The bewildering extent of regulations, legislation, audits, checks and testing, plus the negotiation of contracts with suppliers and customers all underlies this at a price at which the Food Business Operator (FBO) can maintain commercial advantage.
Commerce should never override safety. However, the reality of how to respond to circumstances is not usually so straightforward; there are absolute legal limits, complete prohibitions, guidelines, best practice benchmarks, as well as contractual terms and internal standards, alongside ever increasing sensitivity of testing. Knowledge and control interact with actions, responses and responsibilities.
What approach should be taken to levels of contamination from a food safety and food quality position?
The risk assessment approach underlines all food safety legislation. EU regulation 178/2002 asks FBOs if they “consider or have reason to believe” there is any breach of Food Safety Requirements. Namely whether or not a food may be:
- Injurious the health - based on health vulnerabilities of particular consumers for whom the product is “intended”, “probable” short term/long term effect on health and subsequent generations and “probable” cumulative toxicity.
- Unfit for human consumption - ie by reason of contamination through purification, deterioration or decay or by extraneous matter and whether a food is deemed “acceptable” for human consumption according to its intended use.
This assessment should be based on normal conditions of use at each stage of production and supply and the information provided to the consumer.
In order to have responsibility the FBO must have some control over the food - import, production, process, manufacture or distribution. Where the food has not left the FBOs control, ie not gone to a third party distributor, it may be ring-fenced without any subsequent obligations of notification, withdrawal or recall.
There are a series of rebuttable presumptions, the key ones being the presumption that the entirety of a batch, lot or consignment is unsafe unless evidence is provided to the contrary; food is “deemed” safe in the areas in which it complies with EU requirements or national requirements on food safety, however, conformity with specific food provision will not prevent action by competent authorities.
An investigation will need to ensure that the facts are properly considered. Only where the food may be “injurious to health” is there the requirement that immediate notification should be provided to competent authorities. Otherwise a proactive and responsive notification is needed but there is not the same time critical aspect.
The risk assessment will consider the hazard, ie food poisoning, multiplied against the likelihood of that hazard occurring, steps there might be to ameliorate the hazard/likelihood, and finally the calculation of overall “risk”.
The specifics of the product and the consumer as well as quantities the product is likely to be consumed in should feed into any risk assessment. For example; salmonella coalesces in the fat of chocolate resulting in raised levels in certain chocolate bars. If these are then eaten by a vulnerable consumer group (children), it can result in sickness (and a million pound fine for Cadbury’s).
The risk assessment will provide information as to whether or not the food may be deemed at risk of being “injurious to health”. If this is not the case, next test is to consider the “fitness” of the food; central to this will be the concept of “acceptability” to the ultimate consumer. Is there a discolouration? Unpleasant odour? Taint? All of these aspects impact on a food’s acceptability to a consumer.
Responsibilities for breach of the Food Safety Requirements require notification to competent authorities, ie the Food Standards Agency, and withdrawal from the supply chain, (informing the consumer of reasons for withdrawal if food has reached them). The obligation to recall is only where other measures are not sufficient to achieve a high level of health protection. It is important that product liability insurance therefore covers all withdrawal costs as well as recall as often a recall is not specifically required.
If there is no discernible difference to the consumer and no safety issue it should then be considered if this is a technical breach only of specific mandatory prohibitions which require no notification or withdrawal/recall provisions. This will also pivot on the objective behind the legislation and the level of breach.
Often the precautionary principle is referenced as a cautionary approach. However this is not the precautionary principle (Article 7 General Food Law) refers to specific situations where:
- There are reasonable grounds for concern that an unacceptable level of risk to health exists.
- The unavailable supporting information and data are not sufficiently complete to enable a comprehensive risk assessment to be made.
Any measures then taken should be non-discriminatory, proportionate and provisional until more comprehensive information can be gathered and analysed.
Some contaminants have a zero threshold and so information on the level of testing and ensuring compliance with these requirements need to be monitored. Be clear on the testing regime and have substantiation for this.
De Minimis Amounts
Testing has become so sensitive that there is the chance a whole host of contaminants may be exposed that were always present but were simply not known about. Here it is important to ensure a consistent and objective approach to what level testing is required to and at what point this becomes significant from a technical, legislative and consumer perspective.
Strategic policy review
If your company has a policy for differing levels of contaminants, then there may be a benefit to showing a consistent risk assessment approach.
As an FBO consider in advance different possible contaminants and the levels at which they may have an effect on the product/end product. Also the definition of contamination levels and legislative requirement consider whether onward processing may impact on these levels and what commercial requirements you are under. Be aware of ongoing supply issues and when product may be in scarce supply and ensure that testing of these are increased to reflect this.