labelling cosmetics tentamus

Cosmetic Labeling

According to Article 2 of Regu­la­tion (EC) No. 1223/2009, cosmetics are prod­ucts that come into contact with the exte­rior (e.g. skin, hair, lips, etc.) or the teeth and mucous membranes in order to cleanse them, perfume them, change their appear­ance, protect them, influ­ence body odor or keep them in good condi­tion. The infor­ma­tion on the pack­aging informs consumers about ingre­di­ents, the best-before date, etc., and thus also influ­ences purchasing decisions.

The labelling regu­la­tions for cosmetics are also a chal­lenge for employees from this industry.

What infor­ma­tion must be included on the cosmetic product?

According to Article 19 of the Cosmetic Prod­ucts Regu­la­tion, the following infor­ma­tion must be indelibly, easily legible and clearly displayed on the pack­aging or label:

  • Name or company name with address
  • For imported cosmetic prod­ucts, the country of origin
  • Nominal content at the time of filling as a weight or volume indication
  • Best before date or Period After Opening (PAO)
  • Special precau­tions for use
  • Batch number or mark for identification
  • Intended use
  • List of ingre­di­ents in the national language with the heading Ingre­di­ents”

The ingre­di­ents of cosmetic prod­ucts are labeled according to the so-called INCI (Inter­na­tional Nomen­cla­ture of Cosmetic Ingredients).

Legal require­ments for the labelling of cosmetics

Cosmetics are subject to various legal regu­la­tions in the EU, which must be complied with so that the prod­ucts can be placed safely on the market. Legally applic­able regu­la­tions related to labelling include:

This is how the Tentamus Group supports you with the labelling of cosmetic products

The cosmetic prod­ucts team at Tentamus Group are experts in the field of labelling regu­la­tions and are always up to date with the latest legal require­ments. We provide you with prac­tical and profes­sional advice, support you in all ques­tions concerning the labelling of your prod­ucts and analyt­i­cally test them and their ingredients.

Do you need assistance?
Please contact our cosmetics team at:

cosmetics@​tentamus.​com
+49 30 20 60 38 230

Young woman shopping in grocery store. Mature woman checking food label in supermarket. Latin woman holding shopping basket and choose a product in supermarket.

Food Labeling

Marketable foods require correct labeling. This means that all infor­ma­tion on the pack­aging must be in accor­dance with the applic­able legal regu­la­tions and guide­lines. In the food industry, this also presents manu­fac­turers and distrib­u­tors with major chal­lenges, as there are many excep­tions, special regu­la­tions and also inno­va­tions from time to time, depending on the class of food.

Labeling oblig­a­tions for food

Regu­la­tion (EU) No. 1169/2011, Food Infor­ma­tion Regu­la­tion (LMIV), sets require­ments for food labeling and in Article 9 is a list of manda­tory infor­ma­tion, which includes the following:

  • Name of the food
  • List of ingre­di­ents with the heading Ingre­di­ents”
  • Aller­gens must be highlighted
  • Net quan­tity
  • Best before date or use by date
  • Instruc­tions for storage and use
  • Name or company name with address
  • Country of origin for prod­ucts intended according to Article 26
  • Instruc­tions for use
  • Nutri­tion label

The manda­tory infor­ma­tion must be legible and compre­hen­sible to the consumer, as well as clearly visible and, where appro­priate, perma­nently displayed.

Legal require­ments for food labeling

Manda­tory food labeling is mandated by EU law, so there are uniform legal regu­la­tions for member states. The valid regu­la­tions include:

  • Regu­la­tion (EU) No. 1169/2011 (LMIV) on general food labeling require­ments. This regu­la­tion spec­i­fies which infor­ma­tion is manda­tory as a minimum.
  • Regu­la­tion (EC) No. 834/2007 on the labeling of organic prod­ucts. This spec­i­fies, for example, that the code number of the organic inspec­tion body is a manda­tory indication.
  • Regu­la­tion (EC) No. 1924/2006 on nutri­tion and health claims made on foods. Here are, for example, in the annex approved nutri­tion claims, which may be used if you meet the asso­ci­ated conditions.
  • Regu­la­tion (EU) No. 2015/2283 on novel foods, also called Novel Food. The regu­la­tion addresses the specific require­ments and defi­n­i­tions of Novel Food.
  • Regu­la­tion (EU) No. 2017/2470 on approved novel foods. In this Union list are all approved Novel Foods, which may be placed on the market under the asso­ci­ated conditions.

This is how Tentamus supports you in food labeling

Tentamus Group’s food labeling tea are experts in conducting inspec­tions in compli­ance with all rele­vant food regulations.

Through our global labo­ra­to­ries, we are able to assist you inter­na­tion­ally with testing for the following countries:

  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • China
  • Croatia
  • Cyprus
  • Czech Republic
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Luxem­bourg
  • Moldova
  • Nether­lands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Spain
  • Sweden
  • Switzer­land
  • UK
  • USA

Our experts are constantly under­going further training so that you are always up to date with the latest legis­la­tion and are always on hand to provide you with expert advice.

In addi­tion to labeling veri­fi­ca­tion, we also review your spec­i­fi­ca­tions and docu­ments. We trans­late them if neces­sary, assist you in preparing draft decla­ra­tions, and confirm the infor­ma­tion on the pack­aging (such as nutri­tional values and infor­ma­tion on ingre­di­ents) through analyt­ical tests. Like­wise, we check the stated best-before date or use-by date and test your food for allergens.

We also support you with volun­tary claims, such as the Nutri-Score and the Eco-Score.

Do you need assistance?
Please do not hesitate to contact us:

labelling@​tentamus.​com
+49 30 20 60 38 230

labelling dietary supplements tentamus

Labeling of
Dietary Supplements

Dietary supple­ments belong to the group of food and are defined as follows according to the Food Supple­ments Ordi­nance (NemV):

  • They are intended to supple­ment the diet, for example with vita­mins and minerals.
  • They consist of nutri­ents or other substances with a nutri­tional or phys­i­o­log­ical effect and are present in concen­trated form.
  • They are ingested in a dosed form.

Manu­fac­turers and distrib­u­tors are respon­sible for the correct labeling of dietary supplements.

What infor­ma­tion must be provided on dietary supplements?

Since food supple­ments are part of food, Regu­la­tion (EU) 1169/2011 on labeling must be applied. Here, the manda­tory infor­ma­tion on labeling can be found in Article 9:

  • The name of the food supplement
  • A list of ingredients
  • A note on substances that may cause aller­gies and intolerances
  • The amount of certain ingre­di­ents or classes of ingre­di­ents in %
  • The net quantity
  • The best before date
  • Infor­ma­tion on storage and use
  • Company name and address
  • Country of origin or source according to Article 26
  • Instruc­tions for use
  • Nutri­tional information

In addi­tion, according to NemV, the following infor­ma­tion is manda­tory to be indi­cated on the packaging:

  • For the name of the food product, the words food supple­ment” must be indicated
  • Name(s) of the nutrient(s) or substance(s) that char­ac­terize the product and have a nutri­tional and/​or phys­i­o­log­ical effect (e.g. certain vita­mins or minerals)
  • The amount recom­mended for daily consumption
  • The warning state­ment, Do not exceed the recom­mended daily intake stated.”
  • A state­ment that dietary supple­ments should not be used as a substi­tute for a balanced and varied diet
  • A warning that the product must be stored out of the reach of young children

Legal require­ments for the labeling of dietary supplements

Within the EU, there are regu­la­tions and direc­tives applic­able to food supplements:

  • Regu­la­tion (EC) No. 1924/2006 contains approved nutri­tion and health claims, also known as health claims, which may be used on the label.
  • In Regu­la­tion (EU) 432/2012 are all health claims approved in the EU, which concern the reduc­tion of a disease risk or the devel­op­ment and health of chil­dren and their conditions.
  • Regu­la­tion (EU) No. 2015/2283 on novel foods. The regu­la­tion addresses the specific require­ments and defi­n­i­tions of Novel Food.
  • Regu­la­tion (EU) No. 2017/2470 on approved novel foods. In this Union list are all approved Novel Foods, which may be placed on the market under the asso­ci­ated conditions.
  • Food Supple­ments Regu­la­tion, which imple­ments Direc­tive 2002/46/EC for German law. Here you can find labeling regu­la­tions specif­i­cally applic­able to food supple­ments, as well as the oblig­a­tion to notify food supple­ments that are placed on the market in Germany.

This is how Tentamus supports you with the labeling of dietary supplements

The Tentamus Group has put together an inter­na­tional labeling team to support you in all matters relating to the labeling of dietary supple­ments. Thanks to regular training, the team is always up to date with the latest legal devel­op­ments and will be happy to advise you.

Health claims always present a partic­ular chal­lenge. But don’t worry, our team are experts in this area and will not let you down.

In addi­tion, we offer you the complete spec­trum for the analysis of your prod­ucts. We are happy to advise you on maximum limits for residues and cont­a­m­i­nants, as well as any prohib­ited ingredients.

Dietary supple­ments are often sold on online plat­forms. Also here are a number of things to consider and the regu­la­tions applic­able in retail must also be complied with. To ensure that you can sell your prod­ucts online safely and correctly, and that your prod­ucts do not have to be blocked or possibly even recalled, we offer a special service for prod­ucts in online shops.

Do you need assistance?
Please do not hesitate to contact us at:labelling@​tentamus.​com
+49 30 20 60 38 230

labelling feed tentamus

Feed Labeling

In the EU, feed is subject to a large number of regu­la­tions and controls to ensure safe and high-quality prod­ucts for live­stock and pets. This also applies to the labeling of pet food and animal feed, which falls under the duty of care of manu­fac­turers and distributors.

What infor­ma­tion must be included on feed packaging?

The manda­tory infor­ma­tion for the approval of feed can be found in the Feed Regu­la­tion Regu­la­tion (EC) No. 767/2009 and includes according to Article 15:

  • The type of feed (straight feed, complete feed, comple­men­tary feed)
  • Name or company with address
  • Approval number of the company if available
  • Iden­ti­fi­ca­tion number of the lot or batch
  • Net mass or net volume
  • List of feed addi­tives with the heading Addi­tives”
  • Mois­ture content

In the following arti­cles of the Feed­stuffs Ordi­nance, further oblig­a­tory infor­ma­tion can be found for the indi­vidual types of feed­stuffs. For example, in the case of indi­vidual and compound feeds, the animal species for which the product is intended must be indi­cated on the packaging.

Legal require­ments for the labeling of feed

There are regu­la­tions for feed­stuffs at national and Euro­pean level. These concern, among other things, permitted feed addi­tives and recom­men­da­tions for nutrient compo­si­tion. The most impor­tant regu­la­tions of feed law are listed below:

  • Regu­la­tion (EC) No. 767/2009: In addi­tion to labeling, this regu­la­tion also regu­lates other require­ments, such as the content of addi­tives for placing feed on the market.
  • FEDIAF: This guide­line contains the nutri­tional require­ments of dogs and cats and gives recom­men­da­tions for nutri­tious pet food.

This is how Tentamus supports you in the labeling of feed

To meet the high safety stan­dards for feed, you need a compe­tent partner at your side. The Tentamus Group is your partner when it comes to labeling, analysis and consulting for the approval and marketing of feed. The years of expe­ri­ence of our knowl­edge­able experts enable you to bring your prod­ucts to market safely and with high quality.

Do you need assistance?
Please do not hesitate to contact us at:

labelling@​tentamus.​com
+49 30 20 60 38 230

labelling pharmaceuticals tentamus

Labeling of
medical devices and pharmaceuticals

Medical devices and phar­ma­ceu­ti­cals have very high safety require­ments and must be correctly clas­si­fied or approved. Thus, the labeling inspec­tion of medical devices and phar­ma­ceu­ti­cals poses many chal­lenges, which you can master with us as a partner.

What infor­ma­tion must be included on medical devices?

The labeling of medical devices is stip­u­lated in Regu­la­tion (EU) 2017/745, and the following infor­ma­tion is mandatory:

  • Name or trade name of the product
  • Required infor­ma­tion from which the consumer can conclude what the product is about
  • Name and address of the manufacturer
  • If the manufacturer’s regis­tered office is outside the EU, the name and address of an autho­rized repre­sen­ta­tive must be provided
  • An indi­ca­tion that the product contains a medi­c­inal product, a deriv­a­tive of blood or plasma, tissues or cells of human or animal origin, or their derivatives
  • Lot number or serial number
  • UDI carrier
  • A time limit within which the product can be used
  • Date of manu­fac­ture, if no time limit is specified
  • Storage and use instructions
  • For sterile prod­ucts: Indi­ca­tion of this, as well as ster­il­iza­tion procedures
  • Warn­ings or precautions
  • Note, if the product is intended for single use
  • Note custom made” if this is the case
  • Note if it is a medical device, or if intended for clin­ical inves­ti­ga­tion only”
  • For devices consisting of substances or prepa­ra­tions of substances that are intro­duced through body orifices or the skin, infor­ma­tion on the overall qual­i­ta­tive compo­si­tion and quan­ti­ta­tive infor­ma­tion on the main ingre­di­ents must be provided on the packaging
  • For active implantable devices, the serial number, and for other implantable devices, the serial number or lot number

What infor­ma­tion must be included on pharmaceuticals?

The Medi­cines Act – AMG §10 lists the manda­tory infor­ma­tion for medicines:

  • Name or company name with address of the phar­ma­ceu­tical entrepreneur
  • Name of the drug
  • Indi­ca­tion of strength and dosage form
  • Indi­ca­tion whether it is intended for infants, chil­dren or adults
  • Inter­na­tional non-propri­etary name (INN), if the product contains up to three active ingredients
  • Marketing autho­riza­tion number with the abbre­vi­a­tion Zul.-Nr.”
  • Batch name with the abbre­vi­a­tion Ch.-B.” and if it is not produced in batches, the date of production
  • Dosage form
  • Weight, net volume or number of pieces
  • Method of application
  • Active substances by type and quantity
  • In the case of genet­i­cally engi­neered drugs, the active ingre­dient and the name of the genet­i­cally modi­fied organism or cell line used in manufacture
  • Expiry date with use by” or use by”
  • The indi­ca­tions Prescrip­tion only” or Phar­macy-only”
  • Warning that medi­c­inal prod­ucts should be kept out of the reach of children
  • Precau­tions for disposal
  • Intended use for non-prescrip­tion medi­c­inal products

Legal require­ments for the labeling of medical devices and pharmaceuticals

Key regu­la­tions and direc­tives for medical devices include:

  • Regu­la­tion (EU) 2017/745: The Medical Devices Regu­la­tion, which has been in effect in the EU since 2021, provides spec­i­fi­ca­tions for placing medical devices on the market.

The most impor­tant regu­la­tions and direc­tives for phar­ma­ceu­ti­cals include:

This is how Tentamus supports you in the labeling of medical devices and pharmaceuticals

Our knowl­edge­able experts accom­pany you from the product idea to the approval of your prod­ucts. This also includes advice on labeling, as well as veri­fi­ca­tion of the same. Our team is always up to date with legal changes and accom­pa­nies you on the complete way to marketability.

We also support you in analyses, in the regis­tra­tion process, in the estab­lish­ment and main­te­nance of QM systems, in clin­ical and medical assess­ments, stability studies, audits, and much more.

Do you need assistance?
Please do not hesitate to contact us:

labelling@​tentamus.​com
+49 30 20 60 38 230

Overview of
labeling locations

The following labo­ra­to­ries of the Tentamus Group offer labeling services:

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