EU Revises Food Contact Plastics Regulation

SafeGuardSHardgoods, HardgoodsSeptember 08, 2020

The EU has published Regulation (EU) 2020/1245 to revise Regulation (EU) 10/2011 on food contact plastics. The new law will enter into force on September 23, 2020

On September 3, 2020, the European Union (EU) published Regulation (EU) 2020/1245 to amend and correct Regulation (EU) 10/2011 on plastic materials and articles intended to come into contact with food (‘Food Contact Plastics Regulation’, consolidated version to August 2019 for reference). This comprehensive legislation contains, inter alia, important changes to Annexes I, II, IV and V to the Food Contact Plastics Regulation.

The new law will enter into force on September 23, 2020 – the twentieth day after its publication in the Official Journal of the EU (OJEU).

According to the latest legislation, food contact plastics complying with the Food Contact Plastics Regulation before September 23, 2020, and which were placed on the market before March 23, 2021, may continue to be placed on the market until September 23, 2022 and remain on the market until stocks are exhausted.

Highlights of the new law are summarized in Table 1.

Regulation (EU) 2020/1245 amending and Correcting Regulation (EU) 10/2011
Entry	Section	Highlight
1	Annex I, Table 1 ‘Union list of authorized substances’	A completely new detection limit of 0.002 mg/kg for 1,3-phenylenediamine (1,3-diaminobenzene, CAS 108-45-2) Addition of three new entries, including titanium dioxide surface-treated with fluorine-modified alumina
2	Annex II ‘Restrictions on plastic materials and articles’	Completely replaces Annex II: New Table 1 defines the specific migration limit (SML) for 19 substances where some of the substances are subject to certain conditions, and an additional 5 substances where their migrations are subject to Articles 11(3) and 12 (see Table 2 below) ≤ 0.002 mg/kg for each primary aromatic amine (PAA) listed in Appendix 8 to entry 43 of Annex XVII of Regulation (EC) 1907/2006 ‘Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)’ where there is no migration limit in Table 1 to Annex I ≤ 0.01 mg/kg for the sum of PAAs not listed in Appendix 8 to entry 43 of Annex XVII of REACH where there is no migration limit in Annex I – this obligation is to be verified in accordance with Article 19 ‘Assessment of Substances not Included in the Union List’
3	Annex IV ‘Declaration of Compliance’	Replaces point 6 to include information on the quantity of substances in intermediate materials
4	Annex V ‘Compliance Testing’	Amends point 2.1.3 to Chapter 2 ‘Conditions of contact when using food simulants’ Adds new point (iv) on defining rules for the migration of plastic materials or components in food processing equipment or appliances
		Replaces point 2.1.6 to Chapter 2 ‘Repeated Use Articles’ The migration test(s) for repeated use food contact materials and articles are obliged to be carried out three times on a single sample using a fresh portion of simulant on each occasion. The specific migration value for each occasion must not be higher than the value in the preceding migration test Verification of compliance is based on the level of migration found in the third test and on the basis of stability from the first to the third migration test. The stability of the material will be considered insufficient if the migration value is greater than the detection limit in any one of the three migration tests, and the value increases from the first to the third migration test. In the event of insufficient stability, compliance of the material will not be established even if the SML is not exceeded in any of the three tests No additional test is required if the level of migration decreases in the second and third tests and if the migration limits are not exceeded on the first test Regardless of the above rules, a material or article will not be considered to comply if a prohibited substance is found to migrate in detectable quantities in the first test
		Replaces Table 3 under point 3.1 to Chapter 3 ‘Standardized Conditions for Testing the Overall Migration’: New Test Number OM0 (40 °C, 30 mins) for any food contact at cold or room temperatures for no more than 30 minutes The words ‘or at reflux’ added to the testing conditions in OM4 Editorial changes to footnote to reflect OM0

Table 1

Regulation (EU) 2020/1245 amending and Correcting Regulation (EU) 10/2011 Table 1 to Annex II o ‘General list of migration limits for substances migrating from plastic materials and articles’
Entry	Name	SML (mg/kg)	Entry	Name	SML (mg/kg)
1	Aluminum¹	1	13	Iron¹	48
2	Ammonium^1,3	--	14	Lanthanum^1,6	0.05
3	Antimony^2,4	0.04	15	Lead²	ND (Detection Limit = 0.01)
4	Arsenic²	Not Detected (ND) (Detection Limit = 0.01)	16	Lithium¹	0.6
5	Barium¹	1	17	Magnesium^1,3	--
6	Cadmium²	ND (Detection Limit = 0.002)	18	Manganese¹	0.6
7	Calcium^1,3	--	19	Mercury²	ND (Detection Limit = 0.01)
8	Chromium^2,5	ND (Detection Limit = 0.01)	20	Nickel²	0.02
9	Cobalt¹	0.05	21	Potassium^1,3	--
10	Copper¹	5	22	Sodium^1,3	--
11	Europium^1,6	0.05	23	Terbium^1,6	0.05
12	Gadolinium^1,6	0.05	24	Zinc¹	5
¹Salts allowed ²Salts not allowed ³Migration is subject to Articles 11(3) and 12 ⁴SML might be exceeded at very high temperature (as note for antimony trioxide, FCM No 398) ⁵Less stringent limit of 3.6 mg/kg applies if pre-existing documentation demonstrates Cr (VI) is excluded ⁶Lanthanide substances can be used according to Article 6(3)(a) subject to SML is no more than 0.05 mg/kg for the sum of all lanthanide substances and the analytical evidence using a procedure demonstrating the lanthanide substance(s) used are present in dissociated ionic form in food or food simulant forms part of the documentation in Article 16

Table 2

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