1. Meaning and Content of EN 1186
EN 1186 is a comprehensive series of European standards titled “Materials and articles in contact with foodstuffs – Plastics.”
Its primary purpose is to determine the overall migration from plastic materials into food. Overall Overall migration is the total mass of non-volatile substances transferred from the plastic material to a food simulant (a test medium that mimics food) under specified conditions. It does not identify specific chemicals but measures the total amount, ensuring the material is inert and does not excessively contaminate the food.
The core principle is the Overall Migration Limit (OML), which is set by European legislation at:
- 10 milligrams per square decimeter (mg/dm²) for most containers.
- 60 milligrams per kilogram (mg/kg) for containers intended for infants, small-volume containers, or where the surface area cannot be determined.
EN 1186 provides the standardized laboratory methods to verify that plastic materials comply with this legal limit.
2. What Products Does EN 1186 Apply To?
EN 1186 applies to a wide range of plastic materials and articles intended to come into contact with food. This includes:
- Food Packaging: Bottles, trays, pots, tubs, lids, and films.
- Kitchenware: Plastic utensils, cutting boards, storage containers.
- **Food Food Processing Equipment: Parts like seals, gaskets, tubing, and conveyor belts made from plastics.
- Disposable Items: Cutlery, cups, plates, and straws.
- Laminates and Coatings: Where a plastic layer is in direct contact with food.
While the main focus is on finished plastic articles, it also applies to the base plastic polymers and resins used to manufacture them.
It’s important to note that while EN 1186 is designed for plastics, its test methods for overall migration are sometimes referenced or adapted for testing other materials, like silicones or multi-layer materials with a plastic contact layer.
3. Testing Methods of EN 1186
EN 1186 is not a single test method but a series of documents, each detailing a specific approach depending on the type of plastic and its intended use. The key components are:
- **Food Food Simulants: Instead of real food, which is complex and variable, standardized simulants are used:
- Simulant A: Ethanol 10% (v/v) – for aqueous foods.
- Simulant B: Acetic acid 3% (w/v) – for acidic foods.
- Simulant C: Ethanol 20% (v/v) – for alcoholic foods.
- Simulant D1: Olive oil or alternative synthetic triglyceride – for fatty foods.
- Substitute Tests: Since testing with olive oil can be difficult, some parts of EN 1186 allow for substitute tests using iso-octane or 95% ethanol for certain types of plastics, as these are more aggressive simulants for fat migration.
- Test Conditions (Time & Temperature): The testing conditions simulate real-life use, such as:
- **Cold Cold Storage: 10 days at 5°C
- Room Temperature: 10 days at 20°C or 30 minutes at 100°C (for hot fill)
- Heating in oven/microwave: Specific times at 70°C, 100°C, 121°C, or 175°C.
- The chosen condition must reflect the most severe foreseeable use of the product.
- Common Test Methods (from the EN 1186 series):
- EN 1186-1: Guide to selection of conditions and test methods.
- Total Immersion (e.g., EN 1186-2): The test piece is fully immersed in the simulant. Good for irregular shapes.
- Pouch Method (e.g., EN 1186-3): The plastic film is formed into a pouch, filled with simulant, and sealed.
- Cell Method (e.g., EN 1186-4): A one-sided contact cell is used where only one side of the plastic is exposed to the simulant. Ideal for rigid sheets.
- Article Fill Method (e.g., EN 1186-5): The actual finished article (like a cup or tub) is filled with the simulant.
4. Is EN 1186 a Mandatory Standard?
No, EN 1186 itself is not a mandatory law.
However, it is critically important because it provides the “presumption of conformity” with mandatory European Union regulations.
- The Law: The main EU regulation is the Framework Regulation (EC) No 1935/2004, which sets the general safety requirement for all food contact materials. More specifically, the Plastics Implementation Measure (EU) No 10/2011 (and its amendments) sets the legally binding rules for plastic food contact materials, including the Overall Migration Limit (OML) of 10 mg/dm².
- The Role of EN 1186: To prove compliance with the legal OML, manufacturers must test their products. EN 1186 provides the officially recognized, standardized testing methodology. If a manufacturer tests their product according to the relevant part of EN 1186 and it passes, they can confidently declare it complies with the law. Using a different, non-harmonized method would make it much harder to demonstrate compliance.
In summary: **Com Compliance with the law (EU 10/2011) is mandatory. Using EN 1186 is the standard way to prove that compliance.
5. Additional Notes about EN 1186
- Part of a Larger Framework: EN 1186 deals only with overall migration. Another crucial standard is EN 13130, which specifies methods for determining specific migration of particular substances (like monomers or additives).
- Harmonized Standards: Many parts of the EN 1186 series have been published in the Official Journal of the EU as “harmonised standards.” This gives them a strong legal standing within the single market.
- Global Relevance: While a European standard, EN 1186 is internationally recognized. Manufacturers exporting to the EU must often conduct testing according to its protocols.
- Complexity: Selecting the correct part of EN 1186, the right simulant, and the appropriate time-temperature conditions requires expert knowledge of both the material and its intended use. This is typically done by specialized testing laboratories.
