On 4th December 2020 we were delighted to recieve the following communication from the FSA.
The FSA has reached the following determinations in relation to the consumption of human placenta and placenta products:
Placenta is considered as a ‘food’ in line with the definition as provided in Article 2 Regulation (EC) No. 178/2002
- Placenta is not considered to be a ‘Product of Animal Origin’. This takes account of current legal definitions, other aspects of food law and our position in relation to products of similar origin such as human breast milk.
- Having thoroughly reviewed the required conditions for Novel Food Status, the FSA does not consider raw placenta or placenta products to be ‘Novel Foods’. Although evidence of significant History of Consumption before 15 May 1997 may not specifically be available, it is likely that unquantifiable personal consumption of placenta has been occurring in the EU for many years. We do not believe that any of the ten categories as detailed in Article 3(2)(a) of Regulation (EU) 2015/2283, relate to raw placenta or placenta products.
- As placenta is considered a food, placenta processing businesses are food business operators (FBOs) and should be considered for registration.
- As an FBO, a placenta processing businesses is required to ensure that they produce safe and hygienic foods, and to be able to demonstrate the safety and hygiene of their processes and products, to the satisfaction of their competent authority through the application of a Food Safety Management System based on the HACCP principles.
- Food Hygiene Rating Scheme (FHRS) – this type of FBO should be included unless the Competent Authority determines that they fall into an exemption.
This FSA advice is based upon the current information regarding practices being employed by small businesses providing services directly to mothers who wish to consume their own placenta or products made from it. We consider that our advice is proportionate for this current situation. If there are significant changes and we become aware of wider application or commercialisation we will review and reconsider our determination.
Given the range of scenarios, any risk assessment will vary greatly according to each individual situation and the FSA has concluded that it is appropriate for risks to be managed at a local level on a case by case basis between local authorities (LAs) and FBOs rather than through generic guidance provided by the FSA. It is for the FBO to satisfy the LA that their food safety and hygiene practices and their FSMS based on HACCP principles are sufficient to ensure the safety of the products supplied.
This means that Placenta Remedy Specalists can now confidently operate in co-operation with their local authorities without facing the threat of closure due to the novel food ruling.
We would like to take the opportunity to thank Lynnea Sherif, IPEN’s founder and all those that worked tirelessly along side her for the hours of time and effort that has gone in to support specialists through this.
We know the IPEN FSMA/ HACCP and cleint care portfolio we provide to our learners will support successful business registertation and we are delighted that this ruling means the industry can grow from strength to strenght.