Baby Milk Production: Infant formula manufacturing business

Infant milk formula is produced to replace mother milk. They are diary, concentrate or vegetable based. The production process involves numerous ingredients, blending and heating process. Manufacturers are mandated to register and obtain certification from relevant agencies before production. The product is subjected to quality control, health and safety laws.

Types of infant formula

Types of formula are based on the ingredients and age grade. Common types are milk, animal or vegetable fat, non-milk based. Milk products are derived from cows, vegetable soybeans, non-milk based are from liquid or powder concentrates.


Baby food wholesale business

  • Milk based
  • Vegetable based
  • Non-milk based

Learn the Trade

An entrepreneur needs to obtain training on infant formulation, food regulations and technical services. Others are marketing, equipment, staff, transportation and legal requirements. More considerations are company location, state and federal legislation.

  • obtain training on infant formulation
  • food regulations
  • technical services
  • marketing
  • equipment
  • staff, transportation
  • legal requirements
  • company location
  • state and federal legislation


Select a location close to source of raw materials. Another good strategy is to locate near customer base. The location should have adequate security, utilities, good road network. You need provisions for warehousing and transportation of finished product.


Hire only qualified personnel with cognate experience. Staff are factory workers, receptionist, drivers, security guards, manager.

  • factory workers
  • receptionist
  • drivers
  • security guards
  • manager

Licensing and Certification

An infant formula Manufacture needs to obtain registration certification and license.  The product should have a label and registration number. Register the business as a limited liability company and obtain tax identification number. There are safety standards including raw material quality provisions.

Infant Formula Production Licensing

To obtain an infant formula manufacturing license you need applicant qualification. The producer should show capacity to produce the powder product. The producer is required to have manufacturer registration, accreditation and certification. The registration and certification is provided by the authorized accreditation agency of the country.

  • obtain manufacturing license
  • applicant qualification
  • show capacity to produce
  • manufacturer registration
  • accreditation and certification

Registration Qualification

There are nine kinds of formula and three series namely series 1, 2 and 3. Each series has significant difference in the formulation of each stage. You need the formula license and formula registration before producing the product. This provision is mandatory for manufacturers and importers and subsidiaries.

Dossier Considerations

Things to consider are obtaining an application form, raw material quality including safety standards. Others are production process description, production formula and production formula report. You need extensive product testing with evidence of production capacity. Finally obtain related certificates, specifications and labeling.


  1. Obtaining an application form
  2. raw material quality
  3. safety standards
  4. production process description
  5. production formula
  6. production formula report
  7. extensive product testing
  8. evidence of production capacity
  9. obtain related certificates
  10. specifications and labeling

Registration Procedure

The registration procedure starts with the feasibility analysis then a sample test. The next stage is a dossier preparation before submitting an application. This is followed by an accredited agency technical review. They will then conduct an on-site sampling and inspection before registration approval.

Infant Formula Registration Procedure

  • feasibility analysis
  • product sample testing
  • dossier preparation
  • application submission
  • agency technical review
  • on-site
  • sampling
  • inspection of factory
  • registration approval

Safety Laws, Standards and Regulations

Administrative Product Formula Registration
Dossier Requirements Infant Formula Registration
Technical Guidelines Labelling
Onsite Inspection of factory
Product testing Sampling
registration Approval/rejection


Testing covers industry regulations, laws, 3 batches testing before the finished product.


Equipment needed for infant milk production are stainless steel tanks, industrial mixer, and heater. Other are pasteurization equipment, homogenization mixing equipment standardization equipment, labeling and packaging.

  1. stainless steel tanks
  2. industrial mixer
  3. heater
  4. pasteurization equipment
  5. homogenization mixing equipment
  6. standardization equipment
  7. labeling
  8. packaging

Raw Materials

Raw materials used in production are fats, carbohydrates and proteins. Others are vitamins emulsifier’s minerals, diluents. Common minerals magnesium, sulfur, zinc, chloride, potassium, calcium, phosphate, sodium.

Vitamins are vitamin C, D, A, B12, More are folcan, riboflavin, thiamine, pantothenate, niacin. A good diluent is skim milk, protein sources are soybeans, protein concentrates. To reduce separation of water soluble components and oil emulsifiers like gum or starches are added.

Infant Formula Manufacturing Process

The manufacturing process depends on the type of formula produced. Two basic compositions are liquid milk based formula or powder.

Milk based Formula

Milk based for formula goes through mixing, pasteurization, homogenization, standardization and packaging and sterilization.


Prepare a stainless steel tanks and add ingredients then blend then introduce  skim milk and adjust to 60 C. then add emulsifiers, fats, oil mix and heat appropriately to desired consistency. Introduce stabilizing gum, minierals and vitamis for a rich nutitous blend. Once mixing, heating is completed to required specification it is stored moved to pasteurization equipment.

Pasturization Process

Pasteurization eliminates molds, bacteria or yeast from the product. Undercontrolled environment the mix is cooled and heated to destroy micro-organisms at a 86-94 C for 30 seconds.

Homogenization Process

Homogenization is a process iused to reduce fats and oil particules in the formula. The process sucessfuly provides stability while increasing emulsion uniformity. The process of mixing reduces oil and fat particules into droplets.


Standardization ensures key elements like minerals, viitamis PH level and fat are correct. Insufficient levels require reworking unitil appropriate levels is achieved.


Packaging depends on the type of material preferred by the manufacturer. Common packaging is metal cans, box or nylon bag packaging. The oproduct packaging should have secure tamperproof lid or seal.


Heat treatment or sterilization is used to maintan products bacteriologic properties. The process involves high temperature treatment.

Quality Control, Pricing

The pricing should competitive and similar to other products in the market. Make sure you put inplace proper quality control measures.


The value chain is manufacturer-wholesaler-distributors-retaier. the manufacturer needs capable distributors with financial means with adequate transportation and warehousing. the baby milk industry is highly competitive so effective maketing is esential to sucesss. use television advertisement, radio, print and online advertisement. make sure the product is high quality with federal or sate certification.


webmaster with passion for good content

Leave a Reply

Your email address will not be published. Required fields are marked *