Changes to Infant Formula Regulations – Are You Ready?

July 2016 saw the end of European directive 2009/39/EC on food for particular nutritional uses (PARNUTS) and the replacement with regulation 609/2013 on foods for specific groups (FSG). This reclassified such foodstuffs into 4 groups:

  • Infant formula (IF) & follow-on formula (FOF).
  • Processed cereal-based food and baby food
  • Food for special medical purposes
  • Total diet replacement for weight control

The new framework means all food falling into one of the four categories must comply both with general food law and the new FSG framework and delegated regulations. Delegated regulations for infant formula and special medical purposes now exist, but we are still to see new regulations for the other two groups. EU 2016/128 covers food for special medical purposes and came into force in February this year. The delegated regulation for infant formula (EU 2016/127) is coming into force in February 2020, at which point the old 2006/141/EC directive will be repealed in entirety. Most of the changes are minor and shouldn’t require companies to reformulate, however some changes are significant and, reviewing current products on the market, will require reformulation in order to be compliant by 22nd Feb 2020. Reformulation isn’t as simple as just adding/removing a few nutrients. The composition and stability of the product also needs to be considered. The changes are based on the 2014 EFSA scientific opinion on nutrient requirements and dietary intakes of infants and young children. Interestingly, some of the changes are in contrast to the current CODEX 2007 standard for IF and FOF. Re-labelling, and how you calculate folic acid content also now must be taken into consideration, with the change to dietary folate equivalents amongst other minor unit changes.

The biggest change is the increase in the minimum level of choline to be added to infant formula, increasing by 18 mg/100 kcal from 7 mg/100 kcal to 25 mg/100 kcal. The reason behind this is based on the EFSA opinion on nutrient requirements back in 2013 that a choline intake of 130 mg/day was adequate for infants below 6 months. Based on a 500 kcal/day diet, this means the CODEX level would not be near sufficient to reach that level. Another interesting increase is that of vitamin D from 2.5 µg/100 kcal to 3.0 µg/100 kcal. As noted by EFSA in their 2018 opinion on tolerable upper intakes for vitamin D for infants, this new level could lead to some infants exceeding the 25 µg/day upper level (UL) from formulae alone.

Amongst the minor increases and decreases, there have been several significant decreases based on ULs for certain nutrients. The most significant is the reduction of maximum permitted iodine. The UL for iodine is set at 200 µg/day for children aged 1 to 3 years, based on biochemical changes in thyroid stimulation hormone levels. The previous limit of 50 µg/100 kcal, and a 500 kcal diet, could lead to an excessive iodine intake. The new level of 29 µg/100 kcal reduces this chance. Further changes of interest are summarised below, however it should be noted, that the maximum limits are not targets to aim for, more levels that should not be exceeded. Excess nutrients must be stored or excreted by the infant, which can put a strain on their metabolism. The reductions for zinc, iodine and vitamin A are based on the assumption of a 500 kcal/day diet from formula. An infant taking a formula containing the current maximum permitted levels could potentially lead to an intake above the ULs for these nutrients.

  • Copper – increase from minimum 35 µg/100 kcal to 60 µg/100 kcal
  • Potassium – increase from minimum 60 mg/100 kcal to 80 mg/100 kcal
  • Zinc – reduction from 1.5 mg/100 kcal to 1.0 mg/100 kcal
  • Vitamin A – reduction in maximum level from 180 µg-RE/100 kcal to 114 µg-RE/100 kcal
  • Linoleic acid – increase in minimum content from 300 mg/100 kcal to 500 mg/100 kcal






Start at the Source: Five Steps to Improving Control of Your Infant Formula Supply Chain


By Darryl Sullivan

Who do you trust with your brand? If you are not properly testing your raw materials, your brand’s reputation may be at risk.

Infant formula is one of the most highly regulated products in the world-and with good reason. As often the sole source of nutrition for infants, your end products must be unquestionably safe and consistent.

Often, manufacturers test only their end products for adherence to quality and safety standards. This approach can be inefficient and does not offer solutions to recurring problems. By assuring proper testing of your raw materials, you gain confidence in your suppliers’ Certificates of Analysis, minimize risk and increase efficiency of production.

When manufacturing infant formula, you have more than food safety to think about. Managing regional differences in your global supply chain, maintaining consistency through seasonal variability and refining your process for efficient production are only a few of your challenges. The following five steps will help you strengthen management of your supply chain.

  1. Conserve resources with early nutrient testing

Many nutrient deficiencies can be identified early in the manufacturing process by a thorough and consistent raw materials testing program. By catching these problems in advance, you can avoid expensive losses of time and resources.

All testing laboratories and all testing methods throughout your manufacturing process must be qualified. It is important to assure that only approved testing methods such as AOAC, ISO, CEN or Codex are utilized when testing your products. Since maintaining in-house labs can be expensive, an independent third-party lab may be the best choice.

  1. Mitigate risk with prompt microbiological eradication

An undetected pathogen can contaminate large quantities of your ingredient and your end product. To protect your brand, all raw materials should be screened for major pathogens.

To test for microbiological contaminants, HCAAP and other safety protocols must be standardized and implemented. After screening, consistent routine protocols should be followed to ensure all materials are stored and dispensed aseptically.

  1. Start and end with chemical-free raw materials

Even trace levels of pesticides, heavy metals and other chemical contaminants can put your brand at risk. Many of these contaminants have long-term residual effects.

When testing for heavy metals in your raw materials, geographic origin should be considered. Use only validated testing procedures to ensure that all chemical contaminants meet the levels of quantification specified.

  1. Gain efficiencies by using a risk-based protocol

Partnering with a testing laboratory that is educated about the risks of each potential contaminant allows you to design a testing program that achieves superior quality and safety levels in an efficient, cost-effective manner.

Be sure your testing laboratory is utilizing efficient and accurate screening methods. Combining targeted and non-targeted analysis to identify potential issues is also important. Only perform comprehensive testing to confirm the presence of potential contaminants identified by your screening process.

  1. Secure your future by building relationships with your suppliers

All vendors are not created equal, nor are all third-party testing laboratories. It is important to be informed about your suppliers and the testing laboratory they use in order to maximize a risk-based approach to testing. Test all raw materials from new vendors, and develop quality agreement contracts. For qualified vendors, you may consider a blind testing program for ongoing surveillance. It is always important to use a statistically sound sampling program.

It is important to understand that supplier labs may not be reliable. In-house labs can be inefficient and expensive to maintain. A qualified third-party testing laboratory should be able to partner with you and offer scientific expertise and resources to implement all of these important elements of supply chain management.

Learn more about our Complete Nutrition Services.

Chill Out – CBD is everywhere

By Jennifer Keaveny

It seems lately that CBD is everywhere. The local coffee shop has CBD infused scones. The microbrewery down the street has a CBD beer. Your colleague is treating their migraines with CBD oil purchased online.  Being in the food and supplement testing industry for the past 13 years I have been able to watch the evolution of the Hemp and CBD market and how from a consumer perspective the lines are starting to blur between the traditional supplements and hemp and CBD products.

While it is clear that consumer demand is pushing this market forward the big issue is that Hemp derived CBD is not an approved dietary ingredient. This leaves the market in a bit of a regulatory black hole. The growth of this market has been said to be unprecedented by industry leaders with some estimates reaching as high as $16 billion by 2025. With the lack of regulations in this space how is the CBD market ensuring that there is quality and safety within the products?

It is apparent that there is buzz in the air with everyone in the food and supplement industry discussing CBD and Hemp.  From industry events to academic conferences the hot topic is CBD and Hemp. Not only are the side conversations and discussions being focused on hemp and CBD but I’ve seen a huge number of new entrants in the CBD space compared to last year. This includes established food and supplement companies who are exploring expanding their product lines to include CBD and Hemp.

While financial gains are driving the market growth it is becoming obvious is that safety and quality are becoming a large part of the conversation. The hemp plant has some unique properties that enable it to clean up the soil and environment around it.  Phytoremidiation is a term used to describe this process by scientist Ilya Raskin who tested hemp’s ability to accumulate heavy metals from soil in contaminated fields near Chernobyl in the 1990’s. While this is a promising aspect for environmental cleanup CBD producers want to ensure that the hemp that the CBD is being extracted from is clean from potential toxins in the environment such as heavy metals and pesticides. Residual solvents and microbiological testing also need to be considered due to various extraction and processing procedures.

In addition to potential contaminants the industry also needs to be mindful of the cannabinoid and terpene profile that is being claimed on each bottle of product. Each strain of hemp has a unique CBD fingerprint and it is important to ensure that the levels being claimed on the product are what are in there. This is especially important for THC from a legal perspective.

It is clear that this industry segment is not going away anytime soon. With the trends going towards safety and quality I am looking forward to see what the next 5 years brings for the CBD and Hemp market.