The European Food Safety Authority (EFSA) and European Medicines Agency (EMA) have published a joint statement (click here) on the risk assessment of the veterinary medicine phenylbutazone, known as 'bute', in the context of recent fraudulent practices that has resulted in beef-based products being contaminated with horse meat.

The main risks on residues of bute have been confirmed as; idiosyncratic blood dyscrasias and genotoxic/carcinogenic potential. Although the risk of carcinogenicity to humans from exposure was considered very low based on the available experimental data on organ toxicity and carcinogenicity, as well as on the low exposure levels and the infrequent exposure to bute from horse meat or adulterated beef-based products, thresholds could not be idenitfied and therefore no maximum residue limits established.

Exposure to bute from horse meat consumed as such or present in beef-based products was assessed on the basis of limited monitoring data provided by 19 Member States and of conservative assumptions. Up to 144 and up to 36 800 individuals per 100 million could be potentially exposed across countries and age groups each day. On a given day, the probability of a consumer being both susceptible to developing aplastic anaemia and being exposed to bute was estimated to range approximately from 2 in a trillion to 1 in 100 million. Measures proposed to further minimise the risk included strengthening of the horse passport system, harmonised monitoring of bute and its main metabolite and better reporting of monitoring of veterinary drug residues and other substances across the EU.

The Food Safety Requirements set out under the General Food Regulation 178/2002 deem food 'unsafe' if it is injurious to health or unfit for human consumption with regard to normal conditions of use and information provided to the consumer. There is also the rebuttable assumption that where any affected food is part of a batch then the entirety of that batch is similarly affected. Reference is made to 'probable' short or long term effects on health and subsequent generations, 'probable' cumulative toxic effects. The reference to 'probable' applies the Precautionary Principle. In this context the Precautionary Principle states that where there is scientific uncertainty plus the possibility of harm to health, measures necessary to ensure 'high levels of health protection' should be applied. However, critically, this should also be proportionate and no more restrictive of trade as necessary to provide a high level of health protection.

The responsibility for food business operators to initiate a withdrawal applies where there is 'reason to believe' that a food is not in compliance with these safety requirements and requires an immediate initiation of procedures to withdraw. Where the food has reached the consumer there is an obligation to effectively and accurately inform the consumers of the reason for its withdrawal. Only where other measures are not sufficient to achieve a high level of health protection is a recall specifically required. However, at the level of a perishable food product and a contamination of this kind, the very task of informing consumers would result in a de facto recall. It would ordinarily be deeply unattractive for a food business to seek to differentiate between the two.

Earlier this month, Asda recalled all batch codes of its 'Smart Price' Corned Beef because 'very low levels' of bute found in some batches of the product. The level of bute found were reportedly 'considerably lower' than the highest levels found in carcasses (the highest level found was 1900ppb). Nevertheless, traces of the medicine were identified, consumers informed and a recall instigated of this clearly demarcated product.

In contrast, also this month, some 50,000 tonnes of meat supplied by two Dutch trading companies and sold as beef across Europe since January 2011 that may have contained horsemeat are being recalled where possible. Inspectors examining the records of the Dutch trading companies found that the origin of the supplied meat was unclear. As a result it was not possible to confirm whether slaughterhouses had respected procedures. The Netherlands Food & Consumer Product Safety Authority has been reported as stating there was no evidence that the meat was a threat to human health, and it is likely that much of the meat has already been consumed. The recall is being carried out on the premise that the products only 'may' contain traces of horsemeat (and so presumably the possibility there is the possibility of small amounts of bute present.) Some of the suspect meat was also exported to Germany, France and Spain, where authorities have been alerted. The Food Standards Agency in the UK has confirmed that a small number of UK companies may have received products from the Dutch wholesalers. Due to the timescale involved it is likely that UK buyers have processed the meat and sold it on to consumers in which case they, in turn, are obliged to inform their own customers. In this instance, there should come a point where an appropriate risk assessment on the facts and reference to the requirement of being no more restrictive of trade as necessary to provide a high level of health protection does require an appropriate distinction between 'withdrawal' and 'recall' as anticipated in the Regulation.