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Labeling

Analysis results without objections alone do not guarantee the marketability of your products. In order to provide your customers with the best possible information, legally compliant labeling is of utmost importance. This forms the basis for safe product use and helps consumers make informed choices when shopping.

The Tentamus experts for labeling inspections offer you full support for questions concerning the labeling of your products in the fields of food, food supplements, pet food, cosmetics, medical devices and pharmaceuticals.

As a manufacturer or importer, you are responsible for legally correct labeling of the products you place on the market. Even if you act as a distributor and make a serious change to a product under your name or to an existing product, you are responsible for all information on the product’s packaging.

Incorrect labeling can result in serious consequences, such as a warning letter or even a recall of your product. Therefore, it is of utmost importance that you label your products correctly.

Through the global Tentamus network of laboratories, we can arrange for you to have labeling tests performed in Europe, the United Kingdom, the United States, and China in accordance with the relevant legal and language requirements.

In addition, we offer you the verification of your labeling in online trade and support start-ups with an all-round service.

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 labeling 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 labeling 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 labeling include:

 

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

 

The cosmetic products team at Tentamus Group are experts in the field of labeling 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 labeling of your products and analytically test them and their ingredients.

Learn more here: Cosmetic Testing

Do you need assistance?

Please do not hesitate to contact our service team.
We will be happy to advise you via live chat or by e-mail at cosmetics@tentamus.com or by phone at +49 30 206 038 230

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

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.

Learn more here: Food Testing

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 our team.
We will be happy to advise you via live chat or by e-mail at labelling@tentamus.com or by phone at +49 30 206 038 230

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.

For further information please click here: Dietary Supplement Testing

 

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.

Please find more information here: Challenges in Food-E-commerce

Do you need assistance?

Please do not hesitate to contact our service team.
We will be happy to advise you via live chat or by e-mail at labelling@tentamus.com or by phone at +49 30 206 038 230

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.

Learn more here: Feed Testing

Do you need assistance?

Please do not hesitate to contact our service team.
We will be happy to advise you via live chat or by e-mail at labelling@tentamus.com or by phone at +49 30 206 038 230

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:

  • Medicinal Products Act – AMG: Legal basis for medicinal products valid in Germany, which covers the approval, manufacture and placing on the market.

 

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.

Learn more here: Pharmaceutical Testing & Mechanical Testing of Medical Devices

Do you need assistance?

Please do not hesitate to contact our service team.
We will be happy to advise you via live chat or by e-mail at pharma@tentamus.com or by phone at +49 30 206 038 230

Overview of the labeling locations of the Tentamus Group

 

The following laboratories of the Tentamus Group offer labeling services:

GERMANY

    UK:

    USA: 

    Please get in touch with our experts. We’re happy to help: +49 30 206 038 230 /  labelling@tentamus.com

    Tentamus laboratories in your vicinity