Packaging Eco-Fee Rises to 75% in 2026. What Changed for Pharma Companies Under Law No. 451-FZ.
A company importing a medicinal product into Russia is responsible not only for its registration certificate (RC) and product quality. Since 2024, the list of obligations includes the disposal of the packaging in which the drug enters the country. Cardboard cartons, blister foil, package inserts, and glass vials all fall under Extended Producer Responsibility (EPR) requirements. The obligation to dispose of them can now fall directly on the importer, on par with local packaging manufacturers.
The mandatory recycling target rises every year on a fixed schedule. In 2025, it stood at 55% of packaging mass; in 2026, it reached 75%; and from 2027 onward, it reaches 100%. A company that does not track this trajectory risks two fines at once: one for reporting to Rosprirodnadzor and one for non-payment of the environmental fee.
Before 2024, the Product Manufacturer Was Responsible for Packaging
The EPR system was introduced by Federal Law No. 89-FZ of 24 June 1998, «On Production and Consumption Waste» (hereinafter, 89-FZ). Before the 2024 reform, the payer of the environmental fee for packaging was the company that manufactured or imported the finished goods inside that packaging. A pharmaceutical plant or drug importer reported on cardboard cartons and blisters independently, on the same footing as manufacturers of beverages or household chemicals.
The calculation base was the mass of realized (sold) products. If a batch of drugs stayed in the warehouse unsold, the disposal obligation had formally not yet arisen. This approach let businesses delay reporting and understate their liabilities, especially across long distribution chains.
Responsibility Shifted to Manufacturers and Importers of the Packaging Itself
Federal Law No. 451-FZ of 4 August 2023, «On Amendments to the Federal Law ‘On Production and Consumption Waste’ and Certain Legislative Acts of the Russian Federation» (hereinafter, 451-FZ), took effect on 1 January 2024 and established a new framework of responsibility for the entire packaging sector. Responsibility for packaging disposal now lies with whoever manufactured or imported the packaging itself, rather than whoever used it to package a product.
For the pharmaceutical industry, this split works under two scenarios. If a drug is imported into Russia already packaged from abroad, the importer of the finished product is responsible for the foreign packaging: the government-approved list separately identifies packaging imported from non-EAEU countries and from EAEU member states. If a pharma company buys cardboard boxes, labels, or vials from a Russian packaging manufacturer, the eco-fee obligation rests with that manufacturer, and the purchasing company is exempt.
The calculation base has also changed. The fee is now calculated on the entire volume of packaging manufactured or imported, regardless of whether it has been sold or is still in a warehouse. The obligation is deemed to arise on whichever date comes first: the date the packaging is shipped or the date it is paid for.
| Parameter | Before (prior to 2024) | After (from 2024) |
|---|---|---|
| Who pays for packaging | Manufacturer of the goods inside the packaging | Manufacturer or importer of the packaging itself |
| Fee calculation base | Mass of realized (sold) products | Mass of packaging manufactured or imported |
| Point the obligation arises | Date of the product’s first sale | Earlier of two dates: packaging shipment or payment |
| Packaging recycling target | 10-45%, depending on material | 55% in 2025, 75% in 2026, 100% from 2027 |
Exports and Internal-Use Packaging Are Exempt from the Fee
The law exempts goods and packaging that a company exports outside Russia from disposal and fee obligations. The exporter must confirm the export with documents for Rosprirodnadzor and the Federal Customs Service (FCS of Russia); otherwise the exemption does not apply and the full fee obligation remains.
A second exemption covers packaging for internal use. If a company uses packaging inside its own production and does not sell it as a separate product, the eco-fee obligation does not arise, since the law ties it to sale or import for subsequent resale. For the pharmaceutical industry this exemption rarely applies, because a finished drug almost always reaches the market together with its packaging.
Recycling Targets Rise on a Fixed Schedule Through 2027
The fee calculation rules and the list of packaging subject to disposal are set by Government Decree No. 2414 of 29 December 2023 (hereinafter, Decree No. 2414). In 2024, the target depended on the material and ranged from 10% to 45%. From 2025, the government moved to a single rate for all packaging types: 55% of mass, regardless of whether the material is cardboard, glass, plastic, or composite packaging such as blister foil.
In 2026, the target rose to 75%. From 2027, packaging manufacturers and importers must recycle 100% of the mass they produce or import, and the law provides no grace period for the transition to full coverage.
The fee formula is straightforward. The amount equals the base rate per ton of material, multiplied by the mass of packaging manufactured or imported, multiplied by the current recycling target. If a company has partly recycled the waste itself or through a contractor, the mass confirmed by a disposal act is deducted from the calculated mass.
The rate depends on a material’s environmental coefficient. Multi-layer packaging that is hard to separate into fractions is taxed at a higher rate. Monomaterials, such as single-layer cardboard or clear plastic, lower the total fee, and using secondary raw materials in packaging production grants additional discounts.
Reporting Goes Through EFGIS UOIT and Is Due by 15 April
The Unified Federal State Information System for Recording Waste from the Use of Goods (EFGIS UOIT) receives declarations on the volume of packaging released and reports on fulfillment of the recycling target. The system operator is the Russian Environmental Operator (REO), while Rosprirodnadzor checks the accuracy of the data.
A company must file three documents every year: a declaration of the mass of packaging manufactured or imported during the reporting period, a report on waste actually recycled, and a calculation of the environmental fee due. Reporting and payment for the preceding calendar year are due by 15 April of the current year. For 2026, organizations must report and pay the fee by 15 April 2027.
Missed Deadlines and Non-Payment Are Punished Under Two Separate Code Articles
The Code of Administrative Offences of the Russian Federation (the Code) sets out separate offenses for EPR violations. The fines cover both late or missing reports and non-payment of the fee itself, and they apply independently of one another.
| Violation | Code article | Fine for company officers | Fine for sole proprietors | Fine for legal entities |
|---|---|---|---|---|
| Missing or late reporting | Art. 8.5.1, Part 1 | ₽3,000-6,000 | ₽50,000-70,000 | ₽70,000-150,000 |
| Inaccurate or incomplete reporting | Art. 8.5.1, Part 2 | ₽3,000-6,000 | 2x the fee amount, min. ₽100,000 | 2x the fee amount, min. ₽250,000 |
| Non-payment or late payment of the fee | Art. 8.41.1 | ₽5,000-7,000 | 3x the fee amount, min. ₽250,000 | 3x the fee amount, min. ₽500,000 |
Paying the fine does not close the matter. The company still owes the underlying environmental fee, and Rosprirodnadzor cross-checks production and import volumes against data from the Federal Customs Service (FCS of Russia), the Federal Tax Service (FTS of Russia), and labeling systems. A discrepancy between a company’s reporting and customs or tax data becomes visible right away.
A Contract With an Unverified Recycler Voids the Acts and Doubles the Bill
A company can choose between paying the fee directly or meeting the recycling target itself through a contractor. The contractor route costs less, but it requires vetting the counterparty before signing. Since 2024, Russia has maintained an official registry of waste recyclers, with the procedure for keeping it set by Government Decree No. 2400 of 29 December 2023. Rosprirodnadzor maintains the registry with the REO.
If a recycler is not on the registry, or has not confirmed real processing capacity, the disposal acts it issues are treated as invalid. Rosprirodnadzor then reassesses the full environmental fee and, at the same time, holds the company liable under Part 2 of Article 8.5.1 of the Code for inaccurate reporting and under Article 8.41.1 of the Code for non-payment. Checking a counterparty before signing costs less than either of those outcomes.
What to Do
Determine the import model for each product line. Split your portfolio into drugs that arrive already packaged from abroad and drugs whose cartons and labels are bought from Russian packaging manufacturers. This decides who reports to Rosprirodnadzor.
Recalculate your packaging mass against the 2026 target. Gather data by material type (cardboard, blister foil, glass, polymers) and check it against the current 75% target to get a preliminary fee estimate for the current reporting period.
Check the recycler against the Rosprirodnadzor registry before signing. Request a registry extract and documents confirming real processing capacity, not just a waste-handling license.
File the declaration and report through EFGIS UOIT by 15 April. Set up the personal account well ahead of time so the last week before the deadline is not lost to technical setup.
Budget now for the full move to a 100% target in 2027. Work out which is cheaper for each packaging type: paying the fee directly, switching to monomaterials to lower the rate, or a long-term contract with a registered recycler.
The EPR reform turned packaging disposal into a fixed line in the regulatory budget, on par with registration fees or the cost of a GMP inspection. A company that already tracks packaging mass by material and has vetted its recycler will meet the 100% target in 2027 without emergency assessments or fines.
Regulatory Framework:
1. Federal Law No. 89-FZ of 24 June 1998, «On Production and Consumption Waste» (as amended by Federal Law No. 451-FZ of 4 August 2023)
2. Federal Law No. 451-FZ of 4 August 2023, «On Amendments to the Federal Law ‘On Production and Consumption Waste’ and Certain Legislative Acts of the Russian Federation»
3. Government Decree No. 2414 of 29 December 2023, «On Approving the Lists of Goods and Packaging Whose Waste Is Subject to Disposal, and the Disposal Targets for Waste From the Use of Goods and Packaging»
4. Government Decree No. 2400 of 29 December 2023 (procedure for maintaining the registry of waste recyclers)
5. Government Decree No. 868 of 13 May 2022, «On the Unified Federal State Information System for Recording Waste From the Use of Goods» (legal basis for EFGIS UOIT)
6. Code of Administrative Offences of the Russian Federation, Articles 8.5.1 and 8.41.1