The Food Standards Agency (FSA) have now classed human placenta as a novel food and "any operator who wishes to market foods containing human placenta in the EU will need to apply for an authorisation under Regulation (EC) 258/97. Such an authorisation would require the submission of a dossier to one of the 28 EU Member States, demonstrating that the ingredient (a) does not present a risk to the consumer; (b) does not mislead the consumer; and (c) is not nutritionally disadvantageous compared with other foods that it might replace in the diet."
I have been informed by Melissa Thompson (our food safety expert) that this application process takes roughly 2-3 years, requires extensive laboratory testing, plenty of legal representation and a great deal of financial backing. It would be absolutely impossible for IPEN (a grassroots group of doulas and midwives who provide placenta services) to apply through this process because of our lack of resources and finances. We have until 11 July 2014 to prove that human placenta is not a novel food, or to make an exception in this regulation that placenta consumed by the mother who made that placenta should not fall in this category.
Please see the letter below from the FSA.
The FSA seem to be missing the point that a mother consumes her own placenta and that human placenta is not marketed or sold to the public. We do not sell placenta products, we offer a service the same as a private hire chef.
This action is clear breach of human rights and taking away mothers choice and right to birth services. We need your help to prove to the FSA that mother's should not have their own placentas named a novel food. Mothers own their own placentas and have every right to hire whomever they choose to make their placenta remedies for them after birth.
We are starting a petition, but we would be very grateful if we had your support in fighting this action by the FSA. Can you please send an email to Dr Manisha Upadhyay FSA Novel Foods, explaining how you feel this would be a breach of human rights and mothers choice after birth.
novelfoods@foodstandards.gsi.gov.uk
Please also feel free to circulate this email in attempt to gain more exposure of this breach of human rights by the UK government.
We were not aware that the FSA were considering whether human placenta products fall under the definition of novel food until Tuesday of this week. This is not our area of expertise but looking through the web-link that they sent through, one month will not be sufficient time for IPEN to prove significant history of consumption of these products in the EU before 15 May 1997. We are requesting an extension on this deadline.
We are appealing for anyone who consumed their own placenta prior to 15 May 1997 to contact IPEN immediately by email
info@placentanetwork.com AND
sally@doulacare.me.uk or call 0208 1334404 or 07908 748187
We have asked the FSA if in their deliberations, did they determine whether IPEN’s operation would fall under the definition of ‘placing on the market’ of a novel food?
Our understanding is that the same definition as Reg (EU) No.178/2002, Article 3 would apply i.e.
‘placing on the market’ means holding of food or feed for the purpose of sale, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution, and other forms of transfer themselves.
IPEN do not sell placenta products. IPEN placenta specialists provide a service in which they process a mother’s placenta to be consumed by that mother. Ownership of the placenta and the placenta remedies remains with the mother at all times.
We require URGENT ACTION. As you can imagine the decision will not only impact on the livelihood of the 100 placenta specialists around Europe but also the many thousands of women who have benefited from placenta services in the past, and the many thousands who wish to benefit from placenta services in the future. IPEN has until 11 July 2014 to prevent the regulations from taking effect in European Law.
Thank you for your time. We sincerely hope you can help during this time of serious threat to placenta services across Europe.
Letter from FSA below:
Status of human placenta products
The purpose of this letter is to inform you of the FSA’s advice on the status of human placenta products in relation to European legislation on novel foods.
Following discussion with our counterparts in the other EU member states, we 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 Regulation 258/97, 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. Human placenta and products derived from human placenta have not been authorised under this regulation.
The Agency is not aware of any evidence for a history of consumption of such products anywhere in the EU before May 1997 and we are therefore minded to view them to be novel foods, which cannot legally be sold until they have been formally authorised. As such, any operator who wishes to market foods containing human placenta in the EU will need to apply for an authorisation under Regulation (EC) 258/97. Such an authorisation would require the submission of a dossier to one of the 28 EU Member States, demonstrating that the ingredient (a) does not present a risk to the consumer; (b) does not mislead the consumer; and (c) is not nutritionally disadvantageous compared with other foods that it might replace in the diet.
We are aware that the organisation IPEN (the Independent Placenta Encapsulation Network), has an interest in marketing placenta products and that you have been considering the hygiene aspects of their operation in your locality. The purpose of this letter is to make you aware of our current advice and also, before we circulate this information more widely to UK food enforcement bodies, to give the opportunity for IPEN to provide any evidence that might demonstrate a significant history of consumption of these products in the EU before 15 May 1997.
Any relevant information should be submitted to the FSA Novel Foods Unit,
novelfoods@foodstandards.gsi.gov.uk, by Friday 11 July 2014.
Guidance on the nature and extent of information that is typically required to demonstrate a significant history of consumption can be obtained from the European Commission website[1].
Yours sincerely,
Dr Manisha Upadhyay
Novel Foods Unit, Food Safety Policy
[1]
http://ec.europa.eu/food/food/biotechno ... enc_en.pdf
Link to the post:
http://www.placentanetwork.com/urgent-e ... -services/
Link to Independent Placenta Encapsulation Network:
https://www.placentanetwork.comThe Food Standards Agency (FSA) have now classed human placenta as a novel food and "any operator who wishes to market foods containing human placenta in the EU will need to apply for an authorisation under Regulation (EC) 258/97. Such an authorisation would require the submission of a dossier to one of the 28 EU Member States, demonstrating that the ingredient (a) does not present a risk to the consumer; (b) does not mislead the consumer; and (c) is not nutritionally disadvantageous compared with other foods that it might replace in the diet."
I have been informed by Melissa Thompson (our food safety expert) that this application process takes roughly 2-3 years, requires extensive laboratory testing, plenty of legal representation and a great deal of financial backing. It would be absolutely impossible for IPEN (a grassroots group of doulas and midwives who provide placenta services) to apply through this process because of our lack of resources and finances. We have until 11 July 2014 to prove that human placenta is not a novel food, or to make an exception in this regulation that placenta consumed by the mother who made that placenta should not fall in this category.
Please see the letter below from the FSA.
The FSA seem to be missing the point that a mother consumes her own placenta and that human placenta is not marketed or sold to the public. We do not sell placenta products, we offer a service the same as a private hire chef.
This action is clear breach of human rights and taking away mothers choice and right to birth services. We need your help to prove to the FSA that mother's should not have their own placentas named a novel food. Mothers own their own placentas and have every right to hire whomever they choose to make their placenta remedies for them after birth.
We are starting a petition, but we would be very grateful if we had your support in fighting this action by the FSA. Can you please send an email to Dr Manisha Upadhyay FSA Novel Foods, explaining how you feel this would be a breach of human rights and mothers choice after birth. novelfoods@foodstandards.gsi.gov.uk
Please also feel free to circulate this email in attempt to gain more exposure of this breach of human rights by the UK government.
We were not aware that the FSA were considering whether human placenta products fall under the definition of novel food until Tuesday of this week. This is not our area of expertise but looking through the web-link that they sent through, one month will not be sufficient time for IPEN to prove significant history of consumption of these products in the EU before 15 May 1997. We are requesting an extension on this deadline.
We are appealing for anyone who consumed their own placenta prior to 15 May 1997 to contact IPEN immediately by email info@placentanetwork.com AND sally@doulacare.me.uk or call 0208 1334404 or 07908 748187
We have asked the FSA if in their deliberations, did they determine whether IPEN’s operation would fall under the definition of ‘placing on the market’ of a novel food?
Our understanding is that the same definition as Reg (EU) No.178/2002, Article 3 would apply i.e.
‘placing on the market’ means holding of food or feed for the purpose of sale, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution, and other forms of transfer themselves.
IPEN do not sell placenta products. IPEN placenta specialists provide a service in which they process a mother’s placenta to be consumed by that mother. Ownership of the placenta and the placenta remedies remains with the mother at all times.
We require URGENT ACTION. As you can imagine the decision will not only impact on the livelihood of the 100 placenta specialists around Europe but also the many thousands of women who have benefited from placenta services in the past, and the many thousands who wish to benefit from placenta services in the future. IPEN has until 11 July 2014 to prevent the regulations from taking effect in European Law.
Thank you for your time. We sincerely hope you can help during this time of serious threat to placenta services across Europe.
Letter from FSA below:
Status of human placenta products
The purpose of this letter is to inform you of the FSA’s advice on the status of human placenta products in relation to European legislation on novel foods.
Following discussion with our counterparts in the other EU member states, we 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 Regulation 258/97, 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. Human placenta and products derived from human placenta have not been authorised under this regulation.
The Agency is not aware of any evidence for a history of consumption of such products anywhere in the EU before May 1997 and we are therefore minded to view them to be novel foods, which cannot legally be sold until they have been formally authorised. As such, any operator who wishes to market foods containing human placenta in the EU will need to apply for an authorisation under Regulation (EC) 258/97. Such an authorisation would require the submission of a dossier to one of the 28 EU Member States, demonstrating that the ingredient (a) does not present a risk to the consumer; (b) does not mislead the consumer; and (c) is not nutritionally disadvantageous compared with other foods that it might replace in the diet.
We are aware that the organisation IPEN (the Independent Placenta Encapsulation Network), has an interest in marketing placenta products and that you have been considering the hygiene aspects of their operation in your locality. The purpose of this letter is to make you aware of our current advice and also, before we circulate this information more widely to UK food enforcement bodies, to give the opportunity for IPEN to provide any evidence that might demonstrate a significant history of consumption of these products in the EU before 15 May 1997.
Any relevant information should be submitted to the FSA Novel Foods Unit, novelfoods@foodstandards.gsi.gov.uk, by Friday 11 July 2014.
Guidance on the nature and extent of information that is typically required to demonstrate a significant history of consumption can be obtained from the European Commission website[1].
Yours sincerely,
Dr Manisha Upadhyay
Novel Foods Unit, Food Safety Policy
[1]http://ec.europa.eu/food/food/biotechnology/novelfood/documents/substantial_equivalenc_en.pdf
Link to the post: http://www.placentanetwork.com/urgent-european-fsa-action-banning-human-placenta-services/
Link to Independent Placenta Encapsulation Network: https://www.placentanetwork.com
