Proper product labeling is not just a matter of aesthetics or marketing – above all, it is a legal requirement. Depending on the industry, labels must comply with a range of national and EU regulations. Below, we present an overview of the most important labeling regulations in three key sectors: food, cosmetics, and pharmaceuticals. Labels and the law – the most important regulations.
Labels in the food industry – Transparency and safety
In the food industry, the label is the primary source of information for the consumer. EU and national regulations aim to ensure food safety and enable informed product choices.
The most important legal act is: Regulation (EU) No 1169/2011 of the European Parliament and of the Council, which regulates:
- the obligation to inform about ingredients (including allergens),
- nutritional values (e.g., fat, sugar, salt, protein content),
- minimum durability date or use-by date,
- country of origin,
- legibility (font size at least 1.2 mm for most packaging).
In Poland, these regulations are supplemented by the Act of August 25, 2006 on Food and Nutrition Safety, which sets out the obligations of producers, importers, and distributors regarding the labeling of food products. This act implements EU regulations into national law and governs, among others, rules for allergen information, use of food additives, labeling of organic products, and providing nutritional values.
Additionally, the Chief Sanitary Inspectorate (GIS) issues detailed guidelines and interpretations of the regulations, which help entrepreneurs comply with the law. GIS can also conduct inspections and impose penalties in cases of incorrect labeling or misleading consumers. In practice, this means that every food label must comply not only with EU regulations but also with Polish legislation and current GIS guidelines – both in terms of form and content.
Labels in the cosmetics industry – Safety and ingredient transparency
For cosmetics, the main legal act is Regulation (EC) No 1223/2009, which specifies how labels should inform about the product’s intended use, directions for use, and potential hazards.
A cosmetic label must include:
- the product name and its function (if not obvious from the name),
- manufacturer or distributor details,
- list of ingredients (in accordance with INCI nomenclature),
- minimum durability date or PAO (Period After Opening),
- batch number,
- warnings and special precautions, if required.
The cosmetics industry pays particular attention to transparency of information and allergens – their presence must be clearly indicated, even at low concentrations.
Labels in the pharmaceutical industry – The highest information standards
For medicinal products, the strictest labeling requirements apply. These stem from, among others:
- Directive 2001/83/EC,
- Commission Delegated Regulation (EU) 2016/161 (concerning anti-counterfeiting measures),
- as well as national implementing regulations, such as the Pharmaceutical Law.
A medicine label must include:
- the trade name and active substance,
- dosage and pharmaceutical form,
- full composition (active and excipient substances),
- route of administration (e.g., oral, intravenous),
- marketing authorization number,
- expiry date and batch number,
- warnings and precautions,
- 2D code with a medicine identifier (serialization requirement).
Additionally, medicine labels must comply with so-called “readability” requirements, meaning that readability tests must be conducted before the design is approved.
How to adapt label design to regulations?
Companies designing and producing labels must work closely with legal and regulatory departments. In practice, this means:
- analyzing the regulations in the country of sale,
- using approved materials, e.g., certified for food contact (no substance migration),
- implementing security features, e.g., holograms,
- using legible fonts, durable prints, and correct terminology.
In the pharmaceutical and food industries, label compliance with HACCP (Hazard Analysis and Critical Control Points), GMP (Good Manufacturing Practice), and GHP (Good Hygienic Practice) is often required.
The HACCP system is a mandatory element of food safety management, requiring the identification and control of hazards at all stages of production – including labeling. Labels must not contain incorrect information that could endanger consumer health, e.g., missing allergen information or incorrect expiry date.
GMP, or Good Manufacturing Practice, is a set of standards required in the pharmaceutical industry (and increasingly in the food industry), covering, among others, full repeatability and control over every stage of production, including the printing and application of labels. According to GMP, labels must be durable, legible, correctly assigned to batches, and protected against accidental mix-ups or counterfeiting.
GHP, or Good Hygienic Practice, is a set of procedures ensuring cleanliness and safety at every stage of the production process, including labeling. This applies to both the cleanliness of materials and the labeling process itself – to prevent contamination, damage, or migration of undesirable substances from adhesives or inks.
All three systems are interconnected and form the foundation of quality management systems, where the label is not just an information carrier but also one of the critical control points. Their implementation not only fulfills legal requirements but also increases consumer trust and minimizes the risk of problems during audits or inspections.
The future of labeling – What’s changing?
The European Union is gradually introducing changes aimed at increasing transparency for consumers. In 2025, the following are planned, among others:
- new rules for labeling dietary supplements,
- mandatory carbon footprint labeling,
- expansion of eco-labels,
- mandatory QR codes on medicinal products.
It is worth monitoring these changes in advance and updating label designs accordingly.
FAQ – Frequently asked questions
Can a label be in QR code form only?
No, key information must be available without electronic tools. A QR code can be an addition, but not the sole source of data.
Is a dietary supplement a medicine?
No, it is a food product. However, it is subject to specific regulations and must include warnings and information about the maximum daily dose.
Can a label be bilingual?
Yes, provided all required information is fully translated and not misleading.
Is it necessary to indicate the manufacturer on the label?
Yes – in all industries, it is required to provide the details of the responsible entity or manufacturer.
Label design is a task that requires not only aesthetics and creativity but also an excellent knowledge of legal regulations. The food, cosmetics, and pharmaceutical industries are governed by detailed regulations, compliance with which is key to product market approval and building customer trust.
If you are planning a label for your product – choose solutions that are both legally compliant and visually attractive. Working with an experienced label manufacturer will help you avoid mistakes and achieve success in the market.