How does one seek approval of a food additive in the EU? (&Protect applications?)
Thanks for clicking, I'd welcome any enlightenment and help. If there responses here are generally positive, I will seek some 'official' legal advice and pursue the opportunity fully.
The product in question is a fruit, whose use is historic and on-going outside of Europe, with no adverse effects reported in local populations. It hasn't yet been considered as an additive by regulators in the EU, though it seems that the fruit itself can be sold legally.
The real question is, how does one instigate the regulatory approval process?
In the mean time, would it be legally possible to supply a concentrated form of the fruit separately to the core product to add for flavouring, assuming it made any practical sense? In my eyes, the item sold would be a product bundle rather than a product containing the 'additive', but I'm not sure how the law would see it.
Lastly, assuming it appears that the regulatory changes are possible, would it be possible to protect specific applications of the fruit as an additive?
Thanks and best regards,
CJ
Good Answers (1)
Paul J.
Educator of all visitors to LinkedIn's Q & A web pages
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The following is intended for educational purposes I only. I always suggest you consult an attorney or solicitor of your choosing.
"I am not sure if my substance requires authorisation. Who should I contact?
"An overview of the authorisation process for the various categories of regulated food ingredients can be found on the European Commission’s website. If you have any further questions about your substance and especially whether it requires an authorisation, please contact the Directorate-General for Health and Consumers (DG SANCO), European Commission. For food additives, food enzymes and flavourings, the DG SANCO Unit in charge is Unit E3 – Chemicals, Contaminants and Pesticides. For nutrient sources (vitamins, minerals) added to food, the DG SANCO Unit in charge is E4 – Food law, nutrition and labelling. EFSA’s topics in these areas also contain relevant background information."
The foregoing is intended for educational purposes I only. I always suggest you consult an attorney or solicitor of your choosing.
Links:
- http://www.efsa.europa.eu/en/applicationshelpdesk/foodingredients.htm
- http://ec.europa.eu/food/food/fAEF/authorisation_application_en.htm
Clarification added 5 months ago:
"Procedure
"1. Applicants send their applications to the Commission.
"2. If the requested use is not liable to have an effect on human health, the Commission will ask the European Food Safety Authority (EFSA) for an opinion.
"3. EFSA must give an opinion within 9 months of receipt of a valid application.
"4. The Commission submits a draft regulation to the Standing Committee.
"5. The proposed regulation can be adopted with regulatory procedure with scrutiny (Art. 5a of Decision 1999/468/EC)."
(Second link below.)
More Answers (1)
Ronald V.
Financial Systems specialist
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Maybe these guys can help you out: http://www.efsa.europa.eu/
