Summary

From 20 July 2026, for suppliers serving EU food additive authorization projects, the key differentiator will no longer be whether they can provide a COA, TDS, and SDS. It will be whether they can demonstrate that the product identity, manufacturing process, specification limits, and stability data in those documents relate to the same representative material.

EFSA published its revised scientific data guidance for food additives on 20 January 2026. The revised guidance applies to food additive authorization applications submitted under Regulation (EC) No 1331/2008 on or after 20 July 2026. Applications submitted before that date may continue to follow the previous guidance. The revised requirements cover additive identity and characterization, manufacturing processes, specifications, proposed uses, dietary exposure, and safety data.

This does not mean that every food additive already marketed in the European Union must immediately be resubmitted for authorization. The suppliers that need to adjust their documentation systems first are those supporting new additive authorizations, new use applications, and manufacturing-process or specification changes that may affect existing authorization conditions.

What Does the Update Actually Change?

The revised guidance does not simply increase the number of documents required for routine commercial supply. It increases the need for different datasets to be connected and scientifically explained.

A specification may list limits for assay, moisture, ash, residual solvents, and elemental impurities. An application package must also explain:

• Why those test items were selected;
• Whether the specification limits are supported by actual batch data;
• Whether impurities originate from raw materials, reactions, fermentation, extraction, or degradation;
• Whether the analytical data relate to the additive itself or to a commercial preparation containing a carrier;
• Whether stability studies represent the actual packaging, storage, and food-processing conditions;
• Whether the samples used for analytical, stability, and safety studies are comparable.

One purpose of the revised EFSA guidance is to encourage applicants to submit more complete and internally consistent data at the beginning of the assessment, thereby reducing additional information requests caused by documentation gaps.

Procurement teams should therefore not assume that a supplier has application-support capability simply because it can send a large number of documents. The deciding question is whether those documents collectively describe a clearly defined food additive that can be manufactured consistently and is representative of the proposed use.

Which Projects Need Application-Level Supplier Data First?

Not every food additive purchase requires a complete application-support package. The required depth of information should be determined by the purpose of the project.

Replacement-supplier projects are among the most easily underestimated.

Procurement may assume that two products can be substituted because they have the same name, similar assay, and the same functional purpose. R&D may focus on formulation performance, while quality teams focus on specification compliance. A regulatory assessment, however, may also consider manufacturing origin, impurity-formation pathways, and the representativeness of the supporting data.

If these differences are not identified during sample evaluation, the problem may not appear as immediate sample failure. It may emerge later during an authorization application, customer audit, or bulk-supply change.

Do Not Mistake a Commercial Document Pack for Application-Support Data

To distinguish among procurement purposes, commercial supply documentation and supplier technical data can be divided into three levels. This is not an official EFSA classification, but a practical framework for supplier screening and project management.

A common procurement mistake is to select a supplier using only a standard COA and then request manufacturing-process and complete stability data when the authorization project is already at an advanced stage.

Even when the supplier is willing to cooperate, three problems may arise:

1. The distributor cannot obtain detailed information from the original manufacturer;
2. The available studies were conducted using an older process, a previous manufacturing site, or a different commercial formulation;
3. The data are available, but the parties did not agree in advance whether they could be used in the customer’s EU application.

Access to supporting data should therefore be confirmed before sample approval, rather than when the application package is almost ready for submission.

Where Is Composition Information Most Often Misinterpreted?

Additive Content Is Not the Same as Commercial-Preparation Content

Some food additives are marketed in preparations containing carriers, solvents, anticaking agents, or other auxiliary ingredients.

If the COA reports only an overall commercial-product value without stating whether the result is calculated on an as-is basis, dry basis, additive basis, or functional-component basis, the buyer may be unable to determine the actual use level and the amount of impurities introduced.

The following should be clearly distinguished:

• The additive itself;
• The component responsible for the technological function;
• Carriers or diluents in the commercial preparation;
• Processing materials used during manufacturing that are not necessarily retained in the finished product.

Two suppliers may market products under the same additive name. However, if the functional-component concentration, carrier system, or calculation basis differs, the actual formulation dosage and impurity exposure may also differ.

A Single Marker Does Not Represent the Full Composition of a Complex Mixture

Botanical extracts, fermentation-derived materials, and other complex mixtures cannot be assessed solely through one marker compound or a broad statement of total purity.

A marker may be useful for confirming a characteristic component, but it does not necessarily explain:

• The proportions of major component classes;
• The extent of the unidentified fraction;
• Minor components that may require further attention;
• Whether changes in raw-material origin or manufacturing alter the overall composition.

For a complex material, the supplier should be able to explain why a specific marker was selected and how it relates to product function, process control, or safety assessment, rather than providing only one convenient release parameter.

Specification Limits Must Be Traceable to Actual Batches

Specification limits are not target values that can be separated from production data.

If a supplier permits a wide functional-component range, with both low-assay and high-assay batches meeting the release specification, a larger quantity of the low-assay material will generally be needed to achieve the same technological effect. The actual amounts of residual solvents, elemental impurities, or other accompanying components introduced into the food may therefore also change.

Specification review should not be limited to asking whether a result falls below a stated limit. It should also determine:

• The mass basis on which the limit is calculated;
• The number of batches and production period used to establish the limit;
• Whether batches near the upper and lower limits are representative;
• Whether the relationship between impurities and the functional component remains consistent at different assay levels;
• Whether historical data remain comparable after a change in analytical method.

If a supplier can provide only one recent COA but cannot explain how the specification was established, the document may be sufficient for batch release, but it is not sufficient to demonstrate that the specification is suitable for an authorization application.

When Does a Manufacturing Change Become a Documentation Issue?

Change-notification clauses in procurement contracts often focus on product names, manufacturing addresses, packaging, and specification changes. The actual characteristics of a food additive, however, may be affected by changes occurring much earlier in production.

Changes that may require closer review include:

• A change in the source or grade of a starting material;
• A change in extraction solvent, reaction solvent, or catalyst;
• A change in fermentation strain, culture conditions, or enzyme preparation;
• A change in purification, concentration, decolorization, or drying steps;
• A change in carrier, diluent, or preservative system;
• A change in manufacturing site or contract manufacturer;
• A change in analytical method or calculation procedure.

These changes do not automatically mean that the product is no longer suitable. The supplier should, however, be able to explain whether the change affects product identity, functional-component content, impurity profile, microbiological status, or stability.

A statement that the product “still complies with the existing specification” is not always sufficient. The existing specification may not cover differences introduced by the new process, or it may not contain test items capable of detecting the change.

Stability Data Cannot Be Reduced to Shelf Life

A statement such as “24-month shelf life” is a commercial conclusion, not a complete stability dataset.

For projects supporting an EU application or technical modification, stability information should at least clarify:

• Whether the study tested the additive itself or the final commercial preparation;
• Whether the sample was stored in the actual commercial packaging;
• The temperature, humidity, light, and oxygen conditions used;
• Whether the monitored parameter was total assay, the functional component, or relevant degradation products;
• How accelerated studies relate to actual storage conditions;
• Whether the additive is affected by pH, heat treatment, or storage time after incorporation into the target food.

The revised guidance considers not only the stability of the additive during storage, but also its reactions and fate under the proposed food-use conditions. The required data should therefore be determined according to the material and the intended application. The same general stability report should not automatically be applied to every food system.

For example, a material may remain stable in sealed commercial packaging but behave differently after incorporation into a low-pH food, a high-temperature process, or a product with a long shelf life.

Successful short-term formulation testing does not automatically replace an assessment under representative processing and storage conditions.

A Successful Sample Does Not Mean Bulk-Purchase Data Are Complete

Sample validation usually answers whether the material can function in the current formulation. An authorization application and bulk-purchase decision must also determine whether future commercial supply will continue to represent the material that was evaluated.

The following situations can create a gap between the approved sample and the bulk product:

• The sample comes from a laboratory batch or a specially selected batch;
• The sample and the commercial batch are produced at different manufacturing sites;
• The sample COA contains customer-specific test items that are not included in the commercial supply specification;
• The stability study tests the additive itself, while the purchased product is a preparation containing a carrier;
• Application testing, impurity analysis, and safety studies use batches from different process stages;
• The supplier changes a raw material, item of equipment, or analytical method after sample approval.

Before bulk purchasing begins, the sample batch number, manufacturing site, product form, specification version, analytical method, and future commercial supply conditions should be mapped to one another.

Using different batches for different studies is not necessarily unacceptable. It should, however, be explained why those batches are representative and why the resulting datasets remain comparable.

R&D, Quality, and Procurement Ask Different Questions

The same supplier documentation serves different purposes for different functions.

R&D: Is the Material Suitable for the Intended Food System?

R&D teams are more likely to focus on solubility, dispersibility, technological performance, use level, process tolerance, and application results after storage.

The main mistake to avoid is assuming that supplier documentation is sufficient simply because the sample achieves the expected formulation performance. Application performance may demonstrate formulation suitability, but it cannot replace information on identity, impurities, and manufacturing processes.

Quality: Are the Test Results Comparable?

Quality teams need to confirm analytical methods, calculation bases, test batches, specification versions, and change records.

The key question is not merely whether a supplier has a COA, but whether the data in different reports relate to comparable materials and whether the specification covers risks associated with the manufacturing process.

Procurement: Does the Supplier Have the Right to Provide and Maintain the Data?

Procurement teams need to establish whether the information comes from the manufacturer or a distributor, which information requires a confidentiality agreement, whether the data may be used in a customer application, and whether the supplier can provide timely notice of changes.

Price and lead time can be compared quickly during an inquiry. Data-access rights, allocation of responsibilities, and update frequency generally need to be addressed earlier in a technical or quality agreement.

What Will Not Change Immediately?

The revised guidance will not automatically cancel existing food additive authorizations on 20 July 2026, nor does it mean that every currently purchased material must immediately be supported by a complete application package.

Routine supplier qualification will continue to use specifications, COAs, SDSs, allergen information, microbiological data, packaging information, and storage conditions. The change is that these commercial documents should not automatically be treated as sufficient for a new authorization, new use, or significant technical modification.

The formal food additive re-evaluation programme is also not the same as the direct scope of the revised guidance for new applications. When responding to a specific data call or regulatory request, companies should confirm the information requirements of the relevant procedure rather than applying the same documentation standard to every project.

Proprietary manufacturing information also does not need to be disclosed unconditionally to every buyer. Before the project begins, the parties should determine which documents can be provided routinely, which require a confidentiality agreement, and which information can be used only through a controlled application process.

Short-Term and Mid-Term Implications

Procurement Conclusion

The most practical procurement implication of the EFSA 2026 food additive guidance is that buyers need to distinguish earlier between a product that can be supplied routinely and a product that can support a specific EU authorization project.

Routine repeat purchasing does not require buyers to request a complete application package mechanically. However, replacement suppliers, manufacturing-route changes, specification adjustments, new uses, and new authorization projects should be reviewed before sample approval to confirm:

• Product identity and the composition of the commercial preparation;
• Intended food category and conditions of use;
• Manufacturing route and key changes that may affect the product;
• Specification limits and their supporting batch data;
• Samples and test conditions used in existing stability studies;
• The available level of application-support documentation;
• Access to and permitted use of confidential information;
• The relationship between the sample and future commercial supply batches.

When submitting an RFQ for an EU food additive application or technical modification, buyers should also provide the product name and specification, intended use, food category, expected use level, purchase quantity, target market, required documents, sample quantity, and project timeline. ChemicalCell can use this information to determine whether the supplier’s existing documentation is more suitable for routine quality review or for an application-support procurement assessment.