What is the Swiss FCM Regulation?

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Update time : 2026-11-13

The Swiss Federal Department of Home Affairs (FDHA) has reformed the Ordinance on Food Contact Materials and Articles (No. SR 817.023.21 / RO 2026 374, revised on June 19, 2026, notified by the WTO via G/SPS/N/CHE/103 on July 3, and published on the official website on July 8). The new regulation will officially come into effect on August 1, 2026.

This revision is sweeping and comprehensive, simultaneously absorbing three new EU regulations in one go: (EU) 2025/351, (EU) 2026/245, and (EU) 2026/250. The core changes are clear at a glance.

Background and Overview

Although Switzerland is not a member state of the European Union, many requirements in its Ordinance on Food Contact Materials and Articles are highly harmonized with EU regulations.

In February 2026, the list of authorized substances in the EU Plastics Regulation (EU) 10/2011 was supplemented and revised. To remain consistent with EU regulations, Switzerland's plastics list has also been synchronously supplemented and updated in this revision.

For BISphenol A and its analogues, it is also emphasized that they must comply with the regulatory restrictions in (EU) 2024/3190.

Furthermore, this revision introduces new requirements regarding the selection of cheese simulants, the compliance assessment of migration limits, and the quality assurance system for recycled plastics.

Core Revisions

Bisphenols

Annex 13 (Coatings and Coating Layers) has been updated. The new regulation stipulates:

1.Bisphenol A (BPA) and its salts: Only permitted for use in accordance with the provisions of EU Regulation (EU) 2024/3190;

2.Testing method: For the verification method where BPA must not be detected, the limit of detection (LOD) must reach 1 μg/kg;

3.Definition of hazardous bisphenols/bisphenol derivatives: Refers to substances classified as mutagenic, carcinogenic, toxic to reproduction, or endocrine disruptors (Category 1) in Section 1 of Annex 2 of the Chemicals Ordinance (ChemV);

4.Other hazardous bisphenols: Only permitted for use in accordance with Article 5 and Annex II of EU Regulation (EU) 2024/3190.

Migration Testing of Plastic Materials

Annex 4 makes technical revisions to the compliance assessment rules for the migration limits of plastic materials:

1.Analytical method requirements: The linear range of the analytical method must cover RL×LMS to RU×LMS (where RU=2, RL=0.2), and the measurement uncertainty is to be calculated using a specific coefficient of variation (CVR) formula;

2.Expression of results: Specific migration values should be expressed using the actual surface area-to-volume ratio (S/V); for containers with a capacity of less than 500 mL or more than 10 liters, as well as films, seals, etc., simplified calculation methods may be used;

3.Testing of reusable materials: Reusable materials must undergo three migration tests. Compliance with the migration limit is determined based on the results of the third test, and the migration amount must not show an increasing trend (i.e., the second test must not exceed the first, and the third must not exceed the second). If it is scientifically proven that the migration amount will not increase, and the first test does not exceed the limit, it can be deemed compliant.

Quality Assurance System for Recycled Plastics

Annex 5 imposes stricter quality assurance system requirements on enterprises producing recycled plastics for food contact:

1.Recycling enterprises must establish a systematic quality manual detailing organizational structure, management responsibilities, and competency requirements;

2.Formulate a quality control plan covering key processes such as raw material specifications, supplier qualifications, sorting, washing, deep cleaning, and heating;

3.Establish Critical Control Point (CCP) monitoring procedures and set critical limits;

4.Implement batch quality assessments to ensure every batch of recycled materials complies with regulatory requirements, or to determine whether corrective actions, rejection, or diversion to non-food contact uses are required.

Newly Added and Revised Authorized Substances

Annex 2 and Annex 10 have been updated synchronously, adding several authorized substances or modifying the usage conditions for some existing substances.

FCM No.	CAS No.	Substance Name	Category	Restrictions and Specifications	Type of Change
768	0143925-92-2	Bis(hydrogenated tallow alkyl)amine oxide	Additive	Only for contact with non-fatty foods, ≤0.1 wt% in polyolefins, ≤0.25 wt% in PET	Modification (Replacement)
1084	1821217-71-3	Polymer of triphenyl phosphate with 1,4-cyclohexanedimethanol and polypropylene glycol (C10-16 alkyl ester)	Additive, limit 5 mg/kg	Additive only, ≤0.15% w/w in polyolefins, suitable for room temperature and below, including heating at 100°C for 2 hours, prohibited for infant formula and human milk, molecular weight <1000 Da fraction ≤13% w/w	Addition
1089	81607-35-1	Calcium di-tert-butyl phosphite	Additive	Nucleating agent only, ≤0.15% w/w, maximum heating at 100°C (2 hours) and 130°C (≤15 minutes), prohibited for infant formula and human milk	Addition
1092	1801863-42-2	Oxidized amine-di-C14-C20-alkyl, derived from vegetable oil	Additive	Additive only, ≤0.1% w/w in polyolefins, contact with non-fatty foods, suitable for room temperature and below (including heating at 100°C for 2 hours), prohibited for infant formula and human milk	Addition
1093	1883583-80-9	Oxidized rice bran wax	Additive	Additive only, ≤0.3% w/w in PET, PLA, and rigid PVC, contact with non-fatty foods, suitable for room temperature and below (including heating at 100°C for 2 hours)	Addition
1094	2752-17-2	2,2'-Oxydiethylamine	Monomer, limit 0.05 mg/kg	Comonomer only (≤14% w/w), reacted with adipic acid, caprolactam, and their authorized homologues to manufacture polyamide films ≤25μm, migration of oligomers with molecular weight <1000 Da ≤5 mg/kg food, prohibited for infant formula and human milk	Addition
1096	1850357-57-1	Oxidized rice bran wax calcium salt	Additive	Additive only, ≤0.3% w/w in PET, PLA, and rigid PVC, contact with non-fatty foods, suitable for room temperature and below (including heating at 100°C for 2 hours)	Addition

Transition Period

This revision will officially come into effect on August 1, 2026. To mitigate industry disruption, the Swiss authorities have established a 1-year transition period: ordinary products that do not comply with these new regulations may continue to be imported and sold until August 1, 2027.

In addition, for products that do not meet the requirements of previous amendments, the regulation also provides instructions regarding the transition period, specifically:

1.Conventional products: Products not complying with the new regulations may continue to be imported, produced, and labeled under the old rules until August 1, 2027, with the sales period concluding at the same time.

2.Specific reusable finished products: If they contain substances listed in Item 136 of Annex 2/10, or fail to meet the requirements of Chapter 2 of Annex 13 / Annex 14, they may be placed on the market under the old rules until July 20, 2026 (which is just around the corner), and their sales may continue until July 20, 2027.

Comparison with EU Regulations

Swiss FCM regulations have always closely followed the pace of the EU. This time, RO 2026 374 can be described as a "packaged synchronization" of EU regulations:

1.Annex 2 / Annex 10 (Positive List) aligns with (EU) 2026/245, revising the plastics positive list, adding 6 new substances, and updating existing entries.

2.Annex 2 / 10 / 13 (Bisphenols) links with (EU) 2026/250, calibrating the details of the (EU) 2024/3190 bisphenol ban.

3.Annex 4 (Migration Testing, Reusable Materials) harmonizes with (EU) 2025/351, regulating plastic purity, reusable materials, and compliance assessment rules.

4.Annex 5 (Recycled Plastics QA) integrates with (EU) 2025/351, clarifying the quality assurance system requirements for recycled plastics.