Would you like to know the filling and labelling requirements for cosmetic products destined for the EU? Here is a basic technical guide for manufacturers.
Access to the European cosmetics market requires strict compliance with Regulation (EC) 1223/2009. For manufacturers within the European Union and third countries such as Morocco, Algeria, or Turkey, understanding and applying these requirements is essential. This article provides a technical and up-to-date analysis of the key aspects of filling, labelling and equipment necessary to comply with the regulations, including the machinery solution offered by MarCoPack.
Regulatory context of the cosmetics market in the European Union
Regulation (EC) No 1223/2009 establishes the requirements that all cosmetic products marketed in the EU must meet. It covers aspects such as composition, product safety, prior notification and mandatory labelling.
The regulation affects both European manufacturers and non-EU exporters who wish to introduce their products into the European market, making it essential to have a ‘responsible person’ established in the EU.
Since 2023, the regulation has been updated with significant changes, such as the expansion of the list of allergens that must be declared on the label. The regulation on the use of nanomaterials, prohibited ingredients, and traceability requirements through the Cosmetic Products Notification Portal (CPNP) also remains in force.
Technical requirements for filling cosmetic products
Good Manufacturing Practices (GMP)
The regulations require that the filling process be carried out in accordance with Good Manufacturing Practices (GMP), as per ISO 22716. This standard standardises quality control, cleaning, storage, environmental conditions, documentation, and process validation.
Accuracy and safety in filling
It is essential to guarantee the accuracy of the declared nominal quantity, prevent cross-contamination and ensure the protection of the product against external conditions such as oxidation or microbiological contamination.
The design of the filling equipment should facilitate quick changeovers between formats and products, especially on multi-format lines.
Labelling requirements under Regulation (EC) No 1223/2009
Mandatory information on packaging and labelling
According to Article 19 of the regulation, the label must include:
- Name and address of the person responsible in the EU.
- Country of origin for products manufactured outside the EU.
- Nominal quantity (g or ml).
- Minimum shelf life or symbol for period after opening (PAO).
- Precautions for use and mandatory warnings according to the annexes of the regulation.
- Batch number.
- Product function if not obvious.
- List of ingredients in INCI nomenclature, in descending order. Includes allergens and nanomaterials.
Format and translation
The information must be indelible, easily legible and visible on both the primary and secondary packaging.
Some elements must be translated into the language of the member country where the product is marketed. On small packages, information may be included in an accompanying leaflet, identified with the ‘open book’ symbol.
Nanomaterials declaration
Ingredients in the form of nanomaterials must be indicated in the INCI list accompanied by the word ‘nano’. In addition, they must be notified in advance to the CPNP if they are not regulated in the annexes of authorised substances. This technical aspect requires accurate traceability from the origin of the ingredients and control in the formulation and packaging.
Mandatory notification and traceability
All cosmetics must be notified to the CPNP before being placed on the market. In addition, the manufacturer or responsible party must maintain a Product Information File (PIF), which includes the safety report, tests, origin of raw materials, and description of the manufacturing system. This file must be kept for at least 10 years after the last date of marketing.
Technical requirements for filling and labelling machinery
The machinery used must guarantee:
- Ability to work with different formats and viscosities.
- Compatibility with labelling machines that include batch printing, PAO, INCI and symbols in accordance with the Regulation.
- Adaptation to multilingual formats and the possibility of quickly changing the design.
- Integration with ERP systems and internal traceability.
- Compliance with GMP standards for cleanliness, safety, and design.
Consequences of non-compliance
The authorities in Member States carry out checks on labelling, documentation and product safety. Non-compliance can result in financial penalties, product immobilisation or withdrawal from the market. Therefore, proper design of the production line, use of compatible machinery and document control are key.
Competitive advantages of regulatory compliance
Adopting compliant filling and labelling systems not only allows legal access to the European market, but also strengthens brand image, facilitates entry into multiple countries simultaneously, and enables additional certifications (such as COSMOS for natural and organic cosmetics).
Furthermore, having flexible lines that are ready for multilingual labelling speeds up penetration into markets such as Belgium, Switzerland, Spain, or regions with demanding local regulations.
MarCoPack solution: MCP 4000 machinery for cosmetics
The MarCoPack MCP 4000 industrial packaging machine is specifically designed to meet the filling and labelling requirements of the cosmetics industry:
Adaptability and precision
It allows the filling of creams, gels, lotions and products with different viscosity levels, ensuring accurate dosing through volumetric systems or flow meters. Its hygienic and modular design allows for quick format changes without compromising safety.
Labelling in accordance with the Regulation
The MCP 4000 is compatible with wrap-around and front-and-back labellers, and integrates printers for variable information such as batches, PAO symbols, INCI or CPNP notification numbers. It is also equipped to print in multiple languages depending on the destination country.
GMP compliance and traceability
Complies with GMP manufacturing standards (ISO 22716), facilitating cleaning and maintenance in accordance with industry requirements. Enables integration with traceability and ERP systems, ensuring batch control and the necessary documentation to comply with EU requirements.
For manufacturers in Morocco, Algeria, or Turkey who wish to introduce their cosmetic products to the European market, the MCP 4000 represents a reliable, scalable, and compliant solution from day one.
Conclusion
Compliance with EU cosmetic filling and labelling requirements is essential for market access and to avoid penalties. Understanding the regulations, adapting production to GMP standards, and using compliant machinery such as MarCoPack’s MCP 4000 are key steps in ensuring product safety, consumer confidence, and international competitiveness.
Is your production line ready for European cosmetic requirements? MarCoPack offers engineering solutions and machinery tailored to every regulatory and market need. Contact us for more information!
Alejandro Serrano Romero
Export Executive MARCOPACK
