The Food Standards Agency has announced that in their view, having consulted their European counterparts, placenta is a novel food. If confirmed, placenta's classification as novel food will effectively ban the marketing and sale of placenta products until a decision is taken on a European Union-wide authorisation of the product following a pre-marketing safety assessment (Mesure, 2014).
The decision by the Food Standards Agency threatens the future of the Independent Placenta Encapsulation Network (IPEN), and other placenta product producers, established some 3 years ago to meet demand created by the trend for eating placenta. Typically, members of the network charge £150 to create capsules from a woman's placenta and £25 to make a placenta smoothie. IPEN argue that ingesting the organ after birth can help women produce more breast milk, bleed less and help reduce the incidence of postnatal depression.
Hygiene Emergency Prohibition Notices
The ruling by the Food Standards Agency follows action under domestic UK environmental health law against a producer of placenta products. Two Hygiene Emergency Prohibition Notices, under the Food Safety and Hygiene (England) Regulations 2013, regulation 8, were issued to the director of the IPEN by her local council environmental health department.
As its title suggests, a Hygiene Emergency Prohibition Notice is issued by an authorised environmental health officer where they are satisfied that there is a risk to health from food hygiene or safety. This initial prohibition notice must be followed up by an application to a magistrates court, and, if satisfied of the health risk, the court will issue a hygiene prohibition order effectively closing the food business (Food Safety and Hygiene (England) Regulations 2013, regulation 8).
The council's environmental health department argued that there was an imminent risk to health from the products because placenta was unsafe to eat due to the presence of Staphylococcus aureus in the vagina of one in ten women that could be unknowingly passed on to the placenta (O'Neill, 2014).
The closure notice was confirmed by a district judge in May 2014 who issued the Hygiene Emergency Prohibition Order ruling that raw placenta must not be processed for human consumption (Knowles, 2014).
Novel food
While action by environmental health departments of local councils under Food Hygiene and Safety laws will affect the local production of placenta products, the Food Standards Agency's decision to classify placenta as a novel food will ban the production of placenta products throughout the member states of the European Union.
A key aim of the European Union regulation is to protect public health by requiring that novel foods and novel food ingredients are subject to a single safety assessment throughout the European Union before being marketed to the European Community. The process takes about 2 years to complete and requires extensive scientific evidence of the product's safety.
Following discussion with their counterparts in the other EU member states, the Food Standards Agency are currently of the view that foods containing human placenta are novel and are therefore regulated under Council Regulation (EC) 258/97 on novel foods and food ingredients.
Under the Novel Foods Regulation (1997) a novel food or ingredient is defined as one that was not consumed to a significant degree in the European Community before 15 May 1997. Novel foods and food ingredients may only be marketed if they have been evaluated and authorised under the procedures defined in the regulation. The Food Standards Agency have confirmed that human placenta and products derived from human placenta have not yet been authorised under this regulation and so it would be unlawful to market or sell them.
The Food Standards Agency argues that it is not aware of any evidence of a history of significant consumption of placenta products in the European Union prior to May 1997. Therefore, it is reasonable to view them as novel foods that must not be marketed or sold until they have been formally authorised under novel food pre-marketing safety procedures in a European Union member state.
To continue to market foods containing human placenta in the European Union, a producer must apply for an authorisation under the Novel Foods Regulation (1997) that demonstrates that the ingredient does not present a risk to the consumer; does not mislead the consumer; and is not nutritionally disadvantageous compared with other foods that it might replace in the diet. Compiling that evidence is likely to be costly and challenging given that a court has already granted a Hygiene Emergency Prohibition Order in relation to a placenta product producer.
The quickest way for those in favour of continuing to make placenta products for consumption available to women is to show that there is a significant history of placenta consumption in the European Union prior to May 1997. While it is likely to be possible to show the consumption of placenta dates back over many hundreds of years, it is going to be more difficult to show that this consumption has been significant and not just a ‘fad’ taken up by a few women. The Food Standards Agency set a deadline for the 11 July 2014 for evidence that would convince them of this history of substantial consumption that would mean that the Novel Foods Regulation (1997) did not apply.
Women who wish to consume their placenta can do so
Food Safety and Hygiene law in the UK and the provisions of the Novel Foods Regulation apply to food businesses. There are no legal restrictions on women who wish to process and consume their placenta and this would be the case even where they enlist the help of family and friends to assist in the processing. Mothers have the right to consume their placenta on a private individual basis. It is, however, the case that this would be against the advice of Local Authority environmental health departments that are of the view that there is the risk of harmful pathogens in the placenta. It would also be against the advice of the Food Standards Agency which remains to be convinced of the safety and efficacy of placenta products until it has the evidence from a pre-marketing safety assessment carried out under the Novel Foods Regulation (1997).
The proponents of placenta products are mounting an urgent campaign to prevent the Food Standards Agency from classifying placenta as a novel food or novel food ingredient. If they are unsuccessful then the supply and marketing of placenta products, including placenta capsules and smoothies, will have to cease. It will become unlawful to sell placenta products until a European Union-wide authorisation is obtained.