{"id":304,"date":"2026-10-29T11:05:07","date_gmt":"2026-10-29T11:05:07","guid":{"rendered":"https:\/\/makrolife-biotech.com\/blog\/?p=304"},"modified":"2026-09-15T11:14:47","modified_gmt":"2026-09-15T11:14:47","slug":"functional-food-testing-eu","status":"publish","type":"post","link":"https:\/\/makrolife-biotech.com\/blog\/functional-food-testing-eu\/","title":{"rendered":"What Should Be Tested When Launching a Functional Food in the EU?"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Launching a functional food in the EU involves more than developing a good recipe.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The product also needs to meet requirements for <strong>food safety, composition, labelling and claims<\/strong>. Testing can provide important evidence, but the right analytical programme depends on the ingredients, manufacturing process, intended use and claims.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">That is why a functional food should not automatically receive a generic laboratory test package.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Instead, testing should follow the <strong>specific risks of the product<\/strong>.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">What makes a functional food different?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u201cFunctional food\u201d is not a separate harmonised legal category in EU food law.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A product may be marketed as a food while containing ingredients associated with a nutritional or physiological benefit. The regulatory requirements then depend on what the product contains, how it is presented and what is claimed.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">For example, a fortified drink, protein product, botanical food or fibre-rich snack can have very different testing requirements.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The first step is therefore to define the product correctly.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h1 class=\"wp-block-heading\">Start with the formulation<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">Before deciding which laboratory tests to order, review the complete formula.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Consider:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>vitamins and minerals<\/li>\n\n\n\n<li>botanical ingredients<\/li>\n\n\n\n<li>plant extracts<\/li>\n\n\n\n<li>proteins<\/li>\n\n\n\n<li>amino acids<\/li>\n\n\n\n<li>fibres<\/li>\n\n\n\n<li>probiotics<\/li>\n\n\n\n<li>enzymes<\/li>\n\n\n\n<li>additives<\/li>\n\n\n\n<li>sweeteners<\/li>\n\n\n\n<li>flavours<\/li>\n\n\n\n<li>processing aids<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Each ingredient can introduce different analytical or regulatory risks.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A botanical extract, for example, may require a different assessment from an isolated vitamin.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The testing plan should therefore start with the <strong>actual formulation<\/strong>, not a standard checklist.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h1 class=\"wp-block-heading\">1. Test the nutritional composition<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">If the product makes nutritional claims or provides declared nutrient values, the composition needs to be reliable.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Depending on the product, relevant parameters may include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>protein<\/li>\n\n\n\n<li>carbohydrate<\/li>\n\n\n\n<li>fat<\/li>\n\n\n\n<li>fibre<\/li>\n\n\n\n<li>sugars<\/li>\n\n\n\n<li>salt<\/li>\n\n\n\n<li>vitamins<\/li>\n\n\n\n<li>minerals<\/li>\n\n\n\n<li>energy value<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">This information can support both product specifications and nutrition labelling.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">For example, an EU nutrition claim such as \u201chigh protein\u201d is only permitted when the product meets the conditions defined by Regulation (EC) No 1924\/2006. The European Commission specifies that a \u201chigh protein\u201d claim requires at least 20% of the energy value to come from protein. <a href=\"https:\/\/food.ec.europa.eu\/food-safety\/labelling-and-nutrition\/nutrition-and-health-claims_en?utm_source=chatgpt.com\">Food Safety<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">So the analytical result can directly affect what you are legally allowed to communicate.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h1 class=\"wp-block-heading\">2. Verify the active or functional ingredients<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">Functional foods often contain an ingredient that forms the basis of the product concept.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">That could be:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>a botanical extract<\/li>\n\n\n\n<li>a specific fibre<\/li>\n\n\n\n<li>a vitamin<\/li>\n\n\n\n<li>a mineral<\/li>\n\n\n\n<li>a protein<\/li>\n\n\n\n<li>an amino acid<\/li>\n\n\n\n<li>a probiotic culture<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">The relevant question is not simply whether the ingredient is present.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">You may also need to know:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>How much is present?<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Is the material correctly identified?<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Does the concentration remain within specification?<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">For standardised extracts, marker compounds can be particularly useful for verifying consistency between batches.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h1 class=\"wp-block-heading\">3. Check for contaminants<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">Food contaminants can enter products through raw materials, agricultural practices, environmental exposure, processing or storage.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">EU legislation establishes maximum levels for several contaminant groups, including certain mycotoxins, plant toxins, metals and persistent organic pollutants. <a href=\"https:\/\/food.ec.europa.eu\/food-safety\/chemical-safety\/contaminants\/legislation_en?utm_source=chatgpt.com\">Food Safety<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Depending on the formulation, testing may therefore consider:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>lead<\/li>\n\n\n\n<li>cadmium<\/li>\n\n\n\n<li>mercury<\/li>\n\n\n\n<li>inorganic arsenic<\/li>\n\n\n\n<li>mycotoxins<\/li>\n\n\n\n<li>plant toxins<\/li>\n\n\n\n<li>PFAS<\/li>\n\n\n\n<li>dioxins and PCBs<\/li>\n\n\n\n<li>process contaminants<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Not every functional food needs every test.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The relevant panel should reflect the ingredients and their potential exposure pathways.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h1 class=\"wp-block-heading\">4. Heavy metals: look at the ingredients first<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">Heavy-metal testing is particularly relevant for some botanical, mineral and agricultural raw materials.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">However, a broad \u201cheavy metals\u201d test without considering the product can be inefficient.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The risk assessment should consider:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ingredient origin<\/li>\n\n\n\n<li>agricultural conditions<\/li>\n\n\n\n<li>manufacturing process<\/li>\n\n\n\n<li>known contamination risks<\/li>\n\n\n\n<li>applicable maximum levels<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">The EU contaminant framework currently includes maximum levels for metals such as lead, cadmium, mercury and inorganic tin in specified foods. <a href=\"https:\/\/food.ec.europa.eu\/food-safety\/chemical-safety\/contaminants_en?utm_source=chatgpt.com\">Food Safety<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Therefore, the analytical method and test scope should be connected to the relevant regulatory requirement.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h1 class=\"wp-block-heading\">5. Consider pesticides for plant-based ingredients<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">Plant-based functional foods can also require pesticide-residue assessment.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This is especially relevant when products contain:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>herbs<\/li>\n\n\n\n<li>fruits<\/li>\n\n\n\n<li>vegetables<\/li>\n\n\n\n<li>botanical extracts<\/li>\n\n\n\n<li>agricultural raw materials<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">The need and scope depend on the material and supply chain.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A highly processed ingredient from a well-controlled supplier may have a different risk profile from a minimally processed agricultural ingredient.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Testing should reflect that difference.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h1 class=\"wp-block-heading\">6. Mycotoxins can matter for certain ingredients<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">Mycotoxins are naturally occurring toxins produced by certain fungi.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">They can become relevant in ingredients such as grains, nuts and other agricultural materials.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The EU has established maximum levels for several mycotoxins in specified foods, including aflatoxins, ochratoxin A, deoxynivalenol, zearalenone and fumonisins. <a href=\"https:\/\/food.ec.europa.eu\/food-safety\/chemical-safety\/contaminants\/legislation_en?utm_source=chatgpt.com\">Food Safety<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A risk-based testing plan should therefore consider:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ingredient type<\/li>\n\n\n\n<li>geographical origin<\/li>\n\n\n\n<li>storage conditions<\/li>\n\n\n\n<li>processing<\/li>\n\n\n\n<li>supplier history<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">That approach is more useful than automatically screening every product for every mycotoxin.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h1 class=\"wp-block-heading\">7. Microbiological testing<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">A functional food can also require microbiological testing.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The relevant parameters depend on the product&#8217;s characteristics.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Consider:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>moisture<\/li>\n\n\n\n<li>water activity<\/li>\n\n\n\n<li>pH<\/li>\n\n\n\n<li>processing<\/li>\n\n\n\n<li>packaging<\/li>\n\n\n\n<li>intended storage<\/li>\n\n\n\n<li>ingredients<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Possible analyses can include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>total aerobic microbial count<\/li>\n\n\n\n<li>yeasts and moulds<\/li>\n\n\n\n<li>Enterobacteriaceae<\/li>\n\n\n\n<li>Salmonella<\/li>\n\n\n\n<li>other relevant pathogens<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">A dry protein powder and a refrigerated functional beverage clearly do not have the same microbiological risk.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Therefore, the testing programme should reflect the product&#8217;s actual conditions.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h1 class=\"wp-block-heading\">8. Test for allergens where relevant<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">Allergen management starts with the formulation and manufacturing process.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">EU food labelling rules require the presence of the 14 specified allergens to be clearly indicated when they are used as ingredients. <a href=\"https:\/\/food.ec.europa.eu\/food-safety\/campaign-2026\/labelling_en?utm_source=chatgpt.com\">Food Safety<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Relevant testing may become important when:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>an allergen is intentionally used<\/li>\n\n\n\n<li>cross-contact is possible<\/li>\n\n\n\n<li>manufacturing equipment is shared<\/li>\n\n\n\n<li>supplier controls are uncertain<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Analytical testing does not replace good manufacturing practices.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Instead, it can provide additional evidence where the risk assessment justifies it.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h1 class=\"wp-block-heading\">9. Check the claims before testing<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">This step is often overlooked.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A company may develop a product first and then ask:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u201cWhat claims can we put on the label?\u201d<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A better approach is to consider claims during product development.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">EU Regulation (EC) No 1924\/2006 governs nutrition and health claims made for foods in the EU. Claims must meet the applicable conditions and should not mislead consumers. <a href=\"https:\/\/food.ec.europa.eu\/food-safety\/labelling-and-nutrition\/nutrition-and-health-claims_en?utm_source=chatgpt.com\">Food Safety<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The European Commission also maintains an EU Register containing permitted nutrition claims and authorised health claims together with their conditions of use. <a href=\"https:\/\/food.ec.europa.eu\/food-safety\/labelling-and-nutrition\/nutrition-and-health-claims\/eu-register-health-claims_en?utm_source=chatgpt.com\">Food Safety<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This means the claim strategy can influence the testing strategy.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h1 class=\"wp-block-heading\">10. Test what supports the intended claim<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">Suppose a product is marketed around a defined nutrient.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The analytical data should support the actual amount present in the finished product.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">For a nutrition claim, that may involve measuring:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>protein<\/li>\n\n\n\n<li>fibre<\/li>\n\n\n\n<li>vitamins<\/li>\n\n\n\n<li>minerals<\/li>\n\n\n\n<li>fat<\/li>\n\n\n\n<li>sugars<\/li>\n\n\n\n<li>energy<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">For a product based on a specific functional ingredient, other analytical markers may be more appropriate.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The important point is that <strong>the claim and the analytical evidence need to match<\/strong>.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h1 class=\"wp-block-heading\">A laboratory result does not automatically authorise a claim<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">This distinction is important.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Suppose a laboratory confirms that a product contains a particular botanical compound.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">That result does not automatically mean the company can make a health claim about that compound.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The analytical result tells you what is in the product.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The regulatory framework determines whether the intended claim can be used.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The European Commission explains that health claims require authorisation and must be supported by scientific evidence. <a href=\"https:\/\/food.ec.europa.eu\/food-safety\/labelling-and-nutrition\/nutrition-and-health-claims\/health-claims_en?utm_source=chatgpt.com\">Food Safety<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Therefore:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>composition testing \u2260 claim approval<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Both need to be considered.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h1 class=\"wp-block-heading\">11. Consider novel ingredients<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">Some functional foods contain innovative ingredients that may fall under the EU Novel Food Regulation.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This question should be addressed <strong>before<\/strong> extensive product development.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">If an ingredient requires novel food authorisation, analytical testing alone will not make the product marketable.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The regulatory status of the ingredient needs to be established first.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">That can save considerable time because there is little value in optimising a formulation around an ingredient that cannot be legally marketed for the intended use.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h1 class=\"wp-block-heading\">12. Stability testing<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">Once the formula is defined, stability becomes another important consideration.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A functional food may need to remain within specification throughout its intended shelf life.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Depending on the product, stability testing can monitor:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>active ingredient content<\/li>\n\n\n\n<li>vitamins<\/li>\n\n\n\n<li>oxidation<\/li>\n\n\n\n<li>moisture<\/li>\n\n\n\n<li>microbiological quality<\/li>\n\n\n\n<li>colour<\/li>\n\n\n\n<li>flavour<\/li>\n\n\n\n<li>texture<\/li>\n\n\n\n<li>degradation products<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Packaging can also influence stability.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A powder that is highly sensitive to moisture, for example, may require very different packaging from a dry product with low moisture sensitivity.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h1 class=\"wp-block-heading\">13. Packaging and food-contact materials<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">The packaging should not be treated as completely separate from product development.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Food-contact materials must not transfer their constituents into food at levels that could endanger health or cause unacceptable changes to the food. <a href=\"https:\/\/food.ec.europa.eu\/food-safety\/chemical-safety_en?utm_source=chatgpt.com\">Food Safety<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Depending on the packaging system, relevant assessments can include migration testing.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Potential analytical targets may include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>plasticisers<\/li>\n\n\n\n<li>bisphenols<\/li>\n\n\n\n<li>metals<\/li>\n\n\n\n<li>mineral oil hydrocarbons<\/li>\n\n\n\n<li>other relevant migrants<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">The exact testing depends on the material and intended conditions of use.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h1 class=\"wp-block-heading\">14. Check the finished product, not only the raw materials<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">Supplier documentation can provide valuable evidence.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">However, raw-material COAs do not automatically prove that the finished functional food meets its specifications.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Manufacturing can introduce changes.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">For example:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>blending can affect homogeneity<\/li>\n\n\n\n<li>processing can affect active compounds<\/li>\n\n\n\n<li>heat can cause degradation<\/li>\n\n\n\n<li>storage can change moisture<\/li>\n\n\n\n<li>packaging can affect stability<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Finished-product testing should therefore be considered alongside raw-material controls.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h1 class=\"wp-block-heading\">Raw material testing vs. finished-product testing<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">The two serve different purposes.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Raw material testing<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Answers questions such as:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Is this the correct ingredient?<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Does it meet its specification?<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Are relevant contaminants controlled?<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Finished-product testing<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Answers questions such as:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Does the final product meet its specification?<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Does it contain the expected amount of the functional ingredient?<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Is it microbiologically acceptable?<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Does it remain stable?<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A strong quality strategy uses both where appropriate.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h1 class=\"wp-block-heading\">How much testing does a functional food need?<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">There is no universal testing package.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A useful testing plan depends on:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>formulation<\/li>\n\n\n\n<li>ingredients<\/li>\n\n\n\n<li>processing<\/li>\n\n\n\n<li>target consumer<\/li>\n\n\n\n<li>serving size<\/li>\n\n\n\n<li>packaging<\/li>\n\n\n\n<li>claims<\/li>\n\n\n\n<li>intended shelf life<\/li>\n\n\n\n<li>supplier controls<\/li>\n\n\n\n<li>regulatory requirements<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">This is why two functional foods can require completely different analytical programmes.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A botanical powder and a fortified beverage may both be marketed as functional foods, yet their risks are not comparable.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h1 class=\"wp-block-heading\">A practical testing framework<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">A functional-food testing plan can be structured into five areas:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">1. Composition<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">What is actually in the product?<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2. Safety<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Are relevant microbiological and chemical hazards controlled?<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3. Stability<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Does the product remain within specification over its intended shelf life?<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">4. Claims<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Does the analytical evidence support the intended nutrition or product information?<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">5. Packaging<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Could the packaging affect the product or introduce relevant substances?<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Together, these areas create a much more complete picture than a single laboratory report.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h1 class=\"wp-block-heading\">Example: a botanical functional drink<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">Imagine a company developing a drink containing:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>a botanical extract<\/li>\n\n\n\n<li>vitamin C<\/li>\n\n\n\n<li>added fibre<\/li>\n\n\n\n<li>natural flavour<\/li>\n\n\n\n<li>sweetener<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">A reasonable risk assessment could lead to testing such as:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Botanical extract<\/strong><br>\u2192 identity and marker compounds<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Vitamin C<\/strong><br>\u2192 quantitative assay<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Fibre<\/strong><br>\u2192 fibre content<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Microbiology<\/strong><br>\u2192 relevant microbial parameters<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Botanical raw material<\/strong><br>\u2192 appropriate contaminant screening<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Finished product<\/strong><br>\u2192 composition and specification testing<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Stability<\/strong><br>\u2192 active content, microbiology and relevant physical properties<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Packaging<\/strong><br>\u2192 appropriate food-contact assessment<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The exact programme would depend on the formulation and manufacturing process.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">That is the key point.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h1 class=\"wp-block-heading\">Testing should start before launch<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">Waiting until the finished product is ready can create unnecessary delays.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Imagine discovering late in development that:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>the active concentration is unstable<\/li>\n\n\n\n<li>a contaminant exceeds a relevant limit<\/li>\n\n\n\n<li>a claim cannot be used<\/li>\n\n\n\n<li>the packaging requires further assessment<\/li>\n\n\n\n<li>the ingredient has a regulatory issue<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Each problem can force changes to the formulation or launch plan.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Testing should therefore be integrated into product development.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h1 class=\"wp-block-heading\">Build the testing plan around decisions<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">A useful question for every planned test is:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>What decision will this result support?<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">For example:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Nutrient analysis<\/strong><br>\u2192 Can we substantiate the declared nutritional value?<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Contaminant analysis<\/strong><br>\u2192 Does the product meet the relevant safety limits?<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Microbiology<\/strong><br>\u2192 Is the product microbiologically suitable?<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Stability testing<\/strong><br>\u2192 Can the proposed shelf life be supported?<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Active-ingredient analysis<\/strong><br>\u2192 Does the finished product contain the expected amount?<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Migration testing<\/strong><br>\u2192 Is the packaging suitable for the intended use?<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This makes the testing programme more focused.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h1 class=\"wp-block-heading\">Common testing mistakes<\/h1>\n\n\n\n<h2 class=\"wp-block-heading\">Testing everything<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">A huge analytical panel does not automatically create a safer product.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The relevant risks should determine the tests.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Testing only the active ingredient<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">A functional food can have risks unrelated to its main active component.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Relying only on supplier COAs<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Supplier data are useful, but finished-product verification may still be needed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Testing after the formula is frozen<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Late findings are more expensive to solve.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Ignoring claims<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The formulation and analytical strategy should support the intended communication.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Forgetting packaging<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Packaging can affect both safety and stability.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h1 class=\"wp-block-heading\">What should be ready before launch?<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">Before placing a functional food on the EU market, companies should have a clear evidence package covering the relevant aspects of the product.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Depending on the product, this can include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>final formulation<\/li>\n\n\n\n<li>raw-material specifications<\/li>\n\n\n\n<li>analytical results<\/li>\n\n\n\n<li>microbiological results<\/li>\n\n\n\n<li>contaminant testing<\/li>\n\n\n\n<li>stability data<\/li>\n\n\n\n<li>packaging assessment<\/li>\n\n\n\n<li>nutrition information<\/li>\n\n\n\n<li>claim assessment<\/li>\n\n\n\n<li>supplier documentation<\/li>\n\n\n\n<li>traceability records<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">The exact documentation depends on the product and its regulatory context.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h1 class=\"wp-block-heading\">The Makrolife approach<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">Makrolife supports food and supplement companies with analytical testing and regulatory services designed around the specific product and its risks.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">That can include testing for:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>composition<\/li>\n\n\n\n<li>contaminants<\/li>\n\n\n\n<li>microbiology<\/li>\n\n\n\n<li>active ingredients<\/li>\n\n\n\n<li>stability<\/li>\n\n\n\n<li>food-contact materials<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">The objective is not to create the longest possible test report.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">It is to generate <strong>relevant evidence that supports product quality, safety and regulatory decisions<\/strong>.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h1 class=\"wp-block-heading\">The bottom line<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">Launching a functional food in the EU requires more than proving that the main ingredient is present.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A strong testing strategy considers the <strong>whole product<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">That means looking at:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>composition<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>contaminants<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>microbiology<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>stability<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>claims<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>packaging<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">and <strong>regulatory requirements<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The right testing programme depends on the product.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">So instead of asking:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u201cWhat tests should every functional food have?\u201d<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ask:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u201cWhat could affect the safety, quality or compliance of this specific product?\u201d<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">That question leads to a much more useful testing strategy.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>What should be tested when launching a functional food in the EU? Explore composition, contaminants, microbiology, stability, claims and packaging.<\/p>\n","protected":false},"author":2,"featured_media":305,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[58],"tags":[151,152,80,61,166,165,108,67,167,143],"class_list":["post-304","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-food-supplements","tag-contaminant-testing","tag-eu-food-regulation","tag-food-safety","tag-food-supplements","tag-food-testing","tag-functional-food","tag-health-claims","tag-laboratory-testing","tag-microbiological-testing","tag-stability-testing"],"_links":{"self":[{"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/posts\/304","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/comments?post=304"}],"version-history":[{"count":3,"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/posts\/304\/revisions"}],"predecessor-version":[{"id":308,"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/posts\/304\/revisions\/308"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/media\/305"}],"wp:attachment":[{"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/media?parent=304"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/categories?post=304"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/tags?post=304"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}