Regulatory Information
International standards / Regulations for different tests on food contact materials are listed below:
FDA Macroanalytical Procedures Manual (MPM) V-12
German Food, Articles of Daily Use and Feed Code of September 1, 2005 (LFGB)
(EC) No. 1935/2004
(EU) No. 10/2011
Regulation (EU) No. 2016/1416
Regulation (EU) 2017/752
European Commission Directive 2007/19/EC
BS EN 1388-1
Materials and articles in contact with foodstuffs. Silicate surfaces. Determination of the release of lead and cadmium from ceramic ware
BS EN 1388-2
Materials and articles in contact with foodstuffs. Silicate surfaces. Determination of the release of lead and cadmium from silicate surfaces other than ceramic ware
BS EN 1186-1
Materials and articles in contact with foodstuffs. Plastics. Guide to the selection of conditions and test methods for overall migration
BS EN 1186-2
Materials and articles in contact with foodstuffs. Plastics. Test methods for overall migration into olive oil by total immersion
BS EN 13130-1
Materials and articles in contact with foodstuffs. Plastics substances subject to limitation.
Exploration of EU Regulations for Materials and Articles in Contact with Foodstuffs
The followings provide an exploration of the EU regulations for materials and articles intended to come into contact with foodstuffs, and delve into the scope of FCMs, the regulatory landscape, specific requirements for various materials, testing methodologies, compliance procedures, and emerging challenges in this critical area.
1. The EU Regulatory Framework for Food Contact Materials
The EU has established a comprehensive regulatory framework for FCMs, based on the principles of food safety, consumer protection, and free movement of goods. This framework consists of a hierarchy of regulations, directives, and guidelines.
1.1 Framework Regulation (EC) No 1935/2004: The Foundation of FCM Regulation
Regulation (EC) No 1935/2004, commonly known as the Framework Regulation, is the cornerstone of FCM regulation in the EU. It lays down the general principles of safety and inertness that apply to all FCMs, regardless of their material composition or intended use.
Key Provisions of the Framework Regulation:
• General Safety Requirement (Article 3): FCMs must be manufactured in accordance with good manufacturing practices so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could:
- Endanger human health.
- Bring about an unacceptable change in the composition of the food.
- Bring about a deterioration in its organoleptic characteristics (taste, odor, appearance).
• Traceability (Article 17): FCMs must be traceable throughout the supply chain, from manufacturer to retailer, to facilitate the identification and recall of non-compliant products.
• Good Manufacturing Practice (GMP) (Article 5): FCMs must be manufactured in accordance with GMP to ensure their quality and safety. GMP requirements are further detailed in Regulation (EC) No 2023/2006.
• Labelling (Article 15): FCMs must be labelled appropriately to provide consumers with information about their intended use, safety precautions, and the name and address of the manufacturer or importer.
• Declaration of Compliance (DoC) (Article 16): Manufacturers must provide a Declaration of Compliance (DoC) stating that their FCMs comply with the applicable regulations. The DoC must include specific information about the FCM, its intended use, and the regulations it complies with.
• Specific Measures (Article 5): The Framework Regulation allows for the adoption of specific measures for individual materials or groups of materials, laying down more detailed requirements.
1.2 Specific Measures: Tailoring Regulations to Material Types
Building upon the foundation of the Framework Regulation, the EU has adopted specific measures for certain materials, providing more detailed requirements and testing methodologies. These specific measures take the form of Regulations or Directives.
Key Specific Measures:
• Regulation (EU) No 10/2011 on Plastic Materials and Articles Intended to Come into Contact with Food: This regulation is the most comprehensive and detailed specific measure for FCMs. It sets out detailed rules for the composition, migration limits, and testing requirements for plastic FCMs.
- Positive List (Annex I): A list of authorized monomers, additives, and other substances that can be intentionally used in the manufacture of plastic FCMs. Only substances on the positive list are permitted, subject to specific restrictions and migration limits.
- Overall Migration Limit (OML) (Article 12): A limit on the total amount of substances that can migrate from the plastic into the food simulant (10 mg per square decimeter of the material surface or 60 mg per kg of food).
- Specific Migration Limits (SMLs) (Annex I): Limits on the migration of individual substances, such as Bisphenol A (BPA) and phthalates. SMLs are based on toxicological assessments and are designed to protect consumers from the harmful effects of these substances.
- Testing Requirements (Annex V): Detailed testing methods for verifying compliance with the migration limits, including the use of specific food simulants, testing conditions (temperature, time), and analytical techniques.
• Regulation (EC) No 450/2009 on Active and Intelligent Materials and Articles Intended to Come into Contact with Food: This regulation sets out rules for active and intelligent materials, which are designed to interact with the food to extend shelf life, monitor its condition, or provide information to the consumer.
- Safety Assessment: Active and intelligent materials must undergo a safety assessment to ensure that they do not release harmful substances into the food or compromise its safety.
- Labelling Requirements: Active and intelligent materials must be labelled appropriately to inform consumers about their function and safety precautions.
• Directive 2007/42/EC relating to Materials and Articles Made of Regenerated Cellulose Film Intended to Come into Contact with Food: This directive sets out specific requirements for regenerated cellulose film, which is used for packaging various food products.
- Composition Requirements: Regenerated cellulose film must comply with specific requirements regarding its composition and manufacturing process.
- Migration Limits: Regenerated cellulose film must comply with specific migration limits for certain substances.
• Commission Regulation (EU) 2018/213 on bisphenol A in varnishes and coatings intended to come into contact with food and amending Regulation (EU) No 10/2011 as regards bisphenol A: This regulation specifically addresses the use of Bisphenol A (BPA) in varnishes and coatings applied to FCMs, further restricting its use due to concerns about its endocrine-disrupting properties.
2. Testing Methodologies and Standards for Food Contact Materials
To ensure compliance with the EU regulatory framework, FCMs must undergo rigorous testing to verify their safety and performance. These tests are designed to simulate real-world conditions and assess the potential for migration of harmful substances into food.
2.1 Migration Testing: The Core of FCM Safety Assessment
Migration testing is the most important type of testing for FCMs. It involves measuring the amount of substances that migrate from the material into a food simulant under controlled conditions. The results of migration testing are compared to the OMLs and SMLs specified in the EU regulations to determine whether the FCM is compliant.
Key Aspects of Migration Testing:
• Food Simulants: The choice of food simulant is crucial for accurate migration testing. The EU regulations specify a range of food simulants designed to mimic the properties of different types of food. The appropriate food simulant is selected based on the intended use of the FCM. The main food simulants are:
- Simulant A: Ethanol 10% (v/v) in water (represents aqueous foods).
- Simulant B: Acetic acid 3% (w/v) in water (represents acidic foods).
- Simulant C: Ethanol 20% (v/v) in water (represents alcoholic foods with an alcohol content up to 20%).
- Simulant D1: Ethanol 50% (v/v) in water (represents alcoholic foods with an alcohol content above 20%).
- Simulant D2: Vegetable oil (represents fatty foods).
- Simulant E: Poly(2,6-diphenyl-p-phenylene oxide) (MPPO) (represents dry foods).
• Testing Conditions: The testing conditions, such as temperature and duration, are carefully controlled to simulate the intended use of the FCM. The regulations specify different testing conditions for different types of FCMs and different food types.
• Surface Area to Volume Ratio: The ratio of the surface area of the FCM to the volume of the food simulant is also carefully controlled to simulate the real-world conditions of food contact.
• Analytical Methods: Sophisticated analytical methods are used to measure the amount of substances that migrate into the food simulant. These methods include:
- Gas Chromatography-Mass Spectrometry (GC-MS): For volatile organic compounds.
- Liquid Chromatography-Mass Spectrometry (LC-MS): For non-volatile organic compounds.
- Inductively Coupled Plasma Mass Spectrometry (ICP-MS): For heavy metals.
2.2 Overall Migration Limit (OML) Testing
The Overall Migration Limit (OML) is a limit on the total amount of substances that can migrate from a plastic FCM into the food simulant. Compliance with the OML is verified by measuring the total amount of non-volatile substances that migrate into the food simulant. The OML is typically expressed in milligrams per square decimeter of the material surface (mg/dm²) or milligrams per kilogram of food (mg/kg).
2.3 Specific Migration Limit (SML) Testing
The Specific Migration Limit (SML) is a limit on the migration of individual substances, such as Bisphenol A (BPA) and phthalates. Compliance with the SML is verified by measuring the concentration of the specific substance in the food simulant. SMLs are based on toxicological assessments and are designed to protect consumers from the harmful effects of these substances.
2.4 Other Relevant Testing Standards
In addition to migration testing, other relevant testing standards are used to assess the safety and performance of FCMs. These standards cover various aspects, such as:
• Sensory Testing: To assess whether the FCM imparts any undesirable taste or odor to the food.
• Mechanical Testing: To assess the strength and durability of the FCM.
• Thermal Stability Testing: To assess the FCM's resistance to heat.
• Chemical Resistance Testing: To assess the FCM's resistance to chemicals.
• Heavy Metal Release Testing: For ceramic and metallic FCMs, to assess the release of heavy metals such as lead and cadmium.
2.5 Key European Standards for FCM Testing
The EU regulations often refer to specific European Standards (EN standards) that provide detailed testing methods and requirements for different types of FCMs. Some of the key EN standards include:
• EN 1186 series: Materials and articles in contact with foodstuffs - Plastics. This series of standards provides detailed testing methods for migration testing of plastic FCMs.
• EN 13130 series: Materials and articles in contact with foodstuffs - Plastics substances subject to limitation - Specifications for migrations of substances from plastics into foodstuffs and food simulants and determination of substances in plastics. This series of standards provides specifications for the migration of specific substances from plastics into foodstuffs and food simulants.
• EN 1388-1: Ceramic articles intended to come into contact with food - Release of lead and cadmium - Part 1: Test method. This standard specifies a test method for determining the release of lead and cadmium from ceramic articles.
• EN 601: Stainless steel - Chemical composition. This standard specifies the chemical composition of stainless steel alloys used for FCMs.
• EN 13179-1: Ceramic cookware - Part 1: Resistance to thermal shock. This standard specifies a test method for determining the resistance of ceramic cookware to thermal shock.
