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Dietary supplement analysis & label compliance

Dublin
Tentamus Group GmbH
Posted: 22h ago
Offer description

Vitamins are among the most commonly used dietary supplements. Adequate vitamin intake is particularly important for a functioning metabolism. Dietary supplements containing the following vitamins are mainly sold:Vitamin DBiotinFolic acidPantothenic acidMineralsA mineral is a micronutrient found in plant and animal foods. Minerals perform various functions in metabolism and here the following are sold especially in the form of dietary supplements:PotassiumMagnesiumIronIodineFluorineSeleniumOther ingredientsIn the field of sports,creatineis often taken as a dietary supplement to build muscle, because it is an amino acid that provides muscle tissue with energy.Another amino acid compound that is often used as a dietary supplement isL-carnitine. It is composed of lysine and methionine and plays an important role in energy metabolism.Another popular dietary supplement iscoenzyme Q10, which is responsible for the production of energy in the mitochondria.Omega-3 fatty acidsbelong to the unsaturated fatty acids and are often taken as a dietary supplement, especially when consuming little fatty fish, as well as certain vegetable oils.Dietary supplements withchondroitin sulfateare often taken by people with osteoarthritis, as this is a substance that is formed in the cartilage cells and is supposed to relieve the symptoms.Typical analyses of dietary supplements within the U.S. market include, but are not limited to:DSHEA compliance reviewClaims reviewsFood Information Regulation (FIC)EU: Regulation (EU) No. 1169/2011 contains the general labeling requirements for all foods and therefore also food supplements. Thus, the mandatory information such as a list of ingredients, the best-before date, the filling quantity and the name of the manufacturer must also be provided. However, the mandatory declaration of nutritional values according to Article 29-35 does not apply to food supplements.USA: Title 21 CFR 101 Part A contains the general labeling requirements for all foods and therefore also food supplements. Thus, the mandatory information such as the statement of identity (name of the dietary supplement), the net quantity of contents statement (amount of the dietary supplement), the nutrition labeling, the ingredient list, and the name and place of business of the manufacturer, packer, or distributor. However, some elements/requirements listed are specific to food and some are specific to supplements.Directive 2002/46/EC of the European Parliament and of the CouncilEU: Directive 2002/46/EC specifies which vitamins and minerals may be used in food supplements. However, according to Article 6 of the regulation, other nutrients such as amino acids, essential fatty acids, dietary fiber, and plant and herbal extracts are also permitted as ingredients. However, these are not yet regulated here.USA: There are no specific requirements for vitamins, however for additives in general.Title 21 CFR 170 covers all regulations for additives used in food and dietary supplements.However, only non-dietary ingredients added to a dietary supplement must be used in accordance with a food additive regulation or be GRAS for their intended use.The Food Drug and Cosmetic Act (See Section 413(d) of the FD&C Act, 21 U.S.C. 350b(d).) specifies that any manufacturer wishing to use “new dietary ingredients” (ingredients not in use prior to October 15, 1994) must notify the FDA of such ingredients.Regulation on nutrition and health claimsEU: Regulation (EC) No. 1924/2006 lists the nutrition and health claims that may be made on the packaging of a product under food law. A health claim is a claim that establishes a relationship between a food product and health.USA: Title 21 CFR 101 Part D & Elists the nutrition content and health claims that may be made on the packaging of a product under food law. A health claim is any claim (…) that expressly or by implication (…) characterizes the relationship of any substance to a disease or health-related condition.Regulation setting maximum levels for contaminantsEU: Regulation (EU) No. 2023/915 sets maximum levels for certain contaminants in food. This ensures that food supplements do not contain undesirable concentrations of e.g. heavy metals.USA: There are no specific regulations regarding maximum amounts, only Good Manufacturing Process Guidelines and Compliance Policy Guidelines (CPGs)The laboratories of Tentamus Group are specialized in the analysis of food supplements. We analyze samples for their marketability and other parameters, depending on the customer’s requirements. Our laboratories are your competent partner for the analysis of characteristic ingredients, as well as possible residues and contaminants. We also offer microbiological testing and take over the labeling of your preparations.Determination of ingredientsTentamus Group laboratories analyze your dietary supplement for the containing vitamins, minerals, amino acids, etc. This ensures that you comply with the limits and that there is not too little or too much of an ingredient in your product. The maximum amount ensure that too much of a vitamin or mineral will not have a detrimental effect on health and that the beneficial nutritional effect can be achieved.The international labeling team of the Tentamus Group checks the entirety of all information on your labels or label designs for their conformity with the applicable food law requirements. Included in the testing of the labeling is the testing for health claims. These are scientifically substantiated and only health claims approved in Regulation (EC) 1924/2006 orTitle 21CFR 101may be used.Residues are remnants of substances that were used in the manufacture of products and may still be present in the final product. Contaminants can enter a dietary supplement during the individual processing steps, during storage or through contamination from the environment.Tentamus Group offers comprehensive analysis of your products for residues and contaminants to ensure they do not exceed limits. Among the substances analyzed are:Dioxins, PCBs and dioxin-like PCBsCrop protection products (over 600)Mineral oil residuesMycotoxinsPolycyclic aromatic hydrocarbons (PAHs)SolventsVeterinary drug residuesThe Tentamus Group offers all the microbiological analyses required to verify the safety of your food supplements. Here, the laboratories rely on both conventional methods and novel analytical techniques to determine spoilage agents and pathogens.How can manufacturers ensure the marketability of food supplements before placing them on the market?Marketability is best ensured through a combination of analytical testing and regulatory assessment. This makes it possible to verify whether the product’s composition, dosage, and presentation comply with food law requirements.What is the importance of verifying health claims for food supplements?Health-related claims are particularly sensitive from a regulatory perspective in the field of food supplements. Verification helps companies identify non-compliant claims on labels, packaging, or drafts at an early stage and reduce the risk of objections.How can companies avoid over- or under-dosage in food supplements?By specifically determining characteristic ingredients, it is possible to verify whether a product complies with its intended formulation. This is important to support the desired nutritional effect while identifying critical deviations in vitamins, minerals, or other substances at an early stage.Which testing strategy is particularly suitable for complex food supplement formulations?For complex formulations, a single test is usually not sufficient. Instead, a coordinated testing concept is recommended, combining ingredient analysis, testing for residues and contaminants, microbiological examinations, and label verification. This provides a more robust basis for quality, safety, and market entry.Why should you choose food supplement analysis at Tentamus?Tentamus combines ingredient analysis with testing for residues, contaminants, and microbiological risks, as well as verification of labeling and health claims. This provides companies not just with individual results, but with a comprehensive foundation to position food supplements in a legally compliant, high-quality, and marketable way.The following laboratories of the Tentamus Group offer dietary supplement testing:
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