Materials and articles in contact with food
SATRA's chemical and analytical laboratories can test for the legislative compliance of homeware articles.
Regulation (EU) No. 10/2011 (including amendment 1282/2011) is a European regulation which brings all European Union legislation on food contact plastics under one umbrella, replacing, among others, Directive 2002/72/EC.
The regulation, which came into force on 1st May 2011, was fully enacted on 1st January 2013. It applies to all plastic articles or materials supplied in the European Union which are intended or reasonably expected to come into contact with foodstuffs. This includes plastic food packaging materials, storage containers, cooking utensils and plastic knives and forks. It also applies to items in contact with food during processing, such as protective 'food safe' gloves.
The purpose of the regulation is to limit the release of substances from the plastics which may be harmful to human health. There are two types of limits: 'overall migration limit' (OML) and 'specific migration limit' (SML).
Overall migration limit
This is the maximum permitted amount of non-volatile substances that can be released into the food. The overall migration is determined by exposing the item to a chemical food simulant for a specified and appropriate length of time, after which the extracted residue is dried and weighed. There are two requirements concerning the OML in Regulation (EU) No. 10/2011:
- no more than 10mg of total constituents per dm2 of food contact surface (mg/dm2)
- for food for infants and young children, the limit is no more than 60mg of total constituents released per kg of food simulant (mg/kg).
The appropriate chemical food simulant must be selected that reflects the food type in the intended use of the product. There are six simulants detailed in the regulation:
- simulant A – 10 per cent ethanol (v/v)
- simulant B – 3 per cent acetic acid (w/v)
- simulant C – 20 per cent ethanol (v/v)
- simulant D1 – 50 per cent ethanol
- simulant D2 – Vegetable oil
- simulant E – Poly (2, 6-diphenyl-p-pheylene oxide), particle size 60-80 mesh, pore size 200nm.
Simulants A, B and C are assigned for foods that have hydrophilic properties (attracted to, and tending to be dissolved by water), and can extract hydrophilic substances. These foods are generally aqueous in character. Simulants D1 and D2 are for foods that have lipophilic properties (the ability to dissolve in fats and oils, and non-polar solvents, such as hexane and toluene), and are able to extract lipophilic substances. They are generally fatty in character. Simulant E is assigned for testing specific migration into dry foods.
Conditions – duration of exposure and testing temperature
Appropriate chemical simulants for testing against different food stuffs are selected using the tables in Regulation (EU) No. 10/2011. Once the appropriate simulant(s) have been selected, an exposure period and testing temperature must be chosen. These conditions must replicate the intended use of the plastic food contact material. Testing conditions should represent the worst foreseeable use of the item to ensure meaningful results are obtained. There are seven defined conditions for overall migration to define contact time and intended food contact conditions. Here are three practical examples of when they may be appropriate:
- a pot used for holding yoghurt for sale in a supermarket – 10 days at 20°C – test number OM1, using simulants B (if the food has a pH of less than 4.5) and D1
- plastic container for fresh pasta sauce – 10 days at 40°C – test number OM2, using simulants A, B (if the food has a pH of less than 4.5) and D2
- food preparation gloves where the process requires contact with hot aqueous food – 2 hours at 70°C – test number OM 3, using simulants A, B and C.
Ceramics, glass and vitreous enamel
The European Commission is currently revising the limits for the release of lead and cadmium from ceramic materials and articles intended to come into contact with foodstuffs, detailed in Council Directive 84/500. The Commission is also considering the inclusion of other materials, such as glass, in the new measure. The current limits for ceramic articles intended to come into contact with foodstuffs are 4mg of lead per litre of food simulant and 0.3mg of cadmium per litre of food simulant. It has been proposed that these limits may be revised down to 10µg/kg of food simulant for lead and 5µg/kg of food simulant for cadmium.
SATRA can provide testing to determine the release of lead and cadmium from articles intended to come into contact with food in accordance with the test method BS 6748:1986 + A1:2011 – 'Limits of metal release from ceramic ware, glassware, glass ceramic ware and vitreous enamel ware, Appendix A'.
General framework regulations
Framework Regulations (EC) 1935/2004, in force since 3rd December 2004, is legislation which provides general principles for the manufacture and use of materials that come into contact with food. This covers all types of materials, including woods, metals, silicones, textiles and rubbers.
The general principles state that food contact materials must not transfer their components into food in quantities that could endanger human health, change food composition in an unacceptable way or deteriorate its taste and odour. They must also be labelled or bear the glass-and-fork symbol (figure 1). The labelling is not obligatory if food contact is obvious by the article’s nature – for instance, a knife, fork or wine glass. In addition, food contact materials must be traceable throughout the supply chain.
There are specific measures for testing food contact materials made from ceramics, regenerated cellulose, newly processed plastics and recycled plastics. SATRA currently tests articles intended to come into contact with food using the BS EN 1186 test methods. We are UKAS-accredited to test using the total immersion, article filling low temperature, high temperature and fatty foodstuff 'substitute tests' methods. These tests can be carried out on a large range of products, including gloves, plastic crockery, placemats, plastic straws and food packaging film.
As mentioned earlier, Regulation (EU) No. 10/2011 was fully enacted at the start of 2013. Technical guidelines to support the regulation are currently being written and are expected to be published imminently. These guidelines will provide new test methods to enable testing upon plastic materials intended for food contact to ensure articles comply with Regulation (EU) No. 10/2011. SATRA can provide advice and assistance during this transitional period and ensure that materials comply with EU law.
|Specific migration limits of extracted metals|
|Specific migration of these metals shall not exceed the following limits as detailed in Regulation (EU) No. 10/2011.
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