Plastic food contact materials
The EU has very specific rules on plastics in contact with food. What are the requirements?
For any product put on the market in the EU regulation (EC)1935/2004 covers the general rules applicable to all materials and articles intended to come into contact with food. For specific measures, like materials such as plastics, more detailed legislation has been put in place by the EU.
In the case of a plastic food contact product, material and/or component, detailed requirements in are set out in regulation (EU) 10/2011.
Regulation (EU) 10/2011
This specific regulation applies to any product, component or material which is intended or reasonably expected to come into contact with food and is made from:
- plastic (including printed and covered by coating)
- plastic multi-layer materials held together by adhesives (including printed and covered by coating)
In addition to the above, the regulation also applies to the following materials:
- Plastic layers or plastic coatings, forming gaskets or packingsin caps and closures
- plastic layers in multi-material multi-layer food contact materials ("sandwich materials with a non-plastic food contact layer")
Where a plastic is defined as a "polymer to which additives or other substances may have been added, which is capable of functioning as a main structural component of final materials and articles" ; and is obtained by:
- a polymerisation process
- chemical modification of natural or synthetic macro molecules;
- microbial fermentation;
Note: unmodified natural polymers, like cellulose, are not in scope of this regulation
The regulation provides the following general requirements applicable to all plastics:
- specifications for plastic materials and articles, like composition of substance, purity criteria, details concerning the manufacturing process etc.
- compliance testing requirements for plastic materials and articles.
- requirements for a declaration of compliance (DoC).
- migration limits for certain metalions (Barium(Ba),Cobalt (Co), Copper (Cu), Iron (Fe), Li (Lithium), Mn (Manganese) and Zinc (Zn)) [see note 2]
- limits for the migration of primary aromatic amines.
Note 1: "Migration test" means the determination of the release of substances from the material or article either into food or into a food simulant.
Note 2: Regulation (EU) 2016/1416 has amended (EU) 10/2011 with an additional migration limit for Aluminium (Al) and an updated limit for Zinc (Zn) applicable from 14 September 2018.
In addition the regulation requires that the composition of the substances used to manufacture the plastic materials and articles to be known to the manufacturer of the substance and made available to the competent authorities on request, in other words a bill of substance or ingredient list for a food contact article and/or material needs to be available.
Next to the general requirements, the regulation covers:
- a so-called "Union list" of authorised (approved) substances that can be used in the manufacture of plastic materials and articles for food contact purposes.
- which types of substances are covered by the Union list and which are not.
- restrictions and specifications for these substances.
- to which part of the plastic materials the Union list appliesand to which not.
- specific and overall migration limits for the plastic materials and articles.
In the EU polymers/plastics themselves are not approved or authorised for food contact, but the substances which could be present in and could potentially migrate into food have been authorised under certain conditions. The Union list, Table 1 of Annex I in the Regulation, contains in principle all substances that are approved/authorised to be present in the final plastic material, this includes monomers and other starting substances, as well as substances intentionally added to achieve certain plastic properties and polymer production aids ("PPA").
Note: for PPAs, the Union list is not an exhaustive list. This means that PPAs others than those listed can be used in the manufacture of plastics.
If a substance on the Union list is used or present in the plastic, it has to comply with the specifications and migration limits set out in the list. If these substances are used in coatings, adhesives or printing inks that are part of the plastic materials within the scope the regulation, then the final material also has to comply with the relevant migration limits for these substances.
Relevant specifications as set out by the regulation for the use of substances could be:
- a restriction in relation to the food that may come in contact, e.g. "not to be used for articles in contact with fatty foods";
- the restriction in relation to contact conditions, e.g. "only in repeated use articles".
Note: The Union list is regularly updated with new and updated requirements for substance, latest amendment has been regulation (EU) 2016/1416 and will apply from 14 September 2017.
Substance migration requirements
Plastic materials and articles should not transfer their constituents/substances to foods in amounts exceeding:
- the specific migration limits (SML) as listed in the Union list per substance
- an overall migration limit of maximum 10 milligrams of total substances released per dm2 of food contact surface (mg/ dm2).
Note: for products for infants and young children, the overall migration is a maximum of 60 milligrams of total of substances released per kg of food simulant.
Specific migration limits (SML) are expressed in mg of substance per kg of food (mg/kg). For substances for which no specific migration limit or other restrictions are provided in Annex I, a generic specific migration limit of 60 mg/kg applies.
Verification of compliance with the specific migration limits needs to be carried out in the food the product or materials wil be in contact with, or, more common, in specific foodsimulants as set- out in the regulation (see table 1). The different food simulates described in the regulation are intended to mimic "real" food.
Food simulants A, B and C are assigned for foods that have a so- called hydrophilic character ("water-soluble") and are able to extract hydrophilic substances ("water soluble substances"):
- Food simulant A (ethanol 10% v/v) is mainly used for products made out of fruits, vegetables, eggs, meat and fish.
- Food simulant B (acetic acid 3% v/v) needs be used for those foods which have a pH below 4.5. like juices and vinegar
- Food simulant C (ethanol 20% v/v) needs be used for alcoholic foods with an alcohol content of up to 20 % and foods which contain a relevant amount of organic ingredients that make the food more lipophilic ("fat-soluble"), like coffee, syrups or jams.
Food simulants D1 (ethanol 50% v/v) and D2 (vegetable oil) are assigned for foods that have a lipophilic character ("fat-soluble") and are able to extract lipophilic substances (fat-soluble and therefore not very water soluble substances):
- Food simulant D1 shall be used for alcoholic foods with an alcohol content of above 20 % and for oil in water emulsions, like milk and cheese.
- Food simulant D2 shall be used for foods which contain free fats at the surface, for example roasted foods.
Food simulant E (poly(2,6-diphenyl-p-phenylene oxide), particle size 60-80 mesh, pore size 200 nm) is assigned for testing specific migration into dry foods.
For certain food types it is possible multiple simulants need to be applied. More detailed information can be found in table 2 of Annex II of the regulation, where per different food type the most suitable standard foodsimulant has been provided.
Note: changes to foodsimulants for fruit and vegetables have been published with regulation (EU) 2016/1416 applicable from 14 September 2018
For the compliance testing itself the following general rules apply.
1) Verification method
Verification of compliance of migration into foods with the migration limits have to be carried out under the most extreme conditions of time and temperature foreseeable in the actual use of the product.
2) Sample preparation
The material or article has to be treated and tested as described by the instructions/manual or according to the details given in the declaration of compliance.
3) Test conditions
The sample has to be tested in contact with the food simulant in a manner representing the worst of the foreseeable conditions of use as regard contact time (see table 1)
and contact temperature (see table 2).
note: above table will apply from 14 September 2017 (regulation (EU) 2016/1416), for the current version of table 2 please refer to the latest consolidated version of (EU)/10/2011.
If the material or article is intended to come into repeated contact with foods, the migration test(s) has to be carried out three times on a single sample. Compliance is determined on the basis of the level of the migration found in the third test.
Overall migration testing
For the overall migration requirement standardised conditions are described in column 3 of Table 3 (see also the regulation) below and has to be performed for the time specified and at the temperature specified in column 2. The food simulant used for the overall migration will be similar to the simulants used for the specific migration testing.
More details can be be found at the website of the EU on food contact materials.
The EU has also created a food contact material database, which acts as a tool to inform about the authorised substances allowed be used/present in materials and articles intended to come into contact with food, including all the details and specifications behind it