Food contact testing requirements for plastics

Explaining the European Union’s legislation on the requirements for plastic materials which may come in contact with food.

Regulation (EU) No 10/2011 details the requirements for plastic materials in contact with food. For the purposes of the regulation, ‘plastic’ is defined as ‘a polymer to which additives or other substances may have been added, which is capable of functioning as a main structural component of final materials and articles’.

Within the regulation, the specific requirements that are detailed for plastic materials include overall and specific ‘migration limits’, a list of authorised substances and information on a declaration of compliance.

There are 17 amendments to the 10/2011 regulation, the most recent amendment being Commission Regulation (EU) 2023/1627, which was published in August 2023. Business operators have an 18-month transition period to adapt to the new rules imposed by the amendment.

The previous amendment (Amendment 16, Commission Regulation (EU) 2023/1442) published in July 2023 states that plastic materials and articles complying with the previous regulation and placed on the market before February 1st 2025 can continue to be sold until stocks are exhausted.

One of the most significant changes in Amendment 16 (Commission Regulation (EU) 2023/1442) was the revision of specific migration limits for five phthalates. These are now DBP (0.12 mg/kg), BBP (6.0 mg/kg), DEHP (0.6 mg/kg), and the sum of DINP and DIDP (1.8 mg/kg).

There are also reductions in specific migration limits for five other substances:

• Triethanolamine
• perchloricacid, salts(perchlorate)
• diethyl[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl] phosphonate
• poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) (PHBH)
• phosphorous acid, triphenyl ester, polymer with alpha-hydro omegahydroxypoly[oxy(methyl-1,2-ethanediyl)], C10-16 alkyl esters.

Two substances have also been removed from Annex I and are therefore no longer permitted for use in plastic food contact materials, these are untreated wood flour and fibres, and salicylic acid.

Amendment 17 (Commission Regulation (EU) 2023/1627) changed Annex I to Commission Regulation (EU) No 10/2011 regarding bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate (DEHCH) on the authorisation list. DEHCH is a plasticiser used in polyvinyl chloride (PVC), and this amendment states that the substance is approved for use as an additive in PVC at up to 25 per cent where the migration limit should not exceed 0.05 mg/kg, It should also only be used in PVC in contact with foods where simulants A (10 per cent ethanol) and B (3 per cent acetic acid) (aqueous and acidic foods) are suitable, at room temperature or below.

Testing for overall and specific migration

Testing for overall migration is conducted using the EN 1186 test method series which was updated in 2022, the previous version being in use for 20 years. Overall migration against evaporable simulants is now conducted by EN 1186-3:2022, with this part of the standard then identifying the migration methods (see table 1).

Table 1: Exposure methods
EN 1186-3:2022	Exposure method
Method 1a	Total immersion in conventional oven (4 to 100 ºC)
Method 1b	Total immersion reflux
Method 2	Cell
Method 3	Fillable pouch
Method 4	Reverse pouch
Method 5	Filling a container

Appropriate simulants for the intended use of the product (see table 2) need to be selected for testing. The food category specific assignment of the simulants is outlined in Annex III of the regulation. Regulation 10/2011 confirms that suitability for all food types can be achieved by testing against simulants A, B and D2.

Table 2: Food simulants
Food simulant	Abbreviation
10 per cent ethanol	Simulant A
3 per cent acetic acid	Simulant B
20 per cent ethanol	Simulant C
50 per cent ethanol	Simulant D1
Vegetable oil	Simulant D2
poly(2,6-diphenyl-p-phenylene oxide)	Simulant E

Once the appropriate simulant(s) have been selected, an exposure period and testing temperature must be chosen. Testing conditions should represent the worst foreseeable use of the item in order to ensure that meaningful results are obtained.

There are eight conditions listed for overall migration (see table 3), which give a contact time and temperature to replicate the intended food contact conditions (listed in Annex V of the regulation). The length of time that the article is in contact with the food and the temperature are critical factors, as higher temperatures and longer contact times can allow for a greater migration of constituents from the article to the food. The overall migration limit is 10 milligrams (mg) of migration per squared decimetre (dm²) of the food contact material.

Table 3: Overall migration conditions
Test number	Contact duration and temperature	Intended food contact conditions
OM0	30 minutes at 40°C	Short duration at ambient temperatures
OM1	10 days at 20°C	Frozen or refrigerated
OM2	10 days at 40°C	Long-term storage at room temperature
OM3	2 hours at 70°C	Includes short-term 100°C contact
OM4	1 hour at 100°C	Up to 100°C contact
OM5	2 hours at reflux or 1 hour at 121°C	Up to 121°C contact
OM6	4 hours at 100°C or at reflux	Above 40°C aqueous contact
OM7	2 hours at 175°C	High temperature fatty foods

Specific migration limits of defined substances are listed within Annex II of Commission Regulation (EU) 10/2011 (see table 4). Some of the substances do not have a specific limit listed in the table. Where this occurs, Regulation 10/2011 Article 11(3) – which references regulations for food additives and flavourings – and Article 12 (the overall migration limit) both apply. This is the case for ammonium, calcium, magnesium, potassium and sodium. There are also specific migration limits for primary aromatic amines (PAAs), where the substances should not migrate or be released from plastic materials into food or food simulants. When assessed by analytical equipment, these substances should have a limit of 0.002 mg/kg, below which they are said to be ‘not detectable’. For those amines where a limit is not specified in the regulation, a maximum limit of less than 0.01 mg/kg applies.

For repeat-use articles, the migration must reduce in the successive exposures – that is, the overall migration must be lower for the second exposure and then further reduced in the third exposure.

The specific migration of the substances must also be determined three times for repeat-use articles – once after each exposure. Just like for the overall migration, the specific migration for each substance must be lower for the second exposure and then further reduced in the third exposure.

The latest consolidated version of Commission Regulation (EU) 10/2011 and Amendments 2023/1627 and 2023/1442 are available to download on the Europa website.

Table 4: Specific migration limits
Substance	Migration limit (mg/kg)
Aluminium	1
Ammonium	–
Antimony	0.04
Arsenic	Not detectable
Barium	1
Cadmium	Not detectable
Calcium	–
Chromium	Not detectable
Cobalt	0.05
Copper	5
Europium	0.05
Gadolinium	0.05
Iron	48
Lanthanum	0.05
Lead	Not detectable
Lithium	0.6
Magnesium	–
Manganese	0.6
Mercury	Not detectable
Nickel	0.02
Potassium	–
Sodium	–
Terbium	0.05
Zinc	5

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