Main points published in the Amendment EU 2020/1245 of Regulation (EU) No 10/2011 on food contact plastic materials

Entry

Replaced in table 1  by

236

23050

0000108-45-2

1,3-phenylenediamine

no

yes

no

ND

(28)

398

35760

0001309-64-4

Antimony trioxide

yes

no

no

(6)

Entry

New added  authorised substances in table 1

1075

Montmorillonite clay modified with hexadecyltrimethylammonium bromide

yes

no

no

Only to be used as an additive at up to 4.0 % w/w in polylactic acid plastics intended for long-term storage of water at ambient temperature or below.

Can form platelets in the nanoform that are thinner than 100nm in one or two dimensions. Such platelets shall be oriented parallel to the polymer surface and shall be fully embedded in the polymer.

1076

1227937-46-3

Phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2-ethanediyl)], C10-16 alkyl ester

yes

no

no

0,05

Only to be used as an additive at up to 0.2 % w/w in high-impact polystyrene materials and articles intended or contact with food at room temperature or below, including hot-fill and/or heating up to 100 °C for up to 2 hours. It shall not be used in contact with foods for which simulant C and/or D1 is assigned in Annex III.

1077

Titanium dioxide surface-treated with fluoride-modified alumina

yes

no

no

Only to be used at up to 25.0 % w/w, including in the nanoform.

29

Note nº

Table 3 – New added notes on verification of compliance

28

A detection limit of 0.002 mg/kg food or food simulant applies.

29

In polar polymers which swell in contact with foods for which simulant B is assigned in Annex III, there is a risk that the migration limits for aluminium and fluoride will be exceeded under severe contact conditions. Under contact conditions longer than four hours and at 100 °C or above, this can be greatly exceeded.

List of  PAAs (Entry 43 to Appendix 8 of Annex XVII to REACH Regulation (EC) No 1907/2006)

If they are listed and do not have a corresponding migration limit specified in Table 1 of Annex I.

Detection limit: 0.002 mg/kg food or food simulant applied to each individual PAA.

If they are not listed, but do not have a corresponding migration limit specified in Table 1 of Annex I, compliance with Article 3 of Regulation (EC) No 1935/2004 shall be verified in accordance with Article 19.

The sum of such PAAs should not exceed 0.01 mg/kg in food or food simulant.

Point

Replaced by

6

‘Adequate information relating to the substances used or products of degradation thereof for which restrictions and/or specifications are set out in Annex I and II to the Regulation to allow the downstream business operators to ensure compliance with the Regulation.

At intermediate stages, this information shall include the identification and amount of substances in the intermediate material,

• that are subject to restrictions in Annex II, or
• for which genotoxicity has not been ruled out, and which originate from an intentional use during a manufacturing stage of that intermediate material and which could be present in an amount that foreseeably gives rise to a migration from the final material exceeding 0.00015 mg/kg food or food simulant. ’

CHAPTER 2 Testing for specific migration of materials and articles not yet in contact with food

2.1.3.   Conditions of contact when using food simulants

Additional point (iv) on defining rules for the migration of plastic materials or components in food processing equipment or appliances. The main points are:

• The food or food simulant is processed during testing by the equipment (or part thereof) in accordance with the worst foreseeable conditions that could feasibly arise if the equipment or its part is operated in accordance with its operating instructions, and
• the migration from parts used for storage such as from reservoirs, containers, or capsules or pads which are part of the equipment during the processing of the food, is determined using conditions representative for their use, unless the applied testing conditions for the whole tested equipment or appliance are representative also of their use.

When the result is not in compliance with the Regulation, it shall be determined whether the source of the non-compliance is a plastic part subject to the Regulation or a part made from another material not subject to the Regulation, on the basis of documentary evidence or analytical testing.

2.1.6.    Repeated use materials and articles

Section replaced entirely by:

‘If the material or article is intended to come into repeated contact with foods, the migration test(s) shall be carried out three times on a single sample using another portion of food simulant on each occasion. The specific migration in the second test shall not exceed the level observed in the first test, and the specific migration in the third test shall not exceed the level observed in the second test.

Compliance of the material or article shall than be verified on the basis of the level of the migration found in the third test and on the basis of the stability of the material or article from the first to the third migration test. The stability of the material shall be considered insufficient if migration is observed above the level of detection in any of the three migration tests, and increases from the first migration test to the third migration test. In case of insufficient stability, compliance of the material shall not be established even in case the specific migration limit is not exceeded in any of the three tests.

However, if there is conclusive scientific proof that the level of the migration decreases in the second and third tests and if the migration limits are not exceeded on the first test, no further test is necessary.

Irrespective of the above rules, a material or article shall never be considered to comply with this Regulation if in the first test a substance that is prohibited from migrating or from being released in detectable quantities under Article 11(4) is detected.’

CHAPTER 3 - Testing for overall migration

3.1.   Standardised testing conditions

In the Table 3 ‘Standardised conditions for testing the overall migration’, the main changes are:

• New OM0 test (30 min at 40 °C) for any food contact at cold or ambient temperatures and for a short duration (≤ 30 minutes);
• “or at reflux” has been added to test OM4;
• The OM0 test has been added to all notes to the table.

3.2.    Substitute overall migration tests for tests with food simulant D2

The paragraphs preceding the table in this section have been replaced by the following:

‘If it is not technically feasible to perform one or more of the tests OM0 to OM6 in food simulant D2, migration tests shall be done using ethanol 95 % and isooctane. In addition, a test shall be done using food simulant E in case the worst foreseeable conditions of use exceed 100 °C. The test that results in the highest overall migration shall be used to establish compliance with the Regulation.

In case it is technically not feasible to perform OM7 with food simulant D2, either test OM8 or test OM9 shall be selected as a replacement test by selecting the most appropriate of these two tests on the basis of the intended and the foreseeable use of the material or article that is being tested. Subsequently, a migration test shall be done at each of the two test conditions specified for the selected test, using a new test sample for each test condition. The test condition that results in the higher overall migration shall be used to establish compliance with the Regulation.’

3.3.    Verification of compliance

The text of section 3.3.2. ‘Repeated use articles and materials’ is replaced in its entirety by the following:

‘The applicable overall migration test shall be carried out three times on a single sample using another portion of food simulant on each occasion. The migration shall be determined using an analytical method in accordance with the requirements of Article 34 of Regulation (EU) 2017/625 of the European Parliament and of the Council (*2). The overall migration in the second test shall be lower than in the first test, and the overall migration in the third test shall be lower than in the second test. Compliance with the overall migration limit shall be verified on the basis of the level of the overall migration found in the third test.

If it is not technically feasible to test the same sample three times, such as when testing in vegetable oil, the overall migration test can be carried out by testing different samples for three different periods of time lasting one, two and three times the applicable contact test time. The difference between the third and the second test results shall be considered to represent the overall migration. Compliance shall be verified on the basis of this difference, which shall not exceed the overall migration limit. In addition, the difference between the second and the first test results shall be lower than the first test results and the difference between the third and the second test results shall be lower than the difference between the second and the first test results.

By derogation from the first paragraph, if, on the basis of scientific evidence, it is established that for the material or article being tested the overall migration decreases in the second and third tests and if the overall migration limit is not exceeded in the first test, the first test alone shall be sufficient.’