Before a cosmetic product can be placed on the market, its formula must be proven safe, as must the packaging that comes into contact with it.
According to Regulation (EC) 1223/2009, brands must assess the relevant characteristics of the packaging material, including its purity and stability, as well as the potential presence of prohibited substances, as part of the Cosmetic Product Safety Report.
The regulation requires companies to rely on recognized scientific standards and frameworks already established for materials intended to come into contact with products. Many packaging assessments are thus guided by Food Contact Materials legislation (Regulation 1935/2004), EU 10/2011 for plastics, REACH restrictions and sector guidelines, such as CosPaTox, for recycled polymers.
This article outlines the mandatory cosmetic packaging safety tests required to demonstrate compliance and the additional assessments widely used in the industry to ensure packaging is safe, suitable and aligned with European regulatory expectations.
The regulatory framework behind mandatory tests
To determine which tests are required for cosmetic packaging, it is important to understand the regulatory framework governing product safety in the EU.
Although Regulation (EC) 1223/2009 is the primary cosmetics legislation, it does not provide a predefined list of tests. Instead, the regulation refers to the "relevant characteristics" of packaging materials and requires companies to demonstrate safety using established scientific principles and recognized standards.
For this reason, packaging assessments rely heavily on frameworks originally developed for food contact materials, chemical safety legislation and voluntary industry guidelines.
Now, let's take a look at an overview of the regulations and standards that shape mandatory cosmetic packaging testing.
Regulation (EC) No 1223/2009 — Annex I and Article 17
According to the Cosmetics Products Regulation, the safety assessment of every cosmetic product placed on the EU market must include packaging. Annex I of the Cosmetic Product Safety Report requires information on the following:
- Impurities and traces, including those migrating from packaging;
- Prohibited or restricted substances, when present unintentionally;
- The relevant characteristics of the packaging material, especially purity and stability.
Article 17 clarifies that small, technically unavoidable traces of prohibited substances may be tolerated only if they comply with Article 3, meaning they must not compromise consumer safety.
The regulation does not prescribe specific tests. Instead, it places the responsibility on the safety assessor to evaluate the following:
- Interactions between the formula and the packaging;
- Potential migration of substances;
- The material’s suitability for the intended cosmetic product.
The assessor may refer to other regulatory frameworks when determining which tests are required.
EU 10/2011 for plastics
This regulation provides a detailed and harmonized testing framework for plastic materials. This regulation is the primary reference for evaluating the safety of cosmetic packaging made from or containing plastic components.
This includes Specific Migration Limits (SML) and Overall Migration Limits (60 mg/kg or 10 mg/dm²), as well as the use of standardized food simulants:
- 10% ethanol
- 3% acetic acid
- 20% or 50% ethanol
- Vegetable oils
Although these simulants are designed for food, they often match the chemical behavior of cosmetic formulations, especially water-based, oil-based and emulsified systems. This makes EU 10/2011 a scientifically appropriate reference for packaging–formula interaction studies.
The safety assessor must verify that the selected simulants and test conditions are suitable for the specific cosmetic formulation.
REACH & Waste Directive / PPWR
Beyond migration and stability, cosmetic packaging must comply with chemical safety and waste legislation.
Key obligations include:
- SVHC (Substances of Very High Concern) must not exceed 0.1% w/w under REACH;
- The sum of heavy metals (lead, cadmium, mercury and hexavalent chromium) must remain below 100 ppm, as required by the Packaging Waste Directive (limit maintained under PPWR);
- Under the upcoming Packaging and Packaging Waste Regulation (PPWR), further requirements apply for:
- recycled content
- recyclability
- compostability
- material simplification
- traceability and documentation
CosPaTox guidelines
Due to the increased demand for recycled materials, traditional FCM frameworks are insufficient for cosmetics. To address this issue, industry organizations have developed voluntary standards, such as the CosPaTox guidelines, which focus on post-consumer recycled plastics (HDPE, LDPE and PP).
The CosPaTox guidelines recommend extensive analysis of non-intentionally added substances (NIAS) and screening for contaminants commonly found in recycled materials, such as:
- Polycyclic aromatic hydrocarbons (PAHs);
- Aromatic amines (PAA);
- Bisphenols (BPA, BPS, BPF, etc.) and phthalates;
- Plychlorinated biphenyls (PCBs);
- Dioxins and furans;
- Heavy metals.
The essential mandatory cosmetic packaging tests
Before a cosmetic reaches the market, its packaging must demonstrate that it is safe, stable and suitable for the intended formula. The European regulatory framework does not impose a fixed test list, but it does require companies to verify interactions between the formulation and the packaging, potential migration of substances, material purity and performance across the product’s entire lifecycle.
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Migration testing (global and specific)
Migration testing is essential because it determines if substances can transfer from packaging materials to cosmetics.
Two complementary approaches are used:
- Global migration measures the overall level of non-volatile substances released from the material;
- The second approach is specific migration, which targets individual substances listed in regulatory annexes or known to be present in the material.
These assessments use food simulants listed in Regulation (EU) 10/2011, such as aqueous ethanol, acetic acid and vegetable oils. Migration results must be made available to the Safety Assessor and included in the Cosmetic Product Safety Report (CPSR).
Stability and compatibility testing
These tests examine the relationship between the formula and the packaging over time.
These tests confirm two essential points: first, that the packaging remains structurally and chemically stable when in contact with the product; second, that the product itself does not degrade or become unstable because of the packaging material.
Changes in color, odor, texture, rigidity or surface behavior may indicate incompatibility. These evaluations are required under Annex I of Regulation 1223/2009 and are included in the Cosmetic Product Safety Report.
NIAS (Non-Intentionally Added Substances) screening
This is particularly relevant for recycled plastics and biobased materials. NIAS screening identifies substances that are not intentionally added, but that may appear as impurities, degradation products or residues from previous use cycles.
Advanced analytical techniques, such as gas chromatography-mass spectrometry (GC-MS) or liquid chromatography-mass spectrometry (LC-MS), are used to detect these compounds at trace levels.
The CosPaTox guidelines provide a practical reference for this type of assessment, especially when dealing with HDPE, LDPE, or PP from post-consumer recycling streams.
Heavy metals and restricted substances
Cosmetic packaging must comply with the REACH requirements that regulate the presence of hazardous substances, including substances of very high concern (SVHCs), at concentrations greater than 0.1% w/w.
Additionally, the Packaging Waste Directive and the upcoming PPWR set a combined limit of 100 ppm for lead, cadmium, mercury and hexavalent chromium.
Materials must also comply with the prohibited and restricted substances listed in Annexes II and III of the Cosmetic Regulation. The goal is to ensure that no harmful substances migrate into the cosmetic product during storage or use.
Microbiological integrity
Even if the packaging is not sterile, it must act as a barrier against microbial contamination. Microbiological integrity tests verify that closure systems, including caps, lids, pumps and inner mechanisms, protect the formula throughout the product’s lifespan.
Standards such as ISO 29621 and ISO 17516 help determine if the design, materials and assembly of the packaging maintain conditions that prevent microbial ingress. While these standards primarily address cosmetic microbiological quality, they are used as a reference to evaluate whether packaging acts as an effective barrier against contamination
Mechanical and functional resistance
Packaging must be able to withstand the stresses of transport, handling and repeated use. Mechanical resistance evaluations test factors such as compression strength, torsion and flexural behavior, as well as the durability of opening and closing systems.
These tests confirm that the packaging will maintain its integrity over time, which is an essential requirement for pump systems, threaded caps, refillable structures and any packaging designed for repeated use.
Precision, responsibility and full-package expertise: discover mPackting
mPackting, the Minelli Group division dedicated to cosmetic packaging, develops complete packaging solutions built around material integrity, engineering precision and strict safety standards. Every jar, cap or system is designed and produced with full control over quality, ensuring compliance with the most rigorous tests required in the EU cosmetic framework.
If you want to explore how responsible materials and advanced manufacturing can elevate your next product, contact us at mPackting and start designing packaging that performs safely and sustainably.
