Which rules apply to your products?

Rules and dates

1. Adopted, not yet applyingUnited States

   FSMA 204 Food Traceability Rule (21 CFR Part 1 Subpart S)

   Keep key data elements for critical tracking events and a traceability plan for foods on the Food Traceability List, and give FDA a sortable spreadsheet within 24 hours of a request.

   1. 20 Jan 2023Final rule effective
   2. 7 Aug 2025FDA proposed moving the compliance date by 30 months (still a proposal)
   3. 12 Nov 2025Congress directed FDA not to enforce before 20 July 2028
   4. 6 Nov 2026FDA public meeting on lot-level tracking flexibilities
   5. 20 Jul 2028Earliest enforcement

   Applies to: manufacturers, processors, packers, distributors, retailers, restaurants, farms (with exemptions)

   Source · Checked against the official source

   FSMA 204 checklist
2. Phasing inUnited States

   Drug Supply Chain Security Act (FD&C Act §582)

   Electronic, interoperable package-level tracing and verification of prescription drugs using product identifiers (GTIN, serial, lot, expiry).

   1. 27 Nov 2023Enhanced requirements effective by statute
   2. 27 Nov 2024FDA stabilization period ended
   3. 27 May 2025Exemption ended for manufacturers and repackagers
   4. 27 Aug 2025Exemption ended for wholesale distributors
   5. 27 Nov 2025Exemption ended for dispensers with 26 or more full-time pharmacists and technicians
   6. 27 Nov 2026Headcount date for the small-dispenser exemption (25 or fewer)
   7. 27 Nov 2027Small-dispenser exemption ends

   Applies to: manufacturers, repackagers, wholesale distributors, dispensers, 3PLs

   Source · Checked against the official source

   DSCSA 25-line checkDSCSA checklist
3. Phasing inEuropean Union

   EUDAMED mandatory modules (Decision (EU) 2025/2371)

   Mandatory use of the EUDAMED actor, UDI and device, certificate and market surveillance modules.

   1. 28 May 2026Four modules mandatory
   2. 28 Nov 2026Devices already on the market must be registered in the UDI and device module
   3. 28 May 2027Notified bodies register earlier certificates

   Applies to: manufacturers, authorised representatives, importers, notified bodies

   Source · Checked against a secondary source; confirm before acting

4. Adopted, not yet applyingEuropean Union

   EU Deforestation Regulation (EU) 2023/1115, as amended

   A due diligence statement with plot geolocation proving relevant commodities and products are deforestation-free and legal.

   1. 4 May 2026Commission review: dates not reopened
   2. 30 Dec 2026Applies to large and medium operators and traders
   3. 30 Jun 2027Applies to micro and small operators

   Applies to: operators, traders

   Source · Checked against the official source

5. Phasing inBrazil

   Brazil Anvisa medical device UDI (RDC 591/2021)

   A UDI carrier on device labels and packaging, phased by risk class, with database submission later.

   1. 10 Jul 2025Class IV carrier
   2. 10 Jan 2026Class III carrier
   3. 10 Jan 2027Class II carrier
   4. 10 Jan 2028Class I carrier

   Applies to: registration holders

   Source · Checked against a secondary source; confirm before acting

6. In forceEuropean Union

   EU Falsified Medicines Directive safety features (Del. Reg. (EU) 2016/161)

   Prescription medicines carry a unique identifier (2D DataMatrix) and an anti-tampering device, verified and decommissioned through the national verification systems.

   1. 9 Feb 2019Applies in most Member States
   2. 9 Feb 2025Deferral ended for Belgium, Greece and Italy
   3. 8 Feb 2027Italy's stabilization period ends

   Applies to: manufacturers, parallel importers, wholesalers, pharmacies and hospitals

   Source · Checked against the official source

   Pharma
7. Adopted, not yet applyingEuropean Union

   EU Batteries Regulation (EU) 2023/1542: labels, QR code and battery passport

   Labels and QR codes on batteries, and a battery passport reached through the QR code for light-transport, EV and industrial batteries over 2 kWh.

   1. 18 Feb 2024Regulation applies
   2. 18 Aug 2026Earliest date for labelling; waits on an implementing act not yet adopted
   3. 18 Feb 2027Battery passport for light-transport, EV and industrial batteries over 2 kWh
   4. 18 Feb 2027QR code on all batteries (earliest; waits on an implementing act)

   Applies to: manufacturers, importers, distributors, producers

   Source · Checked against the official source

   Battery passport guideBattery passport checklist
8. Adopted, not yet applyingUnited Kingdom

   UK batteries: EU rules in Northern Ireland

   In Northern Ireland the EU Batteries Regulation applies, including the passport; Great Britain stays on the 2008 regulations while a UK-wide regime is consulted on.

   1. 18 Feb 2027Northern Ireland: battery passport
   2. 18 Aug 2027Northern Ireland: due diligence
   3. Date not setGreat Britain consultation and regulations

   Applies to: producers, importers, distributors

   Source · Checked against the official source

   Battery passport guide
9. Phasing inEuropean Union

   EU MDR and IVDR UDI carrier (Reg. (EU) 2017/745 and 2017/746)

   A Basic UDI-DI and a UDI carrier on device labels and packaging, with direct marking for reusable devices.

   1. 26 May 2021MDR implantable and Class III labels
   2. 26 May 2023MDR IIa and IIb labels; IVDR Class D labels
   3. 26 May 2025MDR Class I labels; IVDR Class C and B labels
   4. 26 May 2027MDR Class I direct marking; IVDR Class A labels

   Applies to: manufacturers

   Source · Checked against the official source

10. Phasing inChina

    China medical device UDI

    UDI on labels and device data submitted to the national UDI database, phased by device class.

    1. 1 Jun 2022All Class III
    2. 1 Jun 2027All Class II, including IVD, and Class I IVD reagents
    3. 1 Jun 2029All Class I devices

    Applies to: manufacturers, distributors, hospitals

    Source · Checked against a secondary source; confirm before acting

11. Phasing inIndia

    India barcode or QR code on formulations (Schedule H2)

    Listed medicines carry a barcode or QR code with a unique product ID, brand, manufacturer, batch, dates and licence number.

    1. 1 Aug 2023Top 300 brands
    2. 22 Jun 2026Rule extended to vaccines, antimicrobials, narcotic and anti-cancer drugs
    3. 1 Jul 2027Vaccines, narcotic and psychotropic, and anti-cancer drugs
    4. 1 Jul 2028Antimicrobials

    Applies to: formulation manufacturers

    Source · Checked against the official source

12. Adopted, not yet applyingEuropean Union

    EU Batteries Regulation: supply-chain due diligence (as amended by Reg. (EU) 2025/1561)

    Due diligence policies on cobalt, lithium, nickel and natural graphite supply chains, with third-party verification.

    1. 18 Aug 2027Due diligence obligations apply

    Applies to: producers above the turnover threshold

    Source · Checked against the official source

13. In forceEuropean Union

    Carbon Border Adjustment Mechanism (EU) 2023/956, as amended

    Importers declare embedded emissions traced to the producing installation and surrender CBAM certificates.

    1. 1 Jan 2026Definitive period starts; 50-tonne yearly threshold per importer
    2. 30 Sep 2027First annual declaration and certificate surrender, for 2026 imports

    Applies to: importers, indirect customs representatives

    Source · Checked against the official source

14. Adopted, not yet applyingEuropean Union

    EU Forced Labour Regulation (EU) 2024/3015

    Bans placing, making available or exporting products made with forced labour; authorities can demand supply-chain mapping and records.

    1. 26 Jun 2026Commission guidelines published
    2. 14 Dec 2027Applies

    Applies to: all economic operators

    Source · Checked against the official source

15. VoluntaryVoluntary standards, United States

    GS1 Sunrise 2027

    An industry goal for retail checkouts to scan 2D barcodes (GS1 DataMatrix, or QR with GS1 Digital Link) alongside UPC and EAN.

    1. 31 Dec 2027Target: retailers can scan 2D at the checkout

    Applies to: retailers, brand owners

    Source · Checked against the official source

16. Adopted, not yet applyingEuropean Union

    Detergents and Surfactants Regulation (EU) 2026/405

    Replaces the 2004 regulation; detergents and surfactants carry a passport linked by a data carrier, and digital labels are allowed.

    1. 22 Mar 2026In force
    2. 23 Sep 2029Applies

    Applies to: manufacturers, importers, distributors

    Source · Checked against a secondary source; confirm before acting

17. In forceEuropean Union

    ESPR ban on destroying unsold apparel and footwear (Del. Reg. (EU) 2026/296)

    Large companies may not destroy unsold apparel, clothing accessories or footwear, except under listed exemptions, and must disclose what they discard.

    1. 19 Jul 2026Ban applies to large companies
    2. 19 Jul 2030Ban applies to medium companies

    Applies to: large and medium companies

    Source · Checked against the official source

18. Adopted, not yet applyingEuropean Union

    EU Toy Safety Regulation (EU) 2025/2509: Digital Product Passport

    Each toy needs a passport, replacing the EU declaration of conformity, registered before it is placed on the market.

    1. 12 Dec 2025Published
    2. 1 Aug 2030Applies, including the passport

    Applies to: manufacturers, importers, distributors, fulfilment service providers

    Source · Checked against the official source

19. In forceUnited States

    FDA Unique Device Identification (21 CFR 801 Subpart B, Part 830)

    A UDI in plain text and machine-readable form on device labels and packages, direct marking of reusable devices, and device data submitted to GUDID.

    1. 24 Sep 2014Class III compliance
    2. 24 Sep 2022Class I and unclassified labeling compliance (final phase)
    3. 8 Dec 2022FDA enforcement discretion ended for Class I and unclassified GUDID submissions

    Applies to: device labelers

    Source · Checked against the official source

20. In forceUnited States

    Uyghur Forced Labor Prevention Act

    Goods made wholly or partly in Xinjiang or by listed entities are presumed made with forced labor; importers must trace their supply chain to get them admitted.

    1. 21 Jun 2022Rebuttable presumption effective
    2. 19 Aug 2025High-priority sectors widened, including lithium, steel and copper

    Applies to: importers of record

    Source · Checked against the official source

21. Phasing inUnited States

    Lacey Act plant product declaration (16 U.S.C. 3372(f))

    Importers declare the plant species, country of harvest, quantity and value of plant material in covered goods.

    1. 1 Dec 2024Phase VII products added, including plywood, tools, footwear and handbags

    Applies to: importers

    Source · Checked against the official source

22. In forceUnited States

    Seafood Import Monitoring Program (50 CFR 300.324)

    Importers of 13 at-risk seafood species groups report and keep harvest-to-entry traceability data.

    1. 1 Jan 2018Mandatory for the first 11 species groups

    Applies to: importers of record

    Source · Checked against a secondary source; confirm before acting

23. Adopted, not yet applyingEuropean Union

    Ecodesign for Sustainable Products Regulation (EU) 2024/1781: Digital Product Passport

    Product groups covered by ESPR delegated acts will need a passport reached by a data carrier, with identifiers registered in the EU DPP registry.

    1. 18 Jul 2024ESPR in force
    2. 16 Apr 2025Working plan: iron and steel act indicated for 2026; textiles, tyres and aluminium 2027; furniture 2028
    3. 20 Jul 2026DPP registry operational
    4. Date not setProduct-group delegated acts; none adopted yet. Each applies no earlier than 18 months after adoption

    Applies to: manufacturers, importers, distributors, online marketplaces

    Source · Checked against the official source

    Passport readiness checkEU DPP checklist
24. Adopted, not yet applyingEuropean Union

    Construction Products Regulation (EU) 2024/3110: Digital Product Passport

    Manufacturers provide a passport for construction products once the delegated acts for the passport system and each product family apply.

    1. 8 Jan 2026Regulation applies
    2. Date not setPassport mandatory 18 months after its delegated act, not yet adopted

    Applies to: manufacturers, importers, distributors

    Source · Checked against a secondary source; confirm before acting

25. In forceEuropean Union

    General Product Safety Regulation (EU) 2023/988

    Consumer products carry a type, batch or serial number and the manufacturer's contact details; online offers show the same; supply-chain records are kept.

    1. 13 Dec 2024Applies

    Applies to: manufacturers, importers, distributors, online marketplaces

    Source · Checked against the official source

26. No longer requiredUnited Kingdom

    UK: medicines safety features no longer required

    The EU unique identifier and repository checks are not required in Great Britain, nor in Northern Ireland under the Windsor Framework; a 2D code is optional.

    1. 1 Jan 2021No longer required in Great Britain
    2. 1 Jan 2025No longer required in Northern Ireland

    Applies to: marketing authorisation holders, wholesalers, pharmacies

    Source · Checked against the official source

27. ProposedUnited Kingdom

    UK product safety reform

    Great Britain runs on the 2005 regulations; 2026 government consultations propose supply-chain traceability records, digital producer information and online-marketplace duties. Northern Ireland follows the EU GPSR.

    1. 23 Jun 2026Consultations closed
    2. Date not setRegulations to be laid

    Applies to: producers, distributors, online marketplaces

    Source · Checked against a secondary source; confirm before acting

28. ProposedUnited Kingdom

    UK forest risk commodities (Environment Act 2021, Schedule 17)

    Large businesses using regulated commodities produced in breach of local law will run due diligence and report; the regulations are not yet made.

    1. 23 Jun 2026Government confirmed it will take the rules forward (soy, palm oil, cocoa, rubber, cattle)
    2. Date not setRegulations expected in 2027

    Applies to: large businesses above the turnover threshold

    Source · Checked against a secondary source; confirm before acting

29. In forceUAE

    UAE Tatmeen pharmaceutical track and trace

    GS1 DataMatrix serialization (GTIN, serial, batch, expiry), aggregation and event reporting to the national Tatmeen platform.

    1. 13 Dec 20212D GS1 barcode on imported products
    2. 13 Dec 2022Serialization reporting, aggregation and GLN for all supply-chain actors

    Applies to: marketing authorisation holders, importers, distributors, pharmacies and hospitals

    Source · Checked against a secondary source; confirm before acting

    UAE and GCC
30. In forceSaudi Arabia

    Saudi SFDA drug track and trace (RSD)

    Serialized GS1 DataMatrix on human medicines, aggregation, and reporting of every supply-chain movement to RSD.

    1. 28 Feb 2018GLN registration for factories and warehouses
    2. 20 Aug 2020Last reported aggregation and integration deadline

    Applies to: manufacturers, importers, distributors, pharmacies and hospitals

    Source · Checked against a secondary source; confirm before acting

31. In forceSaudi Arabia

    Saudi SFDA medical device UDI (Saudi-DI)

    UDI on device labels and registration in the Saudi-DI database.

    1. 1 Sep 2022Class B, C and D
    2. 1 Sep 2023Class A

    Applies to: manufacturers, authorised representatives, importers

    Source · Checked against a secondary source; confirm before acting

32. Phasing inChina

    China drug traceability codes

    Marketing authorisation holders code every packaging level; hospitals and pharmacies scan and upload the codes for insured drugs.

    1. 1 Jul 2025Code scan required before insurance settlement
    2. 1 Jan 2026All medical institutions collect and upload every code
    3. 3 Aug 2026NMPA draft technical requirements published for comment

    Applies to: marketing authorisation holders, distributors, hospitals, pharmacies

    Source · Checked against a secondary source; confirm before acting

33. In forceIndia

    India QR code on active pharmaceutical ingredients

    APIs carry a QR code on each packaging level with product and batch details.

    1. 1 Jan 2023Applies

    Applies to: API manufacturers, importers

    Source · Checked against a secondary source; confirm before acting

34. No longer requiredIndia

    India export track and trace for drug formulations

    The trade-policy serialization rule for exported formulations was withdrawn; export authentication moved to the health ministry's rules.

    1. 31 Jan 2025Rule withdrawn

    Applies to: pharma exporters

    Source · Checked against a secondary source; confirm before acting

35. In forceBrazil

    Brazil medicine traceability (Law 14.338/2022)

    Unit serialization (SNCM) was revoked; registration holders track distribution by batch.

    1. 11 May 2022Serial-number requirement revoked; batch tracking stays

    Applies to: registration holders

    Source · Checked against a secondary source; confirm before acting

36. ProposedCanada

    Canada: no mandatory drug serialization or device UDI

    Health Canada has no mandatory medicine serialization or device UDI rule; UDI was consulted on in 2021 with no regulation since.

    1. 30 Sep 2021UDI consultation closed

    Applies to: nobody yet

    Source · Checked against a secondary source; confirm before acting

37. VoluntaryVoluntary standards

    UN Transparency Protocol (UN/CEFACT)

    An open specification for verifiable product passports, conformity credentials and traceability events.

    1. 13 Jul 2026Version 0.7 public review closed
    2. Date not setVersion 1.0 release

    Applies to: any supply-chain business (voluntary)

    Source · Checked against a secondary source; confirm before acting

    UNTP checklist

No rule in our list matches that combination. That can mean there is no mandatory rule yet, or that we do not track it. Ask us and we will check.

A guide to the rules, not legal advice. Dates move: each rule links to its source, and medium-confidence rows were checked against secondary sources. Tell us about a rule we are missing at [email protected].