Migration testing
Migration tests are fundamental analyses in the field of safety of materials and objects intended to come into contact with other elements, such as food, drinking water or human skin. These tests are used to assess whether and in what quantities certain potentially harmful chemicals may be released from materials or products during their use or prolonged contact with other elements. The main objective of migration testing is to ensure that such products do not pose a risk to human health or the environment.
Migration tests are conducted by simulating the actual conditions of use of a product. The material in question is exposed to liquids or other substances (e.g., water, food, sweat or saliva) for a specified period of time, and then the substances that may be released from the material under these conditions are analyzed. The potentially released substances are then compared with regulatory limits set by specific regulations.
There are different types of migration tests, depending on the context of use:
- Migration testing for food contact materials: Tests whether materials such as plastics, metals, ceramics or other materials used to contain or package food release chemicals into food during use.
- Toy release tests: Assesses whether the materials from which toys are made release hazardous substances, such as heavy metals or other toxic substances, when in contact with saliva or sweat.
- Migration testing for medical devices or materials in contact with skin: This is where materials of devices such as prosthetics, surgical materials or commonly used items (such as jewelry or clothing) are studied to verify that they do not release harmful substances during prolonged contact with skin or body fluids.
The importance of divestment and migration tests
Specific regulations, such as the Food Contact Materials Regulation (e.g., Regulation (EC) No. 1935/2004), set migration limits for chemicals, and it is through release testing that companies can demonstrate compliance with these laws.
In sectors such as food, toys, or medical devices, release and migration tests are an essential tool for complying with regulatory requirements and ensuring that products are safe for human use.
In addition, these migration tests improve the quality and sustainability of products by identifying and reducing the use of materials that could pose long-term risks.
Do you need to verify that your product does not release hazardous substances?
Migration test
Migration testing, is a category of destructive testing and is divided into several types:
- Global migration
- Metal migration
- Migration of total primary aromatic amines
- Migration of specific primary aromatic amines
- Color migration
- Specific migration volatile organic compounds hs-gcms
- Specific migration nonvolatile organic compounds gc-ms
- Specific anion migration (chlorides, fluorides, sulfates, nitrites, nitrates, phosphates, chromates)
- Nickel release
Regulations and limitations
European and international food safety regulations set strict migration limits to ensure that food contact materials do not release hazardous substances in harmful amounts. Release and migration tests are essential tools for verifying compliance with these limits, ensuring that the materials used meet the required standards. In particular, EU regulations set specific threshold values for various substances, which are monitored through targeted release testing. Globally, international standards harmonize these practices to facilitate the safe trade of food products, ensuring that release and migration tests are recognized and accepted everywhere.
TEC Eurolab's migration and divestment tests.
The following regulations all aim to ensure that materials used in critical contexts such as contact with food, drinking water, skin or medical devices are safe for human health and comply with legal requirements. Release tests allow the migration of chemicals to be assessed under actual conditions of use and are therefore essential to demonstrate compliance with these regulations.
At TEC Eurolab we perform release tests for the following applications:
1. FCMs (Food Contact Materials and Objects).
- Regulation (EC) No. 1935/2004: This European framework regulation establishes general principles for materials and articles intended to come into contact with food(FCMs). It requires that these materials not release substances in quantities that endanger human health, alter the composition of food, or change its organoleptic characteristics.
- Regulation (EU) No. 10/2011 (for plastics in contact with food): Establishes specific migration limits for hazardous substances from plastic materials, including additives and monomers.
- Ministerial Decree of March 21, 1973: Establishes Italian standards for materials and articles intended for food contact, including release tests. It regulates materials such as plastics, rubbers, metals, paper and ceramics, imposing specific migration limits for chemicals that could contaminate food. This decree is one of the main Italian references for release testing in FCMs.
2. Drinking water
- Directive (EU) 2020/2184 on the quality of water intended for human consumption: Regulates the quality of drinking water within the European Union. Materials that are used for water distribution (pipes, tanks, etc.) must be tested to ensure that they do not release hazardous substances into water for human consumption.
- Ministerial Decree No. 174 of 2004: Italian regulation of materials and objects that can be used in water distribution systems for human consumption, establishing specific requirements for metallic, plastic and cementitious materials, among others.
3. Release of Nickel
- Regulation (EC) No. 1907/2006 (REACH), Annex XVII: Although REACH does not directly provide for release testing, Annex XVII contains restrictions on nickel release. Specifically, articles such as jewelry, piercings, or skin contact materials must not release nickel in amounts exceeding 0.5 µg/cm² per week, as determined by specific release tests.
4. Medical Devices
- Regulation (EU) 2017/745 (MDR): The European Medical Device Regulation requires that all devices be evaluated for their biocompatibility, and that tests be conducted to ensure that they do not release hazardous chemicals. In particular, materials that come into contact with the human body, such as prosthetics, implants, or monitoring devices, must undergo release testing to assess the migration of toxic, sensitizing, or carcinogenic substances.
- ISO 10993: The standard covers biological evaluation of medical devices, including release testing to detect chemicals that could migrate from materials and come into contact with the human body.