Regulatory Blog | MKVision

Turkey

Pharmaceutical packaging line with serialized medicine boxes

İTS: Turkey's End-to-End Pharmaceutical Track & Trace System Remains Fully Active

Completed in 2012, Turkey's İTS tracks every medicine pack from production to pharmacy with GS1 DataMatrix codes, giving the country one of the world's most complete pharmaceutical serialization systems.

European Union Operator checking serialized pharmaceutical cartons against a verification screen

FMD Transition Timeline Takes Shape: Italy and Greece Connect to the EU Hub

Italy will run its legacy 'Bollino' system alongside EU-FMD verification until February 2027, while Greece has now connected its national hub to EMVO, closing two of the last gaps in Europe's medicine verification network.

Russia

Label printing machine applying codes to packaged consumer goods

Chestny ZNAK Mandatory Marking Expands to New Product Categories

Russia's Chestny ZNAK digital marking system added vegetable oils, beer, textiles, tires, dairy, and medical devices through 2025, with fish oil and enzyme supplements following from March 2026.

Kazakhstan Label application equipment marking packaged goods for a national tracking system

National Goods Catalog Brings Mandatory Digital Tracking Into Force

Kazakhstan's National Goods Catalog launched in August 2025 as a 'Digital Trade Mirror,' with full mandatory tracking from January 2026 starting with motor oils, beer, textiles, and jewelry.

United States Pharmaceutical distribution warehouse with palletized cartons ready for shipment

DSCSA Enforcement Discretion Winds Down: What Full Traceability Means for Pharma

The FDA's DSCSA stabilization period ran through November 2024, with narrower exemptions extending to May 2025, pushing US pharmaceutical supply chains toward fully electronic, unit-level traceability.

European Union Corporate headquarters building representing EU regulatory compliance functions

EU's General Product Safety Regulation (GPSR) Raises the Traceability Bar

Effective since 13 December 2024, the EU's GPSR replaces the old product safety directive with mandatory traceability duties, a required EU Responsible Person, and new obligations for online marketplaces.

European Union Software dashboard displaying digital product data linked to a scannable code

The Digital Product Passport Is Coming for Textiles

Under the EU's Ecodesign Regulation, textiles are set to be among the first product groups required to carry a Digital Product Passport, with a delegated act expected around 2027 and roughly an 18-month transition.

European Union Aerial view of agricultural fields relevant to commodity traceability

EUDR Delayed Again, But Agricultural Traceability Is Still Coming

The EU Deforestation Regulation has been postponed twice and now applies from 30 December 2026 for large operators, but its geolocation-based due-diligence traceability requirements remain unchanged.

United States Medical device packaging displaying a unique device identifier barcode

FDA Refines UDI and GUDID Rules for Medical Devices

The FDA updated its GUDID data submission rules in December 2024 and issued 2025 draft guidance on UDI labeling for combination products, continuing to refine the decade-old Unique Device Identification system.

United States Industrial facility handling regulated explosive materials packaging

US Explosives Marking Rules Keep Every Package Traceable

Federal law requires every package of explosive materials in the US to be marked for identification and tracing, with the ATF's 2025 Annual List of Explosive Materials taking effect 13 June 2025.

United States Fresh produce and packaged food on display in a retail food market

FSMA 204 Food Traceability Rule: Compliance Pushed to July 2028

The FDA has delayed FSMA Section 204's Food Traceability Rule by 30 months, moving the compliance date from January 2026 to July 20, 2028, giving food companies more time to build required recordkeeping.

European Union Food processing facility with packaged goods moving along a production line

EU General Food Law: The 'One Step Back, One Step Forward' Traceability Rule

Regulation (EC) No 178/2002 requires every EU food and feed business to know who supplied them and who they supplied to, forming the legal backbone of Europe's food traceability and recall system.

United States Agricultural field being treated with a registered crop protection product

FIFRA Pesticide Registration: How the EPA Tracks Every Product to Its Label

Under FIFRA, every pesticide sold in the US must carry an EPA registration number tying it to an approved label, giving regulators a direct enforcement link between the product on the shelf and its legal formulation.

European Union Quality control inspection of packaged crop protection products

After the SUR's Withdrawal, EU Pesticide Traceability Still Runs on Existing Law

The EU's proposed Sustainable Use Regulation for pesticides was withdrawn in 2024, leaving Directive 2009/128/EC and Regulation (EC) 1107/2009 as the operative framework behind product authorization and traceability.

United States Serial number marking station used for regulated component identification

ATF's Frame or Receiver Rule Redefined Firearms Serialization Requirements

Effective 24 August 2022, the ATF's Frame or Receiver Final Rule closed the 'ghost gun' loophole by requiring serial numbers and licensed marking on privately made firearms and unfinished receiver kits.

European Union Battery cells and circuitry representing electric vehicle and industrial battery technology

EU Battery Regulation: Digital Battery Passport Becomes Mandatory in 2027

Under Regulation (EU) 2023/1542, EV, LMT, and industrial batteries above 2 kWh must carry a Digital Battery Passport from 18 February 2027, linking every battery to a lifecycle record accessed via QR code.

United States Packaged fresh food items being sorted for shipment in a distribution center

Inside the FDA's Food Traceability List: KDEs, CTEs, and the 24-Hour Rule

The FDA's Food Traceability Rule builds its entire recordkeeping framework around Critical Tracking Events and Key Data Elements, requiring covered foods to remain traceable within 24 hours of a records request.

European Union / United States Packaged veterinary medicine products with batch identification on the label

Veterinary Medicine Traceability: How the EU and US Approaches Compare

The EU's Regulation (EU) 2019/6 built a unified, human-medicine-style traceability framework for veterinary drugs, while the US relies on FDA's separate animal drug approval and labeling system with no equivalent unique identifier mandate.

European Union Chemical container label displaying hazard symbols and a unique identifier code

REACH and the New UFI Barcode Requirement Reshaping Chemical Traceability

Since January 2025, hazardous mixtures sold in the EU must carry a 16-character Unique Formula Identifier on the label, adding a new mandatory traceability layer on top of REACH's existing registration system.

United States Import warehouse with shipping containers and pallets awaiting customs clearance

UFLPA Enforcement Widens: 144 Entities and New High-Priority Sectors in 2025

US Customs expanded the UFLPA Entity List to 144 Chinese entities by August 2025 and added lithium, steel, and caustic soda as high-priority enforcement sectors, raising documentation demands on importers.

European Union Medical device packaging line with UDI barcode labeling equipment

EU MDR Transition and the Expanding UDI/EUDAMED System: Where Things Stand in 2026

A 2026 status update on the EU Medical Device Regulation transition, the extended deadlines for legacy MDD certificates, and the phased rollout of mandatory EUDAMED modules and UDI registration.

European Union Packaging line applying recyclability and traceability labels to product boxes

The EU Packaging and Packaging Waste Regulation: New Traceability and Labeling Duties

How Regulation (EU) 2025/40 on packaging and packaging waste introduces recyclability grading, harmonized labeling, and traceability obligations for packaging placed on the EU market from 2026.

European Union Cosmetic product bottles on a line with batch code printing equipment

EU Cosmetics Regulation 1223/2009: Responsible Person Duties and Batch-Code Traceability

How Regulation (EC) 1223/2009 defines the Responsible Person role and mandatory batch-code traceability for cosmetic products sold in the EU, including CPNP notification and recall obligations.

European Union Chemical drum labeling line printing hazard pictograms and UFI codes

EU CLP Regulation: Unique Formula Identifiers and Poison Centre Traceability

How Regulation (EC) 1272/2008 (CLP) and its Poison Centre Notification annex require a Unique Formula Identifier on hazardous mixture labels, and what that means for chemical and agrochemical producers.

United States Children's product packaging line applying permanent tracking labels

US CPSC Tracking Labels: Marking Duties Under CPSIA and 16 CFR Part 1130

How CPSIA Section 103 and 16 CFR Part 1130 require permanent tracking labels and registration marks on children's products sold in the United States, and how manufacturers meet the marking duty.

United States Industrial chemical facility with labeled containers for EPA traceability

US TSCA and Chemical Data Reporting: How the EPA Tracks Substances Through the Supply Chain

How the Toxic Substances Control Act and the EPA Chemical Data Reporting rule track chemical substances through the TSCA Inventory, including 2026 PFAS reporting deadlines and recordkeeping duties.

United States Controlled chemical shipment marked and tracked for dual-use export compliance

Dual-Use Export Controls for Explosives Precursors: Comparing US EAR and EU Regulation 2021/821

How the US Export Administration Regulations and the EU Dual-Use Regulation (EU) 2021/821 control and track explosives precursor chemicals, and where the two licensing and traceability regimes diverge.

United States Pharmaceutical packaging line with lot and NDC code verification

FDA Drug Recall Classification: How Class I, II, and III Recalls Work

How the FDA classifies drug recalls into Class I, II, and III based on health risk, who initiates a recall, and how lot and NDC-level traceability determines the scope of a pharmaceutical recall action.

European Union Food production line packaging novel food ingredients with traceability codes

EU Novel Food Regulation: Authorization, Labeling, and Traceability Requirements

How Regulation (EU) 2015/2283 defines novel foods, the EFSA authorization process, and the traceability and labeling duties that apply once a novel food ingredient reaches the EU market.

United States Meat processing line with USDA inspection legend and lot code labeling

USDA FSIS Traceability: Inspection Marks, Recordkeeping, and Product of USA Labeling

How USDA FSIS recordkeeping regulations, establishment inspection legends, and the new Product of USA labeling rule combine to create traceability for meat and poultry products in the US market.

Latest Developments in 2D Barcode & Serialization Regulations