Updates to food contact requirements for plastics

Exploring Commission Regulation (EU) No 10/2011 Amendment 2020/1245.

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’.

There are 15 amendments to the 10/2011 regulation, the most significant recent amendment being 2020/1245, which was published in September 2020. Within this amendment, Article 2 states that plastic materials complying with Regulation (EU) Number 10/2011 which were first placed on the market before 23^rd March 2021 may continue to be placed on the market until 23^rd September 2022, and can remain on the market until exhaustion of stocks.

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

Selecting simulants

The first step in overall migration testing is to select appropriate simulants for the intended use of the product (see table 1). The food category specific assignment of the simulants is outlined in table 2 of Annex III. Regulation 10/2011 confirms that suitability for all food types can be achieved by testing against simulants A, B and D2.

Table 1: 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 2), which give a contact time and temperature to replicate the intended food contact conditions (listed in table 3 of Annex V). 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 2: Overall migration conditions
Test number	Contact duration and temperature	Intended food contact conditions
OM 0	30 minutes at 40°C	Short duration at ambient temperatures
OM 1	10 days at 20°C	Frozen or refrigerated
OM 2	10 days at 40°C	Long-term storage at room temperature
OM 3	2 hours at 70°C	Includes short-term 100°C contact
OM 4	1 hour at 100°C	Up to 100°C contact
OM 5	2 hours at reflux or 1 hour at 121°C	Up to 121°C contact
OM 6	4 hours at 100°C or at reflux	Above 40°C aqueous contact
OM 7	2 hours at 175°C	High temperature fatty foods

One of the most important changes under Amendment 15 of the regulation is the inclusion of a new test number – ‘OM 0’. This standardised testing condition of 30 minutes at 40ºC is the first condition specifically suitable for plastic food contact materials intended for short-term use at ambient temperatures. This is an important change, as it will affect the choice of testing conditions for various product sectors, including food handling gloves. For those intended uses that were not previously represented by one of the OM conditions – and therefore were assessed using modified conditions for the overall migration (such as ten minutes at 40ºC) – OM 0 can be used to show compliance with the regulation instead of needing a modification.

The migration requirements for specific substances have changed significantly under Amendment 2020/1245 to include a further ten substances in table 1 of Annex II (see table 3 in this article). This will affect the testing required for food contact materials. One of the additions is antimony, which has been introduced due to the use of antimony trioxide as an additive during polymer production. 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) within table 1 of Annex I in the regulation, which states that these substances should not migrate or be released from plastic materials into food or food simulants. They should not be detectable by analytical equipment with a limit of detection of 0.002 mg/kg. For those amines where a limit is not specified in the regulation, a maximum limit of less than 0.01 mg/kg applies.

Another important inclusion in Amendment 2020/1245 is the change of wording regarding articles intended for repeated contact with food. The migration testing is conducted three times on a single sample using fresh simulant on each occasion. Annex V Chapter 2 now states that for repeated 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 article must be below 10 mg/dm² for all three of the exposures.

The specific migration of the substances listed in table 3 must also be determined three times for repeated-use articles (once after each exposure) and, 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 Amendment 2020/1245 are available to download on the Europa website. For further information about Regulation (EU) No 10/2011 Amendment 2020/1245, a webinar presented by SATRA is free to watch at satra.com/resources

Table 3: 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	Not detectable
Zinc	5

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