Anti-Counterfeit Design

1. Design for evidence, not tamper‑proof. TE features must reliably signal interference rather than promise prevention. US and EU law consistently use tamper‑evident/anti‑tampering device language, and FDA discourages tamper‑proof claims in OTC contexts. [11, 12]
2. Healthcare is prescriptive. US: OTC drugs, certain cosmetics (liquid oral hygiene/vaginal), and contact‑lens solutions require TE/TRP packages with labeling. EU: Rx medicines require a unique identifier (2D DataMatrix) + an anti‑tampering device (ATD) per Delegated Reg. (EU) 2016/161. UK: From 1 Jan 2025, EU FMD safety features no longer apply in NI; MHRA expects ATDs to remain on UK medicine packs. [6, 7, 9, 10, 11, 12, 14, 15]
3. Pick features with performance criteria, not brand names. Use ISO 12931 & ISO 22383 to select and evaluate authentication elements (overt/covert/forensic/digital), anchored in risk analysis and effectiveness assessment. [1]
4. Print quality is part of security. Serialization that fails in market equals compliance risk. GS1 DataMatrix needs correct X‑dimension (often 0.254 mm), 1× quiet zone, and verification to ISO/IEC 15415 with typical minimum grade C (1.5). [17, 18, 19, 20]
5. Security printing is a system, not a feature. Supplier controls are codified in ISO 14298 (+ Amd 1:2024). For higher‑risk programs, source from certified security printers or require equivalent controls. [3, 4]
6. Illicit trade remains material. OECD/EUIPO analyses indicate a persistent share of counterfeit/pirated trade, sustaining the need for layered security and serialization. [21, 22]
7. EU tobacco packs set a useful model. Tamper‑proof security features with visible and invisible elements plus T&T are mandated, offering a reference architecture beyond pharma. [31, 32]

• Map risk with ISO 22380/22383; select a layered feature set (overt + covert + digital + forensic as needed) and define testable acceptance criteria up front. [1]
• For regulated SKUs, align artwork/packaging specs to the exact rule text (21 CFR; EU 2016/161; UK MHRA notices). Include required label statements. [6, 7, 9, 11, 12, 14, 15]
• Lock barcode performance early: design to GS1 specs, verify to ISO/IEC 15415, and require ≥ 1.5 (C) grades at incoming and line‑clearance. [17, 18]
• Source from ISO 14298‑conformant security printers or demonstrate equivalent controls (access, custody, waste destruction). [3, 4]
• Write a post‑market monitoring plan (serial data analytics, returns inspection, channel sweeps) tied to response playbooks.

• UK medicines transition post‑Windsor Framework (implementation details, MHRA updates). [9, 10]
• US DSCSA enhanced system stabilization and enforcement cadence. [23, 24]
• Counterfeit migration to secondary channels and refill fraud; keep artwork‑level microsecurity current. [21, 22]

• US (FDA/21 CFR): OTC drugs (TE + label statement, 21 CFR 211.132); cosmetics (liquid oral hygiene & vaginal) in TRP with labeling (21 CFR 700.25); contact‑lens solutions/tablets (21 CFR 800.12); label placement guidance emphasizes visibility before purchase. [11, 12, 13, 14, 15, 16]
• EU (Medicines, FMD): Rx packs require UI (2D DataMatrix) + ATD per Delegated Reg. (EU) 2016/161 (in force since 9 Feb 2019). [6, 7, 8]
• UK (post‑Brexit & Windsor Framework): From 1 Jan 2025, EU FMD safety features no longer apply in NI; MHRA expects ATDs to remain on UK medicine packs. [9, 10]
• EU (Tobacco, TPD): All unit packets must carry tamper‑proof security features (visible + invisible) and be traceable; 2019/2024 milestones. [31, 32]
• Security printing management: ISO 14298:2021 + Amd 1:2024 (auditable controls for security printers). [3, 4]
• Authentication selection/evaluation: ISO 12931 & ISO 22383 performance criteria and evaluation methodology grounded in risk. [1]
• Barcode & serialization print quality: GS1 DataMatrix Guideline + GS1 General Specifications; verify to ISO/IEC 15415 with grade ≥ 1.5 (C). [17, 18, 19]

• US: 21 CFR 211.132 (OTC TE); 21 CFR 700.25 (cosmetics TRP); 21 CFR 800.12 (contact‑lens); related guidance/CPG documents. [11, 12, 13, 14, 15, 16]
• EU: Delegated Reg. (EU) 2016/161 applied since 9 Feb 2019; TPD security features with 2019/2024 milestones. [6, 31, 32]
• UK: From 1 Jan 2025: FMD safety features disapplied in NI; MHRA expects ATD retained. [9, 10]

• UK medicines: implementation of Windsor Framework expectations through 2025; monitor MHRA updates. [9, 10]
• US DSCSA: stabilization period communications around enhanced system interoperability; watch 2025 enforcement posture. [23]

• ISO 12931/22383: Choose and evaluate authentication solutions via risk‑based criteria and effectiveness assessment. [1]
• ISO 14298: Control the security printer/converter environment. [3, 4]
• EN ISO 21976: TE feature categories and verification concepts for medicinal packaging. [5]
• GS1/ISO/IEC: Barcode design/verification thresholds that impact field readability and traceability. [17, 18]
• Central bank exemplars: Overt/covert feature design patterns (microprinting, UV, color‑shifting). [5, 24]

• Overt: Shrink band, break‑band cap, induction liner tab, TE label that fractures or displays VOID on lift; optically variable/holographic foil patch on high‑risk items. [5]
• Covert: UV‑fluorescent inks, microtext lines/halos in artwork (magnifier required). [24]
• Forensic: Taggants or lab‑verifiable markers with chain‑of‑custody controls (specify assay). [1]
• Digital: Serialized UI tied to repository; device/app‑based verification; anomaly detection in returns. [23]

Design matters: font engineering, stroke shapes, line orientation, and placement resist re‑origination. For packaging processes, specify process‑appropriate microtext or micro‑patterns/linework that survive plate gain/dot spread. Evidence gap: robust, peer‑reviewed, process‑by‑process minimum readable sizes for packaging substrates are sparse; rely on converter guides and trials. [25, 26, 27]

• OECD/EUIPO show a substantial share of world trade in counterfeits → layered authentication and monitoring are justified. [21, 22]
• WCO illicit trade reporting highlights cross‑border seizure trends (methodology differs from OECD/EUIPO macro estimates). [22]

• Never claim tamper‑proof. Use FDA/EU terms; include required consumer‑facing statements (US) prominently (outside peel‑backs). [12]
• Make evidence unmissable. Indicators should break/delaminate/visibly deform with low force yet survive distribution handling. (US cosmetics rule requires TE feature remain intact through manufacturing, distribution, retail display.) [14]
• Layer features. Combine overt + covert + digital; select to ISO 12931/22383 criteria. [1]
• Design for your print process. Microtext/micro‑artwork: favor positive text, avoid reverse microtext on coarse processes; use diagonal/curved placements and layered linework. Security inks/OVD: plan inspection tools for QA. [25, 26]
• Barcodes. Pick X early, protect quiet zones in dielines, and specify ≥ 1.5 grade acceptance. [17, 18]

• TE labels: Define minimum fracture force and adhesion windows; pretest on varnishes and low‑energy plastics (polyolefins); use vendor test methods (e.g., FINAT). [26, 27]
• Shrink bands: Guard against cap‑knurl damage; ensure perforation yields clear break.
• ATD on cartons: Perfs should not compromise ISTA transit performance; run both TE and transit tests.
• Security inks: Specify excitation/emission and luminance thresholds for UV features; define tooling for QC.
• Data & labels: Reserve quiet zones; avoid varnish/emboss over 2D codes.

• Security printers: restricted substrate/ink access, waste destruction, visitor control, job segregation, custody logs — per ISO 14298 (audit‑ready). [3]
• Clear acceptance criteria: barcode grades, TE break signatures (photos/video), microtext reference proofs, first‑article retention.
• Change control: any substrate/ink/plate change can degrade microfeatures or barcode grades; lock down via formal gates.

• Map regions & category (OTC drug, cosmetic, device, Rx); cite exact rule: 21 CFR 211.132/700.25/800.12; EU 2016/161; UK MHRA notice. [6, 9, 11, 12, 14, 15]
• Select TE/ATD category (EN ISO 21976) and define acceptance criteria (visible break, delam pattern). [5]
• Choose authentication set per ISO 12931/22383; classify features (overt/covert/forensic/digital). [1]
• Barcode spec: GS1 DataMatrix, X (start 0.254 mm), quiet zone ≥ 1×, ISO/IEC 15415 ≥ 1.5; lock HRI. [17, 18]
• Artwork: reserve quiet zones; micro‑art per Keesing guidance; avoid reverse microtext on coarse processes. [25]
• Label statements (US): place TE statement visible pre‑purchase (not hidden under peel‑back). [12]
• Trials: on‑press verification, drop/ISTA + TE integrity, UV/visual inspections, line‑clearance.

• A) Choose a TE device (carton vs. bottle): Regulated? → choose carton ATD (perf/TE label) or closure TE (break‑band, induction). Form factor: bottle/jar → break‑band or shrink band; carton → TE label or designed‑to‑break lid. Retail reuse risk high? → add covert (UV in closure) + digital (serialization).
• B) Select micro‑security by process: Flexo/basic digital → micro‑patterns/guilloches, positive microtext ≥ printer capability; avoid reverse microtext; diagonal placements. Offset/intaglio → classic microtext, split‑fountain shifts, latent images. [25, 26]

• RFQ pack: Regions & category with citations; TE device type & acceptance criteria (photos/diagrams); authentication features by class + test methods; barcode spec (X, quiet zone, HRI, ISO/IEC 15415 grade); security printer controls (ISO 14298); change control & sample retention. [3, 17]
• Artwork schema: Layer names for TE, codes, micro‑art; quiet‑zone boxes; inspection target callouts (UV/micro).
• Suggested figures: Dieline quiet zones & TE keep‑outs; Decision trees; DataMatrix sizing nomogram; micro‑art placement; ISO 14298 process flow.

• US: liquid oral hygiene & vaginal products require TRP with labeling; favor shrink bands or frangible seals; statement visible pre‑purchase. [14]
• Add overt TE + covert UV micro‑pattern for refill‑prone SKUs.

No federal US TE mandate; practical TE includes button lids, shrink bands, induction seals—pair with digital lot traceability and covert tells at closures. Evidence gap: harmonized TE mandates for general foods across US/EU/UK.

• Break‑band closures provide strong cues; ensure band fragments cannot be reseated.
• High‑risk SKUs: add holo/OVD + covert taggant + app‑based serial checks (cf. EU tobacco security‑feature structure). [31]

• EU Rx: ATD + UI; use GS1 DataMatrix sized to pack; verify ISO/IEC 15415 grade on line. [6, 18]
• US OTC/cosmetics/device: align TE feature + consumer‑facing statement; document design intent and incoming inspections. [11, 12, 14, 15]

Problem: Category within 21 CFR 700.25; retailer returns flagged reseals. Approach: Perforated shrink band + induction liner tab; front‑panel TE statement; line QC for band integrity. Result: Return rate for opened units dropped; compliance audit passed (statement visible pre‑purchase). [12, 14]

Problem: Fit ATD + UI on tiny carton without occluding brand panels. Approach: GS1 DataMatrix with X = 0.254 mm, 1× quiet zones; TE label over tuck‑flap (21976 type) with covert UV tick; verification to ISO/IEC 15415. Result: Repeated ≥ 1.5 grades on line; pharmacy scans successful; ATD break unambiguous. [5, 6, 18]

Problem: Refills in empty branded bottles. Approach: Break‑band cap + holographic neck‑label with serialized QR and covert UV micro‑pattern. Result: Channel audits show reduced refill incidents; higher perceived authenticity. [31]