All plastic food contact materials (FCMs) placed on the EU market must comply with the general quality criteria specified in the Framework Regulation (EC) 1935/2004, be produced in line with good manufacturing practices described in the GMP Regulation (EC) 2023/2006, and meet the concrete compositional and stability requirements outlined in the Plastics Regulation (EU) 10/2011. Additionally, recycled plastic FCMs must be produced using recycling technologies authorized under Regulation (EU) 2022/1616 and undergo more frequent testing to ensure consistent decontamination efficiency.
This article provides an overview of the testing-related requirements specified in the above regulations. If you wish to discuss the topic further with our experts and have your company’s materials tested, you can contact us using the form at the bottom of this page.
Table of contents
Which types of tests are required for plastic food contact materials under EU legislation?
Article 3 of the Framework Regulation states that food contact materials must not release constituents into food in quantities that could endanger human health or cause unacceptable changes in the composition, taste, or smell of the food.1
The concrete parameters for evaluating whether these criteria are met are outlined in the Plastics Regulation, which lists authorized constituents and migration limits that must not be exceeded for individual substances (specific migration limits, SML) and the sum of all substances (overall migration limit, OML). The regulation also requires the safety assessment to cover known and unknown contaminants, including non-intentionally added substances (NIAS).
Considering all these requirements, a typical compliance testing sequence for plastic food contact materials should include the following tests:
Overall migration testing to ensure that the sum of constituents released into food does not exceed the limit specified in the Plastics Regulation.
Specific migration testing to ensure raw materials, additives, and production aids are not transferred to food in amounts exceeding the SMLs specified in the Plastics Regulation.
NIAS testing to account for unintentional sources of contamination.
Targeted analyses for heavy metals, primary aromatic amines, and other contaminants relevant to the specific material.
Sensory evaluation to ensure compliance with Framework Regulation, Article 3.
Additional tests may be necessary to screen the material for emerging contaminants, such as mineral oils (MOSH and MOAH) and per- and polyfluoroalkyl substances (PFAS). PFAS presence in food packaging will be banned from August 2026 as per the new Packaging and Packaging Waste Regulation (PPWR)2, and plans are underway to incorporate MOAH into the Plastics Regulation.3
Overall migration testing
Overall migration is a measure of FCMs’ general inertness towards food. For a material to comply with the Plastics Regulation, the OML of 10 mg per dm2 of food contact surface must not be exceeded when the material is tested by placing it in contact with appropriate simulants that mimic food.4
OML testing is performed according to the EN 1186 standard, and food simulants and exposure conditions (contact time and temperature) are selected based on the intended use of the material. For example, plastics intended for long-term storage of all food types at room temperature are tested with simulants A, B, and D2 after 10 days of exposure at 40 °C.
Specific migration testing
Specific migration limits apply to individual substances or groups of similar substances that are authorized for use in the production of plastic FCMs. These limits are based on the toxicological risks posed by each substance and are expressed in mg per kg of food. By default, substances with an SML of ND ("not detected") must not be detected with a detection limit of 0.01 mg/kg.5
Specific migration tests are performed according to the standard EN 13130, and test conditions and simulants are selected following similar principles as with OML testing. Target substances are chosen based on the composition of the material, covering starting substances, additives, and polymer production aids. Examples of high-profile substances and their SMLs are listed in Table 1.6
Table 1: Selected substances and their specific migration limits under Regulation (EU) 10/2011
Substance | FCM number | CAS number | SML (in mg/kg) |
Acetaldehyde | 128 | 75-07-0 | 6* |
Acrylamide | 145 | 79-06-1 | 0.01 (ND) |
Formaldehyde | 98 | 50-00-0 | 15** |
Dibutyl phthalate (DBP) | 157 | 84-74-2 | 0.12*** |
Benzyl butyl phthalate (BBP) | 159 | 85-68-7 | 6*** |
Bis(2-ethylhexyl) phthalate (DEHP) | 283 | 117-81-7 | 0.6*** |
Butadiene | 223 | 106-99-0 | 0.01 (ND) |
* The limit applies to the sum of acetaldehyde and propionic acid, vinyl ester, expressed as acetaldehyde.
** The limit applies to the sum of formaldehyde, hexamethylenetetramine, and 1,4-butanediol formal, expressed as formaldehyde.
*** In addition to the individual SMLs, a group limit of 0.6 mg/kg applies to the sum of these phthalates and diisobutyl phthalate (DIBP), expressed as DEHP-equivalents.
Substances can be added or removed from the authorization list when new information on their safety becomes available. One example is bisphenol A (BPA), which was previously listed as FCM No. 151 with an SML of 0.05 mg/kg, but was recently banned under Regulation (EU) 2024/3190.7
Tests for heavy metals and primary aromatic amines
Raw materials used in plastics, such as colorants and pigments, may contain traces of heavy metals or primary aromatic amines (PAAs) as impurities. Annex II of the Plastics Regulation specifies migration limits for PAAs and selected elements, including heavy metals such as lead, cadmium, nickel, and mercury. The limits are, in some cases, lower than the default “not detected” limit of 0.01 mg/kg. For example, migration of cadmium and certain PAAs listed in Annex XVII of the Reach Regulation must not be detected with a LOD of 0.002 mg/kg.8
NIAS testing
According to the Plastics Regulation, substances used to manufacture food contact materials must have a ”high degree of purity” and contain only minor amounts of non-intentionally added substances.9 NIAS testing is performed to confirm this, typically starting with a general GC-MS screening and proceeding to more targeted methods if substances are detected in the initial screening at concentrations above 0.01 mg/kg (10 µg/kg). If there is reason to believe that the material may contain impurities with a lower safety threshold, these need to be assessed separately.
While the general GC-MS screening is typically sufficient for virgin plastics, recycled plastic FCMs should undergo an extended NIAS assessment. This tends to include supplementary tests such as LC-QTOF-MS analysis to screen the material for non-volatile NIAS and extended VOC screening to detect possible volatile residues.
Sensory analysis
A sensory analysis is typically performed to show that the Framework Regulation’s requirement about FCMs not unacceptably affecting odor or flavor is met. Plastic materials are usually tested according to the standard DIN 10955, which specifies a five-step grading scale (0 to 4) for odor and flavor deviations. Scores below 2.5 are typically considered compliant.
One partner for all your food contact material testing needs
Measurlabs offers the tests required under the EU Plastics Regulation, as well as support for drafting the Declaration of Compliance (DoC) that must be provided to downstream operators.10 Testing options are also available for other materials, including ceramics, metals, wood, paper, and board.
Check out the following for more information and indicative pricing for some of our most popular services:
You can request a quote by filling in the form below. In addition to providing the tests themselves, we can help choose the most appropriate testing conditions (simulants, exposure times, etc.) based on the material's composition and intended applications.
References:
1 This requirement is outlined in Article 3 of Regulation (EC) No 1935/2004.
2 The PFAS restriction is outlined in Article 5 of Regulation (EU) 2025/40 on packaging and packaging waste.
3 The plan to include MOAH in Regulation (EU) 10/2011 was discussed at a June 2025 meeting by the EU Standing Committee on Plants, Animals, Food and Feed (SC PAFF). While it is not yet certain when this will happen, elevated MOAH levels can already lead to product withdrawals, as explained in this SC PAFF summary report from April 2022.
4 The requirement to perform overall migration testing is outlined in Article 12 of Regulation (EU) No 10/2011 (consolidated version from 16/03/2025), with further instructions on simulant and test condition selection specified in Annex III.
5 Specific migration testing is mandated by Article 11 of Regulation (EU) No 10/2011, which also specifies the default ND limit of 0.01 mg/kg.
6 Authorized substances and the conditions for their use are outlined in Annex I to Regulation (EU) No 10/2011.
7 Commission Regulation (EU) 2024/3190 on the use of bisphenol A (BPA) and other bisphenols and bisphenol derivatives.
8 Annex II to Regulation (EU) No 10/2011. The specific entry of REACH (Regulation (EC) No 1907/2006) where the PAAs are listed is entry 43 to Appendix 8 of Annex XVII.
9 Article 3a of Regulation (EU) No 10/2011.
10 Article 15 of Regulation (EU) No 10/2011 requires operators to provide a DOC to customers at all stages of the production chain, apart from the retail stage. Information to be included is described in Annex IV.