Typical ingredients
of dietary supplements

Vita­mins

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 A
  • Vitamin D
  • Vitamin E
  • Vitamin K
  • B‑Vitamins
  • Vitamin C
  • Biotin
  • Folic acid
  • Niacin
  • Pantothenic acid

Minerals

A 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:

  • Calcium
  • Potas­sium
  • Magne­sium
  • Iron
  • Iodine
  • Fluo­rine
  • Zinc
  • Sele­nium

Other ingre­di­ents

  • In the field of sports, crea­tine is 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 is L‑carnitine. It is composed of lysine and methio­nine and plays an impor­tant role in energy metabolism.
  • Another popular dietary supple­ment is coen­zyme Q10, which is respon­sible for the produc­tion of energy in the mitochondria.
  • Omega‑3 fatty acids belong 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 with chon­droitin sulfate are 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 review
  • Claims reviews
  • Ingre­dient reviews

Legal requirements
for dietary supplements

  1. Food 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.

  2. Direc­tive 2002/46/EC of the Euro­pean Parlia­ment and of the Council

    EU: 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.

  3. Regu­la­tion on nutri­tion and health claims

    EU: 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 & E lists 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.

  4. Regu­la­tion setting maximum levels for contaminants

    EU: Regu­la­tion (EC) No. 1881/2006 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)

Testing of food supplements
by Tentamus Group

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 ingredients

Tentamus 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.

Label check

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 or Title 21 CFR 101 may be used.

Testing for residues and contaminants

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:

  • Aller­gens
  • Dioxins, PCBs and dioxin-like PCBs
  • Crop protec­tion prod­ucts (over 600)
  • Heavy metals
  • Mineral oil residues
  • Myco­toxins
  • Poly­cyclic aromatic hydro­car­bons (PAHs)
  • Solvents
  • Veteri­nary drug residues

Lassen Sie Ihre Nahrungsergänzungsmittel analytisch prüfen, damit Sie sichere und qual­i­tativ hochw­er­tige Produkte auf den Markt bringen können.

Micro­bi­o­log­ical testing

The 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.

Overview of
laboratories for the analysis of dietary supplements

The following labo­ra­to­ries of the Tentamus Group offer dietary supple­ment testing:

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