Inclusive Design for Packaging

1. Executive Summary

Top insights (what actually governs accessible packs)

“Easy-open” has a formal, testable standard. ISO 17480 defines accessible design for ease of opening across reclosable/non‑reclosable packs, covering opening location/methods and both instrumented and user‑based evaluation. It stops short of prescribing torque/force limits—so you must pair it with user studies and product‑specific benchmarks. [1, 2]
Tactile cues split into safety vs. identification.EU chemical/CLP regimes and ISO 11683 require/define tactile warnings of danger on hazardous packs; EU/UK medicines require Braille on outer packs via Directive 2001/83/EC Article 56a implemented through ISO 17351. [3,4, 5]
High‑contrast text isn’t mandated for all packaging—but WCAG ratios (4.5:1 normal, 3:1 large) are the most defensible baseline for legibility guidance and internal standards, complemented by sector rules for minimum font sizes (e.g., EU FIC x‑height ≥ 1.2 mm; US OTC Drug Facts ≥ 6 pt/8 pt headings). [6,7, 8]
Easy‑open must coexist with child‑resistance and tamper‑evidence where applicable. US PPPA requires CR performance (85/80% child effectiveness + 90% senior‑adult usability) and FDA 21 CFR 211.132 mandates tamper‑evident packaging for OTC drugs. EU Rx medicines require an anti‑tamper device under Delegated Reg. (EU) 2016/161. [9, 10]
Digital accessibility is moving fast. GS1 Digital Link and 2D barcodes are proliferating; UK/EU brands are deploying NaviLens for low‑vision shoppers (Kellogg’s, Pringles). Maintain barcode/quiet‑zone integrity and provide accessible, screen‑reader‑ ready content at the link target. [11,12, 13,14]
Recyclability guardrails matter when adding tactile/extra labels. APR Design® Guidance flags pressure‑sensitive label materials/adhesives and full‑sleeves as frequent PET/HDPE pitfalls—select APR‑recognized options to avoid contaminating streams. [15, 16]

Immediate actions (for design teams)

Bake ISO 17480 checkpoints into DFM gates; test with representative users alongside instrumented force/torque measures. [1]
Set an internal contrast minimum: WCAG 2.2 SC 1.4.3 (4.5:1/3:1) plus EU/US font‑size minima where applicable. [6, 7,8]
Add a tactile cues matrix per SKU: hazard triangle (ISO 11683/CLP), Braille (ISO 17351/EU/UK Rx), product‑ID embossing or notches for differentiation. [3,5]
Protect barcode and 2D codes: maintain GS1 module size/quiet zones; verify print quality to ISO/IEC 15416/15415. [17, 18]
Run a recyclability check on any added sleeves/PS labels/adhesives against APR’s Critical Guidance. [16]

12–24‑month watchlist

EU PPWR entered into force 11 Feb 2025; general application from 12 Aug 2026—expect implementing acts impacting design‑for‑recycling and labeling. [19]
UK EPR labeling: policy timings have shifted; current communications push mandatory consumer recycling labelling to 2027 while details are refined—track DEFRA updates. [20]
2D migration (GS1): more omnichannel and accessibility use‑cases; plan artwork and structure to accommodate GS1 QR/DataMatrix with proper quiet zones. [17]

2. Definitions & Concepts

High contrast. Visual contrast between foreground text/symbols and background measured as a ratio; WCAG AA targets ≥ 4.5:1 for normal text and ≥ 3:1for large text. [21]
Tactile cues. Deliberate physical features that communicate by touch: (i) safety (tactile warning of danger triangle) per ISO 11683/CLP; (ii) identification (Braille for Rx medicines in EU/UK via ISO 17351). [3, 5]
Easy‑open. Design of opening method/location/force that accommodates a wide user range without tools; validated via ISO 17480 instrumented tests and user panels. [1]
Digital accessibility on pack. Machine‑readable codes (GS1 Digital Link, GS1 DataMatrix/QR, NaviLens) that enable assistive tech to obtain product information. [11, 13]

Concept map (bullet view)

Accessibility goals → (Perception) Contrast & type → (Action) Grip/force/open path → (Safety) CR & tamper → (Comms) Braille/tactile/2D codes → (Operations) Barcode printability → (Sustainability) APR‑compatible labels.

3. Standards, Regulations, and Governance (US • EU • UK)

Cross‑cutting standards

ISO 17480 Accessible design—Ease of opening(requirements + test methods). [1]
ISO 11683 Tactile warnings of danger (safety triangle geometry/placement for hazardous packs). [22]
ISO 17351 Braille on packaging for medicinal products(application rules incl. dot characteristics). [23]
ISO/IEC 15416 & 15415 Barcode print quality; enforced via GS1 General Specifications. [18, 24]
WCAG 2.2 Contrast guidance (defensible baseline for physical legibility policies). [6]

United States (selected, binding)

PPPA: Child‑Resistant Packaging—effectiveness specs and testing (85%/80% child; 90% senior‑adult usability). 16 CFR 1700.15 & 1700.20. [9]
OTC Drug Facts format: type sizes (e.g., body ≥ 6 pt; headings ≥ 8 pt) per 21 CFR 201.66 + FDA guidance. [8, 25]
Tamper‑evident (OTC): 21 CFR 211.132 (indicator/barrier + on‑pack statement). [11]

European Union (selected, binding)

Food info: EU FIC Reg. 1169/2011—legibility and minimum x‑height 1.2 mm (0.9 mm on small packs). [7]
Medicines: Directive 2001/83/EC Article 56a—Braille mandatory on packaging; Delegated Reg. 2016/161—anti‑tamper device + unique identifier(2D code). [4, 26]
Hazardous chemicals: CLP requires tactile warnings where relevant; national HSE guidance details GB implementation. [3]
PPWR: in force 11 Feb 2025; general application 12 Aug 2026(design‑for‑recycling, labeling updates forthcoming). [19]

United Kingdom

Medicines: UK retains Braille requirement via EU‑derived law/standards adoption (BS EN ISO 17351). [5]
Recycling labeling under EPR: government communications currently point to 2027 for mandatory consumer labeling after deferrals—monitor DEFRA updates. [20]
OPRL program guidance (widely used): minimum 6 pt text for labels; reversed/mono options for dark backgrounds. [27,28]

Topic	US	EU	UK
Braille on medicines	Not federally required on packs	Mandatory (Art. 56a)	Mandatory (retained; BS EN ISO 17351)
Tamper‑evident (OTC)	Required (21 CFR 211.132)	Rx safety features (UID + ATD) (2016/161)	Mirrors EU for Rx medicines (ATD)
Child‑resistance	PPPA with 90% senior usability	ISO 8317 often referenced nationally	Largely aligns with EU/ISO
Food label legibility	General “prominence” rules; OTC has sizes	x‑height ≥ 1.2 mm (FIC)	Mirrors EU FIC in practice
Recycling labels	No federal mandate; How2Recycle voluntary	PPWR incoming acts	EPR labelling deferred to 2027 (watch)

Known upcoming changes

PPWR delegated/implementing acts may tighten DfR criteria affecting inks/labels/sleeves; track Commission publications through 2026. [29]

4. Evidence Base & Benchmarks

ISO 17480: prescribes how to evaluate (instrumented + user studies); does not set fixed torque/force thresholds. [2]
Jar torque demand: studies report 4.1–10.2 N·m for vacuum‑sealed jars (real‑world range), which exceeds many older adults’ capacity. [30]
Older adults’ capacity: recent normative data show maxima roughly 0.33–1.57 N·m in the oldest cohorts, reinforcing the gap between demand and ability. [31]
Design/QA heuristic (industry): removal torque ≈ 40–60% of application torque (closure engineering rule‑of‑thumb; validate per product). [32]
Contrast: WCAG AA ≥ 4.5:1 (normal) and ≥ 3:1 (large). [21]
Regulated sizes: EU FIC x‑height ≥ 1.2 mm(0.9 mm small packs); US OTC ≥ 6 pt body and ≥ 8 pt headings. [7,8]
Braille: ISO 17351 specifies application on medicine packs (EU/UK). (Dot height/spacing targets exist—confirm with supplier against ISO drawing tolerances.) [23]
Hazard tactile: ISO 11683 defines triangle for dangerous substances; EU/GB CLP requires TWD where applicable. [22]
Barcodes & 2D codes: verify linear to ISO/IEC 15416, 2D to ISO/IEC 15415 per GS1 General Specifications. [18, 24]
Quiet zones: GS1 DataMatrix 1× module; GS1 QR 4× modules. [12]

Evidence gap: No single, cross‑category “openability limit” exists. To resolve, collect force/torque distributions for target users on the actual pack/closure system, and correlate with ISO 17480 instrumented tests.

5. Design & Production Implications

Rules of thumb (with sources)

Type & contrast. Use ≥ 4.5:1contrast for normal text, ≥ 3:1 for large text; meet EU x‑height ≥ 1.2 mm and US OTC sizes where applicable. [21, 7,8]
Opening features. Prefer large tabs, generous undercuts, and guided tear paths; validate with ISO 17480 user studies (don’t rely on lab force alone). [1]
Child‑resistance interplay. If CR is required, design for PPPA adult usability (90% senior) while keeping child effectiveness; co‑develop closure geometry and instructions. [10]
Tactile marking. If hazardous: add ISO 11683 triangle. For EU/UK medicines: implement ISO 17351 Braille (name, form/strength as required). [22,4]
Codes. Reserve barcode/2D quiet zones, avoid overprint/varnish flooding, and verify to ISO/IEC 15416/15415. [18]

Material & format trade‑offs (examples)

Embossing/Braille on cartons may increase caliper/board grade; check die‑pressure vs. fiber tear and ensure APR‑compatible label materials on plastics. [16]
Full‑body sleeves can impair sortation (PET/HDPE): use APR‑recognized sleeves/inks or perforate for removal. [16]

Manufacturability flags

Torque windows drift with closure relaxation; confirm 24‑h removal torque vs. application torque (40–60%) during line trials. [32]
NaviLens/GS1 2D: maintain uninterrupted quiet zones; avoid emboss/deboss through code areas; position for both shelf scanning and in‑home use. [12]

Supplier perspective—what they’ll ask for

Target user profiles and acceptance criteria(e.g., % of seniors able to open within X s). (Tie to ISO 17480 + PPPA where relevant.) [1,10]
Closure finish/liner specs; target application/removal torque windows and test plan. [32]
Barcode symbol spec (symbology, magnification, quiet zones, ISO/IEC verification grade). [18]

6. Sustainability & Compliance Considerations

Recyclability impacts of tactile/labels. Use APR‑recognized pressure‑sensitive label materials/adhesives and sleeves to avoid PET/HDPE contamination; test against APR Critical Guidance if in doubt. [16]
Consumer recycling labeling. In the UK, OPRL artwork guidance enforces minimum 6 pt label text; statutory EPR labelling timelines currently point to 2027 (watch for updates). [27,20]
PPWR (EU). Expect design‑for‑recycling criteria and labeling refinements via implementing acts through 2026. [19, 29]

Claims risk tip: When referencing accessibility features (e.g., “easy‑open”), substantiate with ISO 17480user test data; avoid absolute claims (“accessible to all”). [1]

7. Workflow & Tooling (ready to adapt into PDA tools)

Checklists (extracts)

Print‑ready accessibility: meet font/x‑height rules; verify contrast; reserve quiet zones; place tactile marks and Braille per standard drawings; add tamper‑evident statement if required. [7, 21,18, 23,11]
Pre‑press: barcode verification to ISO/IEC grades; proof 2D/NaviLens placement; test reversed/mono OPRL variants on dark substrates. [18,28]
Compliance: assemble PPPA/ISO 17480 test reports; EU/UK Braille approvals; CLP tactile applicability check. [10, 1,4, 3]

Decision trees (examples)

Choose tactile cue: Hazard present? → ISO 11683 triangle (EU/GB CLP). Medicine in EU/UK? → ISO 17351 Braille. Otherwise: brand tactile (notches, emboss) + digital link. [22, 23]
Select opening method: Need CR? → co‑design with PPPA tests; else follow ISO 17480 ergonomics; if seniors struggle in pilot ⇒ increase tab area / reduce removal torque / alter tear path. [10, 1]

Calculator blueprints

Contrast checker: implement WCAG formula; require ≥ 4.5:1 normal, ≥ 3:1 large. [21]
Torque window estimator: choose target Xth percentile of older‑adult torque (e.g., 10th–20th) from literature/user tests; set removal torque below that percentile with safety margin; validate shelf‑life drift at 24 h/1 w. [31, 32]

Template specs (RFQ extract)

Opening method; initial & 24‑h removal torque (mean/σ); ISO 17480 plan; Braille artwork & emboss depth; ISO/IEC barcode grade target; APR label materials; OPRL variant. [1,18, 16,27]

8. Category‑Specific Guidance (Food • Beauty • Beverage)

Food

Prioritize legible nutrition/allergen info (EU FIC x‑height), clear opening cues for pouches (starter notch + tear path visibility), and ensure tamper cues (rings, bands) don’t defeat openability. [7]

Beauty/Personal care

Differentiate shampoo/conditioner by tactile features (embossed ribs/dimples) and strong contrast on small radiused bottles; watch label/sleeve recyclability per APR. [16]

Beverage

For tethered caps and short hoppers, validate opening forces with seniors (DIN/ISO studies reference ISO 17480 methodology). [33]

9. Case Studies

1) NaviLens on cereals & snacks

RNIB + Kellogg’s trial (2020) led to broader UK/EU rollout and US adoption; now extending to Pringles. Key takeaways: reserve code space; pair with accessible web content; do not compromise GS1 identifiers. [13,34, 14]

2) EU Rx medicines

Braille (Art. 56a + ISO 17351) and anti‑tamper + UID (2016/161) coexist with high‑contrast outer packs. Practice: integrate Braille early in dielines to hit dot height; protect 2D code quiet zones. [4, 23,26]

3) OTC drugs (US)

Tamper‑evident statements (21 CFR 211.132) and standardized Drug Facts format (type sizes) can be delivered with clear tear bands or peelable lidding that still meets easy‑open expectations when ISO 17480 methods guide design. [11, 1]

10. Common Pitfalls & Red Flags

Over‑reliance on lab force data without user testing(fails ISO 17480 intent). [1]
Placing emboss/Braille through barcode quiet zones(verification failures). [18]
Adding sleeves/labels that kill recyclability(APR‑incompatible substrates/adhesives). [16]
“Accessible” claims without test evidence (risk). [1]
Illegible micro‑type on obligatory info (violates EU FIC or US OTC specs). [7, 8]