What Manufacturers Need to Know in September 2026!
In September 2026, the Eurasian Economic Commission published several product‑related amendments and guidance on technical regulations. These include more specific labeling requirements for toys, updated lists of standards for food and medical devices, and requirements regarding the timeliness of inspection reports for medical device registration. At the same time, preparations for the joint registry of chemical substances and mixtures are continuing.
It is therefore crucial for manufacturers and exporters to assess how these developments apply to their respective product groups. A change in labeling requirements, a new version of a standard, and an additional registration requirement all have different implications for existing approvals and planned shipments.
This follow‑up article explains selected developments from September and provides recommendations for preparing future export and approval projects.
More Specific Labeling Requirements for Toys
On September 9, 2026, the Eurasian Economic Commission reported on amendments to the Technical Regulations on Toy Safety. The amendments clarify the requirements for the information that manufacturers, authorized representatives, importers, or sellers must include on the labeling.
This information must not contradict one another. In particular, additional information must not alter the intended use, the age classification, or warnings and restrictions for safe use, nor must it mislead consumers regarding the safety of the toy.
According to the announcement, the amendments will take effect 180 calendar days after the official publication of the amendment decision. The effective date should therefore be determined based on the official publication, not on the date of the press release.
What Manufacturers and Importers Should Prepare
We recommend reviewing the labeling throughout the entire supply chain. Of particular importance are additional labels and translations that are applied by the importer or distributor.
- Verify that age information on the product, packaging, and accompanying materials matches
- Ensure that warning labels are reproduced in full and with consistent content
- Check additional labels for contradictory statements
- Obtain technical approval for changes to translations before printing
- Define responsibilities for the final labeling
A practical example: An age restriction specified by the manufacturer should not be weakened or changed to a different age classification by a retailer sticker applied later.
Updated List of Food Standards
On September 8, 2026, the Eurasian Economic Commission voluntarily announced changes to the list of voluntarily applicable standards under Technical Regulation TR ZU 021/2011 on food safety.
The update includes the addition of three intergovernmental standards and the removal of three national standards, which served as the basis for the new documents. Three additional entries will be updated to reflect the latest versions. According to the Commission, the changes will take effect 180 calendar days after the official publication of the relevant resolution.
For affected companies, we recommend comparing the standards used to date with the revised list. In doing so, companies should work with the testing laboratory to clarify which adjustments are necessary for new test orders and future proofs of conformity.
- Record the editions of standards used in the technical documentation
- Identify affected products and proofs of conformity
- Coordinate transition dates with the testing laboratory
- Base new test orders on the applicable versions of the standards
- Document the evaluation of existing test reports in a traceable manner
The announcement regarding the list of standards alone does not imply a blanket requirement to reissue all existing EAC declarations. The specific resolution and the respective procedure must be reviewed for this purpose.
Medical Devices and Current Inspection Reports
On September 10, 2026, the Eurasian Economic Commission reported on a change to the rules governing the registration and evaluation of the safety, quality, and effectiveness of medical devices. The grounds for suspending a registration certificate are being expanded: If a valid production inspection report is missing from the registration dossier, this may lead to suspension in the future.
According to the announcement, manufacturers of non‑sterile medical devices in risk classes 1 and 2a are exempt from this change. The Commission specifies that the amendment will take effect 30 calendar days after its official publication. The amendment is part of the special EAEU registration procedure for medical devices and may not be applied across the board to EAC certificates for other product groups.
Update inspection records in a timely manner
We recommend that affected manufacturers track the validity of inspection reports as a separate item in their marketing authorization management.
- Verify the validity of the existing inspection report
- Check that the current report is included in the registration dossier
- Plan required follow‑up inspections well in advance
- Verify that changes to manufacturing sites match the information in the dossier
- Define responsibilities between the manufacturer and the authorized representative
This allows for early identification of whether, in addition to a planned product change, manufacturing documentation also needs to be updated.
Demonstration of the Safety of Medical Devices
Another publication dated September 22, 2026, concerns the list of standards for medical devices. The standards listed therein may be used on a voluntary basis to demonstrate compliance with the general safety and performance requirements, as well as the requirements for labeling and instructions for use.
According to the Commission, one standard will be replaced by its current version. In addition, ten standards will be added. The corresponding recommendation provides for a six‑month transition period for adjusting the accreditation scopes of testing laboratories.
Our recommendation for new registration projects: Manufacturers should consult with the testing laboratory to determine which of the added standards are suitable for the specific medical device and whether the required test scope is covered. The expansion of the list does not mean that every product must be tested according to all new standards.
Preparation of the Chemical Substances Registry
On September 17 and 18, 2026, a seminar was held on the inventory of chemical substances in the EAEU member states. During the seminar, the Eurasian Economic Commission explained the process of preparing national substance inventories, which are intended to serve as the basis for the joint register of chemical substances and mixtures.
The publication refers to EEC Council Decision No. 61 of August 1, 2025. This decision calls on the governments of the member states to ensure that the inventory is completed by December 1, 2026, with the participation of industry, and to submit the necessary information to the Commission.
The inventory is to cover substances, including those in mixtures, that are already on the market in the EAEU or are intended to be placed on the market. The deadline mentioned applies to the member states; it does not imply an identical, immediate reporting deadline for every foreign manufacturer.
What Suppliers of Chemical Products Can Do to Prepare
Companies should clarify with their importers whether and how their substances are taken into account in the respective national procedures.
For this coordination, we recommend:
- Compile substance identities and existing CAS numbers
- Document the composition of mixtures in a traceable manner
- Check safety data sheets to ensure they are up to date
- Record products already delivered and those planned for the future
- Coordinate national procedures and points of contact with the importer
The seminar itself does not establish a new general EAC certification requirement. It is an opportunity to review your own substance data and participation in the respective inventory process.
Further Cooperation in Metrology
In its publication dated September 30, 2026, the Eurasian Economic Commission reported on the continued harmonization of metrological requirements within the Union. The focus is on common approaches to the reliability and comparability of measurements. The report describes regulatory cooperation. It does not announce a blanket new approval requirement for all measuring instruments.
We recommend that manufacturers of measuring instruments, as well as machines and systems with measuring functions, review the requirements based on the specific application and target country. Metrological documentation should be explicitly taken into account during project planning.
What Companies Should Specifically Review Now
The following practical checkpoints arise from the selected September topics:
- Clearly assign affected product groups and approval procedures
- Record the decision date, official publication, and effective date separately
- Check labels and translations for conflicting information
- Compare the editions of standards used with updated lists
- Keep inspection reports and registration dossiers up to date
- Coordinate substance data for chemical products with importers
- Evaluate planned changes with testing laboratories and competent authorities
These steps are intended as preparation. The specific adjustments that are actually required depend on the product in question and the applicable regulations.
Conclusion
The September announcements make it clear that companies should track changes on a product‑by‑product basis. Labeling, standards, inspection records, and material data all pertain to different aspects of a certification project.
We therefore recommend documenting, for each affected product group, what the change is, when it takes effect, and which documents need to be updated. This allows manufacturers and exporters to coordinate testing, documentation, and delivery dates well in advance.
Among the developments announced are more specific labeling requirements for toys, updated lists of standards for food and medical devices, and changes to the procedure for handling missing inspection reports in medical device registration. In addition, preparations for the EAEU Register of Chemical Substances and Mixtures continued.
No. The publication of a notice does not mean that the described change takes effect immediately. What matters are the official publication of the relevant legal act, its specified effective date, and any transitional provisions. Recommendations and preparatory measures must also be distinguished from binding requirements.
Information provided by manufacturers, authorized representatives, importers, and sellers must not contradict one another. In particular, additional labels must not alter the intended use, age classification, or warnings and restrictions regarding safe use, nor must they mislead consumers. The changes are scheduled to take effect 180 calendar days after the official publication of the decision.
The update to the list of standards in TR ZU 021/2011 does not, in and of itself, impose a blanket requirement to reissue all existing EAC declarations. Companies should determine which standards and products are affected and what impact the specific decision has on existing test reports and future procedures.
According to the change announced in September, the absence of a valid production inspection report in the registration dossier may constitute grounds for suspension. This change applies specifically to the EAEU registration procedure for medical devices. It should not be applied across the board to EAC certificates for other product groups.
No. According to a statement from the Eurasian Economic Commission, manufacturers of non‑sterile medical devices in risk classes 1 and 2a are exempt from this change. For other products, manufacturers should review the relevant requirements and ensure that their inspection records are up to date.
One standard is being replaced by its current version, and ten additional standards are being added. These standards may be used on a voluntary basis to demonstrate compliance with the relevant requirements. Manufacturers should consult with their testing laboratory to determine which standards are appropriate for their specific product. Not every medical device must be tested against all of the newly added standards.
The deadline specified in the EEC publication is primarily intended for the governments of the EAEU member states. It does not automatically constitute a uniform, direct reporting deadline for all foreign manufacturers. Suppliers should consult with their importers to determine which national inventory procedures apply and whether information on their substances or mixtures must be submitted.
The information session held in September does not, in and of itself, establish a new general EAC certification requirement. It concerns the preparation for the substance inventory and the joint register. Companies should review their substance data, safety data sheets, and the relevant national procedures.
Depending on the product group, the following documents in particular should be reviewed: Product labels, translations, and warnings; EAC certificates; EAC declarations and their registration status; test reports and the editions of standards used therein; registration dossiers and production inspection reports; safety data sheets and information on the composition of chemical products; and documented effective dates and transition periods for applicable regulations.
