Ukraine Regulates Food Contact Plastics

SafeGuardSHardgoodsFebruary 22, 2024

SG 35/24

Ukraine has approved the nation’s requirements for food contact plastics. These will become effective on November 19, 2025

On February 9, 2024, Ukraine’s Ministry of Health (Міністерства охорони здоров'я України) issued two pieces of legislation on food contact plastics in the nation’s Official Gazette. These were:

Order No. 2104 of December 11, 2023, on the approval of ‘Special requirements for plastic materials and articles intended to come into contact with foodstuffs’ (Order 2104/2023).
Order No. 11 of January 2, 2024, to revise Order 2104/2023, with editorial changes for clarity (Order 11/2024)

Order 2104/2023 details a comprehensive set of special requirements for food contact plastics (the Special requirements) by implementing Regulation (EU) No. 10/2011, as amended to Regulation (EU) 2023/1442, from the European Union (consolidated version to August 2023 for reference).

Highlights of the Special requirements in Order No. 2104/2023 are summarized in Table 1.

Special Requirements	Highlights
Section I ‘General Provisions’ Scope	Food contact plastics, including multi-layer materials and articles that are held together by adhesives or other means Materials and articles in the point above that are printed and/or coated Plastic layers in multi-material multi-layer materials and articles Plastic layers or coatings, forming gaskets in caps and closures, that together with those caps and closures compose a set of two or more layers of different types of material
Section I ‘General Provisions’ Exemption	Glues, ion exchange resins, printing inks, rubber, silicones, varnishes and coatings
Section II ‘Requirements for the composition of plastic materials and articles intended for contact with food’	Only substances in Appendix 1 (positive list) or those on the state register are authorized for manufacturing Details derogations for substances that are not on the positive list
Section III ‘General requirements, restrictions and technical specifications’	Details restrictions and specific migration limit (SML) requirements (Appendix 1, Table 1) ≤ 10 mg/dm² overall migration limit (OML), otherwise ≤ 60 mg/kg OML for food contact plastics for infants and young children Provides a general set of specific migration requirements for several substances (Appendix 2) ≤ 0.002 mg/kg for each (of the 22) primary aromatic amines (PAA, Appendix 3) ≤ 0.01 mg/kg for the sum of PAA not listed in Appendix 3 and where there is no migration limit specified in Table 1 to Appendix 1 (positive list) ≤ 0.01 mg/kg SML for substances or groups of substances without an established detection limit Economic operators must draw up a written declaration of compliance (DoC) for plastic materials and articles, products from intermediate stages of manufacturing, as well as substances intended for the production of those materials and articles.
Section IV ‘ Special provisions for multi-layer materials and articles’	Unless exempt, the composition of each layer of plastic must comply with the Special Requirements Plastic layers in a multi-material multi-layer material or article must always comply with the requirements for vinyl chloride monomer (VCM, FCM substance no. 127, Appendix 1)
Appendix I	List of permitted substances and their specifications
Appendix 2	General list of migration limits for substances migrating from food contact plastics (See Table 2 below)
Appendix 3	List of primary aromatic amines (PAA, azo dyes)

Table 1

Appendix 2 to Order 2104/2023 ‘General list of migration limits for substances migrating from plastic materials and articles (per Order text)

Item	Substance	SML (mg/kg)
1	Aluminium	1
2	Ammonium	---
3	Antimony	0.04¹
4	Arsenic	Not detected (ND) (Detection limit = 0.01)
5	Barium	1
6	Cadmium	ND (Detection limit = 0.002)
7	Calcium	---
8	Chromium	ND (Detection limit = 0.01)²
9	Cobalt	0.05
10	Copper	5
11	Europium	0.05³
12	Gadolinium	0.05³
13	Iron	48
14	Lanthanum	0.05³
15	Lead	ND (Detection limit = 0.01)
16	Lithium	0.6
17	Magnesium	---
18	Manganese	0.6
19	Mercury	ND (Detection limit = 0.01)
20	Nickel	0.02
21	Potassium	---
22	Sodium	---
23	Terbium	0.05³
24	Zinc	5
¹ SML may be exceeded at very high temperature ² Less stringent limit of 3.6 mg/kg applies if pre-existing documentation demonstrates Cr (VI) is excluded ³ Lanthanides (europium, gadolinium, lanthanum, and/or terbium) can be used according to Clause 4(2) of Section III to Special Requirements 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 Clause 10 of Section III to Special Requirements

Table 2

Orders 2104/2023 and 11/2024 will apply from November 19, 2025 – the same day that applies to the nation’s law on food contact materials and articles (SafeGuardS 135/22)

Food contact plastics that were manufactured before November 19, 2025, may remain in circulation until stocks are exhausted.

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, paving the way for compliance. From overall migration tests to expert advice on emerging regulations, compliance issues and documentation review, SGS is the partner to trust. Discover more on our website. In the end, it’s only trusted because it’s tested.

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