EU Proposes to Revise Food Contact Plastics Regulation

SafeGuardSHardgoods, HardgoodsMarch 24, 2020

The EU has published a draft regulation to amend and correct the food contact plastics regulation, (EU) 10/2011. If approved, the new law will enter into force on the twentieth day after its publication in the Official Journal.

The European Comitology Register has published a draft Regulation to amend and correct Regulation (EU) 10/2011 on food contact plastics (the Regulation). This comprehensive proposal contains, inter alia, important changes to Annexes I, II, IV and V to the Regulation.

According to the new proposal, the new law will enter into force on the twentieth day after its publication in the Official Journal of the EU. Food contact plastics complying with the Regulation before the entry into force of the new Regulation, and which were first placed on the market within six months after the date of entry into force, may continue to be placed on the market for two years and remain there until stocks are exhausted.

Highlights of the proposal are summarized in Table 1.

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 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 five 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 specific limit in Annex I – this obligation is to be verified in accordance with Article 19 of the Regulation ‘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. Although compliance for migration is based on the third test, compliance cannot be established if the migration value increases from the first migration test to third migration test even if the SML is not exceeded in any of the three tests
		Replaces Table 3 under point 3.1 to Chapter 3 ‘Standardized Conditions for Testing the Overall Migration’: New Test Number OM0 (40 °C, 30 minutes) for any food contact at cold or room temperatures with 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

Entry	Name	Salts allowed according to Article 6(3)(a)	Specific Migration Limit (mg/kg)
1	Aluminum	Yes	1
2	Ammonium	Yes	--*
3	Antimony	No	0.04
4	Arsenic	No	Not Detected (ND) (Detection Limit = 0.01)
5	Barium	Yes	1
6	Cadmium	No	ND (Detection Limit = 0.002)
7	Calcium	Yes	--*
8	Chromium	No	ND** (Detection Limit = 0.01)
9	Cobalt	Yes	0.02
10	Copper	Yes	5
11	Europium***	Yes	0.05
12	Gadolinium***	Yes	0.05
13	Iron	Yes	48
14	Lanthanum***	Yes	0.05
15	Lead	No	ND (Detection Limit = 0.01)
16	Lithium	Yes	0.6
17	Magnesium	Yes	--*
18	Manganese	Yes	0.6
19	Mercury	No	ND (Detection Limit = 0.01)
20	Nickel	No	0.02
21	Potassium	Yes	--*
22	Sodium	Yes	--*
23	Terbium***	Yes	0.05
24	Zinc	Yes	5
Migration is subject to Articles 11(3) and 12 * Less stringent limit of 3.6 mg/kg allowed if pre-existing documentation demonstrates Cr (VI) is excluded ***Lanthanide 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

SGS technical experts have extensive knowledge and testing experience in materials and articles in contact with food. They work to ensure that your products meet the appropriate regulations for food contact materials and pave the way for compliance. From overall migration test to expert advices on emerging regulations and compliance issues and documentation review, SGS is the partner to trust. Please do not hesitate to contact us for further information or visit our website.

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Hingwo Tsang
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