Infant Formula Complete Label Claims Testing

Reason

Importance

Regulatory Compliance

Aligns with strict standards set by FSSAI, Codex, FDA, and EU for infant food

Nutritional Accuracy

Confirms that formula provides essential nutrients for healthy infant growth

Safety Assurance

Detects contaminants, allergens, and undeclared ingredients

Brand Credibility

Ensures transparency and prevents product recalls

Export Approval

Required documentation for global infant formula trade

Source

Description

Cross-contact during production

Shared manufacturing equipment for different formula types

Ingredient variability

Inconsistent nutrient content in raw materials

Incorrect formulation

Errors in pre-mixing or dosing

Packaging mistakes

Mixing up batches or outdated labels

Supply chain issues

Non-compliant or adulterated imported ingredients

Manufacturing process losses

Nutrient degradation due to heat, storage, or shelf life

Category

Requirement

Details

Mother’s Milk Statement

- Statement: “IMPORTANT NOTICE: MOTHER’S MILK IS BEST FOR YOUR BABY” in capital letters.
- Text size: Minimum 5 mm, contrasting with background color.
- Exemption: Not required for products designed for special medical purposes where breastfeeding is medically contraindicated.

Use and Preparation Instructions

- Statement: Product should be used only on the advice of a health worker.
- Warning: Product is not the sole source of nourishment.
- Instructions: Include detailed hygiene precautions, e.g., “Careful and hygienic preparation of infant foods or infant milk substitute is most essential for health. Do not use fewer scoops than directed since diluted feeding will not provide adequate nutrients needed by your infant. Do not use more scoops than directed since concentrated feed will not provide the water needed by your infant.”

Nutritional Information

- Approximate composition of nutrients per 100 g or 100 ml, including energy value.

Storage Instructions

- Example: “Store in a cool and dry place in an airtight container.”

Feeding Chart and Directions

- Instructions for using a measuring scoop and quantity per scoop.
- Directions for discarding leftover feed.

Product Identification and Safety

- Batch number, manufacturing date, expiry date, or recommended last consumption date.
- Warnings about allergenic ingredients and contamination risks, e.g., “Warning: Boiled and cooled water shall be used to prepare this product and any leftover product must be discarded to reduce the risk of infection.”

Restrictions on Imagery and Claims

- No images of infants or women allowed.
- Prohibited terms: “Humanised,” “Maternalised,” “Full Protein Food,” “Energy Food,” “Complete Food,” or “Health Food.”

Milk Content Declaration

- Products without milk or milk derivatives must be labeled: “Contains no milk or milk products or milk derivatives.”

Lactose-Free Infant Milk Substitutes

Lactose-Free Label

- Prominently display “LACTOSE-FREE” in capital and bold letters.

Medical Advisory Warning

- Statement: “RECOMMENDED TO BE USED UNDER MEDICAL ADVICE ONLY” in capital and bold letters.
- Use only for diarrhoea in infants due to lactose intolerance.
- Withdraw if no improvement in symptoms of intolerance.

Hypoallergenic Infant Milk Substitutes

No Milk Declaration

- Label: “CONTAINS NO MILK OR MILK PRODUCTS” conspicuously.

Hypoallergenic Formula Label

- Indicate “HYPOALLERGENIC FORMULA” with the statement “RECOMMENDED TO BE TAKEN UNDER MEDICAL ADVICE ONLY” in capital and bold letters.

Foods for Infants with Inborn Errors of Metabolism (IEM)

Special Medical Purpose Declaration

- Words: “FOOD FOR SPECIAL MEDICAL PURPOSE” in capital and bold letters next to the product name or brand.

Medical Advisory Warning

- Statement: “RECOMMENDED TO BE USED UNDER MEDICAL ADVICE ONLY” in capital and bold letters, separate from other information.

Infant Milk Substitute for Preterm Babies

Preterm Baby Statement

- Statement: “FOR THE PRETERM BABY (BORN BEFORE 37 WEEKS)” in capital and bold letters along with the product name.

Medical Advisory Warning

- Statement: “RECOMMENDED TO BE TAKEN UNDER MEDICAL ADVICE ONLY” in capital and bold letters.

Category

Requirement

Details

General Compliance

Nutrient Composition and Labeling

- Infant formula and follow-on formula must comply with requirements under Regulation (EU) No 609/2013.

Labeling Requirements

Promotion of Breastfeeding

- Labeling must promote breastfeeding.

Safe Preparation Instructions

- Provide clear and safe instructions for preparation.

Restrictions on Claims

- Restrict health or nutrition claims.

Novel Ingredients Labeling

- Mandates specific labeling for novel ingredients like 3-Fucosyllactose (3-FL).

Maximum Levels for Novel Ingredients

3-Fucosyllactose (3-FL)

- Maximum authorized level: 1.75 g/L in the final prepared product.

Overall Standards

Compositional, Safety, and Labeling Standards

- Requires full compliance with these standards for all products.

Applicability

Binding Nature

- Binding and directly applicable across all EU member states.
- Incorporates updates from earlier legislation for infant formula and related products.

Step

Objective

Eurofins Service

1. Review of Label Claims

Understand formulation and regulatory needs

Technical team assessment

2. Sampling

Representative sample collection

Controlled, secure sample intake

3. Analytical Testing

Verify nutrients, contaminants, and safety

Multi-parameter laboratory testing

4. Compliance Comparison

Match results with regulatory limits

Expert interpretation

5. Reporting & Certification

Provide export-ready documentation

Digital CoA via SmartLIMS