A new ingredient appears in the EU Union list of authorised novel foods.<\/p>\n\n\n\n
Does that mean every supplement brand can immediately source an equivalent ingredient, formulate at the authorised dose and launch it across Europe?<\/p>\n\n\n\n
No.<\/p>\n\n\n\n
Commission Implementing Regulation (EU) 2026\/1427<\/strong>, adopted on 2 July 2026 and applicable from 23 July 2026, authorises a specific enzymatically produced egg membrane hydrolysate<\/strong> for use in food supplements.<\/p>\n\n\n\n The authorised use is limited to 500 mg per day for the general adult population<\/strong>, excluding pregnant and lactating women. The regulation also introduces specific labelling requirements, egg-allergen obligations and a five-year period of protected proprietary data.<\/p>\n\n\n\n For supplement brands, the practical lesson is important:<\/p>\n\n\n\n Novel-food authorisation is ingredient-specific.<\/strong><\/p>\n\n\n\n It is not a blanket permission for every material that sounds similar.<\/p>\n\n\n\n The novel food is defined as a protein hydrolysate produced through enzymatic hydrolysis of chicken egg membranes using the food enzyme papain<\/strong>.<\/p>\n\n\n\n The authorised specification describes the ingredient as a water-soluble cream-yellowish powder containing:<\/p>\n\n\n\n The Union-list specification also establishes microbiological criteria for total aerobic microbial count, yeast and mould, E. coli<\/em>, Salmonella<\/em> and Listeria monocytogenes<\/em>.<\/p>\n\n\n\n These details matter.<\/p>\n\n\n\n The authorisation does not simply cover anything marketed commercially as:<\/p>\n\n\n\n egg membrane<\/strong><\/p>\n\n\n\n egg membrane collagen<\/strong><\/p>\n\n\n\n or<\/p>\n\n\n\n egg membrane peptides<\/strong><\/p>\n\n\n\n The production process and specification form part of the identity of the authorised novel food.<\/p>\n\n\n\n Similarity in marketing language is not proof of regulatory equivalence.<\/p>\n\n\n\n The applicant originally applied for authorisation under the description \u201cegg membrane collagen peptides.\u201d<\/strong><\/p>\n\n\n\n The Commission ultimately rejected that as the appropriate regulatory designation.<\/p>\n\n\n\n Why?<\/p>\n\n\n\n Because collagen accounts for only 15\u201330% of the authorised ingredient by weight<\/strong>. The Commission concluded that describing the material as \u201cegg membrane collagen peptides\u201d could therefore mislead consumers about its composition and nutritional properties.<\/p>\n\n\n\n The final authorised novel-food name became:<\/p>\n\n\n\n Egg membrane hydrolysate (enzymatically produced)<\/strong><\/p>\n\n\n\n For food supplements containing the ingredient, the required designation on the label is:<\/p>\n\n\n\n \u201cegg membrane hydrolysate.\u201d<\/strong><\/p>\n\n\n\n This is a useful reminder for supplement developers.<\/p>\n\n\n\n The commercial ingredient name and the legally required ingredient designation are not always the same.<\/p>\n\n\n\n Branding comes after classification.<\/p>\n\n\n\n The authorised food category is narrowly defined:<\/p>\n\n\n\n Food supplements as defined in Directive 2002\/46\/EC for the general adult population, excluding pregnant and lactating women.<\/strong><\/p>\n\n\n\n The maximum authorised amount is:<\/p>\n\n\n\n 500 mg\/day.<\/strong><\/p>\n\n\n\n The label must additionally state that food supplements containing the ingredient should not be consumed by persons under 18 years of age, pregnant women or lactating women<\/strong>.<\/p>\n\n\n\n That creates three separate formulation and labelling checks:<\/p>\n\n\n\n Product format:<\/strong> Is the product legally a food supplement?<\/p>\n\n\n\n Daily dose:<\/strong> Does the complete recommended daily intake remain at or below 500 mg?<\/p>\n\n\n\n Target population:<\/strong> Is the product clearly positioned and labelled for the authorised adult population?<\/p>\n\n\n\n A 500 mg capsule is therefore not automatically compliant if the recommended daily use instructs consumers to take two capsules.<\/p>\n\n\n\n The legal maximum applies to the daily intake.<\/p>\n\n\n\n Not the unit dose.<\/p>\n\n\n\n This distinction is particularly important because egg membrane hydrolysate was already present in the EU Union list before Regulation 2026\/1427.<\/p>\n\n\n\n An earlier authorised egg membrane hydrolysate<\/strong> has been permitted in food supplements for the general adult population at 450 mg\/day<\/strong>. That earlier entry originated from a different authorisation and production process. Its original protected-data period ended in November 2023.<\/p>\n\n\n\n Regulation 2026\/1427 therefore does not simply increase \u201cthe egg membrane limit\u201d from 450 mg to 500 mg.<\/p>\n\n\n\n It creates a separate entry for a specifically characterised enzymatically produced<\/strong> egg membrane hydrolysate.<\/p>\n\n\n\n That means a manufacturer cannot look at a supplier specification saying \u201cegg membrane hydrolysate,\u201d see the new 500 mg\/day figure and automatically apply it.<\/p>\n\n\n\n The first question is:<\/p>\n\n\n\n Which authorised Union-list entry does this exact ingredient correspond to?<\/strong><\/p>\n\n\n\n Same category.<\/p>\n\n\n\n Different authorisation.<\/p>\n\n\n\n Potentially different legal conditions.<\/p>\n\n\n\n This is where the regulation becomes commercially significant.<\/p>\n\n\n\n The Commission granted protection to proprietary scientific evidence used in the safety assessment of the new ingredient.<\/p>\n\n\n\n Under Article 26 of Regulation (EU) 2015\/2283, newly developed proprietary scientific evidence may be protected for five years where defined conditions are met. During that period, the protected data cannot be used for the benefit of a subsequent applicant without the initial applicant’s agreement.<\/p>\n\n\n\n For this ingredient, the regulation states that Eggnovo SL<\/strong> is the company authorised to place the novel food on the EU market during the protected period.<\/p>\n\n\n\n The protection runs from:<\/p>\n\n\n\n 23 July 2026 to 23 July 2031.<\/strong><\/p>\n\n\n\n This means the common interpretation:<\/p>\n\n\n\n \u201cThe ingredient is on the Union list, so I can buy an equivalent material from any supplier.\u201d<\/p>\n<\/blockquote>\n\n\n\n is wrong.<\/p>\n\n\n\n No.<\/p>\n\n\n\n The restriction is narrower than that.<\/p>\n\n\n\n Regulation 2026\/1427 explicitly allows another applicant to obtain an authorisation if that application either:<\/p>\n\n\n\n In other words, the novel-food system does not create a permanent monopoly over the concept of enzymatically produced egg membrane hydrolysate.<\/p>\n\n\n\n It protects the proprietary evidence used to obtain this specific authorisation for a defined period.<\/p>\n\n\n\n That distinction matters when qualifying suppliers.<\/p>\n\n\n\n A procurement team should therefore not ask only:<\/p>\n\n\n\n \u201cCan you supply egg membrane hydrolysate?\u201d<\/strong><\/p>\n\n\n\n It should ask:<\/p>\n\n\n\n \u201cOn what regulatory basis is this exact material legally placed on the EU market?\u201d<\/strong><\/p>\n\n\n\n EFSA’s safety conclusion relied on evidence relating to the novel food’s identity, manufacturing process and allergenicity.<\/p>\n\n\n\n The Commission determined that certain proprietary information met the conditions for data protection because the ingredient could not have been assessed and authorised without that evidence.<\/p>\n\n\n\n That is why this is more than an administrative footnote.<\/p>\n\n\n\n The protected material relates directly to establishing that the ingredient assessed by EFSA is the same ingredient being placed on the market.<\/p>\n\n\n\n Supplier identity and process matter because the safety assessment was not performed on an abstract category called \u201cegg membrane.\u201d<\/p>\n\n\n\n It was performed on a characterised material.<\/p>\n\n\n\n The novel food originates from chicken eggs.<\/p>\n\n\n\n Eggs and products derived from eggs are included in Annex II of Regulation (EU) No 1169\/2011<\/strong> among substances or products causing allergies or intolerances.<\/p>\n\n\n\n Regulation 2026\/1427 specifically confirms that supplements containing the new egg membrane hydrolysate must comply with the allergen-labelling requirements of Article 21 of Regulation 1169\/2011.<\/p>\n\n\n\n Where an ingredient list is present, the reference to egg<\/strong> must be clearly emphasised through typography that distinguishes it from the other ingredients, for example through bold type.<\/p>\n\n\n\n Where no ingredient list is required, the allergen indication must use \u201ccontains\u201d<\/strong> followed by the relevant allergen.<\/p>\n\n\n\n Novel-food authorisation does not override allergen legislation.<\/p>\n\n\n\n Both requirements apply.<\/p>\n\n\n\n There are two different labelling issues here, and they should not be combined.<\/p>\n\n\n\n First:<\/p>\n\n\n\n Egg allergen declaration<\/strong><\/p>\n\n\n\n This derives from Regulation (EU) No 1169\/2011.<\/p>\n\n\n\n Second:<\/p>\n\n\n\n Population restriction<\/strong><\/p>\n\n\n\n Regulation 2026\/1427 requires the supplement label to state that the product should not be consumed by:<\/p>\n\n\n\n A label containing an egg-allergen declaration but no population warning would therefore still miss a condition of the novel-food authorisation.<\/p>\n\n\n\n One statement addresses allergy.<\/p>\n\n\n\n The other addresses authorised conditions of use.<\/p>\n\n\n\n EFSA concluded that the ingredient is safe under the proposed conditions of use for the proposed target population.<\/p>\n\n\n\n That is not the same as saying:<\/p>\n\n\n\n \u201cEgg membrane hydrolysate is safe at any dose for everyone.\u201d<\/strong><\/p>\n\n\n\n The conclusion supports the defined authorisation:<\/p>\n\n\n\n up to 500 mg\/day<\/strong><\/p>\n\n\n\n food supplements<\/strong><\/p>\n\n\n\n general adult population<\/strong><\/p>\n\n\n\n excluding pregnant and lactating women.<\/strong><\/p>\n\n\n\n Regulatory safety conclusions need to be read together with their conditions.<\/p>\n\n\n\n Removing the dose or population from the sentence changes its meaning.<\/p>\n\n\n\n Dose and target population are only part of the authorisation.<\/p>\n\n\n\n The ingredient itself must correspond to the specification entered in the Union list.<\/p>\n\n\n\n For the enzymatically produced hydrolysate, this includes the defined production route and compositional characteristics.<\/p>\n\n\n\n The microbiological specification includes:<\/p>\n\n\n\n For manufacturers, this makes supplier documentation critical.<\/p>\n\n\n\n A suitable specification file should allow the business to establish that the ingredient being purchased corresponds to the authorised novel food.<\/p>\n\n\n\n A product name on an invoice is not enough.<\/p>\n\n\n\n Suppose a supplier provides a COA showing:<\/p>\n\n\n\n Protein: 75%<\/strong><\/p>\n\n\n\n Collagen: 22%<\/strong><\/p>\n\n\n\n Microbiology: Pass<\/strong><\/p>\n\n\n\n Those numbers may be compatible with the Union-list specification.<\/p>\n\n\n\n But they still do not by themselves establish the supplier’s legal right to market the ingredient under the protected authorisation.<\/p>\n\n\n\n The compliance review should therefore address two separate questions:<\/p>\n\n\n\n Does the material correspond to the authorised identity, production process and specification?<\/p>\n\n\n\n Is this supplier legally entitled to place that specific novel food on the EU market during the protected-data period?<\/p>\n\n\n\n Both must work.<\/p>\n\n\n\n A technically similar ingredient can still have the wrong regulatory basis.<\/p>\n\n\n\n Before developing a product around the new ingredient, request enough information to answer:<\/p>\n\n\n\n This review should happen before finalising packaging.<\/p>\n\n\n\n Preferably before placing the ingredient purchase order.<\/p>\n\n\n\n Novel-food authorisation establishes permission to place the ingredient on the market under specified conditions.<\/p>\n\n\n\n It does not<\/strong> automatically authorise marketing statements about joints, collagen synthesis, skin, mobility or other health effects.<\/p>\n\n\n\n Health claims for foods and food supplements remain subject to Regulation (EC) No 1924\/2006 and the relevant EU claims framework.<\/p>\n\n\n\n Makrolife Biotech specifically supports supplement brands with regulatory assessment, label review and health-claim compliance alongside analytical product testing.<\/p>\n\n\n\n An ingredient can be authorised.<\/p>\n\n\n\n Its proposed marketing claim can still be non-compliant.<\/p>\n\n\n\n These are separate regulatory questions.<\/p>\n\n\n\n Suppose a brand already sells a supplement containing another egg-membrane ingredient outside the EU.<\/p>\n\n\n\n Replacing that ingredient with the newly authorised material is not simply a sourcing decision.<\/p>\n\n\n\n The change can affect:<\/p>\n\n\n\n That means an EU adaptation project should review the complete finished product.<\/p>\n\n\n\n Not just the ingredient certificate.<\/p>\n\n\n\n Regulation 2026\/1427 establishes compositional and microbiological specifications for the novel food itself.<\/p>\n\n\n\n Depending on the supply chain and finished product, analytical verification may therefore include parameters relevant to:<\/p>\n\n\n\n Makrolife Biotech currently provides ingredient and food-supplement analysis, regulatory classification, label testing and food-safety testing, including microbiological and allergen-related analytical services.<\/p>\n\n\n\n The testing programme should follow the actual compliance question.<\/p>\n\n\n\n Testing every possible parameter is not the goal.<\/p>\n\n\n\n Verifying the critical ones is.<\/p>\n\n\n\n For a supplement intended to use the new novel food, the compliance workflow should look something like this:<\/p>\n\n\n\n Ingredient identity<\/strong><\/p>\n\n\n\n Confirm the exact authorised novel-food entry.<\/p>\n\n\n\n Supplier authorisation<\/strong><\/p>\n\n\n\n Verify the legal basis for placing the ingredient on the EU market during the protected-data period.<\/p>\n\n\n\n Specification<\/strong><\/p>\n\n\n\n Compare the supplied material with the Union-list requirements.<\/p>\n\n\n\n Daily dose<\/strong><\/p>\n\n\n\n Confirm that the recommended intake does not exceed 500 mg\/day.<\/p>\n\n\n\n Target population<\/strong><\/p>\n\n\n\n Ensure the product is designed for adults and excludes the specified populations.<\/p>\n\n\n\n Allergen declaration<\/strong><\/p>\n\n\n\n Apply the egg-allergen requirements correctly.<\/p>\n\n\n\n Mandatory warning<\/strong><\/p>\n\n\n\n Include the required statement regarding under-18s, pregnancy and lactation.<\/p>\n\n\n\n Claims<\/strong><\/p>\n\n\n\n Review proposed marketing statements separately under the health-claims framework.<\/p>\n\n\n\n Finished product<\/strong><\/p>\n\n\n\n Verify that formulation, specification and labelling all remain consistent.<\/p>\n\n\n\n A novel-food authorisation is one part of market readiness.<\/p>\n\n\n\n Not the entire file.<\/p>\n\n\n\n Not during the protected-data period without the appropriate regulatory basis.<\/p>\n\n\n\n Too broad.<\/p>\n\n\n\n The 500 mg\/day condition applies to this specific enzymatically produced novel food.<\/p>\n\n\n\n No.<\/p>\n\n\n\n The Commission specifically changed the designation because the collagen fraction is only 15\u201330%.<\/p>\n\n\n\n The required novel-food designation is egg membrane hydrolysate<\/strong>.<\/p>\n\n\n\n The novel-food entry requires a specific statement that the product should not be consumed by persons under 18, pregnant women or lactating women.<\/p>\n\n\n\n It does not.<\/p>\n\n\n\n Egg allergen labelling follows Regulation 1169\/2011 separately.<\/p>\n\n\n\n Novel-food authorisation and health-claim authorisation are separate regulatory processes.<\/p>\n\n\n\n For international supplement brands, the difficult part is often not finding an innovative ingredient.<\/p>\n\n\n\n It is making sure the ingredient, formulation, analytical file and final label all describe the same legally compliant product<\/strong>.<\/p>\n\n\n\n Makrolife Biotech supports food and supplement manufacturers with:<\/p>\n\n\n\n Makrolife’s current Food & Supplements portfolio includes ingredient testing, regulatory classification, quality assessment and EU 1169\/2011 label review, while its Food Safety & Compliance services cover allergens and other relevant contaminants.<\/p>\n\n\n\n Regulation 2026\/1427 opens a new route for an enzymatically produced egg membrane hydrolysate in EU food supplements.<\/p>\n\n\n\n But the commercial takeaway is not simply:<\/p>\n\n\n\n \u201c500 mg egg membrane is now allowed.\u201d<\/strong><\/p>\n\n\n\n The real compliance picture is:<\/p>\n\n\n\n a specific ingredient<\/strong><\/p>\n\n\n\n a defined production process<\/strong><\/p>\n\n\n\n a defined specification<\/strong><\/p>\n\n\n\n a maximum daily intake<\/strong><\/p>\n\n\n\n a defined adult population<\/strong><\/p>\n\n\n\n mandatory labelling<\/strong><\/p>\n\n\n\n egg-allergen requirements<\/strong><\/p>\n\n\n\n and<\/p>\n\n\n\n protected regulatory data until 23 July 2031.<\/strong><\/p>\n\n\n\n For supplement brands, that makes supplier qualification just as important as formulation.<\/p>\n\n\n\n Before launching, confirm not only what the ingredient is.<\/p>\n\n\n\n Confirm which authorisation allows your supplier to sell it.<\/strong><\/p>\n\n\n\n EU Regulation 2026\/1427 authorises a new enzymatically produced egg membrane hydrolysate for adult food supplements at up to 500 mg\/day. But protected data, supplier eligibility, allergen labelling and mandatory warnings mean the authorisation is not open to every ingredient supplier.<\/p>\n","protected":false},"author":2,"featured_media":268,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[75,9,1],"tags":[100,103,98,63,101,102,61,104,72,99,89,64],"class_list":["post-265","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-food-supplements-regulatory","category-regulatory","category-uncategorized","tag-data-protection","tag-egg-allergen","tag-egg-membrane-hydrolysate","tag-eu-market-entry","tag-eu-novel-food-regulation","tag-eu-regulation-2026-1427","tag-food-supplements","tag-ingredient-compliance","tag-makrolife-biotech","tag-novel-food","tag-regulatory-affairs","tag-supplement-compliance"],"_links":{"self":[{"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/posts\/265","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=265"}],"version-history":[{"count":1,"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/posts\/265\/revisions"}],"predecessor-version":[{"id":266,"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/posts\/265\/revisions\/266"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/media\/268"}],"wp:attachment":[{"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/media?parent=265"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/categories?post=265"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/tags?post=265"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}What Exactly Has Been Authorised?<\/h2>\n\n\n\n
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Why the Name Changed During the Authorisation Process<\/h2>\n\n\n\n
Who Can Use It?<\/h2>\n\n\n\n
500 mg\/day Is Not a Generic Egg-Membrane Limit<\/h2>\n\n\n\n
The Biggest Trap: Data Protection<\/h2>\n\n\n\n
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Does Data Protection Mean Nobody Else Can Ever Sell the Ingredient?<\/h2>\n\n\n\n
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Why Was Proprietary Data Protection Granted?<\/h2>\n\n\n\n
Egg Allergen Labelling Still Applies<\/h2>\n\n\n\n
The Mandatory Population Warning Is Separate From the Allergen Statement<\/h2>\n\n\n\n
\n
EFSA’s Safety Conclusion Has Boundaries<\/h2>\n\n\n\n
The Ingredient Specification Must Match Too<\/h2>\n\n\n\n
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A Supplier COA Does Not Automatically Prove Novel-Food Equivalence<\/h2>\n\n\n\n
Technical equivalence<\/h3>\n\n\n\n
Regulatory access<\/h3>\n\n\n\n
What Supplement Brands Should Ask Their Supplier<\/h2>\n\n\n\n
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Claims Are a Separate Compliance Question<\/h2>\n\n\n\n
Existing Formulations Need More Than an Ingredient Swap<\/h2>\n\n\n\n
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What Should Be Verified Analytically?<\/h2>\n\n\n\n
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A Practical Pre-Launch Review<\/h2>\n\n\n\n
Common Implementation Mistakes<\/h2>\n\n\n\n
\u201cIt Is on the Union List, So Any Supplier Can Sell It\u201d<\/h3>\n\n\n\n
\u201cThe Limit Is Now 500 mg for Egg Membrane\u201d<\/h3>\n\n\n\n
\u201cEgg Membrane Collagen Peptides\u201d Is the Correct Label Name<\/h3>\n\n\n\n
\u201cAdults Only\u201d Is Enough<\/h3>\n\n\n\n
\u201cThe Novel-Food Warning Covers the Allergen\u201d<\/h3>\n\n\n\n
\u201cAuthorised Means We Can Make Health Claims\u201d<\/h3>\n\n\n\n
How Makrolife Biotech Can Support an EU Launch<\/h2>\n\n\n\n
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Authorisation Is the Starting Point<\/h2>\n\n\n\n
Sources<\/h2>\n\n\n\n
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