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formula (EU 2016/127) is coming into force in February 2020, at which point the old 2006/141/EC directive will be repealed in entirety.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.

The 5 Coolest Things We Did With Our Digital Portal (SampleKinect) This Year

By Nate Ensrud

A great digital tool can make a big difference in how you work with a vendor, and that’s definitely true with your contract laboratory.  Five years ago, we made our first attempt at building a great digital tool with the introduction of SampleKinect.  Since that time we’ve listened to our customers, and we’ve made several sets of changes, both big and small.  About a year ago, we mapped out the biggest set of changes yet, so here are the 5 things customers talked about the most to us.

  1. Streamlined Ordering

Customers told us that ordering was the toughest thing to do in SampleKinect, so we’ve built a guided order that makes it clearer and easier to get an order entered.  This includes separate steps for entering sample info, picking tests, and including specifications.  And now, each of those steps can be completed in one screen.


  1. Easier Repeat Ordering

For customers who work with Food Integrity and Innovation consistently, the easiest way to complete an order is to use previous samples, and simply copy the same sample info, test selections, and specifications.  This was always an option in SampleKinect, but we’ve made it easier to find with a shopping cart-style selection, and it’s now on the home page, to boot.


  1. Filtering Test Selections

We listened. Picking the right test for their sample was sometimes an unintended obstacle to completing an order, and they felt extra time was spent if they had to call their customer service associate (CSA). Good news! We’ve made it simpler. Users can now add the option to filter tests using the sample type. All they need to do is pick the type of sample to be tested, and then see only the tests that are applicable for that type of sample.


  1. Requesting Retests

One of the more common requests we have received from customers is to perform retesting on a sample or conduct an investigation and issue a report for out-of-specification results. Previously, this required a phone call or e-mail.  Well, we’ve greatly streamlined this process. We’ve added the option for customers to make these requests right in SampleKinect. Users can now see the results and quickly get retesting started and request an investigation report right in the SampleKinect tool.


  1. Status Checks from the Home Screen

Receiving an update on the status of their testing was something our customers wanted to know more easily. In short, when will they get their results?  Again, we’ve improved the ease for our users by adding a quick drop down for all in-progress orders that’s visible right from the home screen.  Now, it’s easy to check on expected timing as soon as you log into SampleKinect.

While we’ve spent the last year making some pretty big changes to SampleKinect, we’re not done.  We’d love to hear from you!  Customer feedback is the key to driving continued improvements in the tools we provide to you.  We plan to continue evolving the system as we become part of the Eurofins family.  So, if you have questions or feedback or requests for other changes, please contact your CSA or sales rep.


Beyond ID Testing


Beyond ID Testing

The Need for Additional Testing Beyond ID Verification for Botanicals

 Specifications and Verification

There continues to be a focus within the dietary supplement industry on the requirement to confirm the identity of a dietary ingredient prior to use.  This has been near the top of FDA issued citations and many warning letters include this as an observation as well.  However, the industry has made great strides in this area from the inception of the dietary supplement cGMPS in 2007.  More companies have a better understanding for this requirement and the need for using scientifically valid methods for this

Even though the industry focus in the area of identity verification has increased, it is also necessary to consider additional testing that is required for ingredients and finished products to fully comply with the regulations.

21 CFR 111.70 specifies that the following specifications must be established and verified for each component used in dietary supplements:

  • Identity
  • Purity, strength, and composition
  • Limits for contaminants

The above specifications also must be established and verified for each dietary supplement that is manufactured.  The best way to ensure specifications are met for ingredients and finished products is to test using an appropriate, scientifically valid method.

Botanical Products

Dietary supplement products containing botanicals have increased in popularity and because of this there has been much discussion within industry about how to accurately verify the identity of these dietary ingredients.  There are a variety of techniques including DNA barcoding, HPTLC and HPLC that all are appropriate in certain situations.  Aside from identity, the industry must be aware that specifications must be made for potential contaminants, and these specifications must be verified, ideally by testing.  As botanicals are very complex and diverse, understanding your ingredients is critical to ensure the appropriate specifications are developed.  Unfortunately, there is not a single method that will test for all potential contaminants so each potential contaminant must be identified and tested for using an appropriate method.  These potential contaminants will vary depending on material, but in general the following are most common for all botanicals and could be used as a starting point:

  • Heavy Metals (Arsenic, Lead, Cadmium, Mercury)
  • Pesticides
  • Residual Solvents – if ingredient is an extract
  • Microbiological


Other potential contaminants could be those from economically motivated adulteration.  This may include adding a “filler” to a botanical, replacing some of the target material with a cheaper botanical, or adding a pharmaceutical-type ingredient to improve the efficacy of a product.

As you can see, testing botanicals goes well beyond the id verification. Review your product to understand what additional tests may be needed to ensure quality and safety needed to ensure quality, safety, and compliance with applicable regulations.

Click here to learn more.




Scientifically Valid ID testing for Botanicals

Scientifically Valid ID testing for Botanicals
Jeff Stassi, Senior Program Development Manager
From the onset of the dietary supplement GMPs (21 CFR Part 111) back in 2007, a focus has been, and continues to be, on the mandatory requirement to confirm the identity of a dietary ingredient prior to use.  This requirement was at or near the top of citations issued by FDA for non-compliance as it became obvious that firms were unable or unwilling to understand the process by which to create identity specifications and to perform the appropriate analysis. Now over a decade later, the industry is getting better but still has issues related to this requirement.  One area that continues to be most problematic is using appropriate tests and examinations for herbal/botanical ingredients.  As we have discussed in previous webinars on this subject, we remind you of the definition of a scientifically valid method is one that is accurate, precise and specific for its intended use.
The FDA places an emphasis on the use of scientifically valid methods in the GMPs in 111.320, it reads:


  • You must verify that the laboratory examination and testing methodologies are appropriate for their intended use
  • You must identify and use an appropriately scientifically valid method for each established specification for which testing or examination is required to determine whether he specification is met.


It is also a big part of 111.75:


  • Before you use a component you must:
  • (i) Conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, unless you petition the agency under paragraph (a)(1)(ii) of this section and the agency exempts you from such testing;


As botanical ingredients continue to increase in popularity and more people begin to rely on them for their health benefits, you can rest assured that the FDA will take a closer look as it is their sole mission to keep the food supply safe for the consumer.  So establishing a reliable quality control system for these types of ingredients is extremely important and an emphasis on proper testing is paramount.
So how does a firm establish the appropriate identity testing plan?
First you must understand the tools in the toolbox.  There are a number of techniques that when used appropriately can identify, or help identify herbal ingredients.  These techniques fall mainly into these categories:


  • Macroscopic and microscopic examinations
  • Organoleptic (color, odor, appearance, taste, smell)
  • Genetic (DNA)
  • Chemical analysis
  • Spectroscopy
  • Chromatography


All of these tools serve an important purpose in herbal identity testing, but only when applied in a scientifically valid way.  The more processed an ingredient becomes, the more complex it becomes to identify it. So understanding the tools and when to apply them is an important piece of the puzzle, and one tool may not get the job done. You certainly would not pull a screwdriver out of a toolbox to drive a nail in the wall. 
Secondly, it is important to understand how and when to use the tools at your disposal. A key step is to establish appropriate specifications on the ingredients you purchase so that the testing process can flow much more easily. Confirming these specifications through appropriate scientifically valid methods will help assure the quality of the finished product.  Remember, it may take more than one test to identify the material. In the industry it is known as an orthogonal approach, but it really comes down to performing as many tests or examinations as it takes to confirm 100% identity.  If a visual examination can identify an ingredient with 100% certainty, then that is scientifically valid and you will need no further analysis.  As ingredients are further processed, the likelihood of using only organoleptic techniques would not be appropriate and will require more sophisticated techniques. This may be the more complicated part for compliance as many firms do not have the proper scientific expertise to completely understand the ingredient and the testing that may go into it.  Use a laboratory that has that expertise and will work with you to establish the appropriate program.
 In summary, when producing quality products and minimize your risk of non-compliance, here are  some key points to consider:


  • Create a well-designed identity testing program
  • Create identity specification for all incoming ingredients
  • Use an orthogonal approach where needed
  • Use reputable suppliers for quality ingredients
  • Use only scientifically valid methods


Want to discuss scientifically valid testing specific to your product? Contact us at the link below!