Please note that it is your responsibility to comply with the EU notification requirements if you are selling or intend to sell food products in the EU. You must also comply with national laws and regulations in Member States, which implement EU law. This material is for informational purposes only. It is not intended as legal advice. We encourage you to consult your legal counsel if you have questions about the laws and regulations concerning your products.
EU Food Law applies to any food product sold in the EU and obliges food business operators at all stages of production, processing and distribution within the businesses under their control to ensure that foods satisfy the food law requirements and, in particular, that no unsafe food is sold in the EU (Regulation (EC) 178/2002).
"Food" means any substance or product, whether processed, partially processed or unprocessed intended to be, or reasonably expected to be ingested by humans.
Below are some examples of food products:
The information that follows is not an exhaustive list of notification obligations prior to selling food products in the EU; additional notification obligations may arise, in particular, under the national laws of the EU Member States where you intend to sell your food products. Therefore, we encourage you to seek legal advice to ensure full compliance with the regulatory regime.
For certain food products listed below, EU Food Law includes notification or authorization requirements before such products are sold in the EU. This list is not intended to be exhaustive.
Prior to selling food supplements in the EU, you must confirm whether you are required to notify the competent authority of each Member State in which your product is to be sold and comply with all applicable requirements prior to selling on Amazon (Directive 2002/46/EC).
“Food supplements” means foodstuffs marketed in dose form intended to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect (Directive 2002/46/EC).
Prior to selling infant formula in the EU, you must notify the competent authority of each Member state in which your product is to be sold (Delegated Regulation (EU) 2016/127). Prior to selling follow-on formula containing certain substances listed under EU regulations, you must confirm whether you are required to notify the competent authority of each member state where you intend to sell your products and comply with applicable notification requirements prior to selling on Amazon.
“Infant formula” means food intended for use by infants during the first months of life and satisfying by itself the nutritional requirements of such infants until the introduction of appropriate complementary feeding. “Follow-on formula” means food intended for use by infants when appropriate complementary feeding is introduced and which constitutes the principal liquid element in a progressively diversified diet of such infants.
Prior to selling food for special medical purposes in the EU, you must notify the competent authority of each Member State in which your product is to be sold (Delegated Regulation (EU) 2016/128).
“Foods for special medical purposes” are foods designed to feed patients with medically nutrient requirements whose dietary management cannot be achieved by modification of the normal diet alone (Regulation (EU) 609/2013).
Prior to selling total diet replacements for weight control in the EU, you must notify the competent authority of each Member State in which your product is to be sold (Delegated Regulation (EU) 2017/1789).
“Total diet replacement for weight control” means food specially formulated for use in energy restricted diets for weight reduction which, when used as instructed by the food business operator, replaces the whole daily diet (Regulation (EU) 609/2013).
Prior to selling any Novel foods or products containing Novel foods, you need to notify the competent authority and obtain all necessary authorizations (Regulation (EU) 2015/2283). "Novel food" means any food that had not been consumed to a significant degree by humans in the EU before 15 May 1997 and that is covered by at least one of the categories listed in the EU Regulation.
A list of the EU novel food authorizations can be found here.
Food products which contain food additives, food enzymes and/or food flavorings can be sold in the EU only if the respective food additive, food enzyme and/or food flavoring has been approved in the EU and will be used under the approved conditions (Regulation (EC) 1331/2008, Regulation (EC) 1333/2008, Regulation (EC) 1332/2008, Regulation (EC) 1334/2008).
Lists of the relevant EU approvals can be found here:
Prior to selling dairy foods promoted as being particularly adapted to meet specific needs of young children, pregnant or breastfeeding women, convalescents, the elderly, and more generally any person who has special needs in terms of protein, essential fats, calcium, iron, you must notify the competent authority in France.
Prior to selling pre-packed food that is claimed to specifically not include any of the substances or products mentioned in Annex 2 of the EU Regulation 1169/2011, you must notify the Swedish Food Agency.
EU food laws have been retained in UK law following Brexit. Foods sold in England, Wales and/or Scotland (GB) must comply with UK law, including retained EU laws. Under the Northern Ireland Protocol, foods sold in Northern Ireland (NI) must continue to comply with EU food laws.