Mérieux NutriSciences - Baby food

Baby food provides essential nutrients for a baby’s development during their first 1,000 days. During this crucial period, a baby will grow into a child and their immune system will develop. 

Baby food: highly regulated food for highly vulnerable consumers

How baby food is made matters; babies are vulnerable consumers, who can quickly accumulate dangerous contaminants in their body and can more easily get infections due to their not-yet properly developed immune system.

For all these reasons, baby food manufacturers need to strictly meet all the quality standards and product specifications, which are very stringent with levels considerably reduced in comparison to non-baby food products.

Label claims and mandatory statements need to be supported by very specific and sensitive testing carried out by reliable and accredited laboratories, which can accurately quantify very low concentrations of contaminants.

How is baby food regulated: requirements and limits

Baby food encompasses different categories of products, specifically formulated to meet the nutritional needs of the infants growing into young children.

According to EU Regulation, baby food includes:

  • Infant formula
  • Follow-on formula
  • Processed cereal baby-food
  • Other baby food
  • Young-child formula

Generally speaking, baby formula and baby food have to ensure infants and young children the proper amount of safe bioavailable nutrients with a proper physiological effect; they have  to comply with specific requirements in terms of composition, labeling rules and limits for contaminants, which are far below conventional ones. Young child formula on the contrary, which are destined to 1-3 years’ old children, are not subjected to the same strict limitations and are often treated as vitamin-enriched foods (Reg. no. 1925/2006.

The general rule for baby food is Regulation (EU) no. 609/2013 , which regulates a broader food category called “Food for Specific Groups” (FSG), to which baby food belongs. It covers general composition and labeling rules for all baby food categories: infant formula, follow-on formula, processed cereal-based foods and baby foods for infants and young children.

Commission Directive no. 2006/141/EC is the European legal reference for baby formula, with composition and labeling requirements for infant and follow-on formula. It will be in force until February 2020 and 2021, when a new delegated act of Reg. no. 609/2013 (Reg. no. 127/2016) will replace it and will make its existing requirements compelling from the regulatory point of view.

Commission Directive no. 2006/125/EC specifically applies to processed cereal-based foods and baby foods for infants and young children.

Regulation (EU) no. 127/2016 is the new delegated act of Reg. no. 609/2013, which contains specific compositional and informational requirements for baby formula (infant and follow-on formula) and that will enter into force on February 2020 and 2021, replacing Directive no. 2006/141/EC.

Nutritional baby food components are strictly regulated to ensure the proper bioavailable mix of nutrients with no possible harmful substances inside. Admitted micro and macronutrients (protein, fat, carbohydrate, minerals, vitamins and other ingredients) are listed, as well as their possible source, content and relevant amount, with maximum and minimum limits, where necessary.

For example, proteins must have a specific amino acidic composition to mimic the maternal milk and ensure proper protein intake; fatty acids as well need to be very specific and Regulation (EU) no. 127/2016 will introduce the mandatory addition of DHA (docosahexaenoic acid), a nutrient mainly present in fish and fish oil that improves infant brain development.

Requirements and limits for contaminants and residues in baby food are very stringent, with much lower levels than any other non-baby food product: pesticides, veterinary drugs, mycotoxins, heavy metals, etc. must meet strict requirements to ensure safety and quality.

Pesticides are not tolerated in baby food. According to the precautionary principle established by Regulation (EC) no. 178/2002, baby formula, processed cereal-based foods and baby foods are required to contain no detectable levels of pesticide residues, namely below 0,01 mg/kg, which is the minimum analytically detectable level. In addition, for some very toxic pesticide residues, lower tolerances were established, while the use of others was just banned in agricultural products destined to the production of baby foods. In addition, EFSA is also considering the introduction of new lower LMRs for some pesticides in food intended for infants younger than 16 weeks, as the current model might not be sufficiently protective for this category.

Additives are also regulated in nature and in content, as well as GMOs which undergo country-specific rules - in Italy for example GMO are not allowed, in France there is no binding Regulation yet, but manufacturers took an engagement to ban GMO in baby food products.

For other possible contaminants like those from food processing (acrylamide, MCPD esters, glycidyl-esters, furan and methylfurans), food contact material (bisphenols, MOSH&MOAH, NIAS), microbiological hazards, (Cronobacter, pathogens, quality indicators), specific Regulations apply.

In general, the regulatory situation on baby food is rapidly evolving, with new contaminant levels expected in the near future such as: T-2 and HT-2 toxins (Reg. no. 165/2013), acrylamide, 3-MCPD-esters, glycidyl-esters, alkaloids, etc.

Babies and food allergies

Food allergy is a critical health issue, because a tiny amount of an allergen can cause a reaction that might be fatal.

Infants can develop intolerance or allergy. Globally, food allergies and intolerances affect 6-8% of children under 5 years, depending on age, geographic origin, and ethnicity, with a noticeable rise in West developed countries.

Infant diet plays a central role in the development of food allergy. Formula fed infants, for instance, can show allergic symptoms due to an intolerance to the proteins in food.

In order to prevent childhood food allergies and dangerous health implications, it is of utmost importance that consumers know baby food composition and trust on reliable allergen testing, to ensure babies a safe nourishment.

Legal Bases and Guidelines in Europe

  • Regulation (EU) no. 609/2013 of the European Parliament and of the Council - general baby food rule
  • Commission Directive no. 2006/141/EC - infant formula and follow-on formula
  • Commission Directive no. 2006/125/EC - processed cereal-based foods and baby foods for infants and young children
  • Regulation (EU) no. 127/2016 of the European Parliament and of the Council - infant formula and follow-on formula
  • Commission Regulation (EC) no.1881/2006 - Contaminants in foodstuffs
  • Commission Regulation (EC) no.2073/2005 - Microbiological criteria for foodstuffs
  • Commission Regulation (EC) no.1333/2008 - Food additives
  • Commission Regulation (EC) no.1334/2008 - Food flavors
  • Commission Regulation (EC) no.2158/2017 - Acrylamide
  • Commission Regulation (EC) no.10/2011 - Food contact materials
  • Commission Regulation (EC) no.6/2016 - Import restrictions (Japan, Fukushima)
  • Commission Regulation (EC) no.722/2008 - Import restrictions (Russia, Chernobyl)
  • Commission Regulation (EC) no.52/2016 - Radioactivity
  • Commission Regulation (EC) no.213/2018 - Bisphenol A
  • AOAC SPIFAN Recommended Guidelines and methods (SPIFAN, Stakeholder Panel on Infant Formula and Adult Nutritionals) - Final Action Official MethodsSM with Joint Organizational Approvals, 2016
  • Codex Standard - Guidelines and good manufacturing practices for Country Health Legislation
  • Commission Recommendation no. 583/2006 - Fusarium toxins
  • Commission Recommendation no. 165/2013 - T-2 and HT-2 toxin
  • Commission Recommendation no. 598/2003 - Patulin
  • Commission Recommendation no. 154/2012 - Claviceps spp. alkaloids
  • Commission Recommendation no. 2115/2016 - THC
  • Commission Recommendation no. 976/2015 - Tropane alkaloids
  • Commission Recommendation no. 662/2014 - Opium alkaloids

Baby food: many rules and few standard methods until AOAC SPIFAN

Infant formula is the most regulated food in the world, but lacks standardized testing procedures across regions that impact industry and trade. This can happen when Countries test for the same analyte, by using different analytical methods.

To cope with that, AOAC created a specific group of experts, SPIFAN (Stakeholder Panel on Infant Formula and Adult Nutritionals), fully supported by the infant formula industry and specifically born to establish criteria and reference to become standard methods for key nutrients in infant formula and adult nutritionals.

Over time, AOAC SPIFAN methods have been published by different organizations such as AOAC INTERNATIONAL, the European Committee for Standardization (CEN), the International Dairy Federation (IDF), and the International Organization for Standardization (ISO), and are recommended to CODEX Alimentarius Committee(s) to become reference methods. At present, many standards are now internationally recognized to facilitate the international trade not only of infant formula and adult nutritionals, but also of milk and milk products.

To prevent public health issues and avoid possible trade disputes, it is very important for the baby food industry to rely on laboratories using SPIFAN methods.

Mérieux NutriSciences: a 360° service for the baby food industry

The baby food industry needs reliable and accredited laboratories to ensure product safety, quality and adequate nutritional composition. To launch competitive baby food products on the market, it is also fundamental to draw sensory profiles with both judge panels and consumer tests, to be winning against competitors.

Mérieux NutriSciences provides a complete service covering analytical, regulatory and consulting needs

Physical and chemical analyses on baby food

  • Allergens: RT-PCR, ELISA, LC-MS/MS
  • Contaminants: dioxins, furans, PCBs – DL, PAHs, melamine, heavy metals, etc.
  • Additives: antioxidants, dyes, preservatives, sweeteners, flavorings
  • Mycotoxins and alkaloids
  • Pesticides: full compliance to pesticide requirements in baby food, including banned and restricted molecules
  • Veterinary drugs
  • Hormone residues (naturally present or artificially added)
  • GMOs
  • Process contaminants: MCPD esters, Glycidyl Esters, acrylamide, furan, methylfurans
  • Packaging contaminants: MOSH&MOAH, bisphenols, NIAS, etc.
  • Radioactivity

Nutritional analyses

  • Fibers: total dietary fiber, FOS, GOS
  • Other nutrients: cholesterol, starch, monounsaturated and polyunsaturated fats, etc.
  • Minerals and vitamins: water-soluble and fat-soluble)
  • Organic micronutrients: coline, inositol, carnitine

Microbiological analyses

  • Quality indicators
  • Pathogens (Cronobacter, etc.)

Cleaning Validation and Monitoring

Sensory Analysis and Market Research


Technical and Regulatory Advice

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