Montenegro Revises Rules for Food Contact Plastics

SafeGuardSHardgoodsNovember 12, 2025

SG 165/25

Montenegro has updated its requirements for plastic materials and articles intended to come into contact with food to further align with those in the European Union (EU).

In 2016, Montenegro established the nation’s framework for food contact materials (FCMs) and articles (Official Gazette of Montenegro (OGM) No 80/2016) by adopting provisions from two pieces of EU legislation:

Regulation (EC) No 1935/2004 on FCMs and articles (current consolidated version to 2021 for reference)
Regulation (EC) 2023/2006 on good manufacturing practice (GMP, current consolidated version to March 2025 for reference)

In October 2025, Montenegro issued ‘Regulation on Special Conditions for Plastic Materials and Articles Intended to Come into Contact with Food’ to set new rules for food contact plastics (‘the Regulation’, OGM No 120/2025). This Regulation transposes into the country’s domestic law:

Regulation (EU) No 10/2011 on food contact plastics, as amended to Regulation (EU) 2025/351 (consolidated version to March 2025 for reference)
Regulation (EC) 1895/2005 on certain food contact epoxy derivatives

Key highlights of the Regulation are summarized in Table 1.

Section to the Regulation	Highlight
Article 3 ‘Scope’	Applies to: Materials and articles and their parts consisting exclusively of plastics Plastic multi-layer materials and articles held together by adhesives or other means Materials and articles in the two points above that are printed and/or covered by a coating Plastic layers or plastic 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 Plastic layers in multi-material multi-layer materials and articles
Article 4 'Exception’	Exempts a) ion exchange resins, b) rubber and c) silicones
Article 6 ‘High degree of purity’	A substance is considered as having a high degree of purity if all its constituents form part of its identity, and it otherwise contains a minor quantity of non-intentionally added substances (NIAS) that meet one of the following conditions: They comply with specifications or restrictions listed in Table 1 to Annex 1 They are considered compliant after a risk assessment in accordance with internationally recognized scientific principles (Article 21) ≤ 0.05 mg/kg for an individual migration if a relevant toxicological assessment has been performed in accordance with guidelines from the European Agency for Risk Assessment (European Food Safety Authority, EFSA) and the substances are not genotoxic ≤ 0.00015 mg/kg for the migration of each substance if they have undergone a risk assessment other than an assessment in points ii and iii above
Article 10 ‘General requirements for substances’	Stresses that substances, including those manufactured from waste, must be of a high degree of purity if they are used in the manufacture of food contact plastics and are present in the finished plastic material
Article 12 ‘General restrictions and requirements concerning the composition of plastic materials and articles’	Permits the use of ‘reprocessed plastics’, subject to meeting specified conditions Food contact articles intended for repeated use must have a composition and design that guarantees no increase in the migration of constituents of the material or article to the food will occur when subjected to subsequent use cycles of the articles in accordance with the instructions for intended use as described in documentation or labeling
Article 13 ‘Specific migration limits’	Requires materials and articles to respect specific migration limits (SMLs) listed in Annex 1 Sets the detection limit (DL) at 0.01 mg/kg if no SMLs are established for certain substances or groups of substances
Article 14 ‘Overall migration limits’	≤ 10 mg/dm², otherwise ≤ 60 mg/kg for materials and articles intended for infants and young children
Article 23 ‘Annexes’	Emphasizes that Annexes 1 to 5 are an integral part of the Regulation
Article 24 ‘Repeal’	Repeals OGM No. 63/19 on special conditions for food contact plastics, and its amendment under OGM No 143/22
Annex 1 ‘Substances’	Contains several Tables: Table 1 ‘List of approved monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids: specifies a positive list of more than 1,000 substances and their specifications, including but not limited to DBP (FCM no 157), BBP (159), DEHP (283), diallyl phthalate (316), DINP (728) and DIDP (729) Table 2 ‘Group restriction of substances’: Details group restrictions of substances, including DIBP under group restriction nos. 32 and 36 Table 3 ‘Notes on verification of compliance’ Table 4 ‘Detailed specification on substances’
Annex 2 ‘Restrictions on plastic materials and articles’	Specifies a general list of 24 substances migrating from plastic materials and articles, of which 19 have SMLs
Annex 3 ‘Food simulants’	Details a list of food simulants and their assignments for migration testing, including a table with specific types of food, for demonstrating compliance
Annex 4 ‘Declaration of conformity’	Describes the requirements for a declaration of conformity (DoC)
Annex 5 ‘Compliance testing’	Details general rules applicable to migration testing, including time and temperature Sets criteria for repeated use materials and articles. This includes conducting migration testing three times on a single sample, verifying compliance on the basis of the level of the specific migration observed in the third migration and confirming stability Standardizes testing conditions for overall migration (OM), including the use of conditions for OM1 to OM9 Specifies conditions for using Fat Reduction Factors (FRF) for correction of specific migration in foods containing more than 20% fat

Table 1

The Regulation entered into force on October 28, 2025 – eight days following its publication in the OGM.

Abbreviation	Name of phthalate	CAS
BBP	Phthalic acid, benzyl butyl ester	85-68-7
DBP	Phthalic acid, dibutyl ester	84-74-2
DEHP	Phthalic acid, bis(2-ethylhexyl) ester	117-81-7
DIBP	Diisobutyl phthalate	84-69-5
DIDP	Phthalic acid, diesters with primary saturated C₉-C₁₁ alcohols, more than 90% C₁₀	68515-49-1 26761-40-0
DINP	Phthalic acid, diesters with primary saturated C₈-C₁₀branched alcohols, more than 69% C₉	68515-48-0 28553-12-0

SGS has the expertise to help manufacturers and suppliers of FCM achieve compliance with markets around the globe. Our technical experts have extensive experience of testing materials and articles for many markets. We offer the full range of FCM testing, including migration tests, along with expert advice on emerging regulations, compliance issues and documentation review. Our experience can ensure your products meet the appropriate territorial regulations for food contact materials and help pave the way for compliance. Contact us to know more or visit our website. In the end, it’s only trusted because it’s tested.

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