QMS criterion measurement (maximum permissible quantity of residual substance in the finished material or object)

The measurement of the QMS criterion (maximum permissible amount of residual substance) is an essential regulatory analysis for demonstrating the conformity of materials and finished articles intended for food contact. The QMS criterion corresponds to the maximum permissible amount of a residual substance present directly in the material or finished article, as defined by European regulations on materials in contact with food, in particular Regulation (EU) No 10/2011.

This analysis is aimed at manufacturers in the packaging, materials and polymer sectors who wish to secure the marketing of their products, control health risks and meet the regulatory requirements applicable to substances used in formulations.

QMS criterion principle

The QMS criterion is based on the direct quantification of a residual substance in the material or finished article, independently or in addition to migration tests. Unlike specific migration, which measures the transfer of a substance to a food simulant, the QMS criterion focuses on the maximum permissible content of the substance in the material itself.

Regulation (EU) No 10/2011 sets limits, expressed as maximum quantities in the material or finished article, for certain substances. Compliance with these limits demonstrates regulatory conformity without necessarily requiring migration tests, where permitted by law.

The analysis consists of extracting the targeted substance from the material or implementing a suitable simulated migration, and then quantifying it using high-performance analytical methods.

Analytical methods used

The QMS criterion is measured using chromatographic techniques adapted to the chemical nature of the substance sought and the complexity of the matrix analyzed.

Commonly used methods include gas chromatography coupled with mass spectrometry (GC-MS), high-performance liquid chromatography (HPLC) and liquid chromatography coupled with mass spectrometry (LC-MS or LC-MS/MS).

Sample preparation is defined on a case-by-case basis and may include specific extraction, polymer dissolution, or simulated migration. The choice of analytical method ensures that the quantification limits required by regulations are met and that the reliability of the results is guaranteed.

Measured parameters

The analysis determines the quantity of residual substance present in the material or finished article, expressed according to the applicable regulatory units. The results are compared to the QMS values ​​defined by Regulation (EU) No 10/2011 or other relevant regulatory texts.

This analytical data makes it possible to objectively determine the conformity of the material, to identify any excesses and to document the technical and regulatory files.

Matrices involved

The QMS criterion assay applies to a wide range of materials and finished articles intended for food contact, including plastics, polymers, films, rigid or flexible packaging, coatings and composite materials.

Each type of material undergoes specific analytical preparation to ensure efficient extraction of the targeted substance and representative quantification of the actual content in the finished object.

Industrial applications

This analysis is essential in many industrial contexts. It is required when new materials or products are placed on the market, in the event of a change in formulation, a change of supplier, or as part of quality and regulatory audits.

The QMS criterion dosage is also used to secure declarations of conformity, meet the requirements of control authorities and anticipate the risks of non-compliance before marketing.

It is a key tool for the regulatory management of food contact materials, particularly when regulations explicitly provide for a QMS limit for certain substances.

Regulatory issues and compliance

Compliance with the QMS criterion is a regulatory requirement for certain substances listed in Regulation (EU) No 10/2011 on plastic materials intended to come into contact with food. Failure to comply with these limits may result in regulatory non-compliance, market withdrawals, or penalties.

A reliable analysis of the QMS criterion makes it possible to demonstrate the conformity of materials, to secure trade and to strengthen traceability and control of health risks.

YesWeLab Expertise

YesWeLab relies on a rigorously selected network of partner laboratories, most of which are certified and/or accredited according to recognized standards such as ISO 17025 and COFRAC. Each request is analyzed by our scientific team to direct samples to the analytical method best suited to the targeted substance, the material being analyzed, and the applicable regulatory requirements.

Thanks to its digital platform, YesWeLab enables centralized analysis management, optimized sample tracking, and fast, secure access to analytical results. Since 2020, numerous manufacturers, distributors, and engineering firms have relied on YesWeLab for their regulatory and materials compliance analyses.

Other analyses from the YesWeLab catalogue

The QMS criterion assay can be supplemented by other analyses from the YesWeLab catalogue in order to cover all the requirements applicable to materials and objects in contact with food.

Global and specific migration tests allow for the evaluation of the transfer of substances from the material to food simulants, as a complement or alternative to the QMS criterion according to regulatory requirements.

NIAS (non-intentionally added substances) analysis makes it possible to identify and quantify compounds not intentionally added, which may be present in polymer materials.

The dosage of monomers, additives and plasticizers contributes to the control of formulations and to the verification of compliance with regulatory limits applicable to substances used in plastic materials.

GC-MS, HPLC and LC-MS analyses are also offered for in-depth chemical characterization of materials and management of compliance issues.

Finally, regulatory compliance analyses of food contact materials allow the QMS criterion to be integrated into a comprehensive approach to material validation and safety.

For any quote request or to discuss your specific needs in QMS criterion dosage, contact the YesWeLab team now.