Feed Additive Registration in Russia via Galen. New Rules and Timelines Under Order No. 316
Since September 1, 2025, feed additive registration in Russia operates under new rules. Ministry of Agriculture Order No. 316 extended the total procedure from 33 to 45 business days, but in exchange gave manufacturers predictability: every stage is now clearly regulated. Response deadlines for regulator inquiries, amendment procedures, suspension conditions — everything is specified in a single document. This guide explains how to prepare your dossier and pass the expert review without being sent back for revisions.
How Registration Worked Before September 2025
Prior to 2022, Russia had no dedicated registration procedure for feed additives. Amino acids, probiotics, enzymes, and vitamin complexes entered the market without special verification, provided they contained no medicinal components. Federal Law No. 179-FZ dated June 11, 2021 introduced Section III.1 into the Law on Veterinary Medicine, requiring manufacturers to undergo state registration with a safety assessment.
The transition period lasted until September 1, 2022. Rosselkhoznadzor (the Federal Service for Veterinary and Phytosanitary Surveillance) approved document forms via Order No. 1490, while the Ministry of Agriculture defined dossier requirements via Order No. 779. The total registration period was 33 business days, with 25 allocated to expert review at VGNKI (the All-Russian State Center for Quality and Standardization of Veterinary Medicinal Products for Animals and Feed).
For three years the system operated without a detailed administrative regulation. Intermediate stage timelines were not legally fixed, and amendment procedures were described only in general terms. By mid-2025, the Ministry of Agriculture had accumulated sufficient practical experience and issued a comprehensive document.
The New Procedure Since September 1, 2025
Ministry of Agriculture Order No. 316 dated May 7, 2025 was registered by the Ministry of Justice on June 2, 2025 under number 82511. The document entered into force on September 1, 2025 and will remain effective until September 1, 2031. The Order approved two appendices: the Procedure for State Registration of a Feed Additive and the Procedure for Maintaining the State Register of Feed Additives.
Comparison of Registration Timelines
| Parameter | Before September 1, 2025 | After September 1, 2025 |
|---|---|---|
| Total registration period | 33 business days (Clause 4, Article 11.1 of the Law) | 45 business days (Clause 6 of Order No. 316) |
| Expert review period | 25 business days | 24 business days |
| Dossier completeness check | 8 business days | 3 business days |
| Assignment for expert review | Within the verification period | 2 business days after verification |
| Decision after expert review | Not regulated | 3 business days |
| Response time to regulator inquiry | Not established | 90 business days |
| Amendments without expert review | Not regulated | 6 business days |
| Amendments with expert review | Not regulated | 21 business days |
The increase from 33 to 45 business days is offset by transparent intermediate stages. For standard additives with complete documentation, the procedure typically concludes faster than the maximum timeline.
Which Additives Require Registration
Government Decree No. 3920-r dated December 28, 2021 establishes a list of 16 categories of feed additives requiring state registration:
| No. | Category | Examples |
|---|---|---|
| 1 | Amino acids, their salts and compounds | Lysine, methionine, threonine |
| 2 | Aromatic and flavoring additives | Spice extracts, essential oils |
| 3 | Biologically active protein substances | Enzyme preparations |
| 4 | Substances of plant origin | Flavonoids, herbal extracts |
| 5 | Vitamins and their derivatives | Vitamins A, D, E, B-group |
| 6 | Colorants | Carotenoids for pigmentation |
| 7 | Macro- and microelements | Chelates, metal glycinates |
| 8 | Organic acids | Lactic, propionic, formic acid |
| 9 | Prebiotics | Mannan-oligosaccharides, inulin |
| 10 | Probiotics | Lactobacilli, bifidobacteria |
| 11 | Provitamins | Carotene, ergosterol |
| 12 | Silage additives | Bacterial inoculants |
| 13 | Synthetic nitrogenous substances | Urea, ammonium salts |
| 14 | Toxin binders | Mycotoxin binders |
| 15 | Technological additives | Preservatives, emulsifiers, antioxidants |
| 16 | Enzymes | Phytase, cellulase, xylanase |
Clause 6 of Article 11.1 of the Law on Veterinary Medicine exempts five categories from registration: additives for export outside the EAEU, samples for research purposes, finished compound feeds containing registered components, additives for own consumption (not for sale), and products meeting EAEU food additive requirements.
Timelines and State Fees
Here is how the timeline breaks down by stage. Rosselkhoznadzor verifies dossier completeness within 3 business days. Within 2 business days of verification, it either issues an assignment to VGNKI for expert review, sends a request for revision, or issues a rejection with stated reasons. The expert review takes up to 24 business days. If information is insufficient for safety assessment, the expert institution may issue a one-time request for additional data within 10 business days from the start of the review. The applicant has 90 business days to respond, during which the registration period is suspended. After receiving the conclusion, Rosselkhoznadzor makes its decision within 3 business days.
State fees are established by Clause 144 of Article 333.33 of the Tax Code of the Russian Federation:
| Action | Amount |
|---|---|
| Registration of a new additive | 85,000 ₽ |
| Amendments with expert review | 34,700 ₽ |
| Amendments without expert review | 7,700 ₽ |
Simplified Procedure Until End of 2026
Government Decree No. 353 dated March 12, 2022 provides preferences for import-substituting additives. Russian manufacturers of single-component additives whose active substance was previously used in registered products may omit stability studies, toxicological studies, and biological property studies from their dossier. The condition is a written commitment to supplement the documentation within 12 months. This preference is valid until December 31, 2026.
For multi-component products and additives with new active substances, a complete document package remains mandatory.
Preparing to Work with the Galen System
Feed additives are registered through the Galen component of the Federal State Information System in the Field of Veterinary Medicine (FGIS VetIS). The system operates at galen.vetrf.ru and integrates with other components: Mercury (electronic veterinary certification), Cerberus (register of supervised objects), and VetIS.Passport (user account management).
Three steps must be completed before submitting an application.
Step One: Registration in Cerberus. The company as a business entity must be entered into the register of supervised objects. Applications are submitted to the veterinary administration of the relevant Russian region where the production facility is located. The electronic form is available at cerberus.vetrf.ru/cerberus/request. Required information includes the organization’s name, INN (taxpayer identification number), OGRN (primary state registration number), legal and actual addresses, production site address, and types of activities.
Step Two: Obtaining the Administrator Role. An employee is assigned user management rights within the VetIS.Passport component. With a qualified electronic signature (QES), registration can be completed independently at cerberus.vetrf.ru/cerberus/request/signature. Without a QES, a paper application must be submitted to the territorial Rosselkhoznadzor administration.
Step Three: Access to Galen. Once the account is activated, the administrator assigns roles to employees for working with registration dossiers. System login is performed via ESIA (the Unified Identification and Authentication System, i.e., the Gosuslugi state services portal).
Registration Dossier Structure
Article 11.4 of the Law on Veterinary Medicine and Ministry of Agriculture Order No. 779 define the required documents. A separate dossier must be submitted for each form of feed additive.
Application for State Registration. The form is approved by Rosselkhoznadzor Order No. 1490. It specifies the trade name, release form, purpose of use, applicant and manufacturer details, and payment document information.
Draft Instructions for Use. Contains general information (name, composition, description), biological properties, application procedure (animal species, dosages, duration), contraindications and side effects, shelf life and storage conditions, and developer and manufacturer details. The draft must be signed by the developer’s head and sealed.
Documentation on Characteristics and Control Methods. A specification with quality and safety indicators, methods for determining active substances, impurities, and microbiological indicators.
Safety Study Results. The scope depends on the additive’s intended purpose. Decree No. 3920-r establishes a matrix: for ration enrichment with a new substance, stability, toxicology, biological property, and genetic material studies are required; for known substances, toxicology may be replaced with a literature review from peer-reviewed sources.
Sample Testing Protocols. Issued by an accredited laboratory or VGNKI.
Foreign Manufacturer Documents. Required for imported products: a document from the manufacturing country’s competent authority confirming the name and address, with a Russian translation certified by the applicant.
Representative Power of Attorney (if the applicant acts on behalf of the developer).
GMO Documents. For additives produced using genetically modified organisms: the GMO state registration number and molecular genetic study conclusion.
Application Submission and Expert Review
An application of the type «State Registration of a Feed Additive» is created in the Galen personal account. The system generates the application form. Additive data is entered: trade name, release form, purpose of use from five options under Decree No. 3920-r, and category (single-component or multi-component, new or known substance). Applicant and manufacturer information is pulled from the Cerberus register. Documents are uploaded in PDF and XML formats and signed with a QES.
Rosselkhoznadzor verifies dossier completeness and accuracy. Upon positive results, an assignment is generated for VGNKI expert review. The expert institution evaluates the balance between expected benefits to animal health and risk of negative impact. Two outcomes are possible: a positive conclusion (benefits outweigh risks) or a negative conclusion (risks outweigh benefits).
Upon a positive conclusion, Rosselkhoznadzor issues a state registration order, enters the information into the register on the same day, and issues the approved instructions to the applicant. The register of registered feed additives is published at galen.vetrf.ru. An extract is generated automatically with a QR code containing a link to current records.
Making Amendments to the Dossier
Order No. 316 divides the procedure into two types.
Amendments without expert review cover cases where the applicant’s or manufacturer’s name or address changes without a change in the legal entity itself, or where technical information not affecting safety is clarified. Review period: 6 business days. State fee: 7,700 ₽.
Amendments with expert review are required when changing the composition or concentration of active substances, expanding target animal species, or changing indications for use. Review period: 21 business days, of which up to 15 business days are for expert review. State fee: 34,700 ₽.
Previous instructions for use may be used during import, storage, and sale of additives manufactured before the amendment decision date and for 180 calendar days thereafter.
Common Mistakes During Submission
Mismatch between purpose of use and research scope. The applicant indicates «productivity enhancement» but does not submit residue studies in livestock products. The matrix in Decree No. 3920-r requires these for this purpose.
Address discrepancy. The production address in the application does not match the address in the Cerberus register. The system blocks such applications at the validation stage.
Missing translations. Manufacturer certificates, test protocols, and regulatory documents from the country of origin in a foreign language must be translated into Russian and certified by the applicant.
Incomplete control methods. The specification contains quality indicators but does not describe the methods for determining them. The expert institution returns such dossiers for revision.
Missing the response deadline. Applicants have 90 business days to respond to inquiries. If missed, the expert institution issues a decision based on existing materials, which typically results in rejection.
Action Plan
Verify the product category. Cross-reference the additive’s composition with the list in Decree No. 3920-r. If the product does not fall under any of the 16 categories or meets EAEU food additive requirements, registration is not required.
Register in FGIS VetIS. Create accounts in Cerberus and VetIS.Passport. The procedure takes 5–10 business days. Without registration, Galen access is impossible.
Determine the research scope. Use the matrix in Decree No. 3920-r. For Russian manufacturers of single-component additives with known substances, verify eligibility for the simplified procedure under Government Decree No. 353 (valid until December 31, 2026).
Compile the dossier per Order No. 779. Prepare draft instructions, specifications with control methods, and research results. Ensure all foreign-language documents are translated and certified.
Order laboratory testing. Protocols must be issued by an accredited organization or VGNKI. Stability studies must confirm the declared shelf life.
Pay the state fee of 85,000 ₽. Rosselkhoznadzor payment details are available on its official website. Save the payment document for the application.
Submit the application through Galen. Upload documents, sign with a QES, and submit. Alternative channel: the Unified Portal of State Services (Gosuslugi).
Monitor deadlines. You have 90 business days to respond to inquiries, but delays are inadvisable. Review status is displayed in the personal account.
Feed additive registration under the new procedure takes up to 45 business days for standard review. For additives with complete documentation and no revision requests, the procedure concludes faster. Order No. 316 remains effective until September 1, 2031, giving manufacturers six years of stable regulation.
Regulatory Framework:
1. Decree of the Government of the Russian Federation No. 1140 dated November 7, 2016 (on FGIS VetIS)
2. Law of the Russian Federation No. 4979-1 dated May 14, 1993 «On Veterinary Medicine» (as amended 2025)
3. Order of the Ministry of Agriculture of Russia No. 316 dated May 7, 2025 (effective September 1, 2025 through September 1, 2031)
4. Order of the Ministry of Agriculture of Russia No. 779 dated November 18, 2021 (effective until March 1, 2028)
5. Order of Rosselkhoznadzor No. 1490 dated December 16, 2021
6. Decree of the Government of the Russian Federation No. 3920-r dated December 28, 2021
7. Decree of the Government of the Russian Federation No. 353 dated March 12, 2022 (as amended 2025)