FCMs

Materials and Articles Intended for Food Contact

Food safety does not only concern food itself, but also all materials that come into contact with it during processing, packaging, or consumption.
In this context, the FCMs (Materials and Articles in Contact with Food) regulation applies, defining safety and quality requirements for materials such as plastic, rubber, glass, metal, and single-use devices, such as gloves used by food industry operators.

The main objective of the regulation is to ensure that no material transfers unwanted substances to food, thereby safeguarding consumer health and the quality of the food product.

What is the FCMs regulation

The regulatory framework for Materials and Articles intended to come into Contact with Food is defined by:

Regulation (EC) No. 1935/2004, which establishes the general safety principles;
Regulation (EC) No. 2023/2006, which governs Good Manufacturing Practices (GMP);
Regulation (EU) No. 10/2011, which regulates plastic materials;
Ministerial Decree of 21/03/1973, which concerns natural and synthetic rubbers.

These regulations ensure that the materials used, including those of single-use gloves for food use, do not release components in quantities that could pose a risk to health or alter the composition, taste, smell, or color of food.

Who the regulation applies to

The FCMs regulation applies to all operators in the food supply chain: manufacturers, importers, distributors, processors, and retailers of materials intended to come into contact with food. This also includes manufacturers and distributors of single-use gloves used for food handling, such as those employed in catering, the food industry, and retail.

In practice, anyone who places on the market a material or object that may come into direct or indirect contact with food must ensure its compliance with FCMs requirements.

What obligations are required by the FCMs Regulation

The regulation imposes a series of technical and documentation requirements to ensure the safety of materials intended for food contact, including:

1. Safety and inertness requirements

Materials must be chemically inert, meaning they must not release substances in quantities that could pose a risk to human health or alter the organoleptic properties of food.

2. Production according to GMP

In accordance with Reg. (EC) No. 2023/2006, manufacturers must comply with Good Manufacturing Practices (GMP), ensuring controlled, traceable, and documented processes.

3. Compliance verification

Each FCMs product must undergo specific laboratory tests, including:

Overall migration: verifies the total amount of substances released by the material.

Specific migration: analyzes individual substances (additives, monomers, colorants) within the limits set by Reg. (EU) No. 10/2011.

Color transfer: ensures that pigments are not transferred to food.

4. Migration limits

10 mg/dm² for plastic materials.
8 mg/dm² for rubber materials.

These values represent the maximum amount of substances that may migrate from the material to food without posing a risk to health.

5. Labeling and traceability

Each FCMs product must indicate the conditions of use (contact time and temperature, for example 2 hours at 40 °C for single-use gloves) and ensure full traceability throughout the production chain, as required by Reg. (EC) No. 1935/2004.

How Dr. Protec ensures compliance

Dr. Protec ensures that its disposable gloves intended for food contact fully comply with FCMs regulations. Compliance is verified through:

global and specific migration tests carried out by ISO/IEC 17025 accredited laboratories;
dye transfer resistance checks;
use of certified raw materials compliant with European regulations;
documented traceability throughout the entire supply chain;
FCMs declaration of conformity available for each type of glove.

These procedures ensure that Dr. Protec gloves are safe, compliant, and suitable for use in professional environments where hygiene and food safety are essential.

IN BRIEF

FCMs = Materials and Articles in Contact with Food.

Objective: to protect health and ensure food quality.

Scope: plastic materials, rubber, metals, glass, and disposable devices such as gloves.

Mandatory tests: global and specific migration, color transfer resistance.

Migration limits: 8 mg/dm² (rubber), 10 mg/dm² (plastics).

Compliance verified by accredited laboratories and certified with a FCMs declaration.

Food safety begins with the correct choice of materials. Disposable gloves compliant with FCMs regulations provide a guarantee of hygiene and quality for operators, companies, and consumers.

For more information on current regulations, please contact our Quality Department.