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Issues of contamination, fraud and substitution in recent years have hit infant formula products. Regulators around the globe are addressing the risks and implementing changes to keep the world’ s smallest consumers safe.

Infant formula in developed countries, and some developing countries, is highly regulated in an effort to ensure that the most precious and vulnerable of our community are protected. Most of these regulations include specific nutrient levels, required testing for specific microorganisms, labelling requirements, company registration, manufacturing facility operational requirements and/ or analytical testing for specific levels of chemicals. These stringent regulations are necessary, as for some infants, the formula maybe their primary or even sole source of nutrition. Any deficiencies or contamination can cause major problems immediately, or have future consequences.

New Nutrient Requirements in USA

In the United States, the Infant Formula Act of 19801 was enacted because major manufacturers produced soy based infant formula with inadequate levels of chloride because of the withdrawal of salt in the formula. This act required the establishment of recall procedures, quality control procedures, labeling and nutrient requirements. The act was amended in 1986, with the addition of external and internal auditing, record keeping, Current Good Manufacturing Practices and other requirements. Even with these additional requirements, which are published in 21 Code of Federal Regulations (CFR) part 107, from July 2014 the US Food and Drug Administration (US FDA) introduced final product testing for Cronobacter, Salmonella, Vitamin A, C, E and thiamine, prior to the release of any lot of the formula2 Also, from 23 July 20163, the US FDA will add specific minimum and maximum levels of selenium to those required nutrients that are listed in 21 CFR 107.100. Assuring the correct levels of these nutrients is essential in the quality control procedures of manufacturing these products.

Composition & Labelling in The EU

In the European Union (EU), Commission Directive 2006/141/EC set forth composition and labelling requirements for infant formula and follow-up formula. The composition requirements include protein, fat, carbohydrate, minerals, vitamins and certain ingredient levels. Minimum and/or maximum levels were established as necessary. Also established by this directive are lower tolerances than the normal not detected level of 0.01 mg/kg, for some very toxic pesticide residues. Commission Directive 2013/141/EC extended these requirements to hydrolysates of cows’ milk and infant formula as well as followup formula from goats’ milk protein.4

EU Regulation 609/2013, commonly called “Food for Specific Groups”, which will apply from 20 July 2016 will set general composition and labeling rules. This regulation will establish the restriction of pictures and text that idealise formula, to the follow-up formula category. This Regulation will move the existing requirements of Directive 2006/141/EC to regulatory status and replace that Directive.

Antipodean Consultation

Like the EU and US, the Australia New Zealand Food Standards Code – Standard 2.9.1 for infant formula5, establishes specific nutrient requirements (Standards 1.1.1, 1.3.4), minimum and maximum as appropriate, labeling requirements, prohibition on certain labelling, allowable ingredients (Standard 1.3.1) and microbiological requirements (Standard 1.6.1). A consultation paper is expected to be published in the second half of 2015, to review the nutrient levels and permitted forms of their addition, food additives and processing aids, contaminant maximum levels (Standard 1.4.1) and premarket assessment requirements. The labeling being considered is a declaration of the nutrition information, directions for use, preparation and storage instructions.

Macro & Micro Requirements in China

In China, infant formula must comply with the standard as set by GB 10765-2010, which like all the nations mentioned, include macro and micro nutrient requirements with minimum and maximums as necessary, specific contaminant requirements whether chemical, microbiological or mycotoxin, sensory requirements and specific labelling requirements. There is also additional labelling required, by GB 13432-2004, the general standard for the labelling of pre-packaged foods for special dietary uses. Additionally, many of the amendments in China’s new food safety laws, which became effective 1 October 2015, were specifically designed to address the infant formula regulations. One of these amendments, article 81, requires manufacturers to register brands with the China Food and Drug Administration (CFDA) and keep formulas within specific, limited ingredient parameters.

Contaminated Milk Powder Issues

Why has there been all this recent activity and concern about infant formula? Over a little more than half a decade there have been numerous issues regarding the main component, milk powder, which is the basis for milk based infant formulas. The Chinese public were the unfortunate victims of too many of these issues originating inside and outside their country. Some of these issues were global and some local.

One of the global issues was the melamine contaminant episode in which six unfortunate children died, and some 300,000 fell ill due to milk product contamination.6 Another issue was that a major supplier of milk powder product from New Zealand was believed to have a bacterial strain in some of its products that caused botulism. Infant formula with excessive nitrates and aluminium were recently found and recalled. In New Zealand, milk powder found to be contaminated with dicyandiamide required countrywide testing.

Fighting Fraud

The visible target and money to be made in this industry mean that there are fraud and tampering problems. The Canadian Food Inspection Agency issued an alert in June 20157 to raise public awareness of infant formula that had been altered or where the product was substituted. The problem of substituted infant formula has been identified in the US, New Zealand, Australia and China. This has become such a sensitive issue that in New Zealand recently, a person was arrested for threatening to contaminate infant formula.8

These are just some of the reasons that world governments have instituted strict requirements for the production, labelling and testing of infant formula. It is necessary for society to protect the most vulnerable, and to ensure that they become healthy and productive members of the community.

For the complete range of SGS services and support visit our website.

Jim Cook
Food Scientific and Regulatory Affairs Manager
SGS North America, Inc.
t +1 973 461 1493

1 US FDA - Food Advisory Committee Meeting on Infant Formula

2 Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula

3 US FDA Issues Final Rule to Add Selenium to List of Required Nutrients for Infant Formula

4 European Commission - Food for Infants and Young Children

5 Australia New Zealand Food Standards Code - Standard 2.9.1 - Infant Formula Products

6 BBC News - China to recall Shaanxi baby milk powders

7 Consumer Advisory - CFIA advises consumers to use caution with infant formula products due to potential product substitution and/or tampering

8 NZ police arrest man over infant formula contamination threat