Packaging Compatibility Test in Cosmetics — ISO 18811 / 1223/2009

What Is Compatibility?

The compatibility test holds the product in its packaging under stability conditions and tracks the interaction between the two. The interaction runs both ways: the product can degrade the packaging (swelling, cracking, discolouration), or the packaging can transfer substances into the product or absorb components from it (fragrance and preservative uptake).

Purpose of Compatibility

The purpose is to show the product stays safe and stable in its packaging over the declared shelf life. The compatibility study is an integral part of the stability study and is required in the Product Information File.

Which Products Is Compatibility Applied To?

Creams and lotions in plastic packaging
Fragrance and alcohol-based products
Aerosol and pump systems
Tube- and airless-packaged products
Oil-based formulations

In Which Sectors Is Compatibility Used?

CosmeticsChemistryRetailPackagingPlastics & Rubber

Standards Related to Compatibility

ISO 18811 (guidelines on stability testing of cosmetic products)
TS EN ISO 22716 (cosmetics good manufacturing practice)
TS EN 1186 / 13130 series (migration testing — where applicable)

Compatibility Conditions

Storage conditions: Room, high-temperature, low-temperature and cyclic conditions
Position: Specimens are held upright and inverted; the inverted position reveals seal and closure interaction
Parameters monitored: Weight loss, appearance, colour, odour, pH, viscosity and packaging integrity

Equipment for Compatibility

Climate chambers
Precision balance
pH meter and viscometer
Colour measurement system
GC-MS and LC-MS/MS (for substance migration)
Sensory assessment facilities

Sample Requirements for Compatibility

Specimens filled in their market packaging
A separate specimen for each condition and each time point
Separate sets for upright and inverted positions
Packaging material, seal and closure information must be provided

Duration of Compatibility

The study is run together with the stability programme and is therefore long: accelerated conditions run for months, and long-term monitoring runs for the declared shelf life.

Compatibility Procedure

1Specimens are filled into their market packaging and initial measurements are taken.
2Specimens are placed in chambers at the defined conditions, both upright and inverted.
3Specimens are pulled at the defined time points.
4Weight loss, appearance, colour, odour, pH and viscosity are measured.
5The packaging is examined for swelling, deformation, discolouration and leakage.
6Substance migration from the packaging into the product is analysed if needed.

Compatibility Acceptance Criteria

The acceptance criterion is that the monitored parameters stay within the product specification limits and there is no loss of packaging function. The acceptable limit for weight loss is set according to product type and packaging; the standard does not define a general limit.

Evaluation of Results

Weight loss is the earliest warning sign: evaporation or leakage indicates an inadequate seal or packaging barrier. Issues seen in the inverted position may not appear upright, so both positions are monitored together. The test result alone does not establish compliance: (EC) 1223/2009 also requires appointing a responsible person, maintaining a Product Information File, having a qualified person carry out the safety assessment, and notifying the product to the CPNP. Laboratory data feeds into this file.

Compatibility Report

Product and packaging identification (material, seal, closure)
Storage conditions, positions and time points
Measurement results for each time point
Weight loss data
Packaging integrity observations
Substance migration analysis results, if any

Accreditation

EUROLAB holds internationally recognised accreditation obtained from accreditation bodies party to the IAF and ILAC multilateral recognition arrangements, under ISO/IEC 17025 for laboratory testing, ISO/IEC 17020 for inspection and surveillance, and ISO/IEC 17021-1 and ISO/IEC 17065 for system and product certification. This chain ensures the reports and certificates issued are accepted worldwide.

Whether this test can be offered within accredited scope depends on your product and the standard applied; since accreditation is method-based, the scope is confirmed in writing at the quotation stage.

Scope and authorisations

Related Regulations

(EC) 1223/2009 Cosmetic Products Regulation
(EC) 1935/2004 (for food-contact applications)

Kozmetik Testleri — What Does This Testing Field Cover?

The section below describes the field that the Compatibility test belongs to; the conditions and acceptance criteria of this particular test are given in the sections above. The scope specific to your product is confirmed in writing at the quotation stage.

Cosmetics testing shows that a product stays microbiologically safe throughout its use, delivers the performance it claims and contains no restricted substances. There is NO PRODUCT APPROVAL in this family: no authority approves a cosmetic product; responsibility rests entirely with the manufacturer and with the responsible person established in the EU.

This responsibility model shapes how the field works. Before the product is placed on the market a product information file (PIF) is prepared, a safety assessment (CPSR) is carried out and notification is completed. Inspection comes afterwards and asks for the file; if the file is incomplete the product is withdrawn from the market. Test reports form the evidence base of that file.

On the microbiological side there are two different questions and each is answered by a separate test. The CURRENT microbiological quality of the product is measured by enumeration and testing for specified microorganisms. The EFFECTIVENESS of the preservative system is examined by deliberately inoculating the product with microorganisms (challenge test): can the product resist repeated contamination throughout its use? A jar of cream is touched by a finger at every use; the preservative system must cope with that.

On the performance side, claim substantiation studies are carried out. For sunscreens, determination of SPF and UVA protection and measurement of water resistance are mandatory and are the basis of the value declared on the label. Evidence is also produced by in vivo or in vitro methods for claims such as moisturisation, appearance of wrinkles, hair care and colour retention.

On the chemical side, banned and restricted substances are screened: heavy metals, prohibited colorants, preservative concentrations, UV filter levels and contaminants such as nitrosamines. Products containing nanomaterials carry a separate notification obligation.

The BAN ON ANIMAL TESTING is the most defining constraint of the field. Animal testing cannot be carried out on finished products or ingredients, and a product tested on animals cannot be placed on the market. Alternative in vitro methods (reconstructed human skin models, cell culture based tests) are therefore at the centre of the field, and toxicological assessment rests largely on existing data, read-across approaches and in vitro results.

Stability and packaging compatibility studies determine shelf life and the period after opening (PAO). The interaction of the product with its packaging is also assessed: an active substance may migrate into the packaging, and substances that should not be present may pass from the packaging into the product.

On the process side, good manufacturing practice is demonstrated through ISO 22716; this is separate from product testing but a mandatory part of the file.

Method groups in this field

Microbiological quality
Enumeration of aerobic mesophilic bacteria, yeasts and moulds; testing for Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans and E. coli.
Preservative efficacy
Resistance of the preservative system to repeated contamination by challenge test (ISO 11930).
Sun protection
In vivo SPF determination, in vitro UVA protection determination, water resistance and critical wavelength measurements.
Chemical analysis
Heavy metals, banned and restricted substances, quantification of preservatives and UV filters, contaminant screening.
Safety assessment
In vitro irritation and sensitisation methods, toxicological risk assessment, exposure calculations.
Stability and compatibility
Real-time and accelerated stability, packaging compatibility, PAO determination, sensory and physicochemical monitoring.

Commonly confused in this field

There is NO CE marking on cosmetics; conformity is demonstrated through the PIF, the safety assessment and notification.
The responsible person must be established in the EU; unless the exporter arranges this, the product cannot be placed on the market.
Microbiological quality and preservative efficacy are different tests; a product that comes out clean may still have a weak preservative system.
The animal testing ban covers ingredients too; animal test data generated for another market creates a problem of use.
An SPF claim must be supported by measurement; a formulation change requires a new measurement.
A change of packaging may require the stability and compatibility studies to be repeated.

Which decisions these results support

The product information file and the safety assessment
Verification of the preservative system design
Substantiation of SPF and efficacy claims
Determining shelf life and the period after opening
Compliance with destination market restrictions for export

Related Tests

Frequently Asked Questions About Compatibility

We changed the packaging — do we need to repeat the test?

Yes. Compatibility is specific to the product-packaging pair. A change in material, seal, closure or supplier changes the interaction; existing data does not apply to the new packaging.

Why is it held in the inverted position?

Because continuous contact between the product and the seal, closure and pump components only occurs in this position. Leakage, seal swelling and substance migration from the closure usually only appear in the inverted position.