Migration Testing of Plastics for Food Contact (EU 10/2011, EN 1186, EN 13130, FDA): 6 Simulants, 10 Overall Migration Conditions and How a Result Passes

Migration testing of plastics for food contact measures how much of a plastic's additives, residues and breakdown products passes into a food or a food simulant under a set time and temperature, and Regulation (EU) No 10/2011 judges the result against 2 limits: 10 mg/dm2 for everything that migrates and a specific migration limit for each listed substance. The same PVC gasket can be tested in 10 % ethanol or in vegetable oil, for 30 minutes or for 10 days, so which condition applies? Annex V answers with 6 food simulants, a ladder of test times and temperatures for specific migration, and 10 standardised conditions, OM0 to OM9, for overall migration.

The migrants a test is usually looking for are additives, and 4 groups dominate: antioxidants such as Irganox 1010, Irgafos 168 and BHT; plasticizers such as ESBO, DEHP and DINP; slip and surface additives such as erucamide and the C14 to C18 alkanamides; and metals such as zinc and antimony from stabilizers, pigments and catalysts.

This page covers the 2 tests, the simulants, the time and temperature rules with the full OM0 to OM9 table, EN 1186 and EN 13130, the uncertainty rule of Regulation (EU) 2025/351, the plastic additives a test has to find and the US FDA route. Every one of the plastic additives in a compound is a candidate migrant.

Table 1 summarises the test on one screen, from what it measures to the US route.

Limits and conditions are those of Regulation (EU) No 10/2011 as amended up to Regulation (EU) 2025/351, read on 24 October 2026. EN 1186 parts other than 2 and 3 are given without an edition year because their current status could not be read from the standards themselves.

What Is Migration Testing of Plastics?#

Migration testing of a plastic is the measurement of how much of its substances transfer into a food or a food simulant during a defined contact time and temperature, carried out to prove that a food contact material meets the migration limits of Regulation (EU) No 10/2011 or the extraction limits of the US 21 CFR. Among the methods for testing plastic additives, it belongs to the compliance group, where a result is compared with a legal limit.

Who has to run it? Every business that places a plastic food contact material or article on the market, at each stage except retail, signs a declaration of compliance, and migration test results are part of the supporting documentation behind it.

Overall migration and specific migration: the two tests#

Overall migration measures the total mass of everything that leaves the plastic, judged against 10 mg per dm2 of contact surface, while specific migration measures one named substance, judged against its own specific migration limit in mg per kg of food. The overall migration limit (OML) becomes 60 mg per kg of food simulant for articles intended for infants and young children (Article 12), and where an authorised substance carries no SML of its own, a generic 60 mg/kg applies. Group restrictions cap the sum of related substances with a shared SML(T).

Why are both needed? An antioxidant listed without an SML, such as Irganox 1010 (FCM 496) or Irgafos 168 (FCM 671), is held only by the overall migration limit and the generic 60 mg/kg, while BHT (FCM 315) carries an SML of 3 mg/kg that an overall result cannot attribute to it. Annex V lets an overall result stand in for a specific test when it is already below the SML.

What is an overall migration test?#

An overall migration test is a test that exposes a plastic to a food simulant under one of the standardised conditions OM0 to OM9 and measures the total mass of substances that has transferred, reported in mg per dm2 of contact surface. Evaporable simulants (water, 3 % acetic acid, the ethanol solutions and isooctane) are handled by EN 1186-3:2022. Vegetable oil cannot be evaporated, so it has its own method, EN 1186-2:2022.

Why a plastic additive is the usual migrant#

Additives are the usual migrants because, unlike the polymer chain, they are small molecules that are not chemically bound to it, so antioxidants, plasticizers and slip agents diffuse to the surface and into whatever touches it. The additives in food packaging span 12 functions, each with its EU and FDA limits, under additives for food packaging. Early migration follows the square root of time, so a long, warm contact moves more additive than a short, cold one.

The second class of migrants is the substances nobody added. 2,4-di-tert-butylphenol, a breakdown product of Irgafos 168-type phosphite antioxidants, was measured by Qian and co-workers (2018) at up to 45.568 ± 31.513 mg/kg in BOPP and LDPE food-contact products, and it is not on the Union list. A migration study therefore looks beyond the declared additives to their non-intentionally added substances (NIAS).

Which Food Simulant Is Used? The 6 Simulants and Their Substitutes#

The 6 food simulants of Regulation (EU) No 10/2011 are simulant A (10 % ethanol), B (3 % acetic acid), C (20 % ethanol), D1 (50 % ethanol), D2 (vegetable oil) and E (Tenax, a porous polymer powder for dry foods), and the food, not the packaging, decides which one a test uses. Each food simulant stands for a class of foods rather than one recipe. The simulant should be chosen from the food the article is made to hold, never from the plastic it is made of.

Table 2 adds the testing columns to the 6 simulants: the highest test temperature, the substitute and the EN 1186:2022 method.

Compositions and assignments: Annex III of Regulation (EU) No 10/2011 as substituted by Regulation (EU) 2016/1416. Test temperatures: Annex V Table 2. Methods: the scope statements of EN 1186-2:2022 and EN 1186-3:2022.

Assigning the simulant from the food under EU 10/2011 Annex III#

Annex III of Regulation (EU) No 10/2011 assigns a simulant to each food category, and an article meant for every kind of food is tested in simulants A, B and D2 together. Beyond the aqueous default of simulant A, the assignment follows the 4 cases listed below.

• Acidic foods below pH 4.5: simulant B, 3 % acetic acid.
• Alcoholic and more lipophilic foods: simulant C up to 20 % alcohol, simulant D1 above 20 % and for oil-in-water emulsions.
• Foods with free fat at the surface: simulant D2, vegetable oil.
• Dry foods: simulant E, Tenax.

Simulant B may be left out of an EU 10/2011 test plan for all food types where no substance in the plastic reacts with acidic simulants or foods. The fatty-food risk is written into the Union list of EU 10/2011 itself: notes (2) and (12) of Annex I flag substances whose SML or OML can be exceeded in fatty simulants or from polyolefins, and note (16) flags LDPE with more than 0.3 % w/w of the substance in contact with fatty foods.

Substitute fatty simulants: isooctane, 95 % ethanol and Tenax#

Isooctane and 95 % ethanol replace vegetable oil when a test in simulant D2 is not technically feasible, and the substitute that gives the higher migration decides compliance. Annex V point 3.2 states it plainly: "The test that results in the highest overall migration shall be used to establish compliance with the Regulation." Iso-octane, the spelling of the EN 1186 titles, is therefore always run together with 95 % ethanol.

Above 100 °C the substitute is simulant E. OM8 and OM9 run Tenax for 2 hours at 175 °C plus a D2 contact (2 hours at 100 °C, or 10 days at 40 °C), and one of them replaces OM7 when oil cannot be tested at 175 °C. EN 1186-3:2022 handles isooctane and 95 % ethanol in the same method as the aqueous simulants, having superseded the 2002 substitute-test parts 14 and 15.

Can a test in isooctane replace a test in vegetable oil?#

Yes, where a test in vegetable oil is not technically feasible, but the substitute is not a free choice: isooctane and 95 % ethanol are both tested, and the higher of the 2 results is compared with the limit. For screening, Annex V also accepts substitute simulants backed by scientific evidence (points 2.2.4 and 3.4). Our sources hold no conversion factor between an isooctane result and an oil result.

How Are Test Time and Temperature Chosen?#

Test time and temperature are chosen from the worst contact the article can foreseeably meet in use, rounded up to the next standard condition, so a test is always at least as severe as the real use. A contact of 20 minutes is tested for 30 minutes, and a contact at 35 °C is tested at 40 °C.

Specific migration: rounding real contact up to the next test condition#

A specific migration test rounds the real contact time up to the next of 8 fixed test times, from 5 minutes to 10 days, and the real contact temperature up to the next of 11 test temperatures, from 5 °C to 225 °C. Table 3a sets out the time ladder of Annex V Table 1.

Table 3b sets out the temperature ladder of Annex V Table 2.

Annex V, Chapter 2, Tables 1 and 2, Regulation (EU) No 10/2011. For simulants A, B, C and D1, a test at 100 °C or reflux for 4 times the Table 1 time may replace a test above 100 °C.

A drink stored for 3 weeks at room temperature falls in the "above 3 days, up to 30 days" and "up to 40 °C" steps, so it is tested for 10 days at 40 °C. An aqueous food heated to 121 °C cannot be tested in simulant A at 121 °C, because only D2 and E go above 100 °C; the aqueous test runs at 100 °C or reflux for 4 times the Table 1 time instead.

Storage longer than 30 days: 10 days at 20, 40, 50 or 60 °C#

Storage longer than 30 days is tested by an accelerated 10-day test at 20, 40, 50 or 60 °C, and the longer and warmer the real storage, the hotter the test. Table 4 lists the 4 conditions of Annex V point 2.1.4.

Annex V point 2.1.4, Regulation (EU) No 10/2011. Other combinations are converted with the formula below. An accelerated test may not cause a physical change in the plastic.

Storage that fits none of the 4 rows is converted with the formula of point 2.1.4(f):

t2 = t1 × Exp(9627 × (1/T2 - 1/T1))

Here t1 is the contact time, t2 the test time, T2 the test temperature in kelvin and T1 the contact temperature: 298 K (25 °C) for room temperature, 278 K (5 °C) refrigerated and 258 K (-15 °C) frozen. Calculated from the Annex V formula, 180 days at 298 K corresponds to about 6 days at 333 K (60 °C), so the fixed 10 days at 60 °C covers storage beyond 6 months with margin. The acceleration stops where the plastic would soften, melt or otherwise transform.

Overall migration: the 10 standardised conditions OM0 to OM9#

Overall migration is tested under 10 standardised conditions, OM0 to OM9, and the right one is the condition whose description covers the article's most severe intended contact, from 30 minutes at 40 °C for brief contact to 2 hours at 175 °C for oven use with fatty food. Table 5 lists all 10 with the contact each covers.

Annex V, Chapter 3, Regulation (EU) No 10/2011. Where D2 is not feasible for OM0 to OM6, isooctane and 95 % ethanol are used and the test with the highest result decides compliance. Applying the heating formula gives 15 minutes at 100 °C, 30 minutes at 90 °C and 60 minutes at 80 °C (calculated).

OM2 is the default for anything stored at room temperature or below and also covers OM0, OM1 and OM3. OM6 covers any contact above 40 °C for foods assigned simulants A, B, C or D1, together with OM0 to OM5. OM7 to OM9 are needed only for fatty food beyond the 121 °C of OM5.

Hot-fill, heating and successive contact conditions#

Three rules handle contact that is not one steady condition: a dedicated hot-fill test, a heating allowance inside the standard conditions, and successive testing on one portion of simulant. A laboratory applies them as listed below.

1. Test a hot-filled article that is not stored afterwards for 2 hours at 70 °C.
2. Cover a short heating step inside a longer test with t = 120/2^((T - 70)/10) minutes, which allows 15 minutes at 100 °C within OM2 or OM3 (calculated).
3. Run successive contacts, such as hot filling followed by storage, one after the other on the same portion of simulant.

How Is a Migration Test Run? EN 1186, EN 13130 and the Surface-to-Volume Ratio#

A migration test is run by bringing a measured area of plastic into contact with a measured volume of simulant, holding it at the test condition, and then measuring either the total residue under EN 1186 or one named substance under the EN 13130 series or another validated method. Both series come from CEN/TC 194, the committee for utensils in contact with food.

EN 1186: overall migration by immersion, cell, pouch or filling#

EN 1186 is the European series of test methods for overall migration from plastics, and since 2022 its working methods are EN 1186-3:2022 for evaporable simulants and EN 1186-2:2022 for vegetable oils. EN 1186-3:2022, "Test methods for overall migration in evaporable simulants" (16 August 2022), supersedes parts 3, 5, 7, 9, 14 and 15 of the 2002 series and runs from 4 °C up to reflux; EN 1186-2:2022 covers vegetable oils from 4 °C to 175 °C. EN 1186-3:2022 uses the 4 contact methods listed below.

• Total immersion: the specimen sits fully in the simulant.
• Cell: a clamp exposes one face of a film or sheet.
• Pouch: the film is sealed into a pouch and filled, or turned inside out as a reverse pouch.
• Article filling: a container or closure is filled with the simulant as in use.

EN 1186-1 is the guide to selecting conditions and methods, and EN 1186-3:2022 "does not cover the interpretation of the results". A 2025 study on reprocessed PLA in the journal Polymers ran overall migration into simulant D1 for 10 days at 40 °C.

EN 13130 and substance-specific analysis#

Specific migration is measured in 2 steps: the plastic is exposed to the simulant under the chosen time and temperature, and the simulant is then analysed for one named substance by a method that works from one fifth of its SML to twice its SML. The EN 13130 series, with part 1 as the general guide, frames the exposure; the same 2025 Polymers study used EN 13130-1 for element migration into 3 % acetic acid for 10 days at 60 °C. Since Regulation (EU) 2025/351, the method has to meet Article 34 of Regulation (EU) 2017/625.

EFSA (2025) recorded migration of 0.0038 mg/kg into simulant C, 20 % ethanol, for an oligomeric 2-aminobenzamide acetaldehyde scavenger used at 650 mg/kg in PET. The same chromatographs identify additives inside the plastic in additive analysis.

The 6 dm2 per kg convention and the real surface-to-volume ratio#

Migration measured per dm2 of plastic is converted to mg per kg of food by assuming that 1 kg of food touches 6 dm2 of packaging, unless the real contact surface of a container between 500 mL and 10 L can be used instead. Below 500 mL, above 10 L and wherever the surface cannot be calculated, the convention applies (a 1 L cube has 6 dm2 of surface).

Regulation (EU) 2025/351 makes the correction explicit: a specific result is corrected by the real and the test surface-to-volume ratio under Article 17 before it is compared with the SML. The S/V ratio used in the test should be stated with the result.

Screening instead of a full test: overall migration, residual content and migration modelling#

Annex V accepts 5 screening approaches in place of a full migration test, provided each one is at least as severe as the verification test it replaces. The 5 approaches follow the order of points 2.2.1 to 2.2.5.

• Overall migration as a screen: an overall result already below the SML.
• Residual content: the amount in the plastic, assumed to migrate completely.
• Migration modelling: a diffusion calculation that never underestimates.
• Substitute simulants: accepted with scientific justification.
• One test for successive conditions: using the long-term storage formula.

Migration modelling entered EU law with Directive 2001/62/EC, and a calculated failure must be confirmed by a real test under Article 18(3). Begley and colleagues validated the approach against measured migration at 95 % confidence in Food Additives and Contaminants (2005). The diffusion equation and its polymer constants belong to additive migration in plastics.

A formulator can screen a compound with the additive migration estimator before ordering a test programme.

How Is a Migration Result Judged Against the Limit?#

A migration result is judged in 4 steps: correct it for the real surface-to-volume ratio, apply any fat or simulant correction, compare it with the limit allowing for measurement uncertainty, and, for repeated-use articles, check that it does not rise from test to test. Table 6 collects the 7 rules behind those steps.

1 mg/kg = 10^-6 kg/kg, so the CV_R threshold of 0.12 × 10^-6 kg/kg is 0.12 mg/kg.

Correction factors: FRF, the D2 and E correction and the cap of 5#

The fat reduction factor is (% fat × 5)/100, reaching 5 for pure fat, and it divides the specific migration of a fat-soluble substance into a fatty food, because a food with 40 % fat extracts less than pure oil does. Annex V point 4.1 writes the same formula as (g fat per kg of food)/200, so a food with 20 % fat gives an FRF of 1 (calculated).

Four limits restrict its use: it applies only where the Annex I entry says "FRF applicable", as for Santonox R (FCM 178, SML 0.48 mg/kg) and ADK STAB AO-80 (FCM 858); never to food for infants and young children; never where the surface-to-volume ratio cannot be estimated; and never to a result above 60 mg/kg before correction. Combined with the Annex III Table 2 factor for D2 or E, the total correction is capped at 5 unless the Annex III factor alone is higher.

Measurement uncertainty: when a result above the SML still passes#

Since Regulation (EU) 2025/351 took effect on 16 March 2025, a specific migration result exceeds its SML only when the excess is more than 1.64 times the result's standard measurement uncertainty, so a value slightly above the limit is not automatically a failure. The uncertainty comes from a fixed reproducibility coefficient of variation, CV_R, that depends only on the size of the result.

u(m_c) = CV_R × m_c

CV_R = 0.22 for m_c below 0.12 mg/kg

CV_R = 2^(1 - ½ log10 m_c)/100 for m_c from 0.12 mg/kg to 0.138 kg/kg, with m_c in kg/kg

m_c exceeds the SML when (m_c - SML)/u(m_c) > 1.64

Table 7 applies these formulas to 6 SMLs held by plastic additives; every value is calculated by PlasticAdditives.net from the formula in Annex V as amended by Regulation (EU) 2025/351.

Calculated by PlasticAdditives.net from Annex V of Regulation (EU) No 10/2011 as amended by Regulation (EU) 2025/351 (CV_R = 2^(1 - ½ log10 m_c)/100 with m_c in kg/kg; decision criterion 1.64). Rounded. Corrections for S/V, FRF or simulant are applied before the comparison, and the regulation's text, not this table, is the authority.

The lower the SML, the larger the relative allowance, from about 16 % at 60 mg/kg to about 56 % at 0.05 mg/kg (calculated). A DEHP result of 0.75 mg/kg sits above the 0.6 mg/kg SML but below the calculated 0.822 mg/kg threshold, so it is not considered to exceed the SML. A substance with an SML of 0.05 mg/kg needs a method that works from 0.01 to 0.1 mg/kg (calculated). A migration report should state the uncertainty used with each specific result.

Repeated-use articles: three tests, judged on the third#

A repeated-use article is tested 3 times on the same specimen with fresh simulant each time, and it is judged on the third result, provided migration has not risen from one test to the next. Reusable PVC gaskets and plasticised PVC for repeated use are typical cases. Regulation (EU) 2025/351 wrote the 4 non-compliance conditions listed below into point 2.1.6, each judged with the 1.64 criterion.

• Third result above the SML: m_c,3 exceeds the limit by the 1.64 criterion.
• Second result above the first: migration rose between tests 1 and 2.
• Third result above the second: migration rose between tests 2 and 3.
• Third result above the first: migration rose over the whole sequence.

An article is never compliant if a substance that Article 11(4) prohibits from migrating in detectable quantities is detected in any test. For overall migration in vegetable oil, where one specimen cannot be tested 3 times, 3 specimens are tested for 1, 2 and 3 times the contact time, and the first result and the 2 differences stand for the 3 migrations.

What happens if the second migration is higher than the first?#

The article fails the stability criterion when the second result exceeds the first by more than 1.64 times their combined uncertainty, even if every individual result is below the SML. The one exception is scientific proof that migration does not increase, combined with a first result that does not exceed the limit.

How to read a migration test report#

A migration test report is usable only if it states the 8 inputs that produced the number, because a result without its simulant and condition cannot be compared with any limit. The 8 inputs that Annex V makes decisive are listed below.

• Article and specimen: material, thickness and the face tested.
• Simulant: letter and composition, and any substitute used.
• Condition: test time and temperature, or the OM code.
• Contact method: immersion, cell, pouch or filling, with the EN 1186 or EN 13130 part.
• Surface-to-volume ratio: real, or the 6 dm2 per kg convention.
• Corrections: FRF and any D2 or E factor, with the combined value.
• Result with uncertainty: each specific result with u, and the working range of the method.
• Repeated use: all 3 results, not only the third.

The report then becomes supporting documentation behind the declaration of compliance.

What Did Regulation (EU) 2025/351 Change in Migration Testing?#

Regulation (EU) 2025/351, in force since 16 March 2025, changed 4 things in migration testing: how the analytical method is chosen, how a result is corrected, how measurement uncertainty decides a pass or a fail, and how repeated-use articles are judged. Adopted on 21 February 2025, it was published on 24 February 2025. The 4 changes are listed below.

• Analytical method: chosen to meet Article 34 of Regulation (EU) 2017/625, with a working range from 0.2 to 2 times the SML.
• Corrections: surface-to-volume, simulant and fat corrections applied before comparison with the SML, with a combined cap of 5.
• Uncertainty: a fixed reproducibility formula and a 1.64 decision criterion for specific migration.
• Repeated use: 4 written non-compliance conditions for specific migration and the laboratory's own uncertainty for overall migration.

Article 4 sets the transition: plastic materials and articles that complied with the earlier text and were first placed on the market before 16 September 2026 may continue to be placed on the market until stocks are exhausted. A non-compliant intermediate product or substance first placed on the market after 16 December 2025 must say so in its declaration of compliance. Its purity and off-cut reprocessing rules are covered under Regulation (EU) No 10/2011.

Which Plastic Additives Need Specific Migration Testing?#

A plastic additive needs specific migration testing when its Union list entry carries its own SML, a group restriction or a use restriction, and 4 groups account for most of these: antioxidants, plasticizers, slip and surface additives, and metals. The table lists 13 additives and what a specific migration test has to find for each.

FCM numbers and limits from Annex I and Annex II of Regulation (EU) No 10/2011, consolidated text of 14 July 2026 for Annex II and of 16 March 2025 for Annex I entries. Limits are in mg per kg of food. The complete list is on our SML page.

Compare food-contact antioxidant, plasticizer and slip grades by CAS, not by trade name, with the plastic additive supplier finder.

An additive listed without an SML, such as Irganox 1010, is still covered by the generic 60 mg/kg and the overall limit. Every limit, substance by substance, is in the table of specific migration limits (SML) of plastic additives.

Antioxidants: Irganox 1010, Irgafos 168 and their breakdown products#

Irganox 1010 and Irgafos 168, the 2 most common polyolefin antioxidants, carry no SML and are controlled by the overall limit, while smaller phenolics such as BHT (3 mg/kg) and Irganox 1076 (6 mg/kg) need their own specific migration test. Grade-by-grade SMLs and FDA limits for food contact antioxidants are set out on their own page.

The breakdown products widen the target list. Irgafos 168, the phosphite paired with Irganox 1010 in the standard polyolefin package, breaks down to 2,4-di-tert-butylphenol, which is not on the Union list and which Qian and co-workers (2018) measured at up to 45.568 ± 31.513 mg/kg in BOPP and LDPE products. ADK STAB AO-80's SML of 0.05 mg/kg is the sum of the substance and its oxidation product, so the test measures both.

Plasticizers in PVC film and gaskets: ESBO and phthalates#

Plasticizers are tested against limits as low as 0.12 mg/kg for DBP and 0.6 mg/kg for DEHP since Regulation (EU) 2023/1442 (in force 1 August 2023), because a plasticizer is not bound to PVC and moves readily into fatty foods. BBP carries 6 mg/kg, DINP and DIDP share 1.8 mg/kg (group restriction 26), and group restriction 32 holds all plasticizers to 60 mg/kg. Conditions of use for each of the plasticizers in food contact materials are set out substance by substance.

ESBO, the plasticiser and co-stabilizer of glass-jar lid gaskets, carries an SML of 60 mg/kg, lowered to 30 mg/kg for gaskets on jars of infant formula, follow-on formula, processed cereal-based foods and baby foods. ESBO (epoxidized soybean oil) is therefore tested against 2 limits depending on the jar's contents. DEHA (DOA, FCM 207) at 18 mg/kg and DOTP (FCM 798) at 60 mg/kg sit under the same group restriction 32.

Slip agents and other surface additives#

Slip additives are designed to reach the surface, and their Union list entries reflect that: erucamide (FCM 271) carries no SML, while the C14 to C18 alkanamide mixture (FCM 1065) carries 5 mg/kg and may not be used for foods assigned simulant D2. Bloom rates and dosages of slip additives are covered on the family page. For an alkanamide film, the restriction as well as the food decides the simulant, because fatty-food use is excluded.

Metals from stabilizers, pigments and catalysts#

Metals are tested against Annex II of Regulation (EU) No 10/2011, which sets limits in mg per kg of food for 9 metals plus the lanthanides, with antimony set through its own Annex I entry, and requires arsenic, cadmium, chromium, lead and mercury to be not detectable. The 3 metals tied most directly to plastic additives are listed below.

• Zinc from stearates and heat stabilizers: 5 mg/kg.
• Antimony from antimony trioxide, the flame-retardant synergist and PET catalyst residue: 0.04 mg/kg.
• Barium and aluminium from stabilizers, pigments and aluminium trihydrate: 1 mg/kg each.

Carbon black (FCM 411) has no SML but is limited to 2.5 % w/w in the polymer, and Annex II applies to coloured articles too.

How Does FDA Migration Testing Differ?#

The US has no overall migration limit and no list of food simulants written into law; instead, the FDA writes extraction limits into the regulation for each polymer and attaches every additive clearance to food types and conditions of use A to H. The 5 legal routes are explained under FDA food contact rules, and Table 9 compares the 2 systems.

US entries from 21 CFR 170.39, 176.170, 177.1520 and 178.2010 as read on eCFR during the knowledge-base research (September 2026).

n-Hexane extractables for polyethylene and polypropylene (21 CFR 177.1520)#

21 CFR 177.1520 tests polypropylene by refluxing 1 g of resin in 100 mL of n-hexane for 2 hours and polyethylene by extracting 2.5 g of film in 1 L of n-hexane at 49.5 ± 0.5 °C for 2 hours, and the 2 procedures are not interchangeable. The polyethylene film is 4 mil or thinner, and its weight loss is multiplied by 0.935.

The polypropylene limit is 6.4 % n-hexane extractable at reflux and 9.8 % xylene soluble at 25 °C, and the polyethylene limit 5.5 % at 50 °C and 11.3 % xylene soluble at 25 °C. These are resin limits in % by weight, not food migration in mg/kg. Low-extractable grades and their packages are covered on additives for polyethylene.

Conditions of use A to H as test conditions#

The FDA's 8 conditions of use, A to H, play the role that the time and temperature ladders play in the EU: every clearance names the conditions it covers, from A, heat sterilization above 212 °F (100 °C), to H, frozen food reheated in its container. The 8 conditions of 21 CFR 176.170(c) Table 2 are listed below.

• A: high-temperature heat-sterilized, above 212 °F (100 °C).
• B: boiling-water sterilized.
• C: hot filled above 150 °F (about 66 °C).
• D: hot filled below 150 °F.
• E: room temperature.
• F: refrigerated storage.
• G: frozen storage.
• H: frozen or refrigerated ready-prepared food reheated in the container.

Food contact notification migration studies and the 0.5 ppb threshold#

A new additive reaches the US food-contact market through a Food Contact Notification supported by migration data, or through the Threshold of Regulation exemption when its dietary concentration stays at or below 0.5 ppb, about 1.5 µg per person per day. 21 CFR 170.39 closes the exemption to carcinogens and to substances with a carcinogenic impurity whose TD50 is below 6.25 mg/kg bw/day.

An effective FCN covers only the notifier named in it, so a buyer of the same chemistry from another producer cannot rely on it. The simulants and protocols for FCN migration studies are set out in FDA chemistry guidance, and the filing route is covered under food contact notifications (FCN) and threshold of regulation.

What Migration Testing Cannot Tell You#

A migration test cannot answer 4 questions that are regularly put to it, because it measures a mass in a simulant under worst-case conditions and nothing else. Each is listed below with what does answer it.

• Identity of an overall residue: an overall result is a mass, not a list of substances; identification needs targeted or non-target analysis.
• Unknown substances: a specific test finds only what it is set up to find, so breakdown products such as 2,4-di-tert-butylphenol need non-target screening.
• Toxicity of the mixture: Zimmermann and co-workers (2021) found migrates from 24 plastic products, collected in water after 10 days at 40 °C, baseline-toxic in vitro, which a compliance test does not assess.
• Real exposure: a compliance result describes the worst foreseeable condition in a simulant, not the amount a consumer ingests.

What studies measured in real foods is reviewed under chemicals migrating from plastic food packaging.

Which Other Food-Contact Rules and Tests Sit Next to Migration Testing?#

A migration test result never stands alone: it sits inside 5 neighbouring rules and tests, from the functional-barrier and NIAS rules of the same regulation to the PFAS limits of the PPWR and the migration rules of other countries. The jurisdictions are compared side by side under food contact rules for plastic additives worldwide.

Functional barriers, NIAS and the declaration of compliance#

A functional barrier lets an unlisted, non-CMR substance sit behind a layer as long as its migration through it is not detectable at 0.01 mg/kg, so the migration test becomes the proof that the barrier works. The definition of a functional barrier excludes CMR substances.

NIAS are defined in Article 3(9) of Regulation (EU) No 10/2011 as "an impurity in the substances used or a reaction intermediate formed during the production process or a decomposition or reaction product", assessed under Article 19. How to assess NIAS from plastic additives is a risk assessment, not a fixed limit.

The declaration of compliance under Article 15 and Annex IV is required at every stage except retail. Test reports become supporting documentation for the declaration of compliance (DoC).

Recycled plastics under Regulation (EU) 2022/1616#

Recycled plastic for food contact has its own regulation, Regulation (EU) 2022/1616, in force since 10 October 2022, which replaced Regulation (EC) No 282/2008 and adds process-level evidence on top of the migration test. Suitable and novel technologies are explained under recycled plastics regulations.

PFAS and heavy metals in food packaging under the PPWR#

Since 12 August 2026 the PPWR adds a content test to the migration test for food-contact packaging: below 25 ppb for any single targeted PFAS, 250 ppb for their sum and 50 mg/kg for total PFAS, including polymeric PFAS such as fluoropolymer processing aids. Targeted and total-fluorine methods are compared under PFAS testing of plastics and packaging. These are content limits, not migration limits.

Lead, cadmium, mercury and hexavalent chromium together are capped at 100 mg/kg. The heavy-metal sum comes from Article 5(4) of the Packaging and Packaging Waste Regulation (PPWR).

Migration test requirements in China, Japan, India and Korea#

Outside the EU and the US, migration testing follows national positive lists: Japan's for food utensils, containers and packaging has applied since 1 June 2020 and was revised from 1 June 2025, and China's rules sit in GB 9685 and the GB 4806 series. China's additive list is covered under GB 9685 and GB 4806.

Japan's revised tables (MHLW Notification No. 324 of 30 November 2023) are explained under Japan positive list for food contact plastics. According to a regulatory news source, Korea's MFDS requires DEHP migration from PVC food-contact materials to be not detected from 27 March 2027.

Is IS 9845 an Indian migration test?#

Yes: IS 9845 is the Indian standard that the FSSAI Packaging Regulations of 2018 cite for overall migration from plastic packaging, against a limit of 60 mg/kg or 10 mg/dm2, the same values as the EU. IS 9833 for colorants completes the India food contact rules.

Plasticizer migration and extraction tests outside food contact#

Three plasticizer tests carry the word migration or extraction without being food-contact tests: ISO 177 for migration into an absorbent solid, ASTM D1239-22a for extraction by liquids, and ASTM D1203-23 for volatile loss. Causes and fixes are covered under plasticizer migration, extraction and volatility.

Do you need an accredited laboratory or a certificate?#

No EU certificate for migration exists: compliance is declared by the business itself in a declaration of compliance, and the test reports behind it are supporting documentation that an authority can request. ISO/IEC 17025 accreditation is the usual evidence of a fit method, and this page quotes no test price because no verified figure exists. Check an additive's regulatory status first with the additive regulatory status checker.

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