Material responsibilities

03 April 2020

Who is responsible for ensuring that food contact materials meet the Framework Regulation? Eric Partington reports.

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Despite lead being the oldest known form of poisoning, it was not until 1970 that the UK banned its use in piping for the supply of potable water to industrial and domestic premises. The first Materials and Articles in Contact with Food legislation - Directive 76/893/EEC came into force in 1976. Its Article 2 required that materials in contact with food must not be harmful to the consumer. Since then, this piece of legislation has developed through 89/109/EEC and it has been elevated to a Regulation ? EU 1935/2004 (more commonly known as the Framework Regulation). However, the stipulation (now in Article 3) remains the same – word-for-word ? that materials put into contact with food ‘must not transfer their constituents to that food in quantities which could endanger human health, or bring about an unacceptable change in the composition of the food, or cause a deterioration in its organoleptic characteristics’.

Even materials we may think of as inert in a food context have been found to be harmful. Ceramics, for example, can release unacceptable levels of lead and cadmium. We now know that Bisphenol A – which has been used since the 1960s to produce polycarbonate food containers – can leach from those plastics into food, and BPA is an endocrine disruptor which can cause birth defects and cancers. So, it is vital that the constituents which may be released from a food contact material are known and quantified.

The most common materials of construction in food production are either metallic or synthetic. In terms of 'endangering human health' the maximum amounts of each element which a metallic material is allowed to release into food have been set by the World Health Organisation, according to the accepted 'severity of consequence' of their release. For example, the limit for iron is 40mg/kg of food and for aluminium it is 5 mg/kg. But, for lead the limit is just 0·004mg/kg.

The European Directorate for the Quality of Medicines and Healthcare's guidance booklet Metals and alloys used in food contact materials and articles first issued in 2001 and updated in 2013 details test procedures for the determination of release levels.

Not all materials need to be tested before they can be put into service. Currently the demonstration that they are not harmful under defined operating conditions can (for most metals, some alloys, some synthetics and for glasses) be based on 'significant and relevant past experience.' Stainless steels, for example, have been used in most food production plants for many, many years, as have many nitrile rubbers, and silicone rubbers, and PTFE and EPDM.

However, plastics, recycled plastic materials, composites and ceramics are never afforded the 'significant and relevant past experience' exemption. Nor is any synthetic material which is to be used in an environment of which there is no experience. The Plastics Directive EC 2019/37, which supersedes EC 2016/1416 (which, in turn, superseded EC 2015/174) includes a positive list of monomers authorised for specific applications. However, it also states that any plastic not currently on that list must be tested, in the final form in which it will be in contact with the food or beverage, either in that medium or in one of a certain number of approved simulants.

Common misunderstandings

It seems to be a common misunderstanding that the way for a buyer to ensure compliance with food contact materials legislation is simply to stipulate that ‘all food contact materials are FDA- or NSF-approved’. Not so! Not only is it a meaningless claim, but it is also insufficient to meet the obligations laid down in UK law – it is compliance with the Framework Regulation – now embodied in UK Statutory Instrument 2619 (2012) – that must be demonstrated, not American legislation.

So, how do we ensure that materials comply? There is a very important first step in the process of selecting materials for food contact such that they meet the requirements of Article 3; one that is often overlooked. The food-business operator must determine the working conditions under which the product will be expected to perform and these conditions need to be provided to the equipment supplier in appropriately-detailed technical terms. Telling a potential supplier that the pump you are looking to buy will be 'for food use' is not quite good enough! What is the chemistry of that food or beverage, such as its chloride levels and its pH. At what temperature and for how long will it be in contact with the material? Hot mustard is more demanding of materials than cold milk - white wine is more acidic than red wine. And similar chemistry/time/temperature data should be determined not only for the foods which it is intended to process but also for the cleaning procedures it is intended to apply.

Manufacturers generally have extensive knowledge of the materials they use and given the correct information should be able to suggest the most appropriate material to meet those conditions. Only by combining the food-business operator's knowledge of his processes with the engineer's knowledge of materials can the most appropriate materials for the application be specified. So, while primary responsibility for meeting the Framework Regulation lies with the equipment manufacturer, the food business operator has an important secondary responsibility to provide sufficient technical data for the manufacturer to be able to ensure compliance.

But the Framework Regulation requires more. So that, should concern about some piece of food processing or storage equipment be raised, it can be recalled, every single example must be marked with a unique identification such as a serial number. Records of these must be kept and if any or all of those items are sold or passed to another owner, the record of their serial numbers must be kept by both parties.

The Framework Regulation warrants the attention of both supplier and customer. But its purpose is very straightforward – to ensure that the customer can continue to enjoy the safe, untainted food to which he has a legal right.

Eric Partington is chairman of the Regional Section of the European Hygienic Engineering and Design Group (EHEDG).