Requirements for Selling Food Intended for Infants and Young Children in the EU and in the UK

Amazon’s policies require that certain safety products sold through Amazon meet specified certification standards. This material is for informational purposes and you should not take it as a substitute for legal advice. We encourage you to consult your legal counsel for any concerns about the laws and regulations concerning your product. This material only reflects the position at the date of writing and requirements across the EU and in the UK and may change – particularly in light of the developing position with Brexit. You should refer to current UK Brexit guidance about your products (see below) to learn more about changes that may affect you following the end of the transition period.

On this page, you will find:

• What is food intended for infants and young children?
• What information do I need to submit to Amazon to be able to sell food intended for infants and young children in the EU?
• How do I provide the required information to Amazon?
• What additional legal requirements apply for food intended for infants and young children in the EU?
• What information do I need to submit to Amazon to be able to sell food intended for infants and young children in the UK?
• What will happen if I do not follow Amazon’s requirements on selling food intended for infants and young children?
• Additional Resources
• Additional Questions

What is food intended for infants and young children?

We distinguish between three product types in this category

1. Infant formula

   Food intended for use by infants during the first months of life and satisfying all the nutritional requirements of such infants until the introduction of appropriate complementary feeding. Usually, the age range for this type of product is 0-6 months. These can be in powder form or ready to drink versions. The labelling needs to clearly define and differentiate infant formula intended for babies of this age range [0-6 months]

2. Follow on formula

   Food intended for infants when appropriate complementary feeding is introduced [i.e., from 6 months onwards] and which constitutes the principal liquid element in a progressively diversified diet of such infants. These can be in powder form or ready to drink versions. The labelling needs to clearly define and differentiate infant formula intended for babies of this age range [6 months+]

3. Baby food and processed cereal-based food intended for infants and young children

   These products are able to satisfy infant nutritional needs and are used by infants during weaning and by young children as a supplement to their diet and/or for their progressive adaptation to ordinary food. These can be in various formats, such as pouches, jars, packets and can range from meals to snacks / biscuits etc.

l. EU Requirements

What information do I need to submit to Amazon apply to sell food intended for infants and young children in the EU?

You need to send an email with two documents as detailed below to product-compliance-it@amazon.it

Please note that you must satisfy both requirement 1 and 2.

Infant formula

Follow On Formula and Baby Food

How do I provide the required information to Amazon?

Please send an email that includes all the information listed above to product-compliance-it@amazon.it

Apart from the above required information what additional legal requirements apply for food intended for infants and young children in the EU?

It is your responsibility to comply with food safety legislation. The following material is not intended as legal advice. Amazon encourages you to consult your legal counsel if you have questions about the laws and regulations concerning your product.

For food intended for infants and young children, you must also comply with the following legal requirements. For information on general requirements for food products refer to the Food and Beverage Help page

It should be noted that the following requirements are mainly applicable for infant and follow-on formula. Food intended for young children is regulated at a national level. Please refer to the Food and Beverage Help page for more information.

• (A) Compositional requirements

  Infant formula shall comply with the compositional requirements according to Annex I of Delegated Regulation (EU) No. 2016/127 and follow-on formula shall comply with compositional requirements according to Annex II.

  For the composition of both product types, the values for amino acids according to Annex III need to be taken into account as well.

• (B) Requirements for pesticides

  Infant formula and follow-on formula shall not contain residues at levels exceeding 0,01 mg/kg per active substance or exceeding levels for specific active substances listed in Annex IV of Delegated Regulation (EU) No. 2016/127.

• (C) Notification

  Before placing infant formula on the market, the food business operator shall notify the competent authority of each Member State. This requirement is also applicable for follow-on formula manufactured from protein hydrolysates or follow-on formula containing other substances than those listed in Annex II.

• (D) Labelling requirements

  Additional to the obligations of the Food Information for Consumers Regulation (FIC) infant formula and follow-on formula need to comply with the following labelling requirements of Delegated Regulation (EU) No. 2016/127.

• These are applicable for the provision of information at the point of sale (on the detail page) and at the point of delivery (on the product label).

• Following legal names are mandatory to be used:
  • Product not entirely manufactured from cow or goat’s milk proteins: “Infant formula” or “Follow-on formula”

  • Product entirely manufactures from cow or goat’s milk proteins: “Infant milk” or “Follow-on milk”

• Instructions for appropriate preparation, storage and disposal and a warning against the health hazards of inappropriate preparation and storage need to be displayed
• Following statements shall be given for infant formula:
  • Product is suitable for infants from birth when they are not breast fed
  • Concerning the superiority of breast feeding and recommending that the product be used only on the advice of independent persons having qualifications in medicine, nutrition or pharmacy
• Following statements shall be given for follow-on formula:
  • Product is suitable only for infants over the age of six months, form only a part of a diversified diet and shall not to be used as a substitute for breast milk during the first six months of life
  • Decision to begin complementary feeding, including any exception to six months of age, should be made only on the advice of independent persons having qualifications in medicine, nutrition or pharmacy
• Requirements on the nutritional declaration from FIC are adjusted for infant formula and infant formula as follows:
  • Display of all vitamins and minerals except molybdenum listed in Annex I or rather Annex II
  • Not include the amount of salt
  • Be expressed per 100 ml after preparation
  • The label element nutritional declaration shall not be repeated on the labelling
  • Reference values of the FIC Regulation shall not be used, but for follow-on formula the percentage of reference values for vitamins and minerals from Annex VII may be used
  • For infant formula: Display the amount of choline, inositol and carnitine

Statements on food intended for infants and young children shall never discourage breast-feeding.

Nutrition and Health claims shall not be made for infant formula. Point-of-sale advertising to induce sale of infant formula is also not permitted.

What will happen if I do not follow Amazon’s requirements on selling food intended for infants and young children?

Listing food intended for infant or young children without Amazon’s approval and failing to comply with legal requirements will result in the removal of listings.

Additional Resources

• EU regulation requiring pre-market notification of infant formula
• Relevant authority for submitting infant formula pre-market notification in Spain
• Relevant authority for submitting infant formula pre-market notification in France
• Relevant authority for submitting infant formula pre-market notification in Germany
• Relevant authority for submitting infant formula pre-market notification in the UK
• Relevant authority for submitting infant formula pre-market notification in Italy
• Relevant authority for submitting infant formula pre-market notification in Sweden
• EU regulation detailing labelling requirements for all food [FIC]

ll. UK Requirements

Products first made available in the UK or EU on or before December 31, 2020 should comply with the EU requirements set out above. Products that are first made available in the EU or UK on or before December 31, 2020 can continue to circulate until they reach their end user and do not need to comply with the changes that take effect from January 1, 2021. You can retain evidence of when products were first made available in the UK or EU by keeping documents including contracts of sale, invoices, and documents concerning the shipping of goods for distribution.

After the end of the Brexit transition period there will be different provisions for Great Britain (England, Scotland, and Wales, “GB”) and Northern Ireland. You can read more about the position in Northern Ireland (“NI”) below . For products first made available in Great Britain (England, Wales, and Scotland) after December 31, 2020, you need to send an email with two documents as detailed below to product-compliance-uk@amazon.co.uk

Please note that you must satisfy both requirement 1 and 2.

Infant formula

Follow On Formula and Baby Food

How do I provide the required information to Amazon?

Please send an email that includes all the information listed above to product-compliance-uk@amazon.co.uk

Apart from the above required information what additional legal requirements apply in GB for food intended for infants and young children after 31 December 2020?

For food intended for infants and young children, you must also comply with the following legal requirements. For information on general requirements for food products refer to Food and Beverage Help page

It should be noted that the following requirements are mainly applicable for infant and follow-on formula. Food intended for young children is regulated at a national level. Please refer to Food and Beverage Help page for more information.

• (A) Compositional requirements

  Infant formula and follow-on formula shall comply with the compositional requirements of The Infant Formula and Follow on Formula Regulations 2007. For the composition of both product types, the values for amino acids in the regulation need to be taken into account as well.

• (B) Requirements for pesticides

  Infant formula and follow-on formula shall not contain residues at levels exceeding 0,01 mg/kg per active substance or exceeding levels for specific active substances listed in The Infant Formula and Follow on Formula Regulations 2007.

• (C) Notification

  Before placing infant formula on the market, the food business operator shall notify the Department of Health & Social Care. This requirement is also applicable for follow-on formula manufactured from protein hydrolysates or follow-on formula containing other substances than those listed in the Infant Formula and Follow on Formula Regulations 2007.

• (D) Labelling requirements

  As well as the obligations of the Food Information Regulations 2014 infant formula and follow-on formula need to comply with the following labelling requirements of Infant Formula and Follow on Formula Regulations 2007.

• These are applicable for the provision of information at the point of sale (on the detail page) and at the point of delivery (on the product label).
• Following legal names are mandatory to be used:
  • Product not entirely manufactured from cow or goat’s milk proteins “Infant formula” or “Follow-on formula”
  • Product entirely manufactures from cow or goat’s milk proteins: “Infant milk” or “Follow-on milk”
• Instructions for appropriate preparation, storage and disposal and a warning against the health hazards of inappropriate preparation and storage need to be displayed
• Following statements shall be given for infant formula:
  • Product is suitable for infants from birth when they are not breast fed
  • Concerning the superiority of breast feeding and recommending that the product be used only on the advice of independent persons having qualifications in medicine, nutrition or pharmacy
• Following statements shall be given for follow-on formula:
  • Product is suitable only for infants over the age of six months, form only a part of a diversified diet and shall not to be used as a substitute for breast milk during the first six months of life
  • Decision to begin complementary feeding, including any exception to six months of age, should be made only on the advice of independent persons having qualifications in medicine, nutrition or pharmacy
• Requirements on the nutritional declaration from the Food Information Regulations are adjusted for infant formula and infant formula as follows:
  • Display of all vitamins and minerals as set out in the Infant Formula and Follow on Formula Regulation
  • Be expressed per 100 ml after preparation
  • The label element nutritional declaration shall not be repeated on the labelling
  • Reference values shall not be used, but for follow-on formula the percentage of reference values for vitamins and minerals from Annex VII may be used
  • For infant formula: Display the amount of choline, inositol, and carnitine

Statements on food intended for infants and young children shall never discourage breast-feeding.

Nutrition and Health claims shall not be made for infant formula. Point-of-sale advertising to induce sale of infant formula is also not permitted.

What will happen if I do not follow Amazon’s requirements on selling food intended for infants and young children?

Listing food intended for infant or young children without Amazon’s approval and failing to comply with legal requirements will result in the removal of listings.

Northern Ireland

Please note that different rules will apply in Northern Ireland (NI) from January 1, 2021 as a result of the Northern Ireland Protocol. In particular:

• You should ensure that products sold in NI meet EU requirements .
• You are an importer if you are established in the EU or NI and you sell products from a country outside of the EU and Northern Ireland (including from GB) into NI. Products sold in NI should be marked with details of any EU / NI based importer.
• “Qualifying Northern Ireland goods” will be able to be sold in GB with the CE mark. The UK Government is issuing guidance on how this will work.

The relevant authority for authorising health claims in Northern Ireland is the Department of Health

BREXIT: UK Government Guidance

The UK Government has released guidance on selling products in GB and NI after Brexit. We encourage you to visit the following UK government website for guidance on changes that may affect you from January 1, 2021:

• https://www.food.gov.uk/business-guidance/the-uk-transition

Additional Information

We encourage you to visit the Business Companion website, which contains guidance on UK product compliance rules:

• https://www.businesscompanion.info/en/quick-guides/food-and-drink/labelling-of-prepacked-foods-general
• https://www.businesscompanion.info/en/quick-guides/food-and-drink/nutrition-and-health-claims

Additional Questions

Why am I not allowed to sell food intended for infants and young children on Amazon when I was previously approved to sell?

As part of our ongoing efforts to provide the best possible customer experience, starting on September 28, 2020 , Amazon is implementing additional requirements for infant formula, follow on formula and baby food.

How do I know that I am approved to sell food intended for infants and young children?

Approved sellers will receive an email notification from Amazon confirming you are approved to sell food intended for infants and young children.

What is a GFSI certificate?

Global Food Safety Initiative (GFSI) is an industry-driven, globally accepted set of food safety standards for vendors. Food manufacturer certified against the GFSI audit schemes are “GFSI certified” and typically meet the requirements of most retailers.

What is a HACCP certificate?

HACCP stands for Hazard Analysis and Critical Control Point. It is an international standard defining the requirements for effective control of food safety. Food manufacturers certified against HACCP requirements by a 3rd party meet the Amazon food safety bar.