaluation and validation.
Our specialists help you with the formula analysis, labelling compliance and the mandatory notification(s) for your product in the countries you want to market it in.
A health claim is any statement about a relationship between food and health.
We help you understand what you have the right to say about your product and the relationship between its ingredients and health benefits. We determine if you can use an already known and authorized claim, or if you need to do an health claim dossier; if it is the latter, we work with you to obtain a new one.
Food additives may also be added to dietary supplements for a variety of reasons ( coating agents for tablets, sweeteners for flavour, etc.). Food additives authorized for use in dietary supplements can be found in Regulation (EC) 1333/2008. We support businesses by evaluating the regulatory status of food additives within this regulation, conducting the scientific pre-diagnosis of the data in accordance with regulatory requirements of admissibility, and help to build application dossiers and communicate with the appropriate authority (EFSA, European Commission) if further follow-up is required.
Our Efficacy & Safety Literature Review Service supports businesses by researching, analysing and synthesizing all data related to the efficacy/physiological effect/safety of ingredients when taken orally, according to existing scientific literature published in peer reviewed journals and applicable regulatory requirements.
The quality of your products depends on the quality of the development and manufacturing processes in place. Our experts can help ensure the quality of your products and protect your brand by developing manufacturing subcontractor specifications (standards, rules, etc)); integrating European and other national quality standards (microbiological criteria, heavy metals, pesticides, solvent residues, GMOs, allergens and more) and evaluating procedures already in place (ingredient quality standards, controls, batch records, etc.)
Our team develops theoretical formulations, taking into account appropriate efficacy and safety dosages of selected ingredients, potential additional ingredients more likely to be identified and recognized by consumers, and other ingredients that may allow the use of Health claims.
Our experts are recognized as one of the leaders in designing EFSA-compliant clinical study protocols aiming to substantiate health claims or novel food authorizations. Following the evaluation of the strengths and weaknesses of the previously performed studies and EFSA opinions we will design the relevant protocol in line with EFSA-requested criteria for the evaluation of applications for authorization of health claims made on foods.
We provide training to help your team to understand the regulatory framework, regulatory status of ingredient, health claims, labeling and formulation, so they have the skillset to launch compliant products in the US, Europe, and Asia.
Manage risk by having our experts evaluate your product portfolio. We can review regulatory compliance (formulation, claims, etc), scientific support compliance (efficacy, interactions, safety), quality assurance (process, controls, analys), and export feasibility for new markets. Our broad-ranging expertise in the industry Strategic recommendations.
Strategic Regulatory, Quality & Scientific Intelligence (Ingredients, Product categories, Health applications, Claims, Countries).
-
Dozens of Novel Food Successes
-
6407 Product Analyses/Notifications Completed
-
Experts with 12 Years of Experience
I would highly recommend (this team). They have delivered regulatory service beyond what was expected. I trust the (them) to deliver the most up-to-date and relevant information. During a very challenging EU Novel Food application – my consultant was able to navigate a strategy with positive results. In fact, our project was completed within budget and ahead of schedule. I would not hesitate to engage FoodChain ID on any of our future EU projects.
An expert will contact you quickly.
Supplements R&D Insight assist you in the daily creation of compliant products for the European, American and Asian markets: finding regulatory statuses, gathering scientific evidence, choosing the right regulatory status or monitoring the market and its evolutions is still as easy as ever.
Supplements Compliance: automate the audit of your formulas and the generation of your labels with the same ease!
United States: FDA sent Warning Letters to companies selling dietary supplements that claim to treat cardiovascular disease
On November 17, 2022, the U.S. Food and Drug Administration (FDA) sent warning letters to seven companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent cardiovascular disease (or related conditions, such as atherosclerosis, stroke, or …United States: FDA sent Warning Letters to companies for illegally selling food and beverage products that contain CBD
On November 21, 2022, the U.S. Food and Drug Administration (FDA) sent warning letters to five companies for illegally selling products containing cannabidiol (CBD). According to the FDA, these companies are selling CBD containing products that people may confuse for traditional …United States: FDA concludes that NMN is excluded from the dietary supplement definition
Recently, the U.S. Food and Drug Administration (FDA) concluded that beta-nicotinamide mononucleotide (NMN) is excluded from the definition of a dietary supplement and may not be marketed as or in a dietary supplement because NMN is “an article authorized for …Europe: amendment of Delegated Regulation (EU) 2017/1798 on total diet replacement for weight control
Commission Delegated Regulation (EU) 2022/2182 of 30 August 2022 amending Delegated Regulation (EU) 2017/1798 as regards the lipid and magnesium requirements for total diet replacement for weight control was published in the Official Journal of the European Union on 9 …Europe: Commission requests to EFSA to provide scientific opinions on the safety of berberine, hydroxycitric acid and bitter and sweet fennel
In July 2022, the European Commission sent requests to EFSA to provide scientific opinions on the safety of three substances according to article 8 of Regulation (EC) 1925/2006: Berberine (and plant preparations containing it), following a request by the French authorities Hydroxycitric …Europe: Publication of the regulation on green tea extracts containing EGCG
![Europe: Publication of the regulation on green tea extracts containing EGCG]()
Regulation (EU) 2022/2340 of 30 November 2022 amending Regulation 1925/2006 as regards green tea extracts containing EGCG was published on 1rst December in the Official Journal of the European Union and will apply from 22 December 2022. Foodstuffs containing green tea extracts …Europe: Updated specifications for additive E 960c
![Europe: Updated specifications for additive E 960c]()
Regulation (EU) 2022/1922 of 10 October 2022 amending the Annex to Regulation (EU) No 231/2012 laying down specifications for food additives has updated the specifications of the currently authorised food additive ‘Enzymatically produced steviol glycosides’ (E 960c): – update of the specifications …Belgium: Postponement of the European consultation period on the draft text amending the Royal Decree of 31 August 2021 on plants
![Belgium: Postponement of the European consultation period on the draft text amending the Royal Decree of 31 August 2021 on plants]()
As a reminder, on 29 July 2022, the Belgian Authorities notified the European Commission of a draft text amending the annex to the Royal Decree of 31 August 2021 on the manufacture of and trade in foodstuffs consisting of or containing plants …
*Nutraveris joined FoodChain ID companies in 2020. All the services, expertises and tools provided by Nutraveris are now available under the unique brand FoodChain ID.