Packaging regulations for cosmetic products: the absence of rules does not mean the absence of obligations!

Unlike cosmetic ingredients, which are subject to extremely detailed regulatory oversight at the European level (positive lists, restrictions, prohibitions, purity requirements, etc.), packaging for cosmetic products remains a largely implicit topic in Regulation (EC) No. 1223/2009. However, it plays a central role: unsuitable packaging can alter the formula, cause the migration of undesirable substances, impact the stability of the product, or even pose a health risk to consumers. The founding principle of the regulation is clear: “a cosmetic product placed on the market must be safe for human health under normal or reasonably foreseeable conditions of use.” This requirement necessarily includes packaging, especially when it is in direct contact with the product. The absence of specific rules does not therefore mean the absence of obligations. On the contrary, it transfers a large part of the responsibility to the “Responsible Person,” the safety assessor... and therefore to the quality of the documentation provided by packaging suppliers. Explanations by Laurent Bousquet*, Adepro, toxicologist and independent consultant specializing in the safety and regulation of cosmetic products.

What does Regulation (EC) No. 1223/2009 say and what does it not say?

Laurent Bousquet: The European cosmetics regulation does not include any annex dedicated to packaging materials, any list of authorized or prohibited materials, or any numerical migration values applicable to packaging.
However, several articles indirectly impose strict requirements, starting with Article 3 (general obligation of finished product safety), Article 10 (safety assessment taking into account the characteristics of the product), and Annex I / Part A / Annex 4 on the safety of cosmetic products, which must contain the “relevant characteristics of the packaging material, in particular its purity and stability.”

Packaging is therefore fully integrated into the risk analysis.

Laurent Bousquet: In practice, the safety assessor must therefore ask themselves several key questions... Is the packaging compatible with the nature of the formula (aqueous, alcoholic, oily, anhydrous)? Is there a risk of substances migrating from the material to the formula? Can storage conditions (temperature, duration, exposure to light) aggravate this risk? Does the intended use (leave-on, rinse-off, application to mucous membranes, sensitive users) change the level of requirement?

Because “migration” is at the heart of the packaging issue!

Laurent Bousquet: Migration refers to the transfer of chemical substances from the packaging material to the cosmetic product.
These substances may be residual monomers, additives (plasticizers, stabilizers, antioxidants), inks, glues, or varnishes present on the packaging, or degradation products of the material.
The risk of migration therefore depends heavily on the chemical nature of the formula (fatty and alcoholic phases are particularly extractive), the duration of contact (products stored for several years), the temperature (transport, storage in hot climates), but also the surface area/volume ratio (small containers, droppers, sticks).

Do you have any concrete examples?

Laurent Bousquet: Yes! For example, a plastic bottle suitable for an aqueous lotion may be unsuitable for a perfumed oil, and a jar compatible with a rinse-off cream may pose a problem for a leave-on lip balm.

Given this regulatory uncertainty, the most robust and widely accepted practice is ultimately to rely on the regulations applicable to food contact suitability.

Laurent Bousquet: That’s right! This approach is based on several observations: First, the principle of consumer protection is the same. Second, food requirements are among the strictest in terms of safety.
The concepts of overall and specific migration are also clearly defined, and the regulatory authorities implicitly recognize this logic.
Finally, for the safety assessor, a declaration of compliance with food contact is required, ideally accompanied by overall or (as the case may be) specific migration data.
This provides a solid technical and regulatory basis for concluding that the packaging is compatible with the cosmetic product.
But be careful! It is important to note that this reference to food contact is not explicitly required by cosmetic regulations, but it remains the most pragmatic and defensible solution today.

Is the main difficulty related to supplier documentation?

Laurent Bousquet: Indeed, in practice, the files provided by packaging manufacturers are very heterogeneous.
The most common issues are the total absence of a declaration of conformity, generic documents not linked to a specific reference, vague references such as “food grade” without a clear regulatory framework, and the presence of disclaimers indicating that the information is provided “for information purposes only” or “without guarantee of end use.”
It should be noted that these disclaimers can legally weaken the value of the document and make it difficult to use in the context of the Product Information File (PIF).
They also generate unnecessary time loss for all parties involved, i.e., the person in charge who does not have a directly usable document, the safety assessor who is forced to make multiple requests for clarification, and the supplier itself, who is repeatedly asked for additional information or reformulations that could have been avoided from the outset.

Do you have any examples of this?

Laurent Bousquet: Yes, for example, “This product is manufactured with materials suitable for food contact. This information is provided without any commitment regarding the end use.” Or, found in an “EU Food Contact Compliance Certificate,” “This document does not constitute a declaration of compliance for materials intended to come into contact with foodstuffs within the meaning of Article 16 of Regulation (EC) No. 1935/2004.”
In this case, responsibility is not clearly assumed by the supplier, or the supplier wants to provide information that no one understands.

What do you recommend?

Laurent Bousquet: To ensure the safety of the assessment and the DIP, it is recommended that suppliers be required to provide a formal and clear declaration of conformity, dated and signed, clearly stating the exact reference of the packaging and specifying the regulatory framework invoked (food contact), ideally accompanied by migration data.
But let’s be clear, “It is not up to the safety assessor to decide whether packaging is suitable for food contact.” This responsibility lies solely with the manufacturer or supplier of the packaging. The assessor’s role is to analyze the consistency of the documents provided with the formula, use, and context of the cosmetic product.

So, in conclusion, even though European cosmetics regulations remain vague on packaging, product safety requirements dictate a rigorous analysis of their compatibility.

Laurent Bousquet: In the absence of a dedicated cosmetics framework, alignment with food contact requirements remains the most pragmatic, technically robust, and defensible reference in the event of an inspection.
However, this approach is only fully effective if the supplier documentation is clear, consistent, and legally usable. Without this, the safety assessment is based on fragile foundations, unnecessarily exposing the Responsible Person and the assessor.
Packaging is therefore not a simple accessory to the cosmetic product: it is an integral component, whose compliance directly determines the safety of the finished product.

*Laurent Bousquet, founder of ADEPRO, has been helping brands, artisans, startups, and SMEs for over 20 years to bring their products into compliance with European regulations, in particular Regulation (EC) No. 1223/2009.
His expertise covers safety assessment, the compilation of Product Information Files (PIFs), and the compliance of raw materials, fragrances (IFRA), claims, and packaging.
He also works on requirements relating to good manufacturing practices (ISO 22716), traceability, risk management, and exchanges with the competent authorities.
In addition to his consulting work, he is a trainer and lecturer, with a rigorous, educational, and operational approach to cosmetics regulations.
He is also involved in health and development projects in Africa (West and Central) and collaborates with NGOs and local institutions on field actions combining scientific expertise and social impact.